(30 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 G3 SF 1.6 System is a catheter system designed with a fixed 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 G3 SF 1.6 System consists 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: - Catheter with Control Pod: A sterile, single-use unit consisting of an electrically-driven Catheter with attached Control Pod. As with the predicate device, the Jetstream G3 SF 1.6 Catheter continues to utilize a differentially cutting tip and includes both aspiration and infusion capabilities, and the Control Pod provides a user interface with keypad control. The Catheter with Control Pod, 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. This 510(k) is for modifications to the Jetstream G3 SF System. The primary modification is a slight decrease in the diameter of the distal tip to allow the Jetstream G3 SF 1.6 System to treat lesions in slightly smaller anatomy within the identically indicated peripheral vasculature.
The provided text is a 510(k) summary for the Jetstream G3 SF 1.6 System. It outlines the device's description, modifications, indications for use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.
The document states:
- "Performance Standards do not currently exist for these devices. None are established under Section 514." This indicates that there are no formal performance standards or specific acceptance criteria predefined by regulatory bodies that the device needed to meet.
- The "Testing Summary" lists types of in vitro tests performed (e.g., Dimensional Verification, Catheter Pull, Weld Joint Strength, System Reliability/Life Test, Infusion and Aspiration Flow Rates, Catheter Trackability and Pushability, Aspiration Efficiency and Crossing Time, Heat Generation, Rotational Speed, Control Pod Logic Verification, Intended Use).
- The conclusion is that these tests "demonstrate that the technological and performance characteristics of the modified Jetstream G3 SF 1.6 System is comparable to the predicate devices" and "support the safety and effectiveness of the modifications... and ensure that the modified device can perform in a manner equivalent to the listed predicate devices with the identical intended use."
This 510(k) submission relies on demonstrating substantial equivalence through comparison to predicate devices using in vitro bench testing, rather than meeting specific quantifiable performance acceptance criteria in a clinical study. Therefore, most of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert involvement, and clinical study details cannot be extracted from this document.
Based on the provided text, here is what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the document. The document states "Performance Standards do not currently exist for these devices." The reported performance is generally stated as "comparable to the predicate devices" and "equivalent to the listed predicate devices." Specific quantitative acceptance criteria or performance metrics for each test (e.g., "Aspiration Efficiency ≥ X%") and the corresponding device performance values are not provided.
Regarding items 2-9: The provided document describes in vitro testing for substantial equivalence, not a clinical study involving human patients, ground truth experts, or training/test sets for an AI algorithm. Therefore, the following information is not applicable or not present in the text:
2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set is described. The document refers to in vitro tests (e.g., mechanical tests, flow rates), but specific sample sizes for these bench tests are not provided. Data provenance is implied to be from internal laboratory testing at Pathway Medical Technologies, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable; no adjudication method for a test set is described.
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: Not applicable; no AI or MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable; no algorithm or standalone performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable; the ground truth concept is not relevant for the described in vitro bench testing. The "truth" for these tests would be objective physical measurements or functional assessments against engineering specifications or predicate device performance.
8. The sample size for the training set: Not applicable; no training set for an AI algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable; no training set or ground truth establishment for it is mentioned.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a modified atherectomy catheter through in vitro bench testing against predicate devices. It does not contain details about clinical acceptance criteria, outcome measures, expert-established ground truth, or AI performance studies as requested. The "acceptance criteria" were implicitly met by demonstrating "comparability" and "equivalence" to the predicate devices in the described in vitro tests.
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JUN - 1 2011
510(k) SUMMARY
General Information:
Date of Summary Preparation: April 29, 2011 Name and Address of Manufacturer: Pathway Medical Technologies, Inc. 10801 120th Ave NE Kirkland, Washington 98033 Contact Person: Cyndy Adams Regulatory Affairs Sr. Manager Phone: 425-636-4047 Fax: 425-636-4001 JETSTREAM G3® SF 1.6 System Device Trade Names:
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
Pathway Medical Technologies, Inc.
510(k) SUMMARY
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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 G3 SF 1.6 System is a catheter system designed with a fixed 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 G3 SF 1.6 System consists 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:
- Catheter with Control Pod: A sterile, single-use unit consisting of an . electrically-driven Catheter with attached Control Pod. As with the predicate device, the Jetstream G3 SF 1.6 Catheter continues to utilize a differentially cutting tip and includes both aspiration and infusion capabilities, and the Control Pod provides a user interface with keypad control. The Catheter with Control Pod, 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.
This 510(k) is for modifications to the Jetstream G3 SF System. The primary modification is a slight decrease in the diameter of the distal tip to allow the Jetstream G3 SF 1.6 System to treat lesions in slightly smaller anatomy within the identically indicated peripheral vasculature.
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:
- . Jetstream G3 SF System (K110626)
- Jetstream G3 SF System (K101334) .
- . Pathway PVTM Atherectomy System (K081328)
Testing Summary: To demonstrate substantial equivalence of the Jetstream G3 SF 1.6 System to the predicate device, the technological and performance characteristics were evaluated using the following in vitro testing:
- Dimensional Verification
- Catheter Pull .
- . Weld Joint Strength
- System Reliability/Life Test .
- . Infusion and Aspiration Flow Rates
- . Catheter Trackability and Pushability
- Aspiration Efficiency and Crossing Time .
- . Heat Generation
- . Rotational Speed
- Control Pod Logic Verification ●
- Intended Use .
The results from these tests:
- . demonstrate that the technological and performance characteristics of the modified Jetstream G3 SF 1.6 System is comparable to the predicate devices.
- . support the safety and effectiveness of the modifications that are the subject of this 510(k), and
- ensure that the modified device can perform in a manner equivalent to the listed . predicate devices with the identical intended use.
Conclusion (Statement of Equivalence): The data and information presented within this submission and the similarities between the modified and predicate devices support a determination of substantial equivalence. The devices have identical indications for use and the same technological characteristics. Bench testing supports the safety and effectiveness of the modifications that were the subject of this 510(k).and therefore market clearance of the modified Jetstream G3 SF 1.6 System through this 510(k) Premarket Notification.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the wings and a base that resembles a stylized staff with intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pathway Medical Technologies, Inc. c/o Ms. Cyndy Adams Regulatory Affairs Senior Manager · 10801 120" Ave NE Kirkland, WA 98033
Re: K111229
Trade/Device Name: Jetstream G3 SF 1.6 System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: MCW Dated: April 29, 2011 Received: May 2, 2011
Dear Ms. Adams:
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.
JUN - 1 20117
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Page 2 - Ms. Cyndy Adams
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/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 Óffice 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.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
1/11/229 510(k) Number (if known):
Device Name: Jetstream G3™ SF 1.6 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 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 OF NEEDED)
・
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K111229 |
Pathway Medical Technologies, Inc. 510(k)
CONFIDENȚIAL
Appendix 2
§ 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).