(21 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, which is a medical procedure to treat vascular disease, indicating a therapeutic purpose.
No
The device, the Jetstream G2™ System, is an atherectomy catheter system intended for the treatment and debulking of vascular disease in the peripheral vasculature. Its function is to remove excised tissue, thrombus, and fluid, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical hardware components including a catheter, control pod, and console with pumps, power supply, and keypad interface. It is an atherectomy system, which is a physical intervention device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "atherectomy of the peripheral vasculature." This is a surgical procedure performed directly on the patient's blood vessels to remove plaque.
- Device Description: The device is a catheter system designed for mechanical removal of tissue and thrombus from within the body. It involves physical interaction with the patient's anatomy.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) outside the body. IVD devices are used to perform tests on these samples to diagnose or monitor conditions.
The Jetstream G2™ System is a therapeutic device used for a surgical intervention, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / Indications for Use
The Jetstream G2TM System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Product codes
MCW
Device Description
The Jetstream G2TM 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 atherectorny procedure.
The Jetstream G27M 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 G2TM 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 with modifications to change the location of the distal tip aspiration ports to a single aspiration port located just proximal to the differentially cutting tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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)
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)
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/1 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a circular graphic on the left and the company name on the right. The graphic contains a mountain and a winding path inside of a circle. The text reads "PATHWAY MEDICAL TECHNOLOGIES" with "PATHWAY" on top and "MEDICAL TECHNOLOGIES" on the bottom.
510(k) SUMMARY
JAN 1 3 2009
| Date of Summary Preparation: | December 22, 2008 |
|---|---|
| Name and Address of Manufacturer: | Pathway Medical Technologies, Inc. |
| 10801 120th Ave NE | |
| Kirkland, Washington 98033 | |
| Contact Person: | Brian Cleary |
| Sr. Director of Regulatory Affairs | |
| Phone: 425-636-4079 | |
| Fax: 425-636-4001 | |
| Trade Name: | Jetstream G2TM System |
| Common Name: | Peripheral Atherectomy Catheter |
| Regulation Number: | 21 CFR 870.4875 |
| Regulation Name: | Intraluminal Artery Stripper |
| Regulatory Class: | Class II |
| Classification Panel: | Cardiovascular |
| Product Code: | MCW |
| Predicate Device: | 510(k) Number: K082664 |
| Manufacturer: Pathway Medical Technologies, Inc. | |
| Trade Name: JetstreamTM Pathway PVTM | |
| Atherectomy System |
Indications for Use: The Jetstream G27M System is intended for use in atherectorny of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.
000043
General Information:
Appendix 5
1
Device Description: The Jetstream G2TM 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 atherectorny procedure.
The Jetstream G27M 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 G2TM 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 with modifications to change the location of the distal tip aspiration ports to a single aspiration port located just proximal to the differentially cutting tip.
Substantial Equivalence: The Jetstream G2 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2009
Pathway Medical Technologies, Inc. c/o Brian Cleary, Senior Director of Regulatory Affairs 10801 120th Ave NE Kirkland; WA 98033
Re: K083837
Trade/Device Name: Jetstream G2TM System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: December 22, 2008 Received: December 23, 2008
Dear Mr. Cleary:
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 such 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.
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
3
Page 2 - Mr. Brian Cleary
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
bma R. barlener
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE
510(k) Number (if known): K083837
Device Name: Jetstream G2TM System
Indications for Use: The Jetstream G2™ System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Prescription Use ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
e R. L. L. A. A.
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_k 683837
000027
Pathway Medical Technologies, Inc. 510(k)
)
CONFIDENTIAL
Appendix 1