GRAFTSAVER

K043515 · Vescare, Inc. · GBX · Mar 31, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043515
• Device Name: GRAFTSAVER
• Applicant: Vescare, Inc.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Mar 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1

Intended Use

The device is used for the preparation and irrigation of venous vessels prior to use as a bypass graft. The device allows the user to limit the nominal pressure up to 150 mmHg, 250 mmHg or 350 mmHg.

Device Story

Distention and irrigation syringe; used for preparation of venous vessels for bypass grafting. Device limits nominal pressure to 150, 250, or 350 mmHg to prevent endothelial damage. Components include polypropylene syringe barrel/tip shield, nitrile rubber ball, stainless steel spring/pin/rod, and acetal setting knob/ring/body/pusher. Operated by clinicians in surgical settings. Provides controlled pressure distention to overcome vessel spasm and identify leaks, serving as an alternative to uncontrolled pressure methods. Benefits include reduced risk of late consequences from early endothelial damage to vein grafts.

Clinical Evidence

No clinical data. Evidence consists of literature review articles (Bonchek 1980; Okon et al. 2004) discussing the physiological necessity of controlled pressure distention to prevent endothelial damage and improve vasomotor function in saphenous vein grafts.

Technological Characteristics

Manual syringe assembly. Materials: Polypropylene (barrel/tip shield), nitrile synthetic rubber (ball, NBR per ASTM D1418/ISO 1629), stainless steel (spring/pin/rod per ASTM F899), acetal (knob/ring/body/pusher per ASTM F1855). Pressure limiting mechanism allows settings of 150, 250, or 350 mmHg. 60mL capacity. Packaged in Tyvek blister peel pouch.

Indications for Use

Indicated for the distention and irrigation of venous vessels prior to use as a bypass graft.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• DMC Saphenous Vein Distention System (K000704)

Submission Summary (Full Text)

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10(k) Summary

Company:

| 28 Cook Street | |
|---------------------|--------------|
| Billerica, MA 01821 | |
| Tel: | 978 663 2475 |
| Fax: | 978 663 4364 |

Vost an 130

MAR 3 1 2005

510(k) Number: K043515

Common/Usual Name: Distention and irrigation syringe

Classification: Class I

The device is comprised of 10 biocompatible components including a syringe stopper, a Description: The device is comprised oring and rod, a green acetal ring, a black acetal pusher, a white acetal knob and body. The device is packaged in a Tyvek blister peel pouch.

> The device is used for the preparation and irrigation of venous vessels prior to use as a bypass The device is used for the properation hish allow the user to limit the nominal pressure up to 150 mmHg, 250 mmHg or 350 mmHg.

Material:

- The syringe barrel and tip shield are made of polypropylene, the syringe stopper is made of . The syringe outrer and the bailicone - 60mL Becton Dickson Disposable Single-Use Syringe per ISO 7886-1, ISO 7886-2 and ISO 594-1&2.
- the ball is made of nitrile synthetic rubber (butadiene and acrylonitrile) per ASTM D1418, ISO . 1629 Designations: NBR.
- the spring, pin and rod are made from stainless steel per ASTM F899. .
- the setting knob, ring, body and pusher are made from colored acetal per ASTM F1855. ◆
- The device is indicated for use in the distention and irrigation of venous vessels prior to use as a Indications: bypass graft.
- Performance Data: In a review article by Bonchek, LI, in "Prevention of endothelial damage during the preparation of saphenous veins for bypass grafting", J Thorac Cardiovasc Surg 79;911-915, 1980, the author states that because of the potential late consequences of early endothelial damage to vein grafts, distention of veins before grafting to overcome spasm and to identify leaks must be done at controlled pressures.

In a review article by Okon et al, in "Effect of Moderate Pressure Distention on the Human Saphenous Vein Vasomotor Function" Ann Thorac Surg 2004;77:108-15, the authors state that the distention of the human saphenous vein at moderate pressure combined with the application of the effective combination of vasodilative drugs before grafting into the arterial circulation could be a beneficial alternative to the current practice of uncontrolled pressure distention.

Substantial Equivalence: This device is substantially equivalent to the DMC Saphenous Vein Distention System by DMC medical limited per K000704 cleared on May 19, 2000.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

MAR 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Walsh MI. David Walsh
Director, Quality Assurance & Regulatory Affairs VesCare, Inc. 28 Cook Street Billerica, Massachusetts (01821

Re: K043515

K049313
Trade/Device Name: Distention and Irrigation Syringe Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: 1 Product Code: GBX Dated: February 17, 2005 Received: February 28, 2005

Dear Mr. Walsh:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained in substantially equivalent (for the indications referenced andve and nave uctchined the asketed predicate devices marketed in interstate for use stated in the encrosule, to regally manation por the Medical Device Amendments, or to commerce prior to May 28, 1776, the chaeffiton of the Federal Food. Drug.
devices that have been reclassified in accordance with the provel explication (PMA) devices that have been recure approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a presidions of the Art, "I and Cosmetic Act (Act) that to not require approvine of the general controls provisions of the Act. The You may, therefore, market the devices, seejoer to the general registration, listing of
general controls provisions of the Act include requirements for annual registrations i general controls provisions of the net necesses and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it ff your device is classified (see above) mis entier as a cregulations affecting your device can
may be subject to such additional controls. Existing major regulations differ may be subject to such additional controllar introlling and be found in the Courseements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs include Please be advised that I DA 3 issuates of a backannel and other requirements of the Act that FDA has made a determination that Journer Federal agencies. You must of any Federal Statutes and regulations damind.org, but not limited to: registration and listing (21 comply with an the Act s requirements, 01); good manufacturing practice requirements as set CITK Fatt 807), adomig (21 OF RT an 820); and if applicable, the electronic form in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. David Walsh

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin marketing of substantial equivalence of your device to a legally premarket notification. The PDA midning of Subscribed on thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) ), please If you desire specific advice for your ac not the regulation of the regulation on the regulation of the work of the world shten contact the Office of Compliance at (210) =F6 eart 807.97). You may obtain "Misbranding by reference to premation notification of Sct from the Division of Small
other general information on your responsibilities under the Act from the 1800 638, 00 other general International and Consumer Assistance at its toll-free number [phone] or and Codex by Nov Manufacturers, International and Oolisanhitp://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Styp Flurdia

Mirian C. Provost, Ph.D. Acting Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VesCare, Inc. 28 Cook Street Billerica, MA 01821 978 663 2475 Tiel: 978 663 4364 liax:

## 510(k) Number: K043515

Device Name: Distention and Irrigation Syringe

## Indications for Use:

The device is indicated for use in the distention and irrigation of venous vessels prior to use as a bypass graft.

Prescription Use
(Part 21 CFR 801 Subpart D) X

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Styt. Rhodes
(Division Sign-Off)

Division of General, Restorative. and Neurological Devices

Koy7515

5101k) Number

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