LL-55 (methafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

Device Description

The LL-55 contact lenses are available as lathe cut spherical lens. The lens material (methafilcon A) is a hydrophilic polymer of hydroxyethylmethacrylate and methacrylic acid.

AI/ML Overview

Here's an analysis of the provided information regarding the acceptance criteria and study for the Biocompatibles Evecare Inc. Parametric Release 510(k) methafilcon A hydrophilic contact lenses (LL-55):

This submission is a Parametric Release 510(k), which means it focuses on the sterility release mechanism rather than a new device design or clinical performance. The key point is that the lenses themselves remain unchanged from a previously approved 510(k) (K941877). Therefore, the "acceptance criteria" and "device performance" discussed here specifically pertain to the sterilization process validation for parametric release, not the clinical effectiveness or safety of the contact lens as a medical device in terms of vision correction or wear.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Steam Sterilization Process: Capable of achieving more than a 10^-6 sterility assurance level (SAL).	Achieved more than a 10^-6 SAL upon completion of a calculated exposure time of 20 minutes and an exposure temperature of 121°C on normal finished product lenses.
Product Bioburden: Pre-sterilization bioburden consistently and significantly below 1000 vegetative CFU and 40 spore-forming CFU.	Monthly average CFU per pre-sterilized product unit for 5 months (July 1997 to November 1997) ranged from a high of 294 to a low of 29 vegetative CFU, and less than 1 spore-forming CFU.
Bioburden Monitoring Technique Validity: Adequacy of microorganism removal, enumeration, microbiological counting, culture conditions, and recovery efficiency established.	Validation of the process used to determine bioburden included assessment of adequacy of removal, enumeration, counting techniques, culture conditions, and establishment of recovery efficiency for correction factor calculation.
Laminar Flow Workstation Bioburden Level (Airborne): Consistently low results on settle plates.	Results are consistently low.
Laminar Flow Workstation Bioburden Level (Surface): Consistently low results on surface touch plates.	Results are consistently low.
Steam Sterilizer Calibration: Operating within manufacturer design specifications; capable of regulating temperature and displaying/recording pressure.	Sterilizer successfully demonstrated capability to regulate temperature. Pressure gauge successfully demonstrated ability to display and record pressure.
Data Logger Calibration: Output temperatures from 10 validation thermocouple readings deviated less than 1°C from setpoint.	All output temperatures from the 10 validation thermocouple readings deviated less than 1°C from the setpoint.
Pressure Monitoring during Cycle: Pressure held to 15 psi ± 0.5 psi during timing portion of the cycle.	Pressure was held to 15 psi ± 0.5 psi during the timing portion of the cycle.
Annual Sterilizer Calibration & Validation: Verify consistent parameter measurement recordings, consistent operations to specifications, and adequacy of cycle times to achieve 10^-6 SAL.	Annual calibration and validation are performed; recent validation demonstrated compliance with operating specifications and cycle time exceeding time necessary to achieve 10^-6 SAL.
Annual Laminar Air Flow Workstation Certification: Compliance with Federal Standard 209E to Class 100 requirements.	Recent certification demonstrated compliance with Federal Standard 209E to Class 100 requirements.

Study Details (Focusing on Sterilization Validation)

Sample size used for the test set and the data provenance:
- Steam Sterilization Validation: "Normal finished product lenses" were used, but a specific sample size for this part of the test is not explicitly stated. The validation demonstrated the process's capability.
- Product Bioburden Monitoring: Bioburden results were obtained "monthly over a 5 month period" (July 1997 to November 1997). The number of product units sampled per month for bioburden is not specified, only the average CFU per unit.
- Thermocouple Readings: 10 validation thermocouple readings were used for data logger calibration.
- Data Provenance: Retrospective, based on internal validation and monitoring data from Biocompatibles Eyecare Inc. (USA). This is typical for process validation data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a process validation study, not a clinical study involving expert interpretation of medical images or patient outcomes. The "ground truth" here is objective physical and microbiological measurements demonstrating sterility assurance.
Adjudication method for the test set:
- Not applicable. This is a scientific and engineering validation of a sterilization process, relying on quantifiable measurements and established standards (e.g., SAL). There is no "adjudication" in the sense of resolving discrepancies between human readers.
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:
- Not applicable. This is a sterilization process validation for a contact lens, not a diagnostic AI device requiring human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This submission is about the process of sterilization and its parametric release, not an algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth is based on scientific and engineering measurements against established standards for sterilization (e.g., 10^-6 SAL, specific temperature, pressure, and time parameters), and microbiological assays to quantify bioburden.
- It relies on calibrated equipment and validated microbiological testing methods.
The sample size for the training set:
- Not applicable. This is a process validation, not a machine learning model's development. There is no "training set" in this context. The underlying principles for determining sterilization parameters are based on extensive scientific literature and regulatory guidelines, not a specific training dataset for this device.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

{0}------------------------------------------------

K 980218

Biocompatibles Evecare Inc. Parametric Release 510(k) methafilcon A hydrophilic contact lenses

MAR 2 3 1998

SAFETY AND EFFECTIVENESS SUMMARY

1.	Name andaddress ofsubmitter	Biocompatibles Eyecare Inc.1215 Boissevain AvenueNorfolk VA USA 23507Contact Person: Lisa Hahn
		Telephone number: 800-225-3069 or 757-664-2421
		Date summary prepared: January 15, 1998
2.	Identification ofDevice	Trade Name: LL-55 (methafilcon A) Soft Contact Lens
		Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear)Classification: Group II
3.	Predicate Device	LL-55 (methafilcon A) Contact Lens

র্থ Description of Device

The LL-55 contact lenses are available as lathe cut spherical lens. The lens material (methafilcon A) is a hydrophilic polymer of hydroxyethylmethacrylate and methacrylic acid.

5. Intended Use (indications)

Ga Characteristics comparison of predicate to this device

Design, material, and chemical composition remain unchanged from those approved in Premarket 510(k) Notification K941877

Sb . Clinical tests and results

Not performed; lenses remain unchanged from approved Premarket 510(k) Notfication K941877.

6c. Non Clinical tests and results

The final product lenses will be processed through packaging, sealing, sterilization and staged for QC release in same manner as currently established and validated. The only change to the process will be the elimination of Biological Indicators. This submission supports use of physical parameters of sterilization cycle to meet specifications as the basis for sterility release mechanism.

{1}------------------------------------------------

Biocompatibles Eyecare Inc. Parametric Release 510(k) methafilcon A hydrophilic contact lenses

6c 1. Validation of the Steam Sterilization Process:

Validation of the steam sterilization process demonstrated that the steam steellizer is capable of achieving more than a 10 sterility assurance level (SAL) upon completion of a calculated exposure time of twenty (20) minutes and an exposure temperature of 121° C on normal finished product lenses.

6c 2. Product Bioburden Monitorina

Results obtained monthly over a 5 month period have determined that bioburden of product in production is well controlled. Presterilization bloburden results are consistently significantly below both 1000 vegetative CFU and 40 spore forming CFU. Each month average CFU per presterilized product unit for the 5 months from July 1997 to November 1997 is low; counts range from a high of 294 to a low of 29 vegetative CFU and less than 1 sporeforming CFU.

The process used to determine bioburden has been validation included assessment of the adequacy of the technique used to remove micro-organisms from the final lens product, assessment of the adequacy of the technique used to enumerate removed micro-organisms, including micro-biological counting techniques and culture conditions; and establishment of the recovery efficiency for the method used in order that the correction factor be calculated.

6c 3. Laminar Flow Workstation Bioburden Level

Settle plates are routinely used in the manufacturing facility laminar flow workstations to monitor the airborne bioburden. Results are consistently low.

Surface touch plates are used to routinely sample bioburden levels on workstation surfaces. Results are consistently low.

6c 4. Calibration/ Certification of Relevant Equipment

The steam sterilizer was calibrated to demonstrate that the apparatus is operating within manufacturer design specifications. The sterilizer successfully demonstrated its capability to regulate temperature. The pressure gauge on the stenlizer also successfully demonstrated it's ability to display and record pressure. The

Upon performing the zero and span calibration procedures on the data logger all output temperatures from the 10 validation thermocouple readings deviated less than 1°C from the setpoint.

The pressure readings were monitored and pressure was held to 15 psi ± 0.5 psi during the timing portion of the cycle.

Annual calibration of steam stenlizer is performed to verify consistent parameter measurement recordings. Additionally annual sterilizer validations are performed to Summary of Safety and Effectiveness 2

{2}------------------------------------------------

Biocompatibles Eyecare Inc. Parametric Release 510(k) methafilcon A hydrophilic contact lenses

ensure consistent operations of sterilizer to specifications and to verify adequacy of cycle times. Recent validation results demonstrated that the sterilizer is in compliance with operating specifications and cycle time exceeds time necessary to achieve 100 sterility assurance level (SAL ).

To ensure consistent operating efficiency, annual certification of the laminar air flow workstations is performed. Recent certification results demonstrated that the laminar air flow workstations were in compliance with Federal Standard 209E to Class 100 requirements.

{3}------------------------------------------------

Image /page/3/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 curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 1998

Ms. Lisa Hahn Director of Regulatory Affairs Biocompatibles Eyecare, Inc. 1215 Boissevain Avenue Norfolk, VA 23507

Re: K980218

Trade Name: LL-55 (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (Parametric release) Regulatory Class: II Product Code: 86 LPL Dated: January 15, 1998 Received: January 16, 1998

Dear Ms. Hahn:

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 - Ms. Lisa Hahn

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 at (301) 443-6597.

Sincerely yours,

Alberl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(K) Number : K980218

LL-55 (methafilcon A) Daily Wear Contact Lens Device Name:

Indication for use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Myro Smith

(Division Sign-Off)

Division of Ophthalmic Devices 510(k) Number_K 9802 18

Prescription Use X

Over the counter use

(Optional format 1-2-96)

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.