JETSTREAM G3 (R) SF 1.6 SYSTEM
Device Facts
| Record ID | K111229 |
|---|---|
| Device Name | JETSTREAM G3 (R) SF 1.6 SYSTEM |
| Applicant | Pathway Medical Technologies, Inc. |
| Product Code | MCW · Cardiovascular |
| Decision Date | Jun 1, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.4875 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
The Jetstream G3 SF 1.6 System is a peripheral atherectomy catheter used to debulk and treat vascular disease. The system comprises a sterile, single-use catheter with a differentially cutting tip and a reusable PV Console. The catheter features separate lumens for continuous aspiration of excised tissue/thrombus and infusion of sterile saline. The console includes peristaltic pumps for aspiration/infusion, a system controller, and a keypad interface. The device is operated by a physician in a clinical setting. The primary modification in this version is a reduced distal tip diameter to access smaller peripheral anatomy. The system provides mechanical debulking and thrombus removal, with the console managing fluid dynamics and operational status via LED indicators.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included dimensional verification, catheter pull, weld joint strength, system reliability/life testing, infusion and aspiration flow rates, trackability, pushability, aspiration efficiency, crossing time, heat generation, rotational speed, and control pod logic verification.
Technological Characteristics
System consists of a single-use catheter with a differentially cutting tip and a reusable PV Console. Features include dual-lumen design for continuous aspiration and saline infusion, peristaltic pumps, and a keypad-controlled user interface. Connectivity is limited to the console-catheter link. Sterilization is implied for the single-use catheter component. The system is electromechanically driven.
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 SF System (K110626)
- Jetstream G3 SF System (K101334)
- Pathway PVTM Atherectomy System (K081328)
Submission Summary (Full Text)
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K111229
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JUN - 1 2011
## 510(k) SUMMARY
## General Information:
Date of Summary Preparation: April 29, 2011 Name and Address of Manufacturer: Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033 Contact Person: Cyndy Adams Regulatory Affairs Sr. Manager Phone: 425-636-4047 Fax: 425-636-4001 JETSTREAM G3® SF 1.6 System Device Trade Names:
Device Trade Names:
Common Name:
.
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Panel:
Product Code:
Peripheral Atherectomy Catheter
21 CFR 870.4875
Intraluminal Artery Stripper
Class II
Cardiovascular
MCW
Pathway Medical Technologies, Inc.
## 510(k) SUMMARY
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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 SF 1.6 System is a catheter system designed with a fixed 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 G3 SF 1.6 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:
- 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 G3 SF 1.6 Catheter continues to utilize a differentially cutting tip and includes both aspiration and infusion capabilities, and the Control Pod provides a user interface with keypad control. The Catheter with Control Pod, 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 G3 SF System. The primary modification is a slight decrease in the diameter of the distal tip to allow the Jetstream G3 SF 1.6 System to treat lesions in slightly smaller anatomy within the identically indicated peripheral vasculature.
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 G3 SF System (K110626)
- Jetstream G3 SF System (K101334) .
- . Pathway PVTM Atherectomy System (K081328)
Testing Summary: To demonstrate substantial equivalence of the Jetstream G3 SF 1.6 System to the predicate device, the technological and performance characteristics were evaluated using the following in vitro testing:
- Dimensional Verification
- Catheter Pull .
- . Weld Joint Strength
- System Reliability/Life Test .
- . Infusion and Aspiration Flow Rates
- . Catheter Trackability and Pushability
- Aspiration Efficiency and Crossing Time .
- . Heat Generation
- . Rotational Speed
- Control Pod Logic Verification ●
- Intended Use .
The results from these tests:
- . demonstrate that the technological and performance characteristics of the modified Jetstream G3 SF 1.6 System is comparable to the predicate devices.
- . support the safety and effectiveness of the modifications that are the subject of this 510(k), and
- ensure that 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 and the similarities between the modified and predicate devices support a determination of substantial equivalence. The devices have identical indications for use and the same technological characteristics. Bench testing supports the safety and effectiveness of the modifications that were the subject of this 510(k).and therefore market clearance of the modified Jetstream G3 SF 1.6 System 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 and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a base that resembles a stylized staff with intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pathway Medical Technologies, Inc. c/o Ms. Cyndy Adams Regulatory Affairs Senior Manager · 10801 120" Ave NE Kirkland, WA 98033
Re: K111229
Trade/Device Name: 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: April 29, 2011 Received: May 2, 2011
Dear Ms. Adams:
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.
JUN - 1 20117
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Page 2 - Ms. Cyndy Adams
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 Óffice 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 (800) 638-2041 or (301) 796-7100 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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## INDICATIONS FOR USE
1/11/229 510(k) Number (if known):
Device Name: Jetstream G3™ SF 1.6 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)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|------------------------------------|---------|
| Division of Cardiovascular Devices | |
| 510(k) Number | K111229 |
Pathway Medical Technologies, Inc. 510(k)
CONFIDENȚIAL
Appendix 2
