MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS

K021213 · Boston Scientific Corp · MAL · Apr 19, 2002 · Cardiovascular

Device Facts

• Record ID: K021213
• Device Name: MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
• Applicant: Boston Scientific Corp
• Product Code: MAL · Cardiovascular
• Decision Date: Apr 19, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hemashield Platinum vascular grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Device Story

Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts are synthetic vascular prostheses used for arterial replacement or repair. Device functions as a conduit for blood flow in patients with aneurysmal or occlusive disease. Modification involves updated label claims regarding permeability compared to Hemashield Gold grafts. Device is implanted by surgeons in clinical settings. No change to manufacturing, materials, or operating principles.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical design, materials, and manufacturing processes to the predicate device.

Technological Characteristics

Woven/Microvel double velour vascular graft. Materials, manufacturing process, and sterilization methods are identical to the predicate device. Shelf-life is 5 years.

Indications for Use

Indicated for patients requiring arterial replacement or repair due to aneurysmal or occlusive disease, including those requiring systemic heparinization during surgery.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Hemashield Gold vascular grafts

Submission Summary (Full Text)

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### APR 1 9 2002

Ko2/a13

Special 510(k) -- Device Modification Hemashield Platinum Woven Double Velour Vascular Grafts Hemashield Platinum Microvel Double Velour Vascular Grafts April 9, 2002

## Section 5

# Summary of Substantial Equivalence

| Summary of<br>Modifications | As shown previously in this submission, the Hemashield Platinum<br>grafts are different from the Hemashield Gold grafts only in the label<br>claim for permeability. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The modified vascular grafts have the following similarities to those<br>which previously received 510(k) concurrence:<br><br>• Identical indications for use<br>• Identical labeling<br>• Identical manufacturing process flow<br>• Identical operating principle<br>• Incorporate identical materials<br>• Have the identical shelf-life (5 years)<br>• Are packaged and sterilized using identical packaging materials<br>and processes<br><br>In summary, the Hemashield Platinum vascular grafts described in this<br>submission are equivalent to the predicate device. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### APR 1 9 2002

Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

K021213 Re:

Trade Name: Modification to Hemashield Platinum Woven/Microvel Double Velour Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular graft prosthesis of 6 millimeters and greater diameter. Regulatory Class: Class II (two) Product Code: MAL Dated: April 16, 2002 Received: April 17, 2002

Dear Ms. Bolton:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for two based in the 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , aross provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - Ms. Jennifer Bolton, RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

hre

Donna Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) - Device Modification Hemashield Platinum Woven Double Velour Vascular Grafts Hemashield Platinum Microvel Double Velour Vascular Grafts April 9, 2002

## Indications For Use

| 510(k)<br>Number<br>(if known) | Unknown |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Name: | Hemashield Platinum Woven Double Velour Vascular Grafts<br>Hemashield Platinum Microvel Double Velour Vascular Grafts |
| Indications<br>for Use | The Hemashield Platinum vascular grafts are indicated for use in the<br>replacement or repair of arteries affected with aneurysmal or occlusive<br>disease. The prosthesis is also recommended for use in patients<br>requiring systemic heparinization prior to, or during, surgery. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use_ (Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices 510(k) Number_ Koz Z/Z-(Z-12-12-12-12-12-12-12