(24 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 Atherectorny System consists of two primary components: (1) 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 the Console to add a check of the Control Pod's parameter settings at the time of device use.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary (K082664) for the Jetstream™ Pathway PVT™ Atherectomy System does not contain explicit acceptance criteria or details of a study proving the device meets specific performance criteria in the way you might expect for an AI/algorithm-based device.
Instead, this 510(k) is for a modification to an existing, already cleared device (K081328, K082186). The primary claim for this submission is substantial equivalence to the predicate device.
The document states:
- "This 510(k) is for the same device with modifications to the Console to add a check of the Control Pod's parameter settings at the time of device use."
- "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 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."
This indicates that the "study" was focused on demonstrating the safety and effectiveness of the modification (the Console's parameter check) through bench testing, rather than a full-scale clinical performance study with predefined acceptance criteria for a new device.
Therefore, for many of your requested points, the answer is that the information is not applicable or not provided in this type of 510(k) submission, which focuses on substantial equivalence for a physical device modification.
Detailed Breakdown of Requested Information:
-
A table of acceptance criteria and the reported device performance
- Not provided. The document does not list quantitative acceptance criteria or specific performance metrics. The "performance" demonstrated was that the modified console's parameter check maintained the safety and effectiveness established by the predicate device through bench testing.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. Since the study involved bench testing for a physical modification, there isn't a "test set" of patient data in the typical sense for algorithms.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not provided. Ground truth, in the context of expert review of images or clinical outcomes, is not relevant for this type of bench testing study for a physical device modification.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
-
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
- No. This device is a physical atherectomy system, not an AI/algorithm for image analysis or diagnosis. Therefore, an MRMC study is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For the bench testing mentioned, "ground truth" would likely relate to engineering specifications, mechanical performance, or functional checks, rather than clinical ground truth types. The document only states "Bench testing was completed and provided to support the safety and effectiveness of the modifications."
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The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established
- Not applicable. See point 8.
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page 1 of 2
OCT 0 6 2008
510(k) SUMMARY
General Information:
| Date of Summary Preparation: | September 11, 2008 |
|---|---|
| Name and Address of Manufacturer: | Pathway Medical Technologies, Inc.10801 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 Device: | 510(k) Number: K081328, K082186Manufacturer: Pathway Medical Technologies, IncTrade Name: JetStream™ Pathway PVT™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.
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The Pathway PV Atherectorny System consists of two primary components: (1) 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 the Console to add a check of the Control Pod's parameter settings at the time of device 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 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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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 6 2008
Pathway Medical Technologies c/o Mr. Ken Perino Director of Regulatory Affairs 10801 120th Ave NE Kirkland, WA 98033
Re: K082664
Jetstream™ Pathway PVTM Atherectomy System Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II Product Code: MCW Dated: September 11, 2008 Received: September 12, 2008
Dear Mr. Perino:
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.
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.
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Page 2 - Mr. Ken Perino
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,
Dana R. Van Luner
A Bram D. Zuckerman, M.D. - Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K082664
Device Name: Jetstream™ Pathway PV™ Atherectomy System
Indications for Use: The Pathway PV™ 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. V. chmer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko87664
§ 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).