(164 days)
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No
The device description and intended use focus on standard ultrasonic imaging and measurement techniques, with no mention of AI or ML algorithms for image analysis, diagnosis, or calculation. The IOL calculations are based on established formulas (SRK, Holladay, Hoffer Q), not learned models.
No
The device is used for diagnostic purposes (measuring axial length, calculating IOL power, imaging internal structures, diagnosing pathological or traumatic conditions) and does not directly provide therapy.
Yes
The B-scan function of the device is explicitly stated as being used to "image the internal structure of the eye... for the purpose of diagnosing pathological or traumatic conditions in the eye."
No
The device description explicitly details hardware components including transducers, a CRT display, a keyboard, and accessories like a printer and camera, indicating it is not software-only.
Based on the provided information, the MENTOR® Advent™ A/B System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The MENTOR® Advent™ A/B System uses ultrasound to image and measure structures within the eye. It does not analyze blood, urine, tissue, or any other biological sample.
- The intended use describes direct interaction with the patient's eye. The system is used to measure axial length, image internal structures, and aid in IOL calculations based on these measurements. This is a direct diagnostic and measurement tool applied to the patient, not a test performed on a sample.
Therefore, the MENTOR® Advent™ A/B System falls under the category of a medical device, specifically an ophthalmic ultrasonic imaging and measurement system, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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 eve.
Product codes (comma separated list FDA assigned to the subject device)
86 HPR
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
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasonic
Anatomical Site
Eye
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence is not based on an assessment of any performance data, clinical or non-clinical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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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.
K960765 The assigned 510(k) number is:
AUG - 8 1996
Submitted By:
David Downey Director, Quality Assurance & Regulatory Affairs Mentor O&O. Inc. 3000 Longwater Drive Norwell, MA 02061 Tel: (617) 871-8184 Fax: (617) 871-7785
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
510(k) Summary: Mentor O&O Advent A/B System
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