(36 days)
No
The summary describes standard contact lenses and does not mention any AI or ML capabilities.
No.
The device is indicated for the correction of refractive ametropia (myopia, hyperopic and astigmatism), which is a corrective function, not a therapeutic one that treats a disease or condition.
No
Explanation: The device is a soft contact lens intended for the correction of refractive ametropia (myopia, hyperopic and astigmatism). It is a corrective device, not a diagnostic one.
No
The device is a physical contact lens, not a software application. The description details the material, design, and physical properties of the lens.
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 refractive ametropia (myopia, hyperopia, and astigmatism) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details a soft contact lens designed to fit on the corneal surface to correct vision. This aligns with a medical device for vision correction, not a diagnostic test performed in vitro (outside the body).
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples from the body (like blood, urine, or tissue) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This contact lens does not perform any such function.
N/A
Intended Use / Indications for Use
The Horizon 38 (polymacon). Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.
The lens may be disinfected using either a heat or chemical system .
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The soft contact lenses that are manufactured from W-38 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of ametropia (myopia, hyperopic and astigmatism). Each lens provides corrective power, which corresponds to the refractive power of the eye to which it is being treated.
Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary, as well as, beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Corneal surface of the 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.
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
Image /page/0/Picture/0 description: The image shows the text 'K023530' in a bold, sans-serif font. The numbers and letters are closely spaced together. Below this text is the phrase '510 (k) Summary' in a smaller font size.
| 1.0 | Name and
address of
submitter | Westcon Contact Lens Company, Inc.
611 Eisenhauer Street
Grand Junction, CO. 81503 |
|--------------|-------------------------------------|------------------------------------------------------------------------------------------|
| | Contact Person | Carol Noble
970-245-3845 |
| | Fax | 970-245-4516 |
| | Date Prepared | 10/14/02 |
| NOV 2 6 2002 | | |
2.0 Name of Device
- ♦ Trade Name:
Spherical: Horizon 38 (polymacon) and Horizon 38 Westint (polymacon)
Toric:
Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)
- Common Name: Daily Wear Soft Contact Lens �
- � Generic (USAN) Name: Polymacon
- Classification Name: Soft Hydrophilic Contact Lens �
3.0 Indications
The Horizon 38 (polymacon). Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.
The lens may be disinfected using either a heat or chemical system .
1
Traditional 510(k)-Submission
8.0 510 (k) Summary
Device Description 4.0
The soft contact lenses that are manufactured from W-38 lens blanks, clear or tinted, can be lathe cut into a hemispherical shell that are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves that conform to the shape of the radius of the cornea and center over the apex of the cornea to provide correction of ametropia (myopia, hyperopic and astigmatism). Each lens provides corrective power, which corresponds to the refractive power of the eye to which it is being treated.
Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens, generally of a diameter greater than 6 mm. The primary and secondary, as well as, beveled edge configurations are built into the lens for the purpose of aiding on the lens centration and comfort.
5.0 Substantially Equivalent To:
Westcon will be claiming equivalency to our own contact lenses that are currently FDA approved in 510(k) K963837.
Summary of Safety and Effectiveness 6.0
W-38 (polymacon) lens blanks were subjected to leachability studies and showed no identifiable evidence of tint pigment leaching.
7.0 Technical Summaries
7.1 Toxicology:
Cytotoxicity, systemic toxicity and ocular irritation studies were. Test results showed no evidence of cellular or systemic toxicity, or ocular irritation.
2
-
Physical/Optical Characteristics 7.2
Light transmittance, refractive index, water content, linear expansion, radial expansion and tensile strength were determined. A comparison of data from these studies showed that the W-38 polymacon is equivalent in physical and optical characteristics as 510(k) K963837 -
7.3 Microbiology
There will be no changes to the validated process in 510(k) K954524 -
7.4 Compatibility
The spectra measurement after the numerous cleaning and disinfecting cycles remained the same as the before measurement. -
7.5 Shelf Life
The three year shelf life study has been started on the lenses manufactured from W-38 and will be completed later this year. The packaging remains the same as 510(k) K954524 and 510(k) K963837.
8.0 Conclusion
In conclusion, it is Westcons' conviction that the data submitted shows that manufacturing with W-38 polymacon instead of Benz's polymacon material does not raise different questions of safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Westcon Contact Lens Co., Inc. c/o Ms. Carol Noble Management Representative 611 Eisenhauer Street Grand Junction, CO 81505
Re: K023530
Trade/Device Name: The Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: October 14, 2002 Received: October 21, 2002
Dear Ms. Noble:
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters and is evenly spaced around the circle.
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Page 2 – Ms. Carol Noble
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. 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) 594-4692. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
5
INDICATIONS FOR USE STATEMENT
Device Name:
Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon)
:
Indication of Use:
The Horizon 38 (polymacon), Horizon 38 Westint (polymacon), Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes.
The lenses may be disinfected using either a heat or chemical system .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devices | |
| 510(k) Number | K023530 |
| Prescription Use | X |
| OR | |
| Over-The-Counter Use | |
| (Per 21 CFR 801.109 | |
| (Optional Format 1-2-96) |