(41 days)
Not Found
No
The summary describes a physical contact lens and its materials and parameters. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: A therapeutic device is used to treat or prevent a disease or condition. This device is primarily for the correction of refractive ametropia and for the temporary reduction of myopia, which are considered corrections rather than treatments for a disease. While it can also be used for managing irregular corneal conditions, this is usually a supportive measure, not a cure or treatment for the underlying disease itself.
No
The device, eLens contact lenses, is indicated for the correction of refractive ametropia and management of irregular corneal conditions, as well as for the temporary reduction of myopia. It is a treatment device, not one used for diagnosis.
No
The device description clearly states that the device is a physical contact lens made from specific materials and with defined physical parameters. It is not software.
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 eLens Rigid Gas Permeable Contact Lenses are physical devices worn on the eye to correct vision or manage corneal conditions. They do not analyze biological samples.
- Intended Use: The intended use clearly states the lenses are for correcting refractive errors and managing irregular corneal conditions. This is a therapeutic and corrective function, not a diagnostic one.
The description focuses on the physical properties of the lenses, their parameters, and their intended application on the eye, which aligns with the characteristics of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.
Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Product codes
HOD, MUW
Device Description
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are lathe cut from one of the following hydrophobic. FDA Group #3 fluoro-silicone acrylate materials: hexafocon A, hexafocon B, or oprifocon A-with the following properties: Refractive Index, Water Content, Specific Gravity, Wetting Angle, Oxygen Permeability (Dk), Contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Spherical Power, Cylindrical Power, Cylindrical Axis, Multifocal Power.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are available in the following lens parameters: Base Curve, Center Thickness, Diameter, Secondary Curves, Peripheral Curves, Spherical Power, Aspheric Lens Eccentricity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
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)
Non-Clinical Studies: The non-clinical performance data to establish the safety and effectiveness of contact lenses manufactured from hexafocon A, hexafocon B, and oprifocon A has been addressed by reference to the predicate devices.
Clinical Studies: Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from hexafocon A. hexafocon B. and oprifocon A has been addressed in previous applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001960, K003933, K071266, K071043, K170001
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2018
E&E Optics Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068
Re: K181579
Trade/Device Name: eLens (hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lens for Daily Wear. eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD. MUW Dated: June 13, 2018 Received: June 15, 2018
Dear Bret Andre:
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. 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 located 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J Angelo Green -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
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Indications for Use
510(k) Number (if known) K181579
Device Name
eLens (hexafocon A. hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear; eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K
Indications for Use (Describe)
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.
Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Type of Use (Select one or both, as applicable)
| ☑ Recreation Use (Part 91 CFR 201.5(b)) |
|---|
| ☐ On-The-Spot Use (91 CFR 201.5(c)) |
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K181579
I. SUBMITTER
- July 11th, 2018 Date Prepared:
- Name: E&E Optics Inc. Address: 1795 E. Holt Blvd, Unit 104 Ontario, CA 91761 United States Contact Person: Bonnie Wan President (909) 391-8330 Phone number: Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln.
West Linn, OR 97068 Phone number: (503) 372-5226
II. DEVICE
| Trade Name: | eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable
Contact Lenses for Daily Wear;
eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable
Contact Lenses for Daily Wear Ortho-K | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common
Name: | Daily wear rigid gas permeable (hydrophobic) contact lens;
Daily wear rigid gas permeable (hydrophobic) contact lens (Orthokeratology) | |
| Classification
Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) | |
| Regulatory
Class: | Class II | |
| Product Code: | HQD; MUW | |
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III. PREDICATE DEVICE
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are substantially equivalent to the following predicate devices:
- . "Boston XO (hexafocon A) Contact Lens for Daily Wear Orthokeratology" By Bausch + Lomb Inc. 510(k) number; K001960
- . "Boston Equalens II (oprifocon A) Contact Lens for Daily Wear Orthokeratology" By Bausch + Lomb Inc. 510(k) number: K003933
- . "Boston XO2 (hexafocon B) Contact Lens for Daily Wear (Orthokeratology)" By Bausch + Lomb Inc. 510(k) number: K071266
- 트 "Boston XO (Hexafocon A) Rigid Gas Permeable Contact Lens" By Bausch + Lomb Inc. 510(k) number; K071043
- . "Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers Inc. 510(k) number; K170001
DEVICE DESCRIPTION IV.
The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are lathe cut from one of the following hydrophobic. FDA Group #3 fluoro-silicone acrylate materials: hexafocon A, hexafocon B, or oprifocon A-with the following properties:
| HEXAFOCON A | HEXAFOCON B | OPRIFOCON A | |
|---|---|---|---|
| Refractive Index | 1.414 | 1.424 | 1.423 |
| Water Content |