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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bantam OTW PTA Catheter:

Executive Summary:

The Bantam OTW PTA Catheter (280mm balloon lengths) was cleared through a Special 510(k) pathway, demonstrating substantial equivalence to a predicate device (Bantam K093139). The clearance relies entirely on in vitro testing to show that its technological characteristics and performance criteria are comparable to the predicate. No clinical studies, human-in-the-loop performance, or AI-assisted studies were conducted or required for this type of device clearance.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" as pass/fail thresholds with specific numerical values for each test. Instead, it describes "performance criteria" that were evaluated through in vitro testing to demonstrate comparability to the predicate device. The reported device performance is implicitly understood to have met these criteria because the device was granted substantial equivalence.

Acceptance Criteria Category (Evaluated Performance Criteria)	Reported Device Performance (as demonstrated by in vitro testing)
Visual and functional testing	Comparable to predicate device
Catheter Body Diameters	Comparable to predicate device
Inflation/Deflation time	Comparable to predicate device
Introducer sheath withdrawal	Comparable to predicate device
Leak and rated burst pressure testing	Comparable to predicate device
Guidewire lumen stability test	Comparable to predicate device
Tensile testing - Hub bond	Comparable to predicate device
Tensile testing - proximal bond	Comparable to predicate device
Working surface	Comparable to predicate device
Balloon compliance	Comparable to predicate device
Average burst	Comparable to predicate device

Note: The document states that the results "demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device." This implies that the Bantam (280mm) performed within acceptable ranges relative to the Bantam K093139 for all tested parameters. Specific numerical values for the predicate or the new device are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size for each in vitro test. It generally states that "in vitro tests were performed."
Data Provenance: The data is from in vitro testing conducted by Clearstream Technologies Ltd. The country of origin for the data is implicitly Ireland, where Clearstream Technologies Ltd. is located. This is a prospective study in the sense that the testing was performed specifically to support this 510(k) submission, but it is not a clinical (human) prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was an in vitro engineering performance study, not a clinical study requiring expert ground truth or assessment of cases. The "ground truth" for these tests would be the established engineering standards and methodologies (e.g., ISO 10555-1) and the performance of the predicate device under these same tests.

4. Adjudication Method for the Test Set

Not applicable. As this was an in vitro engineering performance study, there was no human reader or panel involved in adjudicating the "correctness" of the findings in the way one would for a clinical study with subjective interpretations. The tests yield objective measurements against predefined standards or comparisons.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable.

This submission is for a medical device (PTA catheter), not an AI algorithm.
No MRMC or human-in-the-loop studies were conducted or required.
The concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device. There is no algorithm component to evaluate in a standalone manner.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:

Engineering standards: Compliance with ISO 10555-1.
Predicate device performance: The performance of the legally marketed Bantam (K093139) under the same in vitro tests, as the new device is compared to it for "substantial equivalence."
FDA guidance: Adherence to FDA guidance on non-clinical testing of medical devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

Summary

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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

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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

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 .

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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

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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

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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

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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

Regulation Number and Section

§ 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).