(24 days)
Not Found
No
The document describes a mechanical atherectomy system with aspiration and infusion capabilities. The modifications mentioned are related to checking parameter settings, not incorporating AI/ML. There is no mention of AI, ML, image processing, or data sets for training or testing.
Yes
The device is used for atherectomy, which is a medical procedure to remove plaque from arteries, thereby treating vascular disease and restoring blood flow. This direct intervention on a disease state qualifies it as a therapeutic device.
No
The device, the Pathway PV™ Atherectomy System, is intended for "atherectomy of the peripheral vasculature" and is described as an "atherectomy catheter system designed with an expandable cutting tip for use in debulking and treating vascular disease." This indicates a therapeutic, not diagnostic, function.
No
The device description clearly outlines hardware components including a catheter, control pod, and console with pumps, power supply, and system controller. The 510(k) is for modifications to the console, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "atherectomy of the peripheral vasculature." This is a surgical procedure performed directly on the patient's blood vessels to remove plaque.
- Device Description: The device is a catheter system designed to physically remove tissue and thrombus from the peripheral vasculature. It involves mechanical cutting, aspiration, and infusion.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device operates within the patient's body.
The device is clearly intended for a therapeutic intervention within the patient's body, not for diagnostic testing of samples in a lab setting.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MCW
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 NE | |
| Kirkland, Washington 98033 | |
| Contact Person: | Brian Cleary |
| Sr. Director of Regulatory Affairs | |
| Phone: 425-636-4079 | |
| Fax: 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, K082186 |
| Manufacturer: Pathway Medical Technologies, Inc | |
| Trade 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.
1
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.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. To the left of the bird is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference.
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.
3
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
4
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