(50 days)
No
The summary describes a physical contact lens and its intended uses and materials. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "also indicated for therapeutic management of ocular surface disease" and "When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases".
No.
The device is a scleral contact lens intended for therapeutic management and correction of refractive error, not for diagnosing conditions.
No
The device description explicitly states it is a "large diameter rigid gas permeable contact lens design" and is "lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials". This clearly describes a physical hardware device, not software.
No, 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 Ampleye Scleral RGP Lens is a physical device that is placed on the eye. Its function is to manage and treat various eye conditions and provide vision correction. It does not analyze biological samples to provide diagnostic information.
The provided text clearly describes a medical device used for therapeutic and corrective purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is indicated for use for the management of irregular astigmatism, corneal degeneration or dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal trauma/scaring, post keratoplasty, post K-Pro, post RK, post LASIK, Salzmann's nodular degeneration. Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers dystrophy.
The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also indicated for therapeutic management of ocular surface disease from dry eye including ocular pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes zoster, familial dysautonomia), Sjogern's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy, ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including myopia, presbyopia and regular astigmatism.
Eye care 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
HQD
Device Description
The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.
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
Eye care 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:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Art Optical Contact Lens, Inc. to manufacture lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20-2016 tolerance.
Bioburden Testing-bioburden testing conducted on rigid gas permeable lenses manufactured at Art Optical Contact Lens, Inc. demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.
Clinical Studies:
Clinical testing to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D, roflufocon E, hexafocon A, paflufocon D has been previously addressed.
Conclusions Drawn from Testing:
Testing presented in this submission for the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) demonstrate no significant differences from the predicate devices-supporting the substantial equivalence claim.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 20, 2017
Art Optical Contact Lens, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068
Re: K172314
Trade/Device Name: Ampleye Scleral RGP Lens (roflufocon D. roflufocon E. hexafocon A, paflufocon D) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: July 28, 2017 Received: August 1, 2017
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. Iisting 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 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 (DICE) 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 (DICE) 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,
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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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: | K172314 |
|---|---|
| -------------------------------- | --------- |
Applicant information:
Date Prepared:
July 28th, 2017
3175 3 Mile Rd NW Grand Rapids, MI 49534
Mike Johnson, FCLSA
Name: Address
Contact Person:
Phone number:
(616) 559-5167
Director
Consultant/Correspondent:
Bret Andre EyeReg Consulting, Inc.
Art Optical Contact Lens, Inc.
Phone number (503) 372-5226 Fax number (503) 419-4475
Device Information:
| Regulatory Class: | Class II |
|---|---|
| Regulation Number: | 21 CFR 886.5916 |
| Product Code: | HQD |
| Regulation Name: | Rigid Gas Permeable Contact Lens |
| Common Name: | Lens, Contact (Other Material) - Daily |
| Trade/Device Name: | Ampleye Scleral RGP Lens (roflufocon D |
| roflufocon E, hexafocon A, paflufocon D) |
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Predicate Devices:
The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is substantially equivalent to the following predicate device(s)
- "BostonSight PD Prosthetic Device" ● Manufactured by Boston Foundation for Sight 510(k) number; K161461
- "Custom Stable" Rigid Gas Permeable Scleral Contact Lens" ● Manufactured by Valley Contax, Inc. 510(k) number; K170335
Device Description:
The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily wear is a large diameter rigid gas permeable contact lens design that vaults over the cornea and rests on the conjunctiva overlying the sclera. The Ampleye Scleral RGP Lens is lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D, roflufocon E, hexafocon A, or paflufocon D.
| ROFLUFOCON D | ROFLUFOCON E | HEXAFOCON A | PAFLUFOCON D | |
|---|---|---|---|---|
| Refractive Index | 1.4333 | 1.4332 | 1.415 | 1.442 |
| Light Transmission (clear) | >97% | >97% | - | >98% |
| Light Transmission (tinted) | >90% | >90% | >89% | >93% |
| Water Content | 98% UVB |
95% UVA | >98% UVB
95% UVA | >95% UVB
97% UVA | >95% UVB
97% UVA |
The physical properties of the Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) are as follows:
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| Parameter | Range | Tolerance |
|---|---|---|
| Base Curve | 5.57mm to 9.64mm | ± 0.10 mm |
| Center Thickness | 0.20mm to 0.50mm | ± 0.02 mm |
| Diameter | 15.00mm to 17.00mm | ± 0.10mm |
| Spherical Power | -30.00 D to +30.00 D | |
| (in 0.25D steps) | ± 0.12 (0 to = 5D) |