(80 days)
Not Found
Not Found
No
The summary describes a mechanical balloon catheter system and does not mention any AI or ML components or functionalities.
Yes
The device is indicated to dilate stenosis in the peripheral vasculature and treat obstructive lesions, directly addressing a medical condition.
No
Explanation: The device is a system for dilating stenosis and treating obstructive lesions, as well as for post-deployed stent expansion. Its intended use is therapeutic, not diagnostic, as it does not gather or analyze data for the purpose of identifying a medical condition.
No
The device description explicitly lists multiple hardware components including a catheter, inflation unit, connecting cable, battery pack, recharging unit, battery receptacle, and a disposable cylinder for the inflation medium.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the body (in vivo) to dilate blood vessels and grafts. IVDs are used to examine specimens from the body (in vitro), such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The device components 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 laboratory procedures, which are hallmarks of IVD devices.
Therefore, the PolarCath Peripheral Dilatation System is a medical device used for therapeutic intervention within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (subclavian, renal, iliac, femoral, popliteal, and infrapopliteal 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.
Product codes (comma separated list FDA assigned to the subject device)
LIT 21 CFR 870.1250, DQY
Device Description
The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon 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 cylinder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature (subclavian, renal, iliac, femoral, popliteal, and infrapopliteal arteries), polytetrafluoroethylene (PTFE) access grafts or native 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)
In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria.
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.
PolarCath Peripheral Balloon Catheter System
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
§ 870.1250 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
4. 510(k) Summary
| Sponsor: | CryoVascular Systems, Inc.
160 Knowles Drive |
|-----------------|-------------------------------------------------|
| | Los Gatos, CA 95032 |
| Contact Person: | Kim Tompkins |
| Phone Number: | 408 866 3203 |
| Fax Number: | 408 376 3677 |
| Prepared: | August 13, 2004 |
| Trade Name: | PolarCath™ |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | LIT 21 CFR 870.1250 |
Predicate Devices: PolarCath Peripheral Balloon Catheter System
Device Description
The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon 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 cylinder.
Indications for Use
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (subclavian, renal, iliac, femoral, popliteal, and infrapopliteal 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.
Substantial Equivalence
The PolarCath Peripheral Dilatation System design, manufacturing process and intended use are substantially equivalent to the predicate device and other marketed PTA catheters.
Performance Data
In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2004
CryoVascular Systems, Inc. c/o Ms. Kim Tompkins Sr. Director of Clinical and Regulatory Affairs 160 Knowles Drive Los Gatos, CA 95032
Re: K042230
PolarCathTM Peripheral Dilatation System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 16, 2004 Received: August 17, 2004
Dear Ms. Tompkins:
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 may or daily of 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
2
Page 2 - Ms. Kim Tompkins
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Duna R. Lochner
Image /page/2/Picture/5 description: The image shows a partial view of a document with the words "Branch" and "Direct" visible. The text is in a simple, sans-serif font and appears to be part of a larger block of text. To the left of the text, there is a small, hand-drawn sketch of a tree branch with leaves.
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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- 510(k) Indications for Use
Page I of 1
510(k) Number (if known):
PolarCath™ Peripheral Balloon Catheter System Device Name:
Indications for use:
The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (subclavian, renal, iliac, femoral, popliteal, and infrapopliteal 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 postdeployed stent expansion in self-expanding peripheral vascular stents.
Over-the-Counter Use X = OR = Prescription Use __ (per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Massa
(Division Sign-Off) Division of Cardiovascular Devices Giollc) number Ko 12230