Aqua Naina Plus Sterile Saline Solution

K221263 · Chemtex USA, Inc. · LPN · Oct 12, 2022 · Ophthalmic

Device Facts

• Record ID: K221263
• Device Name: Aqua Naina Plus Sterile Saline Solution
• Applicant: Chemtex USA, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Oct 12, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

Aqua Naina Plus Sterile Saline Solution The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner. Aqua Naina Sterile Saline Solution The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.

Device Story

Aqua Naina Plus and Aqua Naina Sterile Saline Solutions are sterile, preservative-free, buffered, isotonic aqueous solutions containing sodium chloride, boric acid, and sodium borate. The device functions as a rinsing and insertion solution for contact lenses. It is intended for use by contact lens wearers in a home or clinical setting. The solution is supplied in HDPE containers (single-dose 30ml or multi-dose 118ml) with tamper-evident seals. The user applies the solution directly to the lens or case to rinse or facilitate insertion. By providing a sterile, isotonic environment, the device helps maintain lens hygiene and comfort, reducing the risk of ocular irritation or infection associated with contaminated lenses. No complex processing or electronic components are involved.

Clinical Evidence

Bench testing only. Validation focused on package volume changes using methods previously established in K193441. No clinical data were required for this submission.

Technological Characteristics

Sterile, preservative-free, buffered, isotonic aqueous solution. Ingredients: sodium chloride, boric acid, sodium borate in USP purified water. pH 7.00-7.40; Osmolality 290-320 mOsmol/kg. Packaging: HDPE containers with tamper-evident seals. Sterilization: Terminal gamma irradiation.

Indications for Use

Indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to insertion, following proper disinfection. May be used as an insertion solution for large diameter (scleral) lenses, for rinsing lens cases, and for rinsing lenses throughout the day. No specific age or gender restrictions; contraindications are those associated with standard contact lens care.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• Aqua Naina Sterile Saline Solution (K193441)
• PuriLens Plus Preservative Free Saline (K200747)
• Menicon Saline Rinse Solution (K151768)
• VibrantVue Scleral Saline (K201069)

Submission Summary (Full Text)

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October 12, 2022

Chemtex USA Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn. OR 97068

Re: K221263

Trade/Device Name: Aqua Naina Plus Sterile Saline Solution, Aqua Naina Sterile Saline Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: September 20, 2022 Received: September 20, 2022

Dear Bret Andre:

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.

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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) 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221263

#### Device Name

Aqua Naina Plus Sterile Saline Solution, Aqua Naina Sterile Saline Solution

### Indications for Use (Describe)

Aqua Naina Plus Sterile Saline Solution

The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eye care practitioner.

### Aqua Naina Sterile Saline Solution

The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------|--|--|
| | | |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# Special 510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# The assigned 510(k) number is: K221263

#### I. SUBMITTER

- September 20th, 2022 Date Prepared: Name: Chemtex USA Inc Address: 27-29 Dwight Place Fairfield, NJ 07004-3303 Haribabu Talasila Contact Person: President [phone] Phone number: Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 [phone] Phone number:
#### II. DEVICE

| Trade Name: | Aqua Naina Sterile Saline Solution; Aqua Naina Plus Sterile Saline<br>Solution |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common<br>Name: | Contact Lens Saline Solution |
| Classification<br>Name: | Accessories, Soft Lens Products (21 CFR 886.5928)<br>Products, Contact Lens Care, Rigid Gas Permeable (21 CFR 886.5918) |
| Regulatory<br>Class: | Class II |
| Product Code: | LPN; MRC |

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#### III. PREDICATE DEVICE

Aqua Naina and Aqua Naina Plus Sterile Saline Solutions are substantially equivalent to the following predicate devices:

- . "Aqua Naina Sterile Saline Solution" (Primary Predicate) By Chemtex Usa, Inc. 510(k) number: K193441
- I "PuriLens Plus Preservative Free Saline" By The LifeStyle Company, Inc. 510(k) number: K200747
- . "Menicon Saline Rinse Solution" By Menicon Co., Ltd. 510(k) number; K151768
- . "VibrantVue Scleral Saline" By Dry Eye Innovations, LLC 510(k) number; K201069

#### DEVICE DESCRIPTION IV.

# Aqua Naina Plus Sterile Saline Solution

Aqua Naina Plus Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Plus Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in single dose 1 fl oz (30 ml) high density polyethylene (HDPE) container with a tamper evident seal. Aqua Naina Plus Sterile Saline Solution is for single use only.

# Aqua Naina Sterile Saline Solution

Aqua Naina Sterile Saline Solution is a sterile, preservative-free, buffered, isotonic, clear (colorless) aqueous solution containing isotonic solution of sodium chloride, boric acid and sodium borate in purified water USP. Aqua Naina Sterile Saline Solution has pH of 7.00 to 7.40 and Osmolality of 290 to 320 mOsmol/kg. The Sterile Saline Solution is packed in a multidose 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.

#### V. INDICATIONS FOR USE

# Aqua Naina Plus Sterile Saline Solution

The Aqua Naina Plus Sterile Saline Solution for single use is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus Sterile Saline Solution is indicated for use following proper lens disinfection as recommended by the eve care practitioner.

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### Aqua Naina Sterile Saline Solution

The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as recommended by the eye care practitioner. The Aqua Naina Sterile Saline Solution may be used as needed throughout the day to rinse contact lenses and contact lens cases.

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICE

The Aqua Naina Plus Sterile Saline Solution is substantially equivalent to the predicate devices (cleared under K200747, K193441 and K151768) in terms of the following:

- I Intended use (K200747)
- Indications for use (K200747)
- I Actions (K200747)
- 트 Product Code (K200747) - LPN; MRC
- 트 Classification (K200747) - Accessories, Soft Lens Products (21 CFR 886.5928); Products, Contact Lens Care, Rigid Gas Permeable (21 CFR 886.5918)
- 트 Production method - Terminal sterilization by gamma irradiation (K193441)
- I Single use (K151768)

The Aqua Naina Sterile Saline Solution is substantially equivalent to the predicate devices (cleared under K200747, K193441 and K151768) in terms of the following:

- I Intended use (K193441, K151768)
- 트 Indications for use (K193441, K151768)
- 트 Actions (K193441, K151768)
- 트 Product Code (K193441, K151768) - LPN; MRC
- I Classification (K193441, K151768) – Accessories, Soft Lens Products (21 CFR 886.5928); Products, Contact Lens Care, Rigid Gas Permeable (21 CFR 886.5918)
- ' Production method - Terminal sterilization by gamma irradiation (K193441)
- I Packaging/multi-use (K193441 & K200747)

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The following tables compare the regulatory and technological features of the Aqua Naina Plus Sterile Saline Solution compared to the predicate devices:

| Aqua Naina Plus<br>Sterile Saline<br>Solution | Aqua Naina<br>Sterile Saline<br>Solution | PuriLens Plus<br>Preservative<br>Free Saline | Menicon Saline<br>Rinse Solution | Vibrant Vue<br>Scleral Saline | |
|-----------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Applicant | Chemtex Usa, Inc. | Chemtex Usa,<br>Inc. | The LifeStyle<br>Company,<br>Inc. | Menicon Co.,<br>Ltd. | Dry Eye<br>Innovations,<br>LLC |
| Document<br>Number | Subject Device | K193441 | K200747 | K151768 | K201069 |
| Product Code | LPN; MRC | LPN | LPN; MRC | LPN; MRC | MRC |
| Regulation<br>Number | 21 CFR 886.5928;<br>21 CFR 886.5918 | 21 CFR<br>886.5928 | 21 CFR<br>886.5928;<br>21 CFR<br>886.5918 | 21 CFR<br>886.5928;<br>21 CFR<br>886.5918 | 21 CFR<br>886.5918 |
| Preservative Free | Yes | Yes | Yes | Yes | Yes |
| Supplied Sterile | Yes | Yes | Yes | Yes | Yes |
| Container Usage | Multi dose; Single<br>dose | Multi dose | Multi dose | Single dose | Single dose |
| Packaging | high density<br>polyethylene<br>(HDPE) container<br>with a tamper<br>evident seal | high density<br>polyethylene<br>(HDPE)<br>container with a<br>tamper evident<br>seal | Plastic resin<br>container with<br>puncture,<br>reusable cap | Plastic resin<br>container<br>with twist off<br>cap | Plastic resin<br>container<br>with twist off<br>cap |
| Production<br>Method | terminal<br>sterilization by<br>gamma irradiation | terminal<br>sterilization by<br>gamma<br>irradiation | Not specified | aseptic blow-<br>fill-seal process | aseptic blow-<br>fill-seal process |
| Volume | Multi dose:<br>4oz (118 ml)<br>Single dose:<br>1oz (30 ml) | 4oz (118 ml) | 4.05 oz (120<br>mL); 2.03 oz<br>(60 mL) | 5 ml | 5 ml |

| | Indications for Use |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aqua Naina<br>Plus<br>Sterile Saline<br>Solution<br>(Subject<br>Device) | Aqua Naina Plus Sterile Saline Solution<br><br>The Aqua Naina Plus Sterile Saline Solution is for single use for rinsing soft (hydrophilic) and<br>rigid gas permeable (hard) contact lenses prior to lens insertion. This solution may be used as an<br>insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases,<br>and may be used as needed throughout the day to rinse contact lenses. The Aqua Naina Plus<br>Sterile Saline Solution is indicated for use following proper lens disinfection as recommended<br>by the eye care practitioner.<br><br>Aqua Naina Sterile Saline Solution<br><br>The Aqua Naina Sterile Saline Solution is indicated for rinsing soft (hydrophilic) and rigid gas<br>permeable (hard) contact lenses prior to lens insertion and following proper lens disinfection as<br>recommended by the eye care practitioner. The Aqua Naina Plus Sterile Saline Solution may be<br>used as needed throughout the day to rinse contact lenses and contact lens cases. |

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| Aqua Naina<br>Sterile Saline<br>Solution<br>(K193441) | Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after<br>cleaning and disinfection before use. |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PuriLens Plus<br>Preservative<br>Free Saline<br>(K200747) | PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as<br>recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing<br>soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This<br>solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a<br>rinse for contact lens cases, and may be used as needed throughout the day to rinse contact<br>lenses. |
| Menicon Saline<br>Rinse Solution<br>(K151768) | The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as<br>recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing<br>soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This<br>solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a<br>rinse for contact lens cases, and may be used as needed throughout the day to rinse contact<br>lenses. |
| Vibrant Vue<br>Scleral Saline<br>(K201069) | The VibrantVue Scleral Saline is indicated for use following proper lens disinfection as<br>recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large<br>diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution<br>may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse<br>for contact lens cases, and may be used as needed throughout the day to rinse contact lenses. |

#### VII. PERFORMANCE DATA

The package volume change was validated using the same methods identified in K193441. No other performance data (clinical or non-clinical) are required for this special 510(k) submission.

## VIII. CONCLUSIONS

### Substantial Equivalence

Information presented in this premarket notification establishes that Aqua Naina and Aqua Naina Plus Sterile Saline Solutions is as safe and effective as the predicate devices when used in accordance with the labeled directions for use and indications.

### Risks and Benefits

The risks and benefits of the subject device are the same as those normally attributed to contact lens saline rinsing and filling solutions.