(41 days)
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes which manifest myopia (nearsightedness), hyperopia (farsightedness) and astigmatic correction lower than -2.00 diopters that does not interfere with visual acuity.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses may be prescribed for daily wear. The eye-care practitioner may prescribe the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) contact lenses for single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for scheduled replacement the lens may be disinfected using a chemical (no heat) or hydrogen peroxide disinfecting systems.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):
- plano to -10.00D Asphere .
- . with center thickness from 0.025mm to 0.40mm
- . with base curves of 8.00mm to 9.20mm
- . with diameter of 12.00mm to 18.00mm
The lens material is the same as the one BIOMEDICS® UV described in submission PMA890023/S4 and S7, K982947, K984046, K012425.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum cage thickness and This front optical surface allows for correction of visual acuity in non-aphakic persons with noncontour. diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range.
The provided text describes a 510(k) Premarket Notification for the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens. This notification seeks to establish substantial equivalence to existing predicate devices, rather than proving performance against specific acceptance criteria through clinical studies of the proposed device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of traditional acceptance criteria and device performance as measured in a clinical study for a de novo device, this submission relies on demonstrating substantial equivalence to predicate devices by comparing various characteristics.
| Characteristic | Predicate Device (BIOMEDICS® UV Sphere) Reported Performance | Subject Device (BIOMEDICS® UV Asphere) Reported Performance | Substantial Equivalence Basis |
|---|---|---|---|
| Production Method | Cast molded process | Cast molded process | Same |
| Intended Use | Extended and daily wear, Correction of ametropia | Daily wear, Correction of ametropia (With added UV protection statement) | Similar (adjusted wear time, added UV protection) |
| Material (ocufilcon D) | 55% water content | 55% water content | Same |
| Material Type | Group IV | Group IV | Same |
| Color additive | Vat Blue 6 Dye, CFR 130-20-1 | Vat Blue 6 Dye, CFR 130-20-1 | Same |
| UV additive | Yes | Yes | Same |
| Dk/Harmonic thickness (Minus powers -10.00 to -0.25D) | $15.9 \times 10^{-9}$ | $15.9 \times 10^{-9}$ | Same |
| Dk/Harmonic thickness (Plus powers Plano to +8.00D) | $12.2 \times 10^{-9}$ | $12.2 \times 10^{-9}$ | Same |
| Oxygen transmissibility (-3.00D) | $18.8 \times 10^{-9}$ | $19.5 \times 10^{-9}$ | Similar (within expected range) |
| Light transmittance (Tv, % @ 20°C, 380-780nm) | 97.8% (Labeled: >95%) | 98.2% (Labeled: >95%) | Meets or exceeds predicate's labeled spec |
| Base Curve, mm (-3.00 D) | Measured: 8.61 (Labeled: 8.60) | Measured: 8.59 (Labeled: 8.60) | Similar |
| Diameter, mm (-3.00 D) | Measured: 14.19 (Labeled: 14.20) | Measured: 14.20 (Labeled: 14.20) | Similar |
| Power, D (Predicate BIOMEDICS® UV Sphere, -3.00 D) | Measured: -1.37 (Labeled: -1.50) | Measured: -1.64 (Labeled: -1.75) | Similar (different lens powers for comparison, but demonstrating equivalence in design/manufacturing) |
| Power, D (Predicate FREQUENCY Asphere, -3.00 D) | Measured: -1.44 (Labeled: -1.75) | Measured: -1.68 (Labeled: -1.75) | Similar (different lens powers for comparison, but demonstrating equivalence in design/manufacturing) |
The acceptance criteria for this 510(k) submission are not defined as specific clinical thresholds, but rather the demonstration of substantial equivalence to legally marketed predicate devices in terms of material, design, physical, chemical, and optical properties, and intended use, such that it does not raise new questions of safety or effectiveness. The reported device performance is explicitly compared against the predicate devices to support this claim.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "It was determined that Clinical Studies were not warranted in order to establish the safety and efficacy of the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses."
Therefore, there is no test set of human subjects to report a sample size for, nor any data provenance related to clinical testing. The assessment is based on non-clinical studies including manufacturing information, finished lens parameters, physicochemical properties, and labeling information, with reference to previous PMA/510(k) submissions for the predicate devices. These are laboratory/manufacturing data, not data derived from human subjects.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no clinical studies were performed on the subject device, there was no "ground truth" derived from expert assessment of patient outcomes or conditions for the subject device. The ground truth for the predicate devices (BIOMEDICS® UV Sphere and Frequency 55 Asphere) would have been established during their respective approval processes (PMA890023/S4, S7, K982947, K984046, K012425, K000384), but this information is not provided for the current submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical studies with a test set of human subjects were conducted for this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No clinical studies were performed, and thus no MRMC study comparing human readers with or without AI assistance was conducted. This device is a contact lens, not an AI diagnostic tool.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is a contact lens, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this submission is effectively the established safety and efficacy profiles and characteristic specifications of the identified predicate devices, as confirmed by their previous regulatory approvals (PMAs and 510(k)s). This relies on:
- Physical and chemical property measurements.
- Manufacturing process consistency.
- Toxicology data (referenced from predicate device submissions).
- Microbiology data (referenced from predicate device submissions).
- Previous clinical data that supported the predicate devices (though details aren't included here).
8. Sample Size for the Training Set
Not applicable. This device is a contact lens, not an AI system that requires a "training set." The data provided are related to manufacturing characteristics and comparisons to predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a contact lens, not an AI system.
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510(K) Premarket Notification
(ocufilcon D) soft (hydrophilic) contact lens
SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE
| Reference | : OCDA55 |
|---|---|
| Section | : 3 |
| Version | : 1 |
| Page | : 1 / 5 |
3
FEB 2 8 2002
- APPLICANT'S NAME AND ADDRESS
Ocular Sciences Inc. 1855 Gateway Blvd. Suite 700 Concord, CA 94520 USA
Richard Lippman, OD FAAO Senior Consultant C.L. McIntosh, Inc. 12300 Twinbrook Parkway, Suite 230 Rockville, Maryland 20852 Telephone: (301) 770-9590 Fax: (310) 770-9584
2. IDENTIFICATION OF DEVICE
Common Name; Trade Name:
Contact Person
Classification: Device classification: Hydrophilic Soft Contact Lens BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens Daily Wear Soft (hydrophilic) Contact Lons Class II (21 CFR 886,5925)
3. DESCRIPTION OF DEVICE
BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):
- plano to -10.00D Asphere .
- . with conter thickness from 0.025mm to 0,40mm
- . with base curves of 8.00mm to 9.20mm
- . with diameter of 12.00mm to 18.00mm
The lens material is the same as the one BIOMEDICS® UV described in submission PMA890023/S4 and S7, K982947, K984046, K012425.
The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum cage thickness and This front optical surface allows for correction of visual acuity in non-aphakic persons with noncontour. discased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range,
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| Ocular Sciences | |
|---|---|
| -- | ------------------------ |
| (ocufilcon D) soft (hydrophilic) contact lens | |
|---|---|
| -- | ----------------------------------------------- |
SIO(K) Premarket Notification
SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE
| Reference | OCDA55 |
|---|---|
| Section | 3 |
| Version | 1 |
| Page | 2 / 5 |
INTENDED USE 4.
(NOTE: { The Intended Use Statement has been upgraded to include a statement regarding ultraviolet light protection from BIOMEDICS® INPHEF contain locases that comain a UV additive. The statement is a reference to procession against the transmittance of harmitil UV radiation to the corners and into the eye,
The BIOMEDICS® UV ASPHERE (ocufileon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes which manifest myopia (nearsightedness), hyperopia (farsightedness) and astigmatic correction lower than -2.00 diopters that does not interfere with visual acuity.
The BIOMEDICS® UV ASPHERE (orafilcon D) Soft (Hydrophilic) Contact Lenses may be prescribed for daily wear. The eve-care practitioner may prescribe the BIOMEDICS® UV ASPHERE (ocufileon D) Soft (Hydrophilic) contact lenses for single use disposable wear or for scheduled replacement wear, with clearing, disinfection, and scheduled replacement, When prescribed for scheduled replacement the lens may be disinfected using a chemical (no heat) or hydrogen peroxide disinfecting systems.
BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Rydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
5. PREDICATE DEVICES
The following predicate lenses were selected to address material (FDA Group IV: high water, joing polymer). intended use (daily wear) and lens designs (Asphere).
Lens material, spherical lens design and intended use:
BIOMEDICS® UV (ocufilcon D) Sphere Hydrophilic Contact Lenses, FDA Group IV, high water content, ionic soft contact lenses for daily wear marketed internationally by OCULAR SCIENCES Inc. under PMA 890023/S7.
Asphere lens design:
Frequency 55 Asphere Hydrophilic Contact Leases, FDA Group IV, high water content, ionic soft contact lenses for daily wear marketed internationally by Cooper Vision under K000384.
Indication for Use: The indication for use for the BIOMEDICS® UV ASPHERE is the same as the predicate device under K984046 with the exception of the added statement referencing the UV protection available in the lens that helps to protect against transmission of harmful ultraviolet radiation to the eve. This statement is consistent with other ocufileon lenses (K99264) manufactured by Ocular Sciences, Inc., and supported by documentation presented in P890023/S7.
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Ocular Sciences
510(K) Premarket Notification
(ocufilcon D) soft (hydrophilic) contact lens
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
!
SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE
Reference : OCDA55 Section : 3 Version : I Page : 3 / 5
6. CHARACTERISTICS
The characteristics of the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses arc compared to the characteristics of the predicate device BIOMEDICS® UV sphere in the following table.
TABLE 1
| Material comparison | ||||
|---|---|---|---|---|
| Predicate deviceBIOMEDICS® UV Sphere | Subject deviceBIOMEDICS® UV Asphere | |||
| PRODUCTION METHOD | Cast molded process | Cast molded process | ||
| INTENDED USE | Extended and daily wearCorrection of ametropia | Daily wearCorrection of ametropia | ||
| MATERIAL | ocufilcon D55% | ocufilcon D55% | ||
| Type | Group IV | Group IV | ||
| Color additive | Vat Blue 6 DyeCFR 130-20-1 | Vat Blue 6 DyeCFR 130-20-1 | ||
| UV additive | Yes | Yes | ||
| Dk/Harmonic thicknessANSI Z80.20 (1998) | ||||
| Minus powers -10.00 to -0.25D | $15.9 \times 10^{-9}$ | $15.9 \times 10^{-9}$ | ||
| Plus powers Plano to +8.00D | $12.2 \times 10^{-9}$ | $12.2 \times 10^{-9}$ | ||
| Characteristics comparison | Measured | Labeled | Measured | Labeled |
| Oxygen transmissibility (-3.00D) | $18.8 \times 10^{-9}$ | $19.5 \times 10^{-9}$ | ||
| Light transmittance | Tv, % @ 20°CIlluminant A with a2° observer(between 380 and780 nm) | (between 400 and800 nm) | Tv, % @ 20°CIlluminant A with a 2°observer (between 380 and780 nm) | (between 400 and 800nm) |
| 97.8% | >95% | 98.2% | >95% |
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510(K) Premarket Notification
(ocufilcon D) soft (hydrophilic) contact lens
SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE
| and the comments of the comments of the comments of the comments of the comments of | |
|---|---|
| Reference : OCDA55 | |
| Section : 3 | |
| Version | |
| Page | : 4 / 5 |
TABLE 2
| Lenses design comparison | |||||
|---|---|---|---|---|---|
| Predicate deviceBIOMEDICS® UV Sphere | Subject deviceBIOMEDICS® UV Asphere | ||||
| Characteristics comparison, -3.00 D | Measured | Labeled | Measured | Labeled | |
| Base Curve, mm | 8.61 | 8.60 | 8.59 | 8.60 | |
| Diameter, mm | 14.19 | 14.20 | 14.20 | 14.20 | |
| Power. D | -1.37 | -1.50 | -1.64 | -1.75 | |
| Predicate Asphere designFREQUENCY Asphere | Subject Asphere designBIOMEDICS® UV Asphere | ||||
| Characteristics comparison, -3.00 D | Measured | Labeled | Measured | Labeled | |
| Power, D | -1.44 | -1.75 | -1.68 | -1.75 |
7. NON CLINICAL STUDIES
In support to this application we are providing:
- Additional Manufacturing information .
- Finished Lens Parameters comparison with the predicate device ●
- Physicochemical Properties comparison with predicate device 후
- 1 Labeling Information
By reference PMA890023/S4 and S7, data can be found about;
- . Predicate Device
- Chemistry .
- Manufacturing process
- Toxicology: lens and packaging materials ●
- Residual (leachables) Monomer .
- Shelf life data ■
- Microbiology .
- Packaging ●
8. CLINICAL DATA
It was determined that Clinical Studies were not warranted in order to establish the safety and efficacy of the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses. This determination was based on the following:
- The BIOMEDICS® UV ASPHERE (ocuificon D) Soft (Hydrophilic) Contact Lenses were demonstrated to . be substantially equivalent to the predicate BIOMEDICS® UV Sphere lenses (PMA890023/54 and S7, K984046 and K982947) as per measurements of physiochemical characteristics and parameters,
- The BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lens design was demonstrated . to be substantially equivalent to the predicate Asphere lenses: Frequency Asphere from Cooper Vision (K000384).
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(ocufilcon D) soft (hydrophilic)
contact lens
510(K) PREMARKET NOTIFICATION
SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE
| Reference : OCDA55 |
|---|
| Section : 3 |
| Version : 1 |
| Page : 5 / 5 |
9. CONCLUSIONS DRAWN FROM STUDIES
Substantial Equivalence:
The information provided in this 510(k) application establishes that the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses are substantially equivalent in optical, chemical and physical properties of the predicate devices, are equivalent in their final specification to the predicate devices, and do not raise any additional questions of safety and effectiveness. Therefore the device remains substantially equivalent to the predicate device. The labeled indication for use has been upgraded to be consistent with predicate devices in the ocufilcon family of materials and includes a statement regarding UV protection in the labeled indication for use.
Risk and Benefits:
The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear base. The benefits to the patient are the same as those for other soft (hydrophilic) contact lenses.
10. ROUTE CHOSEN IN THE FLOW CHART FOR 510 (K) DAILY WEAR CONTACT LENS
FIGURE 1
BIOMEDICS® UV Asphere
Image /page/4/Figure/12 description: This image is a flowchart that outlines a process, possibly related to medical device approval or classification. It starts with a 510(k) submission and branches out based on criteria such as "Clear?", "Listed Colors", and "FDA Approved Care Regimen?". The flowchart then leads to different paths involving USAN (United States Adopted Name) considerations, including "Same USAN with Same Suffix", "Same USAN with Different Suffix", and "New USAN", each requiring specific data like physicochemical properties, toxicology, microbiology, and clinical performance data.
96.0006
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's commitment to health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2002
Ocular Sciences, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. Senior Consultant Official Correspondent to Ocular Sciences, Inc. CL McIntosh, Inc. 12300 Twinbrook Parkway, Suite 230 Rockville, MD 20852
Re: K020193
Trade/Device Name: Biomedics® UV Asphere (ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Product Code: LPL, MVN Dated: January 15, 2002 Received: January 18, 2002
Dear Dr. Lippman:
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.
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Page 2 - Richard E. Lippman, O.D., F.A.A.O. T
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 and additionally 21 CFR Part 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" (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
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INDICATION FOR USE STATEMENT
510(k) Number (if known) _
Device Name:
BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) Contact Lenses
Indications for Use:
The BIOMEDICS® UV ASPHERE (ocutilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes which manifest myopia (nearsightedness), lypcropia (farsightedness) and astigmatic correction lower than -2,00 dioplers that does not interfere with visual acuity.
The BIOMEDICS® UV ASPHERE (ocufileon D) Soft (Hydrophilic) Contact Leases may be prescribed for daily wear. The eye-care practitioner may prescribe the BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (Hydrophilic) contact lenses for single use disposable wear or for scheduled replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for scheduled roplacement the lens may be disinfected using a chemical (notheat) or hydrogen peroxide disinfecting systems.
The BIOMEDICS® UV ASPHERB (ocufilcon D) Soft (Hydrophilic) Cortact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-the -counter-use
Division Sig
OR
(Division Sign-off)
Division of Ophthalmic Devices
510(k) Number K020/93
§ 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.