T-ANASTAFLO

K990396 · Edwards Lifesciences Research Medical · DWF · Oct 1, 1999 · Cardiovascular

Device Facts

• Record ID: K990396
• Device Name: T-ANASTAFLO
• Applicant: Edwards Lifesciences Research Medical
• Product Code: DWF · Cardiovascular
• Decision Date: Oct 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.

Device Story

T-AnastaFlo is a sterile, single-use, disposable intraluminal shunt used during coronary artery bypass graft (CABG) surgery. Device consists of a flexible silicone tubular shaft with silicone bulbs at distal ends and a perpendicular shaft ending in a perfusion port stopcock. During surgery, physician inserts shunt into vessel to maintain blood flow or deliver cardioplegic solution distal to anastomosis site, preventing ischemia. Device provides mechanical support for vessel patency during graft construction. Benefits include reduced risk of ischemic injury to myocardium during procedure.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including flow rate, leak characteristics, and tensile strength measurements.

Technological Characteristics

Materials: Silicone. Form factor: Flexible tubular shaft with two distal silicone bulbs and a perpendicular perfusion port stopcock. Single-use, sterile, non-pyrogenic. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing coronary artery bypass graft surgery to prevent ischemia via shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Rivetti-Levinson Intraluminal Shunt (K972261)

Submission Summary (Full Text)

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K990396

T-AnastaFlo 510(k)

## 510(k) Summary IV.

#### Submitter / 510(k) Sponsor A.

John W. Smith, Manager of Regulatory Affairs

Baxter Research Medical, Inc. 6864 South 300 West Midvale, Utah 84047 USA

Phone [phone]

Fax [phone]

Date prepared: 1999-02-05

#### Device Name B.

T-AnastaFlo, IVS-T-xxxx

Classified by FDA under 21 CFR § 870.4210, Cardiopulmonary bypass vascular catheter, cannula, or tubing.

#### C. Predicate Device

Name: Rivetti-Levinson Intraluminal Shunt Manufacturer: Heyer-Schulte Neurocare 510(k) Number: K972261 SE Decision Date: 1997-09-15

### Device Description D.

The T-AnastaFic is a sterile, single use, disposable shunt composed of two silicone bulbs on the distal ends of a flexible silicone tubular shaft. Another silicone tubular shaft is attached perpendicular to the middle of the shunt, ending with a perfusion port stopcock.

Each T-AnastaFlo is individually packaged sterile and non-pyrogenic in a sealed, peeltype pouch.

#### E. Intended Use

The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.

#### F. Summary of Comparison, Proposed and Predicate Devices

The proposed device is substantially equivalent to the cited predicate device in intended use, technology, materials, and design.

ОСТ

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This conclusion is based upon tests performed for device flow rate, leak characteristics, and tensile strength, and upon the equivalence of materials, design and intended use for the proposed and predicate devices.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract design of an eagle with three heads, symbolizing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

## 1 1999 OCT -

Mr. John W. Smith Manager of Requlatory Affairs Baxter Healthcare Corporation Research Medical, Inc. 6864 South 300 West Midvale, UT 84047-1051

K990396 Re : T-AnastoFlo Requlatory Class: II (Two) Product Code: 74 DWF Dated: July 9, 1999 Received: July 12, 1999

Dear Mr. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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# Page 2 - Mr. John W. Smith

This letter will allow you to begin marketing your device as described in your 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### D. Indications for Use Statement

510(k) Number (if known):

K 990396

Device Name:

T-AnastaFlo

Indications for use:

The T-AnastaFlo is indicated for use in preventing ischemia by the shunting and/or perfusion of blood or cardioplegic solution distal to the anastomosis site during the construction of coronary artery bypass grafts.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bette R. Lemperle

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

510(k) Number K990396

Prescription Use_

(Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________