(28 days)
No
The description focuses on mechanical and fluid dynamics for atherectomy and thrombus removal, with no mention of AI/ML terms or functions.
Yes
The device is described as an atherectomy catheter system intended for atherectomy of the peripheral vasculature and removal of thrombus, which are medical procedures to treat disease, making it a therapeutic device.
No
The device is described as an atherectomy catheter system intended for the removal of plaque and thrombus from peripheral arteries. Its function is therapeutic (breaking apart and removing material) rather than diagnostic (identifying or characterizing a medical condition).
No
The device description clearly outlines hardware components including a catheter, control pod, and console with pumps and a power supply.
Based on the provided text, the Jetstream G2TM NXT 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 (in vivo) to treat a condition.
- Device Description: The description details a catheter system with a cutting tip, aspiration, and infusion capabilities designed to physically remove tissue and thrombus from blood vessels. This is consistent with an interventional device used during a procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. The description of the Jetstream G2 NXT System does not mention any such testing or analysis of specimens.
Therefore, the Jetstream G2TM NXT System is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Jetstream G2TM NXT 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
MCW
Device Description
The Jetstream G2 NXT 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 G2 NXT 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 G2 NXT 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) K090325, but changes the catheter shaft material to improve the 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)
(1) Jetstream G2TM System (K090325, K083837), (2) Jetstream™ System (K082186, K083489), (3) Pathway PVTM System (K081328)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 with a stylized mountain inside, followed by the text "PATHWAY" in a sans-serif font, with the words "MEDICAL TECHNOLOGIES" underneath in a smaller font. In the upper right corner of the image, there is a handwritten number "K691509".
JUN 19 2009
510(k) SUMMARY
General Information:
Date of Summary Preparation:
May 21, 2009
Name and Address of Manufacturer:
Contact Person:
Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Panel:
Product Code:
Predicate Devices:
Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033
Brit Baird Regulatory Affairs Specialist Phone: 425-636-4137 425-636-4001 Fax: .
Jetstream G2TM NXT System
Peripheral Atherectomy Catheter
21 CFR 870.4875
Intraluminal Artery Stripper
Class II
Cardiovascular
MCW
Manufacturer: Pathway Medical Technologies, Inc. (1) Jetstream G2TM System (K090325, K083837) (2) Jetstream™ System (K082186, K083489) (3) Pathway PVTM System (K081328)
.
Indications for Use: The Jetstream G2TM NXT 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.
Appendix 5
000060
1
Device Description: The Jetstream G2 NXT 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 G2 NXT 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 G2 NXT 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) K090325, but changes the catheter shaft material to improve the manufacturability of the device.
Substantial Equivalence: The Jetstream G2 NXT System is substantially equivalent to the specified predicate 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).
000061
510(k) SUMMARY
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 1 9 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pathway Medical Technologies, Inc. c/o Mr. Brit Baird Regulatory Affairs Specialist 10801 120th Avenue NE Kirkland, WA 98033
Re: K091509
Trade/Device Name: Jetstream G2 NXT System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal artery stripper Regulatory Class: Class II (two) Product Code: MCW Dated: May 21, 2009 Received: May 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.
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
una R. buchner
1 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
1091509 510(k) Number (if known): _
Device Name: Jetstream G2TM NXT System
Indications for Use: The Jetstream G2TM NXT 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 (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)
Dring R. 170 (Division Simn-Off) Division of Cardiovascular Devices
510(k) Number 2091509
000037
Pathway Medical Technologies, Inc. 510(k)
CONFIDENTIAL
Appendix 1