(54 days)
Not Found
No
The device description and performance studies focus on the material properties and chemical disinfection capabilities of a contact lens case, with no mention of AI or ML.
No
The device is a contact lens storage case, indicated for holding contact lenses during chemical disinfection, not for treating any condition.
No
Explanation: The device is indicated for the storage of contact lenses during chemical disinfection, and its description confirms it is a storage case. There is no mention of it being used to diagnose any condition or disease.
No
The device description explicitly states it consists of a polypropylene cap and body, which are physical hardware components. There is no mention of software.
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 contact lenses during chemical disinfection. This is a physical process related to the care of a medical device (contact lenses), not a diagnostic test performed on a biological sample to obtain information about a patient's health.
- Device Description: The device is a simple case made of polypropylene. It does not contain any components or features typically associated with IVD devices, such as reagents, test strips, or analytical systems.
- 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.)
- Providing diagnostic information about a disease or condition
- Using reagents or chemical reactions for analysis
- Measuring analytes or biomarkers
The device is clearly intended for the maintenance and care of contact lenses, which falls under the category of medical device accessories, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
CyberCases by Bausch & Lomb are indicated for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
CyberCases by Bausch & Lomb consist of a polypropylene cap and polypropylene body for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
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)
A series of in-vitro toxicological and chemical studies were performed to assess the safety and effectiveness of the CyberCases by Bausch & Lomb in accordance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry - Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. All studies were conducted in compliance with the Good Laboratory Practice Regulation for Nonclinical Laboratory Studies.
Results of the testing demonstrate that the safety and effectiveness of the CyberCases by Bausch & Lomb is equivalent to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K013232
NOV 2 0 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CyberCases™ by BAUSCH & LOMB
1. Submitter Information:
Bausch & Lomb Incorporated 1 400 North Goodman Street P.O. Box 30450 Rochester, New York 14603-0450
| Contact Person: | Kim S. DeVitto |
|---|---|
| Manager, Regulatory Affairs | |
| Telephone No.: | 716-338-6401 |
| Fax No.: | 716-338-0702 |
2. Device Name:
Classification Name: Contact Lens Cases
Proprietary Name: CyberCases™ by Bausch & Lomb
Predicate Device: 3.
The Bausch & Lomb® Sight Savers® Contact Lens Case was selected as the predicate device for the CyberCases by Bausch & Lomb.
4. Description of the Device
CyberCases by Bausch & Lomb consist of a polypropylene cap and polypropylene body for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
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ડ. Indications for Use:
CyberCases by Bausch & Lomb are indicated for storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) contact lenses during chemical disinfection.
Description of Safety and Substantial Equivalence ર્.
A series of in-vitro toxicological and chemical studies were performed to assess the safety and effectiveness of the CyberCases by Bausch & Lomb in accordance with the guidelines set forth in FDA's May 1, 1997 Guidance for Industry - Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. All studies were conducted in compliance with the Good Laboratory Practice Regulation for Nonclinical Laboratory Studies.
Results of the testing demonstrate that the safety and effectiveness of the CyberCases by Bausch & Lomb is equivalent to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case.
7. Substantial Equivalence
CyberCases by Bausch & Lomb are substantially equivalent in terms of indications for use, safety and effectiveness to the predicate device, Bausch & Lomb Sight Savers Contact Lens Case, cleared for marketing under 510(k) Notification #K852384 on 7/31/1985. The addition of different colorants to the lens case does not effect the use of this product.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 0 2001
Bausch & Lomb, Inc. c/o Kim S. DeVitto Manager, Regulatory Affairs 1400 N Goodman Street P.O. Box 30450 Rochester, NY 14603
Re: K013232
Trade/Device Name: CyberCases™ by Bausch & Lomb® Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products (contact lens cases) Regulatory Class: Class II Product Code: LRX Dated: September 26, 2001 Received: September 27, 2001
Dear De Vitto:
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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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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NOV 2 0 2001
Bausch & Lomb Incorporated 1400 North Goodman Street P.O. Box 30450 Rochester, NY 14603-0450
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
N/A
Device Name:
CyberCases™ by Bausch & Lomb
Indications for Use:
CyberCases by Bausch & Lomb are indicated for use in the storage of hard, rigid gas permeable (fluro silicone acrylate and silicone acrylate) and soft (hydrophilic) 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) | ||
|---|---|---|
| -- | -------------------------------------------------------- | -- |
| Prescription Use Use (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------- | -- |
| OR | Over-The-Counter | |
|---|---|---|
| (Division Sign-Off) Division of Ophthalmic Devices |
| 510(k) Number | K013232 |
|---|---|
| --------------- | --------- |