Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterile saline solution for inhalation, and the description focuses on its chemical composition, packaging, and intended use with nebulizers. There is no mention of any computational or analytical components that would utilize AI/ML.

Therapeutic

No.
This device is a Sodium Chloride Inhalation Solution, which is a drug product used in conjunction with a nebulizer or for tracheal irrigation/lavage. While it is used in a therapeutic context (respiratory therapy), it is not itself a therapeutic device like a nebulizer or other hardware.

Diagnostic

No

Explanation: The device is a Sodium Chloride Inhalation Solution, which is used for therapeutic purposes such as inducing sputum production or for tracheal irrigation/lavage, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a sterile, preservative-free Sodium Chloride Inhalation Solution, provided in concentrations and supplied in single-use low density polyethylene (LDPE) vials. This describes a physical product, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the solution is for "induction of sputum production" or as "accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage." These are therapeutic or procedural uses, not diagnostic testing performed in vitro (outside the body).
Device Description: The description focuses on the composition and packaging of a sterile solution for inhalation or irrigation.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing information for diagnosis.
Performance Studies: The performance studies described are related to the physical and chemical properties of the solution and its container, not the accuracy or performance of a diagnostic test.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is administered to the body for therapeutic or procedural purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Sodium Chloride Inhalation Solution, USP 3% and 7%
The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.

Sodium Chloride Inhalation Solution, USP 0.9%
The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.

Product codes (comma separated list FDA assigned to the subject device)

CAF

Device Description

The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 0.9%, 3% and 7% with a nominal fill volume of 3 mL & 5 mL (0.9%), 4 mL (3%) and 4 mL (7%) and supplied in single-use low density polyethylene (LDPE) vials.

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

Any patient population where sputum production is indicated.
Any patient population requiring lavage therapy or tracheal irrigation.

Intended User / Care Setting

Hospital, sub-acute care or home

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)

Design verification testing was conducted to ensure the device met the predetermined acceptance criteria for the following tests: Identity, Assay, pH, endotoxin, sterility, fill weight, vial attributes, and vial function (i.e., vial separation, cap removal, occluded orifice, etc.). All results met the predetermined acceptance criteria.
A biocompatibility risk assessment was performed in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." Chemical characterization was performed on the final LDPE containers per ISO 10993-18, "Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process" and assessed extractable constituents based on the principles of ISO 10993-17:2002, "Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances." The extraction solvent was selected in alignment with the recommendations of ISO 10993-12:2021, "Biological evaluation of medical devices - Part 12: Sample preparation and reference materials."
A validated, equivalent bacterial endotoxin test has been used in place of the in vivo rabbit pyrogen test in accordance with USP , met the requirements for the absence of pyrogens.

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.

K101424, K972466

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.

No reference devices were used in this submission.

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

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).

Summary

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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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

April 10, 2024

Mankind Pharma Limited % Parimal Upadhyav Senior Vice President - Business Development & Portfolio Lifestar Pharma LLC (a Mankind Group Company) 1200 MacArthur Blvd. Mahwah, New Jersey 07430

Re: K232523

Trade/Device Name: Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: March 11, 2024 Received: March 11, 2024

Dear Parimal Upadhyay:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-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/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,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and

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Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232523

Device Name

Sodium Chloride Inhalation Solution, USP, 0.9%, 3%, and 7%

Indications for Use (Describe)

Sodium Chloride Inhalation Solution, USP 3% and 7%

The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.

Sodium Chloride Inhalation Solution, USP 0.9%

The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. SUBMITTER

Mankind Pharma Limited 208, Okhla Industrial Estate, Phase-3, New Delhi - 110020, India (IND)

Submission Correspondent:

Contact Person: Parimal Upadhyay Senior Vice President - Business Development & Portfolio Address: Lifestar Pharma LLC (a Mankind Group company) 1200 MacArthur Blvd. Mahwah, NJ, 07430, United States Phone: +1-551-236-5702 Fax: +1 201 818 2045 e-mail: us.regulatory(@mankindpharma.com

Summary Preparation Date: April 05, 2024

II. DEVICE

Name of Device: Sodium Chloride Inhalation Solution, USP, 0.9%, 3%, and 7%. Common or Usual Name:

Sodium Chloride Inhalation Solution, USP, 0.9%, 3%, and 7%.
Saline Solution

Classification Name: Nebulizer (21 CFR 868.5630) Regulatory Class: II

Product Code: CAF

III. PREDICATE DEVICE

PharmaCaribe Inhaled saline solutions 3%, 3.5%, 6%, 7%, and 10%, K101424 ●
Sodium Chloride Inhalation Solution USP 0.45%: 0.9%, K972466 ●

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 0.9%, 3% and 7% with a nominal fill volume of 3 mL & 5 mL (0.9%), 4 mL (3%) and 4 mL (7%) and supplied in single-use low density polyethylene (LDPE) vials.

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V. INDICATIONS FOR USE

Sodium Chloride Inhalation Solution, USP 3% and 7%

The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.

Sodium Chloride Inhalation Solution, USP 0.9%

The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The induction of sputum production is the technological principle for both the proposed and predicate devices when used in conjunction with a nebulizer. The technological characteristics when compared to the predicate device are detailed below.

| Technological
Characteristics
Compared to the

Predicate Device	Proposed Device	Predicate Device		Comparison
		PharmaCaribe (K101424)	Sodium Chloride Inhalation
Solutions, USP 0.45%; 0.9%
(K972466)
Product Name	Sodium Chloride Inhalation
Solution USP 0.9%, 3% and
7%.	PharmaCaribe Inhaled saline
solutions 3%, 3.5%, 6%, 7%,
and 10%.	Sodium Chloride Inhalation
Solution USP 0.45%; 0.9%.	The proposed device
follows the established
name provided in the
USP Monograph;
whereas, the predicate
device uses a
proprietary name.
Design	Sterile, preservative-free
Sodium Chloride Inhalation
Solutions supplied in single use
vials.	Sterile, preservative-free
Sodium Chloride Inhalation
Solutions supplied in single use
vials.	Sterile, preservative-free
Sodium Chloride Inhalation
Solutions supplied in single use
vials.	Similar
(Proposed device
design is equivalent
and no change as that
of the predicate
device)
Material/Chemical
Composition	Water for Injection, USP
Sodium Chloride, USP	Sterile Water for Injection,
USP
Sodium Chloride, USP	Water for Injection, USP
Sodium Chloride, USP	Similar
(Proposed device
material/chemical
composition is
equivalent to the
predicate device)
Concentrations	0.9%, 3% and 7%	3%, 3.5%, 6%, 7%, and 10%	0.45%; 0.9%	Similar
(Proposed device 0.9%
is equivalent to the
Technological
Characteristics
Compared to the
Predicate Device	Proposed Device	Predicate Device	Predicate Device
		PharmaCaribe (K101424)	Sodium Chloride Inhalation
Solutions, USP 0.45%; 0.9%
(K972466)	Comparison
				predicate device
(K972466) and
proposed device 3%
and 7% concentration
is equivalent to the
predicate device
(K101424)
Indications for Use	3% and 7%
Sodium Chloride Inhalation
Solution, USP is used in
conjunction with a nebulizer.
The contents of these vials are
for the induction of sputum
production where sputum
production is indicated.
Concentrations of 3% and 7%.

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8

9

10

Summary: The proposed device is Similar in both indications for use and technological characteristics when compared to the predicate device.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

. Design Verification: Design verification testing was conducted to ensure the device met the predetermined acceptance criteria for the following tests: Identity, Assay, pH, endotoxin, sterility, fill weight, vial attributes, and vial function (i.e., vial separation, cap removal, occluded orifice, etc.). All results met the predetermined acceptance criteria.
Biocompatibility: A biocompatibility risk assessment was performed in accordance with the ● FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." Chemical characterization was performed on the final LDPE containers per ISO 10993-18, "Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process" and assessed extractable constituents based on the principles of ISO 10993-17:2002, "Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances." The extraction solvent was selected in alignment with the recommendations of ISO 10993-12:2021, "Biological evaluation of medical devices - Part 12: Sample preparation and reference materials."
A validated, equivalent bacterial endotoxin test has been used in place of the in vivo rabbit ● pyrogen test in accordance with USP , met the requirements for the absence of pyrogens.

Summary

The safety and effectiveness of the proposed device is demonstrated to be equivalent to the predicate device based on the results of the design verification testing, biocompatibility risk assessment and met the requirements for the absence of pyrogens in accordance with USP .

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Performance Testing Summary

Performance characteristics of proposed device that is the subject of this notification are equivalent to the predicate devices.

The Sodium Chloride Inhalation Solution USP 0.9%, 3% and 7% are manufactured and tested in an identical manner to the Predicate Device. This includes:

USP Water for Injection ●
Filtration - sterility grade filters
USP Sodium Chloride ●
Testing for .
- Description o
- Identification for Sodium and Chloride per USP (191) O
- Minimum fill per USP (755) O
- pH per USP (791) O
- Osmolality per USP (785) O
- Iron content O
- Uniformity of Dosage Unit per USP (905) O
- Container closure integrity USP (1207) O
- Sodium Chloride Assay per USP Monograph O
- Sterility per USP (71) O
- Particulate matter USP (789) O
- Foreign matter USP (790) O
- Bacterial Endotoxin Test per USP (85) O
- Testing for 3 Months stability of solution O
- Extractable study of the LDPE respule and manufacturing components O
- Leachable study for 3 Months stability of solution O
- Vial Attributes and Vial Functionality Testing (Vial separation, Cap removal, O Occluded orifice)

VIII. CONCLUSIONS

Based on a comparison of composition, technological characteristics, intended use, design verification testing, performance testing, biocompatibility risk assessment and met the requirements for absence of pyrogens in accordance with USP , it is concluded that the proposed device is substantially equivalent to the predicate device.