InnerView LC

K232657 · Perimetrics, Inc. · EKX · Sep 1, 2023 · Dental

Device Facts

• Record ID: K232657
• Device Name: InnerView LC
• Applicant: Perimetrics, Inc.
• Product Code: EKX · Dental
• Decision Date: Sep 1, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

InnerView LC is an electromagnetically driven percussion system for dental professionals to quantify tooth and implant mobility. Input: percussion data generated by lightly tapping the buccal surface of a tooth or implant with a free-floating probe. Operation: a piezo sensor in the handpiece detects force absorption; data is wirelessly transmitted to a base station, then via USB to a PC. The system calculates and displays an energy return graph and loss coefficient. Used in dental facilities; operated by dental professionals. Benefits: provides objective mobility data to aid clinical decision-making regarding periodontal or implant health. Features: wireless handpiece, single-use disposable film tips with security chips to prevent reuse, and cloud platform for data storage and loss coefficient calculation. The device is not sterilizable; requires cleaning, disinfection, and use of a barrier sleeve.

Clinical Evidence

No clinical studies were performed. Substantial equivalence was supported by bench testing, biocompatibility testing (ISO 10993-1, ISO 7405), electrical safety/EMC testing (IEC 60601-1, IEC 60601-1-2), and software verification/validation (IEC 62304). Bench testing demonstrated performance equivalent to the predicate.

Technological Characteristics

Electromagnetically driven percussion system. Handpiece housing: medical grade polycarbonate. Percussion probe: stainless steel. Tips: medical grade polypropylene. Sensing: piezo sensor. Connectivity: wireless handpiece to base station; USB to PC; cloud platform for data storage. Power: rechargeable Li-Po battery. Reprocessing: cleaning/disinfection and barrier sleeve (non-autoclavable). Software: moderate level of concern.

Indications for Use

Indicated for all dental patients to measure damping characteristics of the periodontium and associated fixed structures (teeth/implants) to quantify mobility.

Regulatory Classification

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.

Predicate Devices

• Periometer (K072213)

Reference Devices

• Osstell Beacon (K181888)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

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.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K232657

Device Name InnerView LC

Indications for Use (Describe)

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.

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/0 description: The image shows the word "perimetrics" in bold, black font. To the right of the word is a graphic of five curved lines in light blue. The lines are arranged in a way that suggests a wave or sound emanating from a source.

### K232657

## 510(k) Summary

#### I. SUBMITTER

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

Contact Person: Alicia Mszyca Tel. [phone]

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 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.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "perimetrics" in bold black font, followed by a series of curved blue lines that resemble sound waves. The word is written in lowercase letters and is the main focus of the image. The blue lines are arranged in a pattern that suggests movement or propagation of sound.

#### 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.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "perimetrics" in bold, black font. To the right of the word, there are five curved lines in light blue. The lines are arranged in a way that they appear to be emanating from a point, creating a visual effect similar to sound waves or a signal.

## Table 1: Device Comparison Table

| Characteristics | Subject device | Predicate device | Reference device | Comparison<br>subject vs predicate |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | InnerView LC<br>(subject device) | Periometer<br>K072213 | Osstell Beacon<br>K181888 | |
| Product code | EKX | EKX | EKX | Same |
| Intended use | InnerView LC is used to collect the<br>tooth/implant percussion data by the<br>dental professional. | Periometer Instrument is used to<br>collect the tooth/implant percussion<br>data by the dental professional. | Dental implant stability<br>analyzer | Same |
| Indications for Use | InnerView LC precisely<br>measures the damping characteristics<br>of the periodontium and its associated<br>fixed structures (teeth and/or<br>implants). It can provide data to<br>quantify tooth and/or dental implant<br>mobility. | Periometer is a unit that precisely<br>measures the damping characteristics<br>of the periodontium and its associated<br>fixed structures (teeth and/or<br>implants). It can provide data to<br>quantify tooth and/or dental implant<br>mobility | Osstell Beacon is<br>indicated for use in<br>measuring stability of<br>implants in the oral<br>cavity and maxillofacial<br>region. | Same |
| Target Population | All dental patients | All dental patients | All patients with<br>implants | Same |
| Environment of<br>Use | Professional use/dental facility | Professional use/dental facility | Professional use/dental<br>facility | Same |
| Components | The device includes hand-held,<br>wireless, battery driven<br>handpiece, single use disposable<br>film tips, base station with USB<br>interface for charging and data<br>transfer, and software. | The device includes wired hand-held<br>handpiece connected to the base<br>station via a cable, reusable tips,<br>power supply, USB cable for data<br>transfer, and software. | The device is a single<br>hand-held wireless<br>battery driven<br>handpiece with built-in<br>graphical display. The<br>device connects to a PC<br>via USB for charging<br>and includes cloud<br>connection/ Bluetooth<br>data communication. | Convenience only,<br>therefore, substantially<br>equivalent |
| Handpiece | Wireless | Wired | Wireless | Convenience only,<br>therefore, substantially<br>equivalent |
| Tips | Single-use disposable film tips,<br>discarded after single patient use. The<br>front opening of the tip is sealed with<br>a film membrane to prevent ingress of<br>fluids/cross-contamination. In<br>addition, tip has a built-in smart chip<br>sensor to detect reuse attempt. | Reusable, autoclavable after each use | NA<br>Tip built into handpiece.<br>System uses single use<br>Smartpegs. | Convenience only,<br>enhanced infection control<br>protocol, therefore,<br>substantially equivalent |
| Base Station | Stores and charges handpiece<br>battery, transfers percussion data to<br>PC via USB. Powered by USB<br>connection. | Powers handpiece and transfers<br>percussion data to PC via USB.<br>Powered by power supply. | NA | Convenience only,<br>therefore, substantially<br>equivalent |
| Principle of<br>Operation | InnerView LC transfers tooth<br>percussion data, generated by the<br>handpiece, wirelessly to the base<br>station, which forwards the data to the<br>user's PC via USB. Handpiece and<br>base station are automatically paired<br>when the handpiece is placed into the<br>base station. The software allows<br>acquisition of the percussion data and<br>returns output through the User<br>Interface. | Periometer transfers tooth percussion<br>data, generated by the handpiece, to<br>the base station by a wired<br>connection. The base station forwards<br>the data to the user's PC via USB.<br>The software allows acquisition of the<br>percussion data and returns output<br>through the User Interface. | Osstell Beacon<br>measures the frequency<br>response from SmartPeg<br>directly attached to the<br>implant or abutment.<br>The SmartPeg is excited<br>by an electromagnetic<br>pulse and the measured<br>resonance frequency is<br>outputted as an Implant<br>Stability Quotient (ISQ)<br>value. | Slight difference in data<br>transfer, through wireless<br>vs. wired connection.<br>does not raise different<br>safety or efficacy<br>questions, and<br>performance was verified<br>by extensive software<br>validation, therefore,<br>substantially equivalent |
| Mechanism of<br>action | InnerView LC lightly percusses the<br>buccal side of tooth/implant with a<br>free-floating percussion probe,<br>collects energy feedback, calculates<br>and displays the results as energy<br>return graph and loss coefficient,<br>which is also the measure of<br>tooth/implant mobility. | Periometer lightly percusses buccal<br>side of the tooth/implant with a free-<br>floating percussion probe, collects<br>energy feedback, calculates and<br>displays the results as energy return<br>graph and loss coefficient, which is<br>also the measure of tooth/implant<br>mobility. | NA | Same |
| Tapping activation | The force sensor in the handpiece<br>automatically activates solenoid<br>coil, which moves the percussion<br>probe in a linear motion, and<br>initiates tapping when the tip is<br>pressed against the tooth/implant. | A button on the handpiece is pressed<br>to manually activate solenoid coil,<br>which moves the percussion probe in<br>a linear motion, and initiates tapping<br>when the tip is positioned on the<br>tooth/implant. | NA | Automatic vs. manual<br>tapping activation is for<br>user convenience only<br>and does not impact<br>performance as verified<br>by performance testing,<br>therefore, substantially<br>equivalent |
| Data acquisition | The piezo sensor in the handpiece<br>detects the amount force absorbed<br>by tooth/implant, the response data<br>is converted to energy return graph<br>and LC is calculated. | The piezo sensor in the handpiece<br>detects the amount force absorbed by<br>tooth/implant, the response data is<br>converted to energy return graph and<br>LC is calculated. | Electronics in the<br>measurement probe<br>detect the response<br>signal from the<br>detection coil in the tip<br>and calculates the<br>frequency of the<br>response as ISQ. | Same |
| Data transfer | Data is transferred to PC via USB<br>connection from base station, which<br>communicates with handpiece<br>wirelessly.<br>The system uses Windows based<br>software application for viewing and<br>analyzing of the measured data. The<br>system has cloud connection for<br>data storage, calculation of loss<br>coefficient and is not integral to the<br>clinical functioning of the device. | Data is transferred to PC via USB<br>connection from base station, which<br>communicates with handpiece via<br>wired connection.<br>The system uses Windows based<br>software application enabling storage<br>and viewing of measured data. | NA. Handpiece has a<br>built-in display.<br>The measurement data<br>can be transferred to<br>cloud- based ISQ Data<br>Manager Software via<br>USB/PC connection for<br>viewing and monitoring<br>the measurement<br>results.<br>The device has cloud<br>connection/ Bluetooth<br>data communication. | Convenience only,<br>software performance<br>supported by<br>verification/validation<br>testing. Also reference<br>device has a cloud<br>connection for data<br>transfer and monitoring,<br>therefore, substantially<br>equivalent |
| User Interface | PC | PC | Graphical display on<br>Handpiece | Same |
| Power supply | USB interface (base station) /<br>rechargeable Li-Po battery<br>(handpiece) | Medical grade power supply | Rechargeable Li-ion<br>battery | Convenience only,<br>therefore, substantially<br>equivalent |
| Calibration | In house prior to shipment | At point of use by user | NA | Convenience only,<br>therefore, substantially<br>equivalent |
| Operation | Device cannot operate/measure<br>while charging | Device is wired, and has no downtime<br>for charging | Device cannot<br>operate/measure while<br>charging | No performance impact,<br>same as reference device,<br>therefore, substantially<br>equivalent |
| 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 µs<br>increments | NA | No performance impact,<br>therefore, substantially<br>equivalent |
| Output Value(s) | Energy Return Graph (ERG) and<br>Loss Coefficient (LC) | Energy Return Graph (ERG) and Loss<br>Coefficient (LC) | Frequency response as<br>Implant Stability<br>Quotient (ISQ) value | Same |
| Patient Contact | Percussion probe does not directly<br>contact the tooth/implant. | Percussion probe is in direct contact<br>with tooth/implant | NA | Improved infection<br>control protocol,<br>therefore, substantially<br>equivalent. |
| Reprocessing<br>Method | Cleaning and disinfection of<br>handpiece and base station which<br>cannot be autoclaved.<br>Handpiece is used with disposable<br>barrier sleeve. Single use disposable<br>film tips equipped with chip sensor<br>prevent reuse. | Cleaning and sterilization (via<br>autoclave) of reusable handpiece and<br>tips. | Device cannot be<br>autoclaved, must be<br>used with a transparent<br>barrier sleeve.<br>Cleaning and<br>disinfection in the event<br>of barrier sleeve_damage<br>Smartpeg/single patient<br>use | Improved infection<br>control protocol, barrier<br>sleeve/disinfection used<br>for reusable handpiece<br>that cannot withstand<br>sterilization, is consistent<br>with reference device,<br>therefore, substantially<br>equivalent |
| Handpiece<br>housing | Medical grade polycarbonate | Chrome-plated brass & nickel | ABS and PC plastic | Biocompatible materials,<br>therefore, substantially<br>equivalent |
| Percussion<br>rod/probe | Stainless steel | Stainless steel | ABS plastic | Same |
| Tip | Medical grade polypropylene. The<br>same material used for film<br>membrane. | Medical grade plastic (Derlin) | ABS plastic | Biocompatible materials,<br>therefore, substantially<br>equivalent |
| Base Station | Medical grade polycarbonate | Stainless steel | NA | Design simplicity only,<br>therefore, substantially<br>equivalent |

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains the word "perimetrics" in bold, black font. To the right of the word is a graphic of curved lines in a light blue color. The lines are arranged in a way that suggests a wave pattern. The overall design is simple and modern.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "perimetrics" in bold, black font. To the right of the word is a graphic of several curved, blue lines. The lines are arranged in a way that suggests a wave or sound pattern. The overall impression is of a modern and professional logo.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the word "perimetrics" in bold, black font. To the right of the word is a graphic of curved lines in a light blue color. The lines are arranged in a way that suggests a wave pattern. The overall impression is of a modern and professional logo.

{9}------------------------------------------------

# perimetrics )))

#### 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.