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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Jetstream G3 and Jetstream G3 L Systems, which are peripheral atherectomy catheters. This type of document focuses on establishing substantial equivalence to previously cleared devices through pre-clinical (bench and animal) testing rather than clinical studies with explicit acceptance criteria related to a specific disease and the reported performance of the device in a clinical setting.

Therefore, the requested information regarding acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment for test/training sets, expert qualifications, and MRMC studies, is not available in the provided document. These details are typically found in clinical trial reports or publications, which are not part of a 510(k) summary for a substantial equivalence determination where efficacy and safety are often inferred from the predicate device and pre-clinical data.

The document confirms:

Device: Jetstream G3 L System and Jetstream G3 System
Intended Use: Atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries.
Not intended for: Coronary, carotid, iliac, or renal vasculature.
Basis for Clearance: Substantial equivalence to predicate devices (K093918, K093456, K083489, K081328).

No information is provided in the document for the following requests:

A table of acceptance criteria and the reported device performance: Not applicable for this type of submission, which relies on substantial equivalence. Performance data in a clinical context with defined acceptance criteria is not presented.
Sample sizes used for the test set and the data provenance: No clinical test set data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with human-established ground truth is described.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical atherectomy system, not an AI-powered diagnostic tool involving human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a mechanical device.
The sample size for the training set: Not applicable as there is no mention of an algorithm or AI model in the document that would require a "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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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)

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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 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.

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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.

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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

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4: INDICATION

K 100462 510(k) Number (if known):

Device Names: Jetstream G37M System; Jetstream G3TM L System

Indications for Use:

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

Page _ of _

000014

Regulation Number and Section

§ 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).