JMS BYPASS TUBE

K032977 · Jms North America Corp. · DWF · May 25, 2004 · Cardiovascular

Device Facts

• Record ID: K032977
• Device Name: JMS BYPASS TUBE
• Applicant: Jms North America Corp.
• Product Code: DWF · Cardiovascular
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JMS Bypass Tube is indicated to be used to as temporary bypass shunt to internally shunt blood vessels during anastomosis constructions, hence preventing ischemia. The bypass shunt is to be removed prior to the final sutures being performed. The device is for single use only.

Device Story

JMS Bypass Tube is a sterile, single-use nylon tube with distal bulging bulbs; used during coronary artery bypass surgery. A guide-wire facilitates insertion into the target vessel. The device acts as a temporary internal shunt to maintain distal blood flow during anastomosis, preventing ischemia. It is removed by the surgeon before final sutures are placed. The device provides a mechanical solution for maintaining vessel patency during surgical grafting procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Materials conform to ISO 10993 standards.

Technological Characteristics

Nylon tube shaft with distal bulging bulbs; includes guide-wire for insertion; tab on thread at mid-point. Sterile, single-use, non-pyrogenic. Materials conform to ISO 10993.

Indications for Use

Indicated for patients undergoing anastomosis constructions requiring temporary internal blood vessel shunting to prevent ischemia during coronary artery surgical grafting. Device selection based on internal diameter of the target blood vessel.

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

• T-AnastaFLO (K990396)

Submission Summary (Full Text)

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# 510(K) Summary

#### Submitter / 510(K) Sponsor 1.

JMS North America Corporation. 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 U.S.A.

| Contact: | Swee Cheau, Chong |
|----------|---------------------------------------------------|
| | Manager of Regulatory Affairs & Quality Assurance |
| Phone: | [phone] |
| Fax: | [phone] |

Date Prepared: Sep 16, 2003

### 11. Device Name

Classification Name : Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification Number: 21 CFR 870.4210 Device Classification : Class II Device Trade Name : JMS Bypass Tube

# III. Substantial Equivalence Predicate Device

| Name | : T-AnastaFLO |
|------------------|---------------------------------|
| 510(K) Number | : K990396 |
| Manufacturer | : Baxter Research Medical, Inc. |
| SE Decision Date | : Oct 1st, 1999 |

#### IV. Device Description

The JMS Bypass Tube is a sterile, single use, consists of a tube shaft made by nylon with bulging bulbs at the distal ends. A guide-wire is inserted within the tube shaft to guide the easy insertion of tube shunt into target vessel. A tab on a thread is attached near to the mid-point of the flexible shaft. Each JMS Bypass Tube is individually packaged sterile and non-pyrogenic in a sealed, peel type pouch.

# V. Intended Use

JMS Bypass Tube is indicated to be used to as temporary bypass shunt to internally shunt blood vessels during anastomosis constructions, hence preventing ischemia. The bypass shunt is to be removed prior to the final sutures being performed. The device is for single use only.

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# VI. Safety and Effectiveness

Non-clinical performance testing was conducted and had demonstrated that JMS Bypass Tube is safe and effective for use as intended and the device is substantially equivalent to existing predicate devices. All materials used in JMS Bypass Tube conforms to FDA recognized consensus standard ISO 10993.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 2004

JMS North America Corporation c/o Ms. Chong Swee Cheau Manager of Regulatory Affairs & Quality Assurance 22320 Foothill Blvd., Suite 350 Hayward, CA 94541

Re: K032977

JMS Bypass Tube Regulation Number: 21 CFR 870.4210 Regulation Name: Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: May 13, 2004 Received: May 14, 2004

Dear Ms. Chong:

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 I ou mayy arous 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.

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Page 2 - Ms. Chong Swee Cheau

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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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) you may obtain. 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 yours,

Dona R. Vochnel

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): K032977

Device Name: JMS Bypass Tube / Class II

Indications For Use:

JMS Bypass Tube is intended to be used to internally shunt blood vessel during anastomosis constructions. The shunt allows blood to be delivered distally past the anastomosis site preventing ischemia while the target coronary artery is opened and surgical grafted to a donor vessel. The bypass shunt is to be removed prior to the final sutures being performed. Select the blood vessel bypass tube which is appropriate for the internal diameter of the blood vessel.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Yochner

(Division Sign-Off) (Division of Cardiovascular Devices

510(K) Number Ko32977

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