(128 days)
Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Veritas Dry is intended to be used as a staple line buttress. Veritas Dry is composed of dehydrated non-crosslinked bovine pericardium, to facilitate easy loading of the pericardium strips onto the stapler forks, an anvil and a cartridge strip are secured in a mounting unit. One mounting unit is used for each stapler firing. Each Veritas Dry unit is provided sterile in a double pouch.
The provided text is a 510(k) summary for a medical device (Veritas Dry Collagen Matrix) and the associated FDA approval letter. This type of document is for premarket notification of a device claiming substantial equivalence to a predicate device, not for a de novo marketing authorization or a PMA. As such, it does not involve the kind of clinical study with acceptance criteria, ground truth establishment, or AI performance metrics that your request is looking for.
Instead, the submission focuses on demonstrating substantial equivalence to already approved devices. This is typically done through:
- Comparison of technological characteristics: Showing that the new device has similar materials, design, and intended use as the predicate devices.
- Performance testing: Conducting non-clinical (e.g., mechanical, biocompatibility) tests to demonstrate that the device performs as safely and effectively as the predicate devices.
Therefore, many of the requested fields are not applicable to this type of regulatory submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This document doesn't define explicit "acceptance criteria" for clinical performance that would be met by a study with human participants or a machine learning algorithm.
- Implied Acceptance Criteria: The implicit acceptance criterion for a 510(k) is "substantial equivalence" to the predicate devices in terms of safety and effectiveness.
- Reported Device Performance (as stated in the document):
- "Veritas Dry is substantially equivalent to the predicate devices, having equivalent technological characteristics and indications for use."
- "Veritas Dry is substantially equivalent to the predicate devices in terms of physical characteristics and test results."
- The "testing" mentioned would be non-clinical performance tests (e.g., mechanical strength, biocompatibility), not clinical efficacy or diagnostic accuracy. Specific quantitative results of these tests and their acceptance criteria are not provided in this summary but would have been part of the full 510(k) submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a clinical study on human subjects or an AI model evaluation. The "test sets" would refer to samples used for non-clinical performance testing of the material itself. The specific sample sizes for these tests are not disclosed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth in the context of expert consensus is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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
- Not Applicable. This is a surgical mesh, not a diagnostic imaging AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the clinical sense. For non-clinical performance testing, the "ground truth" would be established by validated test methods and established material science standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there's no training set.
9. How the ground truth for the training set was established
- Not Applicable.
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OCT 2 7 2004
K041661
| 510(k) SUMMARY | 1/2 |
|---|---|
| Submitted by: | Synovis Surgical Innovations |
| 2575 University Ave. W. | |
| St. Paul, MN 55114-1024 | |
| Tel: (651) 796-7300 | |
| Fax: (651) 642-9018 | |
| Contact Person: | James Jenkins |
| Tel: (651) 796-7368 | |
| Fax: (651) 796-7468 | |
| Device Trade Name: | To Be Determined |
| Common Name: | Surgical Mesh |
| Classification Name: | Mesh, Surgical |
| 878.3300 | |
| Predicate devices: | Veritas® Collagen Matrix, K030879 |
| Synovis Surgical Innovations | |
| Peri-Strips Dry (PSD), K040415 | |
| Synovis Surgical Innovations | |
| Device Description: | Veritas Dry is intended to be used as a staple line buttress. Veritas Dry iscomposed of dehydrated non-crosslinked bovine pericardium, to facilitateeasy loading of the pericardium strips onto the stapler forks, an anvil and acartridge strip are secured in a mounting unit. One mounting unit is used foreach stapler firing. Each Veritas Dry unit is provided sterile in a doublepouch. |
| Statement ofIntended use: | Veritas Dry Staple Line Reinforcement is intended for use as a prosthesisfor the surgical repair of soft tissue deficiencies using surgical staplerswhen staple line reinforcement is needed. |
| Veritas Dry can be used for reinforcement of staple lines during lung andbronchus resections and during bariatric surgical procedures. | |
| Veritas Dry can be used for reinforcement of staple lines during gastric,small bowel, mesentery, colon, and colorectal procedures. | |
| Veritas Dry is intended to be used for reinforcement of suture-lines andstaple-lines (for example: occlusion of the left atrial appendage duringopen chest procedures) during cardiac surgery. |
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KO41669 i eritas Dr 2/2 Tcchnological Ventas Dry is substantially equivalent to the predicate devices. having Comparisons: equivalent technological characteristics and indications for use. Testing: Veritas Dry is substantially equivalent to the predicate devices in terms of physical characteristics and test results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 2004
Mr. James Jenkins Regulatory Specialist Synovis Surgical Innovations 2575 University Avenue West St. Paul, Minnesota 55114
Re: K041669
Trade/Device Name: Veritas Dry Collagen Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 10, 2004 Received: September 14, 2004
Dear Mr. Jenkins:
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 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.
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Page 2 - Mr. James Jenkins
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K041669 510(k) Number (if known):
Device Name:
Veritas Dry Collagen Matrix
Indications For Use:
Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
| Prescription Use(Part 21 CFR 801 Subpart D) | |
|---|---|
| AND/OR | Over-The-Counter Use(21 CFR 807 Subpart C) |
miriam C. Provost
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Concurrence of CDHR, Office of Device Evaluation (ODE)
| 510(k) Number | K041669 |
|---|---|
| --------------- | --------- |
P9
Confidential & Proprietary
§ 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.