MENTOR ADVENT A/B SYSTEM

K960765 · Mentor Ophthalmics, Inc. · IYO · Aug 8, 1996 · Radiology

Device Facts

• Record ID: K960765
• Device Name: MENTOR ADVENT A/B SYSTEM
• Applicant: Mentor Ophthalmics, Inc.
• Product Code: IYO · Radiology
• Decision Date: Aug 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

MENTOR® Advent™ A/B System is a dual function ultrasonic ophthalmic imaging system. The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior chamber depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.

Device Story

Dual-function ophthalmic ultrasonic system; provides A-scan biometry and B-scan imaging. A-scan uses 8 MHz non-scanning crystal transducer to measure axial length, anterior chamber depth, and lens thickness; calculates IOL power using SRK, Holladay, and Hoffer Q formulas. B-scan uses 11 MHz mechanical sector probe (50° sweep) to visualize internal eye structures/pathology. Operated by clinicians in clinical settings; uses standard keyboard interface and 9" CRT display. Outputs include biometric measurements, IOL power calculations, and diagnostic images. Assists surgeons in IOL selection and diagnosis of ocular conditions.

Clinical Evidence

No clinical data. Determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.

Technological Characteristics

Ultrasonic imaging system. A-scan: 8 MHz non-scanning crystal transducer. B-scan: 11 MHz single crystal mechanical sector probe, oil-filled sealed chamber. 9" high-resolution white phosphor CRT display. Connectivity: printer, video output, camera, VCR. User interface: standard computer keyboard. Software includes IOL calculation programs (SRK, Holladay, Hoffer Q).

Indications for Use

Indicated for patients undergoing cataract surgery requiring axial length measurement and IOL power calculation, and patients requiring diagnostic imaging of internal eye structures, opaque media, or posterior pathology.

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

• Teknar A/B III (K871536)

Submission Summary (Full Text)

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AUG 8 1996

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K960765

## Submitted By:

David Downey
Director, Quality Assurance & Regulatory Affairs
Mentor O&O, Inc.
3000 Longwater Drive
Norwell, MA 02061
Tel: [phone]
Fax: [phone]

Date Prepared: January 27, 1996

## Device Name

Proprietary Name: MENTOR® Advent™ A/B System

Common Name: A-B Scanner

Classification Name: Ultrasonic System, Imaging, Ophthalmic (86 HPR)

## Substantial Equivalence Claim

The substantial equivalence device selected for comparison to this device is Teknar A/B III. Its 510(k) control number is K871536.

## Device Description

MENTOR® Advent™ A/B System is an easy to use ophthalmic ultrasonic system, offering capabilities and versatility for both A-scan and B-scan operations.

The A-Scan biometric unit of the Advent System has the following features:

- Operational modes - Automatic and Manual
- Probe alignment - LED fixation light and audio feedback
- Multiple eye categories - Normal, Aphakic, Cataractous, Dense Cataractous and Pseudophakic
- IOL calculations - programs include the latest in SRK, Holladay and Hoffer Q
- Patient storage - up to 16 patients, including right and left eye
- User interface - standard computer keyboard
- Display - 9" high resolution white phosphor CRT
- Accessories - printer, video output

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The B-Scan imaging unit of the Advent System has the following features:
- Scanning - 50 degrees sector scan probe, allowing eye view from wide variety of angles
- Normal mode - requires selection of parameters
- Windowed mode - allows user selectable scanning angle
- Controls - depth, gain, contrast and brightness
- Display - 9" high resolution white phosphor CRT
- User interface - standard computer keyboard
- Accessories - camera, printer, VCR

MENTOR® Advent™ System uses the following transducer operations and characteristics:

A-Scan: There is a single ultrasound mode where the transducer is pulsed at a repetition frequency of approximately 5 Hz. The transducer is a non-scanning crystal with a frequency of approximately 8 Mhz. This system uses the same ultrasound transducer as in the predicate device.

B-Scan: There are two ultrasound modes, Normal and Windowed. The transducer is a single crystal mechanical sector probe with a center frequency of 11 MHz. It is housed in an oil-filled sealed chamber. The transducer sweeps 8 frames/sec. Sweep angle is 50°, pulse repetition frequency is 5.5 KHz and there are 275 transmitted lines per scan. In the Windowed mode, the size and position of the user selected window affects the pulse rate and spacing of the pulse, and thus the radiated field. Ultrasonic power measurements reported later have been made in the worst case condition.

## Intended Use

MENTOR® Advent™ A/B System is a dual function ultrasonic ophthalmic imaging system. The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior chamber depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye.

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# Substantial Equivalence Comparison

| | MENTOR^{®} Advent^{™}
A/B System | Teknar A/B III |
| --- | --- | --- |
| | | |
| Indication | The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior chamber depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eye. | Same |
| Transducer/Probe Design
A-Scan: | Non-scanning crystal, 8 MHz frequency, transducer in direct contact with eye surface. | Same |
| B-Scan: | Single crystal mechanical sector probe with 11 MHz center frequency focused at 25 mm. Housed in an oil-filled sealed chamber. 8 frames per sec. sweep, 50°sector scan. | Single crystal mechanical sector probe with 10 MHz center frequency focused at 18 mm. Housed in an oil-filled sealed chamber. 15 frames per sec. sweep, 50°sector scan. |
| Probe Physicals
A-Scan: | Weight - 5 oz., Length - 3.875", Diameter - 0.40". | Same |
| B-Scan: | Weight - 1.7 oz., Length - 4.75", Diameter - 0.625". | Weight - 2.6 oz., Length - 6.00", Diameter - 0.625". |
| Scanning Mode
A-Scan: | Automatic & Manual | Automatic, Manual & Diagnostic |
| B-Scan: | Normal and Windowed | Normal |
| A-Scan Eye Categories | Normal, Aphakic, Cataractous, Dense Cataractous and Pseudophakic. | Same |
| A-Scan IOL Calculations | Software programs for SRK, Holladay and Hoffer Q calculations. | Same |
| A-Scan Initialized Velocity | 1532 m/sec - vitreous and aqueous
1642 m/sec - normal lens
1629 m/sec - cataractous lens | Same |
| A-Scan Probe Alignment | LED fixation light and audio feedback. | Same |

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| | MENTOR™ Advent™
A/B System | Teknar A/B III |
| --- | --- | --- |
| | | |
| B-Scan Controls | Depth, gain, contrast and brightness. | Same |
| B-Scan Depth | 20/50/70 mm | 50/70 mm |
| B-Scan Scale | Calibrated to 1550 meters/sec. | Same |

The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.


2-15-96

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