JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100

K101221 · Pathway Medical Technologies, Inc. · MCW · Jun 2, 2010 · Cardiovascular

Device Facts

• Record ID: K101221
• Device Name: JETSTREAM G3 SYSTEM, MODEL PV31300, PV CONSOLE, MODEL PVCN100
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Jun 2, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Jetstream 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. 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, system controller, and keypad interface. Operated by clinicians in a clinical setting; console remains outside the sterile field. Device provides mechanical debulking of plaque and thrombus; aspirated material is collected in a bag. Modifications in this version minimize ingress of aspirated material into the guidewire lumen and add compatibility with PATHWAY JETWIRE. Benefits include effective removal of vascular obstructions in peripheral arteries.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included system reliability, flexibility, accessory compatibility, infusion/aspiration flow rates, trackability, aspiration efficiency, crossing time, thrombus aspiration challenge, guidewire/device wear, EO residuals, and control pod logic verification.

Technological Characteristics

System consists of an electrically driven catheter with a differentially cutting tip and a console with two peristaltic pumps. Catheter includes aspiration and infusion lumens. Console features keypad interface and LED status indicators. Sterilization via ethylene oxide (EO). Connectivity: Standalone system mounted on I.V. stand. Control pod logic manages device operation.

Indications for Use

Indicated for atherectomy and thrombus removal in upper and lower extremity peripheral arteries. 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 G3™ System (K100462)
• Jetstream G3™ System (K093456)
• Jetstream G3™ System (K092332)
• Jetstream G3™ L System (K093918)
• Jetstream G2™ System (K083837)
• Pathway PV™ Atherectomy System (K081328)

Submission Summary (Full Text)

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K101221

Image /page/0/Picture/1 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a circular graphic on the left, with a shaded upper portion and a white lower portion containing a curved shape. To the right of the graphic is the word "PATHWAY" in large, sans-serif font, with the words "MEDICAL TECHNOLOGIES" in a smaller font beneath it.

JUN - 2 2010

## 510(k) SUMMARY

## General Information:

| Date of Summary Preparation: | May 28, 2010 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------|
| Name and Address of Manufacturer: | Pathway Medical Technologies, Inc.<br>10801 120th Ave NE<br>Kirkland, Washington 98033 |
| Contact Person: | Brian Cleary<br>Vice President of Clinical and Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] |
| Trade Name: | Jetstream G3™ 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 |

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Performance Standards: Performance Standards do not currently exist for these devices. None are established under Section 514.

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 atherectorny 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) K093456, but with the primary modifications intended to ensure any ingress of aspirated material into the guidewire lumen is minimized. In addition, the PATHWAY JETWIRE™ has been added as a compatible guidewire in the product labeling.

Indications for Use: The Jetstream 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. It is not intended for use in coronary, carotid, iliac or renal vasculature.

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Substantially Equivalent Devices: Pathway Medical cites the following devices as substantially equivalent predicate devices:

- · Jetstream G3TM System (K100462)
- · Jetstream G3TM System (K093456)
- · Jetstream G3TM System (K092332)
- · Jetstream G3TM L System (K093918)
- · Jetstream G2TM System (K083837)
- · Pathway PVTM Atherectomy System (K081328)

Testing Summary: To demonstrate substantial equivalence of the modified Jetstream G3 System to the predicate devices, the technological and performance chracteristics were evaluated using in vitro testing as outlined below:

- System Reliability/Life .
- Speed Drop Flexibility .
- Accessory Compatibility .
- Infusion and Aspiration Flow Rates .
- Catheter Trackability and Pushability *
- Aspiration Efficiency and Crossing Time .
- Thrombus Aspiration Challenge .
- Guidewire and Device Wear .
- Sterilant (EO) Residuals �
- Control Pod Logic Verification �
- Intended Use .
- Pyrogenicity .

The results from these tests:

- demonstrate that the technological and performance characteristics of the . modified Jetstream G3 System are comparable to the predicate devices,
- support the safety and effectiveness of the modifications that are the subject of . this 510(k), and
- ensure the modified device can perform in a manner equivalent to the listed . predicate devices with the identical intended use.

Conclusion (Statement of Equivalence): The data and information presented within this submission (including in vitro testing) and the similarities between the modified and predicate devices support a determination of substantial equivalence, and therefore market clearance of the modified Jetstream G3 System through this 510(k) Premarket Notification.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird symbol, represented by three curved lines that suggest wings or feathers. The overall design is simple and recognizable, representing the department's role in public health and human services.

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

JUN - 2 2010

Pathway Medical Technologies, Inc. c/o Mr. Brian Cleary Vice President of Clinical and Regulatory Affairs 10801 12000 Ave NE Kirkland, WA 98033

Re: K101221

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: April 30, 2010 Received: May 3, 2010

Dear Mr. Cleary:

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. Drue, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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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 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/Resourcesfor You/Industry/default.htm.

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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510(k) Number (if known): K101221_

Device Names: Jetstream G3TM System

## Indications for Use:

The Jetstream 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. It is not intended for use in coronary, carotid, illiac 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)

W. J. Nagel

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K061221

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