(108 days)
The ACUSEAL™ Cardiovascular Patch is indicated for use in cardiovascular patching.
The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovascular patch with an optional manufacturing modification consisting of an additional interpositional layer or layers of a fluoropolymer material. The additional material is intended to reduce suture hole bleeding through suture holes when stured into place using standard surgical techniques.
This document is a 510(k) premarket notification for the ACUSEAL™ Cardiovascular Patch. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed device performance data in the way a clinical trial for a new drug might.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or available within this type of regulatory submission. The primary method of demonstrating safety and effectiveness for a 510(k) is through comparison to already legally marketed predicate devices.
However, I can extract the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices) | Reported Device Performance (ACUSEAL™ Cardiovascular Patch) |
|---|---|---|
| Materials | Substantially equivalent to currently marketed ePTFE cardiovascular patch devices. | Composed of the same inert ePTFE biomaterial as the GORE-TEX® Cardiovascular Patch, plus an additional interpositional layer of a copolymer material. This is deemed substantially equivalent. |
| Mechanical Properties | Strength values substantially equivalent to predicate devices. | Mechanical testing data demonstrate the applicant device has strength values which are substantially equivalent to the predicate devices. |
| Tissue Response | Not adversely affected by the reduced bleeding feature. | In vivo testing demonstrates that the reduced bleeding feature of the applicant device does not adversely affect its material characteristics or its tissue response properties. |
| Safety/Effectiveness Issues | No new types of safety and effectiveness issues raised by the modification. | No new types of safety and effectiveness issues are raised by the modification of product design or materials to reduce suture hole bleeding. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The submission refers to "Mechanical testing data" and "In vivo testing" but does not provide specific sample sizes for these tests.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by or on behalf of the applicant, W.L. Gore & Associates, Inc., based in Flagstaff, AZ. The nature of the tests (mechanical and "in vivo") implies these were laboratory and/or animal studies rather than human clinical data. The submission does not specify if the in vivo testing was retrospective or prospective, but typically such testing would be prospective in an animal model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in a 510(k) submission as it's not typically required for establishing substantial equivalence through mechanical and in vivo testing. The "ground truth" here is compliance with established performance benchmarks or biological responses set by the predicate devices, not expert human interpretation of results in the way, for example, a diagnostic AI device would require.
4. Adjudication method for the test set
- Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this type of device comparison.
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 device is a cardiovascular patch, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used
- The "ground truth" in this context is based on engineering specifications and biological response data derived from mechanical testing and "in vivo" (likely animal model) studies, benchmarked against the established performance and safety profile of the predicate devices (GORE-TEX® Cardiovascular Patch and CVPro™ Cardiovascular Patch).
8. The sample size for the training set
- Not applicable. This device is a physical medical implant, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this device does not involve a training set as it's not an AI algorithm.
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4/8/99
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Tab 8
Summary of Safety and Effectiveness Page 1 of 2
Applicant:
W.L. Gore & Associates, Inc. 3450 West. Kiltie Lane P.O. Box 500 Flagstaff, AZ 86002-0500
Contact
Timothy J. Rynn
Date Prepared
December 11, 1998
Trade or Proprietary Name
ACUSEAL™ Cardiovascular Patch
Common or Usual Name
Cardiovascular Patch
Classification Name
Intracardiac patch or pledget made of polyethylene terephthalate, or polytetrafluoroethylene (21 CFR § 870.3470).
Device Predicates
GORE-TEX® Cardiovascular Patch (K811841 and K912107); CVPro™ Cardiovascular Patch (K943736).
Device Description
The ACUSEAL™ Cardiovascular Patch is an ePTFE cardiovascular patch with an optional manufacturing modification consisting of an additional interpositional layer or layers of a fluoropolymer material. The additional material is intended to reduce suture hole bleeding through suture holes when stured into place using standard surgical techniques.
Statement of Intended Use
Intended for use in cardiovascular patching; reduces bleeding through suture holes.
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Summary of Safety and Effectiveness Page 2 of 2
Substantial Equivalence
The applicant device is substantially equivalent in materials to currently marketed ePTFE cardiovascular patch devices. Mechanical testing data demonstrate the applicant device has strength values which are substantially equivalent to the predicate devices. In vivo testing demonstrates that the reduced bleeding feature of the applicant device does not adversely affect its material characteristics or its tissue response properties.
The applicant device is composed of the same inert ePTFE biomaterial as the GORE-TEX® Cardiovascular Patch, plus an additional interpositional layer of a copolymer material.
No new types of safety and effectiveness issues are raised by the modification of product design or materials to reduce suture hole bleeding.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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APR 8 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Timothy J. Rynn Requlatory Associate Medical Products Division W.L. Gore & Associates, Inc. 3450 West Kiltie Lane P.O. Box 500 Flaqstaff, AZ 86002-0500
Re: K984526 Acuseal™ Cardiovascular Patch Regulatory Class: II (Two) Product Code: DXZ Dated: March 22, 1999 Received: March 26, 1999
Dear Mr. Rynn:
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 leqally 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 aqainst misbranding and adulteration. Be advised that all promotional materials must also contain the warning regarding lack of clinical data to assess enhanced ingrowth and associated adverse effects.
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
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Page 2 - Mr. Timothy J. Rynn
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.
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 qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K984526 510(k) NUMBER (IF KNOWN): ACUSEALTM Cardiovascular Patch DEVICE NAME:
INDICATIONS FOR USE:
The ACUSEAL" Cardiovascular Patch is indicated for use in cardiovascular patching.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻟﮯ Prescription Use (Per 21 CFR 801.109)
OR
・・
Over-The-Counter-Use (Optional Format 1-2-96)
Bera L. Campell Ce
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_ 484
§ 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).