(30 days)
Not Found
No
The description focuses on mechanical and electrical components for atherectomy and thrombus removal, with no mention of AI or ML capabilities. The 510(k) is for a modification to the cutter design, not the addition of intelligent features.
Yes
The device is intended for atherectomy of the peripheral vasculature and to break apart and remove thrombus from arteries, which are medical treatments for disease conditions.
No
The device is an atherectomy catheter system used for treatment, specifically for debulking and treating vascular disease by removing tissue and thrombus. Its intended use is therapeutic, not diagnostic.
No
The device description clearly outlines hardware components including a catheter, control pod, and console with pumps, power supply, and system controller.
Based on the provided text, the Jetstream G3™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries." This describes a surgical procedure performed within the body, not a test performed on samples outside the body.
- Device Description: The description details a system with a catheter, cutting tip, aspiration, and infusion capabilities designed for use in vivo (within a living organism). This is consistent with a surgical or interventional device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or performing tests to diagnose a condition.
Therefore, the Jetstream G3™ System is a therapeutic device used for interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Jetstream G3™ 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 ≥3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Product codes (comma separated list FDA assigned to the subject device)
MCW
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 atherectomy procedure.
The Jetstream G3 System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately, Each of these system components is described generally as follows:
- . Jetstream G3 Catheter and 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) K091509, but changes the distal cutter design to improve cutting efficiency and manufacturability of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, upper and lower extremity peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K091509, K083837, K090325, K082186, K083489, K081328
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a circle on the left and the company name on the right. The circle contains a stylized mountain range with a dark sky above. The text "PATHWAY" is in large, bold letters, and the text "MEDICAL TECHNOLOGIES" is in smaller letters below.
510(k) SUMMARY
General Information:
SEP - 3 2009
Date of Summary Preparation:
July 31, 2009
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
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Panel:
Product Code:
Predicate Devices:
Jetstream G3TM System
Peripheral Atherectomy Catheter
21 CFR 870.4875
Intraluminal Artery Stripper
Class II
Cardiovascular
MCW
Manufacturer: Pathway Medical Technologies. Inc. (1) Jetstream G2TM NXT System (K091509) (2) Jetstream G2TM System (K083837, K090325) (3) Jetstream™ System (K082186, K083489) (4) Pathway PVTM System (K081328)
Indications for Use: The Jetstream G3™ 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 ≥3.0 mm in diameter. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Pathway Medical Technologies, Inc.
510(k) SUMMARY
Appendix 5
000044
1
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 atherectomy procedure.
The Jetstream G3 System consists of two primary components: (1) a Catheter and Control Pod and (2) a Console, which are packaged separately, Each of these system components is described generally as follows:
- . Jetstream G3 Catheter and 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) K091509, but changes the distal cutter design to improve cutting efficiency and manufacturability of the device.
Substantial Equivalence: The Jetstream G3 System is substantially equivalent to the specified predicate devices. The device has the identical indications for use and the same technological characteristics. Bench testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k).
510(k) SUMMARY
000045
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP - 3 2009
Pathway Medical Technologies, Inc. c/o Ms. Cyndy Adams Regulatory Affairs Senior Manager 10801 1200 Ave NE Kirkland, WA 98033
Re: K092332
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: July 31, 2009 Received: August 4, 2009
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.
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 - 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 contrôl 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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R. Vorhmer
Image /page/3/Picture/8 description: The image shows a black and white close-up of a handwritten symbol or character. The symbol consists of a vertical line with a curved shape attached to the top right. The curved shape resembles a simplified letter 'w' or a series of connected arches. The lines are thick and slightly uneven, suggesting they were drawn quickly or with a broad writing instrument.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Bram D. Zuckerman, M.D.
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): 4092332
Device Name: Jetstream G3TM System
Indications for Use: The Jetstream G3™ 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 ≥3.0 mm in diameter. It is not intended for use in corroary, 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)
Dumer R. le lumes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k 09 z 332
Pathway Medical Technologies, Inc. 510(k)
CONFIDENTIAL
Appendix 1 000029