Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate and Boric Acid. The solution is packaged in plastic sterile single use twist open pods, reusable bottles with dropper tips and caps. Each bottle is closed with tamper resistant cap with a breakable ring, which must be broken in order to open the bottle.

AI/ML Overview

This document describes the premarket submission for Cachet Pharmaceuticals Pvt. Ltd.'s Sterile Saline Solution.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are primarily focused on demonstrating substantial equivalence to existing legally marketed predicate devices and meeting specific safety and performance standards for contact lens care products.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Intended Use	Must be for rinsing and wetting of soft (hydrophilic) contact lenses.	"Sterile Saline Solution is indicated for rinsing & wetting of soft (hydrophilic) contact lenses." This matches the predicate devices' broader indications for use (rinsing, wetting, cleaning, disinfecting, storing). The FDA clearance letter confirms the indication for use: "Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses."
Formulation	Must be comparable to predicate devices in its essential components.	"Sodium chloride, Sodium borate, Boric acid." This is compared favorably to the predicate devices which also contain Sodium chloride and Boric acid, with one also containing Sodium borate.
Preservation	Must be preservative-free (or equivalent to predicate's preservative status).	"No" (preservative). This matches all predicate devices.
Sterility	Must be sterile.	"Sterile." This matches all predicate devices.
Toxicity	Non-toxic / no evidence of toxicity.	"A series of cytotoxicity and eye irritation studies of the Sterile Solution were undertaken. In these studies, there was no evidence of toxicity."
Bacteriostasis	Must demonstrate no significant growth/survival of specified bacteria over the designed discard period for reclosable containers.	"A bacteriostasis study was conducted... The results show that Staphylococcus aureous, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desire discard statement on label up to 30 days."
Compliance with Guidance	Must meet guidelines set forth in FDA's May 1, 1997 Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products.	"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." The bacteriostasis study was explicitly conducted "in accordance with Micro Appendix C" of this document.
Substantial Equivalence	Overall device must be substantially equivalent to legally marketed predicate device(s).	The submission concludes: "The data provide in this 510 (K) submission concludes that Sterile Saline Solution is substantially equivalent to currently cleared Purilens Saline Solution -K002319, Lens Plus Rewetting Drops -K042562, Unisol- P790011 cleared for marketing under 510 (K) for rinsing and wetting of soft (hydrophilic) contact lenses." The FDA's letter (K093367) confirms this determination.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the sample sizes used for the cytotoxicity, eye irritation, or bacteriostasis studies.
Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter is based in India, it is possible the studies were conducted there. The studies are described in a way that suggests they were prospectively conducted for the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable or not provided for this device. The Sterile Saline Solution is a chemical solution, not an imaging or diagnostic AI device that requires expert ground truth establishment for a test set. The "ground truth" for this device relates to established scientific and regulatory standards for sterility, non-toxicity, and inhibition of microbial growth, as determined by laboratory testing and specified protocols rather than expert consensus on interpretations of complex data like medical images.

4. Adjudication Method for the Test Set

This is not applicable or not provided. As explained above, the assessment criteria are based on objective laboratory tests against pre-defined thresholds, not on subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a sterile saline solution, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical product (saline solution), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on:

Laboratory-based scientific testing: This includes cytotoxicity studies, eye irritation studies, and bacteriostasis studies conducted according to established protocols (e.g., Micro Appendix C of FDA Guidance).
Regulatory standards and guidance: Compliance with the FDA's "Guidance for Industry, Premarket Notification 510 (K) Guidance Document for Contact Lens Care products."
Chemical and physical properties: Assessed through the formulation details (components, preservative status, sterility claim).

8. The Sample Size for the Training Set

This is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI algorithms. The development of the solution would involve formulation studies and pilot testing, but these are not considered "training sets" in the AI sense.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reasons as point 8. The "ground truth" for the development of the saline solution would have been established through a combination of pharmaceutical formulation science, existing knowledge of safe and effective ingredients for ophthalmic use, and preliminary laboratory testing to optimize the solution's properties.

Summary

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Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)

510(K) SUMMARY FOR Sterile Saline Solution

SEP 1 0 2010

This summary is provided in accordance with the Safe Medical Devices Act (SMDA) of 1990. The information provided in the 510 (K), Premarket Notification, was in accordance with 21 CFR 807.87

Submitter of 510 (K) 1.

, చా.,

Cachet Pharmaceuticals Pvt. Ltd. 415 Shah Nahar, Worli Mumbai 400 018 India

Contact Person : Mr. Shivkumar Agrawal Telephone No. : 91-22-4082-9999 or 2496-5831 91-22-2497-3691 Fax: E.mail: skagrawal@cachetindia.com

Contact Person (United States): Telephone No. : E mail :

Mr. Haribabu Talasila 732-447-4353 htalasila@chemtexinternational.com.

1. Product Code: LPN
1. Device Name Classification Name: Proprietary Name:

Soft (hydrophilic) Contact Lens Solution Sterile Saline Solution

Legally Marketed Predicate Devices 4. Purilens Saline Solution - K002319 Lens Plus Rewetting Drops - K042562 Unisol -P7900 11

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Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)

5. Description of the Device

Sterile Saline Solution is a sterile, preservative free, buffered, isotonic, clear, colourless aqueous solution containing Sodium Chloride, Sodium Borate and Boric Acid.

The solution is packaged in plastic sterile single use twist open pods, reusable bottles with dropper tips and caps. Each bottle is closed with tamper resistant cap with a breakable ring, which must be broken in order to open the bottle.

6. Indications for Use

Sterile Saline Solution is indicated for rinsing & wetting of soft (hydrophilic) contact lenses.

7. Description of Safety and Substantial Equivalence:

A series of studies were completed to demonstrate the substantial equivalence of Sterile Saline Solution to the predicate device(s). All testing was conducted in accordance with and in conformance to applicable device regulations. Results demonstrate the solution is non-toxic and is comparable to other currently marketed soft contact lens solutions. Results from all tests demonstrate the substantial equivalence to previously approved predicate device(s).

Sterile Saline Solution is substantially equivalent in terms of its actions and indications for use, to Purilens Saline Solution -K002319, Lens Plus Rewetting Drops -K042562. Unisol- P790011 cleared for marketing under 510(K). 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.

Toxicity:

A series of cytotoxicity and eve irritation studies of the Sterile Solution were undertaken. In these studies, there was no evidence of toxicity.

BacteriostasisT est:

A bacteriostasis study was conducted in accordance with Micro Appendix C of the Premarket Notification 510 (K) Guidance Document for Contact Lens Care Products. The purpose of the study is to evaluate the ability of bacteria to survive in the reclosable containers containing Sterile Saline Solution (unpreserved borate buffered saline). The results show that Staphylococcus aureous, Escherichia coli, Pseudomonas aeruginosa, Candida albicans and Aspergillus niger have no significant growth and survive over the designed period. The data support the desire discard statement on label up to 30 days.

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Cachet Pharmaceuticals Pvt. Ltd. Sterile Saline Solution Premarket Submission 510 (K)

8. Substantial Equivalence

The data provide in this 510 (K) submission concludes that Sterile Saline Solution is substantially equivalent to currently cleared Purilens Saline Solution -K002319, Lens Plus Rewetting Drops -K042562, Unisol- P790011 cleared for marketing under 510 (K) for rinsing and wetting of soft (hydrophilic) contact lenses.

SubstantialEquivalency	Sterile SalineSolution	PurilensSalineSolutionK002319	Lens PlusRewetting DropsK042562	UnisolP790011
Manufacturer	Marck BioscicenceLtd.	Purilens Inc.	AdvancedMedical Optics	Alcon ResearchLtd.
Intended use(Indications foruse)	For rinsing andwetting of soft(hydrophilic)contactlenses	For cleaning,disinfectingand storing ofcontact lenses	For moisteningand dehydratingof contact lenses	For heat disinfectingrinsing, storage andwetting of soft(hydrophilic) contactlenses
Formulation	Sodium chloride,Sodium borate, Boricacid	Sodiumchloride, Boricacid	Sodium chloride,Boric acid	Sodium chloride,Sodium borate,Boric acid
Preservative	No	No	No	No
Sterility claim	Sterile	Sterile	Sterile	Sterile

SUBSTANTIAL EQUIVALENCE CHART

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of an eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cachet Pharmaceuticals Pvt., Ltd. c/o Mr. Shivkumar Agrawal 415 Shah Nahar. Worli Mumbai, India 400 018

SEP 1 0 2010

Re: K093367

Trade Name: 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: September 10, 2010 Received: September 10, 2010

Dear Mr. Agrawal:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Malvina B. Eydelman M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K093367

Indications for Use

510(k) Number (if known): K093367

SEP 1 0 2010

Device Name: Sterile Saline Solution

· Indications For Use:

Sterile Saline Solution is indicated for rinsing and wetting of soft (hydrophilic) contact lenses.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation ( ODE)

Duise Haufe, ph.D.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K093367

Page 1 of

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.”