EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER

K112513 · Natec Medical , Ltd. · LIT · Dec 9, 2011 · Cardiovascular

Device Facts

• Record ID: K112513
• Device Name: EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
• Applicant: Natec Medical , Ltd.
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Ebony PTA 0.014" Peripheral Dilatation Catheter is a rapid exchange (RX) balloon catheter used for percutaneous transluminal angioplasty. Device features a semi-compliant inflatable balloon at the distal end and an atraumatic tapered tip to facilitate crossing stenoses. Double-lumen design allows for balloon inflation/deflation and 0.014" guidewire insertion. Radiopaque markers on internal tubing assist in positioning relative to vessel stenosis. Hydrophilic coating on the catheter body reduces friction to improve pushability. Operated by physicians in clinical settings; connected to an external inflation device via a luer lock hub. Balloon expansion follows a pressure-diameter compliance table. Device is single-use and supplied sterile. By dilating stenotic lesions, the catheter restores vessel patency, improving blood flow and potentially alleviating symptoms of peripheral arterial disease.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness demonstrated via non-clinical tests including biocompatibility (ISO 10993, ASTM F756-00), balloon compliance, burst pressure, fatigue endurance, inflation/deflation performance, bond strengths, and dimensional verification.

Technological Characteristics

Rapid exchange (RX) PTA catheter; semi-compliant balloon; double-lumen design; hydrophilic coating; radiopaque markers. Materials tested per ISO 10993 and ASTM F756-00. Available in diameters 2.0-8.0 mm and lengths 10-60 mm. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for dilatation of lesions in iliac, femoral, popliteal, infra-popliteal, renal, and carotid arteries. Contraindicated for use in coronary or neuro-vasculature.

Regulatory Classification

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.

Predicate Devices

• Invatec Amphirion Deep PTA 0.014" Balloon Catheter (K083919)
• Cordis AVIATOR Plus PTA Balloon dilatation catheter (K071189)
• Boston Ultra Soft SV PTA Dilatation Catheter (K050389)

Submission Summary (Full Text)

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K112513 page 1 of 3

DEC - 9 2011

# 510(k) SUMMARY 807.92(c)

### SPONSOR

Company Name: Company Address:

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

Telephone: Fax:

[phone] [phone]

Contact Person:

Alain Valorge Quality Manager [e-mail]

Summary Preparation Date: July 14, 2011

### DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

# 807.92(a)(2)

807.92(a)(1)

Ebony® PTA .014" RX Peripheral Dilatation Catheter PTA .014" Catheter Percutaneous Catheter 21 CFR 870.1250 LIT and DQY Class II

## PREDICATE DEVICE

Legally Marketed Equivalent Devices:

- " Invatec Amphirion Deep PTA 0.014" Balloon Catheter K083919
- Cordis AVIATOR Plus PTA Balloon dilatation catheter K071189
- Boston Ultra Soft SV PTA Dilatation Catheter K050389

### DEVICE DESCRIPTION

#### 807.92(a)(4)

807.92(a)(3)

The Ebony® PTA 0.014'' Peripheral Dilatation Catheter is a standard Rapid Exchange (RX) PTA catheter with a semi-compliant inflatable balloon at the distal part and an atraumatic, tapered tip to aid in crossing the tight stenoses.

The catheter is double lumen in the distal part, one lumen is used for inflation and deflation of the balloon, and the second lumen allows access to the distal part of the catheter for guide wire insertion (max. 0.014"). The maximum recommended guide wire diameter is 0.014". A luer lock fitting (Hub) allows the connection with an inflation device. The internal tubing of the balloon has two radio opaque markers to provide visual reference points for balloon positioning relative to the stenosis within the vessel.

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An hydrophilic coating solution is applied on the catheter body to improve the pushability of the catheter by reduction of the friction coefficient of the outer body. The balloon material expands to a known diameter at specific pressure defined in a compliance table supplied with the catheter. The device is available in balloon diameter of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0 mm, and balloon lengths of 10, 15, 20, 25, 30, 35, 40, and 60 mm.

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

### DEVICE INTENDED USE

### 807.92(a)(5)

The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries.

This catheter is not for use in coronary or neuro-vasculature.

# COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a){6}

The Ebony PTA .014" Dilatation Catheter incorporates substantially equivalent indications for use, design, and dimensional and performance specifications as those found with the aforementioned predicate devices.

### NONCLINICAL TESTS

#### 807.92(b)

SAFETY and EFFECTIVENESS

#### BIOCOMPATIBILITY

All materials used in the Ebony "PTA .014" 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 PTA .014" Catheter has been demonstrated via data collected from non-clinical tests and analyses, which addressed, among other considerations, the following:

- · Biocompatibility
- · Balloon compliance
- · Balloon burst pressure
- Balloon fatigue (repeated balloon inflation) endurance
- Balloon inflation/deflation performance
- · Bond strengths
- Catheter dimensions and balloon profile
- · Catheter body minimum burst strength
- Device preparation (guide wire and introducer compatibility)

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# CONCLUSION

## 807.92(b)(3)

Kbl2 513 page

The subject device, the Ebony PTA 0.014" Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols.

Since the Ebony PTA 0.014'' Catheter have the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, same mode of operation, and no new safety or effectiveness issues, the Ebony PTA 0.014'' Catheter may be considered substantially equivalent to the aforementioned predicate devices.

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

DEC - 9 2011

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

Re: K112513

Trade/Device Name: Ebony PTA 0.014" Peripheral Dilatation Catheter Regulation Number: 21 CFR 870. 1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT, DQY Dated: November 23, 2011 Received: November 23, 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

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/ReportalProblem/default.htm for the CDRI-'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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M. A. Hellelenne

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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510(k) Traditional

Pre-Market Notification

# Indications for Use Statement

510(k) Number:

Device Name:

Ebony 0.014 PTA Catheter

Indication for Use:

The Ebony 0.014'' PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries.

This catheter is not for use in coronary or neuro-vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The —Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEWS OF OF SEE SECTION NEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M.A. Killebenne

(Division Sign-Off) Division of Cardiovascular De

510(k) Number k112513

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