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

{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 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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. {5}------------------------------------------------ # 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. {6}------------------------------------------------ # 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<br>Characteristics<br>Compared to the<br>Predicate Device | Proposed Device | Predicate Device | | Comparison | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | PharmaCaribe (K101424) | Sodium Chloride Inhalation<br>Solutions, USP 0.45%; 0.9%<br>(K972466) | | | Product Name | Sodium Chloride Inhalation<br>Solution USP 0.9%, 3% and<br>7%. | PharmaCaribe Inhaled saline<br>solutions 3%, 3.5%, 6%, 7%,<br>and 10%. | Sodium Chloride Inhalation<br>Solution USP 0.45%; 0.9%. | The proposed device<br>follows the established<br>name provided in the<br>USP Monograph;<br>whereas, the predicate<br>device uses a<br>proprietary name. | | Design | Sterile, preservative-free<br>Sodium Chloride Inhalation<br>Solutions supplied in single use<br>vials. | Sterile, preservative-free<br>Sodium Chloride Inhalation<br>Solutions supplied in single use<br>vials. | Sterile, preservative-free<br>Sodium Chloride Inhalation<br>Solutions supplied in single use<br>vials. | Similar<br>(Proposed device<br>design is equivalent<br>and no change as that<br>of the predicate<br>device) | | Material/Chemical<br>Composition | Water for Injection, USP<br>Sodium Chloride, USP | Sterile Water for Injection,<br>USP<br>Sodium Chloride, USP | Water for Injection, USP<br>Sodium Chloride, USP | Similar<br>(Proposed device<br>material/chemical<br>composition is<br>equivalent to the<br>predicate device) | | Concentrations | 0.9%, 3% and 7% | 3%, 3.5%, 6%, 7%, and 10% | 0.45%; 0.9% | Similar<br>(Proposed device 0.9%<br>is equivalent to the | | Technological<br>Characteristics<br>Compared to the<br>Predicate Device | Proposed Device | Predicate Device | Predicate Device | | | | | PharmaCaribe (K101424) | Sodium Chloride Inhalation<br>Solutions, USP 0.45%; 0.9%<br>(K972466) | Comparison | | | | | | predicate device<br>(K972466) and<br>proposed device 3%<br>and 7% concentration<br>is equivalent to the<br>predicate device<br>(K101424) | | Indications for Use | 3% and 7%<br>Sodium Chloride Inhalation<br>Solution, USP is used in<br>conjunction with a nebulizer.<br>The contents of these vials are<br>for the induction of sputum<br>production where sputum<br>production is indicated.<br>Concentrations of 3% and 7%.<br><br>0.9%<br>The intended use of this sterile<br>device is as accessories to<br>medicinal non-ventilatory<br>nebulizers in respiratory<br>therapy and for tracheal<br>irrigation or lavage. | PharmaCaribe inhaled saline<br>solutions are used in<br>conjunction with a nebulizer.<br>The contents of these vials are<br>for the induction of sputum<br>production where sputum<br>production is indicated.<br>Concentrations of 3%, 3.5%,<br>6%, 7% and 10%. | The intended use of these<br>sterile device is as accessories<br>to medicinal non-ventilatory<br>nebulizers in respiratory<br>therapy or for tracheal<br>irrigation or lavage. | Similar<br>(Proposed device<br>Indications for Use is<br>equivalent to the<br>individual predicate<br>devices) | | Prescription | Yes | Yes | Yes | Similar<br>(No Change) | | Technological<br>Characteristics<br>Compared to the<br>Predicate Device | Proposed Device | Predicate Device | | Comparison | | | | PharmaCaribe (K101424) | Sodium Chloride Inhalation<br>Solutions, USP 0.45%; 0.9%<br>(K972466) | | | Environment of Use | Hospital, sub-acute care<br>or home | Hospital, sub-acute care<br>or home | Hospital, sub-acute care<br>or home | Similar<br>(No Change) | | Patient Population | $3\%$ and $7\%$<br>Any patient population where<br>sputum production is indicated. | Any patient population where<br>sputum production is indicated. | -- | Similar<br>(Proposed device<br>Patient Population is<br>equivalent to the<br>individual predicate<br>devices) | | | $0.9\%$<br>Any patient population<br>requiring lavage therapy or<br>tracheal irrigation. | -- | Any patient population<br>requiring lavage therapy or<br>tracheal irrigation. | | | | | | | | | | | | | | | Used with a<br>Nebulizer | Yes | Yes | Yes | Similar<br>(Proposed device and<br>the predicate device is<br>Used with a Nebulizer) | | Contraindications | None | None | None | Similar<br>(Proposed device<br>Contraindications is<br>equivalent to the<br>predicate device) | | Vial Labeling | $3\%$ and $7\%$<br>Embossed with identifying<br>product text, lot number, and<br>expiration date. | Embossed with identifying<br>product text, lot number, and<br>expiration date. | -- | Similar<br>(Proposed device Vial<br>Labeling is equivalent<br>to the predicate<br>device) | | | $0.9\%$ | | | | | Technological<br>Characteristics<br>Compared to the<br>Predicate Device | Proposed Device | Predicate Device | | Comparison | | | | PharmaCaribe (K101424) | Sodium Chloride Inhalation<br>Solutions, USP 0.45%; 0.9%<br>(K972466) | | | | Embossed with identifying<br>product text, lot number,<br>expiration date and Level<br>markings. | -- | Embossed with identifying<br>product text, lot number,<br>expiration date and Level<br>markings. | | | Shelf Carton<br>Labeling | Includes instructions for use<br>and UDI requirements. | Includes instructions for use<br>and UDI requirements. | Includes instructions for use<br>and UDI requirements. | Similar<br>(Proposed device<br>Shelf Carton Labeling<br>is equivalent to the<br>predicate device) | | Sterility | Contents are sterile | Contents are sterile | Contents are sterile | Similar<br>(Proposed device and<br>predicate device<br>contents are sterile) | | Primary Container<br>Closure System | LDPE vial with twist-off cap | LDPE vial with twist-off cap | LDPE vial with twist-off cap | Similar<br>(Proposed device<br>primary container<br>closure system is<br>equivalent to the<br>predicate device) | | Fill Volume | 0.9%: 3 mL and 5 mL<br>3%: 4 mL<br>7%: 4 mL | 4 mL | 3 mL and 5 mL | Similar<br>(Proposed device 0.9%<br>fill volume i.e. 3 mL<br>and 5 mL is equivalent<br>to the predicate device<br>(K972466) and<br>proposed device 3%<br>and 7% fill volume i.e. | | Technological<br>Characteristics<br>Compared to the<br>Predicate Device | Proposed Device | Predicate Device | | Comparison | | | | PharmaCaribe (K101424) | Sodium Chloride Inhalation<br>Solutions, USP 0.45%; 0.9%<br>(K972466) | | | | | | | 4 mL is equivalent to<br>the predicate device<br>(K101424) | | Compliance with<br>Compendia | United States Pharmacopeia | United States Pharmacopeia | United States Pharmacopeia | Similar<br>(Proposed device and<br>predicate device<br>complies with United<br>States Pharmacopeia) | | Manufacturing<br>Process | Aseptic Processing using<br>Blow-Fill-Seal Technology | Aseptic Processing using<br>Blow-Fill-Seal Technology | Aseptic Processing using<br>Blow-Fill-Seal Technology | Similar<br>(Proposed device<br>Manufacturing Process<br>(Aseptic) is equivalent<br>as the predicate<br>device) | | Shelf Life | 24 months | Unknown | unknown | - | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Summary: The proposed device is Similar in both indications for use and technological characteristics when compared to the predicate device. {11}------------------------------------------------ # 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 <151>, 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 <151>. {12}------------------------------------------------ # 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 <151>, it is concluded that the proposed device is substantially equivalent to the predicate device.