HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT

K012952 · Boston Scientific/Medi-Tech · DSY · Oct 2, 2001 · Cardiovascular

Device Facts

• Record ID: K012952
• Device Name: HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
• Applicant: Boston Scientific/Medi-Tech
• Product Code: DSY · Cardiovascular
• Decision Date: Oct 2, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hemashield Gold ™ Woven Double Velour Vascular Graft is 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 Gold Woven Double Velour Vascular Graft is a synthetic vascular prosthesis; branch graft configuration features 1-4 branches. Device replaces or repairs diseased arteries (aneurysmal or occlusive). Used by surgeons in clinical settings. Device functions as a conduit for blood flow. Substantial equivalence based on identical materials, manufacturing, operating principles, and indications as predicate Hemashield Gold Woven Double Velour Vascular Graft line. Verification testing confirms performance metrics (permeability, burst strength, dimensions) remain consistent with existing product line.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included visual inspection, water/air permeability, burst strength, crimp, dimensions, pyrogenicity, acute systemic toxicity, irritation, hemocompatibility, cytotoxicity, mutagenicity, subchronic toxicity, and implantation studies with histopathology.

Technological Characteristics

Woven double velour vascular graft. Materials and manufacturing processes are identical to the predicate Hemashield Gold line. Technical specifications include water permeability ≤ 4.0 mL/cm²/min, burst pressure > 399.9 lb/inch², and specific dimensional tolerances for main and branch grafts. Sterilization and packaging processes are identical to the predicate.

Indications for Use

Indicated for replacement or repair of arteries affected by aneurysmal or occlusive disease in patients requiring systemic heparinization prior to or 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 Woven Double Velour Vascular Graft (K012952)

Submission Summary (Full Text)

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K012952

OCT - 2 2001

Special 510(k) - Device Modification Hemashield Gold Woven Double Velour Branch Graft August 31, 2001

#### Section 5

## Summary of Substantial Equivalence

previously in this submission, Summary of As shown the Branch Graft Configurations is different from the rest of the Hemashield Gold Woven Modifications Double Velour Vascular Graft product line only in the 1-4 branch configuration in which the grafts are sewn. The modified vascular grafts have the following similarities to those Substantial which received previously received 510(k) concurrence: Equivalence Identical indications for use ● Identical labeling ● Identical manufacturing processes . Identical operating principle . Incorporate identical materials . Have the identical shelf-life (5 years) . Are packaged and sterilized using identical packaging materials ● and processes

In summary, the Branch Graft configuration of the Hemashield Gold Woven Double Velour Vascular Graft product line described in this submission are equivalent to the predicate device.

Continued on next page

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## Summary of Substantial Equivalence, Continued

Summary of Design Control Activities

The design verification tests below are a combination of standard release tests and in-process functional tests conducted on the Hemashield Woven Double Velour Vascular Graft product line. Also included in this list are biocompatibility and shelf life tests conducted on Hemashield Woven Double Velour Vascular Grafts. There is no change to these tests or to their acceptance criteria for the Branch Graft line extension.

| | Test Performed | Acceptance Criteria |
|----|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Visual Inspection -<br>Stains | $\le$ 0.05mm² |
| 2 | Visual Inspection -<br>Foreign Matter | $\le$ 0.03mm² |
| 3 | Water Permeability | Accept: if $\le$ 4.0 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$<br>Reject: if > 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$<br>Repeat test if > 4.0 and $\le$ 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$<br>If re-test values are all < 4.5 mL $\cdot$ cm $^{-2}\cdot$ min $^{-1}$ then<br>batch is acceptable. |
| 4 | Burst | > 399.9 lb/inch² |
| 5 | Crimp | 12.0 turns/inch - circular |
| 6 | Usable Length | Main Graft - 45 ± 5cm<br>Head Branches - 17.5 ± 2.5cm<br>Perfusion Branch - 22.5 ± 2.5cm |
| 7 | Inner Diameter | $\le$ 10.0 mm sizes; nominal diameter ± 0.5 mm<br>> 10.0 mm sizes; nominal diameter ± 1.0 mm |
| 8 | Visual Inspection -<br>Sewing | No sewing defects |
| 9 | Air Permeability | $\le$ 24.5 - 43.5 l/m (depending upon size) |
| 10 | Pyrogenicity: Rabbit<br>Pyrogen | Pass |
| 11 | Acute Systemic<br>Toxicity: Acute Systemic<br>Injection | Pass |
| 12 | Irritation: Acute<br>Intracutaneous Reactivity | Pass |
| 13 | Hemocompatibility:<br>Hemolysis | Pass |
| 14 | Cytotoxicity: ISO L929<br>MEM Elution | Pass |
| 15 | Mutagenicity: Ames Test<br>(Saline extract) | Pass |

Continued on next page

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# Summary of Substantial Equivalence, Continued

| 16 | Subchronic toxicity: 14<br>day IV injection in rats | Pass |
|----|---------------------------------------------------------------------------|-----------------------------------------|
| 17 | Implantation: ISO<br>Muscle Implantation with<br>histopathology (2 week) | Pass |
| 18 | Implantation: ISO<br>Muscle Implantation with<br>histopathology (12 week) | Pass |
| 19 | Physiochemical | Pass |
| 20 | Shelf Life Testing | Meets Product Specification after aging |

All testing was done with standard test methods for these parameters. All testing was dono with Stanch Granch Graft configuration is substantially All tooling onews and ate device. No new issues of safety or equivalent to the products echaration of conformity with design controls is included in Attachment 3.

| 510(k)<br>Statement | A 510(k) Summary and Certification can be found in Attachment 4. |
|---------------------------------------|------------------------------------------------------------------------|
| Truthful and<br>Accuracy<br>Statement | A certification of Truthful and Accuracy can be found in Attachment 5. |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body, facing right. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012952

> Hemashield Gold Woven Double Velour Vascular Graft-Branch Graft Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular graft prosthesis of 6 millimeters and greater diameter. Regulatory Class: II Product Code: DSY Dated: August 31, 2001 Received: September 4, 2001

Dear Ms. Bolton:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) 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 general controls 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

OCT - 2 2001

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Page 2 - Ms. Jennifer Bolton

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) This letter wification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated. The aclassification 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 11 you desire specific and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 011 594-4586. Additionally, for questions on the promotion and advertising of Compliance at (301) 51 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 Oiler general 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,

James E. Dillard III

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications For Use

| 510(k) Number (if known) | Unknown K012952 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Hemashield Gold Woven Double Velour Vascular Graft - Branch Graft |
| Indications for Use | The Hemashield Gold ™ Woven Double Velour Vascular Graft is 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. |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

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 K012952

.