(36 days)
P950031
P950031
No
The summary describes a contact lens cleaner and its intended use, with no mention of AI, ML, image processing, or any related technologies. The performance studies focus on traditional safety and effectiveness testing for a cleaning solution.
No
Explanation: The device is described as a cleaner for contact lenses and its intended use is to clean them. It does not exert any therapeutic effect on the body or treat any medical condition.
No
Explanation: The device is described as a cleaner for various types of contact lenses, which is a therapeutic or maintenance function, not a diagnostic one.
No
The device description and performance studies clearly indicate this is a physical contact lens cleaner, not a software-only device. The studies involve microbiology, toxicology, chemistry, manufacturing, and clinical trials with physical contact lenses.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "clean soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-sillcone acrylate) and hard (PMA) contact lenses." This is a cleaning function for a medical device (contact lenses), not a diagnostic test performed in vitro (outside the body) on biological specimens to provide information about a person's health.
- Device Description: The description confirms it's a "cleaner for rigid gas permeable (RGP) and hard (PMMA) contact lenses" with an added indication for "cleaning soft (hydrophilic) contact lenses." This reinforces its function as a cleaning product.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
IVDs are used to diagnose diseases, monitor health, or screen for conditions by testing samples like blood, urine, or tissue. This device's purpose is solely to clean contact lenses.
N/A
Intended Use / Indications for Use
To clean soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-sillcone acrylate) and hard (PMA) contact lenses.
Product codes
86 LPN
Device Description
Not Found
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
The device is currently marketed as a cleaner for rigid gas permeable (RGP) and hard (PMMA) contact lenses. The current notification is for the added indication of cleaning soft (hydrophilic) contact lenses. Lobob performed non-clinical and clinical testing on the device. The non-clinical testing supports the safety and effectiveness of the device from microbiology, toxicology, chemistry and manufacturing perspectives. Clinical data were obtained from a multi-center study involving a hydrophilic contact lens consisting of 72 eyes followed for 3 months. This data was submitted to and evaluated by FDA in connection with its approval of PMA No. P950031.
Key Metrics
Not Found
Predicate Device(s)
Lobob Cleaner (P950031)
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
2/11/99
510(k) Summary December 30, 1998
Submitted by:
Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street NW (#700) Washington, DC 20036 202-261-1000
On behalf of Lobob Laboratories, inc. 140 Atteberry Lane San Jose, CA 95131-1410
| Device Classification: | Class II -Soft (hydrophilic) contact lens care product (21 CFR 886.5928) |
|---|---|
| Trade Name: | Lobob Universal Contact Lens Cleaner |
| Predicate Device: | Lobob Cleaner (P950031) |
Safety and Effectiveness Information:
The device is currently marketed as a cleaner for rigid gas permeable (RGP) and hard (PMMA) contact lenses. The current notification is for the added indication of cleaning soft (hydrophilic) contact lenses.
Lobob performed non-clinical and clinical testing on the device. The non-clinical testing supports the safety and effectiveness of the device from microbiology, toxicology, chemistry and manufacturing perspectives. Clinical data were obtained from a multi-center study involving a hydrophilic contact lens consisting of 72 eyes followed for 3 months. This data was submitted to and evaluated by FDA in connection with its approval of PMA No. P950031.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with three curved lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 1999
Lobob Laboratories, Inc. c/o Mr. Daniel J. Manelli FARKAS & MANELLI, P.L.L.C. 2000 M Street (#700) Washington, DC 20036
K990044 Re:
Trade Name: Lobob Universal Contact Lens Cleaner Regulatory Class: II Product Code: 86 LPN Dated: January 21, 1999 Received: January 22, 1999
Dear Mr. Manelli:
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. Daniel Manelli
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
revised 01/21/99
Exhibit 3
l 1 Page of
K990044 510(k) Number (if known): j
Device Name:_Lobob Universal Contact Lens Cleaner
Indications For Use:
.
To clean soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-sillcone acrylate) and hard (PMA) contact lenses.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SM Haddle
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number _ 1 990044
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)