MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM

K082186 · Pathway Medical Technologies, Inc. · MCW · Aug 29, 2008 · Cardiovascular

Device Facts

• Record ID: K082186
• Device Name: MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Aug 29, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pathway PVTM Atherectomy 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

Pathway PV Atherectomy System treats peripheral vascular disease via debulking. System comprises sterile, single-use catheter with differentially cutting tip and reusable console. Catheter features integrated lumens for continuous aspiration of excised tissue/thrombus/fluid and infusion of sterile saline. Console includes two peristaltic pumps, power supply, system controller, and keypad interface; mounts on standard I.V. stand outside sterile field. Physician operates device to remove plaque; aspirated material collected in external bag. Modifications in this submission improve catheter manufacturability and console/pod ergonomics.

Clinical Evidence

Bench testing only.

Technological Characteristics

Electrically driven atherectomy catheter with differentially cutting tip. Features integrated aspiration and infusion lumens. Reusable console utilizes two peristaltic pumps for fluid management. System includes keypad interface and LED status indicators. Single-use catheter unit; console mounts to I.V. stand.

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

• Pathway PVTM Atherectomy System (K081328)

Submission Summary (Full Text)

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KO32186 0. 10-2

# 510(k) SUMMARY

| General Information: | AUG 29 2008 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Date of Summary Preparation: | July 31, 2008 |
| Name and Address of Manufacturer: | Pathway Medical Technologies, Inc.<br>10801 120th Ave NE<br>Kirkland, Washington 98033 |
| Contact Person: | Brian Cleary<br>Director of Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name: | Pathway PVTM 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 Device: | 510(k) Number: K081328<br>Manufacturer: Pathway Medical Technologies, Inc.<br>Trade Name: Pathway PVTM Atherectomy System |

Indications for Use: The Pathway PVTM Atherectomy 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 Description: The Pathway PV Atherectomy 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 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.

Pathway Medical Technologies, Inc.

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

- 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.
- A reusable compact Console, with two (2) peristaltic pumps for Console: . 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: (1) the Catheter and Control Pod to improve the manufacturability of the device, and (2) the Control Pod and Console for improved ergonomics and ease of use.

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

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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 the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem with an abstract design of an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2000

Pathway Medical Technologies, Inc. c/o Mr. Brian Cleary 10801 120th Ave NE Kirkland, WA 98033

Re: K082186

Trade/Device Name: Pathway PV Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: July 31, 2008 Received: August 1, 2008

Dear Mr. Cleary:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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

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2 Page - Mr. Brian Cleary

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 (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. 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,

Dma R. Vochner

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

1X ... ) ! ! 510(k) Number (if known):

Device Name: Jetstream Pathway PVTM Atherectomy System

Indications for Use: The Pathway PVTM Atherectomy 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 X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510/k) Number Ko8218 (

CONFIDENTIAL