(32 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and basic function of a hernia repair device.
No
The device is described as a hernia repair device intended to reinforce soft tissue, which is a structural implantation, not a therapeutic treatment.
No
The device is described as an implant used to reinforce soft tissue, specifically for hernia repair. There is no mention of it being used to identify or diagnose a condition.
No
The intended use clearly describes an implantable device, which is a physical object, not software.
Based on the provided information, the SIS Hernia Repair Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be implanted to reinforce soft tissue for hernia and body wall defect repair. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: While the description is "Not Found," the intended use clearly places it as an implantable surgical device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), using reagents, or providing diagnostic information.
Therefore, the SIS Hernia Repair Device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia and body wall defect. The device is intended for one-time use.
Product codes
FTL
Device Description
The SIS Hernia Repair Device is a surgical mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernia, body wall defect
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Special 510(k) Premarket Notification: SIS Hernia Repair Device
Attachment 4
1/2
Special 510(k) Summary
| Submitted by: | Cook Biotech Incorporated
1425 Innovation Place
West Lafayette, IN 47906
Perry Guinn
VP Quality Assurance & Regulatory Affairs
Tel: (888) 299-4224 x 4942
FAX: (765) 497-2361
September 15, 2006 | OCT 13 2006 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Names of Device:
Trade Name: | SIS Hernia Repair Device, Surgisis Gold Hernia Repair Graft | |
| Common/Usual Name: | Surgical mesh | |
| Proposed classification: | Surgical mesh (79FTL)
21 CFR 878.3300
Class II | |
| Performance standards: | No performance standards have been established under
Section 514 of the Food, Drug and Cosmetic Act applicable
to this device. | |
Intended use:
The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissue where weakness exists. Indications for use include the repair of a hernia and body wall defect. The device is intended for one-time use.
1
Special 510(k) Premarket Notification: SIS Hernia Repair Device
Attachment 5
K06 2697
7/2
Summary of Substantial Equivalence:
The SIS Hernia Repair Device as described in this submission is substantially equivalent to its predicate with respect to the following characteristics:
Similarities:
-
- Both have the same intended use.
- Both use the same operating principles. 2.
- Both incorporate the same basic design. 3.
-
- Both incorporate the same materials.
- Both have the same shelf-life. 5.
- Both pass the same set of internal tests and release criteria. 6.
-
- Both are packaged and sterilized using the same materials and processes.
Differences:
-
- A process was changed that did not affect specifications or performance of the final device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the serpent entwined around a staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2006
Cook Biotech Incorporated % Mr. Perry W. Guinn Vice President, Quality Assurance & Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906
Re: K062697
Trade/Device Name: SIS Hernia Repair Device Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: September 14, 2006 Received: September 15, 2006
Dear Mr. Guinn:
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.
If your device is classified (see above) into either 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 mav 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); good manufacturing practice requirements as set
3
Page 2 - Mr. Perry W. Guinn
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.
This letter will allow you to begin marketing your device as described in your Section 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely your
Ron Natt
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K062697
Indications for Use
510(k) Number (if known):
Device Name: SIS Hernia Repair Device
Indications For Use:
The SIS Hernia Repair Device is intended to be implanted to reinforce soft The Ole Homia Ropair Donts. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number__LOG2697