(90 days)
Sonomed Model A2500, Biophysic Ophthascan B
Not Found
No
The description mentions an "automatic measurement" mode, but the explanation of this mode focuses on the system automatically finding structures and making measurements, which is a common feature in medical devices and doesn't necessarily imply AI/ML. There is no mention of AI, ML, or related terms in the document.
No
The device is used for visualization and measurement within the eye, specifically for diagnosis and IOL power determination, not for treatment.
Yes
The device's description explicitly states it is a "multipurpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications." It is intended to visualize and measure structures inside the eye, which are diagnostic functions.
No
The device description explicitly states it includes three separate transducers (hardware components) and describes bench tests involving a phantom and transducer emission tests, indicating it is a hardware-based ultrasound system with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OTI i+tech "i-scan" ultrasound system uses ultrasound to visualize and measure structures inside the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use is for visualizing and measuring internal eye structures and calculating IOL power, all of which are performed directly on the patient's eye.
Therefore, the device falls under the category of a medical device used for imaging and measurement in vivo (within the living body), not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The OTI i+tech "i-scan" ultrasound system is intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
Product codes
90HPR
Device Description
The OTI i+tech "i-scan" ultrasound system is a multipurpose personal-computer-based ultrasonic diagnosis system ophthalmic applications. It includes three separate for transducers which provide:
-
A Biometry X-mode for measurement of axial length, using a focused probe which can be hand-held or placed in a tonometer-holder. The operator has a choice of automatic measurement (in which the system automatically finds the critical structures in the eye and makes the measurements) or manual (in which the A-scan is presented on screen and the operator selects the points for a the measurements) .
-
An A-scan mode for observation and measurement of the internal structures in the eye, with its own handheld probe.
-
A B-scan mode, usinç a hand-held motor-driven transducer, permitting visualization of internal structures in the eye.
In X-mode, the system also performs IOL calculations with a choice of several algorithms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound
Anatomical Site
eye
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
In the clinical tests, it was compared with one of the predicate devices on ten eyes, and the tests showed that its accuracy is equivalent to that of the predicate device. The bench tests include tests on a phantom in both automatic mode(for IOL measurement) and manual mode (for A and B mode measurements), tests for the Canadian Standards Association, Electromagnetic Radiation tests, and Transducer Emission Tests.
Summary of Performance Studies
Clinical tests: compared with predicate device on ten eyes, showed equivalent accuracy. Bench tests: phantom tests (automatic mode for IOL measurement, manual mode for A and B mode measurements), Canadian Standards Association tests, Electromagnetic Radiation tests, Transducer Emission Tests. Biocompatibility tests for materials in contact with the eye.
Key Metrics
accuracy
Predicate Device(s)
Sonomed Model A2500, Biophysic Ophthascan B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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K960622 Prec 1 or 2
Ophthalmic Technologies i-scan
Page A 2
Ophthalmic Technologies Inc. MAY 13 1996 510 (k) Submission i-scan Ophthalmic Ultrasound System
510 (K) Summary
(1) Submitter Information: Name: Ophthalmic Technologies, Inc., Inc. Address: 37 Kodiak Crescent, Unit 12, Downsview, Ontario Canada M3J 3E5 Telephone Number: 416-631-6932 Contact Person: Dr. George Myers, 201-438-2310
(2) Names:
Trade: i-scan Common Usual Name: Ophthalmic A, B, and Biometry ultrasound system. Classification Name: Sy:stem, Imaging, Ultrasonic, Ophthalmic
- (3) Classification, Panel Class II, 90HPR
- ( 4 ) Predicate Devices:
(a) Sonomed Model A2500
(b) Biophysic Ophthascar B
(5) Description
The OTI i+tech "i-scan" ultrasound system is a multipurpose personal-computer-based ultrasonic diagnosis system ophthalmic applications. It includes three separate for transducers which provide:
-
A Biometry X-mode for measurement of axial length, using a focused probe which can be hand-held or placed in a tonometer-holder. The operator has a choice of automatic measurement (in which the system automatically finds the critical structures in the eye and makes the measurements) or manual (in which the A-scan is presented on screen and the operator selects the points for a the measurements) .
-
An A-scan mode for observation and measurement of the internal structures in the eye, with its own handheld probe.
-
A B-scan mode, usinç a hand-held motor-driven transducer, permitting visualization of internal structures in the eye.
1
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Ophthalmic Technologies i-scan
In X-mode, the system also performs IOL calculations with a choice of several algorithms.
(6) Intended Use
The OTI i+tech "i-scan" ultrasound system is intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
(7a) Predicate Devices
The OTI i-scan has as predicate devices Sonomed Model A2500 ultrasound system and the Biophysic Ophthascan B system.
(7b) Testing
The OTI i-scan has undergone both clinical and bench testing. In the clinical tests, it was compared with one of the predicate devices on ten eyes, and the tests showed that its accuracy is equivalent to that of the predicate device. The bench tests include tests on a phantom in both automatic mode(for IOL measurement) and manual mode (for A and B mode measurements), tests for the Canadian Standards Association, Electromagnetic Radiation tests, and Transducer Emission Tests. Results of these tests are in the testing section. All materials in contact with the eye have been tested for biocompatibility. Test reports are included.
These tests all show that the OTI i-scan is safe and effective for its intended use.