(165 days)
Not Found
No
The summary describes a biological tissue-based implant for fistula repair and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is implanted to reinforce soft tissue for the repair of enterocutaneous fistulas, which is a therapeutic function.
No
Explanation: The device is indicated for implantation to reinforce soft tissue for repair of fistulas, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is manufactured from porcine small intestinal submucosa (SIS) and is a physical plug for implantation, indicating it is a hardware 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 is "implantation to reinforce soft tissue for repair of enterocutaneous fistulas." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details a physical plug made from porcine tissue, designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, the modified SIS Fistula Plug is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.
Product codes
FTM
Device Description
The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a flange to provide increased retention of the plug and improved blockage of the fistula. The device is packaged in a lyophilized (freeze-dried) state, and supplied sterile in a sealed double pouch system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The materials comprising the modified SIS Fistula Plug have been subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, adequately disinfected, and with appropriate mechanical characteristics.
Key Metrics
Not Found
Predicate Device(s)
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) Submission, SURGISIS® Biodesign™ Enterocutaneous Fistula Plug September 8, 2008
Page 4
1872
FEB 2 7 2009
510(k) SUMMARY
Submitted By:
Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 412-6318 September 12, 2006
Name of Device:
SURGISIS® Biodesign™ Enterocutaneous Fistula Plug Trade Name: Common/Usual Name: Surgical Mesh Proposed classification name: Surgical Mesh
21 CFR 878.3300 (FTM) Class II
Predicate Device:
The predicate device is the original SIS Fistula Plug (510(k) No. K050337), cleared for marketing by the Food and Drug Administration on March 9, 2005.
Device Description:
The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a flange to provide increased retention of the plug and improved blockage of the fistula. The device is packaged in a lyophilized (freeze-dried) state, and supplied sterile in a sealed double pouch system.
Substantial Equivalence:
The modified SIS Fistula Plug is similar with respect to intended use, materials and technological characteristics to the original, unmodified SIS Fistula Plug as shown through an analysis of risk factors, bench testing and biocompatibility testing.
Discussion of Tests and Test Results:
The materials comprising the modified SIS Fistula Plug have been subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the
1
K082682 pg 2of2
device to be biocompatible, adequately disinfected, and with appropriate mechanical characteristics.
Conclusions Drawn from the Tests:
Outcomes from the evaluation of the modified SIS Fistula Plug provide evidence of its suitability for use in soft tissue reconstruction and substantial equivalency to the predicate device in terms of intended use and technological characteristics.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 27 2009
Cook Biotech. Inc. % Med Institute, Inc. Mr. Perry W. Guinn VP, QA/RA 1425 Innovation Place West Lafayette, Indiana 47906
Re: K082682
Trade/Device Name: SURGIS® Biodesign™ Enterocutaneous Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: February 18, 2009 Received: February 19, 2009
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 Fed-ral 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 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Syrems at (240) 276-3464. 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 vours.
Milton R. Ogden
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
82682
510(k) Number (if known):
Device Name:
SURGISIS® Biodesign™ Enterocutaneous Fistula Plug
Indications for Use:
The modified SIS Fistula Plug is indicated for implantation to reinforce soft tissue for repair of enterocutaneous fistulas.
Prescription Use XX
AND/OR
Over-the-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CRF 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| DK for MYM 2/22/2009 | |
|---|---|
| (Division Sign-Off) |
Division of General, Restorative, and Neurological Devices
510(k) Number K082682
Page 1 of