TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM

K031831 · Topcon Medical Systems, Inc. · HKO · Dec 19, 2003 · Ophthalmic

Device Facts

• Record ID: K031831
• Device Name: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
• Applicant: Topcon Medical Systems, Inc.
• Product Code: HKO · Ophthalmic
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1760
• Device Class: Class 1

Intended Use

The Topcon Model BV-1000 Automated Subjective Refraction System provides sphere, cylinder, and axis measurements of the eye. The BV-1000 assists the eyecare professional in evaluating pre and post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.

Device Story

Topcon Model BV-1000 is an automated subjective refraction system combining an ophthalmic refractometer, visual acuity chart (Landolt C), and motorized refractor. Device performs binocular, simultaneous auto-refraction using built-in rotary prism and 680nm LED illumination. System captures objective measurements followed by subjective refinement steps. Used in clinical settings by eyecare professionals to reduce refraction time by completing portions of the exam in a pre-test environment. Output includes sphere, cylinder, and axis measurements, which assist the clinician in prescribing corrective lenses and evaluating surgical outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and design characteristics to legally marketed predicate devices.

Technological Characteristics

Integrated system combining ophthalmic refractometer, visual acuity chart, and motorized refractor. Uses 680nm LED illumination for objective refraction. Measurement range: Objective (S -25.00D to +22.00D, C 0.00D to -8.00D, A 1° to 180°); Subjective (S -18.00D to +18.00D, C 0.00D to -8.00D, A 1° to 180°). Employs rotary prism technology. AC-powered.

Indications for Use

Indicated for patients requiring refractive assessment for eyeglasses or contact lenses, and for evaluation of pre- and post-operative eye procedures. Intended for use by eyecare professionals.

Regulatory Classification

Identification

An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

Predicate Devices

• Topcon 6500
• Topcon 7000S

Reference Devices

• Bausch & Lomb IVEX
• Reichert Ophthalmic Instruments SR-IV
• Zeiss-Humphrey 515/530/560/570

Submission Summary (Full Text)

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## DEC 1 9 2003

# 031831

### 510(K) SUMMARY

| Applicant: | Topcon Medical Systems, Inc.<br>37 West Century Road, Paramus, NJ 07652 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone], ext. 204 |
| Facsimile Number: | [phone] |
| Contact Person: | Donald H. Winfield |
| Date: | June 6, 2003 |
| Device Proprietary Name: | Model BV-1000, Automated Subjective Refraction System |
| Device Classification Name: | Refractometer, Ophthalmic |
| Device Common Name: | Refractometer/Auto-refractor |
| Device Class: | I |
| Product Code: | HKO, HOX, HKN |
| Regulation Number: | 886.1760, 886.1150, 886.1770 |
| Intended Use: | The Topcon Model BV-1000 Automated Subjective<br>Refraction System provides sphere, cylinder, and axis<br>measurements of the eye. The BV-1000 assists the eyecare<br>professional in evaluating pre and post operative eye<br>procedures and is used as an aid in prescribing eyeglasses<br>and contact lenses. |

#### Description:

The Topcon Model BV-1000 is a safe and effective instrument. In essence, it is a combination of three Class I devices:

- 1) Ophthalmic Refractometer ... an AC-powered device that consist of a fixation system, a measurement and recording system and an alignment system.
- 2) Visual Acuity Chart ... a device, with a Landolt "C" chart in graduated sizes to test visual acuity
- 3) Onthalmic Motorized Refractor ... a device that incorporates a set of lenses of various dioptric powers intended to measure the refractive power of the eyc.

The BV-1000 is designed to perform binocular, simultaneous auto-refraction. It incorporates subjective refinement steps after the objective measurements have been obtained. The BV-1000 reduces the amount of time that eyecare professionals need to spend in refracting their patients as a substantial portion of the traditional refraction can be accomplished in the "pre test" room.

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| COMPARISONS | | | | | | | | |
|---------------------------------|------------------|--------------------------------------------------|-----------------------|----------|------|-------------------------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer / Distributor | Model | Objective Refraction | Subjective Refraction | | | Range | | |
| | | Method | Illumination | Distance | Near | Method | Illumination | |
| Bausch & Lomb | IVEX | Manual Retinoscopy | Halogen | X | X | Snellen Charts; Jackson Cross Cylinder | Fluorescent | (S) -28.00D to +19.75D<br>(C) 0 to -7.75D<br>(A) 0° to 180° |
| Reichert Ophthalmic Instruments | SR-IV | Manual Retinoscopy | Halogen | X | X | Snellen Charts; Simulcross Cross Cylinder | Tungsten | (S) -20.00D to +20.00D<br>(C) 0 to ±8.00D<br>(A) 0° to 180° |
| Zeiss-Humphrey | 515/530/ 560/570 | Built-In Continuously Variable Sphere & Cylinder | 680nm LED | X | X | Cross Cylinder | Tungsten | (S) -12.00D to +20.00D<br>(C) 0 to ±6.00D<br>(A) 0° to 180° |
| Topcon | 6500 | Built-In Rotary Prism | 680nm LED | X | X | Snellen Charts; Jackson Cross Cylinder | Tungsten | (S) -25.00D to +22.00D<br>(C) 0 to ±7D<br>(A) 0° to 180° |
| Topcon | 7000S | Built-In Rotary Prism | 680nm LED | X | X | Snellen Charts; Presbyopic Charts | Tungsten | (S) -25.00D to +22.00D<br>(C) 0 to ±7D<br>(A) 0° to 180° |
| Topcon | BV-1000 | Built-In Rotary Prism | 680nm LED | X | X | Landolt Charts; Jackson Cross Cylinder | Tungsten | Objective Mode:<br>(S) -25.00D to +22.00D<br>(C) 0.00D to -8.00D<br>(A) 1° to 180°<br>Subjective Mode:<br>(S)-18.00D to +18.00D<br>(C) 0.00D to -8.00D<br>(A) 1° to 180° |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Topcon Corporation c/o Donald H. Winfield Topcon Medical Systems, Inc. 37 West Century Road Paramus, NJ 07652

Re: K031831

R051031
Trade/Device Name: Topcon Model BV-1000 Automated Subjective Refraction System Trade Dovice Name: 10 CFR 886.1760; 21 CFR 886.1150; 21 CFR 886.1770 Regulation Name: Ophthalmic refractometer; Visual acuity chart; Manual Refractor Regulatory Class: Class I Product Code: HKO; HOX; HKN Dated: September 17, 2003 Received: September 22, 2003

Dear Mr. Winfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your booker one the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use sured in the encreatives the Medical Device Amendments, or to devices that provision in may 20, 1970, and coardance with the provisions of the Federal Food, Drug, and Cosmetic nave been rechassified in acceration of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general merelors, maintons of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sael adaments. 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 r 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 ally rederal statutes and regulation abut not limited to: registration and listing (21 CFR Part an the Het beequencements, as a sol ); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A halyi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### STATEMENT OF INDICATION FOR USE

The Topcon Model BV-1000 Automated Subjective Refraction System provides sphere, cylinder and axis measurements of the eye. The BV-1000 assists the eyecare spitere, cymider and and measure post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.

Prescription Use
(Per 21 CFR 801.109)

*MKB Nichols*

MLB Nicholas

vision Sign-Off) >ivision of Ophthalmic Ear, ംse and Throat Devises

510(k) Number K031831