The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest.

Device Description

The Perimeter OTIS™ 2.1 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.1 is based on optical coherence tomography (OCT) imaging, which is similar to ultrasound, but uses non-ionizing, low-power optical radiation to produce high resolution, sub-surface images of a tissue sample. Due to the extremely high velocity of light, optical echoes (reflected and backscattered light from the sample) cannot be measured directly using a photodetector. Instead, OCT devices use an interferometer to compare a reference beam of light to the backscattered light returning from the tissue sample. The features in an OCT image are created by changes in the optical properties (namely scattering, absorption, and index of refraction) of the sample. The Perimeter OTIS™ 2.1 collects and displays OCT images of human tissue with comparable image quality to the predicate Perimeter OTIS 2.0 System (K190404). Like its predicate, the Perimeter OTIS™ 2.1 has automated the OCT scanning of the specimen surface, standardizing the image collection process and facilitating image manipulation for review and annotation. OTIS 2.1 allows for the concurrent image review and acquisition.

AI/ML Overview

The provided text does not contain detailed acceptance criteria, device performance data beyond general statements, nor a specific study demonstrating how the device meets such criteria. It primarily focuses on the device's substantial equivalence to a predicate device (Perimeter OTIS™ 2.0, K190404) based on similar intended use, indications for use, principles of operation, and technological characteristics.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can and cannot be answered based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available. The document states that "verification studies demonstrated that outputs met design input requirements, and that validation studies demonstrated that the Perimeter OTIS™ 2.1 fulfilled the intended use and met user needs." However, specific quantitative acceptance criteria or detailed performance metrics are not provided. The table of characteristics (on page 5) compares the subject device (OTIS 2.1) to the predicate (OTIS 2.0) and states "Same" for all listed technical specifications, implying the performance is expected to be identical to the predicate, but it doesn't present acceptance criteria or reported performance outcomes against those criteria.

2. Sample size used for the test set and the data provenance:

Not available. The document mentions "verification and validation activities" and "design verification and validation testing," but does not provide information on the sample size of any test sets (e.g., number of tissue samples tested). Data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not available. The document describes the device as an "imaging tool in the evaluation of excised human tissue microstructure." It does not mention any expert review or ground truthing process in the context of a clinical study or performance evaluation with human readers. The focus is on technical verification and validation against design inputs and the predicate device's performance.

4. Adjudication method for the test set:

Not applicable/Not available. No information about adjudication methods for a test set is provided, as there's no mention of expert evaluation of device outputs.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/Not available. The device, OTIS 2.1, is described as an "imaging tool" for "evaluation of excised human tissue microstructure." There is no indication that it includes AI or that an MRMC study was conducted to evaluate human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable/Not available. The device is an imaging system. The context of "standalone algorithm performance" typically applies to AI/ML software devices. While the system has "image review manipulation software," the document does not discuss any standalone algorithm performance or AI features.

7. The type of ground truth used:

Not available/Implicitly technical specifications. Given that the document mainly focuses on showing equivalence to a predicate and meeting design inputs through "verification and validation activities," the "ground truth" implicitly refers to the device's technical specifications and the expected image quality for human evaluation, rather than a clinical ground truth like pathology or outcomes data for automated diagnosis or detection. The document specifies objective characteristics like "Lateral Resolution" and "Axial Resolution" as being the "Same" as the predicate.

8. The sample size for the training set:

Not applicable/Not available. This device is an imaging system, not explicitly described as an AI/ML device that would require a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable/Not available. As above, a "training set" and its ground truth are not relevant to the information provided about this device.

In summary, the provided FDA document is a 510(k) summary for a "Special 510(k) Submission" seeking clearance for an updated version of an already cleared device (OTIS 2.0). The primary claim is substantial equivalence due to minor changes that do not affect the fundamental scientific technology or intended use. This type of submission relies heavily on demonstrating that the updated device performs identically to the predicate in its core functions and meets established safety and performance standards for imaging systems, rather than presenting new clinical study data with specific acceptance criteria and detailed performance metrics against a defined ground truth.

Summary

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Perimeter Medical Imaging AI, Inc. % Cindy Domecus Regulatory Consultant Domecus Consulting Services, LLC 1171 Barroihet Avenue, Hillsborough, California 94010

February 25, 2021

Re: K203578

Trade/Device Name: OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NQQ Dated: January 29, 2021 Received: February 1, 2021

Dear Cindy Domecus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Neil R.P. Ogden Assistant Director, THT4A4 DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control 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) K203578

Device Name

OTIS 2.1 Optical Coherence Tomography Imaging System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K203578 510(k) Summary

1. Basic Information - 510(k) Owner

510(k) Owner:	Perimeter Medical Imaging AI, Inc.
Address:	359 Eastern Avenue, Suite 110Toronto, Ontario, CanadaPhone: 647-360-0302
Official Contact:	Cindy Domecus, R.A.C. (US & EU)PrincipalDomecus Consulting Services LLCDomecusConsulting@comcast.net
Date Summary Prepared:	December 3, 2020

2. Device Name

Trade Name: Perimeter OTIS™ 2.1 and THiA™

Common Name: Optical Coherence Tomography System

Classification Name: Ultrasonic pulsed echo imaging system

Requlatory Classification: 21 CFR 892.1560

Product Code: NQQ

Classification: Class II

3. Legally Marketed Predicate Devices

Perimeter OTIS™ 2.0, K190404

4. Device Description

Perimeter OTIS™ 2.1 - Special 510(k) Submission

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from the sample) cannot be measured directly using a photodetector. Instead, OCT devices use an interferometer to compare a reference beam of light to the backscattered light returning from the tissue sample. The features in an OCT image are created by changes in the optical properties (namely scattering, absorption, and index of refraction) of the sample.

The Perimeter OTIS™ 2.1 collects and displays OCT images of human tissue with comparable image quality to the predicate Perimeter OTIS 2.0 System (K190404). Like its predicate, the Perimeter OTIS™ 2.1 has automated the OCT scanning of the specimen surface, standardizing the image collection process and facilitating image manipulation for review and annotation. OTIS 2.1 allows for the concurrent image review and acquisition.

5. Indications for Use

The OTIS™ 2.1 is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, realtime depth visualization with image review manipulation software for identifying and annotating regions of interest.

Characteristic	Perimeter OTIS™ 2.1[Subject Device]	Perimeter OTIS™ 2.0[Predicate Device]
Intended Use	Imaging tool in the evaluation of humantissue microstructure by providing two-dimensional, cross-sectional, real-time depthvisualization.	Same
Indications for Use	The OTIS 2.1 Optical Coherence TomographySystem is indicated for use as an imagingtool in the evaluation of excised human tissuemicrostructure, by providing two-dimensional, cross-sectional, real-time depthvisualization, with image review manipulationsoftware for identifying and annotatingregions of interest.	Same
Measurement Technique	Optical Coherence Tomography	Same
Center Wavelength	$1325 \pm 15 \mu$ m	Same
Optical Source	Super Luminescent Diode	Same
Optical Radiation Safety	Safe for Indicated UseClass 1 Laser	Same
Lateral Resolution	$20 \mu$ m	Same
Lateral Range	870 mm	Same
Axial Resolution	10 - 15 $\mu$ m in tissue	Same
Scan Acquisition Time	< 1 minute[5 x 5 cm area]	Same
Input Devices	Touchscreen	Same

6. Predicate Device Comparison

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Characteristic	Perimeter OTIS™ 2.1[Subject Device]	Perimeter OTIS™ 2.0[Predicate Device]
Electrical VoltageFrequency	108 - 132 V, 60 Hz[North American Use]	Same

7. Product and Quality Management Standards

The OTIS™ 2.1 was designed and developed under design controls per 21 CFR 820.30 and ISO 13485:2016. The following standards were followed:

ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007) Medical . Devices - Applications of Risk Management to Medical Devices
AAMI ANSI ES 60601-1:2005/(R)2012, A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 Medical Electrical Equipment – Part 1, Basic Safety and Essential Performance
IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment Part 1-2: ● General Requirements for the Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Disturbances - Requirements and Tests
. IEC 60825-1:2007, Safety of Laser Products - Part 1 Equipment Classification and Requirements
ANSI AAMI ISO 10993-1:2009/(R)2013 Biological Evaluation of Medical ● Devices – Part 1: Evaluation and Testing with a Risk Management Process
ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation of Medical ● Devices – Part 5: Tests for In Vitro Cytotoxicity
IEC 62304:2006/A1:2015 Medical Device Software Software Life Cycle . Processes AAMI ANSI ES 60601-1:2005 - Basic Safety and Essential Performance

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8. Technological Characteristics

The subject of this Special 510(k) submission is a device enhancement to provide an updated version of the predicate OTIS 2.0 device that has a smaller cart foot print, a faster PC, design improvements for manufacturability, component updates to address obsolescence and ensure longer useful life of the product and optimized image acquisition and processing, graphical user improvements for streamlined user experience with consistent screen displays.

These updates do not affect the intended use or alter the fundamental scientific technology of the predicate device.

9. Performance and Safety Testing

Perimeter completed verification and validation activities under Perimeter's Design Control procedure. This ensured that verification studies demonstrated that outputs met design input requirements, and that validation studies demonstrated that the Perimeter OTIS™ 2.1 fulfilled the intended use and met user needs.

Design verification and validation testing for OTIS 2.1 was carried out using the same test protocols/methodology as was used to test OTIS 2.0. Established testing aqainst the same ISO/IEC standards as applicable for OTIS 2.0, was conducted as follows:

. Biocompatibility testing of the Consumable Set per ISO 10993-1:2009/(R)2013 and ISO 10993-5:2009/(R)2014.
. External laser, basic safety and electromagnetic compatibility testing successfully demonstrated the safety of OTIS™ 2.1 in its intended environment.

10. Conclusions

Perimeter's OTIS 2.1 has the same intended use, indications for use, principles of operation and same technological characteristics as compared to the predicate device. The minor differences implemented in the OTIS 2.0 platform to create OTIS 2.1 do not raise different questions of safety and effectiveness.

Design verification and validation testing demonstrates that OTIS 2.1 Optical Coherence Tomography Imaging System is as safe and effective as the predicate device and is substantially equivalent to OTIS 2.0.

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.