I-SCAN

K960622 · Ophthalmic Technologies, Inc. · IYO · May 13, 1996 · Radiology

Device Facts

• Record ID: K960622
• Device Name: I-SCAN
• Applicant: Ophthalmic Technologies, Inc.
• Product Code: IYO · Radiology
• Decision Date: May 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

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.

Device Story

PC-based ultrasonic diagnostic system; utilizes three transducers for A-scan, B-scan, and Biometry (X-mode) imaging/measurement. Operator (clinician) uses hand-held or tonometer-mounted probes to capture ocular ultrasound signals. System processes signals to visualize internal structures and perform axial length measurements. Features automatic or manual measurement modes; includes IOL power calculation algorithms. Used in clinical settings to assist ophthalmologists in diagnostic assessment and surgical planning. Output displayed on screen for clinical decision-making regarding ocular health and IOL selection.

Clinical Evidence

Clinical testing compared i-scan against a predicate device on ten eyes; results demonstrated equivalent accuracy. Bench testing included phantom studies for automatic and manual measurement modes, biocompatibility testing of patient-contact materials, and electrical/emission safety testing per Canadian Standards Association requirements.

Technological Characteristics

PC-based ultrasound system; three transducers (A-scan, B-scan, Biometry). Patient-contact materials tested for biocompatibility. Connectivity via PC interface. Safety testing includes electromagnetic radiation and transducer emissions.

Indications for Use

Indicated for ophthalmic patients requiring visualization of internal eye structures and biometric measurements, including axial length for IOL power determination.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sonomed Model A2500
• Biophysic Ophthalmocan B

Submission Summary (Full Text)

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Ophthalmic Technologies i-scan
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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: System, Imaging, Ultrasonic, Ophthalmic

(3) Classification, Panel
Class II, 90HPR

(4) Predicate Devices:
(a) Sonomed Model A2500
(b) Biophysic Ophthalmocan B

(5) Description

The OTI i+tech "i-scan" ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications. It includes three separate transducers which provide:

1. 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 a screen and the operator selects the points for the measurements).

2. An A-scan mode for observation and measurement of the internal structures in the eye, with its own hand-held probe.

3. A B-scan mode, using a hand-held motor-driven transducer, permitting visualization of internal structures in the eye.

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Ophthalmic Technologies i-scan
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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 Ophthalm can 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.