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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NovaCross Microcatheter:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table detailing acceptance criteria alongside exact numerical performance metrics for each criterion. Instead, it states that "All [mechanical] tests met the predefined acceptance criteria" and "The Test Item successfully achieved all performance criteria defined in the study protocol" for the animal study.

Here's an inferred table based on the information provided:

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Complied with ISO 10993-1. All tests (cytotoxicity, irritation, acute systemic toxicity, sensitization, hemocompatibility) were successfully completed.
Sterilization, Packaging, Shelf Life	Sterilization validation (ISO 11135-1) successfully completed. Shelf life and packaging testing successfully completed to support labeled shelf life.
Mechanical Bench Testing	All tests (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) met the predefined acceptance criteria. (Specific numerical criteria not provided).
GLP Animal Study	The device could be used safely and effectively as a tool to provide support to the guidewire. No discernible pathological adverse effects were detected (local and systemic effects) in terms of treated vessel integrity, gross pathology, and histopathology 1 and 14 days post-procedure. Successfully achieved all performance criteria defined in the study protocol.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Animal Study: 6 pigs.
- Mechanical Testing: Not specified, but implied to be sufficient for each distinct test.
- Biocompatibility / Sterilization / Packaging / Shelf Life: Not specified, but implied to be sufficient for each distinct test.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the animal study is described as a "GLP animal study," indicating it was a prospective, controlled study conducted under Good Laboratory Practice regulations, typically for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Animal Study: The study involved evaluation of gross pathology and histopathology. While not explicitly stated how many experts or their specific qualifications (e.g., "veterinary pathologist with X years experience") were involved, the execution of a "GLP animal study" strongly implies that qualified veterinary professionals, including veterinarians, surgeons, and pathologists specialized in animal models, were involved in the assessment and establishment of ground truth for the animal tissue analysis.
Other Testing (Mechanical, Biocompatibility, etc.): Ground truth for these tests is typically established by engineering specifications, international standards (e.g., ISO), and defined acceptance limits rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Animal Study: The text mentions "Pathology and histopathology analyses confirmed the results of the study." This suggests a formal pathological review process. However, the exact adjudication method (e.g., blinded review, multiple pathologists, consensus meeting) is not detailed.
Other Testing: Adjudication methods are not applicable in the same way as clinical or image-based studies. Tests are pass/fail based on predefined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI. The NovaCross Microcatheter is a medical device (microcatheter) used in interventional procedures, not an AI-powered diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone algorithm performance study was not done. The device described is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

Biocompatibility: Established by standardized biological assays and compliance with ISO 10993-1.
Sterilization, Packaging, Shelf Life: Established by adherence to ISO 11135-1 and company-defined stability/integrity protocols.
Mechanical Testing: Established by engineering specifications and predefined acceptance criteria, often derived from industry standards or predicate device performance.
Animal Study: "No discernible pathological adverse effects were detected, in terms of local and systemic effects" and "Pathology and histopathology analyses confirmed the results of the study." This indicates that pathology and histopathology (tissue analysis) served as the ground truth for safety and effectiveness in the animal model.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reason stated above.

Summary

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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 (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,

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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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: +972-52-396-8925 Fax: +972-72-2501631

Contact Person

Michael A. Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 Tel: 775.392.2970 Cell: 415.407.0223 Fax: 610.545.0799 madaniel@clinregconsult.com

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

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.

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).