(41 days)
Not Found
No
The device description and intended use clearly describe a chemical solution for cleaning contact lenses, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly "Not Found".
No
The device is a protein remover for contact lenses, which cleans and disinfects them. It does not directly treat or diagnose a medical condition in a patient.
No
The device description indicates that Menicon Progent Protein Remover is used to clean, disinfect, and remove protein deposits from contact lenses. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly states it consists of two solutions packaged in ampoules and a cleaning vial, indicating it is a chemical solution and hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clean, disinfect, and remove protein deposits from contact lenses. This is a process applied to a medical device (contact lenses) outside of the body, not a test performed on a biological sample to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a chemical solution used for cleaning contact lenses. It does not involve analyzing biological samples.
- 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
- Measuring biomarkers or analytes
- Using techniques like immunoassays, PCR, or microscopy for diagnostic purposes.
The device is a cleaning and disinfecting solution for contact lenses, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
This product is for professional in-office use only.
Product codes (comma separated list FDA assigned to the subject device)
MRC
Device Description
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses consists of two solutions, Progent A and Progent B, which are mixed together when used. They are packaged separately in natural low density polyethylene (USP classification :VI) ampoules, type "Bottle Pack", containing 5.5 ml of solution, (5 ml being usable). Each package consists of 7 pairs of ampoules.
Progent A contains sodium hypochlorite and sodium carbonate; Progent B contains potassium bromide and sodium carbonate. Rigid Gas Permeable Contact Lenses are placed into the lens holder cap of the cleaning vial (SP Vial). Progent A, then Progent B are poured into the case receptacle, then the lenses are soaked in the Progent mixture for 30 minutes.
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
professional in-office use
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 applicant performed non-clinical stability, toxicology and microbiology testing which supports the claim of substantial equivalence.
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
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
MAY 0 2 2002
Page 1 of 2
510(k) Summary
Menicon Co., Ltd. Applicant's Name and Address: 21-19, Aoi 3-Chome Naka-ku, Nagoya 460-0006 Japan
Tohru Kawaguchi Contact Person: Phone 011 81 (52) 935-1676 011 81 (52) 935-1633 Fax
March 2002 Summary Prepared
Trade Name:
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Classification Name:
rigid gas permeable contact lens solution
Common/Usual Name
periodic cleaner; disinfecting solution
Predicate Device:
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K002140).
Device Description:
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses consists of two solutions, Progent A and Progent B, which are mixed together when used. They are packaged separately in natural low density polyethylene (USP classification :VI) ampoules, type "Bottle Pack", containing 5.5 ml of solution, (5 ml being usable). Each package consists of 7 pairs of ampoules.
Progent A contains sodium hypochlorite and sodium carbonate; Progent B contains potassium bromide and sodium carbonate. Rigid Gas Permeable Contact Lenses are placed into the lens holder cap of the cleaning vial (SP Vial). Progent A, then Progent B are poured into the case receptacle, then the lenses are soaked in the Progent mixture for 30 minutes.
1
Indication for Use:
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Substantial Equivalence:
The claim of substantial equivalence to Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is based on the fact that the product is the same formulation. Only the indications and directions for use have been modified.
The applicant performed non-clinical stability, toxicology and microbiology testing which supports the claim of substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
MAY 02 2002
Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850
Menicon Co., Ltd. c/o Beverly D. Venuti, Ph.D., RAC. Foresight Regulatory Strategies, Inc. 269A Ballardvale St. Wilmington, MA 01887
Re: K020930
Trade/Device Name: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenes
Regulation Number: 21 CFR 886.5918 Regulation Name: RGP Contact Lens Solution Regulatory Class: Class II Product Code: MRC Dated: March 20, 2002 Received: March 22, 2002
Dear Dr. Venuti:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Beverly D. Venuti, Ph.D., RAC
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 vours,
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
4
Indications for Use
K020930 510(k) Number (if known):
Device Name:
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Indications for Use:
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans, disinfects and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
This product is for professional in-office use only.
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Daniel W. C. Brown, PHD.
510(k) Number_K020930
Prescription Use x
(Per 21 CFR 80.109)
Over-The-Counter Use
(Optional Format 1-2-96)