(71 days)
The device is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using linear surgical staplers. The device can be used to reinforce staple lines during lung resections, abdominal and thoracic wall repairs, gastric banding, muscle flap reinforcement, repairs, vaginal prolanse, maluing il vaginal prolapse, pelvic floor reconstruction, urethral sling and diaphragmatic, femoral, incisional, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernial, The device may be used with anastomotic staplers and with non-anastomotic staplers.
Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve form. The sleeve is configured for use with commercially available linear surgical stapless
Here's an analysis of the provided text regarding the acceptance criteria and study for the SEAMGUARD™ Staple Line Reinforcement Material:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Strength | Sufficient to resist staple pull-through | Mean staple failure force: 0.91 kg |
| Sufficient to prevent significant damage to the integrity of the material | Mean material failure force: 2.01 kg | |
| *Conclusion: Staples fail (straighten) before the material fails, indicating the material is stronger than the staple. * | ||
| Biocompatibility | Inert, biocompatible | Composed of inert, biocompatible ePTFE material with a history of safe and effective use. Animal studies show no adverse histologic reactions in lung tissue. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count, but it is implied that "tests conducted" involved multiple staples and material samples to derive mean values.
- Data Provenance: The mechanical tests were conducted by the applicant (W.L. Gore and Associates). The country of origin of the data is not specified, but the applicant is based in the USA. The study appears to be a prospective mechanical testing study conducted in a lab setting, not a clinical trial withpatient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in this context. The "ground truth" for the mechanical performance was established through physical measurements of staple failure force and material failure force, not through expert consensus or interpretation of medical images. For biocompatibility, the ground truth was based on the known properties of ePTFE and observations from animal studies.
-
Adjudication method for the test set:
- Not applicable. As noted above, the "ground truth" was determined by direct physical measurement, not by expert review requiring adjudication.
-
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:
- No. This is not a medical imaging device or an AI-enabled diagnostic tool. Therefore, an MRMC study is not relevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or an AI device. The device's performance was evaluated through direct mechanical testing in a standalone manner (the material itself was tested).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical performance: Directly measured physical properties (force required to cause staple straightening/failure and material tear/failure).
- For biocompatibility: Established material properties (ePTFE's known biocompatibility) and observations from animal studies (histologic reactions).
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The sample size for the training set:
- Not applicable as this is not an AI/ML device requiring a training set. The "training" for this device would be its design and manufacturing process, optimized through engineering principles.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model.
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K955364 (F1 UF 2)
FEB - 1 1996
V. Summary of Safety and Effectiveness Information
A. Submitter: W.L. Gore and Associates P.O. Box 500 Flagstaff, AZ 86002-0500 Contact: R. Larry Pratt.
B. Device Name: SEAMGUARD™ Staple Line Reinforcement Material
520-779-2771
-
C. Applicant Device Description:
Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve form. The sleeve is configured for use with commercially available linear surgical stapless -
Intended Use and Indications: D.
The device is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using linear surgical staplers.
The device can be used to reinforce staple lines during lung resections, abdominal and thoracic wall repairs, gastric banding, muscle flap reinforcement, repairs,
vaginal prolanse, maluing il vaginal prolapse, pelvic floor reconstruction, urethral sling and diaphragmatic, femoral, incisional, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernial, The device may be used with anastomotic staplers and with non-anastomotic staplers.
-
E. Predicate Device:
PERI-STRIPS™ Staple Line Reinforcement-Sleeve Configuration is cited as a predicate device which has been found to substantially equivalent through the premarket notification process. -
F. Technological Characteristics:
The applicant device has the same intended use and the same indications as the predicate device.
The applicant device is composed of inert, biocompatible ePTFE material which has an extensive history of safe and effective use in a variety of medical applications including soft tise in a var applications. Animal studies show no adverse histologic reactions in lung tissue.
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K455364 (N.3 or 2)
Mechanical test results show the applicant device to
have material strength which is sufficiated to have material strength which is sufficient to resist staple pull-through and to prevent significant do resist
to the integrity of the material - Inchient damage to the integrity of the material. In the tests
to the integrity of the material. In the tests
conducted, the mean staple failure (i conducted, the mean staple failure (i.e., staple straightening) force was 0.91 kg and the mean material failure force of the applicant device was 2.01 kg. data show that staples being used in the reinforcement The procedure would fail prior to applicant device and the country of the counterial
- G. Safety and Effectiveness Conclusions:
The applicant SEAMGUARD Staple Line Reinforcement Material is substantially equivalent to the predicate device with regard to intended use, indications and technological characteristics. No new types of safety and effectiveness questions are raised by the applicant and a couveness questions are raised by the device when compared to the predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with three heads or faces, with flowing lines that suggest movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
W.L. Gore & Associates, Incorporated % Mr. R. Larry Pratt Regulatory Affairs 3450 West Kiltie Avenue, P.0. Box 500 Flagstaff. Arizona 86002-0500
Re:K955364
Trade/Device Name: SEAMGUARD™ Staple Line Reinforcement Material Regulation Number: 21 CFR § 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class 2 JUN -6 2012 Product Code: OXD, FTL Dated: November 17, 1995 Received: November 22, 1995
Dear Dr. Titus:
This letter corrects our substantially equivalent letter of February 1, 1996.
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 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 (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 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); medical
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device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ely yours,
J. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
§ 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.