The Ebony® PTA .035 Peripheral Dilatation Catheter is a standard Over the Wire (OTW) PTA Catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing tight stenoses.

It is a double lumen catheter, one lumen for the guide wire used for inflation/deflation of the balloon and one lumen for the guide wire used to access to the distal tip of the catheter (max/0.035″). A luer lock fitting allows the connection with an inflation device (Y hub). The balloon has two radiopaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel.

The distal catheter, proximal to the balloon, is covered with a hydrophilic coating to improve the trackability and pushability characteristics.

The balloon material expands to a known diameter at specific pressure defined in a compliance chart supplied with the catheter. The device is available in balloon. diameters of 5, 6, 7, 8, 9, 10 or 12 mm, balloon lengths of 20, 40, 60, or 80 mm and catheter lengths of 80, 130, or 150 cm.

lt will be supplied sterile and is intended for one time use.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, the Ebony® PTA .035 Peripheral Dilatation Catheter, not a typical AI/ML device, therefore the information you requested like samples size for the test set, provenance of data, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set size and ground truth for training set are not available in the provided document. The study described focuses on nonclinical, bench-top testing to demonstrate substantial equivalence to a predicate device, rather than clinical efficacy studies.

Here's the available information presented in the requested format:

Acceptance Criteria and Device Performance Study for Ebony® PTA .035 Peripheral Dilatation Catheter

This submission refers to non-clinical bench testing to demonstrate substantial equivalence, rather than a clinical study with human patients. As such, many of the typical acceptance criteria and study details relevant to AI/ML device performance or clinical trials are not applicable or not provided in this document.

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are generally understood to be met if the device performs equivalently to the predicate device in a series of in vitro bench tests. The document states that the subject device met all predetermined acceptance criteria.

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Biocompatibility	ISO 10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F756-00, 21 CFR 58 (GLP)	All materials are biocompatible (based on testing results)
Performance Data	Balloon compliance	Equivalent performance to predicate device
	Balloon burst pressure	Equivalent performance to predicate device
	Balloon fatigue	Equivalent performance to predicate device
	Shaft resistance	Equivalent performance to predicate device
	Bond strength	Equivalent performance to predicate device
	Catheter dimensions	Equivalent performance to predicate device
	Deflation time	Equivalent performance to predicate device
	Guide wire and introducer compatibility	Equivalent performance to predicate device

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

Sample Size: Not specified in the provided document. The tests are "in vitro bench tests and analyses."
Data Provenance: The data is generated from in vitro bench tests conducted by Natec Medical Ltd. or its contracted laboratories. No country of origin for the data is specified beyond the company's location in Mauritius. These are experimental, non-clinical tests rather than retrospective or prospective patient data.

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

Not Applicable. For this type of submission involving physical device performance, "ground truth" is established through engineering specifications, validated test methods, and comparison to a predicate device's known performance, rather than expert human interpretation of data.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or data. This submission focuses on objective physical and chemical properties of a medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device submission. This pertains to evaluating the effectiveness of a diagnostic tool or intervention with human readers, which is not the purpose of this submission.

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

Not Applicable. This is a physical medical device (catheter), not an algorithm or AI system.

7. The Type of Ground Truth Used

Engineering specifications, validated test methods, and performance of a legally marketed predicate device (ADMIRAL XTREME™ PTA Catheter). The "ground truth" for the tests is adherence to predefined engineering specifications and demonstrating performance comparable to the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This submission does not involve an AI/ML algorithm that requires a "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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K103354

510(k) Summary 807.92(c)

FEB 2 3 2011

SPONSOR

807.92(a)(1)

Company Name: Company Address

Natec Medical Ltd. Maeva Centre Building - Ebene Business Park Reduit, Mauritius

Telephone: Fax:

+230 466 30 54 +230 466 67 70

Contact Person:

Alain Valorge Quality manager info@natec-medical.com

Summary Preparation Date: October 28, 2010

DEVICE NAME	807.92(a)(2)
Trade Name:	Ebony® PTA .035 Peripheral Dilatation Catheter
Common/Usual Name:	PTA Catheter
Classification Name:	Percutaneous Catheter
Regulation Number:	21 CFR 870.1250
Product Code:	LIT
Device Class:	Class II

PREDICATE DEVICE

807.92(a)(3)

Legally Marketed Equivalent Device

K Number	Trade Name	Manufacturer
K062809	ADMIRAL XTREME™ PTACatheter	Invatec InnovativeTechnologies

DEVICE DESCRIPTION

807.92(a)(4)

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The distal catheter, proximal to the balloon, is covered with a hydrophilic coating to improve the trackability and pushability characteristics.

lt will be supplied sterile and is intended for one time use.

DEVICE INTENDED USE

807.92(a)(5)

The Ebony® .035 PTA Catheter is intended for the dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries.

The Ebony® .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

The Ebony® .035 PTA Catheter and the predicate device, Admiral Xtreme™ PTA Catheter have the same intended use for the dilatation of lesion in the femoral, iliac, infra popliteal and renal arteries. The technological characteristics such as material, biocompatibility, mode of operation, performance properties, sterilization and packaging are substantially equivalent to the predicate device.

NONCLINICAL TESTS

807.92(b)

SAFETY and EFFECTIVENESS

BIOCOMPATIBILITY

All materials used in the Ebony® .035 PTA Catheter are biocompatible based on biocompatibility testing results. The device has been tested according to ISO 10993 Part 1, 2, 4, 5, 10, 11, 12, ASTM F756-00 and 21 CFR 58 (GLP regulations)

PERFORMANCE DATA

The safety and effectiveness of the Ebony® .035 PTA Catheter has been demonstrated through data collected from in vitro bench tests and analyses. Testing results demonstrated equivalent performance of the Ebony® .035 PTA Catheter with the predicate device.

The testing included balloon compliance, balloon burst pressure, balloon fatigue, shaft resistance, bond strength, catheter dimensions, deflation time and guide wire and introducer compatibility.

CONCLUSION

807.92(b)(3)

The subject device, the Ebony® .035 PTA Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable

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. . . . .

. .

standards, guidance, and test protocols. It is the conclusion of Natec Medical, Ltd that the Ebony® .035 PTA Catheter is as safe and effective as the predicate device.

and the state of the state of the states of the states

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes wrapped around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

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

Natec Medical Ltd c/o Mr. E.J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114

FEB 2 3 2011

ﻟﻤﻤﻠﻜﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ

Re: K103354

Trade/Device Name: Ebony .035 PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Regulatory Class: Class II (two) Product Code: LIT Dated: February 8, 2011 Received: February 9, 2011

Dear Mr. Smith:

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.

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Page 2 - Mr. E.J. Smith

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); 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 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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

er D. V. hner

Image /page/4/Picture/8 description: The image shows a black and white drawing of a symbol. The symbol appears to be a stylized letter or character, with curved lines and a loop at the bottom. The lines are thick and bold, and the overall impression is abstract and calligraphic. The symbol is isolated against a white background.

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 Form

Indications for Use

510(k) Number (if known): K103354

Device Name: Ebony .035 PTA Catheter

Indications for Use:

The Ebony® .035 PTA Catheter is intended for the dilation of lesions in the femoral, illac, popliteal, infrapopliteal and renal arteries.

The Ebony® .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Vihnes

(Division Sign-Off) Division of Cardiovascular Devices

Page _1_of ।

510(k) Number_KIO 3354

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).