(52 days)
No
The summary describes standard soft contact lenses and their materials, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is indicated for the correction of visual acuity, which is generally considered a corrective or assistive function rather than a therapeutic one to treat or cure a disease.
No
Explanation: The device is a soft contact lens indicated for the correction of visual acuity, which is a treatment or correction, not a diagnostic purpose. It corrects existing vision problems (myopia, hyperopia, astigmatism) rather than identifying or diagnosing them.
No
The device description clearly states it is a physical contact lens made from specific materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a medical device used to correct vision by being placed on the surface of the eye.
- No Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Anatomical Site: The anatomical site is the eyes, which is consistent with a device for vision correction.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
Product codes
LPL
Device Description
SpecialEyes 59 and 49 soft contact lenses are hemispherical shells available in spherical or toric lens designs and in. hioxifilcon A and hioxifilcon B materials.The lenses are fabricated by lathe cutting hioxifilcon A and hioxifilcon B materials both non-ionic copolymers of 2hydroxeyethylmethacrylate (2-HEMA) and Glycerol Methacrylate (GMA). The water content by weight is 49% for hioxifilcon B and 59% for hioxifilcon A. when immersed in normal saline. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes, cornea
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
Preclinical Testing: Dimensional and verification testing has been completed and included in Section 10 of this submission. As evidenced in the results all product conformed to specification requirements. All other preclinical testing such as toxicology, microbiology, lens compatibility, preservation uptake tests and shelf life studies were completed on the predicate device, which is identical to the device proposed in this 510(k), see K964528.
Key Metrics
Not Found
Predicate Device(s)
K983773, K964528, K042242, K981252, K953199, K964902
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | SpecialEyes, LLC.
P.O. Box 21417
Bradenton, FL 34204
Phone: 886-404-1060 Fax:
886-404-1030 |
|-------------------------|--------------------------------------------------------------------------------------------------------|
| Contact Person: | Steve Brauner |
| Date of Summary: | May 4, 2006 |
| Trade/Proprietary Name: | Special Eyes 59 and Special Eyes 49
Sphere and Toric Soft Contact Lenses |
| Classification Name: | Lenses, soft contact, daily wear |
| Product Code: | LPL |
Intended Use:
The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
Device Description:
SpecialEyes 59 and 49 soft contact lenses are hemispherical shells available in spherical or toric lens designs and in. hioxifilcon A and hioxifilcon B materials.The lenses are fabricated by lathe cutting hioxifilcon A and hioxifilcon B materials both non-ionic copolymers of 2hydroxeyethylmethacrylate (2-HEMA) and Glycerol Methacrylate (GMA). The water content by weight is 49% for hioxifilcon B and 59% for hioxifilcon A. when immersed in normal saline. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent optical surface.
1
Preclinical Testing:
Dimensional and verification testing has been completed and included in Section 10 of this submission. As evidenced in the results all product conformed to specification requirements. All other preclinical testing such as toxicology, microbiology, lens compatibility, preservation uptake tests and shelf life studies were completed on the predicate device, which is identical to the device proposed in this 510(k), see K964528.
Substantial Equivallence to Predicate Device:
SpecialEyes claims the proposed device to be substantially equivalent to the devices previously cleared by FDA as listed below. SpecialEyes claims this equivalence be cause the proposed device has an equivalent intended use, manufacturing materials, operating principles, and physical, operational and biological specification as compared to the predicate devices.
The similarities and differences between the proposed and predicate devices have been identified and explained in the Comparison Matrix which has been included in Section 9 of this submission.
K983773 - BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS K964528 - BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT DAILY WEAR CONTACT LENS K042242 - ALDEN HP SHPERE AND TORIC / OXYLENS K981252 - ALDEN HP SHPERE AND TORIC / OXYLENS K953199 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC K964902 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 18 2006
SpecialEyes, LLC c/o Mr. Arthur J. Ward AJW Technololgy Consultant, Inc. 962 Allegro Lane Apollo Beach, FL 33572
Re: K060821
Trade/Device Name: SpecialEyes59 and SpecialEyes 49 Sphere and Toric soft contact lenes Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lenses Regulatory Class: II Product Code: LPL Dated: May 4, 2006 Received: May 8, 2006
Dear Mr. Ward:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
3
Page 2 -- Mr. Arthur J. Ward
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
M.B. Egelston - M.D.
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
4
Indications for Use
510(k) Number (if known): K060821
Device Name: SpecialEyes 59 and SpecialEyes 49 Sphere and Toric soft contact lenses
Indications for Use:
The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eves with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with nondiseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND
(PLEASE DO NOT WRITE BELOW THIS
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASEDO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
((Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number
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