The InnerView LC is intended to precisely measure the damping characteristic of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

Device Description

The InnerView LC is an electromagnetically driven percussion system used to collect the percussion data of teeth and/or implants by the dental professional. The system is indicated to precisely measure the damping characteristics of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

The InnerView LC consists of a wireless hand-held handpiece, base station, disposable film tip, and software. A USB cable provides a connection from the base station to a PC.

The device utilizes non-invasive quantitative percussion diagnostics (QPD), a mechanics-based methodology that tests the damping capability, and consequently mobility of teeth and dental implants by lightly percussing their buccal surface. The percussion data generated by the handpiece is wirelessly transferred to the base station and forwarded to the USB connection. In addition, the base station acts as a handpiece battery charger when the handpiece is docked. The device requires a fresh single use disposable film tip to be attached to the handpiece prior to each new procedure.

AI/ML Overview

This document does not contain the specific acceptance criteria, reported device performance, or details of a study that proves the device meets acceptance criteria for the "InnerView LC". Instead, it is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study against specific acceptance criteria.

The document states that:

Performance data (Bench Testing): "Performance testing of the InnerView LC was conducted to support substantial equivalence determination. The results demonstrate that the InnerView LC performs as well as the predicate, Periometer."
Clinical Studies: "Clinical studies were not performed since the intended use and indications for use are the same and performance characteristics are equivalent."

Therefore, I cannot provide the requested information. The document implies that the "acceptance criteria" are effectively the performance characteristics of the predicate device, and the "study" is the bench testing demonstrating equivalence. However, the specific metrics, methodologies, and quantitative results of this bench testing are not detailed.

Summary

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September 1, 2023

Perimetrics, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059

Re: K232657

Trade/Device Name: InnerView LC Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: August 28, 2023 Received: August 31, 2023

Dear Dave Yungvirt:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 mediation-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.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K232657

Device Name InnerView LC

Indications for Use (Describe)

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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K232657

510(k) Summary

I. SUBMITTER

Perimetrics, Inc. 8441 154th Avenue NE Building H, Suite 210 Redmond, WA 98052

Contact Person: Alicia Mszyca Tel. 714-325-9887

Date Prepared: June 30, 2023 Date Updated: August 14, 2023

II. DEVICE

Trade Name:	InnerView LC
Common Name:	Dental Handpiece
Classification Name:	Handpiece, Direct Drive, AC-Powered (21 CFR 872.4200)
Device Class:	I
Product Code:	EKX

III. PREDICATE DEVICE

Primary Predicate Device:	Perimetrics Inc., Periometer, K072213
Reference Device:	Osstell AB, Osstell Beacon K181888

IV. DEVICE DESCRIPTION

The InnerView LC consists of a wireless hand-held handpiece, base station, disposable film tip, and software. A USB cable provides a connection from the base station to a PC.

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V. INDICATIONS FOR USE

The InnerView LC is intended to precisely measure the damping characteristics of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

The indication for use statement for the InnerView LC is identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The InnerView LC functions in a manner similar to and is intended for the same use as the Periometer, an electromagnetically driven percussion system used to precisely measure damping characteristics of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.

The handpieces have the same mechanism of action, light percussion on the buccal side of the tooth/implant, same data acquisition through the piezo sensor which detects the amount of force absorbed by tooth/implant from the percussion probe. same user interface and output of results (energy return graph and loss coefficient), percussion /tapping mechanism material, maximum contact/tapping forces and the way data is transferred to the PC from the base station through USB connection.

Technological differences between the InnerView LC and the predicate device include:

. The InnerView LC is used with single use disposable film tips to minimize cross-contamination potential. In addition, each tip is equipped with a security chip which communicates with the handpiece to register only one tip for a single patient procedure.
. Not possible to sterilize. Instead, the device must be cleaned and disinfected between patients, and used with a transparent, commercially available barrier sleeve, as indicated in the User Manual.
Handpiece is battery driven and wirelessly connects with the base station and transfers the ● percussion data. The handpiece charges when docked and cannot be used while charging.
The device uses a cloud platform for storing generated percussion data for each patient and ● calculating the loss coefficient.
The InnerView LC is factory calibrated for ease of use.

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Table 1: Device Comparison Table

Characteristics	Subject device	Predicate device	Reference device	Comparisonsubject vs predicate
	InnerView LC(subject device)	PeriometerK072213	Osstell BeaconK181888
Product code	EKX	EKX	EKX	Same
Intended use	InnerView LC is used to collect thetooth/implant percussion data by thedental professional.	Periometer Instrument is used tocollect the tooth/implant percussiondata by the dental professional.	Dental implant stabilityanalyzer	Same
Indications for Use	InnerView LC preciselymeasures the damping characteristicsof the periodontium and its associatedfixed structures (teeth and/orimplants). It can provide data toquantify tooth and/or dental implantmobility.	Periometer is a unit that preciselymeasures the damping characteristicsof the periodontium and its associatedfixed structures (teeth and/orimplants). It can provide data toquantify tooth and/or dental implantmobility	Osstell Beacon isindicated for use inmeasuring stability ofimplants in the oralcavity and maxillofacialregion.	Same
Target Population	All dental patients	All dental patients	All patients withimplants	Same
Environment ofUse	Professional use/dental facility	Professional use/dental facility	Professional use/dentalfacility	Same
Components	The device includes hand-held,wireless, battery drivenhandpiece, single use disposablefilm tips, base station with USBinterface for charging and datatransfer, and software.	The device includes wired hand-heldhandpiece connected to the basestation via a cable, reusable tips,power supply, USB cable for datatransfer, and software.	The device is a singlehand-held wirelessbattery drivenhandpiece with built-ingraphical display. Thedevice connects to a PCvia USB for chargingand includes cloudconnection/ Bluetoothdata communication.	Convenience only,therefore, substantiallyequivalent
Handpiece	Wireless	Wired	Wireless	Convenience only,therefore, substantiallyequivalent
Tips	Single-use disposable film tips,discarded after single patient use. Thefront opening of the tip is sealed witha film membrane to prevent ingress offluids/cross-contamination. Inaddition, tip has a built-in smart chipsensor to detect reuse attempt.	Reusable, autoclavable after each use	NATip built into handpiece.System uses single useSmartpegs.	Convenience only,enhanced infection controlprotocol, therefore,substantially equivalent
Base Station	Stores and charges handpiecebattery, transfers percussion data toPC via USB. Powered by USBconnection.	Powers handpiece and transferspercussion data to PC via USB.Powered by power supply.	NA	Convenience only,therefore, substantiallyequivalent
Principle ofOperation	InnerView LC transfers toothpercussion data, generated by thehandpiece, wirelessly to the basestation, which forwards the data to theuser's PC via USB. Handpiece andbase station are automatically pairedwhen the handpiece is placed into thebase station. The software allowsacquisition of the percussion data andreturns output through the UserInterface.	Periometer transfers tooth percussiondata, generated by the handpiece, tothe base station by a wiredconnection. The base station forwardsthe data to the user's PC via USB.The software allows acquisition of thepercussion data and returns outputthrough the User Interface.	Osstell Beaconmeasures the frequencyresponse from SmartPegdirectly attached to theimplant or abutment.The SmartPeg is excitedby an electromagneticpulse and the measuredresonance frequency isoutputted as an ImplantStability Quotient (ISQ)value.	Slight difference in datatransfer, through wirelessvs. wired connection.does not raise differentsafety or efficacyquestions, andperformance was verifiedby extensive softwarevalidation, therefore,substantially equivalent
Mechanism ofaction	InnerView LC lightly percusses thebuccal side of tooth/implant with afree-floating percussion probe,collects energy feedback, calculatesand displays the results as energyreturn graph and loss coefficient,which is also the measure oftooth/implant mobility.	Periometer lightly percusses buccalside of the tooth/implant with a free-floating percussion probe, collectsenergy feedback, calculates anddisplays the results as energy returngraph and loss coefficient, which isalso the measure of tooth/implantmobility.	NA	Same
Tapping activation	The force sensor in the handpieceautomatically activates solenoidcoil, which moves the percussionprobe in a linear motion, andinitiates tapping when the tip ispressed against the tooth/implant.	A button on the handpiece is pressedto manually activate solenoid coil,which moves the percussion probe ina linear motion, and initiates tappingwhen the tip is positioned on thetooth/implant.	NA	Automatic vs. manualtapping activation is foruser convenience onlyand does not impactperformance as verifiedby performance testing,therefore, substantiallyequivalent
Data acquisition	The piezo sensor in the handpiecedetects the amount force absorbedby tooth/implant, the response datais converted to energy return graphand LC is calculated.	The piezo sensor in the handpiecedetects the amount force absorbed bytooth/implant, the response data isconverted to energy return graph andLC is calculated.	Electronics in themeasurement probedetect the responsesignal from thedetection coil in the tipand calculates thefrequency of theresponse as ISQ.	Same
Data transfer	Data is transferred to PC via USBconnection from base station, whichcommunicates with handpiecewirelessly.The system uses Windows basedsoftware application for viewing andanalyzing of the measured data. Thesystem has cloud connection fordata storage, calculation of losscoefficient and is not integral to theclinical functioning of the device.	Data is transferred to PC via USBconnection from base station, whichcommunicates with handpiece viawired connection.The system uses Windows basedsoftware application enabling storageand viewing of measured data.	NA. Handpiece has abuilt-in display.The measurement datacan be transferred tocloud- based ISQ DataManager Software viaUSB/PC connection forviewing and monitoringthe measurementresults.The device has cloudconnection/ Bluetoothdata communication.	Convenience only,software performancesupported byverification/validationtesting. Also referencedevice has a cloudconnection for datatransfer and monitoring,therefore, substantiallyequivalent
User Interface	PC	PC	Graphical display onHandpiece	Same
Power supply	USB interface (base station) /rechargeable Li-Po battery(handpiece)	Medical grade power supply	Rechargeable Li-ionbattery	Convenience only,therefore, substantiallyequivalent
Calibration	In house prior to shipment	At point of use by user	NA	Convenience only,therefore, substantiallyequivalent
Operation	Device cannot operate/measurewhile charging	Device is wired, and has no downtimefor charging	Device cannotoperate/measure whilecharging	No performance impact,same as reference device,therefore, substantiallyequivalent
Contact Force	Less than 36N	Less than 36N	NA	Same
Number of taps	5 per measurement at 4 µs increments	16 per measurement at 3.3 µsincrements	NA	No performance impact,therefore, substantiallyequivalent
Output Value(s)	Energy Return Graph (ERG) andLoss Coefficient (LC)	Energy Return Graph (ERG) and LossCoefficient (LC)	Frequency response asImplant StabilityQuotient (ISQ) value	Same
Patient Contact	Percussion probe does not directlycontact the tooth/implant.	Percussion probe is in direct contactwith tooth/implant	NA	Improved infectioncontrol protocol,therefore, substantiallyequivalent.
ReprocessingMethod	Cleaning and disinfection ofhandpiece and base station whichcannot be autoclaved.Handpiece is used with disposablebarrier sleeve. Single use disposablefilm tips equipped with chip sensorprevent reuse.	Cleaning and sterilization (viaautoclave) of reusable handpiece andtips.	Device cannot beautoclaved, must beused with a transparentbarrier sleeve.Cleaning anddisinfection in the eventof barrier sleeve_damageSmartpeg/single patientuse	Improved infectioncontrol protocol, barriersleeve/disinfection usedfor reusable handpiecethat cannot withstandsterilization, is consistentwith reference device,therefore, substantiallyequivalent
Handpiecehousing	Medical grade polycarbonate	Chrome-plated brass & nickel	ABS and PC plastic	Biocompatible materials,therefore, substantiallyequivalent
Percussionrod/probe	Stainless steel	Stainless steel	ABS plastic	Same
Tip	Medical grade polypropylene. Thesame material used for filmmembrane.	Medical grade plastic (Derlin)	ABS plastic	Biocompatible materials,therefore, substantiallyequivalent
Base Station	Medical grade polycarbonate	Stainless steel	NA	Design simplicity only,therefore, substantiallyequivalent

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PERFORMANCE DATA VII.

The InnerView LC was evaluated in accordance with FDA Guidance Document "Dental Handpieces - Premarket Notification [510(k)]" and "Reprocessing Medical Devices in Health Care Setting".

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

The biocompatibility evaluation of the InnerView LC was conducted in accordance with the FDA's guidance document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and recognized consensus standards ISO 10993-1:2018" Biological evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk management Process" and ISO 7405:2018 "Dentistry- Evaluation of biocompatibility of medical devices used in dentistry". The battery of testing included cytotoxicity, sensitization, and irritation. The results demonstrate biocompatibility of the patient-contacting device components.

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the InnerView LC. The results demonstrate compliance with the IEC 60601-1 and IEC 60601-1-6 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation

Software verification and validation was performed, and documentation provided in accordance with the FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" and "Guidance for the Content of Premarket Submission of Management of Cyber Security in Medical Devices". The software for this device was considered an a "moderate" level of concern since a failure or latent flaw in the software could result in a minor injury or delayed treatment. The results of the software testing demonstrate that the InnerView LC performs according to specifications and functions intended. Software design and documentation comply with the IEC 62304 standard "Medical device software lifecycle processes".

Bench Testing

Performance testing of the InnerView LC was conducted to support substantial equivalence determination. The results demonstrate that the InnerView LC performs as well as the predicate, Periometer.

Clinical Studies

Clinical studies were not performed since the intended use and indications for use are the same and performance characteristics are equivalent.

VIII. CONCLUSION

Based on the information above, the InnerView LC is deemed substantially equivalent to the predicate device, Periometer, cleared under K072213.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.