(48 days)
Not Found
No
The summary describes contact lenses and their materials, indications for use, and physical properties. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the contact lenses "are indicated for therapeutic use" for the management of irregular and distorted corneal surfaces and eyes with ocular surface disease.
No
This device is a contact lens indicated for the correction of refractive ametropia and for therapeutic use in managing irregular corneal conditions and ocular surface disorders. It is a treatment device, not a diagnostic one that identifies or characterizes a disease.
No
The device description clearly states that the device is a physical contact lens made from specific materials, not software.
Based on the provided text, 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 description clearly states that this device is a contact lens. Contact lenses are medical devices that are placed directly on the eye for vision correction or therapeutic purposes. They do not analyze samples taken from the body.
- Intended Use: The intended use describes the correction of refractive errors and therapeutic management of corneal and ocular surface conditions. These are all related to the physical interaction of the lens with the eye, not the analysis of biological samples.
Therefore, the OPTIMUM GP and HEXA100 Daily Wear Contact Lenses are medical devices, but they do not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
OPTIMUM GP (roflufocon D. roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. OPTIMUM GP (roflufocon D) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
Product codes (comma separated list FDA assigned to the subject device)
HQD
Device Description
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, or hexafocon A.
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available with or without Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability compared to untreated lenses.
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available in the following lens parameters:
Base Curve: 5.00mm to 8.00mm
Center Thickness: 0.20mm to 0.50mm
Diameter: 7.00mm to 22.00mm
Spherical Power: -20.00 D to +20.00 D (in 0.25D steps)
Cylindrical Power: Up to -10.00 D (in 0.25 D steps)
Cylindrical Axis: 1° to 180° (in 1° steps)
Multifocal Power: +1.00 D to 4.00 D (in 0.25 D steps)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes, corneal surfaces, ocular surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescribing by an eye care professional.
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 purpose of this application is to modify the labeling of previously FDA cleared RGP contact lenses/materials to include a therapeutic indication for use. Non-clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D. roflufocon E, and hexafocon A materials has been addressed in previous applications.
Clinical Studies: Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, and hexafocon A has been previously addressed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 25, 2018
Contamac, Ltd. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068
Re: K180616
Trade/Device Name: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: March 5, 2018 Received: March 8, 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. 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 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.
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.
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
2
Indications for Use
510(k) Number (if known) K180616
Device Name
OPTIMUM GP (roflufocon D. roflufocon E) Daily Wear Contact Lens; HEXA100 (hexafocon A) Daily Wear Contact Lens
Indications for Use (Describe)
OPTIMUM GP (roflufocon D. roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive surgery.
Furthermore, eyes suffering from certain ocular surface disorders may benefit from the physical protection, aqueous hydrated environment and the saline bath provided by scleral lens designs. OPTIMUM GP (roflufocon D) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are indicated for therapeutic use for the management of irregular and distorted corneal surfaces where the subject:
-
- cannot be adequately corrected with spectacle lenses
-
- requires a rigid gas permeable contact lens surface to improve vision
-
- is unable to wear a corneal rigid gas permeable lens due to corneal distortion or surface irregularities
Common causes of corneal distortion include but are not limited to corneal infections, trauma, tractions as a result of scar formation secondary to refractive surgery (e.g. LASIK or radial keratotomy) or corneal transplantation. Causes may also include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann's nodular degeneration) and corneal dystrophy (e.g., lattice dystrophy, granular corneal dystrophy, Reis-Bucklers dystrophy, Cogan's dystrophy). The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may concurrently provide correction of refractive error.
The lenses may be disinfected using a chemical disinfection (not heat) system only.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
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: K180616
I. SUBMITTER
- April 10th, 2018 Date Prepared:
- Name: Contamac Ltd. Address: Carlton House Shire Hill Saffron Walden Essex CB11 3AU Contact Person: Robert McGregor Managing Director Phone number: 01799 514800 Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068
(503) 372-5226
II. DEVICE
Phone number:
| Trade Name: | OPTIMUM GP (roflufocon D, roflufocon E) Daily Wear Contact Lens;
HEXA100 (hexafocon A) Daily Wear Contact Lens |
|-------------------------|-------------------------------------------------------------------------------------------------------------------|
| Common
Name: | Daily wear rigid gas permeable contact lens |
| Classification
Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory
Class: | Class II |
| Product Code: | HQD |
5
III. PREDICATE DEVICE
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are substantially equivalent to the following predicate device:
- 트 "Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lens" By Bausch + Lomb Inc. 510(k) number; K171404
IV. DEVICE DESCRIPTION
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear
Contact Lenses are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, or hexafocon A-with the following properties:
| ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON A | |
|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.414 |
| Light Transmission (clear) | >97% | >97% | - |
| Light Transmission (tinted) | >90% | >90% | >91% |
| Water Content | 98% UVB |
95% UVA | >98% UVB
95% UVA | >98% UVB
84% UVA |
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear
Contact Lenses are available with or without Tangible™ Hydra-PEG-which is a thin polyethylene glycol (PEG)-based polymer that is covalently bonded to the surface of the contact lens and is designed to enhance the surface properties of the contact lens while retaining the mechanical properties of the underlying material. When treated with Tangible™ Hydra-PEG, the underlying material is encapsulated in a thin layer of polymer that results in measurable improvement of wettability compared to untreated lenses.
6
The surface properties of roflufocon D, roflufocon E, and hexafocon A materials uncoated and coated with Tangible Hydra-PEG are depicted in the following table:
| roflufocon D | roflufocon E | hexafocon A | |
|---|---|---|---|
| Captive Bubble Contact | |||
| Angle ± Standard | |||
| Deviation | Coated: 40.40°±5.05° | ||
| Uncoated: 93.28°±2.13° | Coated: 36.90°±8.04° | ||
| Uncoated: 93.64°±3.47° | Coated: 49.1°±5.81° | ||
| Uncoated: 96.4°±2.79° |
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses may be packaged and shipped "dry" or "wet" in a polypropylene contact lens case. The primary container for shipping the OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses is the PolyVial Contact Lens Case. When shipped "wet", the lenses may be packaged and shipped in the Unique pH contact lens care system by Menicon Co., Ltd. The active ingredients in Unique pH solution are Edetate Disodium 0.01% and Polyquaternium 10.0011%.
The OPTIMUM GP (roflufocon D, roflufocon E) and HEXA100 (hexafocon A) Daily Wear Contact Lenses are available in the following lens parameters:
| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 5.00mm to 8.00mm | ± 0.05 mm |
| Center Thickness | 0.20mm to 0.50mm | ± 0.02 mm |
| Diameter | 7.00mm to 22.00mm | ± 0.10mm |
| Spherical Power | -20.00 D to +20.00 D | |
| (in 0.25D steps) | ± 0.12 (0 to = 5D) |