(526 days)
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.
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 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.
The provided 510(k) summary for Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses focuses on establishing substantial equivalence to a previously cleared device (K002140) and to Boston® Cleaner. It describes the product, its indications for use, and a high-level overview of testing performed.
However, the document does not include detailed information regarding specific acceptance criteria, comprehensive study results, sample sizes for test or training sets, expert qualifications for ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies. This type of information is typically found in the full submission, not always in the public-facing summary.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria:
The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for protein removal efficiency, irritation levels, or equivalence metrics). The primary "acceptance" described is the claim of substantial equivalence to predicate devices.
Reported Device Performance:
The document states that "The applicant performed toxicological testing and clinical testing of the instructions for use to support the claim of substantial equivalence." No specific performance metrics (e.g., protein removal percentage, irritation scores, or other quantitative results) are provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document states "clinical testing of the instructions for use" was performed, but does not specify the sample size for this clinical testing or any "test set."
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" and "experts" as typically understood in AI/ML performance evaluation (e.g., for image interpretation) is not applicable in this context. This device is a contact lens care product, and its performance evaluation would likely involve objective laboratory tests (e.g., measuring protein removal) and clinical trials assessing safety and efficacy (e.g., lens comfort, ocular health, user compliance with instructions). These types of studies might involve clinicians, but not in the role of establishing "ground truth" for a machine learning algorithm.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable in this context, as it relates to expert disagreement resolution in diagnostic studies, not to the evaluation of a contact lens cleaning solution.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where multiple human readers interpret cases with and without AI assistance. This device is a physical product for lens care.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This concept is relevant for AI/ML algorithms. This device is a chemical solution.
7. The Type of Ground Truth Used
As mentioned, "ground truth" in the context of AI/ML evaluation is not applicable here. The "truth" for this device's performance would be established through:
- Laboratory testing: Objective measurements of protein removal effectiveness using standardized methods.
- Toxicological testing: Evaluation of the chemical's safety and potential for irritation.
- Clinical testing: Assessment of patient comfort, ocular health, and compliance when using the product as directed.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here, as this device is a chemical solution and not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
The concept of "ground truth for a training set" is not applicable here, as this device is not an AI/ML algorithm.
Summary of what is present and what is missing based only on the provided text:
The document clearly states the intent to establish substantial equivalence for a protein remover for RGP contact lenses. It mentions that toxicological testing and clinical testing of the instructions for use were performed to support this claim. However, it does not provide any details about the methodologies, specific results, sample sizes, or quantitative acceptance criteria for these tests. The bulk of the information requested (related to AI/ML performance evaluation) is not relevant to this type of device.
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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
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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.
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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.
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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
§ 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.”