(71 days)
Not Found
Not Found
No
The summary describes a physical medical device (ePTFE sleeve) used for surgical reinforcement and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical properties and animal studies, not algorithmic performance.
No
Explanation: The device is intended for surgical repair of soft tissue deficiencies and is described as a prosthesis. It reinforces staple lines and repairs hernias and prolapses, acting as a structural support rather than a device that provides therapy or treatment for a disease.
No
Explanation: The device is described as a "prosthesis for the surgical repair of soft tissue deficiencies" and is intended for reinforcing staple lines during various surgical procedures. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is a "Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve form," which is a physical material, 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 describes a device used during surgery to reinforce soft tissue deficiencies and staple lines. This is a surgical implant/accessory, not a diagnostic test performed on samples outside the body.
- Device Description: The description of the device as a biocompatible ePTFE sleeve for use with surgical staplers further supports its role as a surgical aid.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OXD, FTL
Device Description
Biocompatible, expanded polytetrafluoroethylene (ePTFE) in sleeve form. The sleeve is configured for use with commercially available linear surgical stapless
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung, abdominal, thoracic wall, gastric, muscle flap, vaginal, pelvic floor, urethral, diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical
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)
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
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.
PERI-STRIPS™ Staple Line Reinforcement-Sleeve Configuration
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
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.
1
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.
2
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
3
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