(27 days)
The modified SIS Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal fistulas. The device is supplied sterile and is intended for one-time use.
The modified SIS Fistula Plug is manufactured from porcine small intestinal submucosa (SIS) supplied in a tapered configuration with a button 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.
The provided text details a 510(k) submission for a modified medical device, the SIS Fistula Plug. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance (e.g., efficacy, accuracy, or clinical outcomes). The submission focuses on demonstrating substantial equivalence to a predicate device, specifically addressing modifications made to the original SIS Fistula Plug.
Therefore, many of the requested sections about acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth cannot be extracted from this document as such studies were not part of this 510(k) submission.
Here's an analysis of what can be extracted and an explanation of what cannot:
1. Table of acceptance criteria and the reported device performance
- Acceptance Criteria for this submission: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate device (the original SIS Fistula Plug [510(k) No. K050337]). This is achieved by showing that the modified device has similar intended use, materials, and technological characteristics, and that any modifications do not raise new questions of safety and effectiveness.
- Reported Device Performance: The document states that the modified device underwent:
- Biocompatibility testing
- Viral inactivation testing
- Mechanical testing
- An analysis of risk factors.
- Outcomes: "Outcomes show the device to be biocompatible, adequately disinfected, and with appropriate mechanical characteristics." Also, "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."
| Aspect of Equivalence | Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device | Similar to predicate device |
| Materials | Same as or comparable to predicate device with no new safety/efficacy concerns | Manufactured from porcine small intestinal submucosa (SIS) - same base material as predicate. Subjected to biocompatibility and viral inactivation testing. |
| Technological | Similar to predicate device, modifications do not raise new safety/efficacy concerns | Tapered configuration with a button for increased retention and improved blockage. Bench testing and biocompatibility testing performed. Mechanical characteristics found appropriate. |
| Safety | Biocompatible and adequately disinfected | Biocompatible and adequately disinfected. |
| Effectiveness | Appropriate mechanical characteristics and suitable for soft tissue reconstruction | Appropriate mechanical characteristics. Suitability for use in soft tissue reconstruction. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided because this submission relies on demonstrating substantial equivalence through bench testing, biocompatibility testing, and risk analysis, rather than a clinical efficacy study with a test set of patients or data. The testing mentioned (biocompatibility, viral inactivation, mechanical) would typically involve laboratory samples, not human patient data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no "test set" in the context of human data or diagnoses requiring expert ground truth in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a surgical mesh for fistula repair, not an AI-powered diagnostic tool, so MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the assessments performed (biocompatibility, mechanical testing, viral inactivation), the "ground truth" would be established by standard scientific and engineering methodologies, accepted laboratory protocols, and regulatory guidelines for these types of tests, rather than expert consensus on clinical cases or pathology.
8. The sample size for the training set
- Not applicable. There is no mention of "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no mention of "training set" as this is not an AI/ML device.
In summary: This 510(k) submission is for modifications to an existing physical medical device (SIS Fistula Plug). The "study" referenced is a series of tests (biocompatibility, viral inactivation, mechanical, and risk analysis) intended to demonstrate that the modified device remains substantially equivalent to its predicate. It does not involve clinical studies with human participants, AI algorithms, or the kinds of intricate data analysis and expert review typically found in submissions for diagnostic AI devices.
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Special 510(k) Submission Modifications to SIS Fistula Plug Cook Biotech Incorporated September 12, 2006
OCT 10 2006
6.2729
510(k) SUMMARY
Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Submitted By: Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 412-6318 September 12, 2006
Name of Device:
| Trade Name: | SURGISIS® RVPTM Recto-Vaginal Fistula Plug |
|---|---|
| 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 button 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.
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Special 510(k) Submission Modifications to SIS Fistula Plug Cook Biotech Incorporated September 12, 2006
page 2 82
KOB2729
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 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.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2006
Cook Biotech, Inc. % MED Institute, Inc. Mr. Daniel J. Dillon Regulatory Scientist 1400 Cumberland Avenue West Lafayette, Indiana 47906
Re: K062729
Trade/Device Name: Modified SIS Fistula Plug Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 12, 2006 Received: September 13, 2006
Dear Mr. Dillon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 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 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.
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Page 2 - Mr. Daniel J. Dillon
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 yours,
Barbarestuehm
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Submission Modifications to SIS Fistula Plug Cook Biotech Incorporated September 12, 2006
Indications for Use
510(k) Number (if known):
K06 2729
Device Name:
Modified SIS Fistula Plug
Indications for Use:
The modified SIS Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal fistulas. The device is supplied sterile and is intended for one-time use.
Prescription Use XX
AND/OR
Over-the-Counter Use
(Per 21 CFR 801 Subpart D)
ND, OR
(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)
Oarben Bneem
(Division Signalit Division of G rat, Restorative, and Neurological Devices
510(k) Number
Page 1 of 1
§ 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.