(9 days)
Not Found
No
The document describes a mechanical dilatation system and does not mention any AI or ML components or functionalities.
Yes
The device is used to treat medical conditions by dilating stenoses and obstructive lesions in the peripheral vasculature and dialysis access sites.
No
The device is indicated for dilating stenoses and for the treatment of obstructive lesions, which are therapeutic actions, not diagnostic.
No
The device description explicitly lists hardware components such as a Catheter, Inflation Unit, connecting cable, battery pack, and a disposable cartridge containing liquid nitrous oxide. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a system used to physically dilate stenoses and treat obstructive lesions within the peripheral vasculature and dialysis access grafts. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device components (catheter, inflation unit, etc.) and the mechanism of action (using nitrous oxide for dilatation) are consistent with a medical device used for interventional procedures, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose.
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 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/DQY, DQY, LIT
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)
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 safety and effectiveness 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): 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 Dilatation System cleared in K051916, SE 8.5.2005.
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
MAH 1 6 2006
040572
page 1 of 2
4. 510(k) Summary
| Sponsor: | Boston Scientific Corporation
160 Knowles Drive
Los Gatos, CA 95032 |
|-----------------|---------------------------------------------------------------------------|
| Contact Person: | Elaine Aplaon |
| Phone Number: | 408 866 3204 |
| Fax Number: | 408 376 3677 |
| Prepared: | March 1, 2006 |
| Trade Name: | PolarCathTM Peripheral Dilatation System |
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification: | II |
| Product Code: | LIT/DQY |
| | 21 CRF 870.1250 |
Predicate Devices: PolarCath Peripheral Dilatation System
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 safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific.
1
K060572
Page 2 of 2
Modified Device Information II.
-
- General
- Device Name a.
PolarCath™ Peripheral Dilatation System
- b. Sponsor/Contract Sterilizer Registration Numbers
Boston Scientific's establishment registration number is 3003882783. The company's Owner/Operator number is 9912058.
The contract sterilizer is IBA Medical Sterilization and Analytical Labs (Sterigenics) located in Los Angeles, CA. The Establishment registration number is 2011171.
-
Device Class ে.
Class II -
d. Predicate Device Information The predicate device is the PolarCath Peripheral Dilatation System cleared in K051916, SE 8.5.2005.
-
ে. Labeling A draft copy of the Instructions for Use (IFU) and labels can be found in Appendices A and B. All changes to the labeling are highlighted.
-
f. Intended 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. This is the same intended use as previously cleared for the PolarCath Peripheral Dilatation System (K051916, SE 8.5.2005).
The Indications for Use statement can be found on page 11 of this submission.
- Consensus Standards ಸ್ಸಿ A search was conducted of the consensus standards database found at www.CDRH.gov. No applicable standards were found.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2006
Boston Scientific, Inc. c/o Ms. Elaine Aplaon 160 Knowles Drive Los Gatos, CA 95032
Re: K060572
Trade Name: PolarCath™ Peripheral Dilation System Regulation Number: 21 CFR 870.1250 Regulation Name: Angioplasty Catheter Regulatory Class: II (two) Product Code: DQY, LIT Dated: March 3, 2006 Received: March 6, 2006
Dear Ms. Aplaon:
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 - Ms. Elaine Aplaon
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 (OS) 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Bfzimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3. 510(k) Indications for Use
510(k) Number (if known):
Device Name:
KC60572
PolarCath™ Peripheral Dilatation System
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 native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.Rammana
(Division Sign-Off)
n Sign-Off) Division of Cardiovascular Devices
510(k) Number K060572