(126 days)
No
The description focuses on electromagnetic tracking and display of the guidewire's position relative to a pre-operative CT scan, without mentioning any AI/ML algorithms for image analysis, navigation, or other functions.
No.
The device is a navigable guidewire intended to provide access and confirm placement in nasal and sinus spaces, which is a diagnostic or navigational function, not a therapeutic one. It does not actively treat a disease or condition.
No
The device is a navigable guidewire used for access and confirmation of placement within nasal and sinus spaces during surgical procedures, not for identifying the presence or absence of a disease or condition. It assists in navigation based on a CT-based model of anatomy.
No
The device description explicitly states it is an "electromagnetically (EM) trackable guidewire," which is a physical hardware component. The summary also details bench testing and sterilization verification, further indicating it is a physical device, not software only.
Based on the provided information, the Acclarent® NavWire Sinus Navigation Guidewire is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Acclarent NavWire Function: The Acclarent NavWire is a surgical tool used within the body during procedures. It's a navigable guidewire that helps surgeons access and confirm placement in anatomical spaces. It uses electromagnetic tracking and a pre-operative CT scan for navigation, not analysis of bodily specimens.
The device's intended use, description, and performance studies all point to it being a surgical navigation and access tool, not a device for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Acclarent Nav Wire is intended for use as a navigable guidewire to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The Acclarent NavWire is designed for use during procedures where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, can be identified relative to a CT-based model of the anatomy.
Product codes
PGW
Device Description
The Acclarent® NavWire Sinus Navigation Guidewire an electromagnetically (EM) trackable guidewire that provides surgeons a means to access the intranasal and paranasal sinus spaces in endoscopic and image guided sinus surgeries. It is compatible with the CARTO® ENT System to track the NavWire within an electromagnetic field, which displays the magnetic sensor position relative to a patient’s pre-operative CT scan.
conjunction with a compatible surgical navigation system which consists of computer-aided software, CT-imaging, patient tracker, registration probe, and various instruments used in sinus surgery. Acclarent® NavWire Sinus Navigation Guidewire provides real-time tracking at the distal tip of the guidewire in the nasal anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-based model of the anatomy
Anatomical Site
nasal and sinus spaces, paranasal sinuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons doing endoscopic and image guided sinus surgeries
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
Bench testing was performed in order to determine device accuracy and precision. The following nonclinical tests were performed to determine substantial equivalence:
- Nonclinical accuracy testing of the Acclarent® NavWire Sinus Navigation Guidewire with the CARTO® ENT System
- Nonclinical performance testing of the Acclarent® NavWire Sinus Navigation Guidewire with the CARTO® ENT System
- Functionality of the Acclarent® NavWire Sinus Navigation Guidewire after accelerated aging and user conditions
- Simulated use testing of the NavWire with the CARTO® ENT System according to user’s needs and intended use
- Sterilization verification to effectively EtO sterilize the NavWire (SAL 10-6) and EtO residuals are within defined limits
- General requirements and performance testing of Acclarent® NavWire Sinus Navigation Guidewire to assure conformance with identified design and performance specifications
The Acclarent NavWire passed all intended criteria in accordance with appropriate test criteria and standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure, represented by three overlapping profiles facing to the right. The profiles are stylized and appear to be made of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2016
Acclarent, Inc. Ms. Anna Hwang Regulatory Affairs Specialist 33 Technology Drive Irvine, CA 92618
Re: K161697
Trade/Device Name: Acclarent Navwire Sinus Navigation Guidewire Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 21, 2016 Received: September 22, 2016
Dear Ms. Hwang:
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.
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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 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.
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.
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161697
Device Name
Acclarent® Nav Wire Sinus Navigation Guidewire
Indications for Use (Describe)
The Acclarent Nav Wire is intended for use as a navigable guidewire to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The Acclarent NavWire is designed for use during procedures where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, can be identified relative to a CT-based model of the anatomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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FORM FDA 3881 (8/14)
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Image /page/3/Picture/0 description: The image shows the word "Acclarent" in a stylized font. The first part of the word, "Accla," is in black, while the second part, "rent," is in purple. A curved line extends from the top of the "r" in "rent" over the rest of the word, giving it a distinctive appearance.
Acclarent® NavWire Sinus Navigation Guidewire
Traditional 510(k) Premarket Notification CONFIDENTIAL
APPENDIX A: 510(K) SUMMARY
| Sponsor/Submitter: | Acclarent, Inc.
33 Technology Drive
Irvine, CA 92618 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Anna Hwang
Regulatory Affairs Specialist
Email: ahwang@its.jnj.com
Telephone: 949-923-4134
Mobile: 310-780-8792 |
| Date of Submission: | June 17, 2016 |
| Device Trade Name: | Acclarent® NavWire Sinus Navigation Guidewire |
| Common Name: | Image Guided Surgery System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 882.4560 |
| Classification Name: | Ear, Nose, and Throat Stereotaxic Instrument |
| Product Code: | PGW |
| Predicate Device: | The Fiagon Navigation Extended Instrument Set ENT (K141456)
Relieva Spin Sinus Dilation System (K111875) |
| Device Description: | The Acclarent® NavWire Sinus Navigation Guidewire an
electromagnetically (EM) trackable guidewire that provides surgeons a
means to access the intranasal and paranasal sinus spaces in endoscopic
and image guided sinus surgeries. It is compatible with the CARTO®
ENT System to track the NavWire within an electromagnetic field,
which displays the magnetic sensor position relative to a patient's pre-
operative CT scan. |
| Indications for Use: | The Acclarent® NavWire Sinus Navigation Guidewire is intended for
use as a navigable guidewire to provide access to nasal and sinus
spaces, and confirmation of placement in the accessed anatomy. The
Acclarent® NavWire Sinus Navigation Guidewire is designed for use
during procedures where reference to a rigid anatomical structure in the
field of ENT surgery, such as the paranasal sinuses, can be identified
relative to a CT-based model of the anatomy. |
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Image /page/4/Picture/0 description: The image shows the logo for Acclarent. The word "Acclarent" is written in a sans-serif font, with the first part of the word in black and the "ent" in purple. There is a purple swoosh above the "ent" portion of the word.
Acclarent® NavWire Sinus Navigation Guidewire
Traditional 510(k) Premarket Notification CONFIDENTIAL
conjunction with a compatible surgical navigation system which consists of computer-aided software, CT-imaging, patient tracker, registration probe, and various instruments used in sinus surgery. Acclarent® NavWire Sinus Navigation Guidewire provides real-time tracking at the distal tip of the guidewire in the nasal anatomy. Performance Data: Bench testing was performed in order to determine device accuracy and precision. The following nonclinical tests were performed to determine substantial equivalence: Nonclinical accuracy testing of the Acclarent® NavWire Sinus . Navigation Guidewire with the CARTO® ENT System Nonclinical performance testing of the Acclarent® NavWire ● Sinus Navigation Guidewire with the CARTO® ENT System Functionality of the Acclarent® NavWire Sinus Navigation ● Guidewire after accelerated aging and user conditions . Simulated use testing of the NavWire with the CARTO® ENT System according to user's needs and intended use . Sterilization verification to effectively EtO sterilize the NavWire (SAL 106) and EtO residuals are within defined limits General requirements and performance testing of Acclarent® ● NavWire Sinus Navigation Guidewire to assure conformance with identified design and performance specifications The Acclarent NavWire passed all intended criteria in accordance with appropriate test criteria and standards. The Acclarent® NavWire Sinus Navigation Guidewire is substantially Summary of Substantial Equivalence: equivalent to the predicate device Fiagon Navigation Extended Instrument Set ENT (K141456) and reference device Relieva Luma Sentry Sinus Illumination System, cleared as part of the Relieva Spin Sinus Dilation System (K1118755). Like the predicate device, the Acclarent® NavWire Sinus Navigation Guidewire is an electromagnetically trackable guidewire which can be used to navigate tortuous sinus anatomy when used in conjunction with an ENT software application for computer assisted surgery. NavWire, like the predicate and reference devices, consists of a long flexible guidewire with a distal tip used to provide access to nasal and sinus spaces, and confirmation of placement in the accessed anatomy. The proposed navigation wire is similar in connectivity, technological characteristics, intended use, and design as the predicate device. The primary differences between the Acclarent® NavWire Sinus Navigation Guidewire and predicate device do not raise new issues of safety and effectiveness.