LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM

K050856 · Ophthocare , Ltd. · HOY · May 31, 2005 · Ophthalmic

Device Facts

• Record ID: K050856
• Device Name: LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM
• Applicant: Ophthocare , Ltd.
• Product Code: HOY · Ophthalmic
• Decision Date: May 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4750
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.

Device Story

LCG System provides intermittent eye occlusion for amblyopia treatment; replaces traditional eye patching. System consists of Spectacles Unit (LCGU) and Reporting and Compliance Box (RCB). LCGU features refractive optical lens, Liquid Crystal Module (LCM), and electronic controller in holding strap with rechargeable batteries. RCB serves as bedside charger and compliance monitor; records actual wear-time vs. prescribed time to provide feedback to user. Physician/clinician uses LCG Set software on PC to configure performance parameters via RS232 link. Device operates by electronically shuttering the sound eye; allows controlled, intermittent occlusion. Benefits include improved compliance monitoring and automated treatment delivery compared to manual patching.

Clinical Evidence

Bench testing only. Evidence includes electrical safety and electromagnetic compatibility testing per IEC 60601-1 and IEC 60601-1-2, software verification and validation, in vitro performance testing, and hazard analysis per EN 1441 and ISO 14971. No clinical trial data presented.

Technological Characteristics

System includes refractive optical lens, Liquid Crystal Module (LCM), and electronic controller. Powered by rechargeable batteries. Connectivity via RS232 for setup. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, EN 1441, and ISO 14971. Software-controlled shuttering mechanism.

Indications for Use

Indicated for patients requiring intermittent eye occlusion, typically for amblyopic treatment, by covering the sound eye.

Regulatory Classification

Identification

An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

Predicate Devices

• Eye Patches (Product Code: HOY, Regulation Number 886.4750)
• Spectacle frame (Product Code HOZ, Regulation Number 886.5842)
• Prescription (non-custom) spectacle lens (Product Code: HQG, Regulation Number 886.5844)
• Sunglasses (nonprescription) (Product Code: HQY, Regulation Number 886.5850)

Submission Summary (Full Text)

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# MAY 3 】 2005

## 510(K) SUMMARY

#### LCG System

# 510(k) Number K_0 ركة ك

#### Applicant's Name:

OphthoCare Ltd. 4 Yehuda HaNachtom St. Beer-Sheva, 85249 Tel: [phone] Fax: [phone]

## Contact Person:

Dorit Winitz Ph.D Biomedical Strategy Ltd. 11 Menachem Begin Street. Ramat Gan 52521, Israel Tel: [phone] Fax: [phone]

#### Date Prepared:

March 2005

#### Trade Name:

The LCG (Liquid Crystal Glasses) System

| Classification Name: |
|----------------------|
| Medical Specialty: |
| Product Code: |
| Device Class: |
| Regulation Number: |
| Panel: Ophthalmic |

Shield, eye, ophthalmic Ophthalmic HOY I (Exempt) 886.4750

And:

Classification Name: Prescription Spectacle Lens; Medical Specialty: Ophthalmic Product Code: NJH/ HQG Device Class: I (Exempt) Regulation Number: 886.5844

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#### Panel: Ophthalmic

#### Predicate Devices:

OphthoCare Ltd. believes that the LCG System is substantially equivalent to the combination of the following predicate devices:

- 트 Eye Patches (Product Code: HOY, Regulation Number 886.4750: Ophthalmic eye shield, Class I Exempt, for example: Strabismoscope Undirectional Occluder, Welch Allyn, Inc .; Coverlet Eye Occlusion, Beiersdorf, Inc.
- 트 Spectacle frame (Product Code HOZ, Regulation Number 886.5842)
- 8 Prescription (non-custom) spectacle lens (Product Code: HQG, Regulation Number 886.5844)
- . Sunglasses (nonprescription) (Product Code: HQY, Regulation Number 886.5850)

#### Performance Standards:

No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act. However, the LCG System complies with the following voluntary standards:

- IEC 60601-1 (1988) + A1 (1991) + A2 (1995) 피
- 1 IEC/EN 60601-1-2 (2001)
- 프 IEC 60601-1-4 (1996) + A1 (1999)
- 후 EN 1441 (1997)
- l ISO 14971 (2000)

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## Intended Use / Indication for Use:

The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.

#### Device Description:

The LCG System comprises the following main components:

#### The Spectacles Unit (LCGU) .

The Spectacles Unit (LCGU) comprised of the refractive optical lens, Liquid Crystal Module (LCM) and the electronic control that resides in the holding strap.

The adjustable holding strap contains an electronic controller with an activation button (Tact Switch) and small rechargeable batteries that provide the electric power.

#### . The Reporting and Compliance Box (RCB)

The Reporting and Compliance Box (RCB) is a bedside device that serves as a charger of the spectacle's batteries. In addition, it provides a means to monitor the compliance of the patient, while providing a feedback to the user, as it records the actual wear-time of the glasses, comparing it to the prescribed time.

#### . Technician/Factory Setup Software (LCG Set)

The set up software (LCG Set) is software residing on a PC at the factory and is used for setting the LCGU performance parameters. During setup, the LCGU is connected to the PC via the RCB by means of RS232 link.

#### Substantial Equivalence:

For the proposed intended use claim of the LCG System, namely, to provide intermittent occlusions of the sound eye, OphthoCare Ltd. is relying on the Eye Patching method, which is customarily used as a means of an eye occluder, to cover the sound eye during amblyopic treatment.

In addition, the LCG spectacle lens and frame are intended for the same purpose as described for the class I spectacle lens and spectacle frame (regulations 886.5844 and 886.5842, respectively).

The LCG System is an evolution of a well-established method to occlude the eye by means of eye occluder; the classical eye patching.

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Both methods provide a mean of occlusion for the eye, while only the technique to induce this occlusion is different.

A comprehensive testing program was developed and performed in order to verify that the LCG System does not raise any new safety and effectiveness issues in comparison to its predicate devices. This includes the following testing and activities:

- Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards
- Software verification and validation testing
- 비 A set of in vitro (bench) performance testing
- . Hazard analysis including risk level and solutions performed in compliance with EN 1441 (1997) and AAMI/ISO 14971-1, 2000 for the entire system and for the software

Tests results demonstrate the safe and effective performance of the LCG System according to its specifications.

In conclusion, based on the safety and performance testing results, including software verification and validation process and the analysis of similarities and differences as compared to its predicate devices, OphtoCare Ltd. believes that the LCG System is substantially equivalent to its predicate devices, without raising new safety and/or effectiveness issues.

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Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling three abstract birds in flight, arranged in a cascading manner. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

MAY 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OphthoCare Ltd. c/o Dorit Winitz, Ph.D. Biomedical Strategy Ltd. 11 Menachem Begin Street Ramat Gan 52521, Israel

Re: K050856 Trade/Device Name: LCG (Liquid Crystal Glasses) System Regulation Number: 21 CFR 886.4750 Regulation: Ophthalmic Eye Shield Regulatory Class: I Product Code: HOY, HQG, HQY, HQZ Dated: March 31, 2005 Received: April 5, 2005

Dear Dr. Winitz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.

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.

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Page 2- Dorit Winitz, Ph.D.

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/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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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# Indications for Use Statement

510(k) Number (if known): K050856

Device Name: LCG System

Indications for Use:

The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.

Prescription Use √ (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Yaz/ Kaur

vision Sict ion of Ophthalmic Ear Throat Devises

510(k) Number k050856