TruDi Curette

K201174 · Acclarent, Inc. · PGW · Aug 12, 2020 · Neurology

Device Facts

• Record ID: K201174
• Device Name: TruDi Curette
• Applicant: Acclarent, Inc.
• Product Code: PGW · Neurology
• Decision Date: Aug 12, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TruDi™ Curette is intended for use with the TruDi™ Navigation System to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery.

Device Story

Single-use, sterile, electromagnetically (EM) navigated surgical instrument; used with TruDi Navigation System. Device features malleable distal shaft with integrated magnetic sensor; includes bending tool for user-customization of shaft shape. During ENT/skull base surgery, system tracks distal tip location in real-time, displaying position over patient's pre-operative CT/MRI scans. Physician uses visual feedback to confirm access and locate anatomical structures before manipulating or removing tissue. Benefits include enhanced anatomical visualization and precise instrument guidance during complex ENT procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and design validation (simulated use on cadavers). Bench testing confirmed dimensional specs, joint strength, tip sharpness, bending tool functionality, and navigation accuracy (≤ 2mm RMS). Biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and sterilization (ISO 11135) met all acceptance criteria.

Technological Characteristics

Electromagnetically-navigated instrument; polycarbonate handle; malleable distal shaft; integrated magnetic sensor. Connectivity: compatible with TruDi Navigation System (V2.0+). Sterilization: Ethylene oxide (ISO 11135). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ASTM F1980-07/F88/F2096 (packaging/shelf life).

Indications for Use

Indicated for use with TruDi Navigation System to manipulate, dissect, or remove tissue, cartilage, and bone 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

• KARL STORZ EM Frontal Sinus Curette (K161555)

Reference Devices

• TruDi™ Probe (K193453)

Submission Summary (Full Text)

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August 12, 2020

Acclarent. Inc. Leena Sorathia Regulatory Affairs Program Lead 31 Technology Drive Irvine. California 92618

Re: K201174

Trade/Device Name: TruDi Curette Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: July 14, 2020 Received: July 16, 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 probibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting (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-devices/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 (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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201174

Device Name TruDi™ Curette

Indications for Use (Describe)

TruDi™ Curette is intended for use with the TruDi™ Navigation System to manipulate, dissect and/or remove tissue, cartilage and bone 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/0 description: The image shows the logo for Acclarent, which is part of the Johnson & Johnson family of companies. Below the logo, the text "TruDi™ Curette" is displayed. The Acclarent logo features the company name in bold, black letters, with a purple arch above the "ent" portion of the name.

# K201174 - 510(K) SUMMARY

| Sponsor/Submitter: | Acclarent, Inc.<br>31 Technology Drive<br>Irvine, CA 92618 |
|--------------------|------------------------------------------------------------|
| Contact Person: | Leena Sorathia |

Regulatory Affairs Program Lead Email: [e-mail] Tel: [phone]

Date Summary Prepared: July 14, 2020

## [807.92(a)(2)] Name of Device

| Device Trade<br>Name: | TruDi™ Curette |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>Name: | Stereotaxic Instrument |
| Common Name: | Image Guided Surgery System |
| Device<br>Classification: | Class II |
| Regulation<br>Number: | 21 CFR 882.4560 |
| Review Panel: | Ear, Nose, and Throat |
| Product Code: | PGW |
| [807.92(a)(3)] Legally Marketed Devices | |
| Predicate Device: | KARL STORZ EM Frontal Sinus Curette<br>(Cleared as part of KARL STORZ NAV1 Electromagnetic Navigation System<br>under K161555) |
| Reference Device: | TruDi™ Probe (K193453) |
| [807.92(a)(4)] Device Description | |
| Device Description: | The subject device, TruDi™ Curette (K201174), is a single-use and sterile<br>electromagnetically (EM) navigated instrument, which is intended for use with<br>the TruDi™ Navigation System (K192397) to manipulate, dissect and/or remove<br>tissue, cartilage and bone during surgical procedures in ENT and ENT skull<br>base surgery.<br>The TruDi™ Curette consists of one configuration (straight 0°). The TruDi™ |

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Image /page/4/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 red font, it says "PART OF THE Johnson-Johnson FAMILY OF COMPANIES". Underneath the logo is the text "TruDi Curette" in a bolded font. The text is black.

shaft, and a curette cup, which is located at the distal tip and houses a magnetic sensor. The device is sold in sterile packaging. Each package includes one TruDi™ Curette in conjunction with a disposable bending tool. The bending tool is provided to allow the user to customize the shape of the distal shaft as needed.

The TruDi™ Curette 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 to locate anatomical structures during ENT and ENT skull base surgery.

## [807.92(a)(5)] Intended Use

| Indications for<br>Use: | TruDi™ Curette is intended for use with the TruDi™ Navigation System to<br>manipulate, dissect and/or remove tissue, cartilage and bone during surgical<br>procedures in ENT and ENT skull base surgery. |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Difference in<br>Indications from<br>Predicate Device | The indications for use/intended use statement of the subject device is similar to<br>the predicate device. Both the subject and predicate devices are<br>electromagnetically-navigated instruments, which are intended to be used with<br>their compatible EM navigation systems to manipulate, dissect and/or remove<br>tissue, cartilage and bone during surgical procedures in ENT and ENT skull base<br>surgery.<br>For a comparison of the indications for use/intended use of the subject device and<br>its predicate device, please reference Table 1 on the following page. |
| [807.92(a)(6)] Technical Characteristics | |
| Technological<br>Characteristics: | The TruDi™ Curette is substantially equivalent in technological characteristics,<br>as there are no significant differences in fundamental scientific technology or<br>other features as compared to the predicate device, KARL STORZ EM Frontal<br>Sinus Curette (K161555) and reference device, TruDi™ Probe (K193453). |

Both the subject and predicate devices are electromagnetically-navigated instruments, which are intended to be used with their compatible EM navigation systems to manipulate, dissect and/or remove tissue, cartilage and bone during surgical procedures in ENT and ENT skull base surgery. Similar to the predicate device, the subject device incorporates a sensor within the distal shaft, 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 to locate anatomical structures during ENT and ENT skull base surgery.

The primary differences between the subject and predicate device are the following:

- The subject device is a single-use instrument, whereas the predicate ● device is reusable for up to 30 uses.

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Image /page/5/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 Curette" is displayed. The Acclarent logo features the company name in a combination of black and purple, with a curved design above the text.

- The subject device is packaged with a bending tool, whereas the predicate device is not.
- . The subject device consists of one configuration (straight 0°), whereas the predicate devices consists of two configurations (curved 55°and 90°).
- . The distal shaft of the subject device is malleable and can be formed with the provided bending tool per physicians' preference, whereas the predicate device has a rigid distal shaft.
- . The sensor in both the subject and predicate devices are located within the distal shaft of the devices. While the sensor in the subject device is located ~1cm away from the distal tip, the sensor in the predicate device is located ~6cm away from the distal tip.
- . The total length of the subject device is 24cm, whereas the total length of the predicate device is 18cm.
- . The handle construction of subject device consists of polycarbonate material, whereas the predicate device handle consists of stainless steel.

However, these differences do not raise new concerns of safety and effectiveness for the subject device as demonstrated by performance testing and design validation testing (simulated use testing).

Additionally, the technological characteristics of the subject device are similar to the reference device. The subject device utilizes identical sensor subassembly (sensor, wire, PCB, and connector) and navigation platform as the reference device. Similar to the reference device, the sensor of the subject device is located at the distal tip for instrument tracking. See Table 1 for a comparison of the technological characteristics between the subject device and the predicate/reference devices.

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Image /page/6/Picture/0 description: The image shows the Acclarent logo, which is a black, bold font with a purple swoosh above the "ent". Below the logo, in a smaller font, it says "PART OF THE Johnson & Johnson FAMILY OF COMPANIES". Underneath that, it says "TruDi™ Curette" in a bold font.

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

| Attribute | Predicate Device<br>KARL STORZ EM Frontal<br>Sinus Curette | Reference Device<br>TruDi™ Probe | Subject Device<br>TruDi™ Curette | Substantial Equivalence<br>Rationale |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K161555 | K193453 | K201174 | N/A |
| Manufacturer | KARL STORZ Endoscopy<br>America, Inc. | Acclarent, Inc. | Acclarent, Inc. | N/A |
| Trade Name | KARL STORZ EM Frontal Sinus<br>Curette (Cleared as part of KARL<br>STORZ NAV1 Electromagnetic<br>Navigation System under K161555) | TruDi™ Probe | TruDi™ Curette | N/A |
| Classification<br>Name | Stereotaxic Instrument | Stereotaxic Instrument | Stereotaxic Instrument | Same |
| Class | II | II | II | Same |
| Product Code | PGW | PGW | PGW | Same |
| Classification<br>Section | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 | Same |
| Indications for<br>Use | The KARL STORZ NAV 1<br>electromagnetic navigation system<br>and its associated applications are<br>intended as an aid for precisely<br>locating anatomical structures in<br>either open or percutaneous<br>procedures under visual control.<br>Their use is indicated for any<br>medical condition in which use of<br>stereotactic surgery may be<br>appropriate, and where reference to<br>a rigid anatomical structure in the<br>field of ENT surgery, such as<br>paranasal sinuses, mastoid anatomy,<br>can be identified relative to<br>radiological image data or digitized<br>landmarks of the anatomy. | The TruDi™ Probe is intended for<br>use with the TruDi™ Navigation<br>System to locate anatomical<br>structures during surgical<br>procedures in ENT and ENT skull<br>base surgery. | TruDi™ Curette is intended for<br>use with the TruDi™<br>Navigation System to<br>manipulate, dissect and/or<br>remove tissue, cartilage and<br>bone during surgical<br>procedures in ENT and ENT<br>skull base surgery. | The indications for use for the subject<br>device TruDi™ Curette is aligned with<br>the indications for use/intended use of<br>the predicate device. |
| Attribute | Predicate Device<br>KARL STORZ EM Frontal Sinus<br>Curette | Reference Device<br>TruDi™ Probe | Subject Device<br>TruDi™ Curette | Substantial Equivalence<br>Rationale |
| Intended Use | Navigated spoons and curettes aid<br>orientation and the manipulation,<br>dissection and/or removal of tissue,<br>cartilage and bone during invasive<br>and surgically invasive interventions<br>in ENT medicine and skull base<br>surgery not involving contact with<br>the central nervous system. | The TruDi™ Probe is intended for<br>use with the TruDi™ Navigation<br>System to locate anatomical<br>structures during surgical<br>procedures in ENT and ENT skull<br>base surgery. | TruDi™ Curette is intended for<br>use with the TruDi™ Navigation<br>System to manipulate, dissect<br>and/or remove tissue, cartilage<br>and bone during surgical<br>procedures in ENT and ENT<br>skull base surgery. | The intended use for the subject<br>device TruDi™ Curette is aligned with<br>the intended use of the predicate<br>device. |
| Technological<br>Characteristics | The KARL STORZ EM Frontal<br>Sinus Curette is a reusable<br>electromagnetically-navigated<br>instrument, which is intended to be<br>used with the KARL STORZ NAV1<br>electromagnetic navigation system.<br>The device incorporates a sensor<br>within the distal shaft, which is<br>tracked by the navigation system.<br>The location of the distal tip of the<br>device is identified by the<br>navigation system and displayed in<br>real-time view over the patient's<br>pre-operative CT/MRI scan to<br>confirm access of target anatomy.<br>Following confirmation, the<br>physician operates the instrument at<br>the target anatomical structure. | The TruDi™ Probe is a single-use<br>instrument intended to be used<br>with the TruDi™ Navigation<br>System. The instrument is an<br>electromagnetically navigated<br>device that is a navigated pointing<br>device (malleable, sensor within<br>the tip).<br>The device incorporates a sensor<br>at the distal tip, which is tracked<br>by the TruDi™ Navigation<br>System. The location of the distal<br>tip of the device is identified by<br>the navigation system and<br>displayed in real-time view over<br>the patient's pre-operative<br>CT/MRI scan to confirm access<br>and locate anatomical structures<br>during ENT surgery. | The TruDi™ Curette is a single-<br>use electromagnetically-<br>navigated instrument, which is<br>intended to be used with the<br>TruDi™ Navigation System.<br>The device incorporates a<br>sensor within the distal shaft,<br>which is tracked by the TruDi™<br>Navigation System. The<br>location of the distal tip of the<br>device is identified by the<br>navigation system and<br>displayed in real-time view<br>over the patient's pre-operative<br>CT/MRI scan to confirm access<br>of target anatomy. Following<br>confirmation, the physician<br>operates the instrument at the<br>target anatomical structure. | The technological characteristics<br>between the subject device and<br>predicate/reference devices are<br>similar.<br>Both the subject and predicate devices<br>are electromagnetically-navigated<br>instruments, which are intended to be<br>used with their compatible EM<br>navigation systems to manipulate,<br>dissect and/or remove tissue, cartilage<br>and bone during surgical procedures<br>in ENT and ENT skull base surgery.<br>Similar to the predicate device, the<br>subject device incorporates a sensor<br>within the distal shaft, which is<br>tracked by the navigation system.<br>The subject device utilizes identical<br>sensor subassembly (sensor, wire,<br>PCB, and connector) and navigation<br>platform as the reference device.<br>Similar to the reference device, the<br>sensor of the subject device is located<br>at the distal tip for instrument |
| Attribute | Predicate Device<br>KARL STORZ EM Frontal Sinus<br>Curette | Reference Device<br>TruDi™ Probe | Subject Device<br>TruDi™ Curette | Substantial Equivalence<br>Rationale |
| Localization<br>Technology | Electromagnetic (sensor integrated<br>within the distal shaft of the<br>instrument) | Electromagnetic (sensor<br>integrated into distal tip of the<br>instrument) | Electromagnetic (sensor<br>integrated within the distal<br>shaft of the instrument) | Same |
| Location<br>Accuracy | Unknown | The accuracy of TruDi™ Probe<br>used in conjunction with the<br>navigation views of the TruDi™<br>Navigation System is ≤ 2mm<br>RMS over the entire navigation<br>volume. | The accuracy of TruDi™<br>Curette used in conjunction<br>with the navigation views of the<br>TruDi™ Navigation System is ≤<br>2mm RMS over the entire<br>navigation volume. | Location accuracy specifications are<br>identical between the subject and<br>reference devices. |
| Instrument<br>Shaft<br>Configurations | Curved (55°), Curved (90°) | Straight (0°), Frontal (70°) | Straight (0°) | The subject device is packaged with a<br>bending tool to allow the user to<br>customize the distal shaft of the<br>device to surgical profiles ranging<br>from a straight configuration to curve<br>90°. This range also includes curved<br>65°. Additionally, the IFU includes<br>detailed instructions on how to bend<br>the distal shaft per the user's<br>preference. The clinical acceptability<br>of the bending process has been<br>successfully validated as part of the<br>design validation testing. |
| Attribute | Predicate Device<br>KARL STORZ EM Frontal Sinus<br>Curette | Reference Device<br>TruDi™ Probe | Subject Device<br>TruDi™ Curette | Substantial Equivalence<br>Rationale |
| Total<br>Length | 18cm | 24 cm | 24cm | The total length specifications are<br>identical between the subject and<br>reference devices.<br>The difference in total length between<br>the subject and predicate devices is<br>driven by the differences in the length<br>of the handle and working length of<br>the devices.<br>The working length of the predicate<br>device is 7.6 cm as opposed to<br>working length of the subject device<br>at 12.7 cm. The handle length of the<br>subject device is 11.4 cm while handle<br>length of the predicate device is 10.2<br>cm.<br>The difference in the working length<br>of the predicate and subject devices is<br>based on several Voice of Customer<br>(VOC) activities and has been<br>successfully validated during design<br>validation testing. This difference<br>improves usability of the subject<br>device and does not introduce any<br>additional risks.<br>The differences between the handles<br>of the subject and predicate devices<br>are based on guidelines of<br>ANSI/AAMI/HE75:2009/ (R)2018 to<br>enhance human factors characteristics |
| Attribute | Predicate Device<br>KARL STORZ EM Frontal Sinus<br>Curette | Reference Device<br>TruDi™ Probe | Subject Device<br>TruDi™ Curette | Substantial Equivalence<br>Rationale |
| |…