The ReeKross family of over the wire PTA catheters are a balloon dilation catheter for angioplasty. They consist of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut and passivated following completion. A polymer bodybond material is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.

The balloon material is a Nylon/Pebax blend. Low Profile Platinum Radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the ClearStream Technologies PTA Catheters, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a Premarket Approval (PMA) application.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific study designs (like multi-reader multi-case studies), ground truth establishment, or sample sizes for diagnostic performance metrics that are typical for AI/ML device evaluations.

Here's a breakdown of why the requested information isn't present and what the document does provide:

A table of acceptance criteria and the reported device performance:
- Not Applicable. This submission demonstrates substantial equivalence to a predicate device (Savvy Long, K072947) based on "intended use, design characteristics and general physical characteristics." There are no explicit quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic or clinical performance mentioned. The document states, "Performance testing and compliance with recognized standards have established substantial equivalence with regard to safety and effectiveness," implying a battery of engineering and bench tests, but no specific clinical performance targets.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The document describes an angioplasty catheter, which is a medical device used for intervention, not an AI/ML diagnostic algorithm. Therefore, there's no "test set" of data in the context of an AI/ML algorithm's evaluation. The "testing" referred to is likely engineering verification and validation (V&V) related to the physical and functional aspects of the catheter, not a dataset for an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. As above, there's no "test set" or "ground truth" establishment for an AI/ML algorithm's performance in this type of device submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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 is a physical medical device (catheter), not an AI/ML system requiring human reader assistance or evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. For a physical device like a catheter, "ground truth" relating to diagnostic performance as understood for AI/ML is not relevant. Its "performance" is assessed through engineering specifications (e.g., burst pressure, tensile strength, flow rates, steerability) and potentially pre-clinical animal studies or limited human clinical data (though not detailed here) to ensure it performs its intended mechanical function safely and effectively.
The sample size for the training set:
- Not Applicable. There is no AI/ML algorithm being "trained" for this device.
How the ground truth for the training set was established:
- Not Applicable.

Summary of Device and Approval Process based on the document:

This 510(k) submission is for the ClearStream Technologies PTA Catheters (ReeKross™, ReeKross™14, and ReeKross™18), which are balloon dilation catheters used for angioplasty in femoral, popliteal, and infra-popliteal arteries.

The basis for clearance is substantial equivalence to a predicate device, the Savvy Long manufactured by ClearStream Technologies Ltd (K072947). The document states that the new device is equivalent in:

Intended use
Design characteristics
General physical characteristics

The conclusion for approval is based on "Performance testing and compliance with recognized standards," which the FDA determined "established substantial equivalence with regard to safety and effectiveness" to the predicate device. This implies a set of standard engineering and bench tests for catheter performance (e.g., balloon inflation/deflation, burst pressure, trackability, pushability, material compatibility, radiopacity) but no clinical study data, comparative effectiveness data, or AI-specific validation is presented because it is not an AI/ML device.

Summary

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Premarket Notification - ClearStream Technologies PTA Catheters

MAR = 2 2009

510(k) SUMMARY

K083596

11:13:13

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter Information: ClearStream Technologies Ltd, Moyne Upper, Enniscorthy, Co Wexford, Ireland. Phone: 00 353 53 9237111 Fax: 00 353 53 9237100

Date Summary Prepared: March 19, 2008

Contact Person: Fiona Ní Mhullain

Device Name: Trade Name(s): ReeKross™, ReeKross™14 and ReeKross™18 over the wire Peripheral Transluminal Angioplasty (PTA) Catheters

Classification Name: Percutaneous Catheter

Classification Regulation: 21 CFR 870.1250

Panel: Cardiovascular

Product Code: LIT

Predicate Device Information:

Device Name: Savvy Long

Manufacturer: ClearStream Technologies Ltd

Reference: K072947

Device Description:

CONFIDEN

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Premarket Notification - ClearStream Technologies PTA Catheters

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:

This device is equivalent to the predicate device in intended use, design characteristics and general physical characteristics.

Testing and Conclusion:

Performance testing and compliance with recognized standards have established substantial equivalence with regard to safety and effectiveness.

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Page 3 - Mr. Harry van Vugt

(Please include 510(k) number here: K083596)

HFZ #	Last Name	Date
450	Courtney	22209
450	Comage	2/2/01
2-450	Vchuller	7/27/09

HFZ-401 DMC cc: HFZ-404 510(k) Staff HFZ-450 Division D.O.

Prepared by:TDCourtney:myb:02/27/09

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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 outstretched wings, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ClearStream Technologies. Inc. c/o Mr. Robert A. van Boxtel KEMA Quality B.V. Utrechtseweg 310 Arnhem Netherlands NL-6812 AR

MAR - 2 2009

Re: K083596

Trade Name: Reekross OTW PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 19, 2009 Received: February 20, 2009

Dear Mr. van Boxtel:

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, Or to 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 deview 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in

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Page 2 - Mr. Robert van Boxtel

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

una R. Vulin

Image /page/4/Picture/6 description: The image shows a handwritten signature or symbol. It appears to be a stylized combination of letters, possibly an 'S' and an 'm' or 'n', connected in a cursive style. The stroke begins with a curve, forms a loop, and ends with a downward stroke.

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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Premarket Notification - ClearStream Technologies PTA Catheters

Indications for Use

510(k) Number (if known):

Device Name: ClearStream Technologies 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)

Duna R. de Lunes

Division Sign-Off) Division of Cardiovascular Devices

10(k) Number

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).