Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on ultrasonic measurement and calculation based on a fixed target angle and standard deviation, with no mention of learning or adaptive algorithms.

Therapeutic

No.
Explanation: The device is intended to measure eye and head movement to assist in prescribing eyeglasses, not to treat any medical condition or restore function.

Diagnostic

No

The device is intended to measure eye and head movement to assist in prescribing progressive power eyeglass lenses. It does not identify a disease, condition, or health status.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of hardware components including a headset, main body with an ultrasonic transmitter, and ultrasonic receivers.

IVD (In Vitro Diagnostic)

Based on the provided information, this device 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 VPS device measures the pattern of eye and head movement in response to visual stimuli. It does this externally and non-invasively using ultrasonic technology.
Intended Use: The intended use is to guide the prescription of progressive power eyeglass lenses based on these movement patterns. This is a measurement and fitting aid, not a diagnostic test performed on a biological sample.

The device operates on the body's physical responses to external stimuli, not on analyzing biological samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.

Product codes

HLL

Device Description

The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral LED fixation lamps. It consists of a headset and a main body with an ultrasonic transmitter. Two ultrasonic receivers are imbedded in the center nosepiece of the headset. The patient wears the headset and looks at three orange LED fixation lamps in the main body as they light up in succession. As the patient follows the lights from side to side, the device measures the degree of head movement from the center light against a target angle of 40° and a standard deviation. Eye movement is extrapolated to fill the remaining vision angle. The calculated ratio of head/eye movement is used to determine the shape of the peripheral and central fields of the progressive spectacle lenses.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eye, Head

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Not Found

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

In a clinical study, 175 presbyopic patients were measured for head and eye movement by two devices: an electromagnetic sensor -- the Polhemus Fastrak -- and an ultrasound transmitter and receivers. The measurement by the ultrasound device was reproducible. Subjects were measured on two separate days. For 90% of those subjects the differences between the measurements were lower than 0.20. Moreover, the standard deviation - i.e. , the dispersion among the 20 measurements for each subject taken in one session - was similarly reliable, with 98% of the measurement differences lower than 0.11. The measurements taken by the ultrasound device showed a close correlation with those taken by the electromagnetic Polhemus Fastrak.

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

Not Found

Predicate Device(s)

OBER2 Eye Movement Monitor, 510(k) # K902954

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 886.1510 Eye movement monitor.

(a)
Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.(b)
Classification. Class II.

Summary

0

TAB D

510(k) SUMMARY Varilux® VisionPrint™ System Essilor International, Inc.

This 510(k) summary of safety and effectiveness for the Varilux® VisionPrint™ System is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

Applicant:	Essilor International, Inc.
Address:	c/o Essilor of America, Inc.
2400 118" Avenue North
St Petersburg, FL 33176
(727) 572-0844
(727) 592-0358 (FAX)
gwalsh@essilorusa.com
Contact Person:	Marc J. Scheineson, Esq.
Regulatory Counsel
Telephone:	(202) 414-9243 (telephone)
(202) 414-9299 (fax)
Preparation Date:	December 19, 2003
Device Trade Name:	Varilux® VisionPrint™ System or VPS
Common Name:	Eye Movement Monitor
Classification Name:	Eye Movement Monitor (see 21 C.F.R. § 886.1510)
Product Code:	HLL
Predicate Device:	OBER2 Eye Movement Monitor, 510(k) # K902954
Device Description:	The VPS is a non-invasive ultrasonic device intended to
measure the pattern of eye and head movement when
viewing lateral LED fixation lamps. It consists of a headset
and a main body with an ultrasonic transmitter. Two
ultrasonic receivers are imbedded in the center nosepiece of
the headset. The patient wears the headset and looks at
three orange LED fixation lamps in the main body as they
light up in succession. As the patient follows the lights from

1

| | side to side, the device measures the degree of head
movement from the center light against a target angle of 40°
and a standard deviation. Eye movement is extrapolated to
fill the remaining vision angle. The calculated ratio of
head/eye movement is used to determine the shape of the
peripheral and central fields of the progressive spectacle
lenses. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Specifications: | The VPS emits ultrasound at sound pressure levels of 115
dB at 40 kHz, to which the patient is exposed for
approximately 2 minutes during testing. |
| Intended Use: | The VPS is a non-invasive ultrasonic device intended to
measure the pattern of eye and head movement when
viewing lateral visual stimulus, to use as a guide for
prescribing progressive power eyeglass lenses. |
| Performance Data: | In a clinical study, 175 presbyopic patients were measured
for head and eye movement by two devices: an
electromagnetic sensor -- the Polhemus Fastrak -- and an
ultrasound transmitter and receivers. The measurement by
the ultrasound device was reproducible. Subjects were
measured on two separate days. For 90% of those subjects
the differences between the measurements were lower than
0.20. Moreover, the standard deviation - i.e. , the dispersion
among the 20 measurements for each subject taken in one
session - was similarly reliable, with 98% of the
measurement differences lower than 0.11. The
measurements taken by the ultrasound device showed a
close correlation with those taken by the electromagnetic
Polhemus Fastrak. |
| CONCLUSIONS: | Based on the foregoing and other information contained in
this application, Essilor believes that the Varilux® VPS is
substantially equivalent to its claimed predicates under
conditions of intended use. |

·

"

・

2

Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top and bottom of the circle. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2004

Essilor International, Inc. c/o Marc J. Scheineson, Esq. Alston & Bird, L.L.P. 601 Pennsylvania Avenue, N.W. Washington, DC 20004-2601

Re: K033949

K059947
Trade/Device Name: Varilux® VisionPrint™ System Regulation Number: 21 CFR 886.1510 Regulation Name: Eye Movement Monitor Regulatory Class: Class II Product Code: HLL Dated: June 25, 2004 Received: June 25, 2004

Dear Mr. Scheineson:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your becaon 910(x) premained 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 commerce prof to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been reculise in assess approval of a premarket approval application (PMA). and Costience Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, merceive, market the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 is classified (600 abor of ols. Existing major regulations affecting your device can may be subject to succeral Regulations, Title 21, Parts 800 to 898. In addition, FDA may ou found in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advised that I Dri- brosan that your device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must or any I cacial statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Far 607); adoling (21 CFR Part 820); and if applicable, the electronic 101111 m the quality of bections (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

Page 2- Marc J. Scheineson

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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kalpi 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

4

Indications for Use

510(k) Number (if known): KO33949_

Device Name: Varilux® VisionPrint™ System (VPS)

Indications For Use:

The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.

Prescription Use_ X (Part 21 CFR 801 Subpart D)

AND/OR

のお店舗の賃貸マンション (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マンション) (賃貸マン

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number	K033949