(106 days)
Not Found
No
The description focuses on the material composition, intended use, and physical properties of the contact lens, with no mention of AI or ML.
Yes
The device is used for the "temporary reduction of myopia," which is a treatment for a medical condition.
No
The device is a contact lens intended for daily wear in an orthokeratology fitting program to temporarily reduce myopia. It is a treatment device, not a diagnostic one.
No
The device description clearly describes a physical contact lens made of specific materials, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The OPTIMUM GP OK contact lenses are physical devices worn on the eye to temporarily reduce myopia through orthokeratology. They do not perform any tests on biological samples.
- Intended Use: The intended use clearly states the lenses are for "daily wear in an orthokeratology fitting program for the temporary reduction of myopia." This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the materials and physical characteristics of the contact lens itself, not components or reagents used for testing biological samples.
Therefore, the OPTIMUM GP OK contact lens is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OPTIMUM GP OK 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes
MUW
Device Description
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%.
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6. C.I. Solvent yellow No. 18. and FD&C Red No. 17.
In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm – 315nm and 95% in the UVA range of 316 – 380nm. The physical properties of the OPTIMUM GP OK Contact Lens are as follows:
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 cm^2/sec (ml O2/ml x mm Hg @ 35°C), (roflufocon e): 125 x 10^-11 cm^2/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 lens parameters of the OPTIMUM GP OK Contact Lens are as follows:
Chord Diameter: 6.5 to 11.5 mm
Center Thickness: 0.10 to 0.70 mm
Base Curve (BC): 6.5 to 11.0 mm
Secondary Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
Peripheral Curves: 0.10 to 2.0 mm (flatter or steeper than BC)
Spherical Powers: -10.00 to +3.00 D
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
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)
The safety profile for finished lenses manufactured from the (roflufocon D & E) rigid gas permeable (RGP) materials is demonstrated in K033594-which addresses the following areas:
- Biocompatibility
- Shelf Life (Wet Shipping)
- Solution Compatibility
- Clinical Performance
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Contamac Ltd. % Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 Re: K160859 Trade/Device Name: OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E) Regulation Number: 21 CFR 886.5916 Regulation Name: Daily Wear Rigid Gas Permeable (hydrophobic) Contact Lens (Orthokeratology) Regulatory Class: Class II Product Code: MUW Dated: May 25, 2016 Received: June 1, 2016
Dear Mr. 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. 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.
1
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 devicerelated 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" (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 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.
Denise E. Hampton -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K160859
Device Name
OPTIMUM GP OK (Orthokeratology) Daily Wear Contact Lens (roflufocon D & E)
Indications for Use (Describe)
The OPTIMUM GP OK 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
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: | K160859 |
|---|---|
| Applicant information: | |
| Date Prepared: | March 23 rd , 2016 |
| Name: | Contamac Ltd. |
| Address | Carlton House |
| Shire Hill | |
| Saffron Walden | |
| Essex CB11 3AU | |
| Contact Person: | Robert McGregor |
| Managing Director | |
| Phone number: | 44-1799 542 000 |
| Consultant: | EyeReg Consulting, Inc. |
| Bret Andre | |
| 6119 Canter Ln | |
| West Linn, OR 97068 | |
| Phone number | (503) 372-5226 |
| Fax number | (503) 419-4475 |
| Device Information: | |
| Device Classification: | Class II |
| Product Code: | MUW |
| Classification Name: | Daily Wear Rigid Gas Permeable (hydrophobic) Contact |
| Lens (Orthokeratology) (21 CFR 886.5916) | |
| Trade Name: | OPTIMUM GP OK (Orthokeratology) |
| Daily Wear Contact Lens (roflufocon D & E) |
4
Purpose of Submission:
~ New Indication ~
Predicate Devices:
The OPTIMUM GP OK for daily wear is substantially equivalent to the following predicate device(s)
Predicate device:
| Predicate device
| manufacturer | Device name | 510(k) number |
|---|---|---|
| Contamac Ltd. | OPTIMUM GP (Oxygen Permeable) Daily Wear | |
| Contact Lenses (roflufocon A, B, C, D, & E) | K033594 | |
| Contex, Inc. | CONTEX OK (orthokeratology) contact lens | K973697 |
| Polymer Technology | Boston X02 (hexafocon B) Daily Wear Contact | |
| Lens | K071266 |
Device Description:
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescribed in a daily wear orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes.
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is a rigid gas permeable methacrylate copolymer of Methyl methacrylate, 1,1,1,3,3 - Hexafluoroisopropy] Methacrylate, Methacryloxypropyl Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropyl)-1,1,3,3-tetrakis(trimethyl siloxy)disiloxane, 2-Hydroxyethyl Methacrylate, and Methacrylic acid cross-linked with Ethylene Glycol Dimethacrylate.
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP OK lenses is the PolyVial /PolyPack Contact Lens Case. When shipped "wet", the OPTIMUM GP OK lenses may be packaged and shipped in the Optimum Cleaning, Disinfecting and Storage (CDS) GP solution. The active ingredients in Optimum GP Cleaning Disinfecting and Storage solution are Lauryl salt of imidazoline, octylphenoxypolyethoxyethanol, and preserved with benzyl alcohol 0.3% and disodium edetate 0.5%.
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) incorporates a visibility tint to make the lens more visible for handling. The tinted lenses contain one or more of the following color additives: D&C Green No.6. C.I. Solvent yellow No. 18. and FD&C Red No. 17.
In the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) with UV Blocker, a Benzophenone UV blocking monomer is used to block UV radiation. The UV Blocker is 2,2 -Dihydroxy-4,4'dimethoxybenzophenone. The UV blocking for OPTIMUM GP averages > 98% in the UVB range of 280nm – 315nm and 95% in the UVA range of 316 – 380nm. The physical properties of the OPTIMUM GP OK Contact Lens are as follows:
5
| (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 | $100 \times 10^{-11} \frac{cm^2}{sec} (ml O_2/ml x mm \newline Hg @ 35°C)$ | $125 \times 10^{-11} \frac{cm^2}{sec} (ml O_2/ml x mm \newline Hg @ 35°C)$ |
| 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 lens parameters of the OPTIMUM GP OK Contact Lens are as follows:
- 米 Chord Diameter:
- ન્ન્સ Center Thickness:
- 米 Base Curve (BC):
- 米 Secondary Curves:
- 米 Peripheral Curves:
- 米 Spherical Powers:
6.5 to 11.5 mm 0.10 to 0.70 mm 6.5 to 11.0 mm 0.10 to 2.0 mm (flatter or steeper than BC) 0.10 to 2.0 mm (flatter or steeper than BC) -10.00 to +3.00 D
Indication for Use:
The OPTIMUM GP OK 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.
Description of Safety:
The safety profile for finished lenses manufactured from the (roflufocon D & E) rigid gas permeable (RGP) materials is demonstrated in K033594-which addresses the following areas:
- · Biocompatibility
- · Shelf Life (Wet Shipping)
- · Solution Compatibility
- · Clinical Performance
6
Substantial Equivalence:
Comparison to Predicate Device(s):
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is substantially equivalent to the OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses (roflufocon A, B, C, D, & E)cleared under K033594-in terms of the following:
- · contact lens material (roflufocon D. & E)—including physicochemical and mechanical properties of finished lenses
- · lathe cut manufacturing process
- manufacturing facility
- · final packaging and wet shipping procedures
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) is substantially equivalent to the Boston X02 (hexafocon B) Daily Wear Contact Lens and CONTEX OK-cleared under K071266 and K973697, respectively-in terms of the following:
- · indications for use (daily wear orthokeratology)
- orthokeratology lens design
The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) are substantially equivalent to the predicate device as depicted in the following table, and do not raise different questions of safety and effectiveness than the predicate device identified previously.
7
The following table depicts the pre-clinical characteristics of the OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E), as well as the predicate device.
| | OPTIMUM GP OK
(Orthokeratology) | OPTIMUM GP | CONTEX OK | BOSTON XO2 |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| Indication for Use | 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. | May be prescribed in
otherwise non-diseased eyes
that require a rigid gas
permeable lens for the
management of irregular
corneal conditions such as;
keratoconus, pellucid
marginal degeneration of
following penetrating
keratoplasty or following
refractive (e.g. LASIK)
surgery. | Indicated for daily
wear in an
orthokeratology
fitting program for
the temporary
reduction of myopia
of up to 3.00 diopters
in non-diseased eyes.
To maintain the
orthokeratology
effect of myopia
reduction, lens wear
must be continued on
a prescribed wearing
schedule. | 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. |
| Device and
Classification | Class II
Daily Wear Rigid Gas
Permeable (hydrophobic)
Contact Lens (21 CFR
886.5916) | Class II
Daily Wear Rigid Gas
Permeable (hydrophobic)
Contact Lens (21 CFR
886.5916) | Class II
Daily Wear Rigid
Gas Permeable
(hydrophobic)
Contact Lens (21
CFR 886.5916) | Class II
Daily Wear Rigid Gas
Permeable
(hydrophobic) Contact
Lens (21 CFR
886.5916) |
| Product Code | MUW | HQD | MUW | MUW |
| Production Method | Lathe-cut | Lathe-cut | Lathe-cut | Lathe-cut |
| USAN | roflufocon D, & E | roflufocon A, B, C, D, &
E | siflufocon A | hexafocon B |
| FDA Group # | Group # 3 Fluoro Silicone
Acrylate | Group # 3 Fluoro Silicone
Acrylate | Group # 3 Fluoro
Silicone Acrylate | Group # 3 Fluoro
Silicone Acrylate |
| Oxygen Permeability
x 10-11 (cm2/sec)
(ml O2/ml x mm Hg @ 35°C) | Roflufocon D: 100
Roflufocon E: 125 | Roflufocon D: 100
Roflufocon E: 125 | 81 | 141 |
| Water Content |