(167 days)
No
The device is a sterile saline solution for contact lenses, and the description focuses on its chemical composition and physical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is indicated for rinsing soft contact lenses, which makes it a contact lens care product, not a therapeutic device intended for treating a disease or condition.
No
Explanation: The device is a sterile saline solution for rinsing contact lenses, not for diagnosing any medical condition or disease. Its intended use is purely for cleaning and disinfection after use.
No
The device is a sterile saline solution, which is a physical substance, not software. The description details its chemical composition and packaging.
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 "rinsing soft contact lenses after cleaning and disinfection before use." This is a direct application to a medical device (contact lenses) and not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Device Description: The description details the chemical composition of a saline solution, which is a rinsing agent, not a reagent or instrument used for diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the safety and equivalence of the saline solution for its intended use with contact lenses (sterility, irritation, cytotoxicity), not on diagnostic accuracy or performance.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This saline solution does not fit that description.
N/A
Intended Use / Indications for Use
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.
Product codes
LPN
Device Description
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 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 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)
A Series of Studies were completed to demonstrate the substantial equivalence of Aqua Naina Sterile Saline Solution to the predicate devices. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the solution is non-toxic, is comparable to other currently marketed soft contact lens solution and is substantially equivalent to legally marketed predicates. These studies followed the "Testing Matrix for Saline Solution" of the Guidance for Industry-Premarket Notification (510K) Guidance Document for Contact Lens Care Products, issued May 1, 1997" and included:
- Sterility USP
- Bacteriostasis USP
- Ocular irritation
- Cytotoxicity -Direct contact test
- Cytotoxicity- MEM Elution test
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
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May 26, 2020
Chemtex USA, Inc. % Thomas Padula VP Regulatory Compliance Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, NJ 07006
Re: K193441
Trade/Device Name: 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 Dated: April 22, 2020 Received: April 22, 2020
Dear Thomas Padula:
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 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.
J Angelo Green
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) K193441
Device Name Aqua Naina Sterile Saline Solution
Indications for Use (Describe)
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.
| 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
510(K) PREMARKET NOTIFICATION FOR AQUA NAINA STERILE SALINE SOLUTION CHEMTEX USA INC.
510(k) Summary (as required by 807.92)
(1) SUBMITTER:
CHEMTEX USA, INC. 27-29 DWIGHT PLACE FAIRFIELD, NJ 07004-3303
Contact person: HARIBABU TALASILA, PRESIDENT Telephone: 973-447-4373 Email: htalasila@chemtexusa.com
Contact Person: Mr. Hemant Shastri Telephone No: 905 -212-9949 Fax No: 905 -212-7776 Email: hshastri@chemtexinternational.com
Date prepared: December 9, 2019
(2) DEVICE NAME:
Trade Name: Aqua Naina Sterile Saline Solution Common Name: Contact Lens Saline Solution Classification Name: Soft contact lens care products Device Classification: Class II Regulation Number: 21 CFR 886.5928 Product Code: LPN
- (3) PREDICATE DEVICE: Substantial equivalence is based on following legally marketed devices. Eye-Cept Sterile Saline Solution K110221 (Primary Predicate) Purilens Saline Solution - K002319 Unisol Saline Solution - P790011
(4) DESCRIPTION OF THE DEVICE:
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 6.30 to 7.80 and Osmolality of 280 to 320 mOsmol/kg The Sterile Saline Solution is packed in 4 fl oz (118ml) high density polyethylene (HDPE) container with a tamper evident seal.
- (5) INDICATION FOR USE:
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.
4
510(K) PREMARKET NOTIFICATION FOR AQUA NAINA STERILE SALINE SOLUTION CHEMTEX USA INC.
- (6) COMPARISON WITH PREDICATE DEVICES: Following table is a comparison of Aqua Naina Sterile Saline Solution and predicate devices.
Aqua Naina Sterile Saline Solution is substantially equivalent in terms of it actions and indications for use, to Purilens Saline solution -K002319, Unisol Saline Solution P790011, Eye-Cept Saline Solution K110221 (Primary Predicate), cleared for marketing under 510(K). Aqua Naina Sterile Saline Solution meets the guideline set forth in FDA's May 1,1997 Guidance for Industry, Premarket Notification 510(K) Guidance Document for Contact Lens Care Products.
| Equivalency | Aqua Naina
Sterile Saline
Solution | Purilens Saline
Solution K002319 | Unisol
P790011 | Eye-Cept Saline
Solution K110221
(Primary
Predicate) |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------|
| Manufacturer | Niagara
Pharmaceuticals,
Inc. | Purilens Inc | Alcon | Optics Laboratory |
| Product Code | LPN | LPN | LPN | LPN |
| Regulation
Number | 21 CFR 886.5928 | 21 CFR 886.5928 | 21 CFR 886.5928 | 21 CFR 886.5928 |
| Intended use | Only for rinsing | For cleaning | For heat | For rinsing soft |
| (Indications for | soft contact | disinfection and | disinfecting | (hydrophilic) |
| use) | lenses after
cleaning and for
wetting soft
contact lenses
after disinfection
before use. | storing of contact
lenses | rinsing, storage and
wetting of soft
(hydrophilic)
contact lenses | contact lens after
cleaning and
wetting |
| Preservative free | Yes | Yes | Yes | Yes |
| Sterile | Yes | Yes | Yes | Yes |
| Aqueous Solution
of NaCl and
Borates | Yes | Yes | Yes | Yes |
| pH balanced | Yes | Yes | Yes | Yes |
| Volume | 4oz (118 ml) | 4oz (118 ml) | 4oz (118 ml) | 0.34oz (10ml) |
(7) PERFORMANCE STSTANDARDS APPLIED:
A Series of Studies were completed to demonstrate the substantial equivalence of Aqua Naina Sterile Saline Solution to the predicate devices. All testing was conducted in accordance with and in conformance to applicable device regulations and guidance. Results of all testing demonstrate the solution is non-toxic, is comparable to other currently marketed soft contact lens solution and is substantially equivalent to legally marketed predicates. These studies followed the "Testing Matrix for
5
510(K) PREMARKET NOTIFICATION FOR AQUA NAINA STERILE SALINE SOLUTION CHEMTEX USA INC.
Saline Solution" of the Guidance for Industry-Premarket Notification (510K) Guidance Document for Contact Lens Care Products, issued May 1, 1997" and included:
-
- Sterility USP
-
- Bacteriostasis USP
- Ocular irritation 3.
- Cytotoxicity -Direct contact test 4.
- ನ. Cytotoxicity- MEM Elution test
| Standard | Title of Standard | Applied Section |
|---|---|---|
| ISO 10993-1:2009 | Biological Evaluation of Medical Devices - Part 1: | |
| Evaluation and Testing within a Risk Management Process | Section 15. | |
| Biocompatibility | ||
| ISO 10993-5:2009 | Biological Evaluation of Medical Devices - Part 5: Tests for | |
| In Vitro Cytotoxicity | ||
| ISO | ||
| 10993-10:2010 | Biological Evaluation of Medical Devices - Part 10: Tests for | |
| Irritation and Skin Sensitization |
- (8) CONCLUSION: Aqua Naina Sterile Saline Solution has the same intended use and technology characteristics as the predicate devices. Aqua Naina Sterile Saline Solution is as safe, as effective, and performs as well as the predicate devices.