(60 days)
No
The summary describes an electromagnetically navigated guidewire used with a navigation system and a CT-based model. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is standard electromagnetic tracking and navigation based on pre-operative imaging.
No.
The device is a guidewire intended for navigation and access in surgical procedures, not for treating a disease or medical condition.
No
The device is described as an electromagnetically navigable guidewire used during ENT procedures to provide access and confirmation of placement. It aids in navigation and real-time tracking within the anatomy during a procedure based on a CT model, but it does not diagnose a condition or disease.
No
The device description explicitly states it is a "flexible guidewire" and mentions physical attributes like "dimensional specifications," "insertion durability," and "stiffness," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TruDi™ NAV Wire Function: The TruDi™ NAV Wire is a surgical tool used within the patient's body during ENT procedures. It provides navigation and access, not diagnostic information derived from a specimen.
The description clearly states its purpose is to provide "access and confirmation of placement in the patient anatomy" and "real-time tracking at the distal tip of the guidewire in the nasal anatomy." This is a surgical navigation and guidance function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.
Product codes
PGW
Device Description
The subject device, TruDi™ NAV Wire, is a single-use electromagnetically (EM) navigated, flexible guidewire, which is compatible for use with the TruDi™ Navigation System to provide access and confirmation of placement in patient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.
The subject device, TruDi™ NAV Wire, is a modification to the predicate device, Acclarent® NavWire Sinus Navigation Guidewire (K161697), and is similar to the guidewire construction of the reference device, Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687). The TruDi™ NAV Wire, like the predicate Acclarent® NavWire Sinus Navigation Guidewire and reference Relieva SpinPlus® Nav Balloon Sinuplasty System consists of a 0.035" EM navigable guidewire with an EM trackable sensor incorporated at the distal tip to provide access to a rigid anatomical structure that can be identified relative to a CT-based model of the anatomy, and confirm placement in the accessed anatomy when used with the TruDi™ Navigation System. The same EM trackable sensor used in the subject TruDi™ NAV Wire device was cleared in the predicate Acclarent® NavWire Sinus Navigation Guidewire (K161697) and reference Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT-based model of the anatomy.
Anatomical Site
patient anatomy, intranasal and paranasal surgeries, nasal anatomy
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
Non-Clinical Performance Data: Bench testing has been performed and met all acceptance criteria for attributes, such as simulated use testing, dimensional specifications, insertion durability, rotational durability, suction durability, joint separation force, stiffness, swivel functional performance, frictional force, and location accuracy (sensor sensitivity). The sterilization process has been validated per ISO 11135:2014 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals have been tested and meet ISO 10993-7:2008 requirements. The subject device is not tested nor labeled as "non-pyrogenic". Biocompatibility testing was successfully completed to determine that the TruDi™ NAV Wire is biocompatible per ISO 10993-1. Packaging shelf life for the TruDi™ NAV Wire was established through accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, and ASTM F2096-11 requirements and confirmed to meet a shelf life of three months. The TruDi™ NAV Wire passed all intended criteria in accordance with appropriate test criteria and standards.
Clinical Performance Data: Clinical data was not necessary for the TruDi™ NAV Wire. The performance data demonstrated that the device performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Acclarent® NavWire Sinus Navigation Guidewire, (K161697)
Reference Device(s)
Relieva SpinPlus® Nav Balloon Sinuplasty System, (K171687)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
May 3, 2019
Acclarent, Inc. Leena Sorathia Sr. Regulatory Affairs Specialist 33 Technology Drive Irvine, California 92618
Re: K190532
Trade/Device Name: TruDi NAV Wire Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: PGW Dated: March 1, 2019 Received: March 4, 2019
Dear Leena Sorathia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name TruDi™ NAV Wire
Indications for Use (Describe)
TruDi™ NAV Wire is intended for use as an electromagnetically navigable guidewire to provide access and confirmation of placement in the patient anatomy. The device is intended for use during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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 (7/17)
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Image /page/3/Picture/1 description: The image contains the Acclarent logo, which is a medical technology company. Below the logo is the text "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". The image also contains the text "TruDi™ NAV Wire", which is likely a product name.
510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | Acclarent, Inc.
33 Technology Drive
Irvine, CA 92618 |
|--------------------|---------------------------------------------------------------------------------------------------------|
| Contact Person: | Leena Sorathia
Sr. Regulatory Affairs Specialist
Email: lsorathi@its.jnj.com
Tel: 949-923-4118 |
Date Summary Prepared: May 3, 2019
[807.92(a)(2)] Name of Device
| Device Trade
| Name: | TruDi™ NAV Wire | ||
|---|---|---|---|
| Classification | |||
| Name: | Stereotaxic Instrument | ||
| Common Name: | Image Guided Surgery System | ||
| Device | |||
| Classification: | Class II | ||
| Regulation | |||
| Number: | 21 CFR 882.4560 | ||
| Review Panel: | Ear, Nose, and Throat | ||
| Product Code: | PGW | ||
| [807.92(a)(3)] Legally Marketed Devices | |||
| Predicate Device: | Acclarent® NavWire Sinus Navigation Guidewire, (K161697) | ||
| Reference Device: | Relieva SpinPlus® Nav Balloon Sinuplasty System, (K171687) | ||
| [807.92(a)(4)] Device Description | |||
| Device Description: | The subject device, TruDi™ NAV Wire, is a single-use electromagnetically | ||
| (EM) navigated, flexible guidewire, which is compatible for use with the | |||
| TruDi™ Navigation System to provide access and confirmation of placement in | |||
| patient anatomy during intranasal and paranasal surgeries. The TruDi™ NAV |
Wire is intended to provide real-time tracking at the distal tip of the guidewire in the nasal anatomy and is intended to be used during ENT procedures where reference to a rigid anatomical structure can be identified relative to a CT-based model of the anatomy. The subject device, TruDi™ NAV Wire, may be used with compatible non-ferromagnetic instruments that have a lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire onto the instrument.
4
Image /page/4/Picture/1 description: The image shows the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo is the text "TruDi™ NAV Wire". The Acclarent logo is in black and purple.
The subject device, TruDi™ NAV Wire, is a modification to the predicate device, Acclarent® NavWire Sinus Navigation Guidewire (K161697), and is similar to the guidewire construction of the reference device, Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687). The TruDi™ NAV Wire, like the predicate Acclarent® NavWire Sinus Navigation Guidewire and reference Relieva SpinPlus® Nav Balloon Sinuplasty System consists of a 0.035" EM navigable guidewire with an EM trackable sensor incorporated at the distal tip to provide access to a rigid anatomical structure that can be identified relative to a CT-based model of the anatomy, and confirm placement in the accessed anatomy when used with the TruDi™ Navigation System. The same EM trackable sensor used in the subject TruDi™ NAV Wire device was cleared in the predicate Acclarent® NavWire Sinus Navigation Guidewire (K161697) and reference Relieva SpinPlus® Nav Balloon Sinuplasty System (K171687).
[807.92(a)(5)] Intended Use
| Indications for
Use: | The TruDi™ NAV Wire is intended for use as an electromagnetically navigable
guidewire to provide access and confirmation of placement in the patient
anatomy. The device is intended for use during ENT procedures where reference
to a rigid anatomical structure can be identified relative to a CT-based model of
the anatomy. |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Difference in
Indications from
Predicate Device | The indications for use statement of the subject TruDi™ NAV Wire device is
similar to the predicate NavWire device (K161697). The subject and predicate
devices are both indicated for use in ENT procedures where image-guided
surgery is used to provide access to the patient anatomy and to confirm placement
of the device in the accessed anatomy. |
| | The subject device is compatible with non-ferromagnetic instruments that have a
lumen of greater than 1mm in diameter and a luer lock mechanism to fix the wire
onto the instrument. Whereas, the predicate device is compatible with the
RELIEVA ULTIRRA Nav™ Sinus Balloon Catheter (K161698). |
| | The changes in indications for use of the subject device do not raise any
significant issues of safety and effectiveness when used as labeled, as
demonstrated by performance testing. |
| | The difference in indications for use between the subject device and the
predicate/reference devices is supported is presented in Table 1 of this summary. |
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Image /page/5/Picture/1 description: The image contains the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ NAV Wire" is displayed in a bold font. The Acclarent logo features the company name in a combination of black and purple, with a stylized swoosh above the "ent" portion of the name.
[807.92(a)(6)] Technical Characteristics
| Technological
Characteristics: | The subject TruDi™ NAV Wire device is a modification to the predicate
NavWire device (K161697) and is similar to the guidewire construction of the
reference SpinPlus Nav device (K171687). | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | The subject TruDi™ NAV Wire device, like the predicate NavWire device and
reference SpinPlus Nav device, consists of a 0.035" EM navigable guidewire
with an EM trackable sensor incorporated at the distal tip to provide
confirmation in the accessed anatomy when used with the TruDi™ Navigation
System. The same EM trackable sensor used in the TruDi™ NAV Wire device
was cleared in the predicate NavWire device (K161697) and reference SpinPlus
Nav device (K171687). | |
| | Similar to the reference SpinPlus Nav device, the subject TruDi™ NAV Wire
device consists of a fixed proximal connector, a flexible spiral coil instrument
body, and a pre-shaped atraumatic distal tip housing a sensor. Like the reference
SpinPlus Nav device, the subject device incorporates a feature, which allows
rotation of the distal tip of guidewire for steering functionality. | |
| | The TruDi™ NAV Wire, like the predicate NavWire device and reference
SpinPlus Nav device, connects with the TruDi™ Navigation System to track the
EM navigable guidewire within an electromagnetic field, which displays the
magnetic sensor position relative to a patient's pre-operative CT scan. | |
| | The only difference in technological characteristics between the subject TruDi™
NAV Wire device and reference SpinPlus Nav device is how the rotation of the
distal region of the device is achieved. This feature is similar in the subject
device and reference device and do not raise any significant issues of safety and
effectiveness when used as labeled, as demonstrated by performance testing. | |
| | See Table 1 for a comparison of the technological characteristics between the
subject device and the predicate/reference devices. | |
6
Image /page/6/Picture/0 description: The image shows the Acclarent logo, which is a black, bolded font with a purple swoosh above the 'ent'. Below the logo, in smaller font, it says 'PART OF THE Johnson & Johnson FAMILY OF COMPANIES'. Underneath that, the text 'TruDi™ NAV Wire' is displayed in a bold font.
| Attribute | Primary Predicate Device
(Acclarent® NavWire) | Reference Device
(Relieva SpinPlus Nav™ Balloon
Sinuplasty System) | Subject Device
(TruDi™ NAV Wire) |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Acclarent, Inc. | Acclarent, Inc. | Acclarent, Inc |
| 510(k) Number | K161697 | K171687 | K190532 |
| Proprietary Trade
Name | Acclarent® NavWire Sinus Navigation
Guidewire | Relieva SpinPlus Nav™ Balloon Sinuplasty
System | TruDi™ NAV Wire |
| Common Name | Stereotaxic Instrument | Sinus Dilation System | Stereotaxic Instrument |
| Class | Class II | Class I | Class II |
| Product Code | PGW | LRC | PGW |
| Classification Section | 21 CFR 882.4560 | 21 CFR 874.4420 | 21 CFR 882.4560 |
| Indications for Use | The NavWire 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 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. | The RELIEVA SPINPLUS™ Nav Balloon
Sinuplasty System is intended to provide a
means to access the sinus space, within and
across nasal and sinus structures; dilate the
sinus ostia and spaces associated with the
paranasal sinus cavities for diagnostic and
therapeutic procedures; and irrigate from
within a target sinus for therapeutic
procedures and to facilitate diagnostic
procedures.
For children aged 17 and under, the
RELIEVA SPINPLUS™ Nav Balloon
Sinuplasty System is intended to provide a
means to access the sinus space, within and
across nasal and sinus structures; dilate sinus
ostia and spaces associated with the
maxillary sinus for diagnostic and
therapeutic procedures; and irrigate from
within the maxillary sinus for therapeutic
procedures and to facilitate diagnostic
procedures. | The TruDi™ NAV Wire is intended for
use as an electromagnetically
navigable guidewire to provide access
and confirmation of placement in the
patient anatomy. The device is
intended for use during ENT
procedures where reference to a rigid
anatomical structure can be identified
relative to a CT-based model of the
anatomy. |
| Attribute | Primary Predicate Device
(Acclarent® NavWire) | Reference Device
(Relieva SpinPlus Nav™ Balloon
Sinuplasty System) | Subject Device
(TruDi™ NAV Wire) |
| | | The RELIEVA SPINPLUS™ Nav Balloon
Sinuplasty System may be utilized in
conjunction with the ACCLARENT® ENT
Navigation System, to provide access to
nasal and sinus spaces, and to confirm
placement in the accessed anatomy. | |
| Single-Use | Yes | Yes | Yes |
| Sterile | EtO Sterile | EtO Sterile | EtO Sterile |
| Direct Patient Contact | Yes
Limited Duration