(57 days)
Not Found
No
The description focuses on "3-D sonic Vibration Technology" and an "intelligent control circuit" to mimic human hand rubbing. While "intelligent control circuit" might suggest some level of automation, there is no mention of AI, ML, or any learning or adaptive capabilities. The performance studies are focused on safety, compatibility, and cleaning effectiveness, not on the performance of an AI/ML algorithm.
No
The device is described as a cleaning system for contact lenses, mimicking digital rubbing for cleaning purposes, not for treating any medical condition or anatomical site.
No
This device is described as a cleaning system for contact lenses, designed to mimic manual rubbing using sonic vibration technology. Its intended use is purely for cleaning, not for diagnosing any medical condition or disease.
No
The device description explicitly details physical components like a device body, contact lens holder, cleaning cushions, and damping heads, all made of medical silicone. It also mentions a power source and control circuit, indicating hardware is involved in the device's function. While software validation is mentioned in the performance studies, the device is clearly not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "cleaning system for Soft and Hybrid contact lenses" and "cleaning system for Rigid contact lenses". This is a physical cleaning process for a medical device (contact lenses), not a diagnostic test performed on a biological sample.
- Device Description: The description details a mechanical cleaning system using sonic vibration. There is no mention of analyzing biological samples or providing diagnostic information.
- 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 analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a cleaning system for contact lenses, which are medical devices themselves, but the cleaning system itself is not performing a diagnostic function.
N/A
Intended Use / Indications for Use
The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
Product codes (comma separated list FDA assigned to the subject device)
LYL, MRC
Device Description
The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D multi-frequency.
The proposed device consists of two versions:
- . For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and
- . For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.
VueSonic One:
The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses. It consists of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens.
The system is de- signed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.
The proposed device is compatible with Soft and Hybrid contact lens from all the brands with a diameter equal or less than 15mm. This limitation is due to the size of the device and in particular the damping head.
The proposed device is compatible with all "multi-purpose" cleaning solution such as Bausch & Lomb Multi-action Solution and Opti-Free. The only incompatible solution is Clear Care and Clear Care Plus because Clear Care requires its own standing case and contains 3% Hydrogen Peroxide, which may cause serious damage to eyes when used improperly.
VueSonic Advance 2
The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses. It consists of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The system is designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.
The proposed device is compatible with Rigid contact lens from all the brands with a diameter equal or less than 15mm. This limitation is due to the size of the device and in particular the damping head.
The proposed device is compatible with all "multi-purpose" cleaning solution such as Bausch & Lomb Multi-action Solution and Opti-Free. The only incompatible solution is Clear Care and Clear Care Plus because Clear Care requires its own standing case and contains 3% Hydrogen Peroxide, which may cause serious damage to eyes when used improperly.
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 following tests were performed on the subject devices and the test results show that the devices are substantially equivalent to the predicate devices on the market.
| Summary of Non- Clinical Test Reports | ||
|---|---|---|
| Biocompatibility | Ocular Irritation | ISO 10993-10, 12 |
| In Vitro Cytotoxicity Test | ISO 10993-5 | |
| Sensitization | ISO 10993-10 | |
| Systemic Toxicity | ISO 10993-11, 12 | |
| Electrical Safety and Electromagnetic Compatibility | General Requirements electromagnetic compatibility | IEC 60601-1-2 |
| General Requirements electrical safety | IEC 60601-1 | |
| General Requirements home healthcare environment | IEC 60601-1-11 | |
| Usability | Human Factor Engineering and Usability Engineering Evaluation Report | IEC62366-1:2015 |
| Protein and Lipid Removal Test | Protein and Lipid Removal Test | Citation |
| Total Extractive Residues | Total Extractive Residues | FDA 21 CFR 177.2600 |
| Software | Software Validation | FDA Guidance |
| Lens Compatibility Test | Lens Compatibility Test | ISO 18369-2:2017 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 1, 2021
VueSonic, LLC % Marc Sanchez Regulatory Attorney Contract In-House Counsel and Consultants, LLC 1717 Pennsylvania Ave. NW, Suite #1025 Washington, D.C. 20006
Re: K210300
Trade/Device Names: VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LYL, MRC Dated: February 2, 2021 Received: February 3, 2021
Dear Marc Sanchez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
ence determination does not mean that FDA
Page 2
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Angelo Green, PhD Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
VueSonic One Contact Lens Cleaning System VueSonic Advance 2 Contact Lens Cleaning System
Indications for Use (Describe)
The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
The following information is provided as required by 21 CFR
807.92 for the VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning System 510(k) premarket notification.
| Sponsor: | VueSonic LLC
1234 Washington Ave, Suite 205
Miami Beach, FL 33139
Establishment Registration: to be determined
Ph: 855-770-0883 |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | VueSonic LLC
1234 Washington Ave, Suite 205
Miami Beach, FL 33139
Establishment Registration: to be determined
Ph: 855-770-0883 |
| Contact: | Marc C. Sanchez, Esq.
Contract In-House Counsel and Consultants, LLC
1717 Pennsylvania Ave. NW, Suite #1025
Washington, D.C. 20006
Ph: 202-765-4491
Email: msanchez@fdaatty.com |
Date of 510(k) Summary Preparation: March 18, 2021
Proprietary Names: VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
Common Name: Accessories, Solution, Ultrasonic Cleaners For Lenses
Regulation Number: 21 CFR 886.5928/21 CFR 886.5918
Regulatory Class: Class II
Product Code: LYL/MRC
Predicate Device(s): New Comfort Contact Lens Accessory (K974724) and AUTOLENS® System (K021699)
Device Description: The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D
4
multi-frequency.
The proposed device consists of two versions:
- . For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and
- . For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.
VueSonic One:
The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses. It consists of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens.
The system is de- signed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.
The proposed device is compatible with Soft and Hybrid contact lens from all the brands with a diameter equal or less than 15mm. This limitation is due to the size of the device and in particular the damping head.
The proposed device is compatible with all "multi-purpose" cleaning solution such as Bausch & Lomb Multi-action Solution and Opti-Free. The only incompatible solution is Clear Care and Clear Care Plus because Clear Care requires its own standing case and contains 3% Hydrogen Peroxide, which may cause serious damage to eyes when used improperly.
VueSonic Advance 2
The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses. It consists of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The system is designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.
The proposed device is compatible with Rigid contact lens from all the brands with a diameter equal or less than 15mm. This limitation is due to the size of the device and in particular the damping head.
The proposed device is compatible with all "multi-purpose" cleaning solution such as Bausch & Lomb Multi-action Solution and Opti-Free. The only incompatible solution is Clear Care and Clear Care Plus because Clear Care requires its own standing case and contains 3% Hydrogen Peroxide, which may cause serious damage to eyes when used improperly.
5
Indications for Use:
The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
Summary of Non-Clinical Test Reports
The following tests were performed on the subject devices and the test results show that the devices are substantially equivalent to the predicate devices on the market.
| Table 1
| Summary of Non- Clinical Test Reports | ||
|---|---|---|
| Biocompatibility | Ocular Irritation | ISO 10993-10, 12 |
| In Vitro Cytotoxicity Test | ISO 10993-5 | |
| Sensitization | ISO 10993-10 | |
| Systemic Toxicity | ISO 10993-11, 12 | |
| Electrical Safety and Electromagnetic | ||
| Compatibility | General | |
| Requirements | ||
| electromagnetic | ||
| compatibility | IEC 60601-1-2 | |
| General Requirements electrical | ||
| safety | IEC 60601-1 | |
| General Requirements | ||
| home healthcare | ||
| environment | IEC 60601-1-11 | |
| Usability | Human Factor Engineering and | |
| Usability | ||
| Engineering | ||
| Evaluation Report | IEC62366-1:2015 | |
| Protein and Lipid Removal Test | Protein and Lipid Removal Test | Citation |
| Total Extractive Residues | Total Extractive Residues | FDA 21 CFR 177.2600 |
| Software | Software Validation | FDA Guidance |
| Lens Compatibility Test | Lens Compatibility Test | ISO 18369-2:2017 |
6
Traditional 510(k) Submission
Summary of Substantial Equivalence
The VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System, and the predicates use a multipurpose contact lens solution and a physical mode of action to clean contact lenses. The proposed device uses a sophisticated multi-frequency modulated stereo power system, while K974724 uses ultrasonic waves and K021699 uses a tumbling motion. The different motions are all aimed at mimicking hand rubbing to physically clean contact lenses. There may be minor differences in labeling but this does not raise any new questions of safety or effectiveness.
| Device
Name/Model | Vue Sonic One
Contact Lens
Cleaning System,
Vue Sonic
Advance 2
Contact Lens
Cleaning System | New Comfort Contact
Lens Accessory | AUTOLENS® System |
|----------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------|------------------|
| 510(k) Number | K210300 | K974724 | K021699 |
Table 2 Technological Characteristics
7
| Indications for Use | |||
|---|---|---|---|
| The VueSonic | |||
| One Contact Lens | |||
| Cleaning System is a | |||
| cleaning system for Soft | |||
| and Hybrid contact | |||
| lenses by mimicking | |||
| digital rubbing with 3-D | |||
| sonic Vibration | |||
| Technology. The | |||
| VueSonic | |||
| Advance 2 | |||
| Contact Lens Cleaning | |||
| System is a cleaning | |||
| system for Rigid contact | |||
| lenses by mimicking | |||
| digital rubbing with 3-D | |||
| sonic Vibration | |||
| Technology. | The New Comfort Contact | ||
| Lens Care Accessory is | |||
| intended for use in | |||
| conjunction with contact lens | |||
| solutions as an accessory in | |||
| the cleaning of contact lenses. | |||
| The New Comfort Contact | |||
| Lens Care Accessory is | |||
| indicated as aid for cleaning | |||
| as an accessory for soft | |||
| hydrophilic lenses and gas | |||
| permeable lenses when used | |||
| with the appropriate | |||
| Allergan® Soft Mate® | |||
| solutions such as the | The AUTOLENS® Automatic | ||
| Contact Lens Cleaning | |||
| Accessory is indicated for the | |||
| cleaning of soft (hydrophilic) | |||
| rigid gas permeable (RGP) | |||
| and hard | |||
| (PMMA) contact lenses | |||
| when used with | |||
| AUTOLENS® Multipurpose | |||
| Solution. This automatic | |||
| contact lens cleaning | |||
| accessory cleans contact | |||
| lenses without digital | |||
| Consept® Cleaning and | |||
| Disinfection System which is | |||
| comprised of the | |||
| Allergan® Soft Mate® | |||
| Consept®-1 Cleaning and | |||
| Disinfecting solution and | |||
| Allergan® Soft Mate® | |||
| Consept®-2 Neutralizing and | |||
| Rinsing Solution or Spray. | |||
| The New Comfort Contact | |||
| Lens Care Accessory is | |||
| indicated for use for gas | |||
| permeable solutions such as | |||
| Allergan® Gas Permeable | |||
| Daily Cleaner and | |||
| Allergan® ComfortCare GP | |||
| Wetting and Soaking | |||
| Solution. The New | |||
| Comfort Contact | |||
| Lens Care Accessory may be | |||
| used for a receptacle for | |||
| chemical disinfection. | rubbing. The AUTOLENS® | ||
| Automatic Contact Lens | |||
| Cleaning Accessory may be | |||
| used as a receptacle for | |||
| chemical disinfection with | |||
| AUTOLENS® Multipurpose | |||
| Solution. | |||
| AUTOLENS® | |||
| Multipurpose Solution is | |||
| indicated for use in cleaning, | |||
| rinsing, chemical (not heat) | |||
| disinfecting and protein | |||
| removal, storing soft | |||
| (hydrophilic), rigid gas | |||
| permeable fluoro-silicone | |||
| acrylate and silicone acrylate) | |||
| and PMMA | |||
| contact lenses as | |||
| recommended | |||
| by your eye care practitioner. | |||
| Mode of | |||
| Action | 3D multi-frequency | ||
| modulated stereo | |||
| power source and | |||
| corresponding | |||
| intelligent control | |||
| circuit, which make a | |||
| uniform three | |||
| dimensional relative | |||
| movement between | |||
| the damping heads and | Bubbles created from piezo | ||
| electric crystal (ultrasonic) | Tumble motion | ||
| Power Source | 1.5~3V | ||
| battery (one or two | |||
| "AAA" | |||
| batteries) | 110/120v (standard power | ||
| using four- foot UL cord) | 1.5v (three | ||
| "AA" | |||
| batteries) | |||
| Materials | Medical grade | ||
| silicone | ABS | Polypropylene resin plastic | |
| Cleaning Time | 2 minutes | Unknown | Unknown |
| Watts of | |||
| Power per | |||
| Milliliter of | |||
| Fluid | 0.37 to 0.72 watt/ ml | Unknown | Unknown |
8
9
Conclusion:
Therefore, taking into consideration Table 1 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the VueSonic Contact Lens Cleaning System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.