(47 days)
Not Found
No
The document describes a mechanical atherectomy system with electrical and fluid control. There is no mention of AI, ML, image processing, or data-driven decision making. The modifications described are related to simplifying the user interface and minor changes to existing components.
Yes
The device is described as an atherectomy system intended to treat vascular disease by removing plaque and thrombus from peripheral arteries, which is a therapeutic intervention.
No
Explanation: The device is an atherectomy catheter system intended for the treatment (debulking and removal of thrombus) of vascular disease, not for diagnosis.
No
The device description clearly outlines both hardware components (Catheter with Control Pod, PV Console) and software/logic components (Control Pod Logic Verification, system controller). The modifications described are primarily related to the user interface on the hardware Control Pod.
Based on the provided text, the JETSTREAM System is not an IVD (In Vitro Diagnostic) 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 in vivo (within the living body).
- Device Description: The description details a system with a catheter, cutting tip, aspiration and infusion capabilities, and a console. These are all components used for a physical intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, the JETSTREAM System is a medical device used for a therapeutic procedure, 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 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.
Product codes
MCW
Device Description
The Jetstream Systems are atherectomy catheter systems designed with either a fixed (Jetstream G3 SF System) or an expandable (Jetstream Navitus, G3 SE and G3 L Systems) cutting tip intended 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 an external 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 Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:
- Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate devices, the Jetstream Catheters continue to utilize a differentially cutting tip and include 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.
The primary modifications of this 510(k) simplify the user interface by eliminating the two buttons that increase and decrease speed on the Control Pod Membrane. These modifications apply to the entire family of Jetstream Systems. In addition, non-significant changes made to the Jetstream G3 System (which is being given a new trade name -"Jetstream Navitus System" - with the modifications included in this 510(k)) and PV Console are also included.
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. 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)
Testing Summary: To demonstrate substantial equivalence of the modified Jetstream I count be incredicate devices, the technological and performance characteristics were Byoluated using in vitro testing for the primary (and supporting) modifications, as outlined below:
- System Reliability/Life Test
- Main Cable Joint Strength
- Control Pod Electrical Testing
- Control Pod Logic Verification
- Electrical Safety
- Intended Use
In addition, the following in vitro testing was provided to support the previously mentioned non-significant changes to the predicate Jetstream G3 System:
- System Reliability/Life Test
- Accessory Compatibility
- Infusion & Aspiration Flow Rates
- Aspiration Efficiency & Crossing Time
- Rotational Speed
- Material Liberation (Teflon & Polyimide)
- Aggressive Thrombus Testing
The results from these tests:
- demonstrate that the technological and performance characteristics of the modified Jetstream Systems are comparable to the predicate devices,
- modified safety and effectiveness of the modifications that are the subject of this 510(k), and
- ensure the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101221, K101334, K101334, K100462, K093918, K091509, K082186, 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 black circle with a white shape inside that resembles a pathway or road. To the right of the circle, the word "PATHWAY" is written in a simple, sans-serif font, with the words "MEDICAL TECHNOLOGIES" written in a smaller font size below it.
1110626
APR 2 0 2011
510(k) SUMMARY
General Information:
March 3, 2011 Date of Summary Preparation:
Name and Address of Manufacturer: Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033
Contact Person:
Brit Baird Regulatory Affairs Manager 425-636-4137 Phone: 425-636-4001 Fax:
JETSTREAM Navitus™ System
JETSTREAM G3® SF System JETSTREAM G3® SE System JETSTREAM G3® L System
Device Trade Names:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Classification Panel:
Product Code:
Peripheral Atherectomy Catheter
21 CFR 870.4875
Intraluminal Artery Stripper
Class II
Cardiovascular
MCW
1
Performance Standards: Performance Standards do not currently exist for these devices. None are established under Section 514.
Device Description: The Jetstream Systems are atherectomy catheter systems designed with either a fixed (Jetstream G3 SF System) or an expandable (Jetstream Navitus, G3 SE and G3 L Systems) cutting tip intended 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 an external 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 Systems consist of two primary components: a Catheter with Control Pod and a Console, which are packaged separately. Each of these system components is described generally as follows:
- . Jetstream Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate devices, the Jetstream Catheters continue to utilize a differentially cutting tip and include 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.
The primary modifications of this 510(k) simplify the user interface by eliminating the two buttons that increase and decrease speed on the Control Pod Membrane. These modifications apply to the entire family of Jetstream Systems. In addition, non-significant changes made to the Jetstream G3 System (which is being given a new trade name -"Jetstream Navitus System" - with the modifications included in this 510(k)) and PV Console are also included.
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.
2
Substantially Equivalent Devices: Pathway Medical cites the following devices as substantially equivalent predicate devices:
| Primary Predicate Device | Pathway Medical
Predicate 510(k) |
|------------------------------------------|-------------------------------------|
| JETSTREAM G3® System | K101221 |
| JETSTREAM G3® SF System | K101334 |
| JETSTREAM G3® SE System | K101334 |
| JETSTREAM G3® L System | K100462 |
| JETSTREAM G3® L System | K093918 |
| JETSTREAM G2™ NXT System | K091509 |
| JETSTREAM Pathway PV™ Atherectomy System | K082186 |
| Pathway PV™ Atherectomy System | K081328 |
Testing Summary: To demonstrate substantial equivalence of the modified Jetstream I count be incredicate devices, the technological and performance characteristics were Byoluated using in vitro testing for the primary (and supporting) modifications, as outlined below:
- System Reliability/Life Test .
- Main Cable Joint Strength . ●
- Control Pod Electrical Testing ●
- Control Pod Logic Verification �
- Electrical Safety .
- Intended Use .
In addition, the following in vitro testing was provided to support the previously mentioned non-significant changes to the predicate Jetstream G3 System:
- System Reliability/Life Test .
- Accessory Compatibility .
- Infusion & Aspiration Flow Rates .
- Aspiration Efficiency & Crossing Time .
- Rotational Speed ●
- Material Liberation (Teflon & Polyimide) ●
- Aggressive Thrombus Testing .
The results from these tests:
- demonstrate that the technological and performance characteristics of the . modified Jetstream Systems are comparable to the predicate devices,
- modified safety and effectiveness of the modifications that are the subject of . this 510(k), and
- ensure the modified device can perform in a manner equivalent to the listed ◆ predicate devices with the identical intended use.
3
Conclusion (Statement of Equivalence): The data and information presented within this submission (including in vitro testing) and the similarities between the modified and predicate devices support a determination of substantial equivalence, and therefore market clearance of the modified Jetstream Systems through this 510(k) Premarket Notification.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pathway Medical Technologies, Inc. c/o Mr. Brian Cleary Vice President of Clinical and Regulatory Affairs 10801 12000 Ave NE Kirkland, WA 98033
APR 2 0 2011
Re: K110626
Trade/Device Name: Jetstream Navitus, G3 SF, G3 SE and G3 L Systems Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) · Product Code: MCW Dated: April 7, 2011 Received: April 8, 2011
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. 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.
5
Page 2 - Mr. Brian Cleary
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 (OS) 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/ReportalProblem/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,
Bram D. Zuckerman, M.D.
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) Number (if known): K110626
Device Name:
JETSTREAM Navitus™ System JETSTREAM G3® SF System JETSTREAM G3® SE System JETSTREAM G3® 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 (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) |
|---|
| -------------------------------------------------------- |
(Division Sign Off)
Division of Cardiovascular Devices
510(k) Number K11 0626.
CONFIDENTIAL