The OTI-scan HF module is an option for the OTI-scan (K030770), a multi-purpose personal-computer-based ultrasonic B-scan diagnostic system for ophthalmic applications.

Transducer for B-scans with OTI-Scan HF Module

Device Description

The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.

AI/ML Overview

The OTI-Scan HF Module did not report any clinical study to prove the device met acceptance criteria. The submission states "Not required" for clinical tests. The device's equivalency was based on non-clinical tests including accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests, concluding it is equivalent in safety and efficacy to a legally-marketed predicate device.

Table of Acceptance Criteria and Device Performance:

Since no clinical study was conducted or required, no specific acceptance criteria or reported device performance for clinical outcomes were provided in the document. The general acceptance criteria focused on non-clinical aspects:

Acceptance Criteria Category	Reported Device Performance
Accuracy Tests	Passed (Details not specified in the provided text).
Ultrasonic Emissions Tests	Passed (Details not specified in the provided text).
Electrical Safety Tests	Passed (Details not specified in the provided text).
Software Validation Tests	Passed (Details not specified in the provided text).

Details on Clinical Study (or lack thereof):

Sample size used for the test set and the data provenance: Not applicable, as no clinical test set was required or reported.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set was required or reported.
Adjudication method for the test set: Not applicable, as no clinical test set was required or reported.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as no clinical study involving human readers or AI assistance was conducted or reported.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as the device is an ultrasonic B-scan system and not an AI algorithm. Its performance is tied to its physical and software functionality rather than an AI's standalone diagnostic capability.
The type of ground truth used: For the non-clinical tests, the ground truth would have been established by engineering specifications, regulatory standards, and established testing protocols for ultrasonic devices and software.
The sample size for the training set: Not applicable, as no clinical test or AI model training was reported.
How the ground truth for the training set was established: Not applicable, as no clinical test or AI model training was reported.

Summary

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Page A 2

JUN 2 0 2003

Ophthalmic Technologies Inc. Special 510(k) Submission OTI-Scan HF Module April 24, 2003 510(k) Summary

(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: April 24, 2003

(2) Name of Device

Trade Name: OTI-scan HF Module Common Name: Ophthalmic B-scan system Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO

(3) Equivalent legally-marketed devices.

OTI-scan K030770

(4) Description
The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・ . Far and Children

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(5) Intended Use

The OTI-scan HF module is an option for the OTI-scan (K030770), a multi-purpose personal-computer-based ultrasonic B-scan diagnostic system for ophthalmic applications.

(6) Performance Data

(a) Non-clinical tests
The HF Module has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.
(b) Clinical tests
Not required.

The HF Module is equivalent in safety and efficacy to the legally-marketed predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the circumference of the circle.

Public Health Service

JUN 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031391

Trade Name: OTI-scan HF-Module System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: April 29, 2003 Received: June 3, 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 HF-Module System, as described in your premarket notification:

Transducer Model Number

35 MHz B-Scan 50 MHz B-Scan

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

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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,

David A. Bergman

for

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

Enclosure

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OTI-Scan

Diagnostic Ultrasound Indications for Use Form

Page 1

510(k) Number (if known): K031391

Device Name: OTI-scan 35 mHz B-scan transducer

Intended Use: Transducer for B-scans with OTI-Scan HF Module Mode of Operation

CLINICAL	A	B	M	PWD	CWD	COLORDOPPLER	POWER(AMPLITUDE)DOPPLER	COLORVELOCITYIMAGING	COMBINED(SPECIFY)	OTHER(SPECIFY)
APPLICATION
Ophthalmic		x
Fetal
Abdominal
Intra-operative(specify)
Intra-operative
Neurological
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	✓
Counter Use
(Per 21 CFR 810.109)

Over-the-

David A. Soper

(Optional Format 1-2-96)

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

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Diagnostic Ultrasound Indications for Use Form

। Page

510(k) Number (if known): `K031391

Device Name:OTI-Scan 50 Mhz B-scan transducer

Intended Use: Transducer for B-scans with OTI-Scan HF Module Ophthalmic system

Mode of Operation

COLOR COMBINED OTHER COLOR POWER PWD CWD CLINICAL B м | A VELOCITY (AMPLITUDE) (SPECIFY) (SPECIFY DOPPLER APPLICATION DOPPLER IMAGING Ophthalmic × Fetal Abdominal Intraoperative (specify) Intraoperative Neurological Pediatric Small Organ (Specify) Neonatal Cephalic Adult Cephalic Cardiac Transesophageal Trans-rectal Transvaginal Transurethral Intraluminal Peripheral Vascular Laparoscopic Musculo-Skeletal Other (Specify) N= new indication; P= previously cleared by FDA; E= added under Appendix E

N= new Indication; P= previously created by FDA; L= added un

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)
	David R. Symm (Division Sign-Off)

Division of Reproductive, Abdominal, 1122241 and Radiological Devices

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.