TRUE

K993913 · Infinity Extrusion & Engineering, Inc. · LIT · Aug 9, 2000 · Cardiovascular

Device Facts

• Record ID: K993913
• Device Name: TRUE
• Applicant: Infinity Extrusion & Engineering, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Aug 9, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TRUE PTA Balloon Catheter is intended for percutaneous dilatation of the iliac, femoral, popliteal, tibial, renal, infra popliteal, ilio femoral, and tibiopernoeal arteries.

Device Story

TRUE PTA Balloon Catheter is a non-reusable, multiple-lumen catheter featuring a balloon at its distal tip. Designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic arteries, including iliac, femoral, popliteal, tibial, and renal vessels. Operated by physicians in clinical settings. Device is inserted percutaneously; balloon is inflated to dilate the target artery, improving blood flow. Output is the mechanical expansion of the vessel lumen. Benefits include restoration of arterial patency. Device is supplied sterile for single use.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included balloon burst strength, balloon distensibility, inflation/deflation cycles, balloon fatigue, bond strengths, dimensional equivalence, shaft burst pressure, balloon preparation, and tip pulling/torquing. Biocompatibility was also verified.

Technological Characteristics

Multiple lumen catheter with distal balloon. Materials are biocompatible and previously cleared. Non-reusable, sterile, single-use device. Mechanical operation via inflation/deflation of the balloon. No software or electronic components.

Indications for Use

Indicated for percutaneous dilatation of iliac, femoral, popliteal, tibial, renal, infra-popliteal, ilio-femoral, and tibio-peroneal arteries in patients requiring angioplasty.

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

• Smash™ PTA Catheter (Schneider, Incorporated)

Submission Summary (Full Text)

{0}------------------------------------------------

9 2000 AUG

# 510 (k) SUMMARY

### General Information

| Classification | Class II |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | TRUE PTA Balloon Catheter |
| Submitter | Infinity Extrusion & Engineering, Inc.<br>3350 Scott Boulevard. Building 6<br>Santa Clara, CA. 95054<br>[phone]<br>FDA Registration No.: 2951240 |
| Contact | Douglas Wilkins<br>Vice President |

### Intended Use

The TRUE PTA Balloon Catheter is intended for percutaneous dilatation of the iliac, femoral, popliteal, tibial, renal, infra popliteal, ilio femoral, and tibiopernoeal arteries.

### Predicate Devices

The Smash™ PTA Catheter from Schneider, Incorporated.

#### Device Description

The TRUE PTA Balloon Catheter is a non-reusable multiple lumen catheter with a balloon mounted on its distal tip. The TRUE PTA Balloon Catheter is packaged sterile and intended for single use only.

#### Materials

All materials used in the manufacture in the TRUE PTA Balloon Catheter are biocompatible and have been used in numerous previously cleared products.

### Testing

Product testing was conducted to evaluate conformance to product specifications as well as substantial equivalence. Testing included balloon burst strength, balloon distensibility, balloon inflation/deflation, balloon fatigue, bond strengths, dimensional equivalencer, shaft burst pressure, balloon preparation, tip pulling/torquing and biocompatibility.

{1}------------------------------------------------

## Summary of Substantial Equivalence

The TRUE PTA Balloon Catheter is equivalent to the predicate Smash™ product from Schneider, Incorporated. The clinical indications for use, basic overall function,methods of manufacturing, and materials used are all substantially equivalent, Infinity Extrusion & Engineering believes that the TRUE PTA Balloon Catheter is substantially equivalent to existing marketing devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three parallel lines that curve and flow together, resembling a bird in flight or a flowing river. The logo is presented in black and white.

AUG 9 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Douglas Wilkins Vice President Infinity Extrusion & Engineering, Inc. 3350 Scott Boulevard, Building 6 Santa Clara, CA 95054

K993913 Re : TRUE PTA Balloon Catheter Trade Name: Regulatory Class: II (two) Product Code: LIT Dated: July 11, 2000 Received: July 12, 2000

Dear Mr. Wilkins:

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 to A substantially equivalent determination assumes compliance with 895. 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.

{3}------------------------------------------------

## Page 2 - Mr. Douglas Wilkins

This letter will allow you to begin marketing your device as described in Infis feecer will are " John John "The FDA finding of substantial your Jro(k) premarked notification.
equivalence of your device to a legally marketed predicate device results equivalence of 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 (zi Gri), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your Auditionally) 100 god the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on premarket notification" (21CFR 807.97). premarked nocersions ander the Act may be obtained from the Division of your roopeners Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Ben E. Dillard III

James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE

# 510(k) Number (if known):

Device Name:

Indications for Use:

×993913 This application

TRUE PTA Balloon Catheter

Intended for Percutaneous Dilatation of the iliac, femoral, popliteal, tibial, renal, infra popliteal, ilio femoral, and tibiopernoeal arteries. ...

# PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE (IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K993913

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

1