JETSTREAM G3 SYSTEM

K093456 · Pathway Medical Technologies, Inc. · MCW · Dec 1, 2009 · Cardiovascular

Device Facts

• Record ID: K093456
• Device Name: JETSTREAM G3 SYSTEM
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Dec 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetstream G3TM 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. Catheter features separate lumens for continuous aspiration of excised tissue/thrombus and infusion of sterile saline. Console includes two peristaltic pumps, power supply, and system controller. Operated by clinicians in a clinical setting; console mounts on an I.V. stand outside the sterile field. Device modification involves a changed motor gear ratio to increase torque and improve cutting efficiency. Aspiration and infusion capabilities facilitate tissue removal from the treatment site to an external collection bag. Benefits include effective debulking and thrombus removal in peripheral arteries.

Clinical Evidence

Bench testing only.

Technological Characteristics

System consists of an electrically driven catheter with an expandable, differentially cutting tip and a reusable console with two peristaltic pumps. Features continuous aspiration and infusion lumens. Connectivity includes electrical connectors for the control pod and console interface. Sterilization is implied for the single-use catheter component. Operates via motor-driven mechanical cutting.

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 G3TM System (K092332)

Submission Summary (Full Text)

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pare 1 of 2 K0993456

Image /page/0/Picture/1 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a black circle with a white mountain and path inside, followed by the text "PATHWAY" in large, sans-serif font. Below "PATHWAY" is the text "MEDICAL TECHNOLOGIES" in a smaller, sans-serif font.

### 510(k) SUMMARY

DEC - 1 2009

## General Information:

Date of Summary Preparation: November 4, 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: Jetstream G3TM System Common Name: Peripheral Atherectomy Catheter

21 CFR 870.4875

Intraluminal Artery Stripper

Class II

MCW

Cardiovascular

Product Code:

Predicate Devices:

Regulation Number:

Regulation Name:

Regulatory Class:

Classification Panel:

Manufacturer: Pathway Medical Technologies, Inc. (1) Jetstream G3TM System (K092332)

Indications for Use: The Jetstream G3TM 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.

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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 with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:

- Jetstream G3 Catheter with 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) K092332, but changes the motor gear ratio to increase torque and improve cutting efficiency of the device.

Substantial Equivalence: The Jetstream G3 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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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN" around the left side. To the right of the seal is a stylized symbol with three curved lines that resemble a person.

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

DEC - 1 2009

Pathway Medical Technologies, Inc. c/o Ms. Cyndy Adams Regulatory Affairs Sr. Manager 1080 120" Avenue NE Kirkland, WA 56033

Re: K093456

Jetstream G3 system Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (two) Product Code: MCW Dated: November 4, 2009 Received: November 5, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Duma R. Launer

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

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): K093456

Device Name: Jetstream G3TM System

Indications for Use: The Jetstream G3TM System is intended for use in atherectorny 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.

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)

sume R. Vaines

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number L6 9:345 (

Pathway Medical Technologies, Inc. 510(k)

CONFIDENTIAL

Appendix 1

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