(57 days)
Not Found
No
The summary describes a physical implantable surgical patch and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a "prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed," which functions as a structural support rather than providing therapeutic treatment itself.
No
The device is described as an "implantable surgical patch" used for "staple line reinforcement" during surgical procedures, which indicates a therapeutic or supportive function rather than a diagnostic one.
No
The device description explicitly states it is an "implantable surgical patch comprised of crosslinked bovine pericardium," indicating it is a physical hardware device, 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 "surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed." This describes a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The device is described as an "implantable surgical patch." This further confirms its use within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are devices used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a surgical tool/implant used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
Peri-Strips 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.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Product codes
FTM
Device Description
An implantable surgical patch comprised of crosslinked bovine pericardium
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung and bronchus, gastric, small bowel, mesentery, colon, and colorectal
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)
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
3.0 510(k) SUMMARY
Submitted by | Synovis Surgical Innovations |
---|---|
A Division of Synovis Life Technologies, Inc. | |
2575 University Ave. W. | |
St. Paul, MN 55114 | |
Tel: 651-603-3700 | |
Fax: 651-603-5211 |
Angela Mallery Contact Person At address above
Peri-Strips® Staple Line Reinforcement - Sleeve Configuration Device Trade Name: Peri-Strips® Staple Line Reinforcement -- Strip Configuration Peri-Strips® Dry Staple Line Reinforcement
- Common Name Surgical Mesh
- Classification Name Mesh, Surgical 878.3300
Peri-Strips® Staple Line Reinforcement (Synovis Surgical Predicate device Innovations, a division of Synovis Life Technologies, Inc.) -K983162 SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material (W.L. Gore & Associates, Inc., Flagstaff, AZ) K032865
- Device Description An implantable surgical patch comprised of crosslinked bovine pericardium
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Peri-Strips Staple Line Reinforcement is intended for use as a Statement of prosthesis for the surgical repair of soft tissue deficiencies using Intended use surgical staplers when staple line reinforcement is needed.
1040115
Peri-Strips® Staple Line Reinforcement yage 2 46 7
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can also be used for remforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Technological Comparisons
Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device, having the same technological characteristics.
Testing
Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use.
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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Ms. Angela Mallery Regulatory Affairs Manager Synovis Life Technologies, Inc. 2575 University Avenue W. St. Paul, Minnesota 55114
Re: K040119
Trade/Device Name: Peri-Strips Staple Line Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: January 16, 2004 Received: January 20, 2004
Dear Ms. Mallery:
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 Mcdical 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 cither 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); labcling (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. Angela Mallery
This letter will allow you to begin marketing your device as described in your Scction 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 (301) 594-4659. 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
for
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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Peri-Strips Staple Line Reinforcement Device Name:
Indications For Use:
Peri-Strips 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.
Peri-Strips can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Peri-Strips can also be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
Page 1 of
510(k) Number K040119