(101 days)
For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.
The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized according to your requested information.
Please note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/ML device. Therefore, some of the requested information (especially points 2, 3, 4, 5, 8, and 9) is not applicable or cannot be extracted from this type of regulatory submission. The device described is a traditional medical device (vascular grafts) and not an AI/ML powered device.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The document states that the proposed devices ("HEMASHIELD® MICROVEL® Double Velour Knitted" and "HEMASHIELD® Woven Double Velour Vascular Grafts" with modified collagen manufacturing) were tested for various characteristics to demonstrate substantial equivalence to their currently marketed PMA approved predicate devices. The acceptance criterion for each test was effectively "equivalent to marketed product."
| Test Parameter | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Burst Strength | Equivalent to marketed product | equivalent to marketed product |
| Tensile Strength | Equivalent to marketed product | equivalent to marketed product |
| Suture Pull Out | Equivalent to marketed product | equivalent to marketed product |
| Wall Thickness | Equivalent to marketed product | equivalent to marketed product |
| Longitudinal Stretch | Equivalent to marketed product | equivalent to marketed product |
| Needle Penetration | Equivalent to marketed product | equivalent to marketed product |
| Crush Resistance | Equivalent to marketed product | equivalent to marketed product |
| Flexural Rigidity | Equivalent to marketed product | equivalent to marketed product |
| Integral Water Permeability | Equivalent to marketed product | equivalent to marketed product |
| Integral Water Permeability under load | Equivalent to marketed product | equivalent to marketed product |
| Strength of Collagen Bonding | Equivalent to marketed product | equivalent to marketed product |
| Shrinkage Temperature | Equivalent to marketed product | equivalent to marketed product |
| Glycerol Content | Equivalent to marketed product | equivalent to marketed product |
| Collagen Content | Equivalent to marketed product | equivalent to marketed product |
| Scanning Electron Micrographs | Equivalent to marketed product | equivalent to marketed product |
Additionally, "Biocompatibility Testing" was performed to demonstrate safety for intended use and substantial equivalence in biocompatibility to the currently marketed PMA approved devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes for the various mechanical and material tests conducted. There is no mention of data provenance (e.g., country of origin) or whether the data was retrospective or prospective. Given the nature of the tests, it's typically laboratory testing of manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device and testing described. The ground truth for mechanical/material properties is established through standardized laboratory testing methods, not by expert consensus in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical image interpretation or diagnostic performance studies involving human readers, which is not the case here.
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
No, an MRMC comparative effectiveness study was not done. This device is a vascular graft, not an AI-powered diagnostic tool, and involves no human readers in its functional assessment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done, as the testing described (Burst Strength, Tensile Strength, etc.) evaluates the device's physical and material properties directly, without human interaction with the device during the test itself. This is not an "algorithm only" standalone performance as in AI, but rather a direct characterization of the physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the test set was established by the characteristics and performance of the predicate devices (currently marketed PMA approved HEMASHIELD® devices). The studies aimed to show that the new devices were "equivalent to marketed product" across a range of physical, mechanical, and material properties. This is a "predicate comparison" ground truth rather than a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
This information is not applicable. There is no mention of a "training set" as this is not an AI/ML device. The "training" for such a device would be the manufacturing process development itself, not a data-driven model training.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set mentioned or implied for this type of medical device submission.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Owner: | Meadox Medicals. Inc.112 Bauer DriveOakland, NJ 07436(201) 337-6126Fax # (201) 337-5797 | FEB - 1 1996 |
|---|---|---|
| Contact Person: | Carolyn TauberSenior Regulatory Affairs Specialist | |
| Submission Date: | ||
| Device Name: | HEMASHIELD® CARDIOVASCULAR GRAFTS:HEMASHIELD® MICROVEL® Double Velour Knitted Vascular GraftsHEMASHIELD® Woven Double Velour Vascular Grafts | |
| Predicate Devices: | HEMASHIELD® CARDIOVASCULAR GRAFTS:HEMASHIELD® Knitted MICROVEL® Double Velour Vascular Grafts(PMA #P840029. approved April 26, 1989)HEMASHIELD® Woven Double Velour Vascular Grafts(PMA #P840029; S5. approved May 11, 1993) | |
| Description of Device: | The HEMASHIELD® CARDIOVASCULAR GRAFTS are knittedand woven polyester grafts. impregnated with bovine collagen. | |
| Intended Uses: | For use in the replacement or repair of arteries affected withaneurysmal or occlusive disease. which is substantially equivalentto the currently marketed devices. |
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CONFIDENTIAL
Substantial Equivalence: The proposed HEMASHIELD® MICROVEL® Double Velour Knitted and HEMASHIELD® Woven Double Velour Velour Grafts have identical design, components, materials, intended use, and labeling to the currently marketed devices with PMA approval. The only difference between the proposed and the currently marketed devices is there are some modifications in the manufacturing process for the collagen component of the proposed devices. Testing has been performed which demonstrates that in spite of these modifications in the collagen manufacturing process, the proposed devices are substantially equivalent to the currently marketed PMA approved devices.
Product Testing: The following testing has been conducted on HEMASHIELD® MICROVEL® Double Velour Knitted and HEMASHIELD® Woven Double Velour Vascular Grafis to demonstrate the equivalency in safety and efficacy of these devices to their currently marketed PMA approved devices
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Burst Strength
-
· Tensile Strength
-
Suture Pull Out
-
Wall Thickness
-
Longitudinal Stretch
-
· Needle Penetration
-
Crush Resistance
-
· Flexural Rigidity
-
· Integral Water Permeability
-
· Integral Water Permeability under load
-
Strength of Collagen Bonding
-
· Shrinkage Temperature
-
Glycerol Content
-
· Collagen Content
-
· Scanning Electron Micrographs
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
-
equivalent to marketed product
Biocompatibility Testing: Testing performed in accordance with ISO 9000 Standards indicates that the HEMASHIELD® Woven Double Velour and HEMASHIELD® MICROVEL® Double Velour Knitted Velour and Grafts with modifications in the manufacturing process for the collagen component are safe for the intended use and substantially equivalent in blocompatibility to the currently marketed PMA approved devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 1 1996
Ms. Carolyn Tauber Senior Regulatory Affairs Specialist Meadox Medicals, Inc. 112 Bauer Drive Oakland, New Jersey 07436
Re: K954848 HEMASHIELD® MICROVEL® Double Velour Knitted and HEMASHIELD® Woven Double Velour Vascular Grafts Requlatory Class: II (two) Product Code: 74MAL October 20, 1995 Dated: October 23, 1995 Received:
Dear Ms. Tauber:
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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulation.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has
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Page 2 - Ms. Carolyn Tauber
identified under Section 522(a)(1)(A) the device cleared for marketing by this letter as requiring postmarket surveillance.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Suite 405 (HFZ-544) 1801 Rockville Pike Rockville, Maryland 20852
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's You should not begin your postmarket action in writing. surveillance study of this device until the protocol has been Data generated under an unapproved protocol may not approved. satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301 (q) (1) (C) of the Act (21 U.S.C. Further, under section 502(t)(3) of the act (21 331 (q) (1) (C) . U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 52% of Violations of sections 301 or 502 may lead to the act. regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
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Page 3 - Ms. Carolyn Tauber
In addition, on August 16, 1993, the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 Be advised that under Section 519(e) of the Act (copy enclosed). as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients The specific requirement of the regulation are who receive them. found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling If you desire specific advice for your as being approved by FDA. device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at (301) 594-4639. 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 at (301) 443-6597.
Sincerely yours,
DA Spahn
Thomas J. Callahan, Ph.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”