(80 days)
Not Found
No
The summary describes standard OCT imaging and image processing techniques, with no mention of AI or ML. The focus is on automated scanning and image manipulation for review and annotation.
No.
The device is described as an imaging tool for evaluation and visualization of excised human tissue microstructure, rather than for treatment or therapy.
Yes
The intended use explicitly states that the device is "an imaging tool in the evaluation of excised human tissue microstructure," which implies it is used to assess or determine the condition of the tissue.
No
The device description explicitly states it is an "imaging tool" based on optical coherence tomography (OCT) and uses an interferometer, which are hardware components. The summary also mentions biocompatibility testing of a "Consumable Set" and external laser testing, further indicating the presence of hardware.
Based on the provided information, the OTIS 2.1 Optical Coherence Tomography System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is described 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." This focuses on providing visual information about the tissue structure.
- Device Description: The description emphasizes its function as an imaging tool using OCT technology to produce images of the tissue sample.
- Lack of Diagnostic Claim: There is no mention of the device being used to diagnose a disease, condition, or state of health. It provides images for evaluation, but the interpretation and diagnostic conclusion would be made by a qualified professional based on those images.
- No Mention of Analyzing Biological Samples for Diagnostic Information: IVD devices typically analyze biological samples (like blood, urine, tissue) to provide information for diagnosis. While this device images tissue, it's focused on the structural visualization rather than analyzing biomarkers or other diagnostic indicators within the tissue.
In summary, the OTIS 2.1 is an imaging device used to visualize the structure of excised tissue. It does not perform a diagnostic test on the tissue itself.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NQQ
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.
Mentions image processing
optimized image acquisition and processing
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography
Anatomical Site
excised human tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
| 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 110 |
| Toronto, Ontario, Canada | |
| Phone: 647-360-0302 | |
| Official Contact: | Cindy Domecus, R.A.C. (US & EU) |
| Principal | |
| Domecus Consulting Services LLC | |
| DomecusConsulting@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
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
Perimeter OTIS™ 2.1 - Special 510(k) Submission
4
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 human
tissue microstructure by providing two-
dimensional, cross-sectional, real-time depth
visualization. | Same |
| Indications for Use | 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, cross-sectional, real-time depth
visualization, with image review manipulation
software for identifying and annotating
regions 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 Use
Class 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 |