(43 days)
Not Found
No
The device description and performance studies focus on the material properties and basic function of a contact lens case, with no mention of AI or ML.
No
The device is a contact lens case used for storage and disinfection, not for direct therapeutic treatment of a medical condition.
No
A contact lens case is used for storage and disinfection, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens case made of polypropylene resin, which is a hardware component. There is no mention of any software functionality.
Based on the provided information, the Menicon Nect Contact Lens Case is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage of contact lenses during chemical disinfection. This is a device used in the care and maintenance of a medical device (contact lenses), not for diagnosing a condition or analyzing a biological sample.
- Device Description: The description details a physical container for contact lenses and disinfection solution. It does not involve any reagents, tests, or analysis of biological specimens.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device, specifically a contact lens accessory, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Menicon Nect Contact Lens Case is indicated for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. This case is for use during chemical disinfection only. Not to be used with heat disinfection.
Product codes (comma separated list FDA assigned to the subject device)
LRX
Device Description
The Menicon Nect Contact Lens Case consists of a molded dual compartment base unit and two screw caps. Both the base unit and screw caps are made from Polypropylene resin. The right screw cap is marked "R" and has a blue tint to assist patients who are not currently wearing their contact lenses. The lens compartments are of sufficient volume to allow contact lenses to be fully immersed during lens disinfection. The case is available in two models, one with ribs in the lens case wells and one without ribs in the lens case wells.
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
Biocompatibility tests were conducted on the plastic components in accordance with ISO Part 10993 Biological Evaluation of Medical Devices. Testing included Cytotoxicity, Systemic Toxicity and Ocular Irritation. The test results indicate the components are safe for the intended use.
Clinical Data
Clinical studies were unnecessary for this application. Lens care solutions used with this contact lens case are already cleared for use as cleaning, rinsing, disinfection and storage solutions for soft (hydrophilic), rigid gas permeable and hard contact lenses.
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
§ 886.5928 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
510(k) Summary MENICON NECT CONTACT LENS CASE July 17, 2013
1. Applicant Information
| Menicon Nect Co., Ltd: | 12-7, Biwajima 3, Nishi-ku, |
|---|---|
| Nagoya 451-0053, JAPAN | |
| Contact Person: | Mr. Shinji Tanaka |
| Telephone No.: | +81-52-908-2472 |
| Fax No.: | +81-52-529-2465 |
| E-mail: | stanaka@meniconnect.co.jp |
| Date Prepared: | July 17, 2013 |
AUG 06 2013
2. Device Information
| Classification name: | Contact Lens Care Products |
|---|---|
| Device classification: | Class II |
| Regulation number: | 21 CFR 886.5918 (Rigid Gas Permeable Contact Lenses) |
| 21 CFR 886.5928 (Soft (hydrophilic) Contact Lenses) | |
| Product code: | LRX |
| Proprietary name: | Menicon Nect Contact Lens Case |
3. Predicate Devices
Menicon Nect claims substantial equivalence to K121030 Sacks Holdings, Inc. Contact Lens Storage Case cleared by the Food and Drug Administration on July 6, 2012.
4. Description of Device
The Menicon Nect Contact Lens Case consists of a molded dual compartment base unit and two screw caps. Both the base unit and screw caps are made from Polypropylene resin. The right screw cap is marked "R" and has a blue tint to assist patients who are not currently wearing their contact lenses. The lens compartments are of sufficient volume to allow contact lenses to be fully immersed during lens disinfection. The case is available in two models, one with ribs in the lens case wells and one without ribs in the lens case wells.
1
5. Indications for Use
Menicon Nect Contact Lens Case is indicated for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. This case is for use during chemical disinfection only. Not to be used with heat disinfection.
6. Performance Data
Non-Clinical Data
Biocompatibility tests were conducted on the plastic components in accordance with ISO Part 10993 Biological Evaluation of Medical Devices. Testing included Cytotoxicity, Systemic Toxicity and Ocular Irritation. The test results indicate the components are safe for the intended use.
Clinical Data
Clinical studies were unnecessary for this application. Lens care solutions used with this contact lens case are already cleared for use as cleaning, rinsing, disinfection and storage solutions for soft (hydrophilic), rigid gas permeable and hard contact lenses.
Conclusion
Based upon the test data presented, the Menicon Nect Contact Lens Case 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
The claim of substantial equivalence to the previously cleared K121030 Sacks Holdings, Inc. Contact Lens Storage Case is supported by the Comparison of Characteristics in Table 1.
2
7. Substantial Equivalence (continued)
Based upon the comparison the Menicon Nect Contact Lens Case is substantially equivalent to the K121030 Sacks Holdings, Inc. Contact Lens Storage Case. The contact lens cases are similar in design and volume. Both lens cases are manufactured from similar materials that have been proven to be safe for use. Both lens cases can be used for lens chemical disinfection treatments.
Therefore, Menicon Nect Contact Lens Case is substantially equivalent to the predicate device.
3
| Table 1 Comparison of Characteristics | ||
|---|---|---|
| Menicon Nect Co., Ltd. | Sacks Holdings, Inc. | |
| Device Name | Contact Lens Case | Contact Lens Storage Case |
| Trade Name | Menicon Nect Contact Lens Case | Contact Lens Case |
| 510(k) | K131875 | K121030 |
| Classification | Ophthalmic | Ophthalmic |
| Product Code | LRX | LRX |
| Regulation Number | 21 CFR 886.5918 | |
| 21 CFR 886.5928 | 21 CFR 886.5928 | |
| Class | II | II |
| Intended Use | For storage during | |
| chemical disinfection of soft | ||
| (hydrophilic), rigid gas permeable | ||
| and hard contact lenses. | ||
| This case is for use during | ||
| chemical disinfection only. | ||
| Not to be used with heat disinfection. | For storage during | |
| chemical disinfection of soft | ||
| (hydrophilic), rigid gas permeable | ||
| and hard contact lenses. | ||
| This case is for use during | ||
| chemical disinfection only. | ||
| Not to be used with heat disinfection. | ||
| Disinfection Type | Chemical; Not Heat | Chemical; Not Heat |
| Design | Case Bottom with screw on caps | |
| The letter "R" embossed on the right | ||
| cap. Right and Left caps are | ||
| contrasting colors. | Case Bottom with screw on caps | |
| The letter "R" embossed on the right | ||
| cap. Right and Left caps are | ||
| contrasting colors. | ||
| Sterilization | Not Sold Sterile | Not Sold Sterile |
| Materials | Polypropylene resin used for the | |
| lens case base and screw top caps | Polypropylene resin used for the | |
| lens case base and screw top caps | ||
| Volume | 3.6 mL | 3.8 mL |
| Biocompatability | Components used in this lens case | |
| 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 lens case | |
| 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 |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2013
Menicon Nect Co., Ltd. c/o Ms. Ellen Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvalle Street, Suite 180 Wilmington, MA 01887-4461
Rc: K131875
Trade/Device Name: Menicon Nect Contact Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LR X Dated: July 17, 2013 Received: July 19, 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 10 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.
Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
5
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 (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 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" (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,
Kesia Y. Alexander -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Menicon Nect Co., Ltd
Indications for Use
K131875 510(k) Number (if known): __
Device Name: Menicon Nect Contact Lens Case
Indications for Use:
Menicon Nect Contact Lens Case is indicated for storage during chemical disinfection of soft (hydrophilic), rigid gas permeable and hard contact lenses. This case is for use during chemical disinfection only. Not to be used with heat disinfection.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ XX (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jeffrey M. Broclous -S 2013.08.23 10:03:48 -04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
Page 1 of 1
510(k) Number: K131875
Menicon Nect Contact Lens Case 510(k)