(67 days)
For storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.
The Alcon Contact Lens Case is intended for use for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. It consists of a side by side double well plastic case with two screw-on plastic closures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overflow capacity of 5.0 mL in each lens well | Designed to have an overflow capacity of 5.0 mL in each lens well to assure sufficient immersion of contact lenses under use conditions. |
2. Sample Size and Data Provenance
The provided text does not include information about the specific sample size used for testing the overflow capacity.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned. However, the context suggests the testing was likely conducted by Alcon Laboratories, Inc. in the US given their submission to the FDA.
3. Number and Qualifications of Experts for Ground Truth
The provided text does not indicate that experts were used to establish ground truth for the device's performance. The acceptance criterion is a quantifiable engineering specification related to volume.
4. Adjudication Method
The provided text does not mention any adjudication method as external expert review was not indicated for this type of performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed as this device is a contact lens case, not an AI-powered diagnostic or assistive tool for human readers.
6. Standalone Performance (Algorithm Only)
Standalone performance is not applicable as this device is a physical product (contact lens case), not an algorithm or AI.
7. Type of Ground Truth Used
The ground truth for the performance claim (overflow capacity) is based on engineering specifications and design requirements. It's a direct measurement of the physical design, not expert consensus, pathology, or outcomes data.
8. Sample Size for Training Set
A training set sample size is not applicable as this device is a physical product, not an AI/ML algorithm.
9. How Ground Truth for Training Set Was Established
The concept of a "training set" and establishing ground truth for it is not applicable to this device. The performance is based on the physical design and manufacturing specifications of the contact lens case.
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November 13, 1997
510(k) SUMMARY
Submitted by:
Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76132 (817) 551-4702 (Phone) (817) 551-4630 (Fax)
JAN 20 1998
ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134-2099 (817) 293-0450
Device Name:
Common Name: Contact Lens Case Proprietary Name: Alcon Contact Lens Case
Device Classification:
Contact lens have not been officially classified, but have been recommended by the Ophthalmic Devices Panel to be classified in Class II and have historically been regulated through the 510(k) process.
Description:
The Alcon Contact Lens Case is intended for use for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. It consists of a side by side double well plastic case with two screw-on plastic closures.
Performance:
The Alcon Contact Lens Case is designed to have an overflow capacity of 5.0 mL in each lens well. This will be a sufficient volume to assure that the contact lens will remain immersed under use conditions.
Substantial Equivalence Comparison:
The Alcon Contact Lens Case is substantially equivalent to the Alcon Contact Lens Case (K971618). It is intended for storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection. All the materials currently being used in the lens cases or proposed in this submission have passed the relevant physico-chemical, and toxicological tests.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 1998
Mr. Ralph H. Larsen Manager, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099
Re: K974281 Trade Name: Alcon Contact Lens Case Regulatory Class: unclassified Product Code: LRX (0) Dated: November 13, 1997 Received: November 14, 1997
Dear Mr. Larsen: "
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 - Mr. Ralph H. Larsen
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. Roerl. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ The Alcon Contact Lens Case
Indications for Use:
For storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K974281
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use_X
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”