(144 days)
The NMI Coaxial Microintroducer Set is used for the percutaneous introduction of a guidewire into the vascular system.
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.
This 510(k) summary reports on a medical device (NMI Coaxial Microintroducer Set) which is not an AI/ML device. Therefore, acceptance criteria and study data related to AI/ML device performance are not applicable. The provided document details the substantial equivalence of the NMI Coaxial Microintroducer Set to a predicate device based on non-clinical performance and technological characteristics.
However, based on the provided text, I can extract the following information about the device's testing and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the testing performed to demonstrate substantial equivalence, rather than a specific set of acceptance criteria with numerical targets. The "acceptance criteria" are implied by the standards used and the conclusion of substantial equivalence.
| Performance Attribute | Acceptance Criteria/Standard (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:1999 (Tensile strength requirements for introducers) | Tested in accordance with ISO 11070. Assumed to meet requirements to claim substantial equivalence. |
| Leak Integrity | ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:1999 (Leakage requirements) | Tested in accordance with ISO 11070. Assumed to meet requirements to claim substantial equivalence. |
| Radiopacity | ISO 11070: Sterile, Single-Use Intravascular Catheter Introducers:1999 (Visualizability under fluoroscopy) | Tested in accordance with ISO 11070. Assumed to meet requirements to claim substantial equivalence. |
| Dimensional Accuracy | Industry standards for medical device dimensions, likely referenced by ISO 11070 | Dimensional verification performed. Assumed to meet requirements for proper function and substantial equivalence. |
| Biocompatibility | ISO 10993-1 (Biological evaluation for medical devices) | Biocompatibility testing performed per ISO 10993-1. Assumed to meet requirements. |
| Luer Performance | ISO 594-2: Conical Fittings 6% (Luer) Taper for Syringes, Needles, Certain Medical Equipment - Part 2 (1998) | Luer performance testing performed per ISO 594-2. Assumed to meet requirements. |
| Compatibility | Compatibility with other components in the intended use | Compatibility testing performed. Assumed to be compatible with intended accessories/uses. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify the exact sample sizes used for each non-clinical test (e.g., tensile testing, leak testing). It only states that tests were performed "in accordance with" the specified ISO standards. These standards typically outline appropriate sample size requirements for the tests.
- Data Provenance: The data is from non-clinical tests performed by the manufacturer (Navilyst Medical, Inc.). This is not patient data, so concepts like country of origin or retrospective/prospective are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable. This device is evaluated based on non-clinical performance data (material properties, mechanical integrity, etc.) against established engineering standards (ISO). There is no "ground truth" in the clinical sense established by human experts for these types of tests.
4. Adjudication Method for the Test Set:
- Not Applicable. As the evaluation is based on objective non-clinical tests against engineering standards, there is no need for an adjudication method involving human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI/ML or image-based diagnostic device. An MRMC study is not relevant or performed for this type of medical device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
- Not Applicable. This is a physical medical device, not an algorithm. Standalone performance for an algorithm is not relevant. The "performance" here refers to the physical device's characteristics.
7. Type of Ground Truth Used:
- Benchmark Standards and Engineering Specifications: The "ground truth" for this device's performance is derived from established international standards (ISO 11070, ISO 594-2, ISO 10993-1) and the manufacturer's own design specifications, which are compared to those of the predicate device. The goal is to demonstrate that the device performs equivalently to the predicate and meets safety and performance standards.
8. Sample Size for the Training Set:
- Not Applicable. This is not an AI/ML device, so there is no training set in the sense of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set.
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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.
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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.
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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)
Bra 2013
§ 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).