(29 days)
Not Found
No
The summary describes a mechanical microcatheter with a deployable scaffold and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical properties and simulated use.
No.
The microcatheter is intended for accessing regions of vasculature and guidewire exchange, not for treating a condition or disease.
No
The device is described as a microcatheter used for accessing vasculature and guidewire exchange, which are interventional procedures, not diagnostic ones. Although it references fluoroscopy, this is for visualization during the intervention, not for diagnostic image interpretation.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a medical device used within the body (in vivo) to access and support the coronary and peripheral vasculature. It's a physical tool used for procedures, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic results. The device's function is mechanical and procedural.
Therefore, based on the provided information, the NovaCross™ Microcatheter is a medical device used for interventional procedures, not an In Vitro Diagnostic.
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 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.
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
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).
- -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).
Key Metrics
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on people and health.
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
1
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 (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,
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
2
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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "
FORM FDA 3881 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
3
Attachment 4
Image /page/3/Picture/3 description: The image shows the logo for "Nitiloop CROSSING THE LIMITS". The logo consists of a red square with a white curved line inside, followed by the word "Nitiloop" in black, and the phrase "CROSSING THE LIMITS" in smaller black letters below the word "Nitiloop".
510(k) SUMMARY NitiLoop's NovaCross™ Microcatheter
Submitter:
- Nitiloop Ltd. 4 Haomanut Street P.O. Box 12892 Netanya, 4250438 Israel Tel: +972-54-664-5494 Fax: +972-72-2501631
Date Prepared: February 3, 2016
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
Back-up Company Contact:
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:
4
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).
5
- -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.