(43 days)
Not Found
No
The 510(k) summary describes a biological implant (collagen matrix) and its use as a surgical buttress. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The testing described focuses on the material properties and attachment method of the device.
No.
The device is described as a prosthesis for surgical repair and reinforcement of staple lines, which are direct surgical interventions rather than therapeutic treatments.
No
This device is described as an implantable surgical mesh used for the repair of soft tissue deficiencies and reinforcement of staple lines during various surgical procedures. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is an "implantable surgical mesh comprised of non-crosslinked bovine pericardium," which is a physical, hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the surgical repair of soft tissue deficiencies using surgical staplers. This is a surgical implant used in vivo (within the body) during a procedure.
- Device Description: The device is described as an implantable surgical mesh comprised of bovine pericardium. This is a physical implant, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical reinforcement and tissue remodeling in vivo.
Therefore, Veritas Collagen Matrix (Dry) is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Veritas Collagen Matrix (Dry) 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 Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example: occlusion of the left atrial appendage during open chest procedures).
Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
Veritas Collagen Matrix is an implantable surgical mesh comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is procured in the United States from cattle less than 30 months of age.
Veritas Collagen Matrix allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. Veritas Collagen Matrix also minimizes tissue attachment to the device in case of direct contact with viscera.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, lung, bronchus, gastric, bariatric, small bowel, mesentery, colon, colorectal, heart (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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
2.0 510(K) SUMMARY
Submitted by
| | 2575 University Avenue West
St. Paul, MN 55114-1024
Tel: 651-796-7300
Fax: 651-642-9018 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV 2 6 2008 |
| Contact Person | Jodi Jorgenson
At address above |
| Date Prepared | October 13, 2008 |
| Device Trade Name: | Veritas® Collagen Matrix (Dry)
Marketed as Peri-Strips Dry® with Veritas® Collagen Matrix. |
| Common Name | Surgical Mesh |
| Classification Name | Mesh, Surgical
21 CFR 878.3300
Product Code: FTM |
| Predicate devices | Veritas® Collagen Matrix (Dry) K041669 and Veritas®
Collagen Matrix (Wet) K062915
(Device acting as its own predicate.) |
| Device Description | Veritas Collagen Matrix is an implantable surgical mesh
comprised of non-crosslinked bovine pericardium. Veritas
Collagen Matrix bovine pericardium is procured in the United
States from cattle less than 30 months of age. |
| | Veritas Collagen Matrix allows for neo-collagen formation and
neo-vascularization of the implanted device and permits
replacement of the device with host tissue, or remodeling.
Veritas Collagen Matrix also minimizes tissue attachment to the
device in case of direct contact with viscera. |
:
:
. . .
Synovis Surgical Innovations
Veritas Collagen Matrix (Dry) is used for buttressing and reinforcing surgical staple lines and is currently available in configurations for multiple sizes and brands of both linear and circular staplers.
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| Statement of Intended use | Intended Use (Unchanged from previous clearances) |
|---|---|
| The device is intended to be used as a staple line buttress | |
| Indications for Use (Unchanged from previous clearances) | |
| Veritas Collagen Matrix (Dry) 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 Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example: occlusion of the left atrial appendage during open chest procedures). | |
| Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera. | |
| Technological Comparisons | Veritas Collagen Matrix (Dry) is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the method of attachment of the buttress to the stapler, which is the subject of this submission. |
| Technology/Device Testing | Veritas Collagen Matrix (Dry) is unchanged and previous testing applies. The testing presented in this submission is specifically related to the use of an adhesive, which is the new method for attachment of the buttress to the stapler. The testing focuses on the biocompatibility of the adhesive and its ability to allow the device to function as intended. |
. The same of the same of the same of the states of the many
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synovis Surgical Innovations % Ms. Jodi Jorgenson Sr. Regulatory Affairs Specialist 2575 University Avenue West St. Paul, Minnesota 55114-1024
NOV 2 6 2008
Re: K083039
Trade/Device Name: Veritas Collagen Matrix (Dry) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: October 13, 2008 Received: October 14, 2008
Dear Ms. Jorgenson:
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 (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.
3
Page 2 - Ms. Jodi Jorgenson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark M. Mulhern
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K083039
Device Name: Veritas Collagen Matrix (Dry)
Indications For Use:
Veritas Collagen Matrix (Dry) 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 Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example, occlusion of the left atrial appendage during open chest procedures.
Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.
Mark N. Milliken
-torative, Division of Ge and Neurologic
510(k) Number K0830
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)