(105 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a saline solution, with no mention of AI or ML.
Yes
The device is described as "Sodium Chloride Inhalation Solution USP, 3%, 7% or 10%" used for "induction of sputum production." This is a medical intervention intended to produce a physiological effect (sputum production) for diagnosis or treatment, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a sodium chloride inhalation solution used to induce sputum production for specimen collection, which is a preparatory step for diagnostics but not a diagnostic test in itself. It facilitates the collection of a specimen that can then be used for diagnostic purposes.
No
The device description clearly states the device is a physical vial containing a sodium chloride solution, intended for use with a nebulizer. This is a drug/device combination product, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the induction of sputum production where sputum production is indicated." This is a procedure to help a patient produce a biological sample (sputum). It is not a test performed on a biological sample to diagnose or monitor a condition.
- Device Description: The device is a solution used in conjunction with a nebulizer. It's a substance administered to the patient to facilitate sample collection.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze a biological sample or provide diagnostic information. The performance studies focus on the properties of the solution itself, not its performance in a diagnostic test.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue, sputum) to provide information for diagnosis, monitoring, or screening. This device is used to obtain the specimen, not to test it.
N/A
Intended Use / Indications for Use
To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The subject devices are 4mL Sodium Chloride Inhalation Solution USP, 3%, 7% or 10%. The single-use devices are a clear blow-fill-sealed, low density polyethylene (LDPE) vials containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. Sodium Chloride Inhalation Solution USP, 3%, 7% or 10% are used in conjunction with a nebulizer. The product contains 3%, 7% or 10% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
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
Not Found
Intended User / Care Setting
Not Found
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)
Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physicalchemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence.
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.
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.
Not Found
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
§ 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
Image /page/0/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo features two beakers with tubes coming out of the top. To the right of the beakers is the text "nephron pharmaceuticals corporation" stacked on three lines.
Section 5: 510(k) Summary
120051
Date Premarket Notification Summary was Prepared
This 510(k) premarket notification summary was prepared January 02, 2012 in conjunction with the notification.
Applicant Name & Address
Nephron Pharmaceuticals Corporation 4121 SW 34th Street Orlando, FL 32811 Phone: (407) 246-1389 Fax: (407) 872-0001
Contact Persons:
Lou Kennedy President/CEO
Marcus Juliano Vice President, Quality Assurance & Regulatory Affairs (regulatory contact)
Kimberly Grevera Manager, Regulatory Affairs (regulatory contact)
Proprietary or Trade Name: Sodium Chloride Inhalation Solution USP, 3%, 7% and 10% Common/Usual Name: Saline Solution Classification Name: Nebulizer (Direct Patient Interface) - Accessory CAF - 868.5630 Class II Device: Inhaled saline solution Pari Innovative - K070498 Predicated Devices: PharmaCaribe - K101424 Dey-Laboratories - K972778
Device Description
The subject devices are 4mL Sodium Chloride Inhalation Solution USP, 3%, 7% or 10%. The single-use devices are a clear blow-fill-sealed, low density polyethylene (LDPE) vials containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. Sodium Chloride Inhalation Solution USP, 3%, 7% or 10% are used in conjunction with a nebulizer. The product contains 3%, 7% or 10% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
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Image /page/1/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo features two Erlenmeyer flasks with tubes coming out of the top on the left side of the image. To the right of the flasks is the text "nephron pharmaceuticals corporation" stacked on top of each other.
Section 5: 510(k) Summary
| Contents | Volume | Container |
|---|---|---|
| 3% Sodium Chloride Inhalation Solution, USP | 4mL Fill | Clear, Embossed Label |
| 7% Sodium Chloride Inhalation Solution, USP | 4mL Fill | Clear, Embossed Label |
| 10% Sodium Chloride Inhalation Solution, USP | 4mL Fill | Clear, Embossed Label |
Indications for Use
To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.
Limitations for Use
These devices are not intended for parenteral use or for preparations intended for parenteral use. The use of this device requires a prescription.
Technological Characteristics of the Subject Devices and Predicate Devices
The subject unit-dose devices of this premarket notification are formed of polyethylene resins meeting the direct food and drug contact criteria. The formed units meet the criteria for direct food and drug contact as prefilled unit containers. The solution component, at the stated concentration of Sodium Chloride Inhalation Solution, meets the USP monograph requirements.
The single-use containers are embossed with identifying product text.
The finished device product configuration characteristics of this inhalation device are similar to those of the predicate devices.
The Blow/Fill/Seal system on which these devices are manufactured represents technological advances in the production of these devices for inhalation therapy and in the control of the manufacturing environment. These devices are manufactured under conditions of current Good Manufacturing Practices (cGMP).
There are no technological differences between the subject devices and predicate devices that raise new questions of safety and effectiveness. Performance characteristics of these devices that are the subject of this notification are equal to or greater than the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo consists of two Erlenmeyer flasks on the left, followed by the company name in a sans-serif font. The word "nephron" is on the top line, "pharmaceuticals" is on the second line, and "corporation" is on the third line.
Section 5: 510(k) Summary
Nonclinical and Clinical Testing
The component materials of the accessory device container have been substantiated to each meet the criteria for direct food and drug contact or additive respectively. The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria. The finished device undergoes testing to meet the stated USP monograph and container criteria.
Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physicalchemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence.
Summary Conclusions
The subject devices:
3% Sodium Chloride Inhalation Solution, USP 7% Sodium Chloride Inhalation Solution, USP 10% Sodium Chloride Inhalation Solution, USP
as manufactured by Nephron Pharmaceuticals Corporation of Orlando, FL claims substantial equivalence, with the same intended use, to several devices which have received market clearance through established equivalence.
These devices are designed to meet current USP specifications. The device containers have embossed unit identification and shelf carton labeling so that label requirements are met.
Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use.
The devices, as manufactured by Nephron, are produced using Blow Fill Seal technology specifically designed filling operations. These manufacturing systems represent a technological advance for the production of these types of devices.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Marcus Juliano Vice President. Ouality Assurance & Regulatory Affairs Nephron Pharmaceuticals Corporation 4121 SW 34th Street Orlando, Florida 32811
APR 2 0 2012
Re: K120051
Trade/Device Name: Sodium Chloride Inhalation Solution USP, 3%, 7%, AND 10% Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 30, 2012 Received: April 2, 2012
Dear Mr. Juliano:
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.
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Page 2 - Mr. Juliano
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.
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/CDRH/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
ph too
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo consists of two beakers on the left side of the image. To the right of the beakers is the text "nephron pharmaceuticals corporation" in a sans-serif font.
Section 4: Indications for Use Statement
Not Known 510(k) Number:
Sodium Chloride Inhalation Solution USP, 3%, 7%, and 10% Device Name:
Indications for Use:
To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.
Prescription Use X (21 CFR 801 Subpart D) and/or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schillito
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K120051