(35 days)
Not Found
No
The summary describes a standard OCT imaging system with image review and manipulation software, and there is no mention of AI or ML capabilities for image analysis, interpretation, or other functions.
No.
The device is described as an "imaging tool" used for "evaluation of excised human tissue microstructure" and provides "real-time depth visualization." Its function is to produce images and assist in identifying and annotating regions of interest, not to treat or cure a disease or condition.
Yes
The device is described as an "imaging tool in the evaluation of excised human tissue microstructure" and provides "real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest," indicating its use in diagnostic assessment.
No
The device description explicitly states it is an "imaging tool" based on optical coherence tomography (OCT) and uses "non-ionizing, low-power optical radiation" to produce images. This indicates the presence of hardware components for image acquisition, not just software for processing or analysis.
Based on the provided information, the OTIS 2.0 Optical Coherence Tomography System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "as an imaging tool in the evaluation of excised human tissue microstructure". While it uses excised tissue, the evaluation is done through imaging and visualization of the tissue's structure, not through the analysis of biological samples (like blood, urine, or tissue fluids) for diagnostic information about a patient's health status.
- Device Description: The description focuses on the imaging technology (OCT) and how it produces images based on the optical properties of the tissue. It doesn't mention any analysis of biological markers or substances within the tissue.
- Lack of IVD Characteristics: The description and intended use do not align with the typical definition of an IVD, which involves examining specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
The device is an imaging system used to visualize the physical structure of excised tissue, which is a different function than an IVD.
N/A
Intended Use / Indications for Use
The OTIS 2.0 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™ 2.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.0 is based on optical coherence tomography (OCT) imaging, and it 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™ 2.0 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems and, specifically, the predicate Perimeter OTIS 1B System (K171560). Like its predicate, the Perimeter OTIS™ 2.0 has automated the OCT scanning of the specimen surface, standardizing the image collection process.
The Perimeter OTIS™ 2.0 includes a white light image (photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the photograph and the OCT image scan position. The Perimeter OTIS™ 2.0 also includes user interface options, such as the ability to "scroll" through the OCT images, across a specimen's surface, as well as to zoom and pan in more closely to examine areas of interest, as desired.
Mentions image processing
Not Found
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)
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™ 2.0 fulfilled the intended use and met user needs.
Perimeter validated the usability of the OTIS™ 2.0 per IEC 62366:2015 -Application of usability engineering to medical devices. Testing was performed with representative users in a simulated use environment.
Perimeter validated that the OTIS™ 2.0 can obtain OCT images with sufficient image quality to identify excised tissue microstructure features, at a level comparable to other OCT imaging systems, including the predicate device, OTIS 1B.
External laser, basic safety and electromagnetic compatibility testing successfully demonstrated the safety of OTIS™ 2.0 in its intended environment. OTIS™ 2.0 is classified as a class 1 laser per IEC 60825-1:2007, requiring no special optical safety precautions.
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.
Perimeter OTIS™ 1B, K171560
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.
Not Found
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.
0
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, Inc. % Cindy Domecus Regulatory Consultant Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, California 94010
March 26, 2019
Re: K190404
Trade/Device Name: OTIS Optical Coherence Tomography SY stem Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: February 15, 2019 Received: February 19, 2019
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sincerely,
Neil R
Digitally signed by Neil
R Ogden -S
Ogden -S
Date: 2019.03.26
13:52:07 -04'00'
For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director
Division of Surgical Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190404
Device Name
OTIS 2.0 Optical Coherence Tomography Imaging System
Indications for Use (Describe)
The OTIS 2.0 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) |
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
SECTION 5 510(K) SUMMARY
4
K190404
510(k) Summary
1. Basic Information - 510(k) Owner
| 510k) Owner: | Perimeter Medical Imaging, Inc. |
|---|---|
| Address: | 1 Yonge Street, Suite 201 |
| Toronto, Ontario, Canada | |
| Phone: 647-360-0302 | |
| Official Contact: | Cindy Domecus, R.A.C. (US & EU) |
| Principal | |
| Domecus Consulting Services LLC | |
| Date Summary Prepared: | March 13, 2019 |
2. Device Name
Trade Name: Perimeter OTIS™ 2.0 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™ 1B, K171560
4. Device Description
The Perimeter OTIS™ 2.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS™ 2.0 is based on optical coherence tomography (OCT) imaging, and it 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
5
K190404
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™ 2.0 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems and, specifically, the predicate Perimeter OTIS 1B System (K171560). Like its predicate, the Perimeter OTIS™ 2.0 has automated the OCT scanning of the specimen surface, standardizing the image collection process.
The Perimeter OTIS™ 2.0 includes a white light image (photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the photograph and the OCT image scan position. The Perimeter OTIS™ 2.0 also includes user interface options, such as the ability to "scroll" through the OCT images, across a specimen's surface, as well as to zoom and pan in more closely to examine areas of interest, as desired.
5. Indications for Use
The OTIS™ 2.0 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™ 2.0
[Subject Device] | Perimeter OTIS™ 1B
[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 2.0 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 ± 15 µm | Same |
| Optical Source | Super Luminescent Diode | Same |
6. Predicate Device Comparison
6
| Characteristic | Perimeter OTIS™ 2.0
[Subject Device] | Perimeter OTIS™ 1B
[Predicate Device] |
|---------------------------------|--------------------------------------------|------------------------------------------|
| Optical Radiation Safety | Safe for Indicated Use
Class 1 Laser | Same |
| Lateral Resolution | 20 µm | Same |
| Lateral Range | 870 mm | 500 mm |
| Axial Resolution | 10 - 15 µm in tissue | Same |
| Scan Acquisition Time |