(245 days)
Not Found
No
The summary describes a manual refractor with digital components and remote capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies. The technology described (micro lens array, embedded display, tunable lens) is not inherently AI/ML.
No
The device is identified as a refractor, used for diagnosis by measuring refractive errors, not for treating a condition.
Yes
The device is described as subjectively measuring sphere, cylinder, and axis refractive errors, and determining refractive error, which are diagnostic activities.
No
The device description explicitly mentions hardware components such as a micro lens array, a high-density embedded display, and a tunable lens. The performance studies also include testing of hardware aspects like the cooling system and lenses.
Based on the provided information, the LFR-260 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LFR-260 Function: The LFR-260 is a manual refractor used to measure refractive errors of the eye. It interacts directly with the patient's eye and visual system, not with a specimen taken from the body.
- Intended Use: The intended use clearly states it's for performing distance vision testing and subjectively measuring refractive errors in patients. This is a direct assessment of a physiological function, not an analysis of a biological sample.
Therefore, the LFR-260 falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LFR-260 is a portable manual refractor providing capabilities to the eyecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.
Product codes
SBI
Device Description
The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions. The LFR-260 achieves the similar functionality as Comprehensive Phoropter, MDR-680, which is a standard refractor, but relies on the use of a micro lens array, a high-density embedded display, and a tunable lens. The reduced number of lenses allows for higher portability and a smaller footprint.
The LFR-260 system is able to perform the same distance vision traditional refractive test with the standard optotypes (Snellen, ETDRS, Landolt C, pediatric optotypes) as a standard refractor, such as:
- Determining the required spherical correction
- Determining the required astigmatic correction measuring with fan and block test and/or JCC (Jackson cross-cylinder)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
12-65 years old
Intended User / Care Setting
Licensed eye care practitioner / Professional Healthcare Facility Environment/Optometric Clinics, Home Healthcare Environment
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
Both bench and clinical testing were performed to demonstrate that LFR-260 performs safely and effectively in achieving its intended use.
Bench testing evaluated:
- Visual acuity chart or display with specified size, distance, and range of acceptable luminance based on the standard of ANSI Z80.21-2020.
- Lenses to measure refractive error.
- Jackson Cross Cylinder (JCC) unit.
- Inter-Pupillary Distance (IPD).
- The system's ability to produce both double and quad view and the ability of the cooling system to maintain the temperature of the tunable lenses.
In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met.
Clinical testing:
- Performed to demonstrate comparability of the device's refractive measurements to the predicate device.
- Based on Bland Altman analysis, in three subgroups (
§ 886.1770 Manual refractor.
(a)
Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye.(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. The device is also 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, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
May 31, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Evolution Optiks Limited % John Smith Partner Hogan Lovells US LLP 555 13th Street NW Washington, District of Columbia 20004
Re: K233295
Trade/Device Name: LFR-260 Regulation Number: 21 CFR 886.1770 Regulation Name: Manual Refractor Regulatory Class: Class I Product Code: SBI Dated: May 3, 2024 Received: May 3, 2024
Dear John Smith:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 either 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elvin Y. Ng -S
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
510(k) Number (if known) K233295
Device Name LFR-260 System
Indications for Use (Describe)
The LFR-260 is a portable manual refractor providing capabilities to the evecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
K233295
510(k) SUMMARY
Evolution Optiks LFR-260 System
Submitter
Evolution Optiks Limited
PASEA FINANCIAL CENTRE CORNER HARTS GAP & DAYRELLS ROAD CHRIST CHURCH BARBADOS BB14030
Phone: (203) 981 5489
Contact Person: Raul Mihali
Date Prepared: May 30, 2024
1. Device Information
Name of Device: LFR-260 System Common or Usual Name: Manual Refractor Classification Name: Manual Refractor
Regulation Number: 21 C.F.R. 886.1770
Product Code: SBI
Regulatory Class: Class I
2. Predicate Device Information
510(k) number K936205
Trade name: Comprehensive Phoropter, MDR-680
Classification Name: Manual Refractor
Regulation Number: 21 C.F.R. 886.1770
3. Device Description
The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions. The LFR-260 achieves the similar functionality as Comprehensive
5
Phoropter, MDR-680, which is a standard refractor, but relies on the use of a micro lens array, a highdensity embedded display, and a tunable lens. The reduced number of lenses allows for higher portability and a smaller footprint.
The LFR-260 system is able to perform the same distance vision traditional refractive test with the standard optotypes (Snellen, ETDRS, Landolt C, pediatric optotypes) as a standard refractor, such as:
- Determining the required spherical correction ●
- . Determining the required astigmatic correction measuring with fan and block test and/or JCC (Jackson cross-cylinder)
The visual acuity tests will always be administered by an eye care practitioner licensed and registered by the appropriated body in the region intended to be used.
4. Intended Use / Indications for Use
The LFR-260 is a portable manual refractor providing capabilities to the eyecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.
5. Summary of Technological Characteristics
The intended use of LFR-260 is consistent with Comprehensive Phoropter, MDR-680, which is a manual refractor. The substantial equivalence table is provided below:
| | LFR-260 | Comprehensive Phoropter,
MDR-680 | Discussion |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The LFR-260 system
includes a micro lens array,
tunable lenses, and high
pixel-density display to
provide the same
functionality as a
traditional reel of lenses to
allow the measure of
refractive error of the eye. | The Comprehensive
Phoropter, MDR-680, is a
manual refractor and is
defined as a device that is
a set of lenses of various
dioptric powers intended
to measure the refractive
error of the eye. | Differences in
technological
characteristics do
not raise different
questions of
safety and
effectiveness.
Performance data
demonstrates
comparable
performance and
safety. |
| Overview of Device | The LFR-260 is a portable
manual refractor providing
capabilities to the eyecare
provider to perform
distance vision testing and
subjectively measure
sphere, cylinder and axis
refractive errors in patients
aged from 12-65 years old
with healthy visual systems. | The Comprehensive
Phoropter, MDR-680 is
regulated under 886.1770,
primary product code HKN.
A manual refractor, which
is a device that is a set of
lenses of various dioptric
powers intended to
measure the refractive
error of the eye. | Both devices are
intended to
measure
refractive error of
the eye. |
| Operation/Tests
Available | The LFR-260 device
provides similar subjective | As a manual refractor, the
comprehensive phoropter | Substantially
similar. Both |
| | refraction as manual
refractors including sphere,
cylinder, and axis
measurements.
The LFR-260 can be used
to administer comparable
eye examination that is
standard of care in eye care
professionals' clinics.
Specifically, the LFR-260 is
able to perform comparable
traditional refractive tests
with the standard optotypes
(e.g., Snellen, ETDRS,
Landolt C, pediatric
optotypes) such as:
• Determining the required
spherical correction
• Determining the required
astigmatic correction
measuring with fan and
block test and/or JCC
(Jackson cross-cylinder) | MDR-680 provides
subjective refraction
including sphere, cylinder
and axis measurements. It
can be used to administer
the eye examination that is
standard in eye care
professionals' clinics.
Manual refractors can
perform traditional
refractive tests such as:
• Determining the required
spherical correction
• Determining the required
astigmatic correction
measuring | systems provide
examinations to
measure
refractive error of
the eye. The LFR-
260, however is
indicated for
distance vision
testing only. |
| Type of Display | High pixel-density display | Traditional screen is used
to display eye charts | A high pixel-
density display is
used to view the
eye charts with
the subject device
while a traditional
screen is used
with manual
refractors.
Though there are
technological
differences, both
displays provide
users with eye
charts for use
during a routine
eye examination.
There are no new
questions of
safety or
effectiveness due
to this difference. |
| Type of Lenses | Tunable Lenses | Traditional reel of lenses | Both types of
lenses enable the
devices to
perform
subjective
refractive tests.
There are no new
questions of
safety or
effectiveness due
to this difference. |
| Included Software | Proprietary Software used
to control the LFR-260
system by an ECP | No software required | The software
controls the LFR-
260 to achieve its
intended use.
There are no new
questions of
safety or
effectiveness. |
| Use Environment | Professional Healthcare
Facility
Environment/Optometric
Clinics,
Home Healthcare
Environment | Professional Healthcare
Facility
Environment/Optometric
Clinics | Differences in use
environment do
not impact the
intended use of
the device.
There are no new
questions of
safety or
effectiveness.
Performance data
demonstrates
comparable
performance and
safety. |
| Intended User | Licensed eye care
practitioner | Licensed eye care
practitioner | Same |
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6. Performance Data
Both bench and clinical testing were performed to demonstrate that LFR-260 performs safely and effectively in achieving its intended use.
The LFR-260 underwent bench testing to evaluate the following characteristics:
- Visual acuity chart or display with specified size, distance, and range of acceptable luminance ● based on the standard of ANSI Z80.21-2020.
- Lenses to measure refractive error. .
- Jackson Cross Cylinder (JCC) unit. ●
- Inter-Pupillary Distance (IPD). ●
Additionally, the system was evaluated to ensure it is able to produce both double and quad view and the ability of the cooling system to maintain the temperature of the tunable lenses.
In all instances, LFR-260 functioned as intended and each test's pre-specified success criteria were met.
The company also performed clinical testing to demonstrate comparability of the device's refractive measurements to the predicate device.
Based on Bland Altman analysis, in three subgroups (