Technical Characteristics and Performance Parameters
Among other aspects, the document addresses the matters related to the technical characteristics and performance parameters of the devices covered by the scope of the guidance and describes the way they should be reflected in labeling. According to the guidance, the following details should be provided:
- List of staples with which the stapler has been demonstrated to be compatible. First of all, the labeling should identify the staples the device is compatible with, provided such compatibility has been duly checked by the medical device manufacturer. However, there is no need to provide an exhaustive list – it would be sufficient to indicate at least one model. Moreover, such a list should not be treated as something preventing from using other devices, for which compatibility has been checked separately.
- Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device. In terms of the most important technical characteristics, the guidance provides a list of particular aspects to be covered, namely:
- Maximum and minimum tissue thickness that can be comfortably compressed for each staple type based on their open and closed staple heights;
- Angle(s) of articulation (manufacturers should consider the use of diagrams to illustrate angles of articulation when possible);
- Cartridge size;
- Maximum number of consecutive firings the stapler can perform;
- Staple line reinforcement products with which the stapler is compatible (or include a statement if no evaluation with staple line reinforcing materials has been completed).
- Information regarding issues on which the stapler is intended to be used. The manufacturer should provide some examples of types of tissues the device could be used for.
- Identification of safety mechanisms of the stapler. The manufacturer should also indicate whether the device has any control intended to ensure it would not be used, should the tissue thickness be outside the range the device is initially intended to be used for.
- Package labels must indicate critical information and technical characteristics necessary for proper device selection. According to the guidance, the manufacturer should ensure all important information regarding the way the device should be used is duly communicated to its users. As it is stated by the FDA, the information to be included in the labeling should be sufficient to ensure the use of the device safely and efficiently. The particular scope of information to be provided would depend on the type of the device and its specific features. To assist medical device manufacturers with complying with the point above, the guidance provides lists of points to be covered in case of (1) manual and powered linear cutting staplers for open/endoscopic surgery, and transverse approximation non-cutting open staplers; (2) manual and powered circular staplers for open/endoscopic surgery. Apart from device-specific requirements, the document also highlights the general rules to be considered about the information to be included in the package label. According to the guidance, this information should contain the details about:
- Cartridge color(s) and corresponding open and closed staple height(s) and intended tissues for approximation,
- Number of staple rows per cartridge,
- Models of staplers (e.g., identified by manufacturer, trade name, model number) with which the staple has been demonstrated to be compatible.
The document also contains an appendix that provides several examples of package labels and outlines the scope of information to be included there in terms of technical characteristics and performance parameters for surgical staplers and staples for internal use.
In terms of regulatory requirements to be applied about surgical staplers for internal use, the document refers to 21 CFR 878.4740 and the respective FDA’s Final Order “General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers”. It is also important to mention that the authority expects medical device manufacturers to implement the changes described in the guidance no later than 180 days from the date the guidance has been published.
In cases of changes to medical devices already placed on the market, the manufacturer should evaluate such changes to determine their regulatory status and identify the actions to be taken to ensure compliance with the respective regulatory requirements in the sphere of change control. In this regard, the authority also refers to the guidance document “Deciding When to Submit a 510(k) for a Change to an Existing Device”.
Class I Software Medical Devices
Class I is the lowest class under the applicable classification system and applies to the devices with the lowest risk associated thereto. Hence, the applicable regulatory controls are quite low as well. In the case of software-based medical devices, this class applies for the devices that are:
- Intended to monitor the state or progression of a disease;
- Providing information that does not indicate if an individual may be in danger;
- Associated with a low public health risk.
Class IIa Software Medical Devices
This category applies to medical devices associated with medium risk. An example provided by the TGA describes diabetes diagnosis software that is intended to be used by a healthcare professional. Thus, such a product is a Class IIa medical device as the device provides information to a relevant health professional to inform the diagnosis of a serious disease. This category also covers risk prediction software, as well as the tools that record data from a patient monitor or images directly from an MRI scanner (provided that such software does not impact the operations of a scanner itself).
Class IIb Software Medical Devices
This category applies to medical devices associated with medium-high risk. For instance, such classification should be applied to a product that is intended to analyze a cardiac MRI in order to provide information used in making diagnoses of related diseases. As in the previous example, the software is intended to provide information to healthcare professionals only. As described in the guidance, Class IIb applies to medical software that is intended by the manufacturer (the software developer) to provide information to a relevant health professional to inform the diagnosis of a serious disease. Other examples of Class IIb products include tools intended to be used to diagnose an acute arterial occlusion due to the severity of potential consequences of this disease if the necessary treatment is not applied. This category also covers software products that are intended to provide recommendations for treatment or intervention on the basis of input data (e.g., a coronary angiogram). As in the previous cases, such software should be used only by healthcare professionals. Consequently, a Class IIb software-based medical device is the one that is intended to:
- Recommend a treatment or intervention to a relevant health professional for the purposes of making a decision about the treatment or intervention; and
- Be used in cases when the absence of a treatment or a treatment itself could result in severe health deterioration or other adverse consequences.
The same classification applies to wearable devices intended to collect and analyze data for screening for serious heart diseases, as well as questionnaire apps intended to analyze the information provided by a patient and provide a diagnostic output.
Package Labels: Examples
As it was mentioned before, the FDA guidance on surgical staplers and staples for internal use contains an appendix that provides some examples of labeling to assist medical device manufacturers in interpreting the applicable regulatory requirements and following the recommendations provided in the guidance. In particular, the appendix provides device-specific requirements and highlights the most important aspects to be considered.
According to the first example, a package label for an endoscopic linear cutting stapler should contain the following details:
- Cartridge color(s) and corresponding open and closed staple heights and intended tissues for approximation;
- Cartridge size;
- Shaft length;
- Tissue gap or distal jaw opening;
- Angle(s) of articulation;
- Total number of staple rows per cartridge;
- Staple pattern(s);
- Maximum number of reloads;
- Pre-fire compression type;
- Number of incremental firings (e.g., trigger actualizations) required to complete a staple line;
- Safety mechanism(s) for tissue thickness;
- Type of ready-to-fire indicator;
- Compatible trocar sizes.
In summary, the present FDA guidance provides additional clarifications and recommendations on labeling requirements in the context of surgical staplers and staples for internal use. The document highlights the most important aspects to be considered, especially the ones related to the scope of information to be provided in labeling.
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