JETSTREAM G2 NXT SYSTEM, MODEL PV20300

K091509 · Pathway Medical Technologies, Inc. · MCW · Jun 19, 2009 · Cardiovascular

Device Facts

• Record ID: K091509
• Device Name: JETSTREAM G2 NXT SYSTEM, MODEL PV20300
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Jun 19, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetstream G2TM NXT 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 G2 NXT System is an atherectomy catheter 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 separate 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. Operated by clinicians in a clinical setting; console remains outside the sterile field. Device removes obstructive material from peripheral arteries, potentially improving blood flow and patient outcomes. This submission covers a modification to the catheter shaft material to improve manufacturability.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

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 controller. Catheter is sterile, single-use; console is reusable and mounts on an I.V. stand. Electrical energy drives the catheter tip.

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 System (K090325, K083837)
• 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 with a stylized mountain inside, followed by the text "PATHWAY" in a sans-serif font, with the words "MEDICAL TECHNOLOGIES" underneath in a smaller font. In the upper right corner of the image, there is a handwritten number "K691509".

JUN 19 2009

## 510(k) SUMMARY

## General Information:

Date of Summary Preparation:

May 21, 2009

Name and Address of Manufacturer:

Contact Person:

Trade Name:

Common Name:

Regulation Number:

Regulation Name:

Regulatory Class:

Classification Panel:

Product Code:

Predicate Devices:

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

Brit Baird Regulatory Affairs Specialist Phone: [phone] Fax: .

Jetstream G2TM NXT System

Peripheral Atherectomy Catheter

21 CFR 870.4875

Intraluminal Artery Stripper

Class II

Cardiovascular

MCW

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

.

Indications for Use: The Jetstream G2TM NXT 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.

Appendix 5

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Device Description: The Jetstream G2 NXT 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 G2 NXT 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 G2 NXT 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) K090325, but changes the catheter shaft material to improve the manufacturability of the device.

Substantial Equivalence: The Jetstream G2 NXT System is substantially equivalent to the specified predicate 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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### 510(k) SUMMARY

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

JUN 1 9 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pathway Medical Technologies, Inc. c/o Mr. Brit Baird Regulatory Affairs Specialist 10801 120th Avenue NE Kirkland, WA 98033

Re: K091509

Trade/Device Name: Jetstream G2 NXT System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (two) Product Code: MCW Dated: May 21, 2009 Received: May 22, 2009

#### Dear Mr. Baird:

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 - Mr. Brit Baird

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 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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

una R. buchner

1 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

#### 1091509 510(k) Number (if known): _

Device Name: Jetstream G2TM NXT System

Indications for Use: The Jetstream G2TM NXT 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. .

Prescription Use (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)

Dring R. 170 (Division Simn-Off) Division of Cardiovascular Devices

510(k) Number 2091509

000037

Pathway Medical Technologies, Inc. 510(k)

CONFIDENTIAL

Appendix 1