(359 days)
Not Found
No
The summary describes a standard soft contact lens and its material composition. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a contact lens used to correct visual acuity, which is a functional correction rather than a therapeutic treatment for a disease or condition.
No
This device is a contact lens intended for the correction of visual acuity, which is a treatment or corrective measure, not a diagnostic tool for identifying a condition.
No
The device description clearly describes a physical contact lens made of specific materials, indicating it is a hardware device, not software only.
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 the eye. This is a therapeutic and corrective function, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the physical properties and materials of a contact lens, which is a medical device used on the eye. It does not describe a device that analyzes biological samples.
- Anatomical Site: The anatomical site is the eyes, which is where the device is applied directly for its intended purpose. IVDs typically interact with specimens from the body, not the body itself in this manner.
The information clearly describes a contact lens, which is a medical device used for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
59% Extreme H2O (hioxifilcon A) soft contact lenses are hemispherical shells and are available as spherical (G59 S-Thin and G59 S-Xtra) or toric (G59 Toric) lens designs. The 59% Extreme H2O (hioxifilcon A) soft contact lens is fabricated from hioxifilcon A, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium perforate. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
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)
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
FEB ~ 2 2005
HYDROGEL VISION CORPORATION 510(K) Premarket Notification - Supplement 2
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: | K040303 |
|---|---|
| Applicant information: | |
| Date Prepared: | January 27, 2005 |
| Name: | |
| Address: | Hydrogel Vision Corporation |
| 6447 Parkland Drive | |
| Sarasota, FL 34243 | |
| Contact Person: | Donna Hovanec |
| Quality System Coordinator | |
| Hydrogel Vision Corporation | |
| Phone number: | 941-739-1382 |
| Device information: | |
| Device Classification: | Class II |
| Classification Number: | LPL |
| Classification Name: | Lens, Soft Contact, Daily Wear |
| Trade Name: | 59% Extreme H2O (hioxifilcon A) Soft Contact |
| Lens for Daily Wear (cast-molded, with a | |
| visibility tint) |
Purpose of 510(k) Submission:
Hydrogel Vision Corporation is requesting clearance from the FDA to expand the Indications for Use for the 59% Extreme H2O soft contact lens. The lens was originally approved on October 18, 1999, under 510(k) K992692, for the indication of daily wear correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. We are submitting this 510(k) to expand the indication to include toric lenses. The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and
1
HYDROGEL VISION CORPORATION 510(K) Premarket Notification - Supplement 2
scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
Equivalent Device:
The 59% Extreme H2O (hioxifilcon A) toric soft contact lens is substantially equivalent to our already cleared 59% Extreme H2O (hioxifilcon A) spherical lens under 510(k) K992692.
Device Description:
59% Extreme H2O (hioxifilcon A) soft contact lenses are hemispherical shells and are available as spherical (G59 S-Thin and G59 S-Xtra) or toric (G59 Toric) lens designs. The 59% Extreme H2O (hioxifilcon A) soft contact lens is fabricated from hioxifilcon A, which is a non-ionic, copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buffered with either sodium bicarbonate or sodium perforate. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).
Intended Use (Indications):
The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
Substantial Equivalence:
The information provided in this 510(k) establishes that the 59% Extreme H2O (hioxifilcon A) toric soft contact lens differs only in design to the 59% Extreme H2O (hioxifilcon A) spherical soft contact lens and meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hydrogel Vision Corporation c/o Donna Hovanec Quality System Coordinator 6447 Parkland Drive
Re: K040303
Sarasota, FL 34243
Trade/Device Name: 59% Extreme H2O (hioxifilcon A) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: January 13, 2005 Received: January 14, 2005
Dear Ms. Hovanec:
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.
FEB - 2 2005
3
Page 2 - Donna Hovanec
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/cdrh/industry/support/index.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
Enclosure
4
HYDROGEL VISION CORPORATION 510(K) Premarket Notification - Supplement 2
INDICATIONS FOR USE STATEMENT
Device Name: 59% Extreme H2O® (hioxifilcon A) toric soft contact lens
INDICATIONS FOR USE:
The 59% Extreme H2O (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using 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)
Prescription Use
Use (Per 21 CFR 801.109) or
Over-The-Counter
(Optional Format 1-2-96)
Smisler
sion of Ophthalmic
510(k) Number K040303