(78 days)
Not Found
No
The device description focuses on the physical properties, materials, and manufacturing process of a contact lens, with no mention of AI or ML technologies for design, fitting, or any other function.
No.
The primary stated indications are cosmetic, with some mention of refractive correction and occlusive therapy, which while therapeutic, are not the primary or sole purpose of the device.
No
This device is a prosthetic soft contact lens designed to enhance or alter the appearance of the eye, correct refractive errors, and for occlusive therapy. Its intended uses do not involve diagnosing any medical conditions.
No
The device description clearly states it is a physical contact lens made of hefilcon A, a material, and includes details about its physical properties, pigments, and manufacturing process. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly indicate that this is a contact lens applied directly to the eye for cosmetic, refractive, or therapeutic purposes. It does not involve the analysis of any biological samples.
- The device description focuses on the physical properties and manufacturing of the contact lens. It describes the materials, opaquing agents, and coloring techniques, all of which relate to a physical device, not a diagnostic test.
- The intended use describes the application of the lens to the eye for various conditions or cosmetic changes. This is a direct intervention or modification of the eye's appearance or function, not a diagnostic process.
Therefore, this device falls under the category of a medical device, specifically a contact lens, but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eye. including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The Prosthetic (hefilcon A)Soft Lens is a partially or totally white opaque lens that is painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The approved pigment, titanium dioxide, is incorporated into the lens matrix as the white opaquing agent. Lenses are printed or painted by skilled artists to a eye care practitioners specifications with approved reactive dyes. The opaquing agent and colorants are permanent and are not leached from a lens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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)
Not Found
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
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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
Nov 1 8 1999
510(k) #K992950
510(k) SUMMARY
Applicant Information:
Date Prepared: August 26, 1999
Submitted by: Prosthetic Soft Lens Company 2890 South Tejon Street Englewood, CO 80110
Contact Person: Phone: Fax: Email:
William Hoffman 303-789-0933 303-789-4506 lagado@lagado.net
Device Information:
| Trade Name: | Prosthetic (hefilcon A) Soft Lens |
|---|---|
| Classification Name: | Lens, Soft Contact, Daily Wear |
| Class and Number: | Class II, LPL |
Substantially Equivalent to:
- (1) Prosthetic (polymacon) Hydrophilic Contact Lens, K984259
- (2) Classic Prosthetic (polymacon), K983053
(3) Oxylens tinted Prosthetic (hioxifilcon B), K983278
Device Description:
The Prosthetic (hefilcon A)Soft Lens is a partially or totally white opaque lens that is painted or printed with an iris or other pattern to mask a disfiguring or unsightly eye condition. The lens may be totally opaque for a non-sighted eye or clear in the center for a sighted eye. The approved pigment, titanium dioxide, is incorporated into the lens matrix as the white opaquing agent. Lenses are printed or painted by skilled artists to a eye care practitioners specifications with approved reactive dyes. The opaquing agent and colorants are permanent and are not leached from a lens.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings and tail feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 1999
Mr. William Hoffman President Prosthetic Soft Lens Corporation 2890 South Tejon Street Englewood, CO 80110
Re: K992950 Trade Name: Prosthetic (hefilcon A) Soft Contact Lens Product Code: 86 LPL Dated: September 8, 1999 Received: September 14, 1999
Dear Mr. Hoffman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
2
Page 2 - Mr. William Hoffman
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ARalph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
510(k) NUMBER (IF KNOWN): K992950
DEVICE NAME: Prosthetic (hefilcon A) Soft Contact Lens
INDICATIONS FOR USE:
The Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eve. including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W.C. Brown
510(k) Number ..
ion Sign-Off)
ion of Ophthalmic Devices
) Number: K992950
Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)