(254 days)
No
The summary describes a woven polyester graft and does not mention any AI or ML components or functionalities.
Yes
The device is a vascular graft used for systemic vascular reconstructions in cases of aneurysmal or occlusive disease, which treats a medical condition.
No
Explanation: The device is a vascular graft used for replacement in systemic vascular reconstructions, not for diagnosing conditions.
No
The device description explicitly states it is a "woven polyester graft, impregnated with bovine collagen," which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "systemic vascular reconstructions... in the peripheral region." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a "woven polyester graft, impregnated with bovine collagen." This is a physical implant used to replace or repair blood vessels. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the HEMASHIELD VANTAGE™ Vascular Graft is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in systemic vascular reconstructions, e.g., replacement in the case of aneurysmal or occlusive disease, in the peripheral region.
Product codes
Not Found
Device Description
The HEMASHIELD VANTAGE™ Vascular Graft is a woven polyester graft, impregnated with bovine collagen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral region
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
The following testing has been conducted on HEMASHIELD Product Testing: VANTAGE™ Vascular Grafts to demonstrate the equivalency in safety and efficacy of these devices to their currently marketed predicate devices.
- · Burst Strength
- · Tensile Strength
- · Suture Pull Out
- · Wall Thickness
- · Needle Penetration
- · Crush Resistance
- · Flexural Rigidity
- · Integral Water Permeability
- · Integral Water Permeability under load
- · Strength of Collagen Bonding
- · Shrinkage Temperature
- · Glycerol Content
- · Collagen Content
- · Hydrolytic Stability Testing
- 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 VANTAGE™ Vascular Grafts fabricated from polyester textile materials and with the same collagen composition and method of manufacture as its predicate devices are safe for their intended use and substantially equivalent in biocompatibility to the currently marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
HEMASHIELD® CARDIOVASCULAR GRAFTS: HEMASHIELD® MICROVEL® Double Velour Knitted Vascular Grafts HEMASHIELD® Woven Double Velour Vascular Grafts [510(k) #K954848, determined substantially equivalent Feb. 1, 1996)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JAN 22 1997
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Meadox Medicals, Inc. Owner: 112 Bauer Drive Oakland, NJ 07436 (201) 337-6126 Fax# (201) 337-5797 Carolyn Tauber Contact Person: Senior Regulatory Affairs Specialist May 9, 1996 Submission Date: HEMASHIELD VANTAGE™ Vascular Grafts Device Name: Predicate Devices: HEMASHIELD® CARDIOVASCULAR GRAFTS: HEMASHIELD® MICROVEL® Double Velour Knitted Vascular Grafts HEMASHIELD® Woven Double Velour Vascular Grafts [510(k) #K954848, determined substantially equivalent Feb. 1, 1996) The HEMASHIELD VANTAGE™ Vascular Graft is a woven Description of Device: polyester graft, impregnated with bovine collagen. For use in systemic vascular reconstructions, e.g., replacement in the Intended Uses: case of aneurysmal or occlusive disease, in the peripheral region. The indications are substantially equivalent to the predicate devices, except for the specification of the region of application (peripheral region) of the devices.
1
The HEMASHIELD VANTAGE™ Vascular Graft is substantially Substantial Equivalence: equivalent in design, components, materials, intended use and labeling to the currently marketed predicate devices. The modifications in this device compared to the predicate devices are:
- It combines a smooth inner surface and veloured outer . surface in the same graft; predicate Meadox grafts have the same inner and outer surface: both surfaces are either smooth or velour.
- Like its predicate devices, it is intended for use in . vascular replacement in the case of aneurysmal or occlusive disease; with the exception that this device is intended for application in the peripheral region.
- The labeling is distinct from that for the predicate devices . to reflect the above described modifications in this device compared to the predicate devices.
Testing has been performed which demonstrates that in spite of these modifications in the proposed device, the proposed devices are substantially equivalent in safety and performance to the currently marketed predicate devices.
The following testing has been conducted on HEMASHIELD Product Testing: VANTAGE™ Vascular Grafts to demonstrate the equivalency in safety and efficacy of these devices to their currently marketed predicate devices.
- · Burst Strength
- · Tensile Strength
- · Suture Pull Out
- · Wall Thickness
- · Needle Penetration
- · Crush Resistance
- · Flexural Rigidity
- · Integral Water Permeability
- · Integral Water Permeability under load
- · Strength of Collagen Bonding
- · Shrinkage Temperature
- · Glycerol Content
- · Collagen Content
- · Hydrolytic Stability Testing
- 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
2
CONFIDENTIAL
Testing performed in accordance with ISO 9000 Standards Biocompatibility Testing: indicates that the HEMASHIELD VANTAGE™ Vascular Grafts fabricated from polyester textile materials and with the same collagen composition and method of manufacture as its predicate devices are safe for their intended use and substantially equivalent in biocompatibility to the currently marketed predicate devices.