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 line extension adds a 1.5 mm diameter balloon and additional balloon lengths to the currently available sizes.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a peripheral dilatation catheter. It details the device, its indications for use, and a summary of performance testing to establish substantial equivalence to predicate devices. However, this type of submission focuses on demonstrating equivalence rather than proving device performance against specific acceptance criteria for a new clinical claim or an AI algorithm.

Therefore, the requested information regarding acceptance criteria, study details for proving the device meets those criteria, and specifics about AI algorithms, ground truth, experts, and multi-reader studies cannot be fully extracted from this document. This document describes a traditional medical device (a catheter) and its mechanical/physical performance, not an AI-powered diagnostic or therapeutic device.

Here's a breakdown of what can be extracted and why other parts cannot:

What can be extracted (and partially inferred):

Acceptance Criteria (Implied): The document states that "The new balloon sizes met all of the verification/validation acceptance criteria." While explicit numerical acceptance criteria are not listed, the types of performance tests performed serve as the basis for these criteria.
- Balloon compliance
- Balloon burst pressure
- Balloon fatigue
- Shaft resistance (Torque Test)
- Bond strength
- Catheter dimensions
- Deflation time
- Guide wire and introducer compatibility
Study Proving Acceptance Criteria: The document mentions "bench testing" was performed. This refers to in-vitro (laboratory) testing, not human clinical trials or observational studies for typical AI device evaluation.

Information that CANNOT be extracted from this document, as it pertains to a different type of device (AI/diagnostic) and study design:

A table of acceptance criteria and the reported device performance: While the types of tests are mentioned, the actual numerical acceptance criteria (e.g., "burst pressure > X atm") and the specific reported performance results are not included in this summary. It only states they "met all... criteria."
Sample size used for the test set and the data provenance: This refers to patient data for AI algorithms. The "sample" here refers to physical catheter units tested in a lab, not a patient test set. The document does not specify the number of catheters tested for each bench test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant for a physical device like a catheter. Ground truth in this context would be engineering specifications and measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for bench testing of a physical device.
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 document is not for an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the catheter, the "ground truth" for the bench tests would be established by validated test methods, engineering specifications, and industry standards, measured using calibrated equipment. This is not "expert consensus" in the diagnostic sense, nor is it pathology or outcomes data.
The sample size for the training set: Not applicable. This device does not use a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

This document describes the 510(k) clearance for the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter, which is a physical medical device. The submission focuses on demonstrating substantial equivalence to predicate devices for a line extension (new balloon diameter and lengths).

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

Acceptance Criteria (Implied by Bench Tests Performed)	Reported Device Performance
Balloon compliance	Met all verification/validation acceptance criteria
Balloon burst pressure	Met all verification/validation acceptance criteria
Balloon fatigue	Met all verification/validation acceptance criteria
Shaft resistance (Torque Test)	Met all verification/validation acceptance criteria
Bond strength	Met all verification/validation acceptance criteria
Catheter dimensions	Met all verification/validation acceptance criteria
Deflation time	Met all verification/validation acceptance criteria
Guide wire and introducer compatibility	Met all verification/validation acceptance criteria

(Note: Specific numerical criteria and performance values are not provided in this summary document, only the confirmation that the device "met all of the verification/validation acceptance criteria" for each listed test.)

2. Sample size used for the test set and the data provenance:
The document refers to "bench testing" performed on the modified catheter. The specific sample size (number of catheters tested) for each bench test is not provided. Data provenance is from in-vitro (laboratory) testing conducted by the manufacturer, Natec Medical Ltd. It is retrospective in the sense that the tests were completed before the 510(k) submission.

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 physical device bench testing, "ground truth" is established by engineering specifications, validated test methods, and industry standards, not by an expert consensus process involving human readers.

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:
No, this was not done. This study is for a physical medical device (catheter), not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for the bench tests would be defined by the engineering specifications, design requirements, and relevant industry standards against which the physical performance (e.g., burst pressure, dimensions) of the catheter units were measured and compared.

8. The sample size for the training set:
Not applicable. This device does not have a "training set" as understood in machine learning.

9. How the ground truth for the training set was established:
Not applicable.

Summary

{0}------------------------------------------------

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

February 3, 2015

Natec Medical Ltd. c/o Ms. Judith Danielson Senior Regulatory Consultant CardioMed Device Consultants, LLC 5523 Research Park Drive Suite 205 Baltimore, MD 21228

Re: K142459

Trade/Device Name: Ebony PTA 0.014" Rx Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: December 2, 2014 Received: December 3, 2014

Dear Ms. Danielson.

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 CFR

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Bram D. Zuckerman -S

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 Building - Ebene Business ParkReduit, 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 17, 2014

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) ●
ev3 Inc., RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter (K123544) ●
ev3 Inc., NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter . (K141118)

Device Description:

The modified EBONY® PTA 0.014" RX Dilatation Catheter line extension adds a 1.5 mm diameter balloon and additional balloon lengths to the currently available sizes.

{4}------------------------------------------------

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.

The balloon size matrix of the Ebony® PTA 0.014" RX Peripheral Dilatation Catheter was modified to include 1.5 mm diameter balloons, and longer balloon lengths (up to 200 mm) to the previously cleared balloon sizes. The new balloon sizes are similar to ev3's NanoCross™ Elite 0.014" PTA catheter with 1.5 mm diameter balloon, and RapidCross™ PTA Catheter with balloon lengths ranging up to 210mm long.

Performance Data:

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

I Balloon compliance
트 Balloon burst pressure
I Balloon fatigue
트 Shaft resistance (Torque Test)
I Bond strength
I Catheter dimensions
I Deflation time
I Guide wire and introducer compatibility.

Conclusion

The modified Ebony® 0.014" RX Peripheral Dilatation Catheters and the predicate Ebony 0.014" RX Peripheral Dilatation Catheter (K112513) have the same intended use, same materials and the same RX design. The new balloon sizes met all of the verification/validation acceptance criteria and demonstrated that the modified Ebony® 0.014" RX Peripheral Dilatation Catheters are as safe and effective as 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).