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.

AI/ML Overview

The provided text describes the 510(k) Premarket Notification for Aqua Naina Sterile Saline Solution and its substantial equivalence to predicate devices. It focuses on the chemical composition, intended use, and various safety tests (sterility, biocompatibility, ocular irritation, cytotoxicity).

However, this document does not describe acceptance criteria, performance data, or study details relevant to a machine learning or AI device. The device in question is a sterile saline solution, which is a chemical product, not a medical imaging or AI diagnostic device. Therefore, the requested information about test sets, data provenance, expert consensus, MRMC studies, or training sets is not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to a series of chemical and biological tests conducted on the saline solution to demonstrate its safety and performance, as outlined in section (7) "PERFORMANCE STSTANDARDS APPLIED".

Here's a breakdown of what is provided and why it doesn't fit the typical AI/ML device study format:

Device: Aqua Naina Sterile Saline Solution (a chemical product for contact lens care).
Acceptance Criteria & Reported Performance: These are presented implicitly through the successful completion of various tests against established standards for saline solutions.
- Sterility: USP <71>
- Bacteriostasis: USP <71>
- Ocular irritation: Tested per ISO 10993-10:2010
- Cytotoxicity (Direct contact test & MEM Elution test): Tested per ISO 10993-5:2009
- Biocompatibility: Tested per ISO 10993-1:2009
- pH: 6.30 to 7.80 (reported in description)
- Osmolality: 280 to 320 mOsmol/kg (reported in description)
  The document states: "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." This is the reported device performance meeting the acceptance criteria set by these standards.
Sample Size for Test Set and Data Provenance: Not applicable. This refers to chemical and biological samples, not image datasets. The tests are laboratory-based, not based on patient data in the sense of AI/ML.
Number of Experts, Qualifications, Adjudication Method: Not applicable. These relate to human interpretation of diagnostic data, which is not relevant for testing a saline solution.
MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating AI assistance in diagnostic tasks.
Standalone Performance (algorithm only): Not applicable, as there is no algorithm.
Type of Ground Truth: Not applicable in the AI/ML sense. Ground truth here is established by laboratory measurements and biological assays, comparing results against defined pass/fail criteria from recognized standards (e.g., USP, ISO).
Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. There is no machine learning model involved, therefore no training set. The "training" of the product is its formulation and manufacturing process, and its "ground truth" is its chemical and physical properties verified through standard laboratory testing.

In summary, the provided document details the regulatory clearance of a contact lens saline solution, not an AI/ML-based medical device. Therefore, the questions posed regarding AI/ML device acceptance criteria and study methodology cannot be answered from this information.

Summary

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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.

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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 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

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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)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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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:

(5) INDICATION FOR USE:
Aqua Naina Sterile Saline Solution is indicated only for rinsing soft contact lenses after cleaning and disinfection before use.

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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 NainaSterile SalineSolution	Purilens SalineSolution K002319	UnisolP790011	Eye-Cept SalineSolution K110221(PrimaryPredicate)
Manufacturer	NiagaraPharmaceuticals,Inc.	Purilens Inc	Alcon	Optics Laboratory
Product Code	LPN	LPN	LPN	LPN
RegulationNumber	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 aftercleaning and forwetting softcontact lensesafter disinfectionbefore use.	storing of contactlenses	rinsing, storage andwetting of soft(hydrophilic)contact lenses	contact lens aftercleaning andwetting
Preservative free	Yes	Yes	Yes	Yes
Sterile	Yes	Yes	Yes	Yes
Aqueous Solutionof NaCl andBorates	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

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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:

1. Sterility USP<71>
1. Bacteriostasis USP<71>
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 forIn Vitro Cytotoxicity
ISO10993-10:2010	Biological Evaluation of Medical Devices - Part 10: Tests forIrritation 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.

Regulation Number and Section

§ 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.”