TruDi Probe

K193453 · Acclarent, Inc. · PGW · Mar 23, 2020 · Neurology

Device Facts

• Record ID: K193453
• Device Name: TruDi Probe
• Applicant: Acclarent, Inc.
• Product Code: PGW · Neurology
• Decision Date: Mar 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended 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.

Device Story

TruDi™ Probe is a single-use, sterile, electromagnetically (EM) navigated instrument used in ENT and skull base surgery. It features a malleable stainless steel shaft with an integrated magnetic sensor at the distal tip. The probe connects to the TruDi™ Navigation System, which tracks the sensor's position in real-time. The system overlays the probe's location onto the patient's pre-operative CT/MRI scans, allowing surgeons to confirm access and navigate anatomical structures. A disposable bending tool is provided to customize the distal tip shape. The device is operated by surgeons in a clinical/surgical setting. By providing real-time visualization of the instrument tip relative to patient anatomy, the device assists in precise surgical navigation, potentially improving access and safety during complex ENT procedures.

Clinical Evidence

No clinical data was required. Substantial equivalence was demonstrated through non-clinical bench testing, including dimensional verification, mechanical integrity (connector/joint separation forces), tip flexure, navigation accuracy (mean 0.43 mm, SD 0.15 mm), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), sterilization validation (ISO 11135), biocompatibility (ISO 10993-1), and shelf-life testing (ASTM F1980-07). Simulated use testing on cadavers verified functional performance in a clinical setting.

Technological Characteristics

Electromagnetically navigated instrument; stainless steel shaft; integrated magnetic sensor at distal tip; 1.65mm tip diameter; single-use; sterile (EO sterilization per ISO 11135:2014); compatible with TruDi™ Navigation System. Handle design complies with ANSI/AAMI/HE75:2009/(R)2018. Electrical safety per IEC 60601-1 (3rd Ed) and IEC 60601-1-2 (4th Ed).

Indications for Use

Indicated for use with the TruDi™ Navigation System to locate anatomical structures during ENT and ENT skull base surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Fiagon Navigation – FlexPointer 1.5 (K150473)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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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.<br>31 Technology Drive<br>Irvine, CA 92618 |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Contact Person: | Leena Sorathia<br>Regulatory Affairs Program Lead<br>Email: [e-mail]<br>Tel: [phone] |

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.<br><br>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. |

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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<br>Use: | The TruDi™ Probe is intended for use with the TruDi™ Navigation System to<br>locate anatomical structures during surgical procedures in ENT and ENT skull<br>base surgery. |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Difference in<br>Indications from<br>Predicate Device | The indications for use statement of the subject device is similar to the predicate<br>device. Both the subject and predicate devices are electromagnetically-navigated<br>instruments, which are intended to be used with their compatible EM navigation<br>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<br>Characteristics: | The TruDi™ Probe is substantially equivalent in technological characteristics, as<br>there are no significant differences in fundamental scientific technology or other<br>features as compared to the predicate device, Fiagon FlexPointer 1.5mm<br>(K150473).<br><br>Both the subject and predicate devices are electromagnetically-navigated<br>instruments, which are intended to be used with their compatible EM navigation<br>systems to locate anatomical structures during ENT surgery. Similar to the<br>predicate device, the subject device incorporates a sensor at the distal tip, which<br>is tracked by the navigation system. The location of the distal tip of the device is<br>identified by the navigation system and displayed in real-time view over the<br>patient's pre-operative CT scan to confirm access and locate anatomical<br>structures during ENT surgery.<br><br>The primary differences between the subject and predicate devices are the<br>following:<br>The subject device is a single-use instrument, whereas the predicate device<br>is reusable for up to 10 uses. The subject device is packaged with a bending tool, whereas the predicate<br>device is not. The distal tip diameter of the subject device is 1.65 mm, whereas the distal<br>tip diameter of the predicate device is 1.5mm. The handle of subject device is different from the handle of predicate device<br>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 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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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.

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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<br>Fiagon FlexPointer 1.5mm | Subject Device<br>TruDi™ Probe | Substantial Equivalence<br>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<br>Section | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Indications for Use | The FlexPointer 1.5 is intended as an aid for<br>precisely locating anatomical structures in either<br>open or percutaneous procedures. It is indicated<br>for use with the Fiagon Navigation system using<br>electromagnetic navigation.<br>It is indicated for any medical condition in which<br>the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid<br>anatomical structure in the field of ENT surgery,<br>such as the paranasal sinuses, mastoid anatomy,<br>can be identified relative to a CT or MR<br>based model of the anatomy.<br>Example procedures include, but are not limited<br>to:<br>ENT Procedures:<br>Transphenoidal access procedures.<br>Intranasal procedures.<br>Sinus procedures, such as Maxillary<br>antrostomies, Ethmoidectomies,<br>Sphenoidotomies/Sphenoid explorations,<br>Turbinate resections, and Frontal sinusotomies.<br>ENT related anterior skull base procedures. | The TruDi™ Probe is intended for use with<br>the TruDi™ Navigation System to locate<br>anatomical structures during surgical<br>procedures in ENT and ENT skull base<br>surgery. | The indications for use of the subject<br>TruDi™ Probe device is aligned with the<br>indications for use of the predicate device. |

# Table 1: Comparison of Technological Characteristics between Subject Device and Predicate Device

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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<br>Fiagon FlexPointer 1.5mm | Subject Device<br>TruDi™ Probe | Substantial Equivalence<br>Rationale |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The FlexPointer 1.5 is intended as an aid for<br>precisely locating anatomical structures in either<br>open or percutaneous procedures. It is indicated<br>for use with the Fiagon Navigation system using<br>electromagnetic navigation. | The TruDi™ Probe is intended for use with<br>the TruDi™ Navigation System to locate<br>anatomical structures during surgical<br>procedures in ENT and ENT skull base<br>surgery. | The intended use of the subject TruDi™ Probe device is aligned with the intended<br>use of the predicate device. |
| | It is indicated for any medical condition in<br>which the use of stereotactic surgery may be<br>appropriate, and where reference to a rigid<br>anatomical structure in the field of ENT surgery,<br>such as the paranasal sinuses, mastoid anatomy,<br>can be identified relative to a CT or MR based<br>model of the anatomy. | | |
| | Example procedures include, but are not limited<br>to:<br>ENT Procedures;<br>Transphenoidal access procedures.<br>Intranasal procedures.<br>Sinus procedures, such as Maxillary<br>antrostomies, Ethmoidectomies,<br>Sphenoidotomies/Sphenoid explorations,<br>Turbinate resections, and Frontal sinusotomies.<br>ENT related anterior skull base procedures. | | |
| Attribute | Predicate Device<br>Fiagon FlexPointer 1.5mm | Subject Device<br>TruDi™ Probe | Substantial Equivalence<br>Rationale |
| Technological<br>Characteristics | The Fiagon Navigation - FlexPointer 1.5 is a<br>reusable instrument intended to be used with the<br>Fiagon Navigation system. The instrument is an<br>electromagnetically navigated device that is a<br>navigated pointing device (malleable, sensor<br>within the tip). | The TruDi™ Probe is a single-use<br>instrument intended to be used with the<br>TruDi™ Navigation System. The instrument<br>is an electromagnetically navigated device<br>that is a navigated pointing device<br>(malleable, sensor within the tip). | The technological characteristics have been<br>tested through non-clinical testing and they<br>do not impact substantial equivalence. The<br>differences do not raise any new concerns. |
| | The device incorporates a sensor at the distal tip,<br>which is tracked by the navigation system. The<br>location of the distal tip of the device is<br>identified by the navigation system and<br>displayed in real-time view over the patient's<br>pre-operative CT/MRI scan to confirm access<br>and locate anatomical structures during ENT<br>surgery. | The device incorporates a sensor at the<br>distal tip, which is tracked by the TruDi™<br>Navigation System. The location of the<br>distal tip of the device is identified by the<br>navigation system and displayed in real-<br>time view over the patient's pre-operative<br>CT/MRI scan to confirm access and locate<br>anatomical structures during ENT surgery. | |
| Localization<br>Technology | Electromagnetic (sensor integrated into distal tip<br>of the instrument) | Electromagnetic (sensor integrated into<br>distal tip of the instrument) | Same |
| System or Instrument<br>Accuracy<br>Requirements | A mean bench accuracy of 1.1 mm (Standard<br>deviation 0.27 mm) was measured for the<br>device. | A mean bench accuracy of 0.43 mm<br>(Standard deviation 0.15 mm) was<br>measured for the device. | The system and instrument accuracy<br>requirements have been tested through non-<br>clinical testing and they do not impact<br>substantial equivalence. The differences do |
| | All 95% confidence levels were < 2mm which<br>compares to the values 0.9 mm and 1.2 mm<br>(mean) resp. <2 mm (95% confidence) reported<br>for the unmodified devices. | With 95% confidence measured devices<br>have location accuracy of ≤ 2 mm RMS<br>over the entire navigation volume. | not raise any new concerns. |
| Instrument Shaft<br>Configurations | Straight (0°) | Straight (0°), Frontal (70°) | The instrument shaft configurations have<br>been tested through non-clinical testing and<br>they do not impact substantial equivalence.<br>The differences do not raise any new<br>concerns. |
| Distal Tip Diameter | 1.5mm | 1.65mm | The distal tip diameter has been tested<br>through non-clinical testing and does not<br>impact substantial equivalence. The<br>differences do not raise any new concerns. |
| Attribute | Predicate Device<br>Fiagon FlexPointer 1.5mm | Subject Device<br>TruDi™ Probe | Substantial Equivalence<br>Rationale |
| Handle | Length: ~ 1 inch<br>Shape: Rectangular profile<br>Cross-section: Rectangular (~ 1.0 inch x<br>0.7 inches x 0.4 inches) | Length: 4.5 inches<br>Shape: Cylindrical profile<br>Cross-section: Circular<br>Diameter: 0.45 inches | The handle design of the subject device<br>complies with ANSI/AAMI/HE75:2009/<br>(R)2018. Handle design features i.e. length,<br>shape, cross-section and diameter were<br>evaluated and verified through several VOC<br>activities to ensure that the handle met<br>ergonomic and functional expectations of<br>prospective users. In addition, the clinical<br>acceptability and functionality of the handle<br>design were validated through design<br>validation testing (simulated use testing).<br>Therefore, the handle differences of the<br>subject and predicate devices do not affect<br>safety and effectiveness of the subject<br>device. |
| Supplied as<br>"Reusable Use" | Yes, 10x reusable | No, supplied sterile single use | This attribute has been tested through non-<br>clinical testing and does not impact<br>substantial equivalence. The differences do<br>not raise any new concerns. |
| Location of Sensor | Sensor is built-in at the distal tip of the<br>instrument | Sensor is built-in at the distal tip of the<br>instrument | Same |
| Compatible<br>Navigation System | Fiagon FlexPointer 1.5mm is compatible with<br>the Fiagon Navigation system. | TruDi™ Probe is compatible with the<br>TruDi™ Navigation System. | This attribute has been tested through non-<br>clinical testing and does not impact<br>substantial equivalence. The differences do<br>not raise any new concerns. |

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Image /page/8/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in bold, black letters, with a stylized purple arc above the "ent" portion of the name. Below the name, in smaller font, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".

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Image /page/9/Picture/0 description: The image shows the logo for Acclarent, a medical technology company. The logo features the company name in bold, black letters, with a purple arc above the "ent" portion of the name. Below the name, in smaller red letters, is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES".

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Image /page/10/Picture/0 description: The image shows the Acclarent logo, which is part of the Johnson & Johnson family of companies. Below the logo, the text "Traditional 510(k)" is displayed, followed by "TruDi™ Probe". The text suggests that the image is related to a medical device or product that has undergone the traditional 510(k) approval process.

# [807.92(b) (1)] Determination of Substantial Equivalence

| Non-Clinical Performance<br>Data: | Bench testing has been performed and met all acceptance criteria for<br>attributes, such as dimensional specifications, connector joint separation<br>force, tip flexure, distal tube to handle separation force, cable strain<br>relief separation force, bending tool functionality and navigational<br>location accuracy.<br>Electrical safety and EMC tests were performed by a nationally<br>recognized testing laboratory to verify compliance with the<br>requirements of IEC 60601-1 (3rd Edition) and IEC60601-1-2 (4th<br>Edition).<br>The sterilization process has been validated per ISO 11135:2014 and<br>demonstrated a sterility assurance level of 10-6. The method used for<br>sterilization validation is the overkill (half-cycle approach) in a fixed<br>chamber. Ethylene oxide residuals have been tested and meet ISO<br>10993-7:2008 requirements. The subject device is not tested nor labeled<br>as "non-pyrogenic".<br>Biocompatibility testing was successfully completed to determine that<br>the TruDi™ Probe is biocompatible per ISO 10993-1.<br>Packaging shelf life for the TruDi™ Probe was established through<br>accelerated aging via ASTM F1980-07, ASTM F88/F88M-09, and<br>ASTM F2096-11 requirements and confirmed to meet a shelf life of<br>three months.<br>Simulated use testing on cadavers was successfully conducted to verify<br>that the TruDi™ Probe functions in accordance with its intended use and<br>design specifications in a simulated clinical setting. The packaging and<br>instructions for use were also successfully assessed by evaluators as part<br>of the study.<br>The TruDi™ Probe passed all intended criteria in accordance with<br>appropriate test criteria and standards. |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [807.92(b) (2)] Determination of Substantial Equivalence | |
| Clinical Performance Data | Clinical data was not necessary for the TruDi™ Probe. The performance<br>data demonstrated that the device performs as intended. |
| Conclusion from Non- | Based on the information provided in this premarket notification, |
| Clinical and Clinical Tests | Acclarent concludes that the TruDi™ Probe is as safe and effective as the<br>predicate device. |

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Image /page/11/Picture/0 description: The image shows the Acclarent logo, which is a medical device company that is part of the Johnson & Johnson family of companies. Below the logo, the text "Traditional 510(k)" and "TruDi™ Probe" are displayed. The text indicates that the image is related to a medical device, specifically the TruDi™ Probe, and its regulatory pathway, which is the Traditional 510(k) clearance.

# [807.92(b) (3)] Conclusion