(68 days)
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No
The document describes a standard soft contact lens made from a specific material and with defined physical properties. There is no mention of any computational or analytical capabilities, let alone AI or ML.
No
The device is a contact lens used for vision correction (correcting visual acuity in myopic or hyperopic individuals), not for treating a disease or therapeutic condition.
No
Explanation: The device is a soft contact lens for correcting visual acuity (myopia or hyperopia) and astigmatism. Its stated purpose is to correct vision, not to diagnose a condition.
No
The device description clearly describes a physical contact lens made of specific materials with defined physical properties, not a software program.
Based on the provided text, 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 performed in vitro (outside the body).
- Device Description: The description details the physical properties and composition of a contact lens designed to be worn on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for the diagnosis of a disease or condition.
- Anatomical Site: The device is applied directly to the eye, which is in vivo (within the body), not in vitro.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The 59% extreme H2O® (hioxifilcon A) soft contact lens for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The leas may be worn by persons who exhibit refractive astigmatism of .75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tint.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When presentbed for frequent/planned replacement wear, the lens may be disinfected using either a heat or chemical disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The 59% extreme H2O® (hioxifilcon A) soft contact lens are hemispherical shells with molded sphencal base curves and molded from surfaces. The 59% extreme H100 soft contact lens are fabricated from (hioxifilcon A) which is a non-ionic ultra high molecular weight copolymer of 2-hydroxyethy) methacy wate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buttered with either sodium bicarbonate or sodium perborate. The lens is available in clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The physical properties of the lens are:
Refractive Index: 1.515 (dry), 1.404 (hydrated)
Light Transmission: greater than 95%
Water Content: 59%
Specific Gravity: 1.308 (dry), 1.136 (hydrated)
Oxygen Permeability (Dk Value): 18 X 10-11 Fatt Units (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), revised Fatt method
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Eyecare 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)
Side by side comparison test results yield that the physical/chemical/optical and toxicological performance characteristics of the cast-molded contact lens are equivalent to the lathe-cut predicate device contact lens,
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.
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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
OCT 1 8 1999
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;
Applicant information:
Date Prepared:
August 9, 1999
P.O. Box 1839
Sarasota, Fl 34230-1839
Name: Address
Contact Person:
Phone number:
Jose A. Ors, Ph.D. Vice President Benz Research & Development, Inc. (941) 758-8256
Benz Research and Development
USA Consultant:
Phone number Fax number
Med-Vice Consulting, Inc. Martin Dalsing (970) 243-5490 (970) 243-5501
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 |
1
Purpose of 510(k) Submission:
Benz Research and Development is requesting clearance from the FDA to implement the manufacturing process change of "lathe-cut to cast-molded" for the 59% extreme H2O" soft contact lens.
Equivalent Device:
The 59% extreme H20 "cast-molded" soft contact lens is substantially equivalent to the Benz Research and Development Benz Lens "lathe cut" version.
Device Description:
The 59% extreme H2O® (hioxifilcon A) soft contact lens are hemispherical shells with molded sphencal base curves and molded from surfaces. The 59% extreme H100 soft contact lens are fabricated from (hioxifilcon A) which is a non-ionic ultra high molecular weight copolymer of 2-hydroxyethy) methacy wate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifilcon A and 59% water by weight when immersed in normal saline solution buttered with either sodium bicarbonate or sodium perborate. The lens is available in clear and with a blue visibility handling tint, phthalocyanato (2) - (copper).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The physical properties of the lens are:
| PROPERTY | VALUE |
|---|---|
| Refractive Index | 1.515 (dry) |
| 1.404 (hydrated) | |
| Light Transmission: | greater than 95% |
| Water Content | 59% |
| Specific Gravity | 1.308 (dry) |
| 1.136 (hydrated) | |
| Oxygen Permeability | |
| (Dk Value) | 18 X 10-11 Fatt Units |
| (cm²/sec)(ml O₂/ml x mm Hg @ | |
| 35°C), revised Fatt method |
2
Intended Use:
The 59% extreme H2O (hioxifilcon A) soft contact leas for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tim.
Eyecare 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 either a heat or chemical disinfection system.
Substantial Equivalence:
The 59% extreme H2O® (hioxifilcon A) soft contact leas will be manufactured according to specified process controls and an ISO 9001/EN46001 and CGMP quality assurance program currently in place. The established safety profile (physical/chemical/optical and toxicological performance) of the 59% extreme H2O° (hioxifilcon A) soft contact lens "cast-molded" is equivalent to the 59% extreme H2O° (hioxifilcon A) soft contact lens "lathe-cut", the predicate device previously identified. Side by side comparison test results yield that the physical/chemical/optical and toxicological performance characteristics of the cast-molded contact lens are equivalent to the lathe-cut predicate device contact lens,
Being similar with respect to the physical/chemical/optical performance characteristics to the predicate device, this 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.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 1999
Benz Research and Development Company C/O Mr. Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K992692 Trade Name: 59% extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, clear and visibility tint) Regulatory Class: II Product Code: 86 LPN Dated: August 9, 1999 Received: August 11, 1999
Dear Mr. Dalsing:
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.
4
Page 2 - Mr. Martin Dalsing
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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
Device Name:
59% extreme H2O® (hioxifilcon A) soft contact lens
INDICATIONS FOR USE:
The 59% extreme H2O® (hioxifilcon A) soft contact lens for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The leas may be worn by persons who exhibit refractive astigmatism of .75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tint.
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When presentbed for frequent/planned replacement wear, the lens may be disinfected using either a heat or chemical disinfection system.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lucille L. Brown, Ph.D
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K992692
X Prescription Use (Per 21 CFR 801.109)
OL
Over-The-Counter Use
(Optional Format 1-2-96)