(70 days)
Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:
Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.
Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).
Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.
An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
The provided text does not contain a table of acceptance criteria or specific performance metrics of the device as would typically be found in a formal study. Instead, it describes a 510(k) Premarket Notification for the Veritas® Collagen Matrix, which asserts substantial equivalence to previously marketed predicate devices.
However, based on the provided text, we can infer some information relevant to the "acceptance criteria" through the lens of a substantial equivalence determination and the single study mentioned.
Here's an attempt to structure the information based on your request, highlighting what is present and what is not:
Acceptance Criteria and Device Performance for Veritas® Collagen Matrix
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Intended Use/Predicate Equivalence) | Reported Device Performance (Summary from Study) |
|---|---|
| Substantial equivalence in technological characteristics and intended use to predicate device(s) (Veritas® Collagen Matrix K002233, K030879, K040119, and others). | Stated to be substantially equivalent. The device is acting as its own predicate for previous uses in terms of testing and technological characteristics. |
| New Indication: Minimize tissue attachment to the device in case of direct contact with viscera. (This is the specific new indication for which a study was conducted.) | An animal study concluded that "Veritas® Collagen Matrix demonstrates minimal tissue attachment to the viscera when compared to a named predicate." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The text only states "An animal study was conducted."
- Data Provenance: The study was an "animal study," implying pre-clinical data (not human clinical data). The location/country of origin is not specified. It is inherently prospective as it was conducted for this specific submission to evaluate the new indication.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not provided. As an animal study for a pre-market notification, the "ground truth" would likely be established by the researchers/veterinarians involved in the study, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided. Given that it's an animal study assessing physical characteristics (tissue attachment), formal adjudication methods like 2+1 or 3+1 are typically not applicable in the same way they would be for image-based diagnostic studies. The evaluation method would be part of the individual study's protocol.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The study described is an animal study, not a human clinical trial involving multiple readers. Therefore, there is no effect size of human readers improving with AI assistance vs. without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This document describes a physical medical device (surgical mesh), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The "standalone" performance here would refer to the device's functional characteristics in the animal model.
7. Type of Ground Truth Used
- The ground truth for the animal study (regarding tissue attachment) would be based on direct observation and histopathological analysis (implied) of the animal tissues post-implantation, assessing the degree of attachment. This would fall under direct scientific observation and potentially pathology.
8. Sample Size for the Training Set
- Not applicable/Not provided. This is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design based on prior knowledge and predicate devices.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no training set for an AI algorithm. For the development of the device itself (manufacturing, processing), ground truth is established through extensive material science testing, bio-compatibility studies, and prior pre-clinical/clinical data from its own previous iterations and predicate devices, ensuring it meets specified material properties and safety profiles. The specific animal study discussed was for a new indication, not for the fundamental development/training of the device itself.
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Veritas® Collagen Matrix
3.0 SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted by | Synovis Surgical Innovations2575 University Ave. W.St. Paul, MN 55114Tel: 651-796-7300Fax: 651-642-9018 | DEC - 6 2006 |
|---|---|---|
| Contact Person | Cynthia LamarucciolaAt address above | |
| Device Trade Name: | Veritas® Collagen Matrix | |
| Common Name | Surgical Mesh | |
| Classification Name | Mesh, Surgical878.3300 | |
| Predicate devices | Veritas® Collagen Matrix K002233, K030879 and K040119Synovis Surgical Innovations (Acting as its own predicate.)PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955GORE-TEX® Dualmesh® Biomaterial, K992189Genzyme Serpramesh™ IP, K040868 | |
| Device Description | An implantable surgical patch comprised of non-crosslinkedbovine pericardium. Veritas® Collagen Matrix undergoesproprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacementof the device with host tissue, or remodeling. |
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| Statement ofIntended use | Veritas Collagen Matrix is intended for use as an implant for thesurgical repair of soft tissue deficiencies, this includes but is notlimited to the following: |
|---|---|
| Buttressing and reinforcing staple lines during lungresection (e.g., wedge resection, blebectomy, lobectomy,bullectomy, bronchial resection, segmentectomy,pneumonectomy / pneumectomy, pneumoreduction) andother incisions and excision of the lung and bronchus. | |
| Reinforcement of the gastric staple line during the bariatricsurgical procedures of gastric bypass and gastric banding. | |
| Abdominal and thoracic wall repair, muscle flapreinforcement, rectal and vaginal prolapse repair, urinaryincontinence treatment, reconstruction of the pelvic floor,and repair of hernias (e.g., diaphragmatic, femoral,incisional, inguinal, lumbar, paracolostomy, scrotal,umbilical). | |
| Veritas Collagen Matrix minimizes tissue attachment tothe device in case of direct contact with viscera. | |
| TechnologicalComparisons | Veritas Collagen Matrix is acting as its own predicate and istherefore substantially equivalent, having the same technologicalcharacteristics and intended use with the exception of theadditional intended use, which is the subject of this submission. |
| Technology/DeviceTesting | Veritas Collagen Matrix is acting as its own predicate and istherefore substantially equivalent in terms of testing. |
| Indication Testing | An animal study was conducted, specific to the subject of thissubmission. The study concluded that Veritas ® Collagen Matrixdemonstrates minimal tissue attachment to the viscera whencompared to a named predicate. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines and two stylized feet.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Synovis Surgical Innovations % Ms. Cynthia Lamarucciola Regulatory Affairs Manager 2575 University Avenue, West St. Paul, Minnesota 55114-1024
May 2, 2013
Re: K062915
Trade/Device Name: Veritas® Collagen Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXE, OXB, PAJ Dated: October 31, 2006 Received: November 2, 2006
Dear Ms. Lamarucciola:
This letter corrects our substantially equivalent letter of December 6, 2006.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Cynthia Lamarucciola
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K062915 510(k) Number (if known):
Device Name:
Veritas Collagen Matrix
Indications For Use:
Vertas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:
Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.
Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).
Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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 Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K962915
§ 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.