(61 days)
Not Found
No
The summary describes a standard PTA catheter with no mention of AI or ML capabilities. The performance studies focus on physical and functional characteristics, not algorithmic performance.
Yes
The device is described as a "PTA catheter" used for "Balloon dilatation of the femoral, popliteal and infra-popliteal arteries," which is a therapeutic intervention.
No
The device description clearly states its purpose is for "Balloon dilatation" of arteries, indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly describes a physical catheter with a balloon, lumens, and guidewire access, indicating it is a hardware medical device, not software-only.
No, 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 procedure performed on a patient's body (in vivo), not a test performed on a sample taken from a patient (in vitro).
- Device Description: The description details a physical catheter designed to be inserted into blood vessels for mechanical dilation. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic tool used to treat a condition within the body.
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 Bantam (280mm balloon lengths) catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon expands to a known diameter at specific pressure.
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)
In Vitro Testing
Using FDA guidance and ISO standards on non-clinical testing of medical devices the following in vitro tests were performed:
- Visual and functional testing
- Catheter Body Diameters
- Inflation/Deflation time
- Introducer sheath withdrawal
- Leak and rated burst pressure testing
- Guidewire lumen stability test
- Tensile testing - Hub bond
- Tensile testing - proximal bond
- Working surface
- Balloon compliance
- Average burst
The results from these tests demonstrate that the technological characteristics and performance criteria of the Bantam (280mm balloon lengths) OTW PTA Catheter are comparable to the predicate device 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).
0
K112235 page 1 of 3
OCT 12 2011
Clearstream Technologies Ltd. Special 510 (k) Bantam 280mm
510(K) SUMMARY
Rev 01
Proprietary Name:
Bantam OTW PTA Catheter
Common Name:
OTW PTA Catheter
Classification Name:
Percutaneous Catheter (per 21 CFR 870.1250)
Device Classification:
Product Classification and Code: DQY/LIT
Classification Panel:
Cardiovascular
Class II
Establishment Registration Number: 9616666
Contact Person:
Fiona Ni Mhullain Regulatory Affairs Manager Clearstream Technologies Ltd. Moyne Upper Enniscorthy, Co.Wexford
Telephone: 00353 53 9237111 Facsimile: 00353 53 9237100 E-mail: fnimhullain@clearstream.ie
1
K112335 page 2 of 3
Clearstream Technologies Ltd. Special 510 (k) Bantam 280mm
Performance Standards
Performance testing was carried out in compliance with ISO 10555-1 (# 6-6161).
Device Description
The Bantam (280mm balloon lengths) catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon expands to a known diameter at specific pressure.
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.
Substantially Equivalent Devices
The following devices are substantially equivalent predicate devices:
- · Bantam K093139
Comparison to predicate device
The predicate device is the Bantam (280mm balloon lengths) in material composition, design, intended use and functionality. The Bantam (280mm balloon lengths) includes the addition of longer balloon lengths to the product range. A dimensionally differing outer will also be included to facilitate these longer balloons.
Brief Comparison Summary
To demonstrate substantial equivalence of the applicant Bantam (280mm balloon lengths) to the predicate devices, technological characteristics and performance criterion were evaluated using in vitro testing as indicated below:
In Vitro Testing
Using FDA guidance and ISO standards on non-clinical testing of medical devices the following in vitro tests were performed:
- Visual and functional testing .
2
K112335 page 3 of 3
Clearstream Technologies Ltd. Special 510 (k) Bantam 280mm
- . Catheter Body Diameters
- . Inflation/Deflation time
- Introducer sheath withdrawal .
- . Leak and rated burst pressure testing
- . Guidewire lumen stability test
- . Tensile testing - Hub bond
- . Tensile testing - proximal bond
- Working surface .
- . Balloon compliance
- Average burst ●
The results from these tests demonstrate that the technological characteristics and performance criteria of the Bantam (280mm balloon lengths) OTW PTA Catheter are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
Conclusion (Statement of Equivalence)
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 Bantam (280mm length balloon) OTW PTA Catheter through this 510(k) Premarket Notification
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
CCT 1 2 201
Clearstream Technologies Ltd. c/o Ms. Tina Lochner 4377 County Line Road Chalfont, PA 18914
Re: K112335
Trade/Device Name: Bantam OTW PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY, LIT Dated: October 3, 2011 Received: October 5, 2011
Dear Ms. Lochner:
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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not misleding,
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 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
4
Page 2 – Ms. Tina Lochner
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 (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.
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/ReportalProblem/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,
Bram D. Zuc
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
indications for Use – ClearStream Technologies Bantam OTW PTA Catheters
Indications for Use
510(k) Number (if known): K112335
Device Name: Bantam OTW 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
ivision Sign-Off) avision of Cardiovascular Deci-
:10(k) Number K112335