(84 days)
Durasis® Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is provided sterile and intended for one-time use.
Durasis® Dural Substitute is manufactured from porcine small intestinal submucosa and is supplied in various sizes ranging up to 140 cm². The device is packaged in sterile, sealed double pouches.
The provided text is a 510(k) summary for the Durasis® Dural Substitute, a medical device intended for use as a dura substitute. It describes the device, its intended use, predicate devices, and conclusions drawn from tests. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving it.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states: "The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." However, the specific acceptance criteria (e.g., tensile strength thresholds, biocompatibility limits, burst pressure) and the numerical or detailed qualitative performance results are not provided in this summary.
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 in the 510(k) summary. It only generally states that the material was subjected to "in vitro, in vivo, and clinical evaluation."
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)
This information is not provided in the 510(k) summary. The document does not describe a study involving "experts" establishing a "ground truth" in the context of diagnostic or interpretive performance, which is typically where such details are relevant. This device is a surgical implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
Given that this device is a dural substitute (a surgical implant) and not an AI-powered diagnostic tool, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" would not be relevant or performed for this type of product. Therefore, this information is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Again, this is not a diagnostic device with an algorithm. A "standalone" performance evaluation for a physical implant would refer to its direct physical and biological performance characteristics, which are generally summarized as "in vitro, in vivo, and clinical evaluation." The document confirms these evaluations were done but does not detail them.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a dural substitute, "ground truth" would typically refer to established biomechanical standards, biocompatibility requirements (e.g., lack of toxicity, immunogenicity), and successful integration/repair in animal or human subjects. The document states "The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." This implies that the 'ground truth' was based on established scientific and medical standards for dural repair materials, likely validated through histological findings (for biocompatibility and tissue integration), mechanical testing, and clinical observations of successful repair (outcomes data). However, the specific types of ground truth for each test are not explicitly detailed. For example, pathology would be used for in vivo biocompatibility, and biomechanical standards for in vitro testing.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this primarily biological and mechanical medical device.
9. How the ground truth for the training set was established
As above, the concept of a "training set" and its "ground truth" is not applicable here.
Summary Table of Available Information:
| Information Requested | Available in Document (K031850 510(k) Summary) |
|---|---|
| Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly detailed (e.g., no specific tensile strength values). Reported Performance: "The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." (General statement) |
| Sample Size (Test Set) & Data Provenance | Sample Size: Not specified. Data Provenance: Not specified (e.g., country, retrospective/prospective). |
| Number of Experts & Qualifications (Ground Truth - Test Set) | Not applicable for this type of device/study. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study & Effect Size (Human Readers w/wo AI) | Not applicable (device is a surgical implant, not an AI diagnostic tool). |
| Standalone Performance (Algorithm-only) | "In vitro, in vivo, and clinical evaluation" were done, but specific details of "standalone" performance metrics (e.g., a specific algorithm's output without human intervention) are not relevant here. |
| Type of Ground Truth Used | Implied to be based on established biomechanical, biocompatibility, and clinical standards for dural repair materials, likely including histological and outcome data. Specifics are not detailed. |
| Sample Size (Training Set) | Not applicable (not an AI/ML device). |
| How Ground Truth for Training Set was Established | Not applicable. |
In essence, this 510(k) summary provides a high-level overview of the tests performed and the conclusion of substantial equivalence. It lacks the granular detail of specific acceptance criteria, test methodologies, sample sizes, and expert qualifications that would be present in a comprehensive study report or a more detailed submission. This is typical for a 510(k) summary, which is a brief outline rather than a full scientific paper.
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510(k) Summary
SEP - 8 2003
Mark Bleyer, President Submitted By: Cook Biotech Incorporated 3055 Kent Avenue West Lafavette, IN 47906 (765) 497-3355 June 13, 2003
Names of Device:
| Trade Name: | Durasis® Dural Substitute |
|---|---|
| Common/Usual Name: | Dural substitute, dural graft, dural repair patch |
| Classification Name: | Dura Substitute |
| 21 CFR § 882.5910 (84GXQ) |
Intended Use:
Durasis® Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is intended for one-time use.
Predicate Devices:
Predicate devices are Dura-Guard® Dural Repair Patch (K950956), manufactured by Bio-Vascular, Inc., Tutoplast® Processed Dura Mater (K910555), marketed by Biodynamics International, Inc., CODMAN ETHISORB™ Dura Patch (K991413), marketed by Johnson & Johnson, Surgisis Soft Tissue Graft (K980431), manufactured by Cook Biotech Incorporated, and DuraGen Dural Matrix (K982180) manufactured by Integra Neurosciences.
Device Description:
Durasis® Dural Substitute is manufactured from porcine small intestinal submucosa and is supplied in various sizes ranging up to 140 cm². The device is packaged in sterile, sealed double pouches.
Substantial Equivalence:
Durasis" Dural Substitute is comparable with respect to intended use, materials of composition, and technical characteristics to predicate devices in terms of 510(k) substantial equivalence.
Discussion of Tests and Test Results:
The material comprising Durasis® Dural Substitute was subjected to in vitro, in vivo, and clinical evaluation to assess biocompatibility, mechanical properties, performance characteristics, and safety. The material met the criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
Conclusions Drawn from Tests:
Outcomes from the evaluation of Durasis® Dural Substitute provide evidence of its suitability for dura mater replacement and of substantial equivalency to predicate devices in terms of intended use and technological characterstics.
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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 stylized depiction of an eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle. The eagle is drawn in a simple, bold style, and the overall design is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2003
Mr. Mark Bleyer President Cook Biotech, Inc. 3055 Kent Avenue West Lafayette, Indiana 47906
Re: K031850
Trade/Device Name: Durasis® Dural Substitute Regulation Number: 21 CFR 882.5910 Regulation Name: dura substitute Regulatory Class: II Product Code: GXQ Dated: June 13, 2003 Received: June 19, 2003
Dear Mr. Bleyer:
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 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. Mark Bleyer
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1031800
510(k) Number (if known): K031850
Durasis® Dural Substitute Device Name:
Indications For Use:
Durasis Dural Substitute is intended for use as a dura substitute for repairing dura mater. The device is provided sterile and intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031850
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).