(28 days)
The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.
The Pathway PV Atherectomy 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 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 Pathway PV Atherectomy System consists of two primary components: (I) a Catheter and Control Pod and (2) a Console, which are packaged separately.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study information:
Analysis of Acceptance Criteria and Study Information for Pathway PV Atherectomy System (K082186)
The provided 510(k) summary for the Pathway PV Atherectomy System (K082186) focuses on demonstrating substantial equivalence to a predicate device after modifications to improve manufacturability, ergonomics, and ease of use. It explicitly states that the device has "identical indications for use and the same technological characteristics" as its predicate.
Crucially, this 510(k) summary does not detail specific acceptance criteria for performance, nor does it describe a clinical study or a standalone algorithm performance study with a test set, ground truth, or expert involvement. The documentation primarily relies on bench and laboratory testing to support the safety and effectiveness of the modifications to the device.
Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided document.
The document states: "Bench and laboratory testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k) for the Pathway PV Atherectomy System." However, it does not specify what parameters were tested, what the acceptance criteria for those tests were, or the quantitative results of those tests. These details would typically be found in the comprehensive testing reports submitted to the FDA, but they are not part of this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not available concerning clinical data or a test set for performance assessment.
The "bench and laboratory testing" mentioned would have involved a certain number of test units or trials, but the sample sizes for these engineering tests are not disclosed. There is no mention of a clinical "test set" in terms of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/available.
Since there is no described clinical "test set" and no ground truth establishment process involving expert review for performance, this information is not provided. The 510(k) pathway for this device focused on demonstrating equivalence through engineering modifications, not on a new clinical efficacy study.
4. Adjudication Method for the Test Set
Not applicable/available.
No test set for performance requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done.
This type of study is relevant for diagnostic imaging AI devices, comparing human performance with and without AI assistance. The Pathway PV Atherectomy System is a mechanical atherectomy device, not a diagnostic AI system, so an MRMC study would not be applicable or expected.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done.
The device is an electromechanical system for atherectomy, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
Not applicable/available.
Without a clinical or diagnostic performance study described, there is no mention of ground truth types (e.g., pathology, outcomes data, expert consensus). The "ground truth" for the engineering changes would have been the established performance specifications of the predicate device and relevant industry standards.
8. The Sample Size for the Training Set
Not applicable/available.
The device is not an AI/ML system that utilizes a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable/available.
As the device is not an AI/ML system, there is no training set or associated ground truth establishment process.
Summary Limitations:
The provided 510(k) summary is typical for a device with minor modifications where substantial equivalence is demonstrated primarily through engineering verification and validation (bench and lab testing) rather than new clinical trials. It confirms that the modifications did not alter the safety, effectiveness, or indications for use compared to the predicate device. Therefore, the detailed information requested about clinical acceptance criteria, expert reviews, and AI-specific study designs is not within the scope of this particular document.
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KO32186 0. 10-2
510(k) SUMMARY
| General Information: | AUG 29 2008 |
|---|---|
| Date of Summary Preparation: | July 31, 2008 |
| Name and Address of Manufacturer: | Pathway Medical Technologies, Inc.10801 120th Ave NEKirkland, Washington 98033 |
| Contact Person: | Brian ClearyDirector of Regulatory AffairsPhone: 425-636-4079Fax: 425-636-4001 |
| Trade Name: | Pathway PVTM 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 Device: | 510(k) Number: K081328Manufacturer: Pathway Medical Technologies, Inc.Trade Name: Pathway PVTM Atherectomy System |
Indications for Use: The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. It is not intended for use in coronary, carotid, iliac or renal vasculature.
Device Description: The Pathway PV Atherectomy 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 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.
Pathway Medical Technologies, Inc.
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The Pathway PV Atherectomy System consists of two primary components: (I) a Catheter and Control Pod and (2) a Console, which are packaged separately. Each of these system components is described generally as follows:
- 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.
- A reusable compact Console, with two (2) peristaltic pumps for Console: . 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 with modifications to: (1) the Catheter and Control Pod to improve the manufacturability of the device, and (2) the Control Pod and Console for improved ergonomics and ease of use.
Substantial Equivalence: The Pathway PV Atherectomy System is substantially equivalent to the specified predicate device. The device has the identical indications for use and the same technological characteristics. Bench and laboratory testing was completed and provided to support the safety and effectiveness of the modifications that were the subject of this 510(k) for the Pathway PV Atherectomy System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem with an abstract design of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2000
Pathway Medical Technologies, Inc. c/o Mr. Brian Cleary 10801 120th Ave NE Kirkland, WA 98033
Re: K082186
Trade/Device Name: Pathway PV Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: July 31, 2008 Received: August 1, 2008
Dear Mr. Cleary:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 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.
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
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2 Page - Mr. Brian Cleary
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 (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. 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,
Dma R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
1X ... ) ! ! 510(k) Number (if known):
Device Name: Jetstream Pathway PVTM Atherectomy System
Indications for Use: The Pathway PVTM Atherectomy System is intended for use in atherectomy of the peripheral vasculature. 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)
R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
510/k) Number Ko8218 (
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).