(86 days)
Not Found
No
The summary describes a biological patch for dural repair and does not mention any AI or ML components or functionalities.
No
The device is a dural substitute for closure, which is a structural repair, not a therapeutic treatment for a disease or condition.
No
Explanation: The device is described as a dural substitute for closure of dura mater during neurosurgery, which is a therapeutic rather than a diagnostic function. The performance studies also focus on physical properties and biocompatibility as a repair patch, not on detecting or diagnosing medical conditions.
No
The device description clearly states it is a physical patch manufactured from bovine pericardium, 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 "For use as a dural substitute for the closure of dura mater during neurosurgery." This describes a device used in vivo (within the body) during a surgical procedure to repair tissue.
- Device Description: The device is a "dural repair patch manufactured from bovine pericardium." This is a physical implant used for structural support.
- 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. The provided description does not mention any such use or interaction with patient specimens.
Therefore, Dura-Guard, as described, is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use as a dural substitute for the closure of dura mater during neurosurgery.
Product codes
GXO
Device Description
Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dura mater
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)
Product samples were subjected to various antibiotic treatments. Both control and test samples were subjected to burst strength, suture retention, ultimate tensile and shrink temperature testing. Results showed no significant difference between the test and control articles. Biocompatibility testing also showed no significant difference between the test and control articles. BVI believes that product subjected to antibiotics perform in a manner substantially equivalent to product not subjected to antibiotics, and that the exposure to antibiotics poses no additional questions of safety or effectiveness.
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.
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
§ 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).
0
5973706
Bio-Vascular, Inc.
DEC 2 4 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant Name & Address: | Bio-Vascular, Inc., 2575 University Ave., St. Paul,
MN 55114-1024 | |
|-----------------------------|----------------------------------------------------------------------|--|
| Contact: | Barbara Atzenhoefer, Regulatory Affairs Manager | |
| Date Prepared: | September 26, 1997 | |
| Common or Usual Name: | Dura-Guard® | |
| Device Classification Name: | Dural Repair Patch | |
| Substantial Equivilance: | Dura-Guard K950956 | |
Dura-Guard is a dural repair patch manufactured from bovine Device Description: pericardium cross-linked with glutaraldehyde.
Statement of Intended Use:
For use as a dural substitute for the closure of dura mater during neurosurgery.
Summary/Comparison of Technological Characteristics:
Product samples were subjected to various antibiotic treatments. Both control and test samples were subjected to burst strength, suture retention, ultimate tensile and shrink temperature testing. Results showed no significant difference between the test and control articles. Biocompatibility testing also showed no significant difference between the test and control articles. BVI believes that product subjected to antibiotics perform in a manner substantially equivalent to product not subjected to antibiotics, and that the exposure to antibiotics poses no additional questions of safety or effectiveness.
F:\DATA\WP\REGAFF\SUBMISON\USA\DG\ANTIBIO.1
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 4 1997
Ms. Barbara Atzenhoefer Regulatory Affairs Manager Bio-Vascular, Inc. 2575 University Avenue Saint Paul, Minnesota 55114-1024
Re: K973706
Trade Name: Dura-Guard - Dura Repair Patch Regulatory Class: II Product Code: GXO Dated: September 26, 1997 Received: September 29, 1997
Dear Ms. Atzenhoefer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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.
2
Page 2 - Ms. Barbara Atzenhoefer
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,
Willy Wold
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K97 3 J O _ 6
Device Name: Dura-Guard - Dural Repair Patch
Indications for Use:
For use as a dural substitute for the 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 X Per 21 CFR 801.109
OR
Over-The-Counter Use
Ulan will
(Division Sign-Off) Division of General Restorative Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________