(30 days)
CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
CV Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
The provided 510(k) summaries (K983602 for CV Peri-Guard, Vascu-Guard, and Supple Peri-Guard) do not describe a study involving acceptance criteria in the typical sense of a diagnostic or AI device performance study. Instead, these summaries focus on establishing substantial equivalence to predicate devices by comparing the technological characteristics of a modified manufacturing process (1M NaOH treatment).
The acceptance criteria here are implicitly met by demonstrating "no significant difference" in various tests between the NaOH-treated pericardium and the control (non-NaOH-treated) pericardium. The study performed is a series of laboratory and animal tests to support the safety and effectiveness of the modified product.
Here's a breakdown of the information requested, based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant difference in shrink testing between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in suture testing between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in thickness testing between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in bioburden between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in sterility between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in pH between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in pyrogenicity between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in chemical residuals between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant differences in biocompatibility when comparing treated versus non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility when comparing the treated versus non-treated pericardium. |
| No significant differences in inflammation when comparing treated versus non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in inflammation when comparing the treated versus non-treated pericardium. |
| Does not pose additional questions of safety or effectiveness. | 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. (This is the conclusion based on all the above tests, supporting substantial equivalence rather than explicit performance metrics against a defined threshold.) |
2. Sample Size for the Test Set and Data Provenance
The documents do not specify the exact sample sizes used for each individual test (shrink, suture, thickness, bioburden, sterility, pH, pyrogen, chemical residuals, biocompatibility, and animal testing). The data provenance is implied to be from in vitro laboratory testing and in vivo animal testing. No country of origin for the data is explicitly stated, but the applicant is based in the USA. The studies would be considered prospective in the context of evaluating the new manufacturing process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study (material characterization and animal testing for substantial equivalence) does not typically involve "experts establishing ground truth" in the way a diagnostic imaging study would. The acceptance criteria are based on measurable physical, chemical, and biological properties, which are assessed by standard laboratory methodologies. The interpretation of animal testing results would be done by qualified veterinarians and pathologists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. This is not a study that involves human interpretation requiring adjudication. Performance is based on objective laboratory measurements and animal observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic device or an AI system that would typically undergo an MRMC study. The study compares material properties and biological responses of a physical patch, not human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical patch material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this study is derived from:
- Objective laboratory measurements: For physical characteristics (shrink, suture, thickness) and chemical/biological properties (bioburden, sterility, pH, pyrogen, chemical residuals).
- Animal testing results: For biocompatibility and inflammation, which would involve macroscopic and microscopic observations by trained personnel (e.g., pathologists).
The comparison is made against the control samples (non-NaOH-treated pericardium), which represent the established predicate device's characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device evaluation.
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K9 8 3602
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Applicant Name & Address:NOV 12 1998 | 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: | CV Peri-Guard™ Cardiovascular Patch |
| Device Classification Name: | Intracardiac patch or pledget |
| Substantial Equivalence: | CV Peri-Guard K971726 |
| Device Description: | CV Peri-Guard is prepared from bovine pericardium which iscross-linked with glutaraldehyde. |
| Statement of Intended Use: | CV Peri-Guard is intended for use as a patch material forintracardiac defects, great vessel, septal defect and annulusrepair, and suture-line buttressing. |
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.
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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: | Vascu-Guard® Peripheral Vascular Patch |
| Device Classification Name: | Intracardiac patch or pledget |
| Substantial Equivalence: | Vascu-Guard K942010 |
| Device Description: | Vascu-Guard is prepared from bovine pericardium which iscross-linked with glutaraldehyde. |
| Statement of Intended Use: | Vascu-Guard is intended for peripheral vascularreconstruction including the carotid, renal, iliac, femoral,profunda, and tibial blood vessels and arteriovenous accessrevisions |
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 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.
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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: | Supple Peri-Guard® Pericardium |
| Device Classification Name: | Mesh, surgical, polymeric |
| Substantial Equivalence: | Supple Peri-Guard K961810, K921895 |
| Device Description: | Supple Peri-Guard is prepared from bovine pericardiumwhich is cross-linked with glutaraldehyde. |
| Statement of Intended Use: | Supple Peri-Guard is intended for the repair of pericardialstructures and for use as a prosthesis for the surgical repairof soft tissue deficiencies which include: defects of theabdominal and thoracic wall, gastric banding, muscle flapreinforcement, rectal and vaginal prolapse, reconstruction ofthe pelvic floor, and hernias (including diaphragmatic,femoral, incisional, inguinal, lumbar, paracolostomy, scrotal,and umbilical hernias) |
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 residuals testing. 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.
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Image /page/3/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 three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 12 1998
Ms. Dianna L. Geck Regulatory Affairs Associate Bio-Vascular, Inc 2575 University Avenue Saint Paul, MN 55114-1024
Re: K983602 Various Tissue Patches Requlatory Class: II Product Code: DXZ Dated: October 9, 1998 October 13, 1998 Received:
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 legally marketed predicate 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. Any promotional or advertisement materials referring to the sodium hydroxide treatment must contain the lanquaqe agreed upon regarding reducing infectivity.
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have
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Page 2 - Ms. Dianna L. Geck
under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4648. 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahar Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K98 3602 510(k) Number (if known):
CV Peri-Guard™ Cardiovascular Patch Device Name:
Indications for Use:
CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices ka83602 510(k) Number _
Prescription Use Per 21 CFR 801.109
OR
Over-The-Counter Use
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510(k) Number (if known): KAB
Vascu-Guard® Peripheral Vascular Patch Device Name:
Indications for Use:
Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _
Prescription Use Per 21 CFR 801.109 OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
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Supple Peri-Guard® Pericardium Device Name:
Indications for Use:
Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hemias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
(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
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).