(51 days)
No
The summary describes a physical contact lens and its material properties and parameters. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
Explanation: The device is indicated for the "temporary reduction of myopia," which is a treatment for a medical condition.
No
The device is an orthokeratology contact lens, indicated for the temporary reduction of myopia, which is a treatment or correction for an existing condition, not a diagnostic tool.
No
The device description clearly states that the device is a physical contact lens made from specific materials with defined physical parameters. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The iSee contact lenses are physical devices worn on the eye to temporarily reshape the cornea and reduce myopia. They do not analyze any biological samples.
- Intended Use: The intended use is for an orthokeratology fitting program to reduce myopia, which is a physical intervention, not a diagnostic test.
- Device Description: The description focuses on the material properties and physical parameters of the contact lens itself.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic information based on biological markers.
This device is a Class II medical device (based on the predicate device classification) that falls under the category of contact lenses for vision correction and orthokeratology.
N/A
Intended Use / Indications for Use
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are 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. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes (comma separated list FDA assigned to the subject device)
MUW
Device Description
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties:
Refractive Index: ROFLUFOCON D: 1.4333, ROFLUFOCON E: 1.4332
Light Transmission (clear): ROFLUFOCON D: >97%, ROFLUFOCON E: >97%
Light Transmission (tinted): ROFLUFOCON D: >90%, ROFLUFOCON E: >90%
Wetting Angle (Dynamic contact receding angle): ROFLUFOCON D: 3°, ROFLUFOCON E: 6°
Specific Gravity: ROFLUFOCON D: 1.166, ROFLUFOCON E: 1.155
Oxygen Permeability (Dk) ISO/FATT Method: ROFLUFOCON D: 100 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), ROFLUFOCON E: 125 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
Visitint lenses contain one or more of the following color additives conforming to: 21 CFR Part 73 & 74, Subpart D: ROFLUFOCON D: D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18, ROFLUFOCON E: D & C Green No. 6, FD & C Red No. 17, CI Solvent Yellow 18
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are available in the following lens parameters:
Parameter: Base Curve, Range: 6.50mm to 11.00mm, Tolerance: ± 0.05 mm
Parameter: Center Thickness, Range: 0.10mm to 0.70mm, Tolerance: ± 0.02 mm
Parameter: Diameter, Range: 6.50mm to 11.50mm, Tolerance: ± 0.10mm
Parameter: Spherical Power, Range: -10.00 D to +3.00 D (in 0.25D steps), Tolerance: ± 0.12 (0 to = 5D) ± 0.18 (5 to = 10.0D) ± 0.25 (10 to = 15D) ± 0.37 (15 to = 20D) ± 0.50 (over 20D)
Parameter: Secondary Curves, Range: 0.10mm to 2.00mm (flatter or steeper than base curve), Tolerance: ± 0.10mm
Parameter: Peripheral Curves, Range: 0.10mm to 2.00mm (flatter or steeper than base curve), Tolerance: ± 0.10mm
Parameter: Multifocal Power, Range: +1.00 D to 3.75 D (in 0.25 D steps), Tolerance: ± 0.25D
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
Not Found
Intended User / Care Setting
Eyecare practitioners
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 roflufocon D and roflufocon E 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 roflufocon D and roflufocon E have been addressed in previous applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
"OPTIMUM GP OK Daily Wear Contact Lens (Roflufocon D & E)" By Contamac, Ltd. 510(k) number; K160859
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.
0
510(K) Premarket Notification
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: K183200
I. SUBMITTER
| Date Prepared: | November 15th, 2018 |
|---|---|
| Name: | |
| Address: | C&E GP Specialists, Inc. |
| 15970 Bernardo Center Drive | |
| San Diego, CA 92127 | |
| United States | |
| Contact Person: | Steve Wagner |
| President | |
| Phone number: | (949) 272-2424 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact
Lenses |
|-------------------------|--------------------------------------------------------------------------------|
| Common
Name: | 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: | MUW |
1
III. PREDICATE DEVICE
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are substantially equivalent to the following predicate devices:
- . "OPTIMUM GP OK Daily Wear Contact Lens (Roflufocon D & E)" By Contamac, Ltd. 510(k) number; K160859
DEVICE DESCRIPTION IV.
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties:
| ROFLUFOCON D | ROFLUFOCON E | |
|---|---|---|
| Refractive Index | 1.4333 | 1.4332 |
| Light Transmission (clear) | >97% | >97% |
| Light Transmission (tinted) | >90% | >90% |
| Wetting Angle (Dynamic contact | ||
| receding angle) | 3° | 6° |
| Specific Gravity | 1.166 | 1.155 |
| Oxygen Permeability | ||
| (Dk) | ||
| ISO/FATT Method | 100 x $10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ | |
| 35°C) | 125 x $10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ | |
| 35°C) | ||
| Visitint lenses contain one or more of | ||
| the following color additives conforming | ||
| to: 21 CFR Part 73 & 74, Subpart D | D & C Green No. 6, FD & C Red No. | |
| 17, CI Solvent Yellow 18 | D & C Green No. 6, FD & C Red No. | |
| 17, CI Solvent Yellow 18 |
The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are available in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 6.50mm to 11.00mm | ± 0.05 mm |
| Center Thickness | 0.10mm to 0.70mm | ± 0.02 mm |
| Diameter | 6.50mm to 11.50mm | ± 0.10mm |
| Spherical Power | -10.00 D to +3.00 D | |
| (in 0.25D steps) | ± 0.12 (0 to = 5D) Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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