(25 days)
Not Found
Not Found
No
The summary describes a mechanical dilatation system and explicitly states that AI, DNN, or ML were not found in the document.
Yes
The PolarCath Peripheral Dilatation System is intended for the "dilatation of stenoses" and "treatment of obstructive lesions," which directly addresses and rectifies a medical condition.
No
Explanation: The device description and intended use clearly state that the PolarCath Peripheral Dilatation System is used for "dilatation of stenoses" and "treatment of obstructive lesions," which are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify, detect, or analyze medical conditions.
No
The device description explicitly lists hardware components such as a Catheter, Inflation Unit, connecting cable, battery pack, recharging unit, battery receptacle, and a disposable cartridge.
Based on the provided information, the PolarCath Peripheral Dilatation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (in vivo) to treat blockages in blood vessels and grafts. IVDs are used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to diagnose or monitor conditions.
- Device Description: The device components (catheter, inflation unit, etc.) are designed for a surgical or interventional procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or diagnostic tests, which are hallmarks of IVD devices.
Therefore, the PolarCath Peripheral Dilatation System is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Product codes
LIT, DOY
Device Description
The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries); polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae
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)
The substantial equivalence of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
| Sponsor: | Boston Scientific Corporation
150 Baytech Drive
San Jose, CA |
|-----------------|--------------------------------------------------------------------|
| Contact Person: | Shannon Pettit |
| Phone Number: | 763-494-2833 |
| Fax Number: | 763-494-2981 |
| Prepared: | |
| Trade Name: | PolarCath™ Peripheral Dilatation System |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | LIT
21 CFR 870.1250 |
PolarCath Peripheral Dilatation System Predicate Devices:
Device Description
The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.
Indications for Use
The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Substantial Equivalence
The PolarCath Peripheral Dilatation System design, materials, manufacturing process and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.
Performance Data
The substantial equivalence of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific.
1
Image /page/1/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an abstract bird.
SEP 0 4 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Shannon Pettit Senior Regulatory Affairs Specialist Boston Scientific Corporation One Scimed Place Maple Grove, MN 55311
Re: K092455
PolarCath Peripheral Dilatation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DOY Dated: August 6, 2009 Received: August 10, 2009
Dear Ms. Pettit:
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. Drue, 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 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 mav publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Shannon Pettit
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/CDRH/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/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Duna R. Valuner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement
510(k) Number (if known)
K092 455
Device Name
PolarCath Peripheral Dilatation System
Indications for Use
The PolarCath Peripheral Dilatation System's intended use is for the dilatation of stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109
✓
OR
Over-The-Counter Use
Dune R. Achmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K092455