EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN

K052964 · Boston Scientific Corp · DSY · Jan 6, 2006 · Cardiovascular

Device Facts

• Record ID: K052964
• Device Name: EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
• Applicant: Boston Scientific Corp
• Product Code: DSY · Cardiovascular
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Standard Wall Exxcel™ and Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal) and to provide vascular access. Thin Wall Exxcel™ soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal). The Microvel Double Velour, Woven Double Velour and Cooley Veri-Soft Grafts are indicated for use in the replacement or repair of arteries affected by aneurysmal or occlusive disease (Descending Thoracic Aorta, Abdominal Aorta, Axillary, Iliac, Femoral, Popliteal, Renal).

Device Story

Vascular graft prostheses; synthetic ePTFE or polyester materials; used for arterial repair/replacement or vascular access. ePTFE grafts feature cross-helical yarn wraps or spiral support coils for kink/compression resistance. Polyester grafts utilize knitted or woven double velour construction with concentric pleats for length adjustment and lumen maintenance. All grafts include alignment stripes. Implanted by surgeons in clinical settings (OR). Devices function as permanent conduits to restore blood flow in aneurysmal or occlusive disease. No changes to device attributes; submission clarifies specific anatomical indications for use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the fact that the devices are identical to previously cleared predicates with no changes to design or materials; the submission only clarifies existing indications.

Technological Characteristics

Materials: extruded expanded polytetrafluoroethylene (ePTFE) or polyester. Construction: knitted or woven double velour, cross-helical yarn wraps, spiral support coils, concentric pleats. Features: GUIDELINE™ alignment stripes. Sterilization: not specified. Connectivity: N/A (mechanical implant).

Indications for Use

Indicated for patients requiring repair or replacement of peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate, Axillary, Renal) due to aneurysmal or occlusive disease; Standard Wall ePTFE grafts also indicated for vascular access. Thin Wall ePTFE grafts are not indicated for vascular access.

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

• EXXCEL™ and EXXCEL™ Soft ePTFE Vascular Grafts (K955460, K960766, K962433)
• MICROVEL™ DOUBLE VELOUR Knitted Vascular Grafts (K810845)
• WOVEN DOUBLE VELOUR Woven Vascular Grafts (K820696)
• COOLEY™ VERI-SOFT™ Woven Vascular Grafts (K820696)

Submission Summary (Full Text)

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JAN G 2006

K052964

# 510(k) SUMMARY

| Date Prepared: | January 3, 2005 |
|----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Owner: | Boston Scientific Corporation<br>2 Scimed Place<br>Maple Grove, MN 55311-1566 |
| Contact Personnel:<br>Title:<br>Email:<br>Phone:<br>Fax: | Katie Gerbensky<br>Regulatory Affairs Specialist<br>[e-mail]<br>(763)-494-1479<br>(763)-494-2981 |
| Trade Name(s): | EXXCEL™ and EXXCEL™ Soft ePTFE Vascular Grafts<br>MICROVEL™DOUBLE VELOUR Knitted Vascular Grafts<br>WOVEN DOUBLE VELOUR Woven Vascular Grafts<br>COOLEY™ VERI-SOFT™ Woven Vascular Grafts |
| Device Generic Name: | Vascular Graft Prosthesis |
| Classification: | According to Section 513 of the Federal Food, Drug and<br>Cosmetic Act, these devices are Class II, Performance<br>Standards. |
| Predicate Devices: | EXXCEL™ and EXXCEL™ Soft ePTFE Vascular Grafts<br>MICROVEL™DOUBLE VELOUR Knitted Vascular Grafts<br>WOVEN DOUBLE VELOUR Woven Vascular Grafts<br>COOLEY™ VERI-SOFT™ Woven Vascular Grafts |
| Device Description: | EXXCEL™ & EXXCEL™ Soft ePTFE Vascular Grafts:<br>EXXCEL™ & EXXCEL™ Soft ePTFE Vascular Grafts are<br>synthetic vascular grafts constructed of extruded, expanded<br>polytetrafluoroethylene (ePTFE). They are available in<br>various configurations, with the following features:<br>EXXCEL™ grafts have a unique cross-helical PTFE<br>yarn wrap to enhance mechanical strength, minimize<br>kinking and increase suture retention strength.EXXCEL™ Soft grafts are ePTFE grafts without a<br>yarn wrap, that possess enhanced handling<br>characteristics.Straight grafts (available in EXXCEL™ & EXXCEL™<br>Soft)have a uniform diameter throughout their length.Short Taper and Step grafts (available in EXXCEL™<br>& EXXCEL™ Soft) are designed to have the arterial<br>anastomosis of vascular access procedures created |

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with the smaller diameter end to reduce the risk of steal syndrome.

- Externally Supported grafts (available only in . EXXCEL™ Soft) have a removable, continuous spiral support coil to increase compression resistance and to minimize kinking.
- Centrally Supported grafts (available in EXXCEL™ & . EXXCEL™ Soft) have a non-removable, continuous spiral support coil located in the center of the graft's length, to provide additional kink and compression resistance for grafts implanted in a looped configuration for vascular access.

All EXXCEL™ & EXXCEL™ Soft ePTFE Vascular Grafts feature a GUIDELINE™ Stripe to facilitate proper graft alignment.

### MICROVEL™ KNITTED DOUBLE VELOUR:

This seamless knitted double velour polyester graft incorporates a lower inner pile for minimal luminal compromise and a higher outer pile to promote perigraft tissue adherence. This graft is soft, pliable, and complies with ease to the host vessel. This graft features CONCENTRICRIMP™ Pleats, which assist in proper length adjustment of the prosthesis and maintenance of an open lumen at the anastomosis, and throughout the entire graft. There is a GUIDELINE™ Stripe to facilitate proper graft alignment. The knitted velour construction of this graft is preferred by surgeons in abdominal and peripheral procedures. Not recommended for thoracic procedures.

#### WOVEN DOUBLE VELOUR :

This seamless woven polyester graft incorporates a velour inner pile to promote attachment of the pseudointima and a velour outer pile to promote perigraft tissue adherence. The unique woven double velour construction provides soft and supple handling characteristics, while maintaining a low porosity. CONCENTRICRIMP™ Pleats help in proper length adjustment of the prosthesis and maintenance of an open lumen at the anastomosis, and throughout the entire graft, while the two GUIDELINE™ Stripes help provide greater assurance of proper graft alignment. The Woven Double Velour graft is suitable for use in thoracic, abdominal and peripheral procedures.

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## COOLEY™ VERI-SOFT™:

The COOLEY™ VERI-SOFT™ graft is tightly woven polyester to maintain a low, controlled porosity level for minimal blood loss and high burst strength. This unique design offers significant advantages to heparinized patients or to those with rare blood types or coagulopathies. The soft texture provides a supple graft with enhanced healing characteristics. CONCENTRICRIMP™ Pleats resist kinking, reduce stress on the suture line and assist in proper length adjustment. The intrawoven GUIDELINE™ Stripe aids in graft alignment. The COOLEY™ VERI-SOFT™ woven graft is suitable for use in thoracic and abdominal procedures. Indications for Use: EXXCEL™ and EXXCEL™ Soft ePTFE Vascular Graft: Standard Wall EXXCEL™ & EXXCEL™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal) and to provide vascular access. Thin Wall EXXCEL™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal). NOTE: Insufficient data is available on which to base any conclusions regarding the use of the Thin Wall EXXCEL™ Soft ePTFE Vascular Grafts for vascular access procedures.

> MICROVEL™DOUBLE VELOUR Knitted Vascular Grafts, WOVEN DOUBLE VELOUR and COOLEY™ VERI-SOFT™ Woven Vascular Grafts:

> The Microvel Double Velour, Woven Double Velour and Cooley Veri-Soft Grafts are indicated for use in the replacement or repair of arteries affected by aneurysmal or occlusive disease (Descending Thoracic Aorta, Abdominal Aorta, Axillary, Iliac, Femoral, Popliteal, Renal).

- Technological Characteristics, Safety and Performance: No changes have been to any device attribute. This 510(k) clarifies the indications for use statement by indicating the specific arteries the devices are indicated to repair or replace.
- Conclusion: The above mentioned devices are safe and effective for their intended uses since the only change made to these already cleared devices is the addition of a listing of arteries in which the devices have a safe history of use.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 2006

Boston Scientific Corporation c/o Ms. Katherine Gerbensky Specialist. Regulatory Affairs, Vascular Surgery Two Scimed Place Maple Grove, MN 55311-1566

Re: K052964

Standard Wall Exxcel™ and Exxcel™ Soft ePTFE Vascular Grafts Microvel™ Double Velour Knitted Vascular Graft Woven Double Velour Vascular Grafts Cooley™ Veri-Soft™ Woven Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis of Less than 6MM Diameter Regulatory Class: Class II Product Code: DSY Dated: December 15, 2005 Received: December 15, 2005

Dear Ms. Gerbensky:

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

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Page 2 - Ms. Katherine Gerbensky

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ed tonic 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 logally 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Blymmimor for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _K052964 (covers vascular grafts previously cleared under K955460, K960766, K962433, K810845, K820696)

Device Name: Standard Wall Exxcel™ and Exxcel™ Soft ePTFE Vascular Grafts Microvel™ Double Velour Knitted Vascular Graft Woven Double Velour Vascular Grafts Cooley™ Veri-Soft™ Woven Vascular Graft

Indications For Use: The Standard Wall Exxcel™ and Exxcel™ Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal) and to provide vascular access.

> Thin Wall Exxcel™ soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries (Iliac, Femoral, Popliteal, Infrageniculate Vessels, Axillary, Renal).

> The Microvel Double Velour, Woven Double Velour and Cooley Veri-Soft Grafts are indicated for use in the replacement or repair of arteries affected by aneurysmal or occlusive disease (Descending Thoracic Aorta, Abdominal Aorta, Axillary, Iliac, Femoral, Popliteal, Renal).

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blhemma

Division Sign-Off) Division of Cardiovascular Deyloes 510(k) Number Kosa)964

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