NAVAJO PTA BALLOON DILATATION CATHETER

K141354 · Curative Medical, Inc. · DQY · Jan 30, 2015 · Cardiovascular

Device Facts

• Record ID: K141354
• Device Name: NAVAJO PTA BALLOON DILATATION CATHETER
• Applicant: Curative Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Navajo™ PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

Navajo PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) device. It consists of a proximal adaptor, coaxial lumen shaft, and distal dilatation balloon. Compatible with 0.035" guide wires and 5F-7F introducer sheaths. Used by physicians in clinical settings to dilate stenoses in peripheral arteries and treat obstructive lesions in arteriovenous dialysis fistulae. The device is inserted percutaneously; the balloon is inflated to dilate the target vessel or fistula, improving blood flow. Hydrophilic coating on the shaft facilitates navigation. Output is mechanical dilation of the vessel/lesion. Benefits include restoration of patency in peripheral vasculature and dialysis access sites.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included catheter dimension, tip profile, inflation/deflation time, fatigue integrity, balloon compliance, rated rupture pressure, shaft pressure integrity, lumen collapse pressure, and tensile strength for various catheter components. Compliance with ISO 10555-1, ISO 10555-4, ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, and ISO 10993-11 was demonstrated.

Technological Characteristics

Over-the-wire PTA catheter; coaxial lumen shaft; distal dilatation balloon; hydrophilic shaft coating. Compatible with 0.035" guidewires and 5F-7F introducer sheaths. Lengths: 80, 100, 120, 130 cm. Sterilization: Ethylene oxide (EN ISO 11135-1). Materials and design verified per ISO 10555-1/4 and ISO 10993 series.

Indications for Use

Indicated for patients requiring dilation of stenoses in peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal) or treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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

• AgilTrac .035 Peripheral Dilatation Catheter (K022738)

Submission Summary (Full Text)

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

January 30, 2015

Curative Medical Inc. Bill Jacqmein Regulatory Affairs Consultant 1591 Deephaven Dr. Woodbury, Minnesota 55129

Re: K141354

> Trade/Device Name: Navajo PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: PTA Balloon Dilatation Catheter Regulatory Class: Class II Product Code: LIT Dated: May 15, 2014 Received: December 24, 2014

Dear Bill Jacqmein,

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 Part 807); labeling (21 CFR Part 809); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for Bram 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

510(k) Number (if known)

Device Name

Navajo PTA Balloon Dilatation Catheter

#### Indications for Use (Describe)

The NavajoTM PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliofemoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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# 510(k) SUMMARY

| Submitter: | Curative Medical Inc.<br>3227 Kifer Road<br>Santa Clara, CA 95051<br>Establishment Number: 3008361782 |
|---------------------------|--------------------------------------------------------------------------------------------------------|
| Company Contact Person: | Jessica Chiu, VP of R&D |
| | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Submission Correspondent: | Bill Jacqmein, Regulatory Affairs Consultant |
| | Address: 2320 Parkview Lane, Woodbury, MN 55125<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | 15 May 2014 |
| Proprietary Name: | Navajo PTA Balloon Dilatation Catheter |
| Common Name: | Percutaneous catheter |
| Product Code: | LIT -Catheter, Angioplasty, Peripheral, Transluminal |
| Device Classification: | Class II, 21 CFR 870.1250 - Percutaneous Catheter |
| Predicate Devices: | AgilTrac .035 Peripheral Dilatation Catheter (K022738 |

### Device Description:

The Navajo™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal adaptor, coaxial lumen shaft, and a distal dilatation balloon. The Navajo PTA Balloon Dilatation Catheter is compatible with guide wires with a maximum diameter of 0.035" and with 5F to 7F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating on the shaft and is available in useable catheter lengths of 80, 100, 120 and 130cm.

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### Intended Use:

The Navajo™ PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

### Comparison of Technological Characteristics:

The Navajo™ PTA balloon dilatation catheter incorporates substantially equivalent device materials, configurations, packaging, technology, sterilization process and intended use as those featured in the AgilTrac .035 Peripheral Dilatation Catheter.

| Characteristic | Proposed compared to Predicate |
|----------------------------|-------------------------------------------------------------------------------------------------------|
| Components | Same components, similar configuration, design and function. |
| Materials | Same materials |
| Packaging | Same Packaging |
| Guidewire compatibility | Same compatibility |
| Balloon Lengths | Similar Lengths; Navajo™ Lengths are inside the minimum<br>and maximum range of the predicate device. |
| Effective Length | Similar Lengths; Navajo™ Lengths are inside the minimum<br>and maximum range of the predicate device |
| Rated Burst Pressure (RBP) | Same or higher RBP; better safety margin for Navajo™ |
| Intended Use | Same intended use |

## Summary of Performance Data and Substantial Equivalence:

Navajo™ PTA Balloon Dilatation Catheters were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. Curative Medical Inc. has determined that the Navajo™ PTA Balloon Dilatation Catheters are safe and effective. The Navajo™ PTA Balloon Dilatation Catheters have been tested and shown to be compliant with the following standards documents:

- . ISO 10555-1:2009- Sterile, single-use intravascular catheters - Part 1: General requirements
- ISO 10555-4:1996- Sterile, single-use intravascular catheters Part 4: Balloon dilatation . catheter
- . ISO 10993-1:2009- Biological evaluation of medical devices – Part 1: Evaluation and testing

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- . ISO 10993-4:2002+AMD1:2006-Biological testing of medical and dental materials and devices - Part 4: Selection of tests for interactions with blood
- ISO 10993-5: 2009- Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
- . ISO 10993-10:2010 - Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006- Biological testing of medical and dental materials and devices -Part 11: Tests for systemic toxicity
- . EN ISO 11135-1: 2007 Sterilization of Medical Devices – Validation and routine control of ethylene oxide sterilization
- EN ISO 11607-1: 2009- Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems

Performance Testing:

The following performance tests were completed:

| Catheter Dimension, Balloon & Tip Profile |
|--------------------------------------------------------------|
| Catheter Prep, In/deflation Time |
| Catheter Fatigue Integrity |
| Balloon Compliance |
| Balloon Rated Rupture Pressure |
| Catheter Shaft Pressure Integrity |
| Catheter Interface Compatibility, GW Lumen Collapse Pressure |
| Catheter Luer - Shaft Tensile Strength |
| Catheter Shaft - Balloon Bond Tensile Strength |
| Catheter Soft Tip Tensile Strength |
| Catheter Shaft Coating Integrity |
| Catheter Flexibility, Kink and Torque Strength |

This 510(k) submission presents the results of the testing and detailed descriptions to demonstrate that Navajo PTA Balloon Dilatation Catheter is substantially equivalent to the AgilTrac .035 Peripheral Dilatation Catheter (K022738).

### Conclusion:

Based on the indications for use, technological characteristics, safety and performance testing, the Navajo™ PTA Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered substantially equivalent to the AgilTrac .035 Peripheral Dilatation Catheter (K022738).