(24 days)
Not Found
No
The summary describes a biological implant material and its physical and biological properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to cover orbital implants in enucleation surgery to facilitate tissue ingrowth, protect surrounding tissue, and allow muscle reattachment for motility, all of which are actions aimed at treating or alleviating a condition.
No
This device is described as an orbital implant wrap, used to cover and protect orbital implants, facilitate tissue ingrowth, and allow muscle reattachment. Its function is reconstructive/supportive, not to diagnose a condition or disease.
No
The device description clearly states it is prepared from bovine pericardium, which is a biological material, not software. The performance studies also focus on the physical and biological properties of this material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as an orbital implant wrap used in surgery. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is made from bovine pericardium and is a physical implant.
- No mention of in vitro testing: There is no indication that this device is used to test samples outside of the body.
Therefore, Ocu-Guard Supple falls under the category of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.
Product codes
86 HQX
Device Description
Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orbital
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
Cross-linked pericardium was treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOH-treated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical resting. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.3340 Extraocular orbital implant.
(a)
Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.(b)
Classification. Class II.
0
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant Name & Address: | Bio-Vascular, Inc.
2575 University Avenue
St. Paul, MN 55114-1024
Fax: (651) 642-9018 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dianna L. Geck
Regulatory Affairs Associate
Phone: (651) 603-3700 |
| Date Prepared: | September 9, 1998 |
| Common or Usual Name: | Ocu-Guard Supple™ Orbital Implant Wrap (Flat & Preformed) |
| Device Classification Name: | Eye sphere implant |
| Substantial Equivalence: | Ocu-Guard Supple K973552 |
| Device Description: | Ocu-Guard Supple is prepared from bovine pericardium
which is cross-linked with glutaraldehyde. |
| Statement of Intended Use: | Ocu-Guard Supple is indicated for use as an orbital implant
wrap to cover any type or shape of orbital implant used in
enucleation surgery. The product is easy to handle and trim
and conforms to the shape of the implant. Ocu-Guard
Supple allows for tissue ingrowth through the vascularization
process and protects the surrounding orbital tissue from the
surface of the orbital implant, decreasing the risk of implant
exposure. Ocu-Guard Supple also allows for muscle
reattachment to facilitate motility of the implant. |
Summary/Comparison of Technological Characteristics:
Cross-linked pericardium was treated with 1 molar sodium hydroxide (1M NaOH) for 60-75 minutes at 20 -25 C, rinsed with deionized (DI) water and neutralized with citrate solution, followed by a final DI water rinse. Sodium hydroxide treated and control (non-NaOH-treated) samples were subjected to shrink, suture, and thickness testing. Results showed no significant difference between the test and control samples. The test and control samples were subjected to bioburden, sterility, pH, pyrogen, and chemical resting. Results showed no significant difference between the test and control samples. Samples of the NaOH-treated pericardium were also subjected to biocompatibility and animal testing. Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium.
Bio-Vascular believes that product subjected to 1M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness.
1
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 caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 1998 NOV
Bio-Vascular, Inc. c/o Dianna L. Geck Regulatory Affairs Associates 2575 University Avenue St. Paul, MN 55114-1024
Re: K983581 Trade Name: Ocu-Guard ™ Supple Orbital Implant Wrap (Flat&Performed) Regulatory Class: II Product Code: 86 HQX Dated: October 9, 1998 Received: October 13, 1998
Dear Ms. Geck:
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 (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 - Ms. Dianna L. Geck
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) 594-4613. 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,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K98 3581 510(k) Number (if known):
Ocu-Guard™ Supple Orbital Implant Wrap (Flat & Preformed) Device Name:
Indications for Use:
Ocu-Guard Supple is indicated for use as an orbital implant wrap to cover any type or shape of orbital implant used in enucleation surgery. The product is easy to handle and trim and conforms to the shape of the implant. Ocu-Guard Supple allows for tissue ingrowth through the vascularization process and protects the surrounding orbital tissue from the surface of the orbital implant, decreasing the risk of implant exposure. Ocu-Guard Supple also allows for muscle reattachment to facilitate motility of the implant.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Gougé Acting Branch Chief
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K983581
Prescription Use -Per 21 CFR 801.109
OR
Over-The-Counter Use