(128 days)
Not Found
No
The 510(k) summary describes a physical staple line reinforcement device made of bovine pericardium. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device is intended for the surgical repair of soft tissue deficiencies and reinforcement of staple lines during various surgical procedures, which are therapeutic interventions.
No
The device is described as a prosthesis for surgical repair, specifically for reinforcing staple lines, rather than for diagnosing conditions. Its intended use is to buttress tissue during surgery, not to identify or monitor diseases or conditions.
No
The device description explicitly states it is composed of dehydrated non-crosslinked bovine pericardium and is provided as a physical, sterile unit for surgical use. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Veritas Dry Function: Veritas Dry is a surgical implant used inside the body during surgical procedures to reinforce staple lines. It is a physical prosthesis for tissue repair.
- Intended Use: The intended use clearly describes its application in surgical procedures for reinforcing staple lines in various anatomical locations. It does not mention any testing of biological samples.
- Device Description: The description details its composition and how it's used with surgical staplers, all within the context of a surgical procedure.
Therefore, Veritas Dry falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
FTM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, lung, bronchus, gastric, small bowel, mesentery, colon, colorectal, left atrial appendage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Veritas® Collagen Matrix, K030879, Peri-Strips Dry (PSD), K040415
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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. | |
| Statement of | |
| 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. |
1
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.
2
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.
3
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
4
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