TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM

• K Number: K031831
• Device Name: TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
• Manufacturer: TOPCON MEDICAL SYSTEMS, INC.
• Date Cleared: 2003-12-19 ( 189 days)
• Product Code: HKO HKN HOX
• Regulation Number: 886.1760

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 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.

Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a combination of traditional ophthalmic devices and does not mention AI, ML, or related concepts.

Therapeutic

No
The device is used to measure the refractive power of the eye and assist in prescribing eyeglasses and contact lenses, which are diagnostic and assistive functions, not therapeutic.

Diagnostic

Yes
The device provides "sphere, cylinder, and axis measurements of the eye" and "assists the eyecare professional in evaluating pre and post operative eye procedures," which are diagnostic functions used for assessing a patient's condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a combination of three Class I hardware devices (Ophthalmic Refractometer, Visual Acuity Chart, and Ophthalmic Motorized Refractor) and describes physical components like an AC-powered device, fixation system, measurement and recording system, alignment system, and a set of lenses.

IVD (In Vitro Diagnostic)

Based on the provided information, the Topcon Model BV-1000 Automated Subjective Refraction System is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The BV-1000 directly interacts with the patient's eye to measure its refractive properties and visual acuity. It does not analyze samples taken from the body.
• Intended Use: The intended use clearly states it provides measurements of the eye and assists in prescribing eyeglasses and contact lenses. This is a direct assessment of the eye's function, not an analysis of a biological sample.

Therefore, the BV-1000 falls under the category of an ophthalmic device used for direct patient examination, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 professional in evaluating pre and post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.

Product codes

HKO, HOX, HKN

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eye

Indicated Patient Age Range

Not Found

Intended User / Care Setting

eyecare professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 886.1760 Ophthalmic refractometer.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

Summary

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DEC 1 9 2003

031831

510(K) SUMMARY

| Applicant: | Topcon Medical Systems, Inc.
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
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. |

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
(C) 0 to -7.75D
(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
(C) 0 to ±8.00D
(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
(C) 0 to ±6.00D
(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
(C) 0 to ±7D
(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
(C) 0 to ±7D
(A) 0° to 180°
Topcon	BV-1000	Built-In Rotary Prism	680nm LED	X	X	Landolt Charts; Jackson Cross Cylinder	Tungsten	Objective Mode:
(S) -25.00D to +22.00D
(C) 0.00D to -8.00D
(A) 1° to 180°
Subjective Mode:
(S)-18.00D to +18.00D
(C) 0.00D to -8.00D
(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