JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM

K122916 · Medrad, Inc. · MCW · Oct 19, 2012 · Cardiovascular

Device Facts

• Record ID: K122916
• Device Name: JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
• Applicant: Medrad, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Oct 19, 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 Systems are rotational atherectomy devices for peripheral vascular disease. System comprises a sterile, single-use catheter with a differentially cutting tip (fixed or expandable) and a reusable PV Console. Catheter features separate lumens for continuous aspiration of excised tissue/thrombus and infusion of sterile saline. Console includes peristaltic pumps, power supply, and controller. Operated by clinicians in a clinical setting; console remains outside the sterile field. Modification removes tachometer function and rotational speed displays from the console. Device debulks plaque and removes thrombus, potentially improving peripheral blood flow. Clinicians monitor procedure via standard imaging and device feedback.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included system reliability/life tests, aspiration efficiency, crossing time, label cleanability/durability, and auditory feedback evaluation to confirm performance equivalence following the removal of the tachometer function.

Technological Characteristics

Rotational 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 controller. Connectivity: Standalone console with keypad interface and LED indicators. Sterilization: Single-use catheter is sterile. Modification: Removal of tachometer/RPM input and rotational speed displays.

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® L System (K120242)
• JETSTREAM Navitus® System (K110626)
• JETSTREAM G3® SF System (K110626)
• JETSTREAM G3® SF 1.6 System (K111229)

Reference Devices

• JETSTREAM G3® SF System (K101334)
• JETSTREAM Pathway PV™ Atherectomy System (K082186)
• Pathway PV™ Atherectomy System (K081328)

Submission Summary (Full Text)

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K122916

OCT 19 2012

### 510(k) SUMMARY

## General Information:

Date of Summary Preparation:

September 20, 2012

MEDRAD, Inc.

Name and Address of Manufacturer:

Contact Person:

Device Trade Names:

Common Name:

Regulation Number:

Regulation Name:

Regulatory Class:

Classification Panel:

Product Code:

Brit Baird Regulatory Affairs Manager Phone: [phone] Fax: [phone]

9055 Evergreen BLVD NW Minneapolis, MN 55433-8003

JETSTREAM Navitus® L System JETSTREAM Navitus® System JETSTREAM G3® SF System JETSTREAM G3® SF 1.6 System

Peripheral Atherectomy Catheter

21 CFR 870.4875

Intraluminal Artery Stripper

Class II

Cardiovascular

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 Systems are rotational atherectomy catheter systems designed with either a fixed (Jetstream G3 SF, Jetstream G3 SF 1.6) or an expandable (Jetstream Navitus L, Jetstream Navitus) 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 Systems consist 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 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 modified Jetstream 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.

The primary modification of this 510(k) removes the tachometer function (i.e., speed/RPM inout) in the Control Pod, and correspondingly removes the rotational speed displays on the PV Console. This modification applies to the entire family of Jetstream Systems.

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: MEDRAD cites the following devices as the primary predicate devices for the aforementioned modification and substantial equivalence basis.

| Primary Predicate Devices | Pathway Medical<br>Predicate 510(k) |
|-----------------------------|-------------------------------------|
| JETSTREAM Navitus® L System | K120242 |
| JETSTREAM Navitus® System | K110626 |
| JETSTREAM G3® SF System | K110626 |
| JETSTREAM G3® SF 1.6 System | K111229 |

However, the design rationale for and device testing of the modified devices also includes references to the additional predicate devices listed in the table below:

| Other Predicate Devices | Pathway Medical<br>Predicate 510(k) |
|------------------------------------------|-------------------------------------|
| JETSTREAM G3® SF System | K101334 |
| JETSTREAM Pathway PV™ Atherectomy System | K082186 |
| Pathway PV™ Atherectomy System | K081328 |

Testing Summary: To demonstrate substantial equivalence of the modified Jetstream Systems to the predicate Jetstream Systems, the technological and performance characteristics were evaluated using in vitro testing for the primary modification, as outlined below:

- . System Reliability/Life Test
- Aspiration Efficiency & Crossing Time .
- Label Cleanability and Durability
- Auditory Feedback ●

The results from these tests:

- demonstrate that the technological and performance characteristics of the . modified Jetstream Systems are comparable to the predicate Jetstream Systems,
- . support the safety and effectiveness of the modification that is the subject of this 510(k), and
- ensure the modified devices can perform in a manner equivalent to the predicate . Jetstream Systems 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 Systems through this 510(k) Premarket Notification.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, represented by three stylized strokes.

#### Public Health Service

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

OCT 19 2012 :

Medrad, Inc. c/o Mr. Brit Baird Regulatory Affairs Manager 9055 Evergreen Blvd NW Minneapolis, MN 55433

Re: K122916

Trade/Device Name: Jetstream Navitus L System, Jetstream Navitus System, Jetstream G3 SF System, and Jetstream G3 SF 1.6 System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: September 20, 2012 Received: September 21, 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 go to http://www.fda.gov/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 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 vours.

.g.killelea

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

510(k) Number (if known):

Device Name:

JETSTREAM Navitus® L System JETSTREAM Navitus® System JETSTREAM G3® SF System JETSTREAM G3® SF 1.6 System

1/22916

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 IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| <div><img alt="signature" src="signature.png"/></div> | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K122916 |

CONFIDENTIAL

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