POLAR CATH PERIPHERAL DILATATION SYSTEM

K051916 · Cryo Vascular Systems, Inc. · LIT · Aug 5, 2005 · Cardiovascular

Device Facts

• Record ID: K051916
• Device Name: POLAR CATH PERIPHERAL DILATATION SYSTEM
• Applicant: Cryo Vascular Systems, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

Device Story

System consists of catheter, inflation unit, connecting cable, rechargeable battery pack, and disposable 14g liquid nitrous oxide cartridge. Operates as percutaneous transluminal angioplasty (PTA) catheter; utilizes cryotherapy (liquid N2O) for vessel dilation. Used by physicians in clinical settings for peripheral vascular interventions. Provides controlled dilation of stenoses and obstructive lesions; facilitates post-stent expansion. Benefits include effective vessel recanalization and graft/fistula patency maintenance.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes catheter, inflation unit, connecting cable, and rechargeable battery. Inflation medium is liquid nitrous oxide (disposable 14g cartridge). Class II device per 21 CFR 870.1250.

Indications for Use

Indicated for patients requiring dilation of stenoses in peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, subclavian arteries), treatment of obstructive lesions in PTFE access grafts or native arteriovenous dialysis fistulae, and post-deployed expansion of self-expanding peripheral vascular stents.

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

• PolarCath Peripheral Dilatation System (K051916)

Submission Summary (Full Text)

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

K051916
p. 1 of 1

#### 4. 510(k) Summary

| Sponsor: | CryoVascular Systems, Inc. |
|-----------------|------------------------------------------------|
| | 160 Knowles Drive |
| | Los Gatos, CA 95032 |
| Contact Person: | Elaine Aplaon |
| Phone Number: | 408 866 3204 |
| Fax Number: | 408 376 3677 |
| Prepared: | July 12, 2005 |
| Trade Name: | PolarCath™ Peripheral Dilatation System |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | LIT/DQY |
| | 21 CRF 870.1250 |

### Predicate Devices: PolarCath Peripheral Dilatation System

## Device Description

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

# Indications for Use

The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

# Substantial Equivalence

The PolarCath Peripheral Dilatation System design, materials, manufacturing process and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.

## Performance Data

The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc.

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 5 - 2005

CryoVascular Systems, Inc. c/o Ms.Elaine Aplaon 160 Knowles Drive Los Gatos, CA 95032

Re: K051916

Trade/Device Name: PolarCath™ Peripheral Dilation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: LIT Dated: July 14, 2005 Received: July 15, 2005

Dear Ms. Aplaon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications forchered above and harrsure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) 70 ttg enactment date of the Medical Device Amendments, or to conniner of they 20, 2017, 12:53 in accordance with the provisions of the Federal Food, Drug, de noos mat hat o occir voat do not require approval of a premarket approval application (PMA). and Cosmetic Frev (110) 210, 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 (PMA), it if your device 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.

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

Page 2 - Ms.Elaine Aplaon

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 and additionally 21 CFR Part 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 Part 807.97). 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,

Duna R. Kulmer

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

#### 510(k) Indications for Use 3.

| 510(k) Number (if known): | K051916 |
|---------------------------|-----------------------------------------|
| Device Name: | PolarCath™ Peripheral Dilatation System |

Indications for use:

The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Van Auken

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K0519| 6 - - - - - - - -