(92 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a staple line reinforcement material, with no mention of AI or ML technologies.
No.
The device is a reinforcement material used in surgical procedures for staple line reinforcement, not a device that itself provides therapy or treatment. Its function is to support tissue and improve the stapling process outcome, rather than to treat a condition directly.
No.
The device is a reinforcement material for staple lines during surgical procedures, not a diagnostic tool.
No
The device description clearly states it is an assembly of three physical components: an implantable device, loading carriers, and a protective cover. It is a physical medical 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 describes a device used during surgical procedures to reinforce staple lines in various soft tissues. This is a direct surgical intervention on the patient's body.
- Device Description: The device is an implantable assembly of materials designed to be placed within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples taken from the body. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures, GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Product codes (comma separated list FDA assigned to the subject device)
OXC
Device Description
The subject GORE® SEAMGUARD® Reinforcement device is an assembly of three components: 1) the implantable device, 2) two (2) loading carriers (for anvil & cartridge side of stapling device), and 3) a protective cover. The implantable device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, lung, liver, bladder, bronchus, colon, colorectum, esophagus, stomach, mesentery, pancreas, small bowel, spleen, 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)
Bench study: Testing of the GORE® SEAMGUARD® Reinforcement consisted of a simulated use performance testing. The tests demonstrated the performance of the subject SEAMGUARD device is substantially equivalent to the predicate SEAMGUARD device.
Animal study: Testing of the GORE® SEAMGUARD® Reinforcement device also included biocompatibility testing in accordance with ISO 10993-1 and in vivo safety studies. The results of these tests revealed the device is biocompatible for its intended use and demonstrated no clinically relevant device-related complications, no adverse tissue response, and histological results comparable to the predicate device.
Clinical: No clinical evaluations of this product have been conducted.
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.
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K131658 Page 1/3
W. L. Gore & Associates, Inc. GORE® SEAMGUARD® Reinforcement Section 5. 510(k) Summary
Image /page/0/Picture/2 description: The image shows the logo for GORE. The logo has the word "GORE" in bold, block letters. Above and to the right of the word is a black arrow shape. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font.
510(k) SUMMARY (Per 21CFR807.92)
510(k) Owner:
Owner/Operator: W. L. Gore & Associates, Inc. 1505 N. Fourth Street Flagstaff, AZ 86004
Regulatory Contact:
W. L. Gore & Associates, Inc. 301 Airport Road Elkton, Maryland 21921 Barbara L. Smith Phone: 410-506-8189 Fax: 410-506-8221 E-mail: blsmith@wlgore.com
EP 0 6 2013
Date Prepared:
May 15, 2013
Device Names/Classification
| Trade Name: | GORE® SEAMGUARD® Reinforcement |
|---|---|
| Common Name: | Staple line reinforcement material |
| Classification Name: | Mesh, Surgical, absorbable, staple line |
| reinforcement (21CFR878.3300) | |
| Product Code: | OXC |
Predicate Device
- K043056 GORE® SEAMGUARD® Bioabsorbable Staple Line . Reinforcement Material
Device Description
The subject GORE® SEAMGUARD® Reinforcement device is an assembly of three components: 1) the implantable device, 2) two (2) loading carriers (for anvil & cartridge side of stapling device), and 3) a protective cover. The implantable
Gore and Designs are trademarks of W. L. Gore & Associates, Inc.
1
Image /page/1/Picture/1 description: The image shows the logo for GORE. The logo features the word "GORE" in a bold, sans-serif font, with a stylized arrow pointing to the right. Below the word "GORE" are the words "Creative Technologies Worldwide" in a smaller font. The logo is black and white.
W. L. Gore & Associates. Inc. GORE® SEAMGUARD® Reinforcement Section 5. 510(k) Summary
device consists of three layers - Web, Film, and Adhesive. The Web and Film layers are comprised of synthetic bioabsorbable polyglycolide (PGA) and trimethylene carbonate (TMC). A thin layer of bioabsorbable adhesive is coated onto one surface of the implantable device, and is composed of a synthetic bioabsorbable polylactide and trimethylene copolymer. The adhesive's function is to affix the device onto the surgical stapler for delivery to the implant site. The bioabsorbable copolymers degrade via a combination of hydrolytic and enzymatic pathways. The device is supplied sterile for single use only.
Indications for Use
GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures, GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Summary of Similarities and Difference in Technological Characteristics, Performance and Intended Use
The intended/indications for use for the subject SEAMGUARD device is identical to the predicate SEAMGUARD device. The primary difference between the subject and predicate SEAMGUARD devices is in the feature for loading and delivery of the device to the implantation site. The subject SEAMGUARD device utilizes loading carriers and an adhesive to secure the device on the stapler as an alternative to the sleeve with suture pull cord feature of the predicate SEAMGUARD device.
Performance Data / Predicate Device Comparison
Non-Clinical
Bench study: Testing of the GORE® SEAMGUARD® Reinforcement consisted of a simulated use performance testing. The tests demonstrated the performance of the subject SEAMGUARD device is substantially equivalent to the predicate SEAMGUARD device.
Animal study: Testing of the GORE® SEAMGUARD® Reinforcement device also included biocompatibility testing in accordance with ISO
Gore and Designs are trademarks of W. L. Gore & Associates, Inc.
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K131658 Page 3/3
Image /page/2/Picture/1 description: The image shows the logo for GORE. The logo is in a black box. The word "GORE" is in bold, sans-serif font. Below the word "GORE" is the text "Creative Technologies Worldwide" in a smaller font.
W. L. Gore & Associates, Inc. GORE® SEAMGUARD® Reinforcement Section 5. 510(k) Summary
10993-1 and in vivo safety studies. The results of these tests revealed the device is biocompatible for its intended use and demonstrated no clinically relevant device-related complications, no adverse tissue response, and histological results comparable to the predicate device.
Clinical: No clinical evaluations of this product have been conducted.
Conclusion
W.L. Gore & Associates concludes that the subject GORE® SEAMGUARD® Reinforcement device is substantially equivalent to the predicate GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement device in terms of indications for use, design, materials, biocompatibility, packaging, sterilization, labeling, and performance.
Gore and Designs are trademarks of W. L. Gore & Associates, Inc.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
September 6, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
W.L. Gore & Associates, Incorporated % Ms. Barbara L. Smith 301 Airport Road Elkton, Maryland 21921
Re: K131658
Trade/Device Name: GORE® SEAMGUARD® Reinforcement Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXC Dated: August 9, 2013 Received: August 20, 2013
Dear Ms. Smith:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Barbara L. Smith
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/deliault.htm for the CDRH's Office of Surveillance and Biometries/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 (30!) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson - S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
W. L. Gore & Associates, Inc. GORE® SEAMGUARD® Reinforcement Section 4. Indications for Use
Indications for Use
510(k) Number (if known):
Device Name: GORE® SEAMGUARD® Reinforcement
Indications For Use:
GORE® SEAMGUARD® Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. GORE® SEAMGUARD® Reinforcement can be used for reinforcement of staple lines during hysterectomy, lung resection, liver resection, bladder reconstruction, bronchial, bariatric, colon, colorectal, esophagus, gastric, mesentery, pancreas, small bowel, and spleen procedures. GORE® SEAMGUARD® Reinforcement is also intended to be used for reinforcement of staple lines (i.e., occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
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)
David Krause -S
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K131658