TYSHAK, MODEL 102 AND Z-MED, MODEL 302

K991977 · NuMED, Inc. · LIT · Sep 27, 2000 · Cardiovascular

Device Facts

• Record ID: K991977
• Device Name: TYSHAK, MODEL 102 AND Z-MED, MODEL 302
• Applicant: NuMED, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 27, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) for pulmonary applications. A patient with isolated stenosis. A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.

Device Story

Coaxial over-the-wire catheter with distal noncompliant polyethylene balloon; used for pulmonary valvuloplasty. Features two lumens: one for guidewire, one for balloon inflation/deflation. Z-MED model features increased wall thickness for higher pressure tolerance. Catheter body constructed of pebax; includes radiopaque platinum image bands (one or two) for visualization. Operated by physicians in clinical settings to dilate stenotic pulmonary valves. Output is mechanical dilation of the valve; healthcare providers use fluoroscopic guidance to position the device and monitor inflation. Benefits include minimally invasive treatment of pulmonary stenosis.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Coaxial over-the-wire catheter; noncompliant polyethylene balloon; pebax outer/inner body tubing; radiopaque platinum image bands. Dimensions: balloon diameter specific to pressure. Energy: mechanical inflation. Sterilization: not specified. Software: none.

Indications for Use

Indicated for patients with isolated pulmonary stenosis or valvular stenosis with minor congenital heart disease not requiring surgery, undergoing Percutaneous Transluminal Valvuloplasty (PTV).

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• NuMED Tyshak (K931009)
• NuMED Z-MED PTA Catheters (K931009)

Submission Summary (Full Text)

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## SECTION SIX: 510(K) Summary

| A. Trade Name: | NuMED, Inc. Tyshak ^TM PTV Catheter Z-MED ^TM PTV Catheter |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------|
| B. Common Name: | PTV Catheter |
| C. Device Class: | II, 74MAD; 21 CFR 870.1250 |
| D. Predicate Devices: | This catheter is the same as the approved NuMED Tyshak ^TM , and Z-MED ^TM PTA Catheters, 510(K) 931009. |

- E. Description - The Tyshak™, and Z-MED™ PTV Catheters are coaxial over-the-wire catheters with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter into the pulmonary valve while the other lumen is for balloon inflation and deflation.
The balloon of the Tyshak™, and Z-MED ™ models are all made of a noncompliant polyethylene, however the Z-MED™ balloon is manufactured with an increased wall thickness. The increased wall thickness allows the balloon to achieve a higher pressure before rupture occurs. The balloons are designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures.

The catheter body ends proximally in a molded 'Y' connector with a guidewire port and a balloon extension. The balloon extension is marked with the product lot number and the balloon size.

The outer body and inner body tubing is made of pebax. The area under the balloon is enhanced with either one or two radiopaque platinum image bands depending on the model. If marked with one image band, it is centered under the midpoint of the balloon. If it is marked with two image bands, they are located under the shoulders of the balloon.

- F. Indication - This catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) for pulmonary applications.
- A patient with isolated stenosis. .
- A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.
- G. Technological Characteristics - The technological characteristics for the PTV catheter are the same as the approved PTA catheter, because it is the same catheter with a different intended use.

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SEP 2 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nichelle LaFlesh Requlatory Affairs Manager NuMed, Inc. P.O. Box 129 Nicholville, NY 12965

K991977 Re: Tyshak™ PTV Catheter and Z-Med™ PTV Catheter Trade Name: Requlatory Class: II (two) Product Code: LIT Dated: June 28, 2000 Received: June 29, 2000

Dear Ms. LaFlesh:

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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory 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.

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### Page 2 - Ms. Nichelle LaFlesh

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toll-free number [phone] or [phone] htmll coll-free number (000)
address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Les Qan Till
Lester F. Dillard III

Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE

510(k) Number (if known):

#### NuMED, Inc. PTV Catheter Device Name:

Indications For Use:

Transluminal Percutaneous is recommended for catheter This Valvuloplasty (PTV) for pulmonary applications.

- A patient with isolated stenosis. ●
- A patient with valvular stenosis with other minor congenital heart disease that does not require surgical intervention.

#### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER-PAGE/F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices

| 510(k) Number | K991977 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div>(Per 21 CFR 801.109)</div> | OR | Over-The-Counter-Use |
|------------------|---------------------------------|----|----------------------|
|------------------|---------------------------------|----|----------------------|

(Optional Format 1-2-96)

F:\FDA Submissions\PTV\510(k)\Indications