(144 days)
Not Found
No
The device description and performance studies focus on physical characteristics and standard non-clinical tests, with no mention of AI or ML.
No
The device is used for percutaneous introduction of a guidewire into the vascular system, which is an access procedure, not a therapeutic intervention.
No
The device is described as an introducer set used for percutaneous introduction of a guidewire into the vascular system, enabling vascular access. Its intended use is not for diagnosing a condition or disease.
No
The device description clearly outlines physical components such as needles, guidewires, sheaths, and dilators, and the performance studies involve testing of physical properties like tensile strength and leak testing, indicating it is 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 directly on a patient's body to gain access to blood vessels.
- Device Description: The device components (needle, guidewire, sheath, dilator) are all instruments used for this physical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body's internal systems in the way this microintroducer set does.
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 (comma separated list FDA assigned to the subject device)
DRE
Device Description
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:1999 and ISO 594-2: Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Medical Equipment - Part 2 (1998), which included:
- Tensile Testing
- Leak Testing
- Radiopacity Testing
- Dimensional verification
- Compatibility Testing
- Luer performance
- Biocompatibility per ISO 10993-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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510(k) Summary for the NMI Coaxial Microintroducer Set
APR 0 1 2013
Date prepared: 19-October-2012
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:
D. Predicate Device(s)
Predicate Name: Predicate 510(k):
Director. Global Regulatory Affairs 508-658-7929
Wanda Carpinella
NMI Coaxial Microintroducer Set Vessel Dilator / Introducer Sheath Class II-21CFR§870.1310-ProCode: DRE Vessel dilator for percutaneous catheterization
Vaxcel™ Mini-Stick Coaxial Dilator Set K974640
E. Device Description
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:1999 and ISO 594-2: Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Medical Equipment - Part 2 (1998), which included:
- . Tensile Testing
- . Leak Testing
- . Radiopacity Testing
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- Dimensional verification .
- . Compatibility Testing
- . Luer performance
- Biocompatibility per ISO 10993-1 .
Conclusion I.
The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle with its wings spread.
April 1, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Navilyst Medical, Inc. Wanda Carpinella 26 Forest Street Marlborough, MA 01752 US
Re: K123445
Trade/Device Name: NMI Coaxial Microintroducer set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel Dilator for Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: March 4, 2013 Received: March 12, 2013
Dear Ms. Carpinella:
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 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.
3
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor 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/Resourcesfor You/Industry/default.htm.
Sincerely yours. Bram D厚yckerman
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
K123445 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) 风 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)