VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD

K041669 · Synovis Surgical Innovations · FTM · Oct 27, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041669
• Device Name: VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
• Applicant: Synovis Surgical Innovations
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Veritas Dry is a surgical mesh prosthesis composed of dehydrated, non-crosslinked bovine pericardium. It functions as a staple line buttress to reinforce tissue during surgical procedures. The device is provided in a mounting unit that secures an anvil and cartridge strip, facilitating easy loading onto surgical stapler forks. One mounting unit is utilized per stapler firing. The device is used by surgeons in clinical settings (e.g., OR) to provide mechanical reinforcement to staple or suture lines, potentially reducing leakage or tissue trauma. It is supplied sterile in a double pouch.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Material: Dehydrated, non-crosslinked bovine pericardium. Form factor: Staple line buttress with mounting unit for stapler loading. Sterilization: Sterile. Class II device.

Indications for Use

Indicated for patients requiring soft tissue repair or staple/suture line reinforcement during lung, bronchus, bariatric, gastric, small bowel, mesenteric, colon, colorectal, and cardiac surgeries (e.g., left atrial appendage occlusion).

Regulatory Classification

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.

Predicate Devices

• Veritas® Collagen Matrix (K030879)
• Peri-Strips Dry (PSD) (K040415)

Submission Summary (Full Text)

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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: [phone] |
| | Fax: [phone] |
| Contact Person: | James Jenkins |
| | Tel: [phone] |
| | Fax: [phone] |
| 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 is<br>composed of dehydrated non-crosslinked bovine pericardium, to facilitate<br>easy loading of the pericardium strips onto the stapler forks, an anvil and a<br>cartridge strip are secured in a mounting unit. One mounting unit is used for<br>each stapler firing. Each Veritas Dry unit is provided sterile in a double<br>pouch. |
| Statement of<br>Intended use: | Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis<br>for the surgical repair of soft tissue deficiencies using surgical staplers<br>when staple line reinforcement is needed. |
| | Veritas Dry can be used for reinforcement of staple lines during lung and<br>bronchus resections and during bariatric surgical procedures. |
| | Veritas Dry can be used for reinforcement of staple lines during gastric,<br>small bowel, mesentery, colon, and colorectal procedures. |
| | Veritas Dry is intended to be used for reinforcement of suture-lines and<br>staple-lines (for example: occlusion of the left atrial appendage during<br>open 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 [phone]. 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 [phone] or [phone] 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<br>(Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:top;"><img height="5" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/w+Y0AIwYGBiYGBgYGBgYGBgYAAgwAAQy3j+sAAAAAElFTkSuQmCC" width="5"/></div> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| AND/OR | Over-The-Counter Use<br>(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