(28 days)
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.
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.
The provided document is a 510(k) summary for a medical device called the Jetstream G2™ NXT System. This document describes a device used for atherectomy and thrombus removal in peripheral arteries. It primarily focuses on demonstrating substantial equivalence to previously cleared devices through bench testing, rather than a clinical study evaluating specific performance metrics against acceptance criteria in a human population.
Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not present in this type of regulatory submission. This document confirms the device meets the general requirements for substantial equivalence based on bench testing of manufacturing material changes.
Here's the information that can be extracted or inferred from the provided text, along with explanations for unavailable information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific acceptance criteria or performance metrics for clinical efficacy. The submission is for a device that is "substantially equivalent" to predicate devices, and the changes are related to "catheter shaft material to improve manufacturability." The performance assessment in this 510(k) is based on bench testing to support the safety and effectiveness of these material modifications.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of clinical performance. The "test set" here refers to bench testing performed on the device itself.
- Data Provenance: Not applicable for clinical data. The testing mentioned (bench testing) would be conducted by the manufacturer, Pathway Medical Technologies, Inc., based in Kirkland, Washington, USA.
- Retrospective/Prospective: Not applicable. The "study" mentioned is bench testing of the modified device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for bench testing is typically based on engineering specifications and physical measurements, not expert clinical consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or outcomes, not for bench testing of device components.
5. 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
Such a study was not done. This device is an atherectomy catheter system, not an AI diagnostic tool. MRMC studies are not relevant to this device's regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench testing conducted, the "ground truth" would be established by engineering specifications, physical measurement standards, and material science properties to ensure the modified catheter shaft material performs as intended and is safe. This would be based on validated test methods and established standards for medical device materials.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be manufacturing processes and quality control.
9. How the ground truth for the training set was established
Not applicable.
{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
§ 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).