(687 days)
The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.
The Shelhigh No-React® dura Substitute is a glutaraldehyde fixed sheet of bovine pericardium.rinsed with the detoxification process No-React®. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.
This document is a 510(k) summary for the Shelhigh No-React® Dura Shield, a Class II medical device intended as a dura substitute for closure of dura mater during neurosurgery.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum degradation rate) or a direct comparison of the device's performance against such criteria in a tabular format. Instead, it relies on demonstrating substantial equivalence to a predicate device.
The reported performance aspects, derived from the text, are descriptive rather than quantitative, and are primarily focused on equivalence and biocompatibility:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate | - "Substantially equivalent to the Dura Guard® manufactured by Bio-vascular and identical to the Shelhigh No-React® pericardial Patch manufactured by Shelhigh Inc." - "Exhibits substantially equivalent physical/mechanical properties as measured by suture retention, tensile strength, and shrink temperature" to the predicate devices. - "The Shelhigh No-React® performance in a substantially equivalent to the predicate device and there were no significant differences between the two devices which pose new questions of safety and effectiveness." |
| Biocompatibility | - "The material exhibits excellent biocompatibility." - "An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher level of biocompatibility." - "The non clinical /Animal testing data showed that the Shelhigh No-React® patch has high level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage." |
| Mechanical Properties | - "The material exhibits good tensile strength, shrink temperature and suture retention." - "The material reapproximates well around suture holes." - "It is soft and pliable making it convenient to implant." |
| Sterility / Packaging | - "The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar." (Implied acceptance for sterility) |
| Effectiveness of No-React® Process | - "Extensive validation of the effectiveness of the Patch with the Extonoro validation process, No-React® indicates that these differences do not pose new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions an "animal study" to evaluate biocompatibility.
- Sample Size: The specific sample size for the animal study is not provided.
- Data Provenance: The study was an "animal study," but the country of origin or whether it was retrospective or prospective is not specified.
Physical/mechanical test information is "discussed above" in relation to substantial equivalence, implying laboratory testing, but specific sample sizes for these tests are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document describes a device for surgical implantation, not an interpretive diagnostic device. Therefore, the concept of "ground truth" established by experts in the context of a test set (e.g., for image interpretation) is not applicable in the way it might be for an AI diagnostic tool.
The "ground truth" for the animal study would be scientific observations of biocompatibility, tissue response, and macroscopic/microscopic examination, and these would be conducted by qualified veterinarians, histopathologists, and researchers, but their number and specific qualifications are not mentioned.
4. Adjudication Method for the Test Set:
Given that this is not an interpretive diagnostic device, an "adjudication method" in the sense of reconciling expert opinions on diagnoses is not applicable.
For the animal study, it's reasonable to assume standard scientific practices for data collection, analysis, and interpretation were followed, potentially involving multiple researchers and statistical analysis, but a specific "adjudication method" is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is typically performed for diagnostic devices where human readers interpret cases with and without AI assistance. This is a standalone medical device (dura substitute) for surgical implantation, not a diagnostic tool that assists human readers.
Therefore, an MRMC comparative effectiveness study was not performed, and is not applicable for this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This device is a physical implant, not an algorithm. Therefore, the concept of a "standalone" study for an algorithm's performance is not applicable. The performance evaluated is the physical and biological performance of the material itself.
7. Type of Ground Truth Used:
The primary "ground truth" used for this device includes:
- Physical/Mechanical Properties: Bench testing data (suture retention, tensile strength, shrink temperature).
- Biocompatibility: Animal study observations and histological findings. These would typically be confirmed by pathology and scientific consensus within the study.
- Clinical Outcomes/Safety in Predicate: The long history of successful use of glutaraldehyde processed bovine pericardium as a permanently implanted material (mentioned in the product description) provides a form of "ground truth" for similar materials.
8. Sample Size for the Training Set:
The concept of a "training set" is primarily relevant for AI/machine learning algorithms. This device is a physical product, not an algorithm, so there is no training set in that context.
The manufacturer likely has internal data and experience from manufacturing previous batches and product iterations, but this isn't a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established:
As there is no "training set" in the AI/ML context, this question is not applicable. The "ground truth" for the development and testing of the Shelhigh No-React® Dura Shield would have been established through standard material science, biocompatibility testing, and preclinical animal models.
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Image /page/0/Picture/1 description: The image contains a sequence of characters and numbers. The sequence starts with a lowercase letter 'k', followed by the numbers '982101'. There is a period before the letter 'k'.
Class II 510(K) Summary
Shelhigh No-React® Dura Shield
This summary of the 510(k) information is being submitted as required by section 807.92(a).
l. Proprietary and Common Name:
Patch is the Shelhigh No-React®Dura Shield Proprietary name: Common name : Dura Substitute
II. Regulatory Class:
Class II device
III. Intended Use
The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.
V. Product Description
The Shelhigh No-React® dura Substitute is a glutaraldehyde fixed sheet of bovine pericardium.rinsed with the detoxification process No-React®. The device is provided sterile in a 2% benzyl alcohol solution, packaged in a glass jar. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.
The material exhibits excellent biocompatibility. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldhyde processed bovine pericardium has a long history of success as a permanently implanted material.
VI. Substantial Equivalence
It is substantially equivalent to the Dura Guard®manufactured ny Bio-vascular and identical to the Shelhigh No-React® pericardial Patch manufactured by Shelhigh Inc..
VII. Comparison with Predicate Device
The Shelhigh No-React® Dura Shield like the Shelhigh No-React®pericardial patch and like the Dura quard is a glutaraldehyde cross-linked bovine pericardium membrane which exhibits substantially equivalent
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physical/mechnical properties as measured by suture retention, tensile strength, and shrink temperature. The only difference is the addition of the detoxification process No-React®.
Extensive validation of the effectiveness of the Patch with the Extonoro validation process, No-React® indicates that these differences do not pose new questions of safety and effectiveness.
Nonclinical / Animal Tests VIII.
Physical/Mechanical test information is discussed above . An animal study was conducted to evaluate Shelhigh No-React® vs. the conventional glutaraldehyde treated patch, the Shelhigh No-React® patch shows higher level of biocompatibility.
IX. Conclusions
The non clinical /Animal testing data showed that the Shelhigh No-React® patch has high level of cytocompatibility when compared with the conventional glutaraldehyde treated and storage. The Shelhigh No-React® performance in a substantially equivalent to the predicate device and there were no significant differences between the two devices which pose new questions of safety and effectiveness.
Page 2 of 2 of Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, represented by three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2000
Shlomo Gabbay, MD Chief Scientific Officer Shelhigh, Inc. P.O. Box 884 Millburn, New Jersey 07041
K982101 Re: Trade Name: No-React® Dura Shield Regulatory Class: II Product Code: GXQ Dated: February 28, 2000 Received: March 7, 2000
Dear Dr. Gabbay:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your booker by (2) is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls Continer 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 (Premarket Approval), it may be subject to such additional controls. Existing major (1 remains affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Shlomo Gabbay, MD
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
bmux R. bochner.
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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Page _ 1_of __ 1__
510(k) Number (if known): 长ያያረ | o |
Device Name: Shelhigh No-React® Dura Shield Indications For Use:
The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
Irma R. Kocher.
(Division Sign-Off) (Division Sign-Orr)
Division of General Restorative Devices 510(k) Number K98210
§ 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).