(56 days)
The LCG (Liquid Crystal Glasses) System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
The LCG System comprises the following main components:
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) 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) 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.
The LCG System's acceptance criteria and studies are summarized below, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device equivalence) | Reported Device Performance |
|---|---|---|
| Safety | - Electrical safety (compliance with IEC 60601-1 and amendments) - Electromagnetic compatibility (compliance with IEC 60601-1-2) - Hazard analysis and risk mitigation (compliance with EN 1441 and ISO 14971) | - Device underwent and passed Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards. - 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. |
| Effectiveness/Performance | - Ability to provide intermittent occlusions of the eye (equivalent to eye patching) - Software performs as specified - Physical integrity and function (in-vitro bench testing) | - The LCG System provides a means of occlusion for the eye, with the technique being the primary difference from traditional eye patching. - Software verification and validation testing conducted. - A set of in vitro (bench) performance testing was performed. |
| Substantial Equivalence | Device does not raise any new safety and effectiveness issues compared to predicate devices (Eye Patches, Spectacle frame, Prescription spectacle lens, Sunglasses). | - "Tests results demonstrate the safe and effective performance of the LCG System according to its specifications." - "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, OphthoCare Ltd. believes that the LCG System is substantially equivalent to its predicate devices, without raising new safety and/or effectiveness issues." |
2. Sample Size for the Test Set and Data Provenance:
The provided document does not specify a sample size for a clinical test set for evaluating the LCG System's performance for its intended use. The studies mentioned are primarily in vitro (bench) testing, electrical safety, electromagnetic compatibility, and software verification/validation. These tests do not typically involve patient-specific clinical data in the same way an efficacy study would. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The reported studies are primarily engineering and bench tests, not clinical performance studies requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence based on engineering tests and the established method of eye occlusion, rather than a direct comparison of human reader performance with and without AI assistance. The device is the therapeutic intervention (eye occlusion), not an AI diagnostic aid for human readers.
6. Standalone Performance Study:
A standalone performance evaluation was done in the sense that the LCG System itself underwent "a comprehensive testing program... to verify that the LCG System does not raise any new safety and effectiveness issues." This included:
- Electrical safety and electromagnetic compatibility testing
- Software verification and validation testing
- A set of in vitro (bench) performance testing
- Hazard analysis
These studies assessed the device's functionality and safety independently. However, this is not a "standalone performance" in the context of an algorithm's diagnostic accuracy, but rather the performance of the physical device and its software.
7. Type of Ground Truth Used:
For the engineering and safety tests, the "ground truth" would be established by:
- Engineering specifications and regulatory standards: For electrical safety, EMC, and software function.
- Physical measurements and observation: For in-vitro bench testing.
- Risk assessment methodologies: For hazard analysis.
There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for the verification of the LCG System, as it's not a diagnostic device. Its "performance" is its ability to occlude the eye, which is a functional rather than interpretive outcome.
8. Sample Size for the Training Set:
Not applicable. The LCG System is a hardware device with embedded software, not a machine learning or AI algorithm that requires a "training set" of data in the conventional sense. The "LCG Set" software is described as "residing on a PC at the factory and is used for setting the LCGU performance parameters," indicating it's for configuration, not for training a predictive model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML model described for this device.
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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: +972-8-6231212; +972-9-7724280 Fax: +972-3-7256211
Contact Person:
Dorit Winitz Ph.D Biomedical Strategy Ltd. 11 Menachem Begin Street. Ramat Gan 52521, Israel Tel: +972-3- 6123281 Fax: +972-3-6123282
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 (301) 827-8910. 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/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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Yaz/ Kaur
vision Sict ion of Ophthalmic Ear Throat Devises
510(k) Number K050856
§ 886.4750 Ophthalmic eye shield.
(a)
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.(b)
Classification. Class I (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.