(296 days)
The Navis Torquer is intended to facilitate guide wire manipulation during interventional procedures.
The Navis Torquer is a guide wire accessory intended to assist with the manipulation and placement of guide wires during interventional procedures. It accommodates guide wires with diameters from 0.010 to 0.038 inches and is composed of the following two components: 1) a polycarbonate cylindrical body and collet; and 2) an acetal rotatable cap.
The side-entry design of the device allows single-handed operation. To mount the device on a guide wire, the cylinder body is rotated into the cap until a tactile 'click' is felt and the longitudinal slots in both parts are aligned, the device is then mounted on the guide wire. Holding the guide wire stationary, the device is rotated onto the guide wire until the guide wire is aligned within the center of the device. The device is positioned optimally on the guide wire and then secured by rotation of the cap or cylinder body. As the cap is rotated on the body, the collet grips the guide wire.
This 510(k) summary for the Navis Torquer describes a device intended to facilitate guide wire manipulation during interventional procedures. The submission is based on substantial equivalence to predicate devices, rather than a clinical trial with specific acceptance criteria as would be seen for new technology. Therefore, the information provided below will reflect the data available in the 510(k) summary regarding performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Top Tests) | Reported Device Performance (Bench Top Tests) |
|---|---|
| Equivalent grip characteristics to predicate devices | Navis Torquer demonstrated equivalent grip characteristics to predicate devices. |
| Equivalent torque characteristics to predicate devices | Navis Torquer demonstrated equivalent torque characteristics to predicate devices. |
| Biocompatibility (cytotoxicity) | Navis Torquer passed biocompatibility testing for cytotoxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a defined sample size in the context of human data or a statistically powered study. The performance testing mentioned refers to "bench top tests" comparing the Navis Torquer to predicate devices. The exact number of units tested, the material properties of those units, or the number of trials performed during these bench top tests are not specified in the provided text.
The data provenance is from bench top testing conducted by Navis Medical, Inc. The document does not indicate any human or animal data, nor does it mention a country of origin for such data, as it's not applicable to the type of testing described. It is retrospective in the sense that the testing was performed, and the results are being reported to support substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the ground truth was established through direct physical measurements during bench top testing, comparing the device to predicate devices. There was no 'ground truth' that required expert consensus in the context of clinical outcomes or imaging interpretation.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Bench top tests involve direct measurement and comparison, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission relies on bench top testing and comparison to predicate devices, not on human readability or interpretation of medical images/data. The device is a mechanical accessory, not a diagnostic or therapeutic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Navis Torquer is a physical medical device, not an algorithm or software. Its function inherently involves human interaction for manipulating a guidewire.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing was established by direct measurement of physical characteristics (grip and torque) of the Navis Torquer and its predicate devices, as well as standard biocompatibility testing. This is a functional comparison based on engineering and material science principles, not clinical outcomes, pathology, or expert consensus on a disease state.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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K112674
page 1 of 2
Navis Torquer 510(k)
JUL
6 2012
510(k) Summary
APPLICANT NAME:
APPLICANT ADDRESS:
CONTACT PERSON:
10000 Cedar Road Cleveland, OH 44106
Navis Medical, Inc.
Richard G. Ganz Phone: (216) 264-6031 (216) 445-6514 Fax:
DATE OF SUMMARY:
PROPRIETARY NAME OF DEVICE:
COMMON NAME:
PROPOSED CLASSIFICATION:
September 2, 2011
Navis Torquer
Guide wire torque device
Cardiology Devices Panel (70)
21 CFR 870.1330 Classification Name: wire, guide, catheter Product Code: DQX
PANEL:
PREDICATES:
Torque Device for Guide Wire (K910969) Guide Wire Torque Device (K072552)
INTENDED USE:
The Navis Torquer is intended to facilitate guide wire manipulation during interventional procedures.
DEVICE DESCRIPTION:
The Navis Torquer is a quide wire accessory intended to assist with the manipulation and placement of guide wires during interventional procedures. It accommodates quide wires with diameters from 0.010 to 0.038 inches and is composed of the following two components: 1) a polycarbonate cylindrical body and collet; and 2) an acetal rotatable cap.
The side-entry design of the device allows single-handed operation. To mount the device on a guide wire, the cylinder body is rotated into the cap until a tactile 'click' is felt and the longitudinal slots in both parts are aligned, the device is then mounted on the guide wire. Holding the guide wire stationary, the device is rotated onto the guide wire until the guide wire is aligned within the center of the device. The device is positioned optimally on the guide wire and then secured by
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· Navis Medical, Inc.
Image /page/1/Picture/1 description: The image shows the text "K112674 page 2 of 2 Navis Torquer 510(k)". The text is written in a clear, legible font. The text is likely part of a document or report, and the numbers may be a reference or identification number. The words "page 2 of 2" indicate that this is the second page of a two-page document.
rotation of the cap or cylinder body. As the cap is rotated on the body, the collet grips the guide wire.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The Navis Torquer device is loaded onto a guide wire, positioned along the quide wire at a desired location and tightened to grasp the guide wire for improved manipulation. The Navis Torquer uses the same collet-based gripping method as one of the predicate torque devices described above whereby the cap is screwed upon the cylindrical body (collet) to clamp the collet firmly against the guide wire. It is then unscrewed to release the collet's grip on the guide wire. The primary difference between the Navis Torquer and the included predicate devices is the method by which it is loaded onto the guide wire. The intended use and effect of the Navis Torquer is exactly the same as the predicate devices.
SUMMARY OF PERFORMANCE TESTING:
The Navis Torquer utilizes polymers and possesses similar working dimensions as compared to the listed predicate devices. Bench top tests have been performed to demonstrate equivalent grip and torque characteristics of the Navis Torque device compared to the predicate devices. The Navis Torquer has been evaluated and passed biocompatibility testing for cytotoxicity.
CONCLUSION:
The use of similar component materials, a similar indication for use statement and acceptable performance and biocompatibility data provides sufficient information to demonstrate that the Navis Torquer is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Navis Medical, Inc. C/O Mr. Matthew Huddleston, Regulatory Consultant Biomedical Device Solutions, LLC 5705 Whispering Trail Galena, OH 43021
6 2012 JUL
Re: K112674
Trade/Device Name: Navis Torquer Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: June 15, 2012 Received: June 18, 2012
Dear Mr. Huddleston:
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
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Page 2 - Mr. Matthew Huddleston
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 (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 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.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M.J. Killelea
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): K112674
Device Name: Navis Torquer
Indications for Use:
The Navis Torquer is intended to facilitate guide wire manipulation during interventional procedures.
Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Cmg Hillel
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K112674
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.