(318 days)
No reference devices were used in this submission.
No
The summary describes a simple saline solution and its container, with no mention of any computational or analytical capabilities that would involve AI/ML.
Yes
Explanation: The device is a Sodium Chloride Inhalation Solution, USP, used for the induction of sputum production, which is a therapeutic purpose. It is also listed as a predicate device (K101424 PharmaCaribe Inhaled saline solutions) which implies a medical, thus therapeutic, function.
No
Explanation: The device is a solution used to induce sputum production, not to diagnose a condition. It facilitates a process that might be used for diagnostic purposes, but it is not a diagnostic tool itself.
No
The device description clearly states it is a sterile, preservative-free Sodium Chloride Inhalation Solution, which is a physical substance, not software. The performance studies also focus on chemical and physical properties of the solution and its container.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "induction of sputum production where sputum production is indicated," used "in conjunction with a nebulizer." This describes a therapeutic or diagnostic procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a "sterile, preservative-free Sodium Chloride Inhalation Solution." This is a substance administered to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing a biological sample (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description. It is a therapeutic/diagnostic aid used in a procedure.
N/A
Intended Use / Indications for Use
Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of the induction of sputum production where sputum production is indicated.
Concentrations of 3%, 3.5%, 7%, and 10%.
Product codes
CAF
Device Description
The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 3%, 3.5%, 7%, and 10% with a nominal fill volume of 4 mL 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.
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: 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 toxicological risk assessment was performed on the chemicals observed during the chemical characterization study. The organic chemicals extracted above the threshold of 1.5 µg/day, are considered to have a low potential for toxicity (low potency) and the calculated margin of safety is acceptable. Therefore, the chemicals observed do not pose significant systemic, genotoxic, or carcinogenic toxicological safety risks to all patients (adult and child). Additionally, material-mediated pyrogenicity testing was performed in accordance with USP and met the requirements for the absence of material-mediated pyrogens under the conditions employed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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12/3/2021
The Ritedose Corporation Linda Valentine Director of Regulatory Affairs 1 Technology Circle Columbia, South Carolina 29203
Re: K210126
Trade/Device Name: Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: November 4, 2021 Received: November 5, 2021
Dear Linda Valentine:
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.
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
1
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 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-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 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-device-safety/medical-device-reportingmdr-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,
Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) 210126
Device Name
Sodium Chloride Inhalation Solution, USP 3%, 3.5%, 7% and 10%
Indications for Use (Describe)
Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of the induction of sputum production where sputum production is indicated.
Concentrations of 3%, 3.5%, 7%, and 10%.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
I. SUBMITTER
The Ritedose Corporation 1 Technology Circle Columbia, SC 29203
Phone: (803) 806-3300 (803) 935-4644 Fax:
Contact Person: Linda Valentine, Director of Regulatory Affairs Date Prepared: March 3, 2021
II. DEVICE
Name of Device: Sodium Chloride Inhalation Solution, USP, 3%, 3.5%, 7%, and 10% Common or Usual Name:
- Sodium Chloride Inhalation Solution, USP, 3%, 3.5%, 7%, and 10% -
- 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
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 3%, 3.5%, 7%, and 10% with a nominal fill volume of 4 mL and supplied in single-use low density polyethylene (LDPE) vials.
V. INDICATIONS FOR USE
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.
4
510(k) Summary
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.
| Predicate Device | ||||
|---|---|---|---|---|
| Technological | ||||
| Characteristics Compared to the | ||||
| Predicate Device: | Proposed Device | PharmaCaribe (K101424) | Comparison | |
| Product Name: | Sodium Chloride Inhalation | |||
| Solution, USP, 3%, 3.5%, 7%, | ||||
| and 10% | PharmaCaribe Inhaled saline | |||
| solutions 3%, 3.5%, 6%, 7%, | ||||
| and 10%. | 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. | Same | |||
| Material/Chemical Composition: | Water for Injection, USP | |||
| Sodium Chloride, USP | Sterile Water for Injection, | |||
| USP | ||||
| Sodium Chloride, USP | Sterile Water for Injection is | |||
| used for the PharmaCaribe | ||||
| device. No impact as the final | ||||
| solution is sterilized via | ||||
| filtration. | ||||
| Concentrations | 3%, 3.5%, 7%, and 10% | 3%, 3.5%, 6%, 7%, and 10% | The concentrations of the | |
| proposed device are within | ||||
| the range of the predicate. | ||||
| Technological | ||||
| Characteristics Compared to the | ||||
| Predicate Device: | Proposed Device | Predicate Device | ||
| PharmaCaribe (K101424) | Comparison | |||
| Indications for Use: | 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. | PharmaCaribe inhaled saline | |||
| solutions are used in | ||||
| conjunction with a nebulizer. | ||||
| The contents of these vials are | ||||
| for the induction of sputum | ||||
| production where sputum | ||||
| production is indicated. | The proposed device uses | |||
| the established name and | ||||
| uses "is" instead of "are." | ||||
| Concentrations of 3%, 3.5%, | ||||
| 7%, and 10% | Concentrations of 3%, 3.5%, | |||
| 6%, 7%, and 10% | ||||
| Prescription: | Yes | Yes | Same | |
| Environment of Use: | Hospital, sub-acute care or | |||
| home | Hospital, sub-acute care or | |||
| home | Same | |||
| Patient Population: | Any patient population where | |||
| sputum production is | ||||
| indicated. | Any patient population where | |||
| sputum production is | ||||
| indicated. | Same | |||
| Used with a Nebulizer: | Yes | Yes | Same | |
| Contraindications: | None | None | Same | |
| Vial Labeling: | Embossed with identifying | |||
| product text, lot number, and | ||||
| expiration date | Embossed with identifying | |||
| product text, lot number, and | ||||
| expiration date | Same | |||
| Shelf Carton Labeling: | Includes instructions for use | |||
| and UDI requirements. | Includes instructions for use | |||
| and UDI requirements. | Same | |||
| Technological | ||||
| Characteristics Compared to the | ||||
| Predicate Device: | Proposed Device | Predicate Device | ||
| PharmaCaribe (K101424) | Comparison | |||
| Sterility: | Contents are sterile | Contents are sterile | Same | |
| Primary Container Closure | ||||
| System: | LDPE vial with twist-off cap | LDPE vial with twist-off cap | Same | |
| Fill Volume: | 4 mL | 4 mL | Same | |
| Compliance with Compendia: | United States Pharmacopeia | United States Pharmacopeia | Same | |
| Manufacturing Process: | Aseptic Processing using | |||
| Blow-Fill-Seal Technology | Aseptic Processing using | |||
| Blow-Fill-Seal Technology | Same | |||
| Shelf Life: | 24 months | unknown |
5
510(k) Summary
6
510(k) Summary
Summary
The proposed device is identical in both indications for use and technological characteristics when compared to the predicate device.
7
510(k) Summary
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 toxicological risk assessment was performed on the chemicals observed during the chemical characterization study. The organic chemicals extracted above the threshold of 1.5 µg/day, are considered to have a low potential for toxicity (low potency) and the calculated margin of safety is acceptable. Therefore, the chemicals observed do not pose significant systemic, genotoxic, or carcinogenic toxicological safety risks to all patients (adult and child). Additionally, material-mediated pyrogenicity testing was performed in accordance with USP and met the requirements for the absence of material-mediated pyrogens under the conditions employed.
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 material-mediated pyrogenicity testing.
8
510(k) Summary
VIII. CONCLUSION
Based on a comparison of composition, technological characteristics, intended use, design verification testing, biocompatibility risk assessment, and material-mediated pyrogenicity testing, it is concluded that the proposed device is as safe and effective and is substantially equivalent to the predicate device.