The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, 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 Description

The OTI-scan is a compact Ultrasonic ophthalmic A-scan system and B-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria / Test Type	Reported Device Performance
Accuracy	Not explicitly defined	Accuracy tests performed
Ultrasonic Emissions	Not explicitly defined	Emissions tests performed
Electrical Safety	Not explicitly defined	Safety tests performed
Software Validation	Not explicitly defined	Validation tests performed
Equivalency to Predicate	Safety and Efficacy	Found equivalent to OTI i-scan (K960622)

2. Sample Size Used for the Test Set and Data Provenance

The document states:

"Clinical tests: Not required."
"Non-clinical tests: The A-B scan has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests."

Based on this, no clinical test set was used. The device's performance was established through non-clinical (laboratory/engineering) testing and comparison to an existing predicate device. Therefore, there's no information on sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no clinical test set was required or performed, there's no information on experts used to establish ground truth. The acceptance was based on non-clinical testing and substantial equivalence to a predicate device.

4. Adjudication Method for the Test Set

As no clinical test set was required, there is no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical tests: Not required."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This refers to the device's inherent technical performance. The non-clinical tests (accuracy, ultrasonic emissions, electrical safety, and software validation) would fall under assessing the device's standalone performance. However, there's no detailed quantitative data provided from these tests, only that they were performed.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would likely be established by:

Reference standards/phantoms for accuracy testing (e.g., measuring known distances or properties).
Physics-based measurements for ultrasonic emissions and electrical safety (conformance to established standards).
Software specifications and formal verification/validation procedures for software validation.

Since no clinical study was performed, there is no clinical ground truth (like expert consensus, pathology, or outcomes data) established.

8. The Sample Size for the Training Set

The document does not describe any training set because the submission is a Special 510(k) for a device that is functionally equivalent to an already marketed device (OTI i-scan, K960622). Machine learning or AI model training data is not mentioned or relevant to this submission. The device is an ultrasonic hardware and software system, not an AI diagnostic algorithm in the modern sense.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or relevant to this type of device submission, this information is not applicable.

Summary

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K030770

Page A 2

Ophthalmic Technologies Inc. Special 510(k) Submission OTI-scan Ophthalmic Ultrasonic System A-B scab

510(k) Summary February 26, 2003

(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: OTI-scan Common Name: Ophthalmic A-scan and B-scan Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO Diagnostic Ultrasound Transducer, 90-ITX

(3) Equivalent legally-marketed devices.

OTI i-scan, K960622

(4) Description

MAR 2 7 2003

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(5) Intended Use

The ()T-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eve. including the measurement of axial length for determination of IOL power.

(6) Performance Data

(a) Non-clinical tests

The A-B scan has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.

(b) Clinical tests

Not required.

The A-B scan is equivalent in safety and efficacy to the legally-marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 7 2003

Ophthalmic Technologies. Inc. % George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604

Re: K030770

Trade Name: OTI-scan Ophthalmic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging sytem Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: 90 IYO and ITX Dated: February 26, 2003 Received: March 11, 2003

Dear Dr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the OTI-scan Ophthalmic Ultrasound System, as described in your premarket notification:

Transducer Model Number

13 MHz (Biometric A-scan) 12 MHz (B-scan)

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Daniel A. Lyman

Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

of of of _____________________________________________________________________________________________________________________________________________________________________ Page 1

510(k) Number (if known): K030770

Device Name: OTI-scan

Intended Use:

The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to mak measurements inside the eye, including the measurement of axial length for determination of IOL power. Mode of Operation

CLINICALAPPLICATION	A	B	OTHER(SPECIFY)
Ophthalmic	P	P	P (3D)
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Trans-rectal
Trans-vaginal
Trans-urethral
Intra-luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other (Specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		OR		Over-the-Counter Use
(Per 21 CFR 810.109)				(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	2030770
---------------	---------

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Diagnostic Ultrasound Indications for Use Form

Page

510(k) Number (if known): K030770

Device Name: OTI-scan B-scan transducer

Intended Use: Transducer for B-scans with OTI-Scan Ophthalmic system Mode of Operation

CLINICALAPPLICATION	A	E	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
Ophthalmic		x
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult
Cephalic
Cardiac
Trans-esophageal
Trans-rectal
Trans-vaginal
Trans-urethral
Intra-luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other(Specify)

usly cleared by FDA; E= added under Appendix E Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use	✓	OR Over-the-
Counter Use
(Per 21 CFR 810.109)	(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number	K030770
---------------	---------

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Diagnostic Ultrasound Indications for Use Form

Page 1 of

510(k) Number (if known): K030770

Device Name:OTI-Scan A-scan transducer

Intended Use: Biometric and diagnostic A-scans with OTI-scan ophthalmic system

Mode of Operation

CLINICALAPPLICATION	A	B	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
Ophthalmic	X
Fetal
Abdominal
Intra-operative(specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
Neonatal
Cephalic
Adult
Cephalic
Cardiac
Trans-esophageal
Trans-rectal
Trans-vaginal
Trans-urethral
Intra-luminal
PeripheralVascular
Laparoscopic
Musculo-Skeletal
Other(Specify)
N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓	OR	Over-the-
Counter Use
(Per 21 CFR 810.109)	(Division Sign-Off)

of Reproductive ological Devi

Regulation Number and Section

§ 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.