The Sleek OTW PTA 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 (0.014"). 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 the study that proves the device meets those criteria:

The document describes a medical device, the Sleek OTW PTA Catheter, and its equivalence to a predicate device, the Bantam α PTA Catheter. The "study" here refers to non-clinical bench testing to demonstrate this equivalence and the device's safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters tested for in both the predicate device (Bantam α) and the Sleek OTW, as well as the additional tests performed for the Sleek OTW. The acceptance criteria for the Sleek OTW are broadly that it "PASSES" these tests.

Acceptance Criteria (Test)	Reported Device Performance (Sleek OTW)
Inflation/Deflation Time	PASS - VP577 ([29 of 5x120mmx150cm])
Introducer Sheath Withdrawal	PASS ([29 of 5x120mmx150cm])
Leak and Rated Burst Pressure	*PASS with deviation
Tensile Test for Proximal Bond	PASS ([29 of 5x120mmx150cm])
Tensile Test for Hub Bond	PASS ([29 of 5x120mmx150cm])
Measurement of the Working Surface,	PASS ([13 of 1.25x15mmx150cm], [13 of
OD and TL of the Balloon	5x120mmx150cm])
Balloon Compliance	PASS ([13 of 1.25x15mmx150cm], [16 of
	5x120mmx150cm])
Average Burst Pressure Testing	PASS ([13 of 1.25x15mmx150cm], [13 of
	5x120mmx150cm])
Profile Measurements of Distal Tip	PASS – VP577 ([29 of 1.25x15x150], [29
	of 5.0x120x150])
Tensile Test of the Distal Tip	PASS ([29 of 1.25x15mmx150cm], [29 of
	5x120mmx150cm])

Note on "PASS with deviation" for Leak and Rated Burst Pressure: The document states "Conclusion: All products had acceptable balloon fatigue performance, noted deviation accepted." This implies that while there might have been a minor deviation from the initial target, it was deemed acceptable for the intended use and did not compromise safety or effectiveness.

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

The sample sizes for the test sets (grouped by specific catheter dimensions and lengths) are indicated in brackets within the "Results Sleek OTW" column of the tables. Examples include:

Inflation/Deflation Time: 29 samples of 5x120mmx150cm catheters.
Introducer Sheath Withdrawal: 29 samples of 5x120mmx150cm catheters.
Leak and Rated Burst Pressure: 29 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
Profile Measurements of Distal Tip: 29 samples each of 1.25x15x150 and 5.0x120x150 catheters.
Tensile Test of the Distal Tip: 29 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
Measurement of Working Surface, OD, TL of Balloon: 13 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.
Balloon Compliance: 13 samples of 1.25x15mmx150cm and 16 samples of 5x120mmx150cm catheters.
Average Burst Pressure Testing: 13 samples each of 1.25x15mmx150cm and 5x120mmx150cm catheters.

Data Provenance: The data is from non-clinical design verification and design validation bench tests conducted by ClearStream Technologies Ltd. The country of origin of the data is not explicitly stated but is implicitly the location of the manufacturing and testing, which is likely Ireland, where ClearStream Technologies Ltd is based. The data is prospective in the sense that these tests were performed specifically for this submission to validate the Sleek OTW PTA Catheter.

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

This document describes a submission for a medical device (catheter), not an AI/software device. Therefore, the concept of "ground truth established by experts" in the context of medical imaging or diagnostic algorithms is not applicable here. The ground truth for device performance is established by engineering specifications and scientific measurement protocols (e.g., ISO 10555-1 and ISO 10555-4).

4. Adjudication Method for the Test Set

As this is a physical medical device and the tests are objective engineering measurements, an "adjudication method" in the sense of expert consensus for medical diagnoses is not applicable. The test results are quantitative and pass/fail criteria are based on predefined specifications.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (catheter), not an AI/software product. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone algorithm-only performance study was not done. This submission is for a physical medical device (catheter), not an AI/software product.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this physical medical device is based on engineering specifications, established industry standards (ISO 10555-1 and ISO 10555-4 requirements), and objective measurements derived from bench testing. It's essentially a set of predefined performance targets that the device must meet to be considered safe and effective.

8. The Sample Size for the Training Set

There is no training set in the context of this traditional medical device submission. The device is not learning or being trained from data. The tests performed are for validation of the final product.

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

As there is no training set for this traditional medical device, this question is not applicable.

Summary

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Special 510(k) Submission - ClearStream Technologies Ltd

510(k) Summary

Technologies Ltd
K102035

DEC

1 2010

Applicant Information

Date Prepared: September 8th 2010 Submitter: ClearStream Technologies Ltd

Address: Moyne Upper, Enniscorthy, Co.Wexford, Ireland.

Establishment Registration No: 9616666

Contact Person: Fiona Ní Mhulláin, RA Manager

Telephone Number: +353 (0) 53 9237111 Fax Number: + 353 (0) 53 9237100

Device Information

Trade Name: Sleek OTW PTA Catheter Common Name: OTW PTA Catheter Classification Name: Percutaneous Catheter Classification: Class II, 21 CFR 870.1250 Product Code: LIT

Predicate Device:

ClearStream Technologies Ltd, proposes its Bantam a PTA Catheter cleared through the following 510(k) number submission: K093139, as the predicate device for this submission.

Device Description:

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tip of the catheter for guidewire insertion (0.014"). The balloon expands to a known diameter at specific pressure.

Raw Materials

Materials	Usage
Pebax	Bridge tubing
Co-extruded Nylon/Pebax	Shaft Inner Material
Blue colorant	Colorant for Inner tube
Nylon/ Pebax blend	Balloon tubing
Platinum / Iridium band	Marker band
Nylon / Pebax Blend	Shaft Outer Material:1.25mm & 1.5mmx15mm
Nylon blend	1.5mmx20mm - 5.0mmx120mm
Loctite	Hub bond.glue
Pebax	Strain Relief
Polycarbonate	Y- Connector
Polycarbonate	Luer hub
Nylon/Pebax Blend	Reinforcement Material
Teflon	Balloon Sleeve
Stainless steel	Flexible Shipping mandrel
Domino Amjet Ink	Print on hub and strain relief
Silicon	SiLX coating
HDPE	Hoop
Polyester / Polyethylene / Tyvek	Pouch

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The Product Specifications of the Sleek OTW PTA Catheter is as follows:

Balloon
Nominal pressure	6Atm
Rated burst pressure 1.25mm and 1.5mm by 15 mm	14Atm
Rated burst pressure 1.5mm by 20-220mm	16Atm
Rated burst pressure 2.0-4.0mm by 20-40mm	16Atm
Rated burst pressure 5.0mm by 20-60mm	14Atm
Rated burst pressure 2.0 - 4.0mm by 80 - 220mm	15Atm
Rated burst pressure 5.0mm by 80-220mm	13Atm
Average burst pressure 1.25mm by 15 mm	23Atm
Average burst pressure 1.5mm by 15 mm	21Atm
Average burst pressure 1.5mm by 20-220mm	22Atm
Average burst pressure 2.0 - 4.0mm by 20 - 40mm	22Atm
Average burst pressure 5.0mm by 20-40mm	20Atm
Average burst pressure 2.0 - 4.0mm by 80 - 220mm	21Atm
Average burst pressure 5.0mm by 80-220mm	19Atm
Average compliance 1.25mm and 1.50mm	10% ± 4%
Average compliance	8% ± 4%
Deflation time	< 45 Secs
Fold	Trifold with memory for 2.5 - 5.0mm, bifold for 1.25 - 2.0mm
Tip lead in profile	<0.018" - 0.021" sliding scale by balloon diameter
Sheath Compatibility 1.5mm - 5.0mm	4F
Shaft
Overall catheter length	100, 130 and 150cm
Shaft Format	Co-axial
Guidewire Max. wire diameter	0.014"
Shaft Outer Diameter	2.5F/3.2F (1.25 and 1.5)2.8F/3.6F (other sizes)
Hub	Polycarbonate with dual standard luer fittings
Marker Bands	Platinum marker bands

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Catalogue number of the Sleek OTW

CatheterLength100cm	Balloon Lengths (mm)
InflatedBalloonDiameter	20	40	80	100	120	150	220
1.5	426-1502L	426-1504L	426-1508L	426-1510L	426-1512L	-	-
2.0	-	426-2004L	426-2008L	426-2010L	426-2012L	426-2015L	426-2022L
2.5	-	426-2504L	426-2508L	426-2510L	426-2512L	426-2515L	426-2522L
3.0	-	426-3004L	426-3008L	426-3010L	426-3012L	426-3015L	426-3022L
3.5	-	426-3504L	426-3508L	426-3510L	426-3512L	-	-
4.0	-	426-4004L	426-4008L	426-4010L	426-4012L	-	-
5.0	-	426-5004L	426-5008L	426-5010L	426-5012L	-	-

CatheterLength130cmInflatedBalloonDiameter	Balloon Lengths (mm)
	20	40	80	100	120	150	220
1.5	426-1502W	426-1504W	426-1508W	426-1510W	426-1512W	-	-
2.0	-	426-2004W	426-2008W	426-2010W	426-2012W	426-2015W	426-2022W
2.5	-	426-2504W	426-2508W	426-2510W	426-2512W	426-2515W	426-2522W
3.0	-	426-3004W	426-3008W	426-3010W	426-3012W	426-3015W	426-3022W
3.5	-	426-3504W	426-3508W	426-3510W	426-3512W	-	-
4.0	-	426-4004W	426-4008W	426-4010W	426-4012W	-	-
5.0	-	426-5004W	426-5008W	426-5010W	426-5012W	-	-

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CatheterLength150cm	Balloon Lengths (mm)
InflatedBalloonDiameter	15	20	40	80	100	120	150	220
1.25	426-1201X	-	-	-	-	-	-	-
1.5	426-1501X	426-1502X	426-1504X	426-1508X	426-1510X	426-1512X	-	-
2.0	-	-	426-2004X	426-2008X	426-2010X	426-2012X	426-2015X	426-2022X
2.5	-	-	426-2504X	426-2508X	426-2510X	426-2512X	426-2515X	426-2522X
3.0	-	-	426-3004X	426-3008X	426-3010X	426-3012X	426-3015X	426-3022X
3.5	-	-	426-3504X	426-3508X	426-3510X	426-3512X	-	-
4.0	-	-	426-4004X	426-4008X	426-4010X	426-4012X	-	-
5.0	-	-	426-5004X	426-5008X	426-5010X	426-5012X	-	-

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 Bantam α product FDA approved under K093139 is the same as the Sleek OTW product in all aspects including material, composition and processing except for the addition of a bridge tubing located in the distal tip of the Sleek OTW product. A list of aspects of the product that are the same is shown below:

Part	Bantam α FDA approved	Sleek
Hub	Same	Same
Strain relief	Same	Same
Outer	Same	Same
Inner	Same	Same
Balloon	Same	Same
Marker bands	Same	Same

as supplied in materials table above

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Bridge material	NA	Pebax
Re-inforcement	Same	Same
		Same
Bonds		Same
Hub	Glued (inner and outer into hub)	Same
Proximal bond	Fused (Outer to balloon)	Same
Marker bands	Crimped (bands to inner)	Same
Distal bond	Fused (inner to balloon + additional pebax)	Same

Details of the bridging material are laid out below:

· The addition of a bridge material, the same as that used in the LitePAC (K100490) (Sleek - K072947) design.
The distal end configuration of Sleek OTW differs slightly to that of . Bantam a, with a tip lead in profile of: 0.018" for a 1.25mm balloon diameter and 0.021" for a 5.0mm balloon diameter for Sleek OTW; while the tip lead in profile for Bantam α is 0.017" for a 1.25mm balloon and up to 0.020" for a 5.0mm balloon.

The only extra testing deemed necessary for Sleek OTW was testing relating to the distal tip due to the bridge tubing addition. All testing of the distal tip passed specification. All testing was done in compliance with ISO 10555-1 and ISO 10555-4 requirements. Due to the minor nature of the change and the fact that all subsequent testing on the Sleek passed requirements the products are deemed substantially equivalent.

Test Data:

The safety and effectiveness of the ClearStream Sleek OTW PTA Catheter has been demonstrated through data collected from non-clinical design verification and design validation tests and analyses.

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Bench Testing

The Sleek OTW bench testing validations consist of the same and additional tests as the previous Bartam & validation. All validation work for the Sleek OTW originally around the distal tip change as this was the only difference between the two products, however after a customer request this validation was extended to cover a wider range of tests.

The Sleek OTW product is identical to the currently CE marked and FDA approved Bantam a product (K093139) except for the inclusion of a bridge tubing in the distal tip, the distal tip configuration has proven its safety and effectiveness and as such Sleek OTW and Bantam x are deemed to be substantially equivalent despite this addition of the bridge material. As everything up to the tip of the same for the Bantam x and the Sleek OTW, further testing would not have provided any further information. Table 1. lays out the testing performed for the Bantam validation was also referenced as part of the Bantam a project due to the same materials and processes being used) and the corresponding testing done for the Sleek OTW is also described.

In addition to the tests carried out in the Bantam x validation, some additional tests were carried out in the Sleek OTW validations described in Table 2 below. These extra validation tests for Sleek OTW were carried out due to a customer request.

A full functional validation of Sleek OTW, VP577, was carried out at the customer's request. The tests, "Catheter Body Dimensions" and "Visual and Functional test" from the functional validation of Bantam or, VP494, were not carried out. The catheter body

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dimension test was not required as the dimensions of the two products are the same up to the distal tip. Visual and functional testing was performed on the line for the Sleek OTW production and so it was not necessary to be performed again as part of the validation.

Table 1

Test	Results Bantam α(VP/VR494) & Bantam(VP/VR421,338 & 222)	Results Sleek OTW(VP/VR577)
Visual andFunctional Testing	PASS - VP494[29 of 1.5x20x150],[29 of 5.0x120x150]Also completed onVP421 - Pass(13 of 2.0x220), (13 of 2.5x220)(13 of 5.0x220), (42 of 6.0x220)	N/A
Catheter BodyDiameters	PASS - VP494[29 of 1.5x20x150],[29 of 5.0x120x150]Also completed onVP421 - Pass(13 of 2.0x220), (13 of 2.5x220)(13 of 5.0x220), (29 of 6.0x220)	N/A
Test	Results Bantam α(VP/VR494) & Bantam	Results Sleek OTW(VP/VR577)
	(VP/VR421,338 & 222)
	PASS - VP494[29 of 5x120mm×150cm]Also completed onVP421 - Pass(13 of 2.5x220)	N/A
	(13 of 5.0x220)
Inflation/Deflation	(29 of 6.0x220)N/A	PASS - VP577
Time		[29 of 5x120mmx150cm]
Introducer Sheath	PASS	PASS
Withdrawal	[29 of 5x120mm×150cm]	[29 of 5x120mmx150cm]
	VP421 - Pass
	(13 of 5.0x220), (29 of 6.0x220)
Leak and Rated	PASS	*PASS with deviation
Burst Pressure	[29 of 1.5x20mmx150cm]	[29 of 1.25x15mmx150cm]
	[29 of 5x120mmx150cm]	[29 of 5x120mmx150cm]
	VP421 - Pass
	(13 of 2.5x220), (13 of 5.0x220)
	(29 of 6.0x220)
	Results Bantam α
Test	(VP/VR494) & Bantam	Results Sleek OTW
		(VP/VR577)
	(VP/VR421,338 & 222)
Tensile Test for	VP/VR 338 - Pass	PASS
Proximal Bond
	(29 of 2x20 Pass)	[29 of 5x120mmx150cm]
	(29 of 2x120 Pass)
	(13 of 5x120 Pass)
	(29+13 of 9x60 Pass)
Tensile Test for Hub	VP222 - Pass	PASS
Bond	(29 of 2x60), (29 of 3x60)	[29 of 5x120mmx150cm]
	(29 of 5x60), (29 of 6x60)
	(29 of 8x60), (29 of 9x60)
Measurement of the	VP 421 - Pass	PASS
Working Surface,	(13 2.0x220)	[13 of 1.25x15mmx150cm]
OD and TL of the		[13 of 5x120mmx150cm]
Balloon
Balloon Compliance	VP 421 - Pass	PASS
Test	(13 2.0x220)	[13 of 1.25x15mmx150cm]
	(13 6.0x220)	[16 of 5x120mmx150cm]
Average Burst	VP 421 - Pass	PASS
Pressure Testing	(13 2.0x220)	[13 of 1.25x15mmx150cm]
	(13 6.0x220)	[13 of 5x120mmx150cm]

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{9}------------------------------------------------

Conclusion: All products had acceptable balloon fatigue performance, noted deviation accepted.

The additional tests carried out for Sleek OTW are detailed in Table 2 below:

{10}------------------------------------------------

Special 510(k) Submission - ClearStream Technologies Ltd

Table 2

Test	Results Sleek OTW(VP/VR577)
Profile Measurements of Distal Tip	PASS – VP577[29 of 1.25x15x150],[29 of 5.0x120x150]
Tensile Test of the Distal Tip	PASS[29 of 1.25x15mmx150cm][29 of 5x120mmx150cm]

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Conclusions

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, making the device as safe and effective and therefore market clearance of the Sleek OTW catheter through this 510(k) premarket notification.

{12}------------------------------------------------

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ClearStream Technologies Ltd. C/O Fiona Ni Mhullain Regulatory Affairs Manager Moyne Upper Enniscorthy, Ireland

DEC 1 2010

Re: K102035

Trade/Device Name: Sleek OTW catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: Undated Received: November 12, 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 (Act (Act that an rot 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 probibitions 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.

{13}------------------------------------------------

Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase be advised that 1 Dr. brounder that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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 devices and reliable (21 CERC 60) good ation (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 11 you dosho specific ad rios to: your conters offices/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 note 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 Tou may 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/ResourcesforYowIndustry/default.htm.

Sincerely yours,

Duma R. Valmer

$\hbar$

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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KiUaUDJ page 'q. 1

Special 510(k) Submission - ClearStream Technologies Ltd

Indications for Use

510(k) Number (if known): K102035

Device Name: Sleek OTW PTA Catheter

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 AND/OR (Part 21 CFR 801 Subpart D)

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)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K102035

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).