(90 days)
Not Found
No
The summary describes a mechanical atherectomy and thrombus removal system with physical components (catheter, console, pumps) and user controls. There is no mention of AI, ML, image processing, or data-driven decision-making within the device's operation.
Yes
The device is described as treating vascular disease by performing atherectomy and removing thrombus from peripheral arteries, which are therapeutic interventions.
No
The device is described as an atherectomy and thrombus removal system, which are treatment procedures, not diagnostic ones. Its function is to break apart and remove substances, not to identify or diagnose medical conditions.
No
The device description clearly outlines hardware components including a Catheter with Control Pod and a PV Console, which contain electrical and mechanical parts like a cutting tip, pumps, power supply, and system controller. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for atherectomy and thrombus removal within the peripheral vasculature. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a system with a catheter that is inserted into the body to physically remove tissue and thrombus. It has mechanical components (cutting tip, pumps) and is used for a surgical/interventional procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. This device does not perform any such analysis of specimens.
Therefore, the Jetstream System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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. (from page 1)
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. (from page 4)
Product codes (comma separated list FDA assigned to the subject device)
MCW
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.
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. It is not intended for use in coronary, carotid, iliac or renal vasculature.
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)
Not Found
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.
K093918, K093456, 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 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
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