NovaCross Microcatheter

K160389 · Nitiloop , Ltd. · DQY · Mar 11, 2016 · Cardiovascular

Device Facts

• Record ID: K160389
• Device Name: NovaCross Microcatheter
• Applicant: Nitiloop , Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 11, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

Device Story

NovaCross™ Microcatheter is a sterile, single-use, over-the-wire percutaneous support catheter. Device consists of a telescopic shaft, over-tube, and proximal handle for manual manipulation and flushing. Key feature is a deployable/retractable distal Nitinol scaffold; scaffold expands to artery width under fluoroscopic visualization to provide anchoring and support near treatment site. Used by physicians in clinical settings to facilitate guidewire access and exchange in coronary and peripheral vasculature. Device provides mechanical support to aid navigation and positioning of guidewires, potentially improving procedural success in challenging vascular anatomy.

Clinical Evidence

Bench testing only. Performance data includes simulated use, tensile strength, kink resistance, and tip flexibility testing conducted at baseline, post-sterilization/transportation, and after 1-year accelerated aging.

Technological Characteristics

Sterile, single-use, single-lumen, over-the-wire percutaneous support catheter. Materials include PEBAX and Nitinol (distal scaffold). Features telescopic shaft, over-tube, and proximal handle. Distal scaffold is radiopaque for fluoroscopic visualization. Manual operation; no energy source or software.

Indications for Use

Indicated for patients requiring access to discrete regions of the coronary and peripheral vasculature for guidewire exchange using a steerable guidewire.

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

• NovaCross™ Microcatheter (K143608)

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

March 11, 2016

Nitiloop Ltd. % Michael Daniel President Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460

Re: K160389

Trade/Device Name: Novacross Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 10, 2016 Received: February 11, 2016

Dear Michael Daniel:

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 801); 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 801), 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 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 Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement on last page |

510(k) Number (if known) K160389

Device Name NovaCross™ Microcatheter

Indications for Use (Describe)

The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

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

X 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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FORM FDA 3881 (1/14)

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#### Attachment 4

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510(k) SUMMARY NitiLoop's NovaCross™ Microcatheter

## Submitter:

- Nitiloop Ltd. 4 Haomanut Street P.O. Box 12892 Netanya, 4250438 Israel Tel: [phone] Fax: [phone]
# Date Prepared: February 3, 2016

## Contact Person:

Michael A. Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 Tel: [phone] Fax: [phone] madaniel(@clinregconsult.com

Back-up Company Contact:

Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: [phone] [e-mail]

## Device:

Name of Device: Common or Usual Name: Classification Name: Regulatory Class: Product Code:

NovaCross™ Microcatheter NovaCross™ Microcatheter Percutaneous catheter (21 CFR 870.1250) II DQY

# Predicate Device:

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The predicate device is the NovaCross™ Microcatheter, cleared under K143608.

# Purpose of the Special 510(k) notice:

The NovaCross™ Microcatheter is a modification to NovaCross™ Microcatheter.

## Intended Use:

The NovaCross™ Microcatheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange.

# Technological Characteristics:

The NovaCross™ Microcatheter is a sterile, single-use, single lumen, over-the-wire, disposable percutaneous support catheter designed for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature for guidewire exchange.

The NovaCross™ Microcatheter consists of telescopic shaft, over tube, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is a temporarily deployable and retractable distal Nitinol Scaffold, which is visible through fluoroscopy when deployed by the user, and expands to the width of the artery to provide anchoring to aid the user in establishing greater support near the treatment site.

The NovaCross™ Microcatheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.

## Performance Data:

The following tests are the same as those submitted in the original submission:

- Simulated use -the test was performed at baseline (immediately following assembly, prior to sterilization), Time 0 (after sterilization and simulated transportation), and Time 1 (after accelerated aging of 1 year and simulated transportation).
- -Tensile Strength- The test was performed at baseline (immediately following assembly, prior to sterilization), Time 0 (after sterilization and simulated transportation), and Time 1 (after accelerated aging of 1 year and simulated transportation).

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- -Kink resistance- The test was performed at baseline (immediately following assembly, prior to sterilization), Time 0 (after sterilization and simulated transportation), and Time 1 (after accelerated aging of 1 year and simulated transportation).
- -Tip Flexibility- the test was performed at baseline (immediately following assembly, prior to sterilization), Time 0 (after sterilization and simulated transportation), and Time 1 (after accelerated aging of 1 year and simulated transportation).

# Substantial Equivalence:

The modified NovaCross™ Microcatheter has the same intended use and indications, principles of operation, and technological characteristics as the cleared NovaCrossTM Microcatheter. The minor differences in the handle design and in the PEBAX material do not raise any new or different questions of safety or effectiveness. Performance data demonstrates that the modified NovaCross™ Microcatheter is as safe and effective as the predicate NovaCross™ Microcatheter. Thus, the NovaCross™ Microcatheter is substantially equivalent to its predicate device.