(79 days)
Not Found
No
The summary describes a mechanical device for accessing vasculature and guidewire exchange. There is no mention of AI or ML in the intended use, device description, or performance studies. The input imaging modality (fluoroscopy) is used for user guidance, not for automated analysis or decision-making by the device itself.
No.
The device description and intended use indicate it is a support catheter for accessing vasculature and guidewire exchange, not for treating a disease or condition.
No
The device is a microcatheter intended for procedural support (accessing discrete regions of the vasculature and guidewire exchange) rather than for diagnosing a condition or disease.
No
The device description clearly outlines physical components like a telescopic shaft, over tube, proximal handle, and a Nitinol Scaffold, indicating it is a hardware device, not software-only.
Based on the provided information, the NovaCross™ Microcatheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for accessing and exchanging guidewires within the coronary and peripheral vasculature. This is an in vivo procedure (within a living organism).
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The NovaCross™ Microcatheter does not perform this function.
Therefore, the NovaCross™ Microcatheter is a medical device used for interventional procedures within the body, not an IVD.
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
DOY, 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 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.
The NovaCross™ Microcatheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device. Minor modifications were implemented including the addition of a middle tube, a shorter handle, increasing the scaffold ID and OD, and increasing the device outer diameter.
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)
To evaluate the modifications to the NovaCross Microcatheter, the following tests were performed:
- Simulated use testing
- Biocompatibility testing based upon a biological risk assessment, cytotoxicity testing and hemolysis testing
- Mechanical tests, including a bond strength test, visibility test, radial force test, and axial force test.
- GLP animal study test to assess the new scaffold and device characteristics
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
October 18, 2017
Nitiloop Ltd. % Mr. Michael Daniel President Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, Nevada 89460
Re: K172297
Trade/Device Name: NovaCross Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: September 14, 2017 Received: September 18, 2017
Dear Mr. 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 of medical device-related 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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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 (DICE) 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 (DICE) 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,
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
510(k) Number (if known) K172297
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY NitiLoop NovaCross™ Microcatheter
Submitter:
Nitiloop Ltd. 4 Ha'Omanut Street P.O. Box 12892 Netanya, 4250438 Israel Tel: +972-54-664-5494 Fax: +972-72-2501631
Date Prepared: July 25, 2017
Contact Person:
Michael A. Daniel Daniel & Daniel Consulting, LLC 340 Jones Lane Gardnerville, NV 89460 Tel: 775.392.2970 Fax: 610.545.0799 madaniel@clinregconsult.com
or Orly Maor 25 Sirkin Street Kfar Saba 44421 Israel Tel: +972-9-7453607 oram.ma@gmail.com
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 and K160389.
Purpose of the Special 510(k) submission:
The NovaCross™ Microcatheter Special 510(k) was submitted to implement modifications to the 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 an 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. Minor modifications were implemented including the addition of a middle tube, a shorter handle, increasing the scaffold ID and OD, and increasing the device outer diameter.
Performance Data:
To evaluate the modifications to the NovaCross Microcatheter, the following tests were performed:
- Simulated use testing
- · Biocompatibility testing based upon a biological risk assessment, cytotoxicity testing and hemolysis testing
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- • Mechanical tests, including a bond strength test, visibility test, radial force test, and axial force test.
- · GLP animal study test to assess the new scaffold and device characteristics
Substantial Equivalence:
The modified NovaCross™ Microcatheter has the same intended use and similar indications, principles of operation, and technological characteristics as the cleared NovaCross™M Microcatheter. The minor differences in the handle design and in the materials do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified NovaCross™ Microcatheter is similar to the cleared NovaCross™ Microcatheter. Thus, the modified NovaCross™ Microcatheter is substantially equivalent to its predicate device.