ULTRAVERSE PTA CATHETER

K964881 · Vas-Cath, Inc. · LIT · May 28, 1997 · Cardiovascular

Device Facts

• Record ID: K964881
• Device Name: ULTRAVERSE PTA CATHETER
• Applicant: Vas-Cath, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: May 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in angioplasty of the peripheral vascular system. The catheter is recommended for use in the following vessels: renal, tibial, popliteal, femoral, and peroneal. The catheter is not for use in coronary arteries. The device is for single use only and must not be resterilized or reused.

Device Story

Dual-lumen PTA balloon dilatation catheter; designed for peripheral vascular angioplasty. Input: 0.016-inch guidewire. Operation: catheter inserted over guidewire; balloon inflated with contrast media to dilate stenotic vessels. Output: mechanical vessel dilation. Used in clinical settings by physicians. Radiopaque marker bands facilitate positioning under fluoroscopy. Benefits: restores blood flow in peripheral vessels. Single-use device.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included balloon burst strength, distensibility, inflation/deflation time, fatigue, joint strength, profile, introducer sheath compatibility, flow/pressure, trackability, and tip torque.

Technological Characteristics

Dual-lumen catheter; nylon shaft and balloon material. 3.5 French shaft diameter. 0.016-inch guidewire compatibility. Radiopaque marker bands. Operating pressure 8 atm. Single-use. Non-electronic/mechanical device.

Indications for Use

Indicated for percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, specifically renal, tibial, popliteal, femoral, and peroneal vessels. Contraindicated for use in coronary arteries.

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

• Ultraverse™ Angioplasty Catheter (K925485)

Submission Summary (Full Text)

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K964881

vas-cath.
INCORPORATED

MAY 28 1997

# 510(k) SUMMARY of SAFETY AND EFFECTIVENESS

## FOR THE

### ULTRAVERSE™ PTA BALLOON DILATATION CATHETERS

2380 Tedlo Street
Mississauga, Ontario
Canada, L5A 3V3

Tel. [phone]
Fax [phone]

A. Submitter Information: Vas-Cath Incorporated
Address: 2380 Tedlo Street
Mississauga, Ontario L5Z 3V3
Canada
Telephone Number: [phone]
Fax Number: [phone]
Contact Person: Dolores McGirr
Date of Preparation: August 23, 1996

B. Device Name: Ultraverse™ Angioplasty Catheter
3.5F Opti-Plast Catheter
Common/Usual Name: Peripheral Angioplasty Catheter
Classification Name: Surgical Vessel Dilator

C. Predicate Device Name: Ultraverse™ Angioplasty Catheter (K925485)
Trade Name: Ultraverse

D. Device Description:

The Vas-Cath Ultraverse™ PTA Catheter is a dual lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation on the balloon with contrast media. The catheters were designed to be used in conjunction with a 0.016 inch diameter guidewire. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature. The balloon inflates to the stated diameter and length at an 8 atmosphere operating pressure.

E. Intended Use:

The Ultraverse™ Small Vessel Peripheral Balloon Dilatation Catheters are recommended for use in the peripheral vascular system, in the following vessels: renal, tibial, popliteal, femoral, and peroneal. This catheter is not for use in coronary arteries. The device is for single use only and must not be resterilized or reused.

F. Technological Characteristics Summary: Summarized in Table 1.

Ultraverse™ Catheter 510(k) Summary Page 1 of 2

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vas-cath. INCORPORATED

TABLE 1 : COMPARISON OF DEVICES

| Characteristics | Predicate K925485 Vas-Cath Ultraverse™ PTA Catheter | Proposed New Sizes for Vas-Cath Ultraverse™ PTA Catheter |
| --- | --- | --- |
| Similarities | | |
| Intended Use | PTA of renal, tibial, popliteal, femoral, and peroneal vessels | PTA of renal, tibial, popliteal, femoral, and peroneal vessels |
| Catheter Shaft Material | Nylon | Nylon |
| Catheter Shaft Diameter | 3.5 French | 3.5 French |
| Inflated Balloon Diameters | 2, 3, 4, 5 mm | 2, 3, 4, 5 mm |
| Balloon Material | Nylon | Nylon |
| Maximum Recommended Inflation Pressure | 8 atmospheres | 8 atmospheres |
| Guidewire Capability | 0.016 inch diameter | 0.016 inch diameter |
| Shaft configuration | Double lumen | Double lumen |
| Radiopaque | Yes | Yes |
| Marker Bands | Yes | Yes |
| Balloon Leg Length | 7 cm | 7 cm |
| Distal Leg Length | 5.5 cm | 5.5 cm |
| Rated Burst Pressures | 2mm by 2cm is 15atm
3mm by 2cm is 15atm
4mm by 2cm is 12 atm
5mm by 2cm is 12 atm | 2mm by 6cm is 15 atm
3mm by 6cm is 15 atm
4mm by 6cm is 12 atm
5mm by 3,4,5 or 6cm is 10 atm |
| Differences | | |
| Inflated Balloon Length | 2 cm | 3, 4, 5, 6 cm |
| Catheter Shaft Length | 75, 100 cm | 75 - 150 cm |

## G. Performance Data

The design, materials and manufacturing processes for the predicate and proposed devices are the same. The additional balloon and shaft sizes proposed in this submission were tested for the following characteristics: balloon minimum burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joint strength, catheter shaft and balloon profile, introducer sheath compatibility, catheter flow/maximum pressure, trackability/ deflatability, and tip torque. The proposed product is substantially equivalent to the current Ultraverse™ Catheters marketed under 510(k) concurrence K925485.

Ultraverse™ Catheter 510(k) Summary Page 2 of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 28 1997

Ms. Dolores McGirr
Vas-Cath, Inc.
2380 Tedlo Street
Canada, L5A 3V3

Re: K964881
Ultraverse™ 3.5F PTA Catheters
Regulatory Class: II (two)
Product Code: 74 LIT
Dated: April 2, 1997
Received: April 15, 1997

Dear Ms. McGirr:

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 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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. Dolores McGirr

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" (21 CFR 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/dsmamain.html".

Sincerely yours,


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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# SECTION 1. D INDICATION(S) STATEMENT*

I state in my capacity as Manager of Quality Assurance and Regulatory Affairs of Vas-Cath Inc. that this premarket notification 510(k) for the Ultraverse™ 3.5 French Angioplasty Catheter is indicated for the following.

The Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in angioplasty of the peripheral vascular system. The catheter is recommended for use in the following vessels: renal, tibial, popliteal, femoral, and peroneal. The catheter is not for use in coronary arteries.


Janet Shaw
Printed Name of Submitter

Date
96/11/15

*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the code of Federal Regulations, Title 21.

# CONCURRENCE OF OFFICE OF DEVICE EVALUATION

K964881

510(k) Number


Division Sign-Off
Office of Device Evaluation