The Ebony® PTA 0.014" RX Peripheral Dilatation Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not intended for use in coronary or neuro-vasculature.

Device Description

The EBONY® PTA 0.014" RX Dilatation Catheter is a standard rapid exchange (RX) PTA catheter with a semi-compliant inflatable balloon and tapered tip on the distal end. Two radiopaque markers facilitate proper balloon positioning across the stenosis, and a hydrophilic coating facilitates advancement of the catheter through the vasculature.

The modified EBONY® PTA 0.014" RX Dilatation Catheter has a new hydrophilic coating, applicable to all lengths to the currently available sizes.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification for a medical device, the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic device.

Therefore, many of the requested sections related to AI device evaluation (e.g., sample sizes for test/training sets, expert qualifications, MRMC study, ground truth types) are not applicable or cannot be extracted from this document, as it describes a physical medical device (a catheter) with a changed hydrophilic coating.

However, I can extract information related to the performance data and conclusion of the substantial equivalence review.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance / Evaluation
Coating Integrity	Bench testing performed. (Specific acceptance criteria not detailed in this summary.)
Particulate Evaluation	Bench testing performed. (Specific acceptance criteria not detailed in this summary.)
Biocompatibility	Bench testing performed. (Specific acceptance criteria not detailed in this summary.)
Intended Use	Same as predicate devices (K112513 and K142459). Intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. Not for use in coronary or neuro-vasculature.
Materials	Same as predicate devices.
RX Design	Same as predicate devices.
Overall Equivalence	Met all verification/validation acceptance criteria, demonstrating substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This document describes bench testing on physical devices. It does not mention "test sets" or "data provenance" in the context of clinical data for an AI device. The tests were performed on the modified Ebony PTA .014" RX Catheter or leveraged from similar catheters. The specific number of catheters tested for each bench test is not provided in this summary.

3. 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. This is for a physical medical device, not an AI diagnostic device requiring expert interpretation of results for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable.

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.

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

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. This document refers to engineering and biocompatibility testing where "ground truth" would be established by physical measurements and accepted industry standards, not clinical expert consensus or pathology.

8. The sample size for the training set

Not applicable. There is no AI algorithm being described, so no training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

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

September 3, 2015

Natec Medical, Ltd Xavier de Buchere Regulatory Affairs and Quality Manager Maeva Centre Building Silicon Avenue Ebene Business Park Reduit 72201 - Mauritius

Re: K152230

Trade/Device Name: Ebony PTA .014" RX Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 25, 2015 Received: August 7, 2015

Dear Mr. de Buchere:

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 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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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Kenneth J. Cavanaugh -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152230

Device Name

Ebony® PTA 0.014" RX Peripheral Dilatation Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Ebony® PTA 0.014'' RX Peripheral Dilatation Catheter 510(k) SUMMARY 21 CFR 807.92

Applicant:

Company Name:	Natec Medical Ltd.
Company Address:	Maeva Centre BuildingSilicon Avenue,Ebene Business ParkReduit 72201,Mauritius
Telephone:	+230 466 30 54
Fax:	+230 466 67 70
Contact Person:	Xavier De BuchereRegulatory Affairs & Quality Managerxdbuchere@natec-medical.com

Summary Preparation Date: August 25th, 2015

Device Name:

Trade Name:	Ebony® PTA 0.014" RX Peripheral Dilatation Catheter
Common/Usual Name:	PTA Catheter
Classification Name:	Percutaneous Transluminal Angioplasty Catheter
Regulation Number:	21 CFR 870.1250
Product Code:	LIT
Device Class:	Class II

Predicate Devices:

Ebony® PTA 0.014" RX Peripheral Dilatation Catheter (K112513)
Ebony® PTA 0.014" RX Peripheral Dilatation Catheter (K142459)

Device Description:

The modified EBONY® PTA 0.014" RX Dilatation Catheter has a new hydrophilic coating, applicable to all lengths to the currently available sizes.

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Indication for Use:

The Ebony® PTA 0.014" RX Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, and renal arteries. This catheter is not for use in coronary or neuro-vasculature.

Technological Characteristics:

The modified Ebony® PTA 0.014" RX Peripheral Dilatation Catheter has the same indication for use and is manufactured using the same rapid exchange design and materials as the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter cleared under K112513 and K142459.

The hydrophilic coating on the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter was modified from Slipskin to Proglide.

Performance Data:

Based on a risk analysis, the following bench testing was performed on the modified Ebony PTA .014" RX Catheter or leveraged from similar catheters:

I Coating Integrity test
트 Particulate evaluation
I Biocompatibility

Conclusion

The modified Ebony® 0.014" RX Peripheral Dilatation Catheters and the predicate Ebony 0.014" RX Peripheral Dilatation Catheter (K112513) & (K142459) have the same intended use, same materials and the same RX design. The modified catheters met all of the verification/validation acceptance criteria and demonstrated that the modified Ebony® 0.014" RX Peripheral Dilatation Catheters are substantially equivalent to the predicate device.

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).