NovaCross Microcatheter

K143608 · Nitiloop , Ltd. · DQY · May 4, 2015 · Cardiovascular

Device Facts

• Record ID: K143608
• Device Name: NovaCross Microcatheter
• Applicant: Nitiloop , Ltd.
• Product Code: DQY · Cardiovascular
• Decision Date: May 4, 2015
• Decision: SESE
• Submission Type: Traditional
• 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. It consists of a telescopic shaft, an over-tube, and a proximal handle for manual manipulation and flushing. A key feature is a deployable/retractable distal Nitinol scaffold, visible under fluoroscopy, which expands to the artery width to provide distal anchoring and guidewire support. Used in coronary and peripheral vasculature by physicians; facilitates access for therapeutic devices like atherectomy catheters, PTCA catheters, or stents. The device does not provide therapeutic benefit itself; it serves as a support tool to improve guidewire positioning. Benefits include enhanced support near the treatment site, facilitating subsequent interventional procedures.

Clinical Evidence

Bench testing included biocompatibility (ISO 10993-1), sterilization (ISO 11135-1), and mechanical testing (torque, tensile, pushability, scaffold durability, radial force). A GLP animal study (n=6 pigs) evaluated safety in coronary and peripheral arteries. Endpoints included vessel integrity, gross pathology, and histopathology at 1 and 14 days post-procedure. Results showed no discernible pathological adverse effects and successful achievement of all performance criteria.

Technological Characteristics

Single-lumen, over-the-wire percutaneous catheter. Features a deployable Nitinol scaffold for anchoring. Compatible with 7F guiding catheters and 0.014" guidewires. Working length 135cm. Materials evaluated per ISO 10993-1. Sterilization per ISO 11135-1. No software or electronic components.

Indications for Use

Indicated for use in conjunction with a steerable guidewire to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange in patients requiring such access.

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

• MultiCross Support Catheter (K121763)

Reference Devices

• Corsair Microcatheter (K083127)

Submission Summary (Full Text)

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Public Health Service

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

May 4, 2015

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

Re: K143608

> Trade/Device Name: NovaCross Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 10, 2015 Received: April 10, 2015

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

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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 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 [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,

M.A. Hillebrand

for 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) K143608

Device Name NovaCross Microcatheter, 1

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) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| <div> <span style="display:inline-block;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="display:inline-block;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# Traditional Premarket Notification Submission - 510(k) NovaCross™ Microcatheter 510(k) Number K143608

#### I. SUBMITTER

Nitiloop Ltd. 8 Hamada St. P.O.Box 12892 Herzliya, Israel 46733 Tel: [phone] Fax: [phone]

#### Contact Person

Michael A. Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 Tel: [phone] Cell: 415.407.0223 Fax: [phone] [e-mail]

#### II. DEVICE

Name of Device: NovaCross™ Microcatheter Common or Usual Name: NovaCross™ Microcatheter Classification Name: Percutaneous catheter (21 CFR 870.1250) Regulatory Class: II Product Code: DQY

#### III. PREDICATE DEVICE

The primary predicate device is the Roxwood Medical, Inc. MultiCross Support Catheter cleared under K121763, (product code DQY, Regulation No. 870.1250).

A reference device was used in this submission: Corsair Microcatheter (Asahi Intecc Co., Ltd. K083127).

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## IV. DEVICE DESCRIPTION

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 Body 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 an anchoring to aid the user in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, therapeutic devices such as atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The NovaCross™ Microcatheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The NovaCross™ Microcatheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate devices.

### V. INDICATIONS FOR 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.

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Both the MultiCross, and the NovaCross™ Microcatheters have a working length of 135cm and are both compatible with a 7F guiding catheter, as well as a 0.014" guidewire. Like the MultiCross Nitinol scaffold, the NovaCross™ Nitinol scaffold is also expanded to the diameter of the artery when deployed.

The two devices use similar technology including a delivery system. The guidewire support with the two devices is accomplished by extending a Nitinol scaffold. The Nitinol element for the NovaCross™, like that of the MultiCross predicate, provides distal anchoring and support, thus exhibiting similar safety questions. These safety questions have been evaluated for the NovaCross™ Microcatheter through extensive design verification and validation testing, including a GLP Animal Study.

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## VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

#### Biocompatibility testing

An evaluation of biocompatibility was performed in compliance with ISO 10993-1. Biocompatibility testing included cytotoxicity, irritation, acute systemic toxicity, sensitization, and hemocompatibility testing. All tests were successfully completed.

### Sterilization, Packaging and Shelf Life Testing

Sterilization validation testing was performed to demonstrate compliance with ISO 11135-1. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.

#### Mechanical Testing

Mechanical bench testing included the following:

- Dimensional
- Simulated use ●
- Tip flexibility ●
- Tip and shaft durability
- Torque response
- Torque strength
- Tensile strength
- Hydrophilic coating integrity
- Corrosion
- Fluid leak
- Air leakage
- Pushability and retractability ●
- Scaffold durability
- Radial force

All tests met the predefined acceptance criteria.

### Animal Study

A GLP animal study, consisting of 6 pigs, was used to test whether the NovaCross™ device could be used safely and effectively as a tool to provide support to the guidewire. The system was used on three arteries (two coronary and one peripheral) in each animal. The safety of the system was evaluated 1 and 14 days post procedure in terms of the integrity of the treated vessels (compared to intact control segments), gross pathology and histopathology. The results demonstrated that no discernible pathological adverse effects were detected, in terms of local and systemic effects

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following the deployment of the Test Item NovaCross™ Microcatheter in coronary and peripheral arteries. The Test Item successfully achieved all performance criteria defined in the study protocol. Pathology and histopathology analyses confirmed the results of the study.

## VIII. CONCLUSIONS

The NovaCross™ Microcatheter was determined to be substantially equivalent to the predicate device.