(136 days)
No
The description focuses on the mechanical design and function of a physical catheter and does not mention any software, algorithms, or data processing related to AI/ML.
No.
The device description explicitly states, "The NovaCross™ Microcatheter by itself does not provide therapeutic benefit beyond simple facilitation of guidewire support."
No
The device is a microcatheter designed to assist in accessing vasculature and exchanging guidewires for interventional procedures, rather than diagnosing conditions.
No
The device description clearly details a physical medical device (microcatheter) with hardware components (telescopic shaft, handle body, Nitinol Scaffold). It is not solely software.
Based on the provided information, the NovaCross Microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to access discrete regions of the coronary and peripheral vasculature and for guidewire exchange. This is a procedural device used in vivo (within the body) to facilitate other medical procedures.
- Device Description: The description details a physical catheter designed for insertion into blood vessels. It does not describe a device used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
- Anatomical Site: The device is used in the coronary and peripheral vasculature, which are parts of the living body.
- Input Imaging Modality: Fluoroscopy is an imaging technique used on a living patient.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. The NovaCross Microcatheter's function is to provide physical support and access within the body during interventional procedures.
N/A
Intended Use / 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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
coronary and peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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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Image /page/4/Picture/0 description: The image contains the logo for "Nitiloop CROSSING THE LIMITS". The logo features a red square with a white design on the left side. To the right of the square is the word "Nitiloop" in a bold, sans-serif font. Below "Nitiloop" is the phrase "CROSSING THE LIMITS" in a smaller, lighter font.
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.