(251 days)
No
The device is a simple saline solution for inhalation, and the description focuses on its chemical composition and physical properties, with no mention of AI or ML.
No.
This device is an accessory (diluent) for nebulizers used in respiratory therapy, not a therapeutic device itself.
No.
The device is a Sodium Chloride Inhalation Solution, which is used as an accessory for respiratory therapy and tracheal lavage, primarily for diluting other solutions used in nebulizers. Its purpose is therapeutic or for preparing other therapeutic agents, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical solution (Sodium Chloride Inhalation Solution USP, 0.9%) contained within a physical vial, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as an accessory to nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy. This involves direct application to the respiratory system for therapeutic purposes, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a sterile solution of sodium chloride for inhalation. It's used for dilution or direct application, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic or accessory medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
Product codes
CAF
Device Description
The subject device is 3mL or 5 mL Sodium Chloride Inhalation Solution USP, 0.9%. The single-use device is a color-coded (pink) blow-fill-sealed, low density polyethylene (LDPE) vial containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for inhalation therapy (respiratory therapy and tracheal lavage. For respiratory therapy, Sodium Chloride Inhalation Solution USP, 0.9% is used for dilution of solutions used in nebulizers. The product contains 0.9% 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)
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 physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence. Summary Conclusions: The subject device: 0.9% 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. This device is 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 this device will have comparable safety and efficacy in use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Holopack – K972466, Steripak – K980829
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Nephron Pharmaceuticals Corporation. The logo consists of two Erlenmeyer flasks with tubes coming out of the top. To the right of the flasks is the text "nephron pharmaceuticals corporation" stacked on three lines.
JUN 1 9 2012
K 113 000 Section 5: 510(k) Summary
Date Premarket Notification Summary was Prepared
This 510(k) premarket notification summary was prepared February 02, 2012 in conjunction with the notification.
Applicant Name & Address
Nephron Pharmaceuticals Corporation 4121 SW 34th Street Orlando, FL 32811 (407) 246-1389 (407) 872-0001 Fax
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, 0.9% |
|---|---|
| Common/Usual Name: | Saline Solution |
| Classification Name: | Nebulizer (Direct Patient Interface) - Accessory |
| CAF – 868.5630 | |
| Class II | |
| Device: | Inhaled saline solution – 0.9% |
| Predicated Devices: | Holopack – K972466 |
| Steripak – K980829 |
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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. The text "nephron pharmaceuticals corporation" is written to the right of the flasks.
Section 5: 510(k) Summary
Device Description
The subject device is 3mL or 5 mL Sodium Chloride Inhalation Solution USP, 0.9%. The single-use device is a color-coded (pink) blow-fill-sealed, low density polyethylene (LDPE) vial containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for inhalation therapy (respiratory therapy and tracheal lavage. For respiratory therapy, Sodium Chloride Inhalation Solution USP, 0.9% is used for dilution of solutions used in nebulizers. The product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
| Contents | Volume | Container |
|---|---|---|
| 0.9% Sodium Chloride Inhalation Solution, USP | 3mL Fill | Pink, Embossed Label |
| 0.9% Sodium Chloride Inhalation Solution, USP | 5mL Fill | Pink, Embossed Label |
Indications for Use
This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
Limitations for Use
This device is not intended for parenteral use or for preparations intended for parenteral use. The use of this device requires prescription.
Technological Characteristics of the Subject Device and Predicate Devices
The subject unit-dose device of this premarket notification is 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 this device is manufactured represents technological advances in the production of this device for inhalation therapy and in the control of the manufacturing environment. This device is manufactured under conditions of current Good Manufacturing Practices (cGMP).
There are no technological differences between the subject device and predicate devices that raise new questions of safety and effectiveness. Performance characteristics of this device that is 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, with the word "nephron" above the words "pharmaceuticals corporation" on the right. The flasks are partially filled with a dark liquid.
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 device:
0.9% 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.
This device is 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 this device will have comparable safety and efficacy in use.
The device, as manufactured by Nephron, is 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 9 2012
Mr. Marcus Juliano Vice President Nephron Pharmaceutical Corporation 4121 S.W. 34th Street Orlando, Florida 32811-6475
Re: K113033
Trade/Device Name: Sodium Chloride Inhalation Solution USP. 0.9% Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF . Dated: May 3, 2012 Received: May 4, 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.
4
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.
Nh for
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 features two Erlenmeyer flasks on the left side, with the company name written in a simple, sans-serif font to the right. The word "nephron" is on the top line, "pharmaceuticals" is on the second line, and "corporation" is on the third line.
Section 4: Indications for Use Statement
| 510(k) Number: | Not Known |
|---|---|
| Device Name: | Sodium Chloride Inhalation Solution USP, 0.9% |
Indications for Use:
This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
This device is not intended for parenteral use or for preparations intended for parenteral use.
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. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113033