(73 days)
No
The device description and performance studies focus on the physical properties and capacity of a contact lens case, with no mention of AI or ML.
No
The device is a contact lens case used for storage and chemical disinfection, not for treating any medical condition or disease.
No
Explanation: The device is a contact lens case used for storage and disinfection, not for diagnosing any medical condition. Its intended use is to hold lenses during chemical disinfection, which is a maintenance function, not a diagnostic one.
No
The device description clearly states it is a "side by side double well plastic case with two screw-on plastic closures," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection." This describes a device used in the care and maintenance of medical devices (contact lenses), not a device used to perform tests on samples taken from the human body to diagnose or monitor a medical condition.
- Device Description: The description of a "side by side double well plastic case with two screw-on plastic closures" aligns with a storage container, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information about a patient's health status
The device is a container for contact lenses during a disinfection process, which is a maintenance step for the contact lenses themselves, not a diagnostic test on a patient.
N/A
Intended Use / Indications for Use
For storage of soft (hydrophilic), rigid gas permeable, and hard contact lenses during chemical disinfection.
Product codes
LRX
Device Description
The Alcon Contact Lens Case is intended for use for 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. A drawing of the Alcon Contact Lens Case is provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
April 30, 1997
K971618 Alcon
JUL | 4 1997
510(K) SUMMARY
Submitted by:
ALCON LABORATORIES, IN 6201 SOUTH FREEWAY FORT WORTH, TEXAS 76134-2099 (817) 293-0450
Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76132 (817) 551-4877 (Phone) (817) 551-4630 (Fax)
Device Name:
Common Name: Contact Lens Case Alcon Contact Lens Case Proprietary Name:
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 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. A drawing of the Alcon Contact Lens Case is provided.
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 identical in its intended use to the OPTI-FREE® Lens Case (K931620) and the OPTI-LENS® Lens Case (K915082). 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.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three lines forming its head and wings, giving it a modern and abstract appearance. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael E. Pfleger Associate Director, Regulatory Affairs Alcon Laboratories, Inc. ................................................. 6201 South Freeway Fort Worth, TX 76134-2099
JUL 1 4 1997
Re: K971618 Trade Name: Alcon Contact Lens Case Regulatory Class: unclassified Product Code: LRX (0) Dated: April 30, 1997 Received: May 2, 1997
Dear Mr. Pfleger:
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.
2
Page 2 - Mr. Michael E. Pfleger
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
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
The Alcon Contact Lens Case __________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________
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)
Daniel W.C. Brunson, Ph.D
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K9711618
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use_X___