JETSTREAM NAVITUS L SYSTEM

K120242 · Pathway Medical Technologies, Inc. · MCW · Feb 24, 2012 · Cardiovascular

Device Facts

• Record ID: K120242
• Device Name: JETSTREAM NAVITUS L SYSTEM
• Applicant: Pathway Medical Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Feb 24, 2012
• 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 Navitus L System is an atherectomy catheter system for debulking and treating peripheral vascular disease. System comprises a sterile, single-use catheter with an electrically-driven, differentially cutting tip and a reusable PV 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. Modifications include increased cutting tip (2.4 mm) and expandable blade (3.4 mm) diameters and decreased catheter length (120 cm). Device enables mechanical debulking of peripheral arteries, potentially improving blood flow and patient outcomes.

Clinical Evidence

Bench testing only. No clinical data provided. In vitro testing included dimensional verification, heat generation, system reliability/life test, aspiration efficiency, crossing time, speed drop flexibility, material liberation, rotational speed, accessory compatibility, infusion/aspiration flow rates, catheter pull, trackability, pushability, torque to failure, contrast injection, aorta strip test, and layered dissection model.

Technological Characteristics

Electrically-driven atherectomy catheter with differentially cutting tip. Features integrated aspiration and infusion lumens. System includes a reusable PV Console with two peristaltic pumps, power supply, and keypad interface. Dimensions: 2.4 mm cutting tip, 3.4 mm expandable blades, 120 cm catheter length. Single-use sterile catheter; reusable console. Connectivity: LED indicators for status. No software algorithm details provided.

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 Navitus System (K110626)
• Jetstream G3 SF 1.6 System (K111229)
• Jetstream G3 SF System (K101334, K101221)
• Jetstream G3 System (K093456, K092332)
• Jetstream G3 L System (K100462, K093918)
• Jetstream G2 NXT System (K091509)
• Jetstream Pathway PV Atherectomy System (K082186)
• Pathway PV Atherectomy System (K081328)

Submission Summary (Full Text)

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K120242

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 stylized mountain and path inside. To the right of the graphic is the word "PATHWAY" in large, sans-serif font, with the words "MEDICAL TECHNOLOGIES" in a smaller font underneath.

FEB 2 4 2012

## 510(k) SUMMARY

## General Information:

January 26, 2012 Date of Summary Preparation: Pathway Medical Technologies, Inc. Name and Address of Manufacturer: 10801 120th Ave NE Kirkland, Washington 98033 Contact Person: Brit Baird Regulatory Affairs Manager Phone: [phone] Fax: [phone] JETSTREAM Navitus™ L System Device Trade Names: Peripheral Atherectomy Catheter Common Name: 21 CFR 870.4875 Regulation Number: Intraluminal Artery Stripper Regulation Name: Class II Regulatory Class: Cardiovascular Classification Panel: MCW Product Code:

Pathway Medical Technologies, Inc.

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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 Navitus L System is an atherectomy catheter system designed with an expandable cutting tip intended 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 an external 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 Navitus L System consists of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:

- Jetstream Navitus L Catheter with Control Pod: A sterile, single-use unit . consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the Jetstream Navitus L Catheter utilizes a differentially cutting tip and includes both aspiration and infusion capabilities, and 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 PV Console mounts on a standard I.V. stand and remains outside the sterile field during the procedure.

This 510(k) is for modifications to the Jetstream Navitus System. The primary modifications of this 510(k) are to increase the cutting tip and expandable blade diameters (i.e., from 2.1 to 2.4 mm for the cutting tip, and from 3.0 to 3.4 mm for the expandable blades), and decrease the overall catheter length (from 135 to 120 cm).

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 Jetstream Navitus™ System (K110626) as the primary predicate device for the aforementioned modifications and substantial equivalence basis. However, the design rationale for and device testing of the modified device also includes references to the additional predicate Pathway Medical devices listed in the table below:

| Predicate Devices | Pathway Medical<br>Predicate 510(k) |
|-------------------------------------------|-------------------------------------|
| Jetstream G3® SF 1.6 System | K111229 |
| Jetstream G3® SF System | K101334 |
| | K101221 |
| Jetstream G3® System | K093456 |
| | K092332 |
| Jetstream G3® L System | K100462 |
| | K093918 |
| Jetstream G2® NXT System | K091509 |
| Jetstream Pathway PVTM Atherectomy System | K082186 |
| Pathway PVTM Atherectomy System | K081328 |

Testing Summary: To demonstrate substantial equivalence of the modified Jetstream Navitus System to the predicate Jetstream Navitus System, the technological and performance characteristics were evaluated using in vitro testing for the primary (and supporting) modifications, as outlined below:

- Dimensional Verification .
- Heat Generation .
- . System Reliability/Life Test
- . Aspiration Efficiency & Crossing Time
- Speed Drop Flexibility .
- . Material Liberation (Teflon & Polyimide)
- . Rotational Speed
- Accessory Compatibility .
- . Infusion & Aspiration Flow Rates
- . Catheter Pull
- . Catheter Trackability and Pushability
- Torque to Failure
- . Contrast Injection
- Aorta Strip Test .
- Lavered Dissection Model .

The results from these tests:

- demonstrate that the technological and performance characteristics of the . modified Jetstream Navitus System are comparable to the predicate Jetstream Navitus System,

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- 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 predicate . . Jetstream Navitus System 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 Navitus System through this 510(k) Premarket Notification.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

FEB 2 4 2012

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

Re: K120242

Trade/Device Name: Jetstream Navitus L Systems Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: January 26, 2012 Received: January 27, 2012

#### 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. 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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### 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 11 Jou active possible . cov/AboutFDA/CentersOffices/CDRH/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 Pour may 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 vours.

M. A. Killebrew

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

K12024Z 510(k) Number (if known):

Device Name:

JETSTREAM Navitus™ L 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, 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) | |
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. H. Wilhelm

(Division Sign-Off) (Bivision of Cardiovascular Devices

16120242 510(k) Number_

CONFIDENTIAL

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