(26 days)
Not Found
No
The description focuses on mechanical and fluidic components (cutting tip, aspiration, infusion, pumps) and a simple control interface. There is no mention of data analysis, learning, or adaptive behavior that would indicate AI/ML. The change described is a mechanical modification (motor gear ratio).
Yes
The device is intended for atherectomy and to remove thrombus, which are therapeutic interventions for treating vascular disease in the peripheral vasculature.
No
The provided text describes the Jetstream G3 System as a device intended for atherectomy and removal of thrombus from peripheral arteries. This is a therapeutic procedure, not a diagnostic one. The text focuses on how the device mechanically treats the condition (cutting, debulking, aspirating) rather than how it identifies or assesses the condition.
No
The device description clearly outlines physical hardware components including a catheter, control pod, and console with pumps, power supply, and system controller. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Jetstream G3 System is an atherectomy catheter system. Its function is to physically break apart and remove plaque and thrombus from blood vessels within the body. It is a surgical/interventional device used in vivo (within the living body).
- Intended Use: The intended use clearly states it's for "atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries." This is a therapeutic procedure performed directly on the patient's anatomy.
- Device Description: The description details a catheter with a cutting tip, aspiration, and infusion capabilities, and a console to control these functions. This aligns with a device used for a physical intervention, not for analyzing biological samples.
The device's purpose is to treat a condition within the body, not to analyze samples taken from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Jetstream G3TM 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 with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- Jetstream G3 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) K092332, but changes the motor gear ratio to increase torque and improve cutting efficiency 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.
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
pare 1 of 2 K0993456
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 mountain and path 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
DEC - 1 2009
General Information:
Date of Summary Preparation: November 4, 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: Jetstream G3TM System Common Name: Peripheral Atherectomy Catheter
21 CFR 870.4875
Intraluminal Artery Stripper
Class II
MCW
Cardiovascular
Product Code:
Predicate Devices:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Panel:
Manufacturer: Pathway Medical Technologies, Inc. (1) Jetstream G3TM System (K092332)
Indications for Use: The Jetstream G3TM 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.
Image /page/0/Picture/16 description: The image shows the text "Appendix 5" above the number "000037". The text is in a simple, bold font. The number is large and bold, and it appears to be part of a document or report.
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 with Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- Jetstream G3 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) K092332, but changes the motor gear ratio to increase torque and improve cutting efficiency of the device.
Substantial Equivalence: The Jetstream G3 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).
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN" around the left side. To the right of the seal is a stylized symbol with three curved lines that resemble a person.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
DEC - 1 2009
Pathway Medical Technologies, Inc. c/o Ms. Cyndy Adams Regulatory Affairs Sr. Manager 1080 120" Avenue NE Kirkland, WA 56033
Re: K093456
Jetstream G3 system Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (two) Product Code: MCW Dated: November 4, 2009 Received: November 5, 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 (OS) 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Duma R. Launer
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
510(k) Number (if known): K093456
Device Name: Jetstream G3TM System
Indications for Use: The Jetstream G3TM 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.
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)
sume R. Vaines
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number L6 9:345 (
Pathway Medical Technologies, Inc. 510(k)
CONFIDENTIAL
Appendix 1
000025