(100 days)
No
The document describes a contact lens solution and does not mention any AI or ML components.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a contact lens solution for cleaning, rinsing, disinfecting, and conditioning, not for treating a medical condition of the eye itself.
No
The device is a multi-purpose solution for cleaning, rinsing, disinfecting, and conditioning contact lenses, not for diagnosing a medical condition.
No
The device description clearly states it is a sterile, buffered aqueous solution containing various chemical ingredients, indicating it is a physical product (a liquid solution) and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning, rinsing, disinfection, and conditioning of 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 lists chemical components of a solution used for contact lens care. It does not describe a device designed to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Diagnosis, monitoring, or screening of diseases or conditions
- Measurement of analytes in biological samples
- Use in a laboratory or clinical setting for diagnostic purposes
The information provided clearly indicates that this is a solution for the care of contact lenses, which are medical devices themselves, but the solution itself is not an IVD.
N/A
Intended Use / Indications for Use
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Product codes (comma separated list FDA assigned to the subject device)
MRC
Device Description
Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.
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)
Non Clinical Data
In support of the Alcon Laboratories RGP Multi-Purpose Solution ID 100136 cleared in K000148, a complete set of testing (preclinical, biocompatibility and container tests) was completed to establish the safety and efficacy of the solution.
Testing conducted on the new device consisted of evaluating the solution manufactured in the Japanese facility. Testing included chemical analysis of the Japanese product to confirm equivalence to the product manufactured by Alcon, container biocompatibility tests and shelf life stability tests.
Clinical Data
The safety and efficacy of this solution has been clinically evaluated in the cleared Alcon Laboratories 510(k) application. Alcon RGP Multipurpose Solution K000148.
This application is for the same formulation with the alternate brand name, Menicon Unique pH Multi-Purpose Solution, which will be manufactured in Japan by Menicon Nect. The new device and the predicate device have the same composition, ingredients and intended use. Based upon this fact there were no additional clinical studies required to establish the safety and efficacy of the new device.
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
Menicon Co., Ltd.
K130805
Page 1 of 3
510(k) Summary
JUL 0 3 2013
MENICON UNIQUE pH MULTI-PURPOSE SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
1. Applicant Information
| Menicon Co., Ltd. | |
|---|---|
| 3-21-19, Aoi, | |
| Naka-ku, Nagoya 460-0006 | |
| JAPAN | |
| Contact Person: | Takahiro Ochi |
| Telephone No.: | +81-52-935-1676 |
| Fax No.: | +81-52-935-1633 |
| E-mail: | t-ochi@menicon-net.co.jp |
| Date Prepared: | April 19, 2013 |
2. Device Information
| Classification name: | Rigid gas permeable contact lens care products |
|---|---|
| Device classification: | Class II |
| Regulation number: | 21 CFR, Subpart F, Section 886.5918 |
| Product code: | MRC |
| Proprietary name: | Menicon Unique pH Multi-Purpose Solution for |
| Rigid Gas Permeable Contact Lenses |
3. Predicate Devices
Menicon claims substantial equivalence to Alcon RGP Multi-Purpose Solution ID 100136 for Rigid Gas Permeable Contact Lenses previously cleared under K000148 on April 11, 2000.
4. Description of Device
Menicon Unique pH Multi-Purpose Solution is a sterile, buffered aqueous solution. It contains hydroxypropyl guar, polyethylene glycol, poloxamine, boric acid, propylene glycol, and is preserve with polyquaternium-1 0.0011%, and edetate disodium 0.01%.
1
Menicon Co., Ltd.
5. Indications for Use
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.
6. Performance Data
Non Clinical Data
In support of the Alcon Laboratories RGP Multi-Purpose Solution ID 100136 cleared in K000148, a complete set of testing (preclinical, biocompatibility and container tests) was completed to establish the safety and efficacy of the solution.
Testing conducted on the new device consisted of evaluating the solution manufactured in the Japanese facility. Testing included chemical analysis of the Japanese product to confirm equivalence to the product manufactured by Alcon, container biocompatibility tests and shelf life stability tests.
Clinical Data
The safety and efficacy of this solution has been clinically evaluated in the cleared Alcon Laboratories 510(k) application. Alcon RGP Multipurpose Solution K000148.
This application is for the same formulation with the alternate brand name, Menicon Unique pH Multi-Purpose Solution, which will be manufactured in Japan by Menicon Nect. The new device and the predicate device have the same composition, ingredients and intended use. Based upon this fact there were no additional clinical studies required to establish the safety and efficacy of the new device.
Conclusion
Based upon the test data presented, the Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses is as safe, as effective and performs as well as the predicate device. A comparison of the new device and the predicate device is presented in Table 1.
7. Substantial Equivalence
Menicon Co., Ltd claims that the Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses is substantially equivalent to the predicate device. Alcon RGP Multi-Purpose Solution ID 100136 for Rigid Gas Permeable Contact Lenses previously cleared under K000148.
The claim of substantial equivalence is made based upon product testing and the fact that the solutions are the same formulation, are manufactured by equivalent manufacturing processes and meet the same product release specifications.
2
.
: ·
·
:
.
:
:
.
.
| Comparison of Characteristics
| Table 1 | |||
|---|---|---|---|
| New Device | Predicate Device | ||
| Manufacturer | Menicon Co., Ltd. | Alcon Laboratories | |
| Device Name | Rigid Gas Permeable Contact | ||
| Lens Care Product | Rigid Gas Permeable Contact | ||
| Lens Care Product | |||
| Trade Name | Menicon Unique pH | ||
| Multi-Purpose Solution | Alcon RGP Multi-Purpose | ||
| Solution (ID 100136) | |||
| 510(K) | K130805 | K000148 | |
| Classification | Ophthalmic | Ophthalmic | |
| Product Code | MRC | MRC | |
| Regulation | |||
| Number. | 21 CFR 886.5918 | 21 CFR 886.5918 | |
| Class | 11 | ll | |
| Intended Use | Menicon Unique pH Multi-Purpose | ||
| Solution is indicated for the | |||
| cleaning, rinsing, disinfection and | |||
| conditioning of fluorosilicone | |||
| acrylate and silicone acrylate rigid | |||
| gas permeable contact lenses. | Alcon RGP Multi-Purpose Solution | ||
| is indicated for the cleaning, | |||
| rinsing, disinfection and | |||
| conditioning of fluorosilicone | |||
| acrylate and silicone acrylate rigid | |||
| gas permeable contact lenses. | |||
| Composition | A sterile, buffered aqueous | ||
| solution. It contains hydroxypropyl | |||
| guar, polyethylene glycol, | |||
| poloxamine, boric acid, propylene | |||
| glycol, and is preserve with | |||
| polyquaternium-1 0.0011%, and | |||
| edetate disodium 0.01%. | A sterile, buffered aqueous | ||
| solution. It contains hydroxypropyl | |||
| guar, polyethylene qlycol, | |||
| poloxamine, boric acid, propylene | |||
| glycol, and is preserve with | |||
| polyquaternium-1 0.0011%, and | |||
| edetate disodium 0.01%. | |||
| Biocompatability | Components used in this product | ||
| have been evaluated in | |||
| accordance with Part 10993 of the | |||
| ISO standard for Biological | |||
| Evaluation. Test results indicate | |||
| the test articles meet the ISO | |||
| standard | Components used in this product | ||
| have been evaluated in | |||
| accordance with Part 10993 of the | |||
| ISO standard for Biological | |||
| Evaluation. Test results indicate | |||
| the test articles meet the ISO | |||
| standard |
י
、
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
July 3, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . WO66-G60 Silver Spring, MD 20993-002
Menicon Co. Ltd. c/o Ms. Ellen M. Beucler. Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street. Suite 180 Wilmington, MA 01887
Re: K130805
Trade/Device Name: Menicon Unique oH Multipurpose Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Product Regulatory Class: Class II Product Code: MRC Dated: April 19, 2013 Received: April 22, 2013
Dear Ms. Beucler:
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 Requlations, 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.
4
Page 2 - Ms. Ellen Beucler
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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Menicon Co. Ltd.
Indications for Use
510(k) Number: K130805
Device Name: Menicon Unique pH Multi-Purpose Solution for Rigid Gas Permeable Contact Lenses
Indications for Use:
Menicon Unique pH Multi-Purpose Solution is indicated for the cleaning, rinsing, disinfection and conditioning of fluorosilicone acrylate and silicone acrylate rigid gas permeable contact lenses.
Prescription Use_ (part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ХХ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Leonid Livshitz
-5 2013.06.20 00'04- 13:49:06
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices K130805 510(k) Number:_
page I of