OTI SCAN WITH TRANSDUCERS

K030770 · Ophthalmic Technologies, Inc. · IYO · Mar 27, 2003 · Radiology

Device Facts

• Record ID: K030770
• Device Name: OTI SCAN WITH TRANSDUCERS
• Applicant: Ophthalmic Technologies, Inc.
• Product Code: IYO · Radiology
• Decision Date: Mar 27, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

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 make measurements inside the eye, including the measurement of axial length for determination of IOL power.

Device Story

OTI-scan is a PC-based ultrasonic diagnostic system for ophthalmic use; utilizes pulsed ultrasound (sonar principles) to visualize eye interior and perform biometric measurements. System inputs include ultrasonic signals captured via A-scan (13 MHz) or B-scan (12 MHz) transducers. Device processes signals to generate visual images and axial length measurements; output displayed on PC monitor for clinician review. Used in clinical settings by eye care professionals to assist in IOL power determination and ocular diagnostics. Benefits include non-invasive assessment of ocular structures and precise biometric data for surgical planning.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing including accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation.

Technological Characteristics

PC-based ultrasonic diagnostic system; utilizes 13 MHz A-scan and 12 MHz B-scan transducers. Operates via pulsed ultrasound (sonar). Software-based processing. Class II device.

Indications for Use

Indicated for ophthalmic patients requiring ultrasonic visualization of the interior of the eye and biometric measurements, including axial length for IOL power determination.

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

• OTI i-scan (K960622)

Submission Summary (Full Text)

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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 [phone] Fax [phone]

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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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.

### (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.

(c) Conclusions

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone].

Sincerely yours,

Daniel A. Lyman

fr

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

| CLINICAL<br>APPLICATION | A | B | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | P | P | | | | | | | | P (3D) |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(specify) | | | | | | | | | | |
| Intra-operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| 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 | <div style="display:inline-block; width:30px;"></div> | OR | <div style="display:inline-block; width:30px;"></div> | 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

| CLINICAL<br>APPLICATION | A | E | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|-------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | x | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-<br>operative<br>(specify) | | | | | | | | | | |
| Intra-<br>operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-<br>vaginal | | | | | | | | | | |
| Trans-<br>urethral | | | | | | | | | | |
| Intra-<br>luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>Skeletal | | | | | | | | | | |
| Other<br>(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

| CLINICAL<br>APPLICATION | A | B | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|----------------------------------------------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | X | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-<br>operative<br>(specify) | | | | | | | | | | |
| Intra-<br>operative<br>Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify) | | | | | | | | | | |
| Neonatal | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Adult | | | | | | | | | | |
| Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-<br>esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-<br>vaginal | | | | | | | | | | |
| Trans-<br>urethral | | | | | | | | | | |
| Intra-<br>luminal | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-<br>Skeletal | | | | | | | | | | |
| Other<br>(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