(28 days)
K 123455
Not Found
No
The device description and performance studies focus on physical characteristics and mechanical testing, with no mention of AI or ML.
No.
The device is used for the "percutaneous introduction of a guidewire into the vascular system" to "gain vascular access," which describes a diagnostic or access function, not a therapeutic one.
No
The device is described as an introducer set used for percutaneous introduction of a guidewire for gaining vascular access, which is a procedural step, not a diagnostic one. No diagnostic function is mentioned.
No
The device description clearly outlines physical components such as needles, guidewires, sheaths, and dilators, and the performance studies involve tensile testing and dimensional verification, indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the percutaneous introduction of a guidewire into the vascular system." This describes a procedure performed on the patient's body to gain access to blood vessels.
- Device Description: The device components (needle, guidewire, sheath, dilator) are all tools used for this physical access procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are designed for testing samples to detect diseases, conditions, or other health indicators.
Therefore, the NMI Coaxial Microintroducer Set is a medical device used for a procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.
Product codes
DRE
Device Description
The NMI Coaxial Microintroducer Sets are offered with a 21 gauge needle (4 CM or 7 CM length with or without Echogenic tip). different guidewire configurations (0.018" stainless steel wire body or a Nitinol wire body and with or without Radiopaque tip), and a sheath and dilator assembly (4F X 10 CM regular or stiff, 5F X 10 CM regular or stiff, and 5F X 15 CM stiff). enable users to gain vascular access.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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 proposed Coaxial Microintroducer Set is substantially equivalent to the specified predicate device based on a comparison of technological characteristics and the results of non-clinical test performed in accordance with ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:, which included:
- . Tensile Testing
- Dimensional verification .
Key Metrics
Not Found
Predicate Device(s)
K 123455
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
510(k) Summary for the NM1 Coaxial Microintroducer Set
Date prepared: 19-August-2013
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Michael Hanley Specialist, Global Regulatory Affairs 508-263-9714
C. Device Name
Trade Name: Common/Usual name: Classification: Classification Name:
SEP 27 2013
NMI Coaxial Microintroducer Set Vessel Dilator / Introducer Sheath Class 11-21CFR&870.1310-ProCode: DRE Vessel dilator for percutaneous catheterization
D. Predicate Device(s)
Predicate Name: Predicate 510(k):
Ministick Max Coaxial Microintroduer Set K 123455
E. Device Description
The NMI Coaxial Microintroducer Sets are offered with a 21 gauge needle (4 CM or 7 CM length with or without Echogenic tip). different guidewire configurations (0.018" stainless steel wire body or a Nitinol wire body and with or without Radiopaque tip), and a sheath and dilator assembly (4F X 10 CM regular or stiff, 5F X 10 CM regular or stiff, and 5F X 15 CM stiff). enable users to gain vascular access.
F. Intended Use
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.
G. Technological Characteristics
The proposed device has similar materials, design and components and technological characteristics as predicate.
H. Performance Data
The proposed Coaxial Microintroducer Set is substantially equivalent to the specified predicate device based on a comparison of technological characteristics and the results of non-clinical test performed in accordance with ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:, which included:
- . Tensile Testing
- Dimensional verification .
1
I. Conclusion
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.
5-3
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its head, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
September 27, 2013
Navilyst Medical, Inc. C/O Michael Hanley Specialist, Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752 US
Re: K132713
Trade/Device Name: NMI Coaxial Microintroducer Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator / Introducer Sheath Regulatory Class: Class II Product Code: DRE Dated: September 18, 2013 Received: September 19, 2013
Dear Mr. Hanley:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Michael Hanley
forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,
Bram D.Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K132713 510(k) Number (if Known):
Device Name:
NMI Coaxial Microintroducer Set
Indications for Use:
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.
Prescription Use (21 CFR 801 Subpart D) 区 And/Or AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/11 description: The image shows the text "Bram D. Zuckerman -S" at the top. Below that is the date and time "2013.09.27 17:13:11". The timezone offset "-04'00'" is at the bottom left. In the center of the image is a stylized FDA logo.