(28 days)
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No
The summary describes a standard ultrasonic A-scan device that uses established formulas for IOL power calculation. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device measures axial distances in the eye and calculates IOL power, which are diagnostic functions, not therapeutic. It does not treat or cure any condition.
No
The device measures axial distances and calculates IOL power, which are measurements used for treatment planning, not for diagnosing a disease or condition. The clinical tests determined that the device is not required to undergo clinical testing and implies it's to be used in conjunction with a treatment plan, not for diagnosing a condition.
No
The device description explicitly states it is a "compact device Ultrasonic ophthalmic A-scan system" and uses "pulsed ultrasound" to measure axial length, indicating it includes hardware components for ultrasound generation and detection.
Based on the provided information, the A-scan 100 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The A-scan 100 directly measures the axial length of the eye using ultrasound, which is a non-invasive method applied to the patient's body, not a specimen taken from the body.
- The intended use describes direct measurement on the eye. The description clearly states it's used for "measurement of axial distances in the eye" and "calculation of the power of an implanted intraocular lens (IOL)". This is a diagnostic procedure performed on the patient.
Therefore, the A-scan 100 falls under the category of a medical device used for diagnostic purposes, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL).
The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in th eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiri. intraocular lenses,
Product codes (comma separated list FDA assigned to the subject device)
90 IYO, ITX
Device Description
The A-scan 100 is a compact device Ultrasonic ophthalmic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes. The device includes four popular formulas to calculate the implanted IOL power, using the Ultrasound Axial Length measurement. The results may be printed through a PC computer printers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasonic
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests
The A-scan 100 has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.
Clinical tests
Not required.
The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device.
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.
0
Section A
510(k) Summary
・
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JAN 1 0 2003
1
KO24/114
Ophthalmic Technologies Inc. Special 510(k) Submission Ophthalmic Ultrasonic A-scan System A-scan 100
510(k) Summary December 10, 2002
(1) Submitter Information
Name: Ophthalmic Technologies Inc.
Address:
Ophthalmic Technologies Inc. 37 Kodiak Crescent, Unit 16 Downsview, Ontario, Canada M3J 3E5
Telephone number:
416-631-9123 • 1-800-517-4444
Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708
Date Prepared: December 10, 2002
(2) Name of Device
Trade Name: A-scan 100 Common Name: Ophthalmic A-scan biometry system Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO
(3) Equivalent legally-marketed devices.
OTI i-scan, K960622
(4) Description
2
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