JETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100

K100462 · Pathway Medical Technologies, Inc. · MCW · May 19, 2010 · Cardiovascular

Device Facts

Record IDK100462
Device NameJETSTREAM G3 L SYSTEM, PV CONSOLE, MODELS PV31400, PV31300, PVCN100
ApplicantPathway Medical Technologies, Inc.
Product CodeMCW · Cardiovascular
Decision DateMay 19, 2010
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 870.4875
Device ClassClass 2
AttributesTherapeutic

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 and G3 L systems are peripheral atherectomy devices designed for debulking and thrombus removal. System consists of a sterile, single-use catheter with an electrically-driven, differentially cutting tip and a reusable PV console. Console features two peristaltic pumps for active infusion and aspiration of fluid, excised tissue, and thrombus. Operated by physicians in clinical settings; console remains outside sterile field. Catheter includes a control pod with keypad for user interface. Active removal of debris from the treatment site facilitates vascular disease treatment. Benefits include effective debulking and thrombus clearance in peripheral vasculature.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance testing.

Technological Characteristics

System comprises a single-use catheter with an electrically-driven, differentially cutting tip and a reusable PV console. Console includes two peristaltic pumps for infusion/aspiration, power supply, system controller, and keypad interface. Connectivity via electrical connectors and tubing. System is designed for peripheral vascular use. Sterilization method for catheter is not specified.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Pathway Medical Technologies. The logo is in black and white and features the company name in a simple, sans-serif font. The word "PATHWAY" is on the top line, and "MEDICAL TECHNOLOGIES" is on the bottom line. # MAY 1 9 2010 ## 510(k) SUMMARY Brit Baird Phone: Class II MCW Cardiovascular Fax: · Regulatory Affairs Specialist Jetstream G3TM L System Jetstream G3TM System 21 CFR 870.4875 Peripheral Atherectomy Catheter Intraluminal Artery Stripper 425-636-4137 425-636-4001 ### General Information: February 17, 2010 Date of Summary Preparation: Name and Address of Manufacturer: Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033 Contact Person: Trade Name: Common Name: Regulation Number: Regulation Name: Regulatory Class: Classification Panel: Product Code: Predicate Devices: A new era of unified, intelligent threat protection for your business. **Sophos** - Manufacturer: Pathway Medical Technologies, Inc. - (1) Jetstream G3TM L System (K093918) - (2) Jetstream G3TM System (K093456) - (3) Jetstream™ Pathway PVTM Atherectomy System (K083489) - (4) Pathway PVTM Atherectomy System (K081328) {1}------------------------------------------------ The Jetstream System is intended for use in atherectomy of the peripheral vasculature nd to break apart and remove thrombus from upper and lower extremity peripheral It is not intended for use in coronary, carotid, iliac or renal vasculature. #### Device Description The Jetstream G3 L and the Jetstream G3 Systems are designed to provide atherectorny and thrombus removal treatment with similar performance requirements. Both are designed with an expandable cutting tip and infusion and aspiration functions intended for use in debulking and treating vascular disease in the peripheral vasculature. These functions allow for the active removal of fluid, excised tissue, and thrombus from the peripheral treatment site. The Jetstream G3 L and the Jetstream G3 Systems thus retain the same two primary components: a Cathefer with Control Pod and a Console. These two system components are packaged separately and described generally below. - Catheter with Control Pod: A sterile, single-use unit consisting of an ● electrically-driven Catheter with attached Control Pod. The 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. #### Substantial Equivalence Information was provided to demonstrate that the Jetstream G3 L and the Jetstream G3 Systems with the modified indications for use are substantially equivalent to the predicate devices. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, symbolizing care and protection. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", arranged in a circular fashion. The text is in all capital letters and is evenly spaced around the circle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 MAY 1 9 2010 Pathway Medical Technologies, Inc. c/o Mr. Brit Baird Regulatory Affairs Specialist 10801 12000 Ave NE Kirkland, WA 98033 Re: K100462 Trade Name: Jetstream G3 L System and Jetstream G3 System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: April 12, 2010 Received: April 13, 2010 #### 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. {3}------------------------------------------------ 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Duna R. V. Auner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### 4: INDICATION K 100462 510(k) Number (if known): Device Names: Jetstream G37M System; Jetstream G3TM 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) purner 2. Values (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K1004 6 2 Page _ of _ 000014
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%