(59 days)
The Pathway PVTM Atherectomy System is intended for use in atherectorny of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity perspheral arteries ≥30 mm in diameter It 1s not intended for use in coronary, carotid, iliac or renal vasculature
The Jetstream™ Pathway PVTM Atherectorny System (hereafter "Jetstream 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 Excised tissue, thrombus, and fluid are aspirated from the peripheral device use treatment site through ports 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 System consists of two primary components (1) a Jetstream Catheter and Control Pod and (2) a PV Console, which are packaged separately Each of these system components is described generally as follows
- Jetstream Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven Jetstream 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 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 Console mounts on a standard I V stand and remains outside the sterile field during the procedure
Here's an analysis of the provided text regarding the Jetstream™ Pathway PVT™ Atherectomy System, focusing on acceptance criteria and study information.
It's important to note that this document is a 510(k) Summary, which typically provides a high-level overview to demonstrate substantial equivalence to a predicate device. It doesn't usually contain the detailed study protocols, raw data, or comprehensive statistical analysis found in a full clinical trial report.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on bench testing to support the expanded indications for use and demonstrates substantial equivalence to predicate devices.
The key reported performance is the "expanded indications for use," which now includes the ability "to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter." The implicit acceptance criterion is that the device is safe and effective for this expanded indication, as demonstrated through bench testing and comparison to predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety and effectiveness | "Bench testing was completed and information provided to support the safety and effectiveness of the expanded indications for use for the Jetstream System." |
| Expanded Indication for Use | System is intended "to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3.0 mm in diameter." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a clinical test set sample size or clinical data provenance (e.g., country of origin, retrospective/prospective). The evidence provided is based on "bench testing." Bench testing typically involves laboratory experiments on models or excised tissue, not human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since the study described is "bench testing" rather than a clinical study evaluating diagnostic accuracy or expert interpretation, the concept of "ground truth for a test set" established by experts does not apply in the traditional sense. Bench testing would likely involve engineers and technicians evaluating mechanical performance, material properties, and the device's ability to perform its intended function in a controlled environment.
4. Adjudication Method for the Test Set
As there's no clinical test set with human interpretation, an adjudication method for test set ground truth is not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned or implied. The study described is bench testing, not a clinical study involving human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
This device is an atherectomy system, a physical medical device. It is not an algorithm or AI system, so the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
For the "bench testing" mentioned, the "ground truth" would be established by controlled experimental conditions and measurements. For example, if testing the ability to remove thrombus, the "ground truth" would be the known amount of simulated thrombus placed in a model, and the performance would be measured by the amount removed. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The Sample Size for the Training Set
This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is a physical device, not an AI/ML model, the concept of establishing ground truth for a "training set" is not applicable.
Summary of Findings from the 510(k) Summary:
The 510(k) summary for the Jetstream™ Pathway PVT™ Atherectomy System primarily relies on demonstrating substantial equivalence to predicate devices and provides evidence through bench testing to support its expanded indications for use. It does not contain information about clinical studies involving human subjects, reader performance, or AI/ML model evaluation. Therefore, many of the requested details regarding sample sizes, expert ground truth, and training data are not present in this type of regulatory document for this category of device.
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ҚОВ 3489 page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Pathway Medical Technologies. The logo consists of a black circle with a white mountain-like shape inside, followed by the word "PATHWAY" in a sans-serif font. Below "PATHWAY" are the words "MEDICAL TECHNOLOGIES" in a smaller font.
JAN 9 3 2009
510(k) SUMMARY
| General Information: | |
|---|---|
| Date of Summary Preparation | November 24, 2008 |
| Name and Address of Manufacturer | Pathway Medical Technologies, Inc10801 120th Ave NEKirkland, Washington 98033 |
| Contact Person | Brian ClearySr Director of Regulatory AffairsPhone 425-636-4079Fax 425-636-4001 |
| Trade Name | Jetstream™ Pathway PVT™ Atherectomy System |
| Common Name | Peripheral Atherectomy Catheter |
| Regulation Number | 21 CFR 870 4875 |
| Regulation Name | Intraluminal Artery Stripper |
| Regulatory Class | Class II |
| Classification Panel | Cardiovascular |
| Product Code | MCW |
| Predicate Devices | 510(k) Numbers K081328, K082186, K082664Manufacturer Pathway Medical Technologies, IncTrade Name Jetstream™ Pathway PVT™Atherectomy System510(k) Number K071514Manufacturer Possis Medical, IncTrade Name AngioJet® Xpeedior® RheolyticThrombectomy Catheter |
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Indications for Use: The Pathway PVTM Atherectomy System is intended for use in atherectorny of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity perspheral arteries ≥30 mm in diameter It 1s not intended for use in coronary, carotid, iliac or renal vasculature
Device Description: The Jetstream™ Pathway PVTM Atherectorny System (hereafter "Jetstream 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 Excised tissue, thrombus, and fluid are aspirated from the peripheral device use treatment site through ports 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 System consists of two primary components (1) a Jetstream Catheter and Control Pod and (2) a PV Console, which are packaged separately Each of these system components is described generally as follows
- Jetstream Catheter and Control Pod: A sterile, single-use unit consisting of an . electrically driven Jetstream 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 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 Console mounts on a standard I V stand and remains outside the sterile field during the procedure
Substantial Equivalence: The Jetstream System is substantially equivalent to the specified predicate devices. Bench testing was completed and information provided to support the safety and effectiveness of the expanded indications for use for the Jetstream System
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a symbol of medicine and health. The caduceus is composed of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2009
Pathway Medical Tcchnologies, Inc. c/o Mr. Brian Cleary Senior Director, Regulatory Affairs 10801 120" Ave NE Kirkland, WA 98033
Re: K083489
Jetstream Pathway PC Atherectomy System, ()V 10300 Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: November 24, 2008 Received: November 25, 2008
Dear Mr. Cleary:
We have reviewed your Scction 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 10 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 (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
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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SECTION 4: INDICATIONS FOR USE
510(k) Number (if known): 1063489
Device Name: Jetstream™ Pathway PV™ Atherectomy System
Indications for Use: The Pathway PV™ Atherectomy System is intended for use in atherectorny 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 __ 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)
(Divisio) Division of Carciovascular Devices 5100k Kamber Kos348
Page _ of /
Pathway Medical Technologies, Inc.
CONFIDENTIAL
Page 16 of 96
§ 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).