(1 days)
No
The summary describes a mechanics-based methodology and data collection system without mentioning any AI or ML components for analysis or interpretation.
No
The device is intended to measure the damping characteristics and quantify mobility, not to treat or modify a condition. Its function is diagnostic/measurement-based.
Yes
The device uses "non-invasive quantitative percussion diagnostics (QPD)" and "is intended to precisely measure the damping characteristic of the periodontium and its associated fixed structures (teeth and/or implants)" to "quantify tooth and/or dental implant mobility." These actions are characteristic of a diagnostic device, as they are used to identify or measure a condition.
No
The device description explicitly states that the InnerView LC consists of a wireless hand-held handpiece, base station, and disposable film tip, in addition to software. These are physical hardware components.
Based on the provided information, the InnerView LC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- InnerView LC Function: The InnerView LC directly interacts with the patient's teeth and implants by percussing them. It measures the mechanical response (damping characteristics and mobility) of these structures in situ within the patient's mouth.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient.
Therefore, the InnerView LC falls under the category of a medical device used for direct patient assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
EKX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontium and its associated fixed structures (teeth and/or implants)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional use/dental facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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) Testing: 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: Performed 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: Not performed since the intended use and indications for use are the same and performance characteristics are equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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)
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)
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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 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.
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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.
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Table 1: Device Comparison Table
| Characteristics | Subject device | Predicate device | Reference device | Comparison
subject vs predicate |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | InnerView LC
(subject device) | Periometer
K072213 | Osstell Beacon
K181888 | |
| Product code | EKX | EKX | EKX | Same |
| Intended use | InnerView LC is used to collect the
tooth/implant percussion data by the
dental professional. | Periometer Instrument is used to
collect the tooth/implant percussion
data by the dental professional. | Dental implant stability
analyzer | Same |
| Indications for Use | InnerView LC precisely
measures 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. | Periometer is a unit that precisely
measures 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 | Osstell Beacon is
indicated for use in
measuring stability of
implants in the oral
cavity and maxillofacial
region. | Same |
| Target Population | All dental patients | All dental patients | All patients with
implants | Same |
| Environment of
Use | Professional use/dental facility | Professional use/dental facility | Professional use/dental
facility | Same |
| Components | The device includes hand-held,
wireless, battery driven
handpiece, single use disposable
film tips, base station with USB
interface for charging and data
transfer, and software. | The device includes wired hand-held
handpiece connected to the base
station via a cable, reusable tips,
power supply, USB cable for data
transfer, and software. | The device is a single
hand-held wireless
battery driven
handpiece with built-in
graphical display. The
device connects to a PC
via USB for charging
and includes cloud
connection/ Bluetooth
data communication. | Convenience only,
therefore, substantially
equivalent |
| Handpiece | Wireless | Wired | Wireless | Convenience only,
therefore, substantially
equivalent |
| Tips | Single-use disposable film tips,
discarded after single patient use. The
front opening of the tip is sealed with
a film membrane to prevent ingress of
fluids/cross-contamination. In
addition, tip has a built-in smart chip
sensor to detect reuse attempt. | Reusable, autoclavable after each use | NA
Tip built into handpiece.
System uses single use
Smartpegs. | Convenience only,
enhanced infection control
protocol, therefore,
substantially equivalent |
| Base Station | Stores and charges handpiece
battery, transfers percussion data to
PC via USB. Powered by USB
connection. | Powers handpiece and transfers
percussion data to PC via USB.
Powered by power supply. | NA | Convenience only,
therefore, substantially
equivalent |
| Principle of
Operation | InnerView LC transfers tooth
percussion data, generated by the
handpiece, wirelessly to the base
station, which forwards the data to the
user's PC via USB. Handpiece and
base station are automatically paired
when the handpiece is placed into the
base station. The software allows
acquisition of the percussion data and
returns output through the User
Interface. | Periometer transfers tooth percussion
data, generated by the handpiece, to
the base station by a wired
connection. The base station forwards
the data to the user's PC via USB.
The software allows acquisition of the
percussion data and returns output
through the User Interface. | Osstell Beacon
measures the frequency
response from SmartPeg
directly attached to the
implant or abutment.
The SmartPeg is excited
by an electromagnetic
pulse and the measured
resonance frequency is
outputted as an Implant
Stability Quotient (ISQ)
value. | Slight difference in data
transfer, through wireless
vs. wired connection.
does not raise different
safety or efficacy
questions, and
performance was verified
by extensive software
validation, therefore,
substantially equivalent |
| Mechanism of
action | InnerView LC lightly percusses the
buccal side of tooth/implant with a
free-floating percussion probe,
collects energy feedback, calculates
and displays the results as energy
return graph and loss coefficient,
which is also the measure of
tooth/implant mobility. | Periometer lightly percusses buccal
side of the tooth/implant with a free-
floating percussion probe, collects
energy feedback, calculates and
displays the results as energy return
graph and loss coefficient, which is
also the measure of tooth/implant
mobility. | NA | Same |
| Tapping activation | The force sensor in the handpiece
automatically activates solenoid
coil, which moves the percussion
probe in a linear motion, and
initiates tapping when the tip is
pressed against the tooth/implant. | A button on the handpiece is pressed
to manually activate solenoid coil,
which moves the percussion probe in
a linear motion, and initiates tapping
when the tip is positioned on the
tooth/implant. | NA | Automatic vs. manual
tapping activation is for
user convenience only
and does not impact
performance as verified
by performance testing,
therefore, substantially
equivalent |
| Data acquisition | The piezo sensor in the handpiece
detects the amount force absorbed
by tooth/implant, the response data
is converted to energy return graph
and LC is calculated. | The piezo sensor in the handpiece
detects the amount force absorbed by
tooth/implant, the response data is
converted to energy return graph and
LC is calculated. | Electronics in the
measurement probe
detect the response
signal from the
detection coil in the tip
and calculates the
frequency of the
response as ISQ. | Same |
| Data transfer | Data is transferred to PC via USB
connection from base station, which
communicates with handpiece
wirelessly.
The system uses Windows based
software application for viewing and
analyzing of the measured data. The
system has cloud connection for
data storage, calculation of loss
coefficient and is not integral to the
clinical functioning of the device. | Data is transferred to PC via USB
connection from base station, which
communicates with handpiece via
wired connection.
The system uses Windows based
software application enabling storage
and viewing of measured data. | NA. Handpiece has a
built-in display.
The measurement data
can be transferred to
cloud- based ISQ Data
Manager Software via
USB/PC connection for
viewing and monitoring
the measurement
results.
The device has cloud
connection/ Bluetooth
data communication. | Convenience only,
software performance
supported by
verification/validation
testing. Also reference
device has a cloud
connection for data
transfer and monitoring,
therefore, substantially
equivalent |
| User Interface | PC | PC | Graphical display on
Handpiece | Same |
| Power supply | USB interface (base station) /
rechargeable Li-Po battery
(handpiece) | Medical grade power supply | Rechargeable Li-ion
battery | Convenience only,
therefore, substantially
equivalent |
| Calibration | In house prior to shipment | At point of use by user | NA | Convenience only,
therefore, substantially
equivalent |
| Operation | Device cannot operate/measure
while charging | Device is wired, and has no downtime
for charging | Device cannot
operate/measure while
charging | No performance impact,
same as reference device,
therefore, substantially
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
increments | NA | No performance impact,
therefore, substantially
equivalent |
| Output Value(s) | Energy Return Graph (ERG) and
Loss Coefficient (LC) | Energy Return Graph (ERG) and Loss
Coefficient (LC) | Frequency response as
Implant Stability
Quotient (ISQ) value | Same |
| Patient Contact | Percussion probe does not directly
contact the tooth/implant. | Percussion probe is in direct contact
with tooth/implant | NA | Improved infection
control protocol,
therefore, substantially
equivalent. |
| Reprocessing
Method | Cleaning and disinfection of
handpiece and base station which
cannot be autoclaved.
Handpiece is used with disposable
barrier sleeve. Single use disposable
film tips equipped with chip sensor
prevent reuse. | Cleaning and sterilization (via
autoclave) of reusable handpiece and
tips. | Device cannot be
autoclaved, must be
used with a transparent
barrier sleeve.
Cleaning and
disinfection in the event
of barrier sleeve_damage
Smartpeg/single patient
use | Improved infection
control protocol, barrier
sleeve/disinfection used
for reusable handpiece
that cannot withstand
sterilization, is consistent
with reference device,
therefore, substantially
equivalent |
| Handpiece
housing | Medical grade polycarbonate | Chrome-plated brass & nickel | ABS and PC plastic | Biocompatible materials,
therefore, substantially
equivalent |
| Percussion
rod/probe | Stainless steel | Stainless steel | ABS plastic | Same |
| Tip | Medical grade polypropylene. The
same material used for film
membrane. | Medical grade plastic (Derlin) | ABS plastic | Biocompatible materials,
therefore, substantially
equivalent |
| Base Station | Medical grade polycarbonate | Stainless steel | NA | Design simplicity only,
therefore, substantially
equivalent |
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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.
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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.
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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.
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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.