(163 days)
Not Found
No
The device description and intended use clearly define a sterile saline solution for contact lens care, with no mention of any computational or analytical capabilities that would involve AI or ML.
No
The device is indicated for rinsing contact lenses, a non-therapeutic purpose, and is not designed to treat, cure, mitigate, or prevent disease.
No
The device is a sterile saline solution for rinsing contact lenses, not for diagnosing medical conditions.
No
The device is a sterile saline solution, which is a physical product (liquid) and not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as rinsing and inserting contact lenses. This is a direct interaction with a medical device (contact lenses) and the user's body (eyes), not for the purpose of diagnosing a disease or condition based on in vitro examination of specimens derived from the human body.
- Device Description: The description details the chemical composition and packaging of a saline solution, which is consistent with a medical device used for contact lens care.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Aqua Naina Plus Sterile Saline Solution and Aqua Naina Sterile Saline Solution are considered medical devices for contact lens care, not In Vitro Diagnostic devices.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
Device Description
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 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.
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 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.
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.
K193441, K200747, K151768, K201069
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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 (732) 447-4353 Phone number: Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 (503) 372-5226 Phone number:
II. DEVICE
| Trade Name: | Aqua Naina Sterile Saline Solution; Aqua Naina Plus Sterile Saline
Solution |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common
Name: | Contact Lens Saline Solution |
| Classification
Name: | Accessories, Soft Lens Products (21 CFR 886.5928)
Products, Contact Lens Care, Rigid Gas Permeable (21 CFR 886.5918) |
| Regulatory
Class: | Class II |
| Product Code: | LPN; MRC |
4
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.
5
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
Sterile Saline
Solution | Aqua Naina
Sterile Saline
Solution | PuriLens Plus
Preservative
Free Saline | Menicon Saline
Rinse Solution | Vibrant Vue
Scleral Saline | |
|-----------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Applicant | Chemtex Usa, Inc. | Chemtex Usa,
Inc. | The LifeStyle
Company,
Inc. | Menicon Co.,
Ltd. | Dry Eye
Innovations,
LLC |
| Document
Number | Subject Device | K193441 | K200747 | K151768 | K201069 |
| Product Code | LPN; MRC | LPN | LPN; MRC | LPN; MRC | MRC |
| Regulation
Number | 21 CFR 886.5928;
21 CFR 886.5918 | 21 CFR
886.5928 | 21 CFR
886.5928;
21 CFR
886.5918 | 21 CFR
886.5928;
21 CFR
886.5918 | 21 CFR
886.5918 |
| Preservative Free | Yes | Yes | Yes | Yes | Yes |
| Supplied Sterile | Yes | Yes | Yes | Yes | Yes |
| Container Usage | Multi dose; Single
dose | Multi dose | Multi dose | Single dose | Single dose |
| Packaging | high density
polyethylene
(HDPE) container
with a tamper
evident seal | high density
polyethylene
(HDPE)
container with a
tamper evident
seal | Plastic resin
container with
puncture,
reusable cap | Plastic resin
container
with twist off
cap | Plastic resin
container
with twist off
cap |
| Production
Method | terminal
sterilization by
gamma irradiation | terminal
sterilization by
gamma
irradiation | Not specified | aseptic blow-
fill-seal process | aseptic blow-
fill-seal process |
| Volume | Multi dose:
4oz (118 ml)
Single dose:
1oz (30 ml) | 4oz (118 ml) | 4.05 oz (120
mL); 2.03 oz
(60 mL) | 5 ml | 5 ml |
| Indications for Use | |
|---|---|
| Aqua Naina | |
| Plus | |
| Sterile Saline | |
| Solution | |
| (Subject | |
| Device) | Aqua Naina Plus Sterile Saline Solution |
The Aqua Naina Plus Sterile Saline Solution is for single use 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 Plus Sterile Saline Solution may be
used as needed throughout the day to rinse contact lenses and contact lens cases. |
7
| Aqua Naina
Sterile Saline
Solution
(K193441) | Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after
cleaning and disinfection before use. |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PuriLens Plus
Preservative
Free Saline
(K200747) | PuriLens Plus Preservative-Free Saline is indicated for use following proper lens disinfection as
recommended by the eye care practitioner. PuriLens Plus Preservative-Free Saline is for rinsing
soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This
solution may also 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. |
| Menicon Saline
Rinse Solution
(K151768) | The Menicon Saline Rinse Solution is indicated for use following proper lens disinfection as
recommended by the eye care practitioner. The Menicon Saline Rinse Solution is for rinsing
soft (hydrophilic), rigid gas permeable and hard contact lenses prior to lens insertion. This
solution may also 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. |
| Vibrant Vue
Scleral Saline
(K201069) | The VibrantVue Scleral Saline is indicated for use following proper lens disinfection as
recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large
diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution
may also 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. |
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.