(85 days)
The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic B-scan Ultrasound system (K960622) to provide a three-dimensional visualization of the interior of the globe. The device is indicated when it is desirable to have a three-dimensional depiction (perspective rendering) of the interior of the globe for diagnostic purposes.
The 3D i-scan works in conjunction with the Ophthalmic Technologies Inc. (OTI) i-scan ophthalmic B-scan system. It automatically makes a series of 201 B-scans at different angles, and then combines them to produce a perspective image, called the "3D image." Scanning is done through a closed eye-lid. The 3D i-scan consists of a computer and computer monitor, and a mechanical scan assembly which holds the B-scan ultrasonic scanner and rotates it at a speed synchronized with the lateral scanning rate of the probe. Ultrasonic gel is used as a coupling medium between the transducer and the surface of the eye-lid. The computer system assembles the multiple images of the interior of the eye, all taken at a slightly different angle, and produces a three-dimensional representation of the interior of the eye on the computer monitor screen. Software facilities are included for a number of types of image manipulation, such as slicing, changing perspective or line, and measurement of distances, areas, and volumes.
The provided text describes a 510(k) submission for the Ophthalmic Technologies 3D i-scan, a program designed to convert ultrasound scans into perspective images for ophthalmic diagnosis. However, the document does not contain detailed acceptance criteria or a comprehensive study plan with explicit performance metrics.
Here's an analysis of the information available based on your request, with significant gaps noted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| None explicitly stated as quantifiable acceptance criteria. The document generally refers to "measurement accuracy" and "imaging capabilities" without defining success thresholds. | - "A test of the measurement accuracy of the system, done by outside experts, is included." (No specific results provided) |
| - "validation test of the imaging capabilities is included, as is the software validation test." (No specific results provided) | |
| Implicit Acceptance: Substantial equivalence to predicate device. | "The OTI 3D i-scan is equivalent in safety and efficacy to the legally-marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. It's implied that "outside experts" conducted the tests, but no geographical origin or retrospective/prospective nature of the data is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. The document states "A test of the measurement accuracy of the system, done by outside experts, is included."
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No MRMC study is mentioned or described. The document focuses on the device's standalone capabilities and its equivalence to a predicate device.
6. If a Standalone (Algorithm-Only Without Human-in-the-Loop Performance) Was Done
- Yes, a standalone performance assessment was done. The described tests for "measurement accuracy" and "imaging capabilities" relate to the device's inherent ability to convert B-scans into 3D images and perform measurements, which are standalone functionalities. The 3D i-scan is described as a "Program to convert Ultrasound scans to perspective images," implying an algorithm-only function in generating the 3D view.
7. The Type of Ground Truth Used
- Implied Ground Truth: For the "measurement accuracy" test, the ground truth would likely be physical measurements or known geometric properties of the objects or phantoms being scanned.
- For the "imaging capabilities" validation, the ground truth would likely be established 2D ultrasound images (B-scans) or known anatomical structures, against which the generated 3D images are compared for fidelity and correct representation. The document does not explicitly state the source (e.g., pathology, clinical outcomes, or expert consensus on a different imaging modality).
8. The Sample Size for the Training Set
- Not specified. The document describes the device as almost entirely a software system but does not detail its development process, including training data.
9. How the Ground Truth for the Training Set Was Established
- Not specified. Due to the lack of information on a training set or machine learning aspects, this detail is absent. The device acts more as an image processing and visualization tool rather than a diagnostic AI that learns from labeled data in the way modern AI models do.
Summary of Device and Study:
The Ophthalmic Technologies 3D i-scan is a software accessory that works with an existing Ophthalmic B-scan Ultrasound system (OTI i-scan) to create 3D visualizations of the eye's interior. It achieves this by automatically taking a series of 201 B-scans at different angles and combining them. The 510(k) submission highlights its "measurement accuracy" and "imaging capabilities" validation through tests conducted by "outside experts." The core argument for substantial equivalence is based on its similarity to the predicate device (Life Imaging Systems Sirus, K961403) and the fact that it is primarily a software addition.
Key Gaps in Information from the Document:
The provided document is a 510(k) summary, which often provides a high-level overview. It lacks the granular detail of a full study report, specifically:
- Quantifiable acceptance criteria (e.g., "accuracy must be within X mm").
- Specific numerical results of the performance tests (accuracy values, image quality metrics).
- Details about the test cases (number, characteristics).
- Specifics about the "outside experts."
- Any mention of AI/ML, training data, or human-in-the-loop performance studies, which are common in more recent device submissions. This device predates the widespread use of deep learning in medical imaging.
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K97 4523
Ophthalmic Technologies 3D i-scan
Page A 4
Ophthalmic Technologies Inc.
FEB 2 5 1998
3D i-scan 510(k) Submission
510 (k) Summary
(1) Submitter Information
Name: Ophthalmic Technologies Inc ..
Address: 37 Kodiak Crescent, Unit 16 Downsview, Ontario M3J 3E5 Canada
Telephone Number: 416-631-9123
;
(Official Myers Person: Dr. George Contact Correspondent) Medsys Inc. 377 Rt 17 S Hasbrouck Heights, NJ 07604 201-727-1703 Fax 201-727-1708
November 7, 1997 Date Prepared:
- (2) Name of Device: Trade Name: 3D i-scan Common Name: Program to convert Ultrasound scans to perspective images. Imaging, Ultrasonic, Classification Name: System, Ophthalmic, (90IYO)
(3) Equivalent legally-marketed devices:
Life Imaging Systems Sirus, K961403
(4) Description
The 3D i-scan works in conjunction with the Ophthalmic Technologies Inc. (OTI) i-scan ophthalmic B-scan system. It automatically makes a series of 201 B-scans at different angles, and then combines them to produce a perspective image, called the "3D image."
Scanning is done through a closed eye-lid. The 3D iconsists of a computer and computer monitor, and ਰ scan mechanical scan assembly which holds the B-scan ultrasonic scanner and rotates it at a speed synchronized with the lateral scanning rate of the probe. Ultrasonic gel is used
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Page A 5
as a coupling medium between the transducer and the surface as a coupring measure loss prevents the rotary motion of the of the from affecting the surface of the eye-lid. The computer system assembles the multiple images of the interior of the eye, all taken at a slightly different angle, and produces a three-dimensional representation of the interior of the eye on the computer monitor screen.
Software facilities are included for a number of types changing as slicing, such manipulation, of image or line, and measurement of distances, areas, and volumes.
(5) Intended Use
ﻤﻌﻤﺪ ﺳ
ﻤﺴﺎﺣﺔ
)
The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic B-scan Ultrasound system (K960622) to provide a three-dimensional visualization of the interior of the globe. The device is indicated when it is desirable to have a three-dimensional depiction (perspective rendering) of the interior of the globe for diagnostic purposes.
(6) Technological characteristics
The device is virtually identical to the predicate device. The device is almost entirely a software system, computer in addition to the OTI i-scan system.
(b) Performance data
(1) Non-clinical tests
Electrical safety tests are provided for the scan rotator. All the other components are commercially-available computers and computer accessories.
(2) Clinical tests
A test of the measurement accuracy of the system, done by outside experts, is included.
validation test of the imaging I S capabilities A included, as is the software validation test.
(3) Conclusions
The OTI 3D i-scan is equivalent in safety and efficacy to the legally-marketed predicate devices.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle's head and neck, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle image.
FEB 2 5 1998
Opthalmic Technologies, Inc. George Myers c/o Medsys, Inc. 377 Route 17 South Hasbrouk Heights, NJ 08601
Re:
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
K974522 3D iscan (3D Ultrasound Opthalmic Image Processing Software Dated: November 26, 1997 Received: December 2, 1997 Regulatory class: II 21 CFR 892.1560/Procode: 90 IYO
Dear Mr. Myers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h.Liau Yu
Lillian Yin, Ph.D. Director. Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1 1 Page of
510(k) Number (if known):_ K974522
Device Name: 3D i-scan
Indications for Use:
The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic Bthree-Ultrasound system (K960622) to provide a scan dimensional visualization of the interior of the eye. The device is indicated when it is desirable to have a threeof the depiction (perspective rendering) dimensional interior of the globe for diagnostic purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use (Per 21 CFR 810.109) (Optional Format 1-2-96)
Vaind L. Stypoon
(Division Sign-Off)
ductive. Abdominal. E 510(k) Numbe
§ 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.