(30 days)
Not Found
No
The description focuses on mechanical and fluidic components (cutting tip, aspiration, infusion, pumps) and a basic control system with keypad interface and LED indicators. There is no mention of AI/ML terms, image processing, or data-driven decision-making.
Yes
The device is intended for atherectomy of the peripheral vasculature and to break apart and remove thrombus, which are therapeutic interventions.
No
The device is an atherectomy catheter system designed to remove plaque and thrombus from peripheral arteries through mechanical means (cutting and aspiration), which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical hardware components including a catheter, control pod, and a console with pumps, power supply, and system controller. This is not a software-only device.
Based on the provided information, the Jetstream G3TM L System is not an IVD (In Vitro Diagnostic) 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 on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter system with a cutting tip, aspiration, and infusion capabilities used to physically remove material from blood vessels. This is consistent with a surgical or interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical removal of material.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Jetstream G3TM L System does not fit this description.
N/A
Intended Use / Indications for Use
The Jetstream G3TM L 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 L 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 L System consists of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- Jetstream G3 L Catheter with 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) K093456, but with the primary modifications of increasing the device cutting tip and expandable blade diameters, shortening the catheter working length, and increasing the device power.
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.
K093456, K092332, K091509, 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
K0933918
Image /page/0/Picture/1 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a black circle with a white, curved shape inside, followed by the text "PATHWAY" in large, sans-serif font. Below "PATHWAY" is the text "MEDICAL TECHNOLOGIES" in a smaller, sans-serif font.
510(k) SUMMARY
JAN 2 1 2010
General Information:
Date of Summary Preparation:
December 18, 2009
Name and Address of Manufacturer:
Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033
Contact Person:
Brit Baird Regulatory Affairs Specialist 425-636-4137 Phone: Fax: 425-636-4001
Peripheral Atherectomy Catheter
Intraluminal Artery Stripper
Jetstream G3TM L System
21 CFR 870.4875
Cardiovascular
Class II
MCW
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Panel:
Product Code:
Predicate Devices:
Manufacturer: Pathway Medical Technologies, Inc. (1) Jetstream G3TM System (K093456)
- (2) Jetstream G3TM System (K092332)
- (3) Jetstream G2TM NXT System (K091509)
- (4) Pathway PVTM Atherectomy System (K081328)
Indications for Use: The Jetstream G37M L System is intended for use in atherectorny 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.
000049
1
Device Description: The Jetstream G3 L System is an atherectorny 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 atherectorny procedure.
The Jetstream G3 L System consists of two primary components: (1) a Catheter with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- Jetstream G3 L Catheter with 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) K093456, but with the primary modifications of increasing the device cutting tip and expandable blade diameters, shortening the catheter working length, and increasing the device power.
Substantial Equivalence: The Jetstream G3 L System is substantially equivalent to the specified predicate device. 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).
000050
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 9 1 2010
Pathway Medical Technologies, Inc. c/o Mr. Brit Baird Regulatory Affairs Specialist 10801 120th Ave NE Kirkland, WA 98033
Re: K093918
Trade/Device Name: Jetstream G3 L System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: December 18, 2009 Received: December 22, 2009
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,
R. Kirchner
Image /page/3/Picture/7 description: The image shows a simple, hand-drawn sketch of a downward-pointing arrow. The arrow has a slightly curved shaft and a distinct arrowhead. The style is minimalist, with thick, dark lines defining the shape against a white background.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ·
4
INDICATIONS FOR USE
Kog3918 510(k) Number (if known):
Device Name: Jetstream G3TM L System
Indications for Use: The Jetstream G3TM L 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.
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)
Nuna R. de Luna
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko93918
000045
Appendix 3
CONFIDENTIAL