(24 days)
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.
Ocu-Guard Supple is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
The provided text describes a 510(k) summary for the Ocu-Guard Supple Orbital Implant Wrap, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance metrics in the way that might be seen for a new, complex algorithm or diagnostic device.
Therefore, many of the requested categories for acceptance criteria and study design are not directly applicable or extractable from this type of regulatory submission. The submission is primarily interested in showing that a modification to an existing product (adding a 1M NaOH treatment) does not negatively impact its safety or effectiveness compared to the previous version of the product.
Here's an attempt to answer as much as possible based on the provided text, with clarifications where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as thresholds, but implied to show no significant difference) | Reported Device Performance |
|---|---|---|
| Material Properties | No significant difference in shrink, suture, and thickness for NaOH-treated vs. control samples. | Results showed no significant difference between the test (NaOH-treated) and control samples. |
| Biocompatibility | No significant difference in biocompatibility for NaOH-treated vs. non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility. |
| Inflammation | No significant difference in inflammation for NaOH-treated vs. non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in inflammation. |
| Safety Testing | No significant difference in bioburden, sterility, pH, and pyrogen for NaOH-treated vs. control samples. | Results showed no significant difference between the test (NaOH-treated) and control samples. |
| Chemical Testing | No significant difference in chemical characteristics for NaOH-treated vs. control samples. | Results showed no significant difference between the test (NaOH-treated) and control samples. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the "test" (NaOH-treated) and "control" (non-NaOH-treated) groups for the various tests (shrink, suture, thickness, bioburden, sterility, pH, pyrogen, chemical, biocompatibility, animal testing).
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given it's a 510(k) submission for a manufacturing change, the data would typically be generated by the manufacturer (Bio-Vascular, Inc.) during product development and testing, implying a prospective and in-house provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to the type of device and study described. The "ground truth" here is objective laboratory measurements (e.g., shrink, suture strength, pH values) and observations in animal models by scientists/technicians, not expert medical opinion on, for example, diagnostic images.
4. Adjudication method for the test set
Not applicable. This device's evaluation is based on objective measurements and animal studies, not subjective assessments requiring adjudication among experts.
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
Not applicable. This is not an AI/imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this evaluation was based on a combination of:
- Physical property measurements: Shrinkage, suture retention, thickness.
- Biochemical/Microbiological assays: Bioburden, sterility, pH, pyrogen, chemical analysis.
- Biological responses in animal models: Biocompatibility and inflammation, observed in animal testing.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses training sets. The study described involves comparing two versions of a physical medical device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned for this product.
{0}------------------------------------------------
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant Name & Address: | Bio-Vascular, Inc.2575 University AvenueSt. Paul, MN 55114-1024Fax: (651) 642-9018 |
|---|---|
| Contact: | Dianna L. GeckRegulatory Affairs AssociatePhone: (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 pericardiumwhich is cross-linked with glutaraldehyde. |
| Statement of Intended Use: | Ocu-Guard Supple is indicated for use as an orbital implantwrap to cover any type or shape of orbital implant used inenucleation surgery. The product is easy to handle and trimand conforms to the shape of the implant. Ocu-GuardSupple allows for tissue ingrowth through the vascularizationprocess and protects the surrounding orbital tissue from thesurface of the orbital implant, decreasing the risk of implantexposure. Ocu-Guard Supple also allows for musclereattachment 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 .
{2}------------------------------------------------
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
{3}------------------------------------------------
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
§ 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.