(113 days)
The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as: - Lung resections . - Biopses . - Lobectomies - Gastric banding - Abdominal and thoracic wall repair
The PeriPatch Aegis is intended be used as a surgical patch reinforce surgical staples during material to stapling procedures. The PeriPatch Aegis device assembly consists of a strip of buttress material, a cartridge which mates the device to the endoscopic stapler, and finally a loader which assists the user to place the device on to the stapler.
The provided text does not contain detailed information regarding specific acceptance criteria, a comprehensive study report, or the associated performance metrics in the format requested. The document primarily describes the device, its intended use, and states that "Tissue functional testing was carried out in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh. The test results demonstrate suitable material properties for the indications of the device."
Therefore, I cannot populate the table or answer most of the specific questions.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail. The document generically states "suitable material properties for the indications of the device." | Not specified in detail. The document only states "test results demonstrate suitable material properties." Specific quantitative performance metrics (e.g., tensile strength, burst pressure, suture retention strength, biocompatibility, porosity, etc.) are not provided. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "Tissue functional testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the study described is "Tissue functional testing" which typically involves laboratory or bench testing of material properties, not human interpretation or a "ground truth" established by experts in the context of imaging or diagnostic devices.
4. Adjudication method for the test set:
- Not applicable as this is not a study involving human interpretation or clinical endpoints requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI-assisted diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a surgical mesh, not an algorithm.
7. The type of ground truth used:
- For "Tissue functional testing," the "ground truth" would be the established scientific and engineering standards and specifications for surgical mesh materials. These standards are typically based on material science, biomechanics, and ISO/ASTM guidelines for medical devices. The document references "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh," implying that the ground truth for performance assessment aligns with these regulatory and scientific guidelines.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning or AI device.
Summary of Study Information:
- Study Type: Tissue functional testing.
- Purpose: To demonstrate suitable material properties for the device's indications.
- Compliance: Conducted in accordance with "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."
- Conclusion: The test results demonstrate suitable material properties.
Missing Information:
The provided text lacks specific details on:
- The exact tests performed (e.g., tensile strength, burst strength, suture retention, biocompatibility).
- The specific quantitative acceptance criteria for each test.
- The quantitative results obtained for the PeriPatch Aegis.
- Sample sizes used for this testing.
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510(k) Summary of Safety & Effectiveness
Submitter:
PM Devices Inc. 13700 Mayfield Place, Unit 2135 Richmond, British Columbia V6V 2E4 Canada Phone: (604) 270-4344 Fax: (604) 270-4384
Contact Person: Tim Verspagen
Device Name: PeriPatch Aegis
Common Name: Surgical Mesh
Classification Name: Surgical Mesh (Product Code: FTM)
Predicate Devices:
- Peri-Strips Staple Line Reinforcement - Sleeve Configuration (K992537)
Device Description:
Intended Use:
Technological Comparison &
Performance Data:
The PeriPatch Aegis is intended be used as a surgical patch reinforce surgical staples during material to stapling procedures. The PeriPatch Aegis device assembly consists of a strip of buttress material, a cartridge which mates the device to the endoscopic stapler, and finally a loader which assists the user to place the device on to the stapler.
The PeriPatch Endo-Sleeve is intended for reinforcing staples and suture lines during a number of resection techniques surgical repair of tissue deficiencies such as:
- Lung resections .
- PeriPatch Sleeve (K033985)
- Biopses .
- Lobectomies .
- Gastric banding .
- Abdominal and thoracic wall repair
Tissue functional testing was carried out in accordance with the Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh. The test results demonstrate suitable material properties for the indications of the device.
The PeriPatch Aegis is substantially equivalent to the predicate devices as it has similar indications for use, similar materials and similar technological characteristics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PM Devices, Inc. % Mr. Tim Verspagen Regulatory Affairs Director 13700 Mayfield Place, Unit 2135 Richmond, British Columbia V6V 2E4 Canada
Re: K063556
Trade/Device Name: PeriPatch Aegis Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 23, 2007 Received: February 26, 2007
MAR 2 0 2007
Dear Mr. Verspagen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 -- Mr. Tim Verspagen
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Mark N. Mallery
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): K063556
Device Name: PeriPatch Aegis
Indications for Use:
The PeriPatch Aegis is intended for reinforcing staples and suture lines during a number of resection techniques - surgical repair of tissue deficiencies such as:
- Lung resections .
- Biopses .
- Lobectomies
- Gastric banding
- Abdominal and thoracic wall repair
Over-The-Counter Use _ X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative,and Neurological Devices | |
| 510(k) Number | 1063556 |
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.