(101 days)
No
The summary describes a navigation probe that uses electromagnetic tracking and displays its location on a pre-operative CT scan. There is no mention of AI or ML in the device description, intended use, or performance studies. The technology described is standard electromagnetic navigation.
No.
The device is used for locating anatomical structures during surgery, not for treating a condition or disease.
No
The TruDi™ Probe is an electromagnetically navigated instrument intended for use with a navigation system to locate anatomical structures during surgical procedures. Its function is to provide real-time positional guidance during surgery, not to diagnose a condition or disease.
No
The device description clearly states the TruDi™ Probe is a physical instrument with hardware components including a handle, shaft, and a magnetic sensor, and it undergoes hardware-specific testing (dimensional specifications, separation force, tip flexure, electrical safety, EMC, sterilization, biocompatibility, packaging shelf life).
Based on the provided information, the TruDi™ Probe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "locate anatomical structures during surgical procedures in ENT and ENT skull base surgery." This describes a device used in vivo (within the body) during a surgical procedure, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine.
- Device Description: The description details a surgical instrument with a sensor for navigation within the patient's body. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on laboratory tests
The TruDi™ Probe is clearly a surgical navigation tool used to guide the surgeon during a procedure by providing real-time location information relative to the patient's anatomy. This falls under the category of a surgical instrument or navigation system, not an IVD.
N/A
Intended Use / Indications for Use
The TruDi™ Probe is intended for use with the TruDi™ System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.
Product codes
PGW
Device Description
The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.
The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed.
The TruDi™ Probe incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT scan to confirm access and locate anatomical structures during ENT surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient's pre-operative CT scan
Anatomical Site
ENT and ENT skull base surgery, paranasal sinuses, mastoid anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
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)
Bench testing has been performed and met all acceptance criteria for attributes, such as dimensional specifications, connector joint separation force, tip flexure, distal tube to handle separation force, cable strain relief separation force, bending tool functionality and navigational location accuracy.
Electrical safety and EMC tests were performed by a nationally recognized testing laboratory to verify compliance with the requirements of IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th Edition).
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™ Probe is biocompatible per ISO 10993-1.
Packaging shelf life for the TruDi™ Probe 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.
Simulated use testing on cadavers was successfully conducted to verify that the TruDi™ Probe functions in accordance with its intended use and design specifications in a simulated clinical setting. The packaging and instructions for use were also successfully assessed by evaluators as part of the study.
The TruDi™ Probe passed all intended criteria in accordance with appropriate test criteria and standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fiagon Navigation – FlexPointer 1.5, (K150473)
Reference Device(s)
Not Found
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 includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 23, 2020
Acclarent, Inc. Leena Sorathia Regulatory Affairs Program Lead 31 Technology Drive Irvine, California 92618
Re: K193453
Trade/Device Name: TruDi Probe Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: PGW Dated: March 3, 2020 Received: March 4, 2020
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 J. 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
Indications for Use
510(k) Number (if known) K193453
Device Name TruDi™ Probe
Indications for Use (Describe)
The TruDi™ Probe is intended for use with the TruDi™ System to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery.
| 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ Probe" is displayed in a bold font. The Acclarent logo features the company name in a bold, sans-serif font, with a purple arc above the "ent" portion of the name.
510(K) SUMMARY
[807.92(a)(1)] Submitter Information
| Sponsor/Submitter: | Acclarent, Inc.
31 Technology Drive
Irvine, CA 92618 |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Leena Sorathia
Regulatory Affairs Program Lead
Email: lsorathi@its.jnj.com
Tel: 949-923-4118 |
Date Summary Prepared: March 20, 2020
[807.92(a)(2)] Name of Device
| [807.92(a)(2)] Name of Device | |
|---|---|
| Device Trade Name: | TruDi™ Probe |
| 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: | Fiagon Navigation – FlexPointer 1.5, (K150473) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The subject device, TruDi™ Probe, is a single-use and sterile electromagnetically (EM) navigated instrument, which is intended for use with the TruDi™ Navigation System (K192397) to locate anatomical structures during surgical procedures in ENT and ENT skull base surgery. |
The TruDi™ Probe consists of two configurations, straight (0°) and frontal (70°). The TruDi™ Probe comprises of a fixed proximal connector, cable, handle, stainless steel shaft, and a distal tip that houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Probe (either straight or frontal) in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of distal tip as needed. |
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, the text "TruDi™ Probe" is displayed in a bold font. The Acclarent logo features the company name in a combination of black and purple, with a curved line above the "ent" portion of the name.
The TruDi™ Probe incorporates a sensor at the distal tip, which is tracked by the TruDi™ Navigation System. The location of the distal tip of the device is identified by the navigation system and displayed in real-time view over the patient's pre-operative CT scan to confirm access and locate anatomical structures during ENT surgery.
[807.92(a)(5)] Intended Use
| Indications for
Use: | The TruDi™ Probe is intended for use with the TruDi™ Navigation System to
locate anatomical structures during surgical procedures in ENT and ENT skull
base surgery. |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Difference in
Indications from
Predicate Device | The indications for use statement of the subject device is similar to the predicate
device. Both the subject and predicate devices are electromagnetically-navigated
instruments, which are intended to be used with their compatible EM navigation
systems to locate anatomical structures during ENT surgery. |
For a comparison of the indications for use of the subject device and its predicate device, please reference Table 1 on the following page.
[807.92(a)(6)] Technical Characteristics
| Technological
Characteristics: | The TruDi™ Probe is substantially equivalent in technological characteristics, as
there are no significant differences in fundamental scientific technology or other
features as compared to the predicate device, Fiagon FlexPointer 1.5mm
(K150473).
Both the subject and predicate devices are electromagnetically-navigated
instruments, which are intended to be used with their compatible EM navigation
systems to locate anatomical structures during ENT surgery. Similar to the
predicate device, the subject device incorporates a sensor at the distal tip, which
is tracked by the navigation system. The location of the distal tip of the device is
identified by the navigation system and displayed in real-time view over the
patient's pre-operative CT scan to confirm access and locate anatomical
structures during ENT surgery.
The primary differences between the subject and predicate devices are the
following:
The subject device is a single-use instrument, whereas the predicate device
is reusable for up to 10 uses. The subject device is packaged with a bending tool, whereas the predicate
device is not. The distal tip diameter of the subject device is 1.65 mm, whereas the distal
tip diameter of the predicate device is 1.5mm. The handle of subject device is different from the handle of predicate device
in length, shape, diameter and cross-section. However, these differences do not raise new concerns of safety and effectiveness for the subject device as demonstrated by performance testing and simulated use |
| ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
5
Image /page/5/Picture/1 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, in a larger, bolded font, it says 'TruDi™ Probe'.
testing. See Table 1 for a comparison of the technological characteristics between the subject device and the predicate device.
6
Image /page/6/Picture/0 description: The image shows the Acclarent logo, which is a medical technology company. Below the logo, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". Underneath that, the text "TruDi™ Probe" is displayed.
| Attribute | Predicate Device
Fiagon FlexPointer 1.5mm | Subject Device
TruDi™ Probe | Substantial Equivalence
Rationale |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K150473 | K193453 | N/A |
| Manufacturer | Fiagon GmbH | Acclarent, Inc. | N/A |
| Trade Name | Fiagon Navigation - FlexPointer 1.5 | TruDi™ Probe | N/A |
| Classification Name | Stereotaxic Instrument | Stereotaxic Instrument | Same |
| Class | II | II | Same |
| Product Code | PGW | PGW | Same |
| Classification
Section | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Indications for Use | The FlexPointer 1.5 is intended as an aid for
precisely locating anatomical structures in either
open or percutaneous procedures. It is indicated
for use with the Fiagon Navigation system using
electromagnetic navigation.
It is indicated for any medical condition in which
the use of stereotactic surgery may be
appropriate, and where reference to a rigid
anatomical structure in the field of ENT surgery,
such as the paranasal sinuses, mastoid anatomy,
can be identified relative to a CT or MR
based model of the anatomy.
Example procedures include, but are not limited
to:
ENT Procedures:
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary
antrostomies, Ethmoidectomies,
Sphenoidotomies/Sphenoid explorations,
Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures. | The TruDi™ Probe is intended for use with
the TruDi™ Navigation System to locate
anatomical structures during surgical
procedures in ENT and ENT skull base
surgery. | The indications for use of the subject
TruDi™ Probe device is aligned with the
indications for use of the predicate device. |
Table 1: Comparison of Technological Characteristics between Subject Device and Predicate Device
7
Image /page/7/Picture/0 description: The image shows the logo for Acclarent, a company that is part of the Johnson & Johnson family of companies. The word "Acclarent" is written in a bold, sans-serif font, with the "A" and "ccla" in black and the "rent" in purple. Above the word "rent" is a purple arc. Below the word "Acclarent" is the phrase "PART OF THE Johnson-Johnson FAMILY OF COMPANIES" in a smaller font, with "Johnson-Johnson" in red.
| Attribute | Predicate Device
Fiagon FlexPointer 1.5mm | Subject Device
TruDi™ Probe | Substantial Equivalence
Rationale |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The FlexPointer 1.5 is intended as an aid for
precisely locating anatomical structures in either
open or percutaneous procedures. It is indicated
for use with the Fiagon Navigation system using
electromagnetic navigation. | The TruDi™ Probe is intended for use with
the TruDi™ Navigation System to locate
anatomical structures during surgical
procedures in ENT and ENT skull base
surgery. | The intended use of the subject TruDi™ Probe device is aligned with the intended
use of the predicate device. |
| | It is indicated for any medical condition in
which the use of stereotactic surgery may be
appropriate, and where reference to a rigid
anatomical structure in the field of ENT surgery,
such as the paranasal sinuses, mastoid anatomy,
can be identified relative to a CT or MR based
model of the anatomy. | | |
| | Example procedures include, but are not limited
to:
ENT Procedures;
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary
antrostomies, Ethmoidectomies,
Sphenoidotomies/Sphenoid explorations,
Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures. | | |
| Attribute | Predicate Device
Fiagon FlexPointer 1.5mm | Subject Device
TruDi™ Probe | Substantial Equivalence
Rationale |
| Technological
Characteristics | The Fiagon Navigation - FlexPointer 1.5 is a
reusable instrument intended to be used with the
Fiagon Navigation system. The instrument is an
electromagnetically navigated device that is a
navigated pointing device (malleable, sensor
within the tip). | The TruDi™ Probe is a single-use
instrument intended to be used with the
TruDi™ Navigation System. The instrument
is an electromagnetically navigated device
that is a navigated pointing device
(malleable, sensor within the tip). | The technological characteristics have been
tested through non-clinical testing and they
do not impact substantial equivalence. The
differences do not raise any new concerns. |
| | The device incorporates a sensor at the distal tip,
which is tracked by the navigation system. The
location of the distal tip of the device is
identified by the navigation system and
displayed in real-time view over the patient's
pre-operative CT/MRI scan to confirm access
and locate anatomical structures during ENT
surgery. | The device incorporates a sensor at the
distal tip, which is tracked by the TruDi™
Navigation System. The location of the
distal tip of the device is identified by the
navigation system and displayed in real-
time view over the patient's pre-operative
CT/MRI scan to confirm access and locate
anatomical structures during ENT surgery. | |
| Localization
Technology | Electromagnetic (sensor integrated into distal tip
of the instrument) | Electromagnetic (sensor integrated into
distal tip of the instrument) | Same |
| System or Instrument
Accuracy
Requirements | A mean bench accuracy of 1.1 mm (Standard
deviation 0.27 mm) was measured for the
device. | A mean bench accuracy of 0.43 mm
(Standard deviation 0.15 mm) was
measured for the device. | The system and instrument accuracy
requirements have been tested through non-
clinical testing and they do not impact
substantial equivalence. The differences do |
| | All 95% confidence levels were