(25 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard PTA catheter, with no mention of AI or ML capabilities.
Yes
The device is used for balloon dilatation of arteries, which is a therapeutic intervention aimed at treating medical conditions (e.g., blockages).
No
Explanation: The device is a "PTA Catheter" used for "Balloon dilatation" of arteries, which is a therapeutic procedure, not a diagnostic one. The description focuses on its mechanical function for dilatation.
No
The device description clearly describes a physical catheter with a balloon, luer hub, and guidewire port, indicating it is a hardware medical device. The performance studies also focus on physical characteristics and testing of the catheter itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Balloon dilatation of the femoral, popliteal and infra-popliteal arteries." This describes a therapeutic procedure performed directly on a patient's body.
- Device Description: The description details a catheter with a balloon for physical intervention within blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY, LIT
Device Description
The LitePAC PTA Catheter is a standard rapid exchange PTA catheter. The proximal end provides a mono luer hub connector which allows the attachment of an inflation device used to inflate and deflate the balloon through the outer lumen.
The rapid exchange port is positioned at the transition area between the stiffer hypotube and the more flexible distal portion and facilitates single operator use for insertion into a 0.014" guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, popliteal and infra-popliteal 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 ClearStream LitePAC Catheter has been demonstrated through data collected from non-clinical design verification and design validation tests and analyses.
In Vitro Testing
Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:
- Visual and functional testing
- Catheter body diameter .
- Measurement of balloon working surface
- Inflation/deflation testing .
- Pull back testing .
- Balloon Compliance .
- Average burst pressure
- Tensile testing of proximal bond
Testing was also performed in compliance with ISO 10555-1 and ISO 10555-4.
The results from the tests demonstrate that the technological characteristics and performance criteria of the LitePAC PTA catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
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
§ 870.1250 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).
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K100490 page 1 of 3
Special 510(k) Submission - ClearStream Technologies Ltd
510(k) Summary
Applicant Information
MAR 1 6 2010
Date Prepared: February 10th 2010 Submitter: ClearStream Technologies Ltd
Address: Moyne Upper, Enniscorthy, Co.Wexford, Ireland.
Establishment Registration No: 9616666
Contact Person: Fiona Ni Mhullain, RA Manager
Telephone Number: +353 (0) 53 9237111 Fax Number: + 353 (0) 53 9237100
Device Information
Trade Name: LitePAC PTA Catheter Common Name: RX PTA Catheter Classification Name: Percutaneous Catheter Classification: Class II, 21 CFR 870.1250 Product Code: DQY
Predicate Device:
ClearStream Technologies Ltd, proposes its Sleek PTA Catheter cleared through the following 510(k) number submission: K072947, as the predicate device for this submission.
Device Description:
The LitePAC PTA Catheter is a standard rapid exchange PTA catheter. The proximal end provides a mono luer hub connector which allows the
1
K100490 page 2 of 3
Special 510(k) Submission - ClearStream Technologies Ltd
attachment of an inflation device used to inflate and deflate the balloon through the outer lumen.
The rapid exchange port is positioned at the transition area between the stiffer hypotube and the more flexible distal portion and facilitates single operator use for insertion into a 0.014" guidewire.
Intended Use:
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Comparison to Predicate Device:
The ClearStream Technologies LitePAC catheter (K100490) is substantially equivalent to the predicate device The Sleek PTA Catheter (K072947).
Test Data:
The safety and effectiveness of the ClearStream LitePAC Catheter has been demonstrated through data collected from non-clinical design verification and design validation tests and analyses.
2
clearStream
Technologies Ltd
Special 510(k)
LitePAC
Brief Comparison Summary
To demonstrate substantial equivalence of the applicant LitePAC PTA catheter to the predicate devices, the technological characteristics and performance criterion were evaluated using in vitro testing performed as outlined below:
In Vitro Testing
Using FDA guidance documents on non-clinical testing of medical devices the following in vitro tests were performed:
- Visual and functional testing
- Catheter body diameter .
- Measurement of balloon working surface
- Inflation/deflation testing .
- Pull back testing .
- Balloon Compliance .
- Average burst pressure
- Tensile testing of proximal bond
Testing was also performed in compliance with ISO 10555-1 and ISO 10555-4.
The results from the tests demonstrate that the technological characteristics and performance criteria of the LitePAC PTA catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Conclusion
ClearStream Technologies Ltd believes that the data and information presented in this application, including in vitro testing and numerous device similarities support a determination of substantial equivalence, and therefore market clearance of the LitePAC PTA catheter through this 510(k) premarket notification.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 1 6 2010
ClearStream Technologies, Ltd. c/o Fiona Ni Mhullain, Regulatory Affairs Manager Moyne Upper, Enniscorthy County Wexford Ireland
Re: K100490
Trade/Device Name: LitePAC PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT, DOY Dated: January 16, 2010 Received: February 19, 2010
Dear Ms. Mhullain:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
4
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/MedicalDevices/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,
Duma R. Lahner
Image /page/4/Picture/8 description: The image shows a handwritten symbol that resembles a cursive letter 'f' with an additional loop at the top. The symbol is drawn in black ink on a white background. The stroke begins with a curved line extending upwards, then loops back down before continuing into the main body of the 'f'. The overall impression is that of a quick, stylized signature or notation.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
page 1 of 1
Special 510(k) Submission - ClearStream Technologies Ltd
Indications for Use
510(k) Number (if known): K100490
Device Name: LitePAC RX PTA Catheters
Indications for Use:
:
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Prescription Use XX Over-The-Counter Use (Part 21 CFR 801 Subpart. AND/OR (21 CFR 801 Subpart C) D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
... . . . . . . . . . . . . . . . . . . ..
Duna R. Holmes
Division Sign Off
Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k100490