JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)

K092332 · Pathway Medical Technologies, Inc. · MCW · Sep 3, 2009 · Cardiovascular

Device Facts

• Record ID: K092332
• Device Name: JETSTREAM G3 SYSTEM, MODEL PV31300 ( JETSTREAM G3 CATHETER AND CONTROL POD)., PVCN100 (PV CONSOLE)
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Sep 3, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetstream G3™ System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Device Story

Jetstream G3 System is an atherectomy catheter system for debulking and treating peripheral vascular disease. System comprises a sterile, single-use catheter with an expandable, differentially cutting tip and a reusable console. During procedures, the catheter is inserted into peripheral arteries; the console provides continuous aspiration and saline infusion via peristaltic pumps. Excised tissue and thrombus are aspirated through the catheter tip into a collection bag. The system is operated by a physician in a clinical setting. The console remains outside the sterile field. By removing obstructive material, the device restores blood flow in peripheral vessels. This iteration features a modified distal cutter design to enhance cutting efficiency and manufacturability.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes an electrically driven catheter with an expandable, differentially cutting tip and a reusable console with two peristaltic pumps. Features integrated aspiration and infusion lumens. Console includes power supply, system controller, keypad interface, and LED status indicators. Operates via electrical drive for the cutting tip and mechanical pumping for fluid management.

Indications for Use

Indicated for atherectomy and thrombus removal in upper and lower extremity peripheral arteries ≥3.0 mm in diameter. 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 G2TM NXT System (K091509)
• Jetstream G2TM System (K083837, K090325)
• Jetstream™ System (K082186, K083489)
• Pathway PVTM System (K081328)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a circle on the left and the company name on the right. The circle contains a stylized mountain range with a dark sky above. The text "PATHWAY" is in large, bold letters, and the text "MEDICAL TECHNOLOGIES" is in smaller letters below.

## 510(k) SUMMARY

## General Information:

SEP - 3 2009

Date of Summary Preparation:

July 31, 2009

Name and Address of Manufacturer:

Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033

Contact Person:

Cyndy Adams Regulatory Affairs Sr. Manager Phone: . [phone] :、 Fax: [phone]

Trade Name:

Common Name:

Regulation Number:

Regulation Name:

Regulatory Class:

Classification Panel:

Product Code:

Predicate Devices:

Jetstream G3TM System

Peripheral Atherectomy Catheter

21 CFR 870.4875

Intraluminal Artery Stripper

Class II

Cardiovascular

#### MCW

Manufacturer: Pathway Medical Technologies. Inc. (1) Jetstream G2TM NXT System (K091509) (2) Jetstream G2TM System (K083837, K090325) (3) Jetstream™ System (K082186, K083489) (4) Pathway PVTM System (K081328)

Indications for Use: The Jetstream G3™ System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Pathway Medical Technologies, Inc.

510(k) SUMMARY

Appendix 5

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Device Description: The Jetstream G3 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 atherectomy procedure.

The Jetstream G3 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 G3 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 most recently cleared under 510(k) K091509, but changes the distal cutter design to improve cutting efficiency and manufacturability of the device.

Substantial Equivalence: The Jetstream G3 System is substantially equivalent to the specified predicate devices. 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).

510(k) SUMMARY

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

SEP - 3 2009

Pathway Medical Technologies, Inc. c/o Ms. Cyndy Adams Regulatory Affairs Senior Manager 10801 1200 Ave NE Kirkland, WA 98033

Re: K092332

Trade/Device Name: Jetstream G3 System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: July 31, 2009 Received: August 4, 2009

#### Dear Ms. Adams:

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 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.

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Page 2 - Ms. Cyndy Adams

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation contrôl provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. Vorhmer

Image /page/3/Picture/8 description: The image shows a black and white close-up of a handwritten symbol or character. The symbol consists of a vertical line with a curved shape attached to the top right. The curved shape resembles a simplified letter 'w' or a series of connected arches. The lines are thick and slightly uneven, suggesting they were drawn quickly or with a broad writing instrument.

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

Bram D. Zuckerman, M.D.

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): 4092332

Device Name: Jetstream G3TM System

Indications for Use: The Jetstream G3™ System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter. It is not intended for use in corroary, carotid, iliac or renal vasculature.

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 OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Dumer R. le lumes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k 09 z 332

Pathway Medical Technologies, Inc. 510(k)

CONFIDENTIAL

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