JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300

K083489 · Pathway Medical Technologies, Inc. · MCW · Jan 23, 2009 · Cardiovascular

Device Facts

• Record ID: K083489
• Device Name: JETSTREAM PATHWAY PC ATHERECTOMY SYSTEM, MODEL OV10300
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Jan 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pathway PVTM Atherectomy System is intended for use in atherectorny of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity perspheral arteries ≥30 mm in diameter It 1s not intended for use in coronary, carotid, iliac or renal vasculature

Device Story

Jetstream System is an atherectomy catheter system for debulking and treating peripheral vascular disease. System comprises a sterile, single-use Jetstream Catheter with an electrically driven, differentially cutting tip and a reusable PV Console. During procedures, the catheter tip performs atherectomy while separate lumens enable continuous infusion of sterile saline and aspiration of excised tissue, thrombus, and fluid. Aspirated material is collected in a bag on the console. The console, operated by clinical staff, features two peristaltic pumps, a system controller, and a keypad interface. The device is used in a clinical setting to treat peripheral arterial disease; by removing obstructive material, it aims to restore blood flow and improve patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

System includes an electrically driven catheter with a differentially cutting tip and a console with two peristaltic pumps. Components include tubing, electrical connectors, and an aspirant collection bag. The console provides power, control, and LED status indicators. Designed for peripheral vasculature use; single-use catheter, reusable console.

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™ Pathway PVT™ Atherectomy System (K081328)
• Jetstream™ Pathway PVT™ Atherectomy System (K082186)
• Jetstream™ Pathway PVT™ Atherectomy System (K082664)
• AngioJet® Xpeedior® Rheolytic Thrombectomy Catheter (K071514)

Submission Summary (Full Text)

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ҚОВ 3489 page 1 of 2

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-like shape inside, followed by the word "PATHWAY" in a sans-serif font. Below "PATHWAY" are the words "MEDICAL TECHNOLOGIES" in a smaller font.

JAN 9 3 2009

## 510(k) SUMMARY

| General Information: | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation | November 24, 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™ Pathway PVT™ Atherectomy 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 Devices | 510(k) Numbers K081328, K082186, K082664<br>Manufacturer Pathway Medical Technologies, Inc<br>Trade Name Jetstream™ Pathway PVT™<br>Atherectomy System<br><br>510(k) Number K071514<br>Manufacturer Possis Medical, Inc<br>Trade Name AngioJet® Xpeedior® Rheolytic<br>Thrombectomy Catheter |

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Indications for Use: The Pathway PVTM Atherectomy System is intended for use in atherectorny of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity perspheral arteries ≥30 mm in diameter It 1s not intended for use in coronary, carotid, iliac or renal vasculature

Device Description: The Jetstream™ Pathway PVTM Atherectorny System (hereafter "Jetstream 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 Excised tissue, thrombus, and fluid are aspirated from the peripheral device use treatment site through ports 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 System consists of two primary components (1) a Jetstream Catheter and Control Pod and (2) a PV Console, which are packaged separately Each of these system components is described generally as follows

- Jetstream Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven Jetstream 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 PV 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

Substantial Equivalence: The Jetstream System is substantially equivalent to the specified predicate devices. Bench testing was completed and information provided to support the safety and effectiveness of the expanded indications for use for the Jetstream System

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Public Health Service

Image /page/2/Picture/2 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 symbol of medicine and health. The caduceus is composed of 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.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2009

Pathway Medical Tcchnologies, Inc. c/o Mr. Brian Cleary Senior Director, Regulatory Affairs 10801 120" Ave NE Kirkland, WA 98033

Re: K083489

Jetstream Pathway PC Atherectomy System, ()V 10300 Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 24, 2008 Received: November 25, 2008

Dear Mr. Cleary:

We have reviewed your Scction 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 10 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 (sec 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.

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Page 2 - Mr. Brian Cleary

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), 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,

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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## SECTION 4: INDICATIONS FOR USE

510(k) Number (if known): 1063489

Device Name: Jetstream™ Pathway PV™ Atherectomy System

Indications for Use: The Pathway PV™ Atherectomy 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 IF NEEDED)

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

(Divisio) Division of Carciovascular Devices 5100k Kamber Kos348

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Pathway Medical Technologies, Inc.

CONFIDENTIAL

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