(172 days)
Not Found
Not Found
No
The document describes a mechanical device (balloon catheter system) and does not mention any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated to "dilate stenosis" and "for the treatment of obstructive lesions," which are therapeutic actions.
No
The device is a therapeutic device designed to dilate stenoses and treat obstructive lesions, rather than diagnose conditions.
No
The device description explicitly lists hardware components such as a catheter, inflation unit, connecting cable, battery pack, and a 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 clearly describes a device used to physically dilate stenosis within the body's vasculature. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The description details a catheter system with a balloon and inflation mechanism, designed for mechanical intervention within blood vessels. This is consistent with a medical device used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through the examination of these samples.
Therefore, the PolarCath Peripheral Balloon Catheter System is a medical device used for therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PolarCath Peripheral Balloon Catheter System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal. infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or native arteriovenous dialysis fistulae.
Product codes
79 LIT
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 (iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries), native or synthetic arteriovenous dialysis fistulae, PTFE access grafts
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.
Not Found
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.
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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
510(k) Summary 4.
| 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: | March 7, 2003 |
| Trade Name: | PolarCath™ |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | 79 LIT |
| Predicate Devices: | PolarCath Peripheral Balloon Catheter System
RX Viatrac 14 Peripheral Dilatation Catheter
Vantage Dilatation Catheter
Cook PTA Balloon Catheter |
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 Balloon Catheter System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Substantial Equivalence
The PolarCath Peripheral Balloon Catheter System design, materials, manufacturing process and intended use are substantially equivalent to the predicate devices.
Performance Data
In vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria.
1
Image /page/1/Picture/2 description: The image shows a logo with three stylized birds in flight, enclosed within a circle. The birds are represented by curved lines, suggesting movement and freedom. The circle is not a solid line but appears to be made up of small, possibly dashed, segments, giving it a textured look. The logo is simple yet dynamic, conveying a sense of aviation or environmental themes.
AUG 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CryoVascular Systems, Inc. c/o Ms. KimTompkins Regulatory Affairs 160 Knowles Drive Los Gatos, CA 95032
Re: K030742
Trade Name: PolarCath™ Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: June 9, 2003 Received: June 10, 2003
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 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
2
Page 2 - Ms. KimTompkins
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,
Jlos. OHAz fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K030742
Device Name: PolarCath™ Peripheral Dilatation System
Indications for Use:
The PolarCath Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal. infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or native arteriovenous dialysis fistulae.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
(Optional Format 3-10-98)
(Posted July 1, 1998)
510(k) Number K030742
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