(526 days)
K002140, P820069
Not Found
No
The device description details a chemical solution for cleaning contact lenses, with no mention of software, algorithms, or any technology that would incorporate AI/ML.
No
This device is a protein remover for contact lenses, not a device used for treating medical conditions or diseases.
No
This device is a cleaning solution for contact lenses, designed to remove protein deposits. It does not diagnose any medical condition or disease.
No
The device description clearly states it is a mixture of two sterile solutions and includes a vial, indicating it is a chemical and hardware-based device, not software-only.
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 and remove protein deposits from contact lenses. This is a process applied to a medical device (contact lenses) to maintain its function, not a test performed on a biological sample to diagnose or monitor a medical condition.
- Device Description: The description details the chemical composition and usage instructions for cleaning contact lenses. It does not describe a test or assay for 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 or prognostic information
- Measuring biomarkers or analytes
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
The device is a cleaning solution for contact lenses, which falls under the category of a medical device used for the maintenance of another medical device.
N/A
Intended Use / Indications for Use
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate RGP contact lenses.
Product codes (comma separated list FDA assigned to the subject device)
MRC
Device Description
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (sodium hypochlorite, sodium carbonate, sodium hydroxide, purified water) and Progent B (potassium bromide, sodium carbonate, purified water). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minute. Soaking for longer than 30 minutes is not recommended. Progent Rinsing Solution (sterile purified water) is provided for rinsing the lenses and SP vial. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eve care professional's directions (to a maximum of every 5 days.
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 applicant performed toxicological testing and clinical testing of the instructions for use to support 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.
K002140, P820069
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
510(k) summary
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
December 2009
1. Applicant Information
| Menicon Co., Ltd. | |
|---|---|
| 21-19, Aoi 3-chome, | |
| Naka-ku, Nagoya, Aichi 460-0006 | |
| JAPAN | |
| Contact Person: | Takahiro Ochi |
| Telephone No.: | +81-52-937-5021 |
| Fax No.: | +81-52-935-1121 |
| E-mail: | t-ochi@menicon-net.co.jp |
MAR - 9 2010
2. Device Information
Classification name: Rigid gas permeable contact lens care products Device classification: Class II Regulation number: 21 CFR 886.5918 Product code: MRC
Menicon Progent Protein Remover for Rigid Gas Permeable Proprietary name: Contact Lenses
3. Predicate Devices
Menicon claims substantial equivalence to Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses previously cleared under K002140.
Substantial equivalence is also claimed to the Boston® Cleaner cleared under P820069. The Boston Cleaner product is an RGP lens cleaner which is a potential irritant if placed directly into the eye, but sold over-the-counter to patients for in-home use.
4. Description of device
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses is the mixture of two sterile solutions, Progent A (sodium hypochlorite, sodium carbonate, sodium hydroxide, purified water) and Progent B (potassium bromide, sodium carbonate, purified water). Progent A and B are mixed in a Menicon SP Vial. Allow lenses to soak in the Progent solution mixture for 30 minute. Soaking for longer than 30 minutes is not recommended. P Progent Rinsing Solution (sterile purified water) is
1
provided for rinsing the lenses and SP vial. The Progent treatment is recommended every two weeks. The frequency may vary according to the condition of your lens. Follow your eve care professional's directions (to a maximum of every 5 days.
5. Indications for use
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses, when used as directed, cleans and removes protein deposits from fluorosilicone acrylate RGP contact lenses.
6. Substantial equivalence
The claim of substantial equivalence to the previously cleared 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 indications have been modified to remove disinfection and the restriction for professional in-office use only. The directions for use have been modified to enhance the safety for use by patients.
The applicant performed toxicological testing and clinical testing of the instructions for use to support the claim of substantial equivalence.
The additional claim of substantial equivalence to the Boston® Cleaner is based on the indications for use as an RGP lens cleaning product which is a potential irritant if placed directly into the eye, but is sold directly to patients for in-home use.
2
Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Foresight Regulatory Strategies, Inc. c/o Beverly D. Venuti, Ph.D., R.A.C. Staff Consultant 187 Ballardvale Street Suite 180 Wilmington, MA 01887-4461
MAR - 9 2010
Re: K082855
Trade/Device Name: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC Dated: February 26, 2010 Received: March 1, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2 - Beverly D. Venuti, Ph.D., R.A.C.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lesia Alexanderfor
Malvina B. Eydelman. M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ ├ ○ 8285S
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 and removes protein deposits from fluorosilicone acrylate rigid gas permeable contact lenses.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
.
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ming-chuen Shih
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of 1
K082855
510(k) Number
K082855/A02 Menicon Progent
CONFIDENTIAL
Page 63 of 82