A-SCAN 100

K024114 · Ophthalmic Technologies, Inc. · IYO · Jan 10, 2003 · Radiology

Device Facts

• Record ID: K024114
• Device Name: A-SCAN 100
• Applicant: Ophthalmic Technologies, Inc.
• Product Code: IYO · Radiology
• Decision Date: Jan 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended 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), indicated for patients requiring intraocular lenses.

Device Story

A-scan 100 is a compact ophthalmic ultrasonic A-scan system; utilizes pulsed ultrasound (sonar principles) to measure eye axial length. Device incorporates four formulas to calculate implanted IOL power based on axial length measurements. Output is printable via PC-connected printer. Used in clinical settings by eye care professionals. Provides objective biometric data to assist clinicians in selecting appropriate IOL power for patients undergoing cataract or lens replacement surgery, potentially improving refractive outcomes.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation.

Technological Characteristics

Compact ophthalmic ultrasonic A-scan system; uses pulsed ultrasound (sonar) for axial length measurement. Includes software for IOL power calculation. Connectivity via PC printer interface. Class II device (Product Codes 90 IYO and ITX).

Indications for Use

Indicated for patients requiring intraocular lenses (IOL) who need measurement of axial distances in the eye for IOL power calculation.

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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K024114

Section A

510(k) Summary

・

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JAN 1 0 2003

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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 [phone] Fax [phone]

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

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/<02-4///4

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.

#### (5) Intended 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).

(6) Performance Data

- (a) Non-clinical tests
The A-scan 100 has had accuracy tests, ultrasonic emissions tests, electrical safety tests, and software validation tests.

- (b) Clinical tests
Not required.

(c) Conclusions

The A-scan 100 is equivalent in safety and efficacy to the legally-marketed predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human figures, possibly representing people, in a flowing, abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 0 2003

George H. Meyers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South HASBROUCK HEIGHTS NJ 07604

Re: K024114

Trade Name: A-Scan 100 Ophthalmic Ultrasound 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: December 11. 2002 Received: December 13, 2002

Dear Mr. Meyers:

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 A-Scan 100 Ophthalmic Ultrasound System, as described in your premarket notification:

# Transducer Model Number

# A-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

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Page 2 - Mr. Meyers

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 (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.

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,

David A. Bergman

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

Enclosure(s)

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Page 9 Diagnostic Ultrasound Indications for Use Form

Page 2011 - of of ____________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K024114

Device Name: A-scan 100

### Intended Use:

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,

| 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 | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| 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) | | | | | | | | | | |

# Mode of Operation

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<br>(Per 21 CFR 810.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over-the-Counter Use<br>(Optional Format 1-2-96) | |
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| (Division Sign-Off) | |
|---------------------------------------------------------------|--------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K02411 |