(687 days)
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Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a bovine pericardium substitute, with no mention of AI or ML.
Yes
The device is described as a "dura Substitute" used for "closure of dura mater during neurosurgery," indicating it is used to treat a medical condition or injury.
No
Explanation: The device is a surgical implant (dura substitute) used for closure during neurosurgery, not for diagnosing medical conditions.
No
The device description clearly states it is a "glutaraldehyde fixed sheet of bovine pericardium" and is provided as a physical material in a glass jar, 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 "as a dura Substitute for closure of dura mater during neurosurgery." This describes a surgical implant used in vivo (within the body) to replace or repair tissue.
- Device Description: The description details a physical material (bovine pericardium) used as a surgical patch.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such diagnostic testing on specimens.
Therefore, the Shelhigh No-React® dura Substitute is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use as a dura Substitute for closure of dura mater during neurosurgery.
Product codes (comma separated list FDA assigned to the subject device)
GXQ
Device 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
dura mater
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical / Animal Tests: 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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).
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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
1
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