The OTIS 1.0 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-section, real-time depth visualization.
The Perimeter Optical Tissue Imaging System (OTIS) 1.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS 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 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems. However, rather than requiring the clinician to move his/her hand to collect "point-by-point" images, the Perimeter OTIS has automated the OCT scanning of the specimen surface, standardizing the image collection process.
The Perimeter OTIS also includes a white light image (e.g., photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the white light image and the OCT image scan position. In addition, the Perimeter OTIS 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.
The provided document is a 510(k) premarket notification FDA letter for the Perimeter OTIS™ 1.0 Optical Coherence Tomography System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics.
Based on the provided text, there is NO explicit table of acceptance criteria or specific quantitative performance metrics reported for the device's ability to "differentiate normal versus specific abnormalities" or for "diagnostic analysis." In fact, the FDA letter specifically states a limitation regarding this:
"The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specified disease has not been evaluated."
Therefore, many of the requested details about acceptance criteria and study results cannot be fully extracted from this document, as the device's diagnostic performance for differentiating abnormalities was not evaluated in this submission.
However, I can extract information related to the device's technical performance and usability as presented for the 510(k) submission, and the general approach to validating the device for its indicated use.
Here's an attempt to answer the questions based solely on the provided text, highlighting what is available and what is explicitly stated as not evaluated:
Acceptance Criteria and Device Performance (Based on available information)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by the document) | Specific Acceptance Criteria (Explicitly stated or derivable) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use | The device is to be an imaging tool for evaluating excised human tissue microstructure by providing 2D, cross-section, real-time depth visualization. | "The OTIS 1.0 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-section, real-time depth visualization." (Stated as the intended use, implying it meets this functionality) |
| Image Quality / Microstructure Identification | Obtain OCT images with sufficient image quality to identify tissue microstructure features comparable to other OCT imaging systems. | "Perimeter validated that the OTIS can obtain OCT images with sufficient image quality to identify tissue microstructure features as compared to histopathology, at a level comparable to other OCT imaging systems." (No quantitative metrics provided, only a qualitative statement of comparability.) |
| Resolution (Technical Specifications) | Lateral Resolution: As good as or better than predicate devices (≤ 50 μm). Axial Resolution: As good as or better than predicate devices (≤ 15 μm). | Lateral Resolution: ≤ 50 μm (Matches predicate and meets/exceeds typical spec for this technology). Axial Resolution: ≤ 15 μm (Matches predicate and meets/exceeds typical spec for this technology). |
| Tissue Penetration (Technical Specifications) | In-depth tissue range: As good as or better than predicate devices (1.5 mm in tissue). | 1.5 mm in tissue [minimum of 2.2 mm in free space (7mm)] (Matches predicate devices). |
| Laser Safety Classification | Meet laser safety standards, aiming for lowest possible classification. | Class 1 Laser (per IEC 60825-1:2014), requiring no special optical safety precautions. (This is safer than predicate Class 3R lasers, indicating improved safety performance). |
| Electrical Safety & EMC | Comply with relevant IEC standards for electrical safety and electromagnetic compatibility. | "External laser, electrical, and EMC testing successfully demonstrated the safety of the Perimeter OTIS in its intended environment." (Implicitly means it met the acceptance criteria defined by these standards, e.g., IEC 60601-1 and IEC 60601-1-2). |
| Usability | Demonstrate usability per IEC 62366. | "Perimeter validated the usability of the OTIS per IEC 62366:2007 – Application of usability engineering to medical devices. Testing was performed with representative users in actual and simulated use environments." (Implies successful completion of usability validation based on the standard's criteria, though specific metrics are not given.) |
| Software Life Cycle Management | AAMI ANSI IEC 62304 compliance. | The device was designed and developed under design controls per 21 CFR 820.30 and complied with AAMI ANSI IEC 62304. |
| Risk Management | ISO 14971 compliance. | The device was designed and developed under design controls per 21 CFR 820.30, in addition to risk management, ISO 14971:2007. |
Crucial Qualification: The document explicitly states: "The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specified disease has not been evaluated." This means the submission does not include studies on the device's diagnostic accuracy or clinical utility for differentiating pathologies. Its evaluation is focused on its role as an imaging tool to visualize microstructure.
2. Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated in the document. The statement "Perimeter validated that the OTIS can obtain OCT images with sufficient image quality to identify tissue microstructure features as compared to histopathology" implies a test set was used, but its size is not provided.
- Data Provenance: The document refers to "excised human tissue." It does not specify the country of origin of this data or if the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The document mentions comparison to "histopathology" as the ground truth, which implies expert pathology review, but details on the number and qualifications of pathologists are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study involving human readers with AI assistance was performed or reported. This device is an imaging tool, not one that incorporates AI for diagnostic assistance. The focus of the 510(k) was on comparing technical and functional equivalence to predicate OCT imaging systems.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance for diagnostic purposes was done or reported. The device generates images for human interpretation. The "Perimeter validated that the OTIS can obtain OCT images with sufficient image quality to identify tissue microstructure features as compared to histopathology" refers to the image quality generated by the device, not an automated diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Histopathology was used as the ground truth for evaluating the image quality's ability to identify tissue microstructure features.
8. The sample size for the training set:
- Not applicable / Not specified. This document describes a 510(k) submission for an imaging device based on established OCT technology, not a new AI/machine learning algorithm that requires distinct training and test sets in the conventional sense. The "development" and "validation" refer to device engineering and performance against specifications, not AI model training.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. As noted above, this context is not relevant to the type of device and submission described.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 13, 2016
Perimeter Medical Imaging, Inc. Elizabeth Munro Engineering Operations and Regulatory Lead 156 Front Street West, Suite 501 Toronto, M5J 2L6 CA
Re: K160240
Trade/Device Name: Perimeter OTIS™ 1.0 Optical Coherence Tomography System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: NOO Dated: April 8, 2016 Received: April 11, 2016
Dear Elizabeth Munro:
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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the warnings section of the device's labeling:
The safety and effectiveness of this device for diagnostic analysis (i.e. differentiating normal versus specific abnormalities) in any tissue microstructure or specified disease has not been evaluated."
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Furthermore, the indication for use "the OTIS 1.0 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-section, realtime depth visualization" must be prominently displayed in all labeling, including pouch box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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Sincerely yours,
William H. Maisel - S
William H. Maisel, MD, MPH Director (Acting) Office of Device Evaluation Deputy Center Director for Science Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160240
Device Name
OTIS 1.0 Optical Coherence Tomography System
Indications for Use (Describe)
The OTIS 1.0 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-section, real-time depth visualization.
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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SECTION 6 510(K) SUMMARY
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510(k) Summary
1. Basic Information - Submitter
| 510(k) Owner: | Perimeter Medical Imaging, Inc. |
|---|---|
| Address: | 156 Front Street West, Suite 501Toronto, Ontario, Canada, M5J 2L6 |
| Official Contact: | Elizabeth MunroEngineering Operations and Regulatory Lead(844) 492-9793(416) 977-1955 (fax)emunro@perimetermed.com |
Date Summary Prepared: January 29, 2016
2. Device Name
Trade Name: Perimeter OTIS™ 1.0 Optical Coherence Tomography (OCT) System Common Name: Optical Coherence Tomography (OCT) System Classification Name: Ultrasonic pulsed echo imaging system Regulatory Classification: 21 CFR 892.1560 Product Code: NQQ Classification: Class II
3. Legally Marketed Predicate Devices
Imalux OCT Imaging Svstem. K033783 Imalux Niris™ Imaging System, K042894
4. Device Description
The Perimeter Optical Tissue Imaging System (OTIS) 1.0 is an imaging tool for use on excised human tissue. The Perimeter OTIS 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 collects and displays OCT images of human tissue with comparable image quality to other previously 510(k)-cleared OCT imaging systems. However, rather than requiring the clinician to move his/her hand to collect "point-by-point" images, the
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Perimeter OTIS has automated the OCT scanning of the specimen surface, standardizing the image collection process.
The Perimeter OTIS also includes a white light image (e.g., photograph) of the specimen, to assist the clinician in viewing the OCT images with a reference to the white light image and the OCT image scan position. In addition, the Perimeter OTIS 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. Intended Use
The OTIS 1.0 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing twodimensional, cross-sectional, real-time depth visualization.
| PRODUCT COMPARISON TABLE | |||
|---|---|---|---|
| Perimeter OTIS™[New Device] | Imalux Niris™ ImagingSystem[Predicate - K042894] | Imalux OCT ImagingSystem[Predicate - K033783] | |
| Measurement Technique | Optical CoherenceTomography | Optical CoherenceTomography | Optical CoherenceTomography |
| Center Wavelength[NIR: 700 - 1400 nm] | 1325 ± 20 nm | 1310 ± 15 nm | 975 ± 15 nm |
| Optical Source | Super Luminescent Diode | Super Luminescent Diode | Super Luminescent Diode |
| Optical Radiation Safety | Safe for Indicated Use,Class 1 Laser | Safe for Indicated Use,Class 3R Laser | Safe for Indicated Use,Class 3R Laser |
| Lateral Resolution | ≤ 50 μm | ≤ 50 μm | ≤ 50 μm |
| Lateral Range (x-axis):Single B-scanWF-OCT Scan | (1.7 mm) 2 mm500 mm [250 2 mm-strips] | 2 mm[Point-by-point by clinician] | 2 mm[Point-by-point by clinician] |
| Axial Resolution[free space units] | ≤ 15 μm | ≤ 15um | ≤ 15 μm |
| In-depth tissue range[free space units] | 1.5 mm in tissue[minimum of 2.2 mm in freespace (7mm)] | 1.5 mm in tissue[2.2 mm in free space] | 1.5 mm in tissue[2.2 mm in free space] |
| Patient Applied Part | No Patient Applied Part | Handheld Fiber OpticProbe | Handheld Fiber OpticProbe |
| Input Devices:KeyboardPointingFoot pedal (optional) | YesYesNo | YesYesYes - Optional | YesYesYes - Optional |
| Electrical VoltageFrequency | 108-132 V,60 Hz [North America Use] | 90-132 V, 198-264 V50/60 Hz | 90-132 V, 198-264 V50/60 Hz |
6. Substantial Equivalence Summary
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Product and Quality Management Standards 7.
The Perimeter OTIS was designed and developed under design controls per 21 CFR 820.30, in addition to risk management, ISO 14971:2007 Application of Risk Management to Medical Devices.
In addition, testing was performed to ensure that the Perimeter OTIS complies with the following recognized standards:
- IEC 60825-1:2014, Safety of Laser Products Part 1: Equipment Classification . and Requirements
- AAMI ANSI IEC 62304 Medical Device Software Software Life Cycle . Management
- . AAMI ANSI ISO 15223-1:2012 Medical Devices – Symbols to be used with Medical Devices Labels, Labeling and Information to be Supplied - Part 1: General Requirements
- . AAMI ANSI ISO 10993-1:2014 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process
- AAMI ANSI ES 60601-1: 2005/(R)2012, A1:2012, C1:2009/(R)2012 and . A2:2010/(R)2012 Medical Electrical Equipment - Part 1 - General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General . Requirements for the Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
8. Technological Characteristics
The Perimeter OTIS is substantially equivalent to the Imalux Niris™ Imaging System [K042894] and the Imalux OCT Imaging System [K033783] as all three devices use the same technology, Optical Coherence Tomography, and have the same intended use.
The Perimeter OTIS provides a standardized "stepping" of the OCT image acquisition probe across a pre-set scan area (e.g., 3 cm - 5 cm). This stepwise Perimeter OTIS surface scanning is analogous to a clinician manually moving the Imalux fiber optic probe step-by-step and acquiring an OCT image at each new position. However, unlike the manual probe image acquisition of the predicate devices, the Perimeter OTIS performs this surface image acquisition by using an automated mechanical stage and precise probe positioning, without probe-tissue direct contact,
The Perimeter OTIS and the predicate devices use near infrared (NIR) light to produce Optical Coherence Tomography images. The Perimeter OTIS center wavelength is 1325 ± 20 nm, while the Imalux Niris™ Imaging System [K042894] center wavelength is 1310
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± 15 nm, and the Imalux OCT Imaging System [K033783] center wavelength is 975 ± 15 nm. Both predicate devices use a detachable, fiber optic probe which requires the operator to place and hold the probe on the correct location during image acquisition. The Perimeter OTIS positions the probe automatically during imaging the operator workload and ensuring consistent sample coverage. While the method of probe positioning is different, the intended use of the predicate devices and the Perimeter OTIS are the same and a comparison of their respective technologies and functional characteristics shows that the Perimeter OTIS is at least as safe and effective as the predicate devices for this intended use.
9. Performance and Safety Testing
Perimeter completed verification and validation activities under Perimeter Design Control procedures to ensure that verification studies demonstrated that outputs met input requirements, and that validation studies demonstrated that the Perimeter OTIS fulfilled the intended use and user needs.
Perimeter validated the usability of the OTIS per IEC 62366:2007 – Application of usability engineering to medical devices. Testing was performed with representative users in actual and simulated use environments.
Perimeter validated that the OTIS can obtain OCT images with sufficient image quality to identify tissue microstructure features as compared to histopathology, at a level comparable to other OCT imaging systems.
External laser, electrical, and EMC testing successfully demonstrated the safety of the Perimeter OTIS in its intended environment. Perimeter OTIS employs a near infrared super luminescent diode for optical image acquisition, as well as a surface sensing laser system. Both laser systems are classified as Class 1 laser, per IEC 60825-1.2014, requiring no special optical safety precautions. This laser classification of Class 1 is a lower (safer) laser classification level than the predicate devices (Class 3R).
10. Conclusions
Perimeter Medical Imaging, Inc. has demonstrated that the OTIS™ 1.0 Optical Coherence Tomography System has the same intended use and is substantially equivalent to its predicate devices, the Imalux Niris™ Imaging System and the Imalux OCT Imaging System. The Perimeter OTIS also complies with recognized standards and guidelines for electrical safety, laser safety, and biocompatibility. Testing has demonstrated that the device is as safe, as effective, and performs as well or better than the predicate devices.
§ 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.