Spherical: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or lyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.
Toric: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic)UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 10.00 diopters.
The lens may be prescribed for Daily Wear in not- aphakic persons. The eyecare practitioner may prescribe the contact lens for wither single use disposable wear.
The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are available with ultraviolet absorbing additive (benzophenone based):

in the power range of -10.00 to +6.00 diopters for sphere
in the cylinder power range pl to -6.00D cylinder .
with center thickness from 0.025mm to 0.27mm
with base curves of 8.00mm to 9.20mm .
. with diameter of 12.00mm to 18.00mm.
This lens material, design, cast molding manufacturing and sterilization process is equivalent to BIOMEDICS® 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses described in submission 52 PMA890023/S4,S6 and S7, 510(K) K003136.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BIOMEDICS® 52 1-Day contact lens, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on demonstrating substantial equivalence to a predicate device and assuring safety and efficacy after a manufacturing process change. Therefore, the "acceptance criteria" are largely framed as demonstrating non-inferiority or equivalence to the control lens and meeting general safety expectations for contact lenses.

Acceptance Criteria (Stated Goal / Benchmark)	Reported Device Performance (BIOMEDICS® 52 1-Day - "Test Lens")
Safety - Absence of significant adverse events/complications:
1. No permanent decreases in Best Corrected Visual Acuity (BCVA) (no 2-line decreases).	No reports of 2-line decreases in BCVA for any Test cohort eyes. (Equivalent to Control)
2. No persistent corneal staining of Grade 3 or 4 at two or more follow-up visits.	No reports of Grade 3 or 4 staining for any Test cohort eyes. (Equivalent to Control)
3. No neovascularization more than 1.5mm and/or more than 1.0mm in 3 or more quadrants.	No neovascularization reported of greater than 1.5mm in any quadrant. Incidence remained stable. (Equivalent to Control)
4. No persistent hyperemia of Grade 3 or 4 at two or more follow-up visits (limbal or bulbar).	No Grade 3 or 4 limbal or bulbar hyperemia reported. (Equivalent to Control)
5. No peripheral or central ulcerative keratitis.	No peripheral or central ulcerative keratitis reported. (Equivalent to Control)
6. No infiltrates of Grade 2 or worse.	No infiltrates reported. (Equivalent to Control)
7. Subjective symptoms (e.g., discomfort, blurred vision) not indicating safety issues when compared to Control.	Discomfort: Reported more frequently (12.5% of follow-ups) with greater severity (avg 2.1/4.0) vs. Control (7.3% of follow-ups, avg 1.1/4.0). Blurred vision: Reported less frequently (1.6% of follow-ups) with lower severity (avg 1.0/4.0) vs. Control (6.3% of follow-ups, avg 1.7/4.0). Conclusion: No safety issues indicated for Test lenses.
Efficacy - Visual Acuity Performance:
1. Similar visual acuity performance to Control lens at final examination.	Both Test and Control lens visual acuities were "essentially the same" at the final examination.
2. Proportion of subjects successfully completing the study duration.	100% of Test cohort subjects completed the 1-month study period. (Equivalent to Control)
3. Percentage of lens visual acuities of 20/20 or better at final visit.	84.8% for Test cohort eyes (vs. 83.3% for Control cohort eyes). Both > measured at study start.
4. Percentage of lens visual acuities of 20/30 or better at final visit.	100% for Test cohort eyes (vs. 100% for Control cohort eyes). Both met expectations.
Other Performance Characteristics (Equivalence to Control):
- Average Wearing Time	Test cohort: 12.8-13.2 hours/day. Control cohort: 13.1-13.3 hours/day. (Acceptable and similar)
- Lens Deposits	Test: 12.5% with deposits (1.4% medium). Control: 11.1% with deposits (only light). (Similar rates, with Test having some medium deposits).
- Material properties (chemical composition, water content, refractive index, Dk permeability, light transmittance)	Material property data generated on BIOMEDICS® 52 and BIOMEDICS® 52 1-Day lenses processed with manufacturing changes showed they were "substantially equivalent." (Specific values are listed in Table 1 and are identical to predicate).
- Toxicology (cytotoxicity, acute systemic injection, ocular eye irritation)	Cytotoxicity: Not cytotoxic. Acute Systemic Injection: No evidence of systemic toxicity. Ocular Eye Irritation: No evidence of ocular irritation. 22-Day Ocular Eye Irritation: Eyes treated with test lenses similar to untreated control eyes. (All met safety requirements for toxicological tests).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 36 subjects (72 eyes) were enrolled.
- Test Cohort: 48 eyes (from 24 subjects, assuming 2 eyes per subject)
- Control Cohort: 24 eyes (from 12 subjects)
- Note: The text states "All of the 36 subjects were determined to be eligible... and were dispensed either the Test or the Control lenses." And later "Female Subjects: Test 19, Control 10; Male Subjects: Test 5, Control 2; Totals: Test 24, Control 12." This implies 24 subjects in the Test group and 12 in the Control group, totaling 36 subjects. It then refers to 48 "Completed Test Eyes" and 24 "Completed Control Eyes," which aligns with 2 eyes per subject.
Data Provenance: Prospective, concurrent cohort control, randomized clinical trial conducted at three (3) investigational sites. The country of origin of the data is not explicitly stated, but the contact person is in Maryland, USA, and the applicant is in California, USA, suggesting a US-based study, although international marketing is mentioned elsewhere.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The study involves clinical observations and examinations by healthcare professionals during "scheduled follow-up visits" and "laboratory observations." However, the text does not explicitly state the number of experts used to establish ground truth nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It can be inferred that licensed eye care practitioners (optometrists or ophthalmologists) at the investigational sites conducted the examinations, as these are standard roles in contact lens clinical trials.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the clinical findings. Clinical trials for contact lenses typically rely on the observations and assessments of the examining clinician(s) at each site.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a contact lens, and the study is a clinical trial comparing a new manufacturing process of a contact lens to a predicate contact lens, not an AI-powered diagnostic device involving human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

No, a standalone algorithm performance study was not done. This device is a physical contact lens, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study was established through a combination of:

Clinical Observations: Daily health observations, macroscopic eye examinations, weekly biomicroscopic slit-lamp examinations, body weight observations by investigators.
Subjective Symptoms and Complaints: Self-reported by subjects.
Measurements: BCVA, wearing time, lens deposits.
Toxicology Studies: Conducted in a laboratory setting (e.g., cell cultures for cytotoxicity, animal models for systemic and ocular irritation).

Essentially, the ground truth is derived from expert clinical assessment and objective measurements within a controlled clinical trial setting, supported by pre-clinical laboratory results.

8. The Sample Size for the Training Set

This submission is for a physical medical device (contact lens) and describes a clinical trial (human subject-based study) and non-clinical (laboratory/animal) studies. There is no "training set" in the context of an AI/algorithm. The sample sizes mentioned (36 subjects, 72 eyes) pertain to the clinical test set.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/algorithm in this context, this question is not applicable. The clinical study was designed to evaluate the safety and efficacy of the contact lens itself through direct observation and measurement, not to train a predictive model.

Summary

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JUN 0 4 2002
K 0 20389

: SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

1. Applicant's Name and Address

Ocular Sciences Inc. 1855 Gateway Blvd. Suite 700 Concord, CA 94520 USA

Contact Person

Richard E. Lippman, OD FAAO Senior Consultant R.P. Chiacchierini & Associates, LLC. 17003 Horn Point Drive Gaithersburg, Maryland 20878 Telephone: (301) 330-4660 Fax: (310) 593-1759

Identification of device 2.

Soft Contact Lens Common Name: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Trade Name: Contact lenses Classification: Daily Wear Soft (hydrophilic) Contact Lens Device classification: Class II (21 CFR 886.5925 (b) (1))

Description of device 3.

The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are available with ultraviolet absorbing additive (benzophenone based):

in the power range of -10.00 to +6.00 diopters for sphere ●
in the cylinder power range pl to -6.00D cylinder .
with center thickness from 0.025mm to 0.27mm ●
with base curves of 8.00mm to 9.20mm .
. with diameter of 12.00mm to 18.00mm.

This lens material, design, cast molding manufacturing and sterilization process is equivalent to BIOMEDICS® 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses described in submission 52 PMA890023/S4,S6 and S7, 510(K) K003136.

4. Intended use

Spherical:

BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or lyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.

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510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

Reference OSL52 : 3 Section Version : 1 Page :218

Toric:

BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic)UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 10.00 diopters.

The lens may be prescribed for Daily Wear in not- aphakic persons. The eyecare practitioner may prescribe the contact lens for wither single use disposable wear.

The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

5. Predicate devices

The predicate lenses were selected to address: material (FDA Group IV: high water, ionic polymer), intended use (daily wear) and lens designs (sphere, toric).

Lens material, spherical and toric lens design and intended use:

BIOMEDICS® 52 1-Day (ocufilcon B) Soft (hydrophilic) UV Blocking Contact lenses, FDA Group IV, high water content, ionic soft contact lenses for daily wear marketed internationally by OCULAR SCIENCES Inc. under K003136.

6. Characteristics

The characteristics of the BIOMEDICS® 52 1-Day (ocufilcon B) Soft (hydrophilic) UV Blocking Contact lenses are compared to the characteristics of the predicate device BIOMEDICS® 52 in the following table.

Material and Parameter comparison
	Predicate deviceBIOMEDICS® 52	Subject deviceBIOMEDICS® 52 1-Day
PRODUCTION METHOD	Cast molded process	Cast molded process
INTENDED USE	Daily wearCorrection of ametropia	Daily wearCorrection of ametropia
MATERIAL	ocufilcon B	ocufilcon B
Type	Group IV	Group IV
Color additive	Vat Blue 6 Dye21 CFR 73.3119CAS #130-20-1	Vat Blue 6 Dye21 CFR 73.3119CAS #130-20-1
UV additive	Yes	Yes
Characteristics comparison	Labeled	Labeled
Water Content % @ 20°C	52	52
Refractive Index @ 20°C	1.41	1.41
Dk permeability, ISO 9913-1Polarimetric method with edgecorrection @ 35°Cx 10-11 (cm²/sec) (ml O₂/ml x mm Hg)	16.8	16.8
Light transmittance	Tv, % @ 20°CIlluminant A with a 2º observer (between380 and 780 nm)97.7% average	Tv, % @ 20°CIlluminant A with a 2º observer (between 380 and780 nm)97.7% average

TABLE 1

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SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

Reference OSL52 Section : 3 Version : 1 Page :318

Characteristics comparison, -300 D40 lenses	Labeled	Labeled
Base Curve, mm	8.70	8.70
Diameter, mm	14.20	14.20
Power, D	-3.00	-3.00

7. Non clinical studies

Ocular Sciences (ocufilcon B) soft (hydrophilic)

contact lens

Non-clinical studies are summarized below:

Chemistry and leachability

Material property data were generated on the BIOMEDICS® 52 and the BIOMEDICS® 52 1-Day lenses ● processed with the manufacturing process changes. The material properties were substantially equivalent.
The lens care product manufacturers have previously shown compatibility of Group IV lenses with their . products.
The shelf life stability for BIOMEDICS® 52 1-Day lenses is based upon stability protocols included with this . notification.
Studies were conducted to determine the residual monomers on the subject device. .

Toxicology, lenses materials

In accordance with the May 1994 Guidance Document for Daily Wear contact lenses, toxicology studies have been conducted on the BIOMEDICS® 52 1-Day containing UV blocker. The results are summarized below:

Cytotoxicity Test: .

Cytotoxicity Tests have been conducted on the subject device according to ISO 10993: Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity: In vitro Methods guidelines, was conducted on the test articles, to determine the potential for Cytotoxicity.

The negative controls and the positive controls performed as anticipated. Under the conditions of the study, the test articles were not cytotoxic.

Acute Systemic Injection Test in the mouse: ●
An evaluation of the test articles for systemic toxicity in mice after a single intravenous administration or a single intraperitoneal administration has been conding to the ISO 10993; Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.

No evidence of systematic toxicity was observed from the test article extracts. Each test article met the test requirements.

. Ocular Eye Irritation Test in the rabbit:
An evaluation of the ocular irritation of 0.9% NaCl of the subject article after a single instillation in the rabbit has been conducted according to ISO 10993: Biological Evaluation of Medical devices, Part 10: Tests for the Irritation and Sensitization.

No evidence of ocular irritation was observed in the rabbits. The test are not considered irritants to the ocular tissue of rabbits.

. 22-Day Ocular Eye Irritation Study in the rabbit

For the evaluation of the safety of the subject device with regard to ocular irritation was conducted in rabbits in accordance with ISO 9394:1997(E). Lens wear was a minimum of 7 hours for 21 consecutive days. On lens wear day 22, lenses were worn for a least 4 hours.

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510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

Laboratory observations during the study included daily health observations, macroscopic eye examinations (during the last hour of lens wear), weekly biomicroscopic slit-lamp examinations and body weight observations.

Under the conditions of this study, eyes treated with test lenses were similar to the untreated control eyes.

Solution Compatibility

Microbiology: The lens care product manufacturers have established a reasonable assurance of disinfection efficacy of their care products with lens groups for which they are approved.

Non-clinical studies and manufacturing information provided by reference PMA890023 S4/S7 and K003136

Cast molded manufacturing process .
Toxicology packaging materials .
Microbiology and sterilization ●

8. Clinical data

Clinical studies were performed to establish the safety and efficacy of the Biomedics® 52 1-Dav lenses with an in-process manufacturing change. The purpose of the clinical investigation was to verify that the change made in the manufacturing process to an unextracted process, substantiated by safety toxicity testing data results, do not raise additional questions of safety or effectiveness.

The study was designed as an open-label, prospective, concurrent cohort control, randomized clinical trial. Subjects were recruited based upon specified inclusion criteria to assure that the appropriate subject population samples were included and inappropriate subjects were excluded. Scheduled follow-up visits were planned for the 1-Week, 2-Week and 4-Week visit intervals based upon the date the subject was dispensed the Test or Control lenses. No subjects were discontinued prior to completion in this investigation. No adverse events were reported for either the Test or Control cohort through the study period.

Thirty-six (36) subjects (72 eyes) were enrolled into the study at three (3) investigational sites. All of the 36 subjects were determined to be eligible to enter the study and were dispensed either the Test or the Control lenses based upon a randomization schedule provided to the site.

The distribution of age and gender of the subjects enrolled into the study by cohort is shown below.

	Distribution of Age and Gender
	Test	Control	Totals
Female Subjects	19	10	29
Male Subjects	5	2	7
Ratio F/M	3.8:1	5:1	4.1:1
Average Age (years)	36.0	38.8	36.9

Safety Results:

Safety is demonstrated if the test lens complications are substantially equivalent in frequency and severity to the control lens complications.

1. Permanent decreases in BCVA: There were no reports of 2-line decreases in best corrected Snellen visual acuity for any of the Test or Control cohort eyes.

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SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

OSL52 Reference Section : 3 Version : I : 5 / 8 Page

Persistent corneal staining of Grade 3 or 4 at two or more follow-up visits: There were no reports 2. of Grade 3 or 4 staining for either the Test or the Control cohort eyes.
Neovascularization more than 1.5mm and/or more than 1.0mm in 3 or more quadrants: There was 3. no neovascularization reported of greater than 1.5mm in any quadrant. The incidence of neovascularization reported for the Completed Test and Control cohort eyes remained stable throughout the period of the study.
Persistent hyperemia of Grade 3 or 4 at two or more follow-up visits: No Grade 3 or 4 limbal or 4. bulbar hyperemia was reported during the period of the study for any Test or Control cohort eyes.
Peripheral or central ulcerative keratitis: No peripheral or central ulcerative keratitis was reported 5. during the period of the study for any Test or Control cohort eyes.
Infiltrates of Grade 2 or worse: No infiltrates were reported during the period of the study for any 6. Test or Control cohort eyes.
1. Subrective symptoms, problems or complaints: Subjective symptoms were reported for both the Test and the Control eves over the course of the study. The areas where the Test and Control cohorts presented with differences were in discomfort and blurred vision.

Discomfort was reported more frequently and with greater severity for the Test cohort eyes with 12.5% of the follow-up examinations for Test eyes resulting in a report of discomfort with an average severity of 2.1 out of 4.0. This is in contrast to the Control cohort eyes where discomfort was reported for 7.3% of the follow-up examinations with an average severity of 1.1 out of 4 0.

Blurred vision was reported more frequently for the Control cohort eves with 6.3% of the follow-up examinations for Control eves resulting in a report of blurred vision with an average severity of 1.7 out of 4.0. This is in contrast to the Test cohort eyes where blurred vision was reported for 1.6% of the follow-up examinations with an average severity of 1.0 out of 4.0.

The findings for symptoms, problems and complaints do not indicate any safety issues with the Test lenses when compared to the Control lenses. The symptom of discomfort was not related to objective (slit lamp) findings for the Test cohort eyes and does not by itself indicate any safety concerns.

Both the Test and the Control cohort eyes had similar outcomes in the evaluation of the safety variables. Very few complications were reported during the study and most were mild and transient. Based upon the safety criteria established in the study protocol and reviewed above, the Test lens demonstrates equivalent safety when compared to the Control lens.

Visual Acuity Results:

The comparison of the beginning and ending lens visual acuties within and between the Test and the Control cohort eyes provides evidence that the Test lens is safe and effective with respect to lens visual acuity. Both the Test and Control lens visual acuities are essentially the same at the final examination.

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510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

	Proportion of Lens Visual AcuitiesDispensing Versus Final Examination
Visit Sample Size	Dispensing	Final Visit
Completed Test Eyes	48	46
Completed Control Eyes	24	24
Proportion of Lens Visual Acuities 20/30 or Better
Eyes with VA of 20/30 or better	Dispensing	Final Visit
Completed Test Eyes	100.0%	100.0%
Completed Control Eyes	95.8%	100.0%
Proportion of Lens Visual Acuities 20/20 or Better
Eyes with VA of 20/20 or better	Dispensing	Final Visit
Completed Test Eyes	83.3%	84.8%
Completed Control Eyes	54.2%	83.3%

Average Wearing Time:

Based upon the average lens wearing times reported by the Test and Control subjects, both cohorts were achieving acceptable and similar average daily wearing times. For the Test cohort the was 12.8 hours per day to 13.2 hours per day over the period of the study. For the Control cohort the average wearing time was 13.1 hours per day to 13.3 hours per day over the period of the study.

Lens Deposits over course of the study:

Over the period of the study the Test and the Control cohort lenses were reported to have similar rates, Test 12.5% and Control 11.1%, with the Test eves reporting 1.4% of the lenses as having medium deposits and the Control eyes only reporting light deposits.

Efficacy Summary:

1. The proportion of subjects in each group (Test or Control) successfully completing the protocol specified study duration: All of the Test and Control cohort subjects completed the 1 month study period. No subjects were discontinued for any reason.
1. The percentage of lens visual acuties of 20/20 and the percentage of lens visual acuittes of 20/30 or Better: The percentage of Completed eyes reporting visual acuities of 20/20 or better at the final study visit was 84.8% for the Test cohort eyes and 83.3% for the Control eves. Both of these proportions are greater than those measured at the study. The percentage of Completed eves reporting visual acuities of 20/30 or better at the final study visit was 100% for the Test cohort eves and 100% for the Control cohort eyes. The percentage of Test eyes reporting VAs of 20/30 at the final visit met the expectations set at the inception of the study.
1. Overall, the visual performance of the Test lens was similar to the performance of the Control lens.

Conclusions:

These conclusion are based upon the review of the data reported during the 1 month evaluation of the safety and efficacy of the Biomedics® 52 1-Day (ocufilcon B) soft (hydrophilic) contact lenses manufactured under a process change used following a daily disposable contact lens regimen.

The results of the slit lamp examinations indicate that the Test lens performs at least as well as the Control lens in terms of safety. Visual acuities and ocular health were all maintained during the study. Except for

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510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

Reference OSL52 Section : 3 Version : I Page : 7 / 8

discomfort, most of the symptoms, problems and complaints were reported at similar rates between the Test and the Control cohorts. The completion of all of the subjects recruited for the study and the excellent visual acuity results demonstrate the efficacy of the Test lens during the study.

The difference in the reports and severity of the symptom discomfort also suggest that the Test lens is associated with excessive discomfort for some of the Test subjects. The findings of this study demonstrate that the Test lens performs equivalently in terms of safety and efficacy when compared to the Control lens cohort.

9. Conclusions drawn from studies

Validity of Scientific Data:

A contract laboratory using Good Laboratory Practices conducted the Toxicology studies. Chemistry leachables studies were conducted by Ocular Sciences, UK Ltd.

Substantial Equivalence:

Information provided in this 510(k) establishes that the Biomedics® 52 1-Day lenses are equivalent in optical, chemical and physical properties of the predicate devices any questions of safety and effectiveness. Therefore, the device is substantially equivalent to the predicate devices® 52 1-Day (ocufilcon B) soft (Hydrophilic) UV blocking contact lenses under K003136.

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 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 Materials Submission

FIGURE 1 [NEXT PAGE]

BIOMEDICS® 52 1-Dav

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850 JUN 0 4 2002

Ocular Sciences, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. Senior Consultant Official Correspondent to Ocular Sciences, Inc. R.P. Chiacchierini & Associates, LLC 17003 Horn Point Drive Gaithersburg, MD 20878

Re: K020389

Trade/Device Name: BIOMEDICS® 52 1-Day (ocufilcon B) Soft (hydrophilic) UV Blocking Contact Lens for Daily Wear (Spherical and Toric)

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL; MVN Dated: May 2, 2002 Received: May 3, 2002

Dear Dr. Lippman:

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

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Page 2 - Richard E. Lippman, O:D., F.A.A.O.

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

SECTION 2 : INDICATIONS FOR USE STATEMENT

510(k) Number (if known)

Device Name:

Indications for Use:

Spherical:

BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.

Toric:

BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic)UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 10.00 diopters.

The lens may be prescribed for Daily Wear in not- aphakic persons. The eyecare practitioner may prescribe the contact lens for single use disposable wear.

The BIOMEDICS® 52 1-Day (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact 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)

CDRII Office of Device Evoluction (QDF)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
------------------	---------------

Over-the-counter-use
----------------------	---------------

(Division Sign-off)
Division of Ophthalmic Devices

510(k) Number	K020389
---------------	---------

Regulation Number and Section

§ 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.