JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)

K083837 · Pathway Medical Technologies, Inc. · MCW · Jan 13, 2009 · Cardiovascular

Device Facts

• Record ID: K083837
• Device Name: JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE)
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetstream G2™ System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Device Story

Jetstream G2 System is an atherectomy catheter system for debulking and treating peripheral vascular disease. System comprises a sterile, single-use catheter with an electrically driven, differentially cutting tip and a reusable console. Catheter features integrated lumens for continuous aspiration of excised tissue/thrombus and infusion of sterile saline. Console includes two peristaltic pumps, power supply, system controller, and user interface. Device is operated by clinicians in a clinical setting. Modification in this submission involves relocating distal tip aspiration ports to a single port proximal to the cutting tip. Output consists of mechanical tissue removal; aspiration of debris into a collection bag. Benefits include effective debulking of peripheral vascular lesions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrically driven atherectomy catheter with expandable, differentially cutting tip. Features integrated aspiration and infusion lumens. System includes a reusable console with two peristaltic pumps, power supply, and system controller. Single-use catheter unit includes control pod with keypad. Sterilized components. No software algorithm described.

Indications for Use

Indicated for atherectomy of peripheral vasculature. Contraindicated for use in coronary, carotid, iliac, or renal vasculature.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Jetstream Pathway PV Atherectomy System (K082664)

Submission Summary (Full Text)

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K083837

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## 510(k) SUMMARY

JAN 1 3 2009

| Date of Summary Preparation: | December 22, 2008 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Name and Address of Manufacturer: | Pathway Medical Technologies, Inc.<br>10801 120th Ave NE<br>Kirkland, Washington 98033 |
| Contact Person: | Brian Cleary<br>Sr. Director of Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name: | Jetstream G2TM System |
| Common Name: | Peripheral Atherectomy Catheter |
| Regulation Number: | 21 CFR 870.4875 |
| Regulation Name: | Intraluminal Artery Stripper |
| Regulatory Class: | Class II |
| Classification Panel: | Cardiovascular |
| Product Code: | MCW |
| Predicate Device: | 510(k) Number: K082664<br>Manufacturer: Pathway Medical Technologies, Inc.<br>Trade Name: JetstreamTM Pathway PVTM<br>Atherectomy System |

Indications for Use: The Jetstream G27M System is intended for use in atherectorny of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

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General Information:

Appendix 5

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Device Description: The Jetstream G2TM System is an atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease in the peripheral vasculature. Separate lumens within the Catheter allow for continuous aspiration and infusion during device use. Excised tissue, thrombus, and fluid are aspirated from the peripheral treatment site through a port in the Catheter tip to a collection bag located on the Console. The distal portion of the Catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectorny procedure.

The Jetstream G27M System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

- . Jetstream G2TM Catheter and Control Pod: A sterile, single-use unit consisting of an electrically driven Catheter and Control Pod. The Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities. The Control Pod provides a user interface with keypad controls. The unit, its electrical connectors, tubing, and aspirant collection bag are packaged in a double-pouched tray.
- PV Console: A reusable compact Console, with two (2) peristaltic pumps for . aspiration and infusion, power supply, system controller, keypad interface, and LED indicators for device operational status. The Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for the same device with modifications to change the location of the distal tip aspiration ports to a single aspiration port located just proximal to the differentially cutting tip.

Substantial Equivalence: The Jetstream G2 System is substantially equivalent to the specified predicate device. The device has the identical indications for use and the same technological characteristics. Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k).

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## 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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2009

Pathway Medical Technologies, Inc. c/o Brian Cleary, Senior Director of Regulatory Affairs 10801 120th Ave NE Kirkland; WA 98033

Re: K083837

Trade/Device Name: Jetstream G2TM System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: December 22, 2008 Received: December 23, 2008

Dear Mr. Cleary:

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 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 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.

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

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### Page 2 - Mr. Brian Cleary

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

bma R. barlener

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

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## INDICATIONS FOR USE

**510(k) Number (if known):** K083837

Device Name: Jetstream G2TM System

Indications for Use: The Jetstream G2™ System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

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

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510(k) Number_k 683837

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Pathway Medical Technologies, Inc. 510(k)

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CONFIDENTIAL

Appendix 1