(101 days)
Not Found
Not Found
No
The device description and performance studies focus on the material properties and physical performance of a vascular graft, with no mention of AI or ML technologies.
Yes
The device is used for the replacement or repair of diseased arteries, which directly treats a medical condition.
No
The device is described as a replacement or repair for arteries, indicating it is a therapeutic device, not a diagnostic one. The performance studies also focus on material properties and equivalency, not diagnostic accuracy.
No
The device description explicitly states it is a "knitted and woven polyester graft, impregnated with bovine collagen," which is a physical implantable device, not software. The performance studies also focus on physical properties like burst strength, tensile strength, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "replacement or repair of arteries affected with aneurysmal or occlusive disease." This describes a surgical implant used directly within the body to treat a physical condition.
- Device Description: The device is a "knitted and woven polyester graft, impregnated with bovine collagen." This is a physical medical device designed for implantation.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, this device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. which is substantially equivalent to the currently marketed devices.
Product codes (comma separated list FDA assigned to the subject device)
74MAL
Device Description
The HEMASHIELD® CARDIOVASCULAR GRAFTS are knitted and woven polyester grafts. impregnated with bovine collagen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arteries
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Burst Strength - equivalent to marketed product
- · Tensile Strength - equivalent to marketed product
- Suture Pull Out - equivalent to marketed product
- Wall Thickness - equivalent to marketed product
- Longitudinal Stretch - equivalent to marketed product
- · Needle Penetration - equivalent to marketed product
- Crush Resistance - equivalent to marketed product
- · Flexural Rigidity - equivalent to marketed product
- · Integral Water Permeability - equivalent to marketed product
- · Integral Water Permeability under load - equivalent to marketed product
- Strength of Collagen Bonding - equivalent to marketed product
- · Shrinkage Temperature - equivalent to marketed product
- Glycerol Content - equivalent to marketed product
- · Collagen Content - equivalent to marketed product
- · Scanning Electron Micrographs - 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Owner: | Meadox Medicals. Inc.
112 Bauer Drive
Oakland, NJ 07436
(201) 337-6126
Fax # (201) 337-5797 | FEB - 1 1996 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Carolyn Tauber
Senior Regulatory Affairs Specialist | |
| Submission Date: | | |
| Device Name: | HEMASHIELD® CARDIOVASCULAR GRAFTS:
HEMASHIELD® MICROVEL® Double Velour Knitted Vascular Grafts
HEMASHIELD® 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 knitted
and woven polyester grafts. impregnated with bovine collagen. | |
| Intended Uses: | For use in the replacement or repair of arteries affected with
aneurysmal or occlusive disease. which is substantially equivalent
to the currently marketed devices. | |
1
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
-
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.
2
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
3
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.
4
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