INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER

K022242 · Intervascular · DSY · Aug 14, 2002 · Cardiovascular

Device Facts

• Record ID: K022242
• Device Name: INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER
• Applicant: Intervascular
• Product Code: DSY · Cardiovascular
• Decision Date: Aug 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2

Intended Use

InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.

Device Story

The InterVascular Graft Sizer is a set of disposable manual instruments used by surgeons during vascular procedures. The set includes 5 dual-gauge sizers and 1 single-gauge sizer, with labeled sizes ranging from 6mm to 24mm. The device is used to measure the lumen of a host vessel; the surgeon uses this measurement to select the appropriate diameter for an InterGard Knitted Vascular Prosthesis. The device is purely mechanical and provides no automated output; the surgeon makes the final clinical decision regarding graft size based on the physical sizing tool.

Clinical Evidence

Bench testing only. Biocompatibility testing demonstrated the device is non-hemolytic, non-cytotoxic, non-mutagenic, and non-irritant, meeting USP XXIII Class VI-50 standards.

Technological Characteristics

Manual sizing instrument set; disposable; biocompatible material meeting USP XXIII Class VI-50 standards; sizes 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm.

Indications for Use

Indicated for use by physicians to determine the lumen size of a host vessel to facilitate selection of the appropriate diameter for an InterGard Knitted Vascular Prosthesis.

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

• Meadox Graft Sizer (K854431)

Submission Summary (Full Text)

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# AUG 1 4 2002

### 510(K) SUMMARY

#### InterVascular InterGard Knitted Vascular Graft Sizer Trade Name: Common Name: Vascular Graft Sizer

The InterVascular Graft Sizer, an accessory to the InterGard Knitted Vascular Prosthesis, consists of a set of 5 disposable dual gauge sizers and 1 disposable single gauge sizer constructed of a biocompatible material. The size indicated on the instrument approximately corresponds to the size of the lumen of the host vessel. The labeled sizes of the instrument are 6, 7, 8, 10, 12, 14, 16, 18, 20, 22, and 24mm. The surgeon makes the ultimate decision on the size of the graft.

The InterVascular Graft Sizer is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.

Biocompatibility tests performed on the finished products show that the device is non-hemolytic and non-cytotoxic. In addition, extensive biocompatibility testing conducted on the material demonstrated its suitability for medical use in devices. The material tested for biological performance meets the requirements of the U.S. Pharmacopeia (USP) XXIII Class VI-50 and are compatible with blood and demonstrate no cytotoxic, mutagenic or irritant potential.

InterVascular considers that this device is substantially equivalent in intended use, composition and function to the predicate device, Meadox Graft Sizer manufactured by Meadox Medical Inc. The Meadox Graft Sizer received premarket clearance on May 7, 1986 under 510(k) K854431.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

AUG 1 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

InterVascular c/o Ms. Amy Aulwes Director, Regulatory Affairs Health Policy Associates, Inc. 20 Walnut Street, Suite 12 Wellesley, MA 02481

Re: K022242

Trade Name: InterVascular InterGard Knitted Vascular Graft Sizer Regulation Number: 21 CFR 870.3460 Regulation Name: Accessory to Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: July 9, 2002 Received: July 11, 2002

Dear Ms. Aulwes:

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 mav publish further announcements concerning your device in the Federal Register.

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### Page 2 - Ms. Amy Aulwes .

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 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 vou 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 vours.

Thosad Oth 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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## PRODUCT INDICATIONS FOR USE

(Page 1 of 1)

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510(k) Number:

Device Names:

InterVascular InterGard Knitted Vascular Graft Sizer

Indications for Use:

InterVascular InterGard Knitted Vascular Graft Sizer is an accessory to the InterGard Knitted Vascular Prosthesis and is designed to assist the physician in determining the size of the lumen of the host vessel in order to select the appropriate knitted vascular graft diameter.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-The-Counter Use **__**
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Cardiovascular
and Respiratory Devices

510(k) Number K022242

8/14/02