(57 days)
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.
An implantable surgical patch comprised of crosslinked bovine pericardium
The provided document is a 510(k) summary for the Peri-Strips Staple Line Reinforcement device. It states that the device is "substantially equivalent to the predicate device in terms of testing and indications for use." However, it does not contain specific details about acceptance criteria or a study that proves the device meets those criteria in the typical sense of a performance study with detailed metrics.
Instead, the submission for this type of device (surgical mesh) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same technological characteristics and intended use as the predicate, rather than conducting a separate clinical or performance study with defined acceptance criteria and statistical analysis as one might find for diagnostic AI/ML devices.
Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria cannot be extracted from this document, as such a study is not detailed here.
Here's what can be inferred or stated based on the provided text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in this document as quantitative performance metrics. The underlying acceptance criterion for a 510(k) submission is "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states, "Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use." This is the primary "performance" metric reported in the context of a 510(k) for this type of device. Specific quantitative performance data from a clinical trial or a standalone study are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided: The document does not describe a test set or data provenance for a performance study. Demonstrating substantial equivalence for this device likely relied on bench testing, material characterization, and comparison to the predicate, rather than a clinical study with a "test set" in the context of AI/ML or diagnostic devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: No such information is present, as there's no mention of a performance study involving expert assessment or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: No such information is present.
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 / Not Provided: This device is a surgical mesh for staple line reinforcement, not an AI/ML diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: This is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided: This concept of "ground truth" as it pertains to diagnostic performance is not relevant for this type of device submission. The "truth" in this context revolves around material properties, biocompatibility, and functional equivalence to the predicate.
8. The sample size for the training set:
- Not Applicable / Not Provided: No "training set" is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not Applicable / Not Provided: No "training set" or "ground truth" establishment for training is mentioned.
Summary based on the document:
The provided document describes a 510(k) submission for a surgical device. The "acceptance criteria" for such a submission are primarily based on demonstrating "substantial equivalence" to a legally marketed predicate device. The study proving this substantial equivalence would have involved comparing the new device's technological characteristics, materials, and intended use to the predicate device, likely through bench testing and material characterization, rather than a clinical performance study with defined acceptance criteria and statistical analysis as one might find for AI/ML or diagnostic devices.
The document explicitly states: "Peri-Strips® Staple Line Reinforcement is substantially equivalent to the predicate device in term of testing and indications for use." This statement, along with the detailed comparison of intended use, is the core of the "study" proving the device meets the regulatory acceptance criteria for 510(k) clearance.
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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.
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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 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.
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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
§ 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.