(300 days)
Not Found
No
The description focuses on electronic control of a liquid crystal lens for intermittent occlusion, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as an electronic shutter module intended to provide occlusions of the eye, which is a therapeutic action, typically used in the treatment of amblyopia. It actively modifies a physiological function (vision) for a specific medical purpose.
No
The device is described as providing occlusions of the eye and acting as an intermittent shutter. Its function is to change a lens from clear to opaque electronically. There is no information provided that suggests the device is used to identify, detect, or monitor a medical condition or disease. It is a therapeutic device intended to provide an intervention.
No
The device description explicitly lists multiple hardware components including a Spectacle Frame, Liquid Crystal Shutter, Earpieces, Nose Piece, Clip to Hold Refractive Lens, Micro-USB Connector, LED Indicator, ON/OFF Switch, and Programming Button. The performance studies also include hardware-specific testing like electrical safety, impact resistance, and climatic testing.
Based on the provided information, the Amblyz™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Amblyz™ System does not interact with or analyze any biological specimens.
- The intended use of the Amblyz™ System is to provide intermittent occlusion of the eye. This is a physical intervention applied to the eye itself, not a diagnostic test performed on a sample.
- The device description clearly outlines an electronic eyewear system with a liquid crystal shutter. This aligns with a therapeutic or assistive device, not a diagnostic one.
- The performance studies mentioned are related to electrical safety, software validation, bench testing of the physical device, packaging, and biocompatibility. These are typical tests for medical devices that interact with the body, but not specifically for IVD devices which would focus on analytical and clinical performance related to specimen analysis.
In summary, the Amblyz™ System is a medical device intended for therapeutic use (treating amblyopia through occlusion), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Amblyz™ System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
Product codes
HOY
Device Description
The Amblyz™ device is an optical eyewear using a Liquid Crystal lens and electronics technology that acts as an intermittent shutter. The shutter incorporated in the optical lens performs an occlusion of the sound eye in an intermittent mode by changing the lens from a clear to an opaque state via electronic control. The system incorporates the following components (as detailed in chapter 12 of this submission):
- Spectacle Frame
- Liquid Crystal Shutter (LCS)
- Earpieces
- Nose Piece
- Clip to Hold Refractive Lens
- Micro-USB Connector
- LED Indicator
- ON/OFF Switch
- Programming Button
- Amblyz™ onboard Software
- Amblyz™ Technician Software
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
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)
A series of safety and performance testing were performed:
- Electrical safety and electromagnetic compatibility testing according to IEC 60601-1 (and amendments), and IEC 60601-1-2 standards. The Amblyz™ has found to comply with the requirements of these standards.
- Software verification and validation testing.
- A set of in vitro (bench) performance testing:
- Lens Impact Resistance/Drop Ball Test: The lenses cracked but did not shatter into pieces and therefore comply with standard requirements.
- Destructive Test: The LC lens glass was cracked and the liquid crystal was spread across the glass. Nevertheless, the laminated films completely held the LCM glass pieces. No change in the overall package and no glass residues were found. Test was performed on four lenses, all resulting in same findings.
- Charge/Discharge Test: Tests show, that glasses have more than enough operating time with the used battery.
- Charging Time Test: All ten (10) test cases comply with the acceptance criteria.
- Climatic Testing: The samples sustained the specified environmental testing, no damage was noted.
- Unpacked Drop Test: All samples have passed all visual and operating/performance checks after the drop.
- Cosmetic Resistance: No visual change on tested samples after the test was completed.
- Sweat Resistance: No visual change observed on tested surfaces in all tested samples.
- Cleaning Resistance: No visual change observed on tested surfaces in all tested samples.
- Thermal Shock: All samples have passed all visual and operating/performance checks after the test.
- Electrical Characteristics Test: All tests passed successfully and meet acceptance criteria.
- Packaging Validation including the following tests:
- Fall Test - Master Packaging: Functional and cosmetic inspections have passed successfully.
- Fall Test - Retail Packaging: All samples passed and meet acceptance criteria.
- Transportation Vibration Test: After the completion of Transportation Vibration Test, units inside the carton box were subjected to functionality check. All test units passed the functionality check with no functionality and cosmetic problem.
- Bump Test: After the completion of Bump Test, units inside the carton box were subjected to functionality check. All test units passed the functionality check with no functionality and cosmetic problem.
- Biocompatibility Testing: Cytotoxicity testing was conducted on components that come into direct contact with the patient (Spectacle Nosepiece, Front frame (Case left & right) prescription frame, and the Amblyz™ Insert left & right part of the handle) based on ISO 10993-5.
- Hazard analysis including risk level and solutions performed in compliance with ISO 14971:2012 for the entire system and for the software.
In conclusion, a series of in vitro, software, electrical safety, and biocompatibility test results demonstrate that the product has acceptable safety and performance characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
APR 2 8 2014
510(K) SUMMARY
510(K) Number K132042
| Applicant's Name: | X6D Ltd.
195, Arch. Makariou III
Neocleous House
3030 Limassol, Cyprus
Tel: +357 25 110000
Fax: +357 25 110010 |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Neta Landman
Duet Medical Consulting Ltd.
21 Hanafa Street
Zur- Moshe 42810, ISRAEL
P.O.Box 536
T +972 54 443 6180
F +972 153 52 833 7207
Email: neta.l@duet-medical.com |
| Date Prepared: | 05 November 2013 |
| Trade Name: | Amblyz™ |
| Classification: | Classification Name: Shield, eye, ophthalmic
Medical Specialty: Ophthalmic
Product Code: HOY
Device Class: I
Regulation Number: 886.4750
Panel: Ophthalmic |
Predicate Devices:
- LCG (Liquid Crystal Glasses) System; cleared under K050856; Product Code . HOY; Regulation Number 886.4750
Intended Use / Indication for Use:
The Amblyz™ System is an electronic shutter module intended to provide occlusions of the eye in an intermittent fashion.
Technological Characteristics:
The Amblyz™ system uses operation principles equivalent to those of the legally marketed LCG System. The device utilizes a Liquid Crystal and electronics technology to create an electronic shutter module that enables the exercise of the amblyopic eye combining with rest periods of the sound eye. There is no control mechanism change
1
and no change in energy type. All changes that do exist are presented in the comparison table presented below under 'substantial equivalence'.
Device Description:
The Amblyz™ device is an optical eyewear using a Liquid Crystal lens and electronics technology that acts as an intermittent shutter. The shutter incorporated in the optical lens performs an occlusion of the sound eye in an intermittent mode by changing the lens from a clear to an opaque state via electronic control. The system incorporates the following components (as detailed in chapter 12 of this submission):
1. Spectacle Frame
The Spectacle frame designed to hold both the liquid crystal lens and the refractive lens. The frame is made of biocompatible durable plastics.
2. Liquid Crystal Shutter (LCS)
The LCS lens, which functions as an electronic shutter is bundled in the glasses frame. Controlled by the microcontroller on the PCB, the designated LCS performs repetitive occlusion and transparent sessions during which the lens is fully transparent ("OFF" state) when no voltage is applied and turns opaque ("ON" state) when voltage is applied.
3. Earpieces
The ear pieces are the part of the spectacle frame that extends from the hinges and to the back end of the device
4. Nose Piece
Nosepiece increases the distance between the nose and the spectacle frame, The nosepiece is detachable from the spectacle frame and the user can choose if to use it or not.
-
- Clip to Hold Refractive Lens
A plastic clip that holds the optic lenses (if needed).
- Clip to Hold Refractive Lens
6. Micro-USB Connector
During normal operation the connector is used only to charge the glasses. X6D technicians also use this connector to upload firmware to the electronic control for tests and/or updates.
7. LED Indicator
The Amblyz™ is equipped with an orange LED. The LED should be OFF when in normal operation and ON when properly connected to the USB charger and charging. Once the battery is fully charged, the LED indicator will turn OFF, even if Amblyz™ glasses are still connected to the USB charger. A flashing LED light indicates that the battery is low and charging is needed.
8. ON/OFF Switch
A mechanical rotary switch used only to power ON the glasses, an action that is performed only once, by the optician who initially sets up the glasses.
9. Programming Button
The programming button is a simple push button, located next to the ON switch. Push button is used for setting the eye to be occluded. This operation is performed only once, by the optician who initially sets up the glasses.
10 Amblyz™ onboard Software
2
An onboard software (referred to as "firmware") controls the Amblyz [ glasses An onboard sonware (referred to as "limitate") Sontere the Amblyz™ glasses unit, is to allow the initial setting, and then after continuously deliver the therapy sequence without any option for user tampering. Other "house holding" functions of the software are to alert on low battery state, support the "watch-dog" component that resets the glasses in case of error.
11 Amblyz™ Technician Software
Amblyz™ PC Maintenance (Technician) Software is intended to be used only by qualified X6D personnel for the purpose of reprogramming / upgrading the onboard Amblyz™ software.
Substantial Equivalence:
The table below presents the comparison between the Amblyz™ System and the legally marketed device - the LCG System.
| Amblyz™ System | LCG System (Predicate) | |
|---|---|---|
| Indications | The Amblyz™ System is an electronic | |
| shutter module intended to provide | ||
| occlusions of the eye in an intermittent | ||
| fashion. | ||
| (As the LCG) | The LCG (Liquid Crystal Glasses) | |
| System is an electronic shutter | ||
| module intended to provide | ||
| occlusions of the eye in an | ||
| intermittent fashion. | ||
| Technological | ||
| Characteristics | Computer derived, electrical and Liquid | |
| Crystal technology. | Computer derived, electrical and | |
| Liquid Crystal technology. | ||
| A Liquid Crystal Module (LCM) lens | ||
| covers a spectacle unit lens, which is | ||
| intermittently occluded when voltage is | ||
| applied. | ||
| (As the LCG) | A Liquid Crystal Module (LCM) | |
| lens covers a spectacle unit lens, | ||
| which is intermittently occluded | ||
| when voltage is applied. | ||
| Materials | The Amblyz™ System's components | |
| that come with direct contact with the | ||
| patient for a continuous duration of use | ||
| are the Spectacle Frame (comprised of | ||
| front frame, nose piece, ear handles | ||
| and clip). | ||
| • The front frame is made of durable | ||
| and biocompatible plastic PC | ||
| Makrolon 2458. | ||
| • The nose piece is made of Texin | ||
| RXT50D | ||
| • The Amblyz™ System's handle | ||
| comprises Elastosil Colour Paste Pt | ||
| Yellow Ral 1021 and Elastosil R | ||
| 401/70 | ||
| All the above materials conform to | The LCG System's parts that come | |
| in direct contact with the patient | ||
| and intended for a continuous | ||
| duration of use are the Spectacle | ||
| Frame and its Strap. | ||
| • The Spectacle Frame is made | ||
| of a durable and biocompatible | ||
| plastic Grilamid TR 90. | ||
| • The Strap is made of | ||
| biocompatible Thermoplastic | ||
| polyurethanes (TPU) | ||
| Carbothane®. | ||
| Amblyz™ System | LCG System (Predicate) | |
| applicable biocompatibility and flammability requirements. | ||
| Mode of Action | • The patient is wearing the AMBLYZ™ (spectacle) Unit. | |
| • Intermittent occlusions are performed. | ||
| • ON/OFF switch is used by technician only – in course of user operation the glasses are always ON | • The patient is wearing the LCG (spectacle) Unit. | |
| • Intermittent occlusions are performed. | ||
| • ON/OFF switch is activated by a touch sensor on the glasses that is activated upon wearing the glasses | ||
| Set-Up | One time only "press button" set-up - done by healthcare professional | Set-up via dedicated PC software. |
| Charging | Mini-USB connection to computer or any other USB port or wall charger (not included in system) | Mini-USB connection to dedicated charging box |
| Compliance monitoring | None | Glasses mounted sensor monitors wear time |
| Occlusion Pattern | 1) Occlusion is performed in an intermittent fashion, enabling rest periods |
- Total occlusion time is approximately 50% of the time
- Occlusion pattern is fixed: 30 seconds and rest period is 30 seconds. | 1) Occlusion is performed in an intermittent fashion, enabling rest period
- Total occlusion time is approximately 50% of the time:
- Occlusion pattern is quasi-random, with occlusion periods varying between 12 up to 35 seconds. |
| Indicators | (On glasses only) A flashing LED light indicates when battery is low.
Constant LED light indicates charging.
Shutter Lenses rapid flashing indicate correct connection to charger. | 1. None on glasses
- The reporting box indicates actual and prescribed wear time and present smiley/sadly icons that indicate compliance. |
| Design | 1. Frame dimensions: L129 x W129 x H40 mm - Weight: 36,4 g
- The electronics and battery are housed within the frame
- Optic lenses on clip, can be detached for cleaning and/or replacement
- Viewing angle (pantoscopic angle) provides a 6 degrees | 1. Frame dimensions: L120xW120xH34mm
- Weight: ~35gr
- The electronics and battery are housed in the spectacles strap.
- Optic lenses are coupled (glued) to device.
- Viewing angel zero (pantoscopic angel not |
| | Amblyz™ System | LCG System (Predicate) |
| | pantoscopic angle | applied) |
| Performance | 1. Operation time without charge: over 48 hours - Charging time: less than 2 hours
- Lens transparency: 40%
- Contrast ratio: Over 400 | 1. Operation time without charge: 20 hours
- Charging time: 8 hours
- Lens transparency: 40%
- Contrast ratio: 1:300 |
3
.
.
:
ォ
4
Safety and Performance Testing
A series of safety and performance testing were performed:
- Electrical safety and electromagnetic compatibility testing according teg. IEC . 60601-1 (and amendments), and IEC 60601-1-2 standards. The Amblyz™ has found to comply with the requirements of these standards. Certificate of Compliance to these standards is attached to this submission.
- Software verification and validation testing .
- A set of in vitro (bench) performance testing: .
| Test Description | Results |
|---|---|
| Lens Impact Resistance/Drop Ball Test | The lenses cracked but did not shatter into pieces |
| and therefore comply with standard requirements | |
| Destructive Test | The LC lens glass was cracked and the liquid |
| crystal was spread across the glass. Nevertheless, | |
| the laminated films completely held the LCM glass | |
| pieces. No change in the overall package and no | |
| glass residues were found. Test was performed on | |
| four lenses, all resulting in same findings | |
| Charge/Discharge Test | Tests show, that glasses have more than enough |
| operating time with the used battery. | |
| Charging Time Test | All ten (10) test cases comply with the acceptance |
| criteria | |
| Climatic Testing | The samples sustained the specified |
| environmental testing, no damage was noted. | |
| Unpacked Drop Test | All samples have passed all visual and |
| operating/performance checks after the drop | |
| Cosmetic Resistance | No visual change on tested samples after the test |
| was completed. | |
| Sweat Resistance | No visual change observed on tested surfaces in |
| all tested samples |
5
| Test Description | Results |
|---|---|
| Cleaning Resistance | No visual change observed on tested surfaces in |
| all tested samples | |
| Thermal Shock | All samples have passed all visual and |
| operating/performance checks after the test | |
| Electrical Characteristics Test | All tests passed successfully and meet acceptance |
| criteria. |
Packaging Validation including the following tests: .
| Test Description | Results |
|---|---|
| Fall Test - Master Packaging | Functional and cosmetic inspections have passed |
| successfully. | |
| Fall Test - Retail Packaging | All samples passed and meet acceptance criteria |
| Transportation Vibration Test | After the completion of Transportation Vibration |
| Test, units inside the carton box were subjected to | |
| functionality check. All test units passed the | |
| functionality check with no functionality and | |
| cosmetic problem. | |
| Bump Test | After the completion of Bump Test, units inside the |
| carton box were subjected to functionality check. | |
| All test units passed the functionality check with no | |
| functionality and cosmetic problem. |
Biocompatibility Testing
According to the Blue Book Memo, G95-1, Use of International Standard ISO-10993, and ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, the components of the Amblyz™ glasses are categorized as surface device with Intact skin permanent (>30days) contact. The parts that come in direct contact with the patient and intended for a continuous duration of use are the Spectacle Nosepiece, Front frame (Case left & right) prescription frame, and the Amblyz™ Insert left & right part of the handle. Cytotoxicity testing was conducted on all the above, based on the requirements of ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
Also, hazard analysis including risk level and solutions performed in compliance with ISO 14971:2012 for the entire system and for the software.
In conclusion, a series of in vitro, software, electrical safety, and biocompatibility test results demonstrate that the product has acceptable safety and performance characteristics.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or a human figure with outstretched arms.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2014
X6D Ltd. % Ms. Neta Landman Duct Medical Consulting Ltd. 21 Hanafa Street Zur- Moshe 42810, Israel P.O. Box 536
Re: K132042
Trade/Device Name: Amblyz™M Regulation Number: 21 CFR 886.4750 Regulation Name: Ophthalmic Eye Shield Regulatory Class: Class I Product Code: HOY Dated: March 21, 2014 Reccived: March 31, 2014
Dear Ms. Landman:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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.
7
Page 2 - Ms. Neta Landman
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Deborah L. Falls -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132042
Device Name Amblyz
Indications for Use (Describe)
The Ambly2TM System is an electronic shutter module intended to provide occlusions of the eye in an internittent fashion.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic and Ear, Nose and Throat Devices | |
| 510(k) Number | K132042 |
Andrew Yang -S
2014.04.25
13:21:30 -04'00'
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (1/14)
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