(27 days)
Not Found
No
The summary describes a biological tissue-based implant for fistula repair and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as "for implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal, and enterocutaneous fistulas," which indicates it is used for treatment or mitigation of a condition.
No
The provided text describes a medical device used for soft tissue reinforcement and fistula repair, not for diagnosing conditions.
No
The device description clearly states it is a physical implant manufactured from porcine small intestinal submucosa (SIS), 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 clearly states the device is for "implantation to reinforce soft tissue" and "repair of anal, rectal, and enterocutaneous fistulas." This describes a surgical implant used directly on the patient's body for therapeutic purposes.
- Device Description: The description details a "rolled configuration" made from "porcine small intestinal submucosa (SIS)" for implantation. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases. The device is implanted in vivo (within the body).
In summary, the SIS Fistula Plug is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SIS Fistula Plug is for implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal, and enterocutaneous fistulas. The device is supplied sterile and is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
The SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) and is provided in a rolled configuration. The device is packaged in a lyophilized (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
soft tissue, anal, rectal, enterocutaneous
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)
The material comprising the SIS Fistula Plug was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be biocompatible, and the material, and mechanical, and mechanical characteristics to be sufficient. Outcomes from the evaluation of the SIS Fistula Plug provide evidence of its suitability for use in the given indication and that its performance is equivalent to predicate devices in terms of intended use and technological characteristics.
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.
The SURGISIS Tissue Graft (K041838) and the SURGISIS Soft Tissue Graft (K041838)
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
K050337 SIS Fistula Plug
37
/
9. 510(K) Summary
| Submitted By: | Mark Bleyer, President |
|---|---|
| Cook Biotech Incorporated | |
| 1425 Innovation Place | |
| West Lafayette, IN 47906 | |
| (765) 497-3355 | |
| March 2, 2005 |
Names of Device:
SIS Fistula Plug Trade Name: Surgical Mesh Common/Usual Name: Proposed classification name: Surgical Mesh 21 CFR 878.3300 (FTM) Class II
Intended Use:
The SIS Fistula Plug is for implantation to reinforce soft tissue where a rolled configuration is a The SIS Fistula Flug is for implanation to remreros securers is supplied sterile and is intended for one-time use.
Predicate Devices:
Predicate Devices:
The SIS Fistula Plug is similar to predicate devices, including the SURGISTS of Tissue Graft The SIS Fistula Frights Shiftin's to productions are results and manufactured by Cook Biotech Incorporated.
Device Description:
The SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) and is I he SISTIStula I lug is manufactured from portiguration. The device is packaged in a lyophilized (dried) state, and supplied sterile in a sealed double pouch system.
Substantial Equivalence:
Substannal Equirateneer
The SIS Fistula Plug is similar with respect to intended use, materials and technological characteristics to the above predicate devices in terms of 510(k) substantial equivalence as shown through bench and biocompatibility testing and clinical experience.
Discussion of Tests and Test Results:
The material comprising the SIS Fistula Plug was subjected to extensive biocompatibility testing, viral inactivation testing, and mechanical testing. Outcomes show the device to be Vilal mactivation tosting, und meetialited. The material, and mechanical, and mechanical characteristics to be sufficient.
Conclusions Drawn from the Tests:
Conclusions Drawn from the Fistula Plug provide evidence of its suitability for use in Outcomes from the evaluation of the USD 1.0.2.1.2018 10:41:48 predicate devices in terms of intended use and technological characteristics.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or birds in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 9 - 2005
Mr. Mark Bleyer President Cook Biotech Incorporated 1425 Innovation Place West Lafayette, Indiana 47906
Re: K050337
Trade/Device Name: SIS Fistula Plug Frade/Don Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: February 9, 2005 Received: February 10, 2005
Dear Mr. Bleyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section >10(t) prematic is substantally equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and have decemined the acres to to case and case of the states for use stated in the enclosure) to tegally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment da provisions of the Federal Food. Drue commerce prior to May 28, 1976, the enactively of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the Federal (PMA) devices that have been reclassified in accordance what as proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general consumer station, ligl You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include requires misbranding and general controls provisions of the Act merade requirements of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it class III (PMA). it If your device is classified (see above) mo entire cass if epenlations affecting your device can
may be subject to such additional controls. Existing major regulations affec may be subject to such additional controls. Existing major vegator 99 in addion. FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 be found in the Code of Pederal Regalations, vour device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean Please be advised that FDA s issuance of a substantal option with other requirements of the Act
that FDA has made a determination that your device arther Fequirements You that FDA has made a determination mar your devres on other Federal agencics. You must or any Federal statutes and regulations administration to: registration and listing (21)
comply with all the Act's requirements, including, but not anglisements as set comply with all the Act s requirements, mendants wardica requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if englicably. the clectronic CFR Part 807); labeling (21 CFK Farl 601); good manatatagon; and if applicable, the clectronic
forth in the quality systems (QS) regulation (2) CFR Patl CHP 1000-1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
2
Page 2 - Mr. Mark Bleyer
This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legally This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of yo premarket notification. The PDA Innung of substantal equivalent of this, 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
r the are and and and 10 10 10 10 10 10 10 10 10 10 100 100 100 100 100 100 If you desire specific advice for your device of our acount of the regulation entitled.
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation contact the Office of Compliance at (240) 270-01-15. Fran 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket normical " (1782 Act from the Division of Small
other general information on your responsibilities under (1800) 638-204 other general intormation on your responsionities and effect number (800) 638-2041 or Manufacturers, International and Consumer Assistance at to very of the news and index.html.
Sincerely yours,
Miriam C. Provost, Ph.D.
ಕ್ಕಿ
Acting Director Division of General, Restorative and Neurological Devices ()ffice of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K050337 Device Name: SIS Fistula Plug Indications for Use:
The SIS Fistula Plug is for implantation to reinforce soft tissue
r The SIS Fistula Flug is for implined, for repair of anal,
where a rolled configuration is required, for repair of supplied where a rolled colliguration for roquired, The device is supplied
rectal, and enterocutaneous fistulas. The device is supplied rectal, and is intended for one-time use.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Fall 21 CFR 001 Baspare)
(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
510(k) Number_KO50332
Page 1 of 1