(47 days)
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.
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.
The provided text does not contain typical acceptance criteria for device performance in the format of a table with specific metrics and thresholds, nor does it describe a study that directly proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy. Instead, the document describes a 510(k) premarket notification for a medical device, the Jetstream Systems, highlighting its substantial equivalence to predicate devices.
The "Testing Summary" section details in vitro testing performed to demonstrate that the modified Jetstream Systems' technological and performance characteristics are comparable to predicate devices, ensuring modified safety and effectiveness. This is a common approach for 510(k) submissions, where the focus is on demonstrating equivalence rather than establishing new clinical effectiveness or diagnostic accuracy via traditional clinical trials with predefined acceptance criteria for clinical endpoints.
Here's a breakdown of the information provided, framed around the typical questions, with explanations for what is not present in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) and corresponding thresholds. The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices. The study performed involved in vitro testing, not a clinical study with outcome-based performance criteria.
The types of tests conducted are listed as:
- System Reliability/Life Test
- Main Cable Joint Strength
- Control Pod Electrical Testing
- Control Pod Logic Verification
- Electrical Safety
- Intended Use
- Accessory Compatibility
- Infusion & Aspiration Flow Rates
- Aspiration Efficiency & Crossing Time
- Rotational Speed
- Material Liberation (Teflon & Polyimide)
- Aggressive Thrombus Testing
The document states that 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)"
- "ensure the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use."
However, specific quantitative acceptance values for each of these tests, and the numerical results achieved, are not provided in this summary. For instance, it doesn't state "Aspiration Efficiency > X mL/min demonstrated Y mL/min".
2. Sample size used for the test set and the data provenance
The document mentions "in vitro testing" without specifying sample sizes for each test type. "In vitro" inherently implies the data provenance is from laboratory tests using models or excised tissue, not human subjects, and therefore originates from the testing facility. The document does not specify country of origin for these in vitro tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and therefore not provided. The testing described is in vitro engineering and performance testing on the device itself (e.g., electrical testing, mechanical strength, flow rates). It does not involve human interpretation or expert assessment for establishing a "ground truth" in the clinical sense (like a diagnosis or lesion presence).
4. Adjudication method for the test set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are used in studies where multiple human readers or experts interpret data to establish a ground truth or resolve discrepancies, typically in clinical or diagnostic accuracy studies. The described testing is in vitro performance testing of the device.
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
An MRMC study was not conducted. This document describes a 510(k) submission for a physical medical device (atherectomy catheter system) and its modifications. It is not an AI/CAD-related device, and thus, studies on human reader improvement with AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in vitro performance testing, the "ground truth" would be established by validated measurement techniques and scientific principles for each specific test (e.g., a calibrated flow meter for flow rates, a force gauge for joint strength, established electrical safety standards). It's based on engineering and scientific measurements rather than clinical ground truth types like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable and therefore not provided. This is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable.
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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
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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.
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Substantially Equivalent Devices: Pathway Medical cites the following devices as substantially equivalent predicate devices:
| Primary Predicate Device | Pathway MedicalPredicate 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.
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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.
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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.
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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
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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
§ 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).