(236 days)
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.
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.
The provided FDA 510(k) summary (K232523) describes a Sodium Chloride Inhalation Solution. This is a medical device (a drug-device combination product, specifically an accessory to a nebulizer) and not an AI/ML-powered medical device.
Therefore, the requested information regarding acceptance criteria, study design for AI model performance (including sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, design verification testing, biocompatibility, and meeting USP (United States Pharmacopeia) standards for pharmaceutical solutions and manufacturing. The "Performance Data" section describes validation of the physical and chemical properties of the solution and its container, not the performance of an algorithm or AI model.
However, to answer your request based on the provided document, I will extract the relevant information regarding the device's performance acceptance criteria and study proving it meets those criteria, as described for this specific non-AI medical device.
Acceptance Criteria and Study for Sodium Chloride Inhalation Solution (K232523)
This device is not an AI/ML device, and therefore the traditional metrics and study designs associated with AI performance are not relevant. Instead, the "acceptance criteria" here refer to the product specifications and quality control parameters for a pharmaceutical solution and its container, and the "study" refers to the testing performed to demonstrate compliance with these specifications and established standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "All results met the predetermined acceptance criteria." Specific numerical criteria and their exact corresponding reported values are not fully detailed in this summary document, as is typical for 510(k) summaries which provide a high-level overview. However, the types of criteria and the confirmation of meeting them are listed.
| Acceptance Criteria (Type of Test/Requirement) | Reported Device Performance (Summary) |
|---|---|
| Design Verification (Product Attributes) | |
| Identity | Met predetermined acceptance criteria. |
| Assay | Met predetermined acceptance criteria. |
| pH | Met predetermined acceptance criteria. |
| Endotoxin | Met predetermined acceptance criteria (absence of pyrogens). |
| Sterility | Met predetermined acceptance criteria (contents are sterile). |
| Fill Weight | Met predetermined acceptance criteria. |
| Vial Attributes (e.g., integrity) | Met predetermined acceptance criteria. |
| Vial Function (separation, cap removal, etc.) | Met predetermined acceptance criteria. |
| Biocompatibility | |
| Chemical Characterization (ISO 10993-18) | Performed; assessed extractable constituents. |
| Leachable Substances (ISO 10993-17) | Principles applied; allowable limits established. |
| Absence of Pyrogens (USP <151>) | Met the requirements for the absence of pyrogens. |
| Performance Testing (Ongoing QC/Compliance) | |
| Description | Tested, equivalent to predicate. |
| Identification (Sodium, Chloride per USP <191>) | Tested, equivalent to predicate. |
| Minimum Fill (USP <755>) | Tested, equivalent to predicate. |
| pH (USP <791>) | Tested, equivalent to predicate. |
| Osmolality (USP <785>) | Tested, equivalent to predicate. |
| Iron Content | Tested, equivalent to predicate. |
| Uniformity of Dosage Unit (USP <905>) | Tested, equivalent to predicate. |
| Container Closure Integrity (USP <1207>) | Tested, equivalent to predicate. |
| Sodium Chloride Assay (USP Monograph) | Tested, equivalent to predicate. |
| Sterility (USP <71>) | Tested, equivalent to predicate. |
| Particulate Matter (USP <789>) | Tested, equivalent to predicate. |
| Foreign Matter (USP <790>) | Tested, equivalent to predicate. |
| Bacterial Endotoxin Test (USP <85>) | Tested, equivalent to predicate. |
| Stability of Solution (3 months) | Tested. (Implies met criteria for stability) |
| Extractable study of LDPE respule/components | Tested. (Implies results were acceptable) |
| Leachable study for 3 Months stability | Tested. (Implies results were acceptable) |
| Vial Attributes and Functionality Testing | Tested. (Implies met criteria) |
| Manufacturing Process | Aseptic Processing using Blow-Fill-Seal Technology (Similar to predicate). |
| Compliance with Compendia | Complies with United States Pharmacopeia standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., "n=X vials tested for fill weight"). It generally states that "Design verification testing was conducted..." and "The Sodium Chloride Inhalation Solution... are manufactured and tested in an identical manner to the Predicate Device." This implies that standard pharmaceutical quality control and validation sample sizes were used, which are typically defined by internal QMS procedures, relevant ISO standards, and USP monographs.
- Data Provenance: The testing was conducted by the manufacturer, Mankind Pharma Limited, based in New Delhi, India, or its affiliates/contract laboratories. The data provenance is effectively the internal testing records of the manufacturer. This is retrospective in the sense that the testing has already been completed and compiled for the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. For this type of device (a sterile saline solution), "ground truth" is established by laboratory analytical methods that measure chemical composition, sterility, pH, etc., against predefined specifications (e.g., USP monographs). Human experts are involved in reviewing and validating the test methods and results, but not in establishing a "ground truth" through consensus reading of images or clinical assessments comparable to an AI/ML study.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication is relevant for subjective assessments (e.g., agreement between multiple readers on image findings). For objective chemical/physical tests, the results are quantitative and either meet or do not meet the specification; there is no "adjudication" in the sense of resolving inter-rater disagreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human performance in diagnostic tasks. This device is a solution used with a nebulizer, not a diagnostic AI tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. There is no algorithm or AI component in this device. The "performance" refers to the intrinsic properties of the sodium chloride solution and its sterile container.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Compendial Standards: Primarily the United States Pharmacopeia (USP) monographs for Sodium Chloride Inhalation Solution and general chapters for various tests (e.g., USP <71> for Sterility, USP <85> for Bacterial Endotoxins, USP <191> for Identification, USP <755> for Minimum Fill, USP <785> for Osmolality, USP <789> for Particulate Matter, USP <790> for Foreign Matter, USP <791> for pH, USP <905> for Uniformity of Dosage Unit, USP <1207> for Container Closure Integrity).
- Internal Specifications: Derived from the device design and quality system, often based on these compendial standards and engineering requirements for the vial and its functionality.
- International Standards: e.g., ISO 10993 series for biocompatibility.
8. The Sample Size for the Training Set
This is not applicable. There is no AI model to train for this device. The "training" in manufacturing refers to process validation and optimization, not data feeding for a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no AI training set.
{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.
| TechnologicalCharacteristicsCompared to thePredicate Device | Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| PharmaCaribe (K101424) | Sodium Chloride InhalationSolutions, USP 0.45%; 0.9%(K972466) | |||
| Product Name | Sodium Chloride InhalationSolution USP 0.9%, 3% and7%. | PharmaCaribe Inhaled salinesolutions 3%, 3.5%, 6%, 7%,and 10%. | Sodium Chloride InhalationSolution USP 0.45%; 0.9%. | The proposed devicefollows the establishedname provided in theUSP Monograph;whereas, the predicatedevice uses aproprietary name. |
| Design | Sterile, preservative-freeSodium Chloride InhalationSolutions supplied in single usevials. | Sterile, preservative-freeSodium Chloride InhalationSolutions supplied in single usevials. | Sterile, preservative-freeSodium Chloride InhalationSolutions supplied in single usevials. | Similar(Proposed devicedesign is equivalentand no change as thatof the predicatedevice) |
| Material/ChemicalComposition | Water for Injection, USPSodium Chloride, USP | Sterile Water for Injection,USPSodium Chloride, USP | Water for Injection, USPSodium Chloride, USP | Similar(Proposed devicematerial/chemicalcomposition isequivalent to thepredicate 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 |
| TechnologicalCharacteristicsCompared to thePredicate Device | Proposed Device | Predicate Device | Predicate Device | |
| PharmaCaribe (K101424) | Sodium Chloride InhalationSolutions, USP 0.45%; 0.9%(K972466) | Comparison | ||
| predicate device(K972466) andproposed device 3%and 7% concentrationis equivalent to thepredicate device(K101424) | ||||
| Indications for Use | 3% and 7%Sodium Chloride InhalationSolution, USP is used inconjunction with a nebulizer.The contents of these vials arefor the induction of sputumproduction where sputumproduction is indicated.Concentrations of 3% and 7%.0.9%The intended use of this steriledevice is as accessories tomedicinal non-ventilatorynebulizers in respiratorytherapy and for trachealirrigation or lavage. | PharmaCaribe inhaled salinesolutions are used inconjunction with a nebulizer.The contents of these vials arefor the induction of sputumproduction where sputumproduction is indicated.Concentrations of 3%, 3.5%,6%, 7% and 10%. | The intended use of thesesterile device is as accessoriesto medicinal non-ventilatorynebulizers in respiratorytherapy or for trachealirrigation or lavage. | Similar(Proposed deviceIndications for Use isequivalent to theindividual predicatedevices) |
| Prescription | Yes | Yes | Yes | Similar(No Change) |
| TechnologicalCharacteristicsCompared to thePredicate Device | Proposed Device | Predicate Device | Comparison | |
| PharmaCaribe (K101424) | Sodium Chloride InhalationSolutions, USP 0.45%; 0.9%(K972466) | |||
| Environment of Use | Hospital, sub-acute careor home | Hospital, sub-acute careor home | Hospital, sub-acute careor home | Similar(No Change) |
| Patient Population | $3%$ and $7%$Any patient population wheresputum production is indicated. | Any patient population wheresputum production is indicated. | -- | Similar(Proposed devicePatient Population isequivalent to theindividual predicatedevices) |
| $0.9%$Any patient populationrequiring lavage therapy ortracheal irrigation. | -- | Any patient populationrequiring lavage therapy ortracheal irrigation. | ||
| Used with aNebulizer | Yes | Yes | Yes | Similar(Proposed device andthe predicate device isUsed with a Nebulizer) |
| Contraindications | None | None | None | Similar(Proposed deviceContraindications isequivalent to thepredicate device) |
| Vial Labeling | $3%$ and $7%$Embossed with identifyingproduct text, lot number, andexpiration date. | Embossed with identifyingproduct text, lot number, andexpiration date. | -- | Similar(Proposed device VialLabeling is equivalentto the predicatedevice) |
| $0.9%$ | ||||
| TechnologicalCharacteristicsCompared to thePredicate Device | Proposed Device | Predicate Device | Comparison | |
| PharmaCaribe (K101424) | Sodium Chloride InhalationSolutions, USP 0.45%; 0.9%(K972466) | |||
| Embossed with identifyingproduct text, lot number,expiration date and Levelmarkings. | -- | Embossed with identifyingproduct text, lot number,expiration date and Levelmarkings. | ||
| Shelf CartonLabeling | Includes instructions for useand UDI requirements. | Includes instructions for useand UDI requirements. | Includes instructions for useand UDI requirements. | Similar(Proposed deviceShelf Carton Labelingis equivalent to thepredicate device) |
| Sterility | Contents are sterile | Contents are sterile | Contents are sterile | Similar(Proposed device andpredicate devicecontents are sterile) |
| Primary ContainerClosure System | LDPE vial with twist-off cap | LDPE vial with twist-off cap | LDPE vial with twist-off cap | Similar(Proposed deviceprimary containerclosure system isequivalent to thepredicate device) |
| Fill Volume | 0.9%: 3 mL and 5 mL3%: 4 mL7%: 4 mL | 4 mL | 3 mL and 5 mL | Similar(Proposed device 0.9%fill volume i.e. 3 mLand 5 mL is equivalentto the predicate device(K972466) andproposed device 3%and 7% fill volume i.e. |
| TechnologicalCharacteristicsCompared to thePredicate Device | Proposed Device | Predicate Device | Comparison | |
| PharmaCaribe (K101424) | Sodium Chloride InhalationSolutions, USP 0.45%; 0.9%(K972466) | |||
| 4 mL is equivalent tothe predicate device(K101424) | ||||
| Compliance withCompendia | United States Pharmacopeia | United States Pharmacopeia | United States Pharmacopeia | Similar(Proposed device andpredicate devicecomplies with UnitedStates Pharmacopeia) |
| ManufacturingProcess | Aseptic Processing usingBlow-Fill-Seal Technology | Aseptic Processing usingBlow-Fill-Seal Technology | Aseptic Processing usingBlow-Fill-Seal Technology | Similar(Proposed deviceManufacturing Process(Aseptic) is equivalentas the predicatedevice) |
| 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.
§ 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).