(217 days)
Hudson RCI AQUAPAK/S
Not Found
No
The device description and performance studies focus on the sterility and packaging of the water/saline solution, with no mention of AI or ML.
No
The device is sterile water with saline used for inhalation and humidification during inhalation therapy. It facilitates a therapy but is not a therapeutic device itself.
No
The device is sterile water with saline for inhalation and humidification, which is a therapeutic product, not a diagnostic one. It does not identify or detect any medical conditions.
No
The device description clearly states it is "Sterile Water with Saline for Inhalation Therapy" and is a physical product packaged in a closed system. It does not describe any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy." This describes a therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the composition (Sterile Water with Saline), packaging (closed system, disposable), and quality (sterile, endotoxin free). It does not mention any components or functions related to analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples, detecting biomarkers, or providing diagnostic information.
- Predicate Device: The predicate device listed, Hudson RCI AQUAPAK/S, is also a sterile water product for inhalation therapy, which is not an IVD.
Therefore, this device falls under the category of a therapeutic device used for inhalation therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.
Product codes
Not Found
Device Description
This product is Sterile Water with Saline for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.
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
See Test Data Results in Section 11, "Confidential Testing, Methods and Results."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Hudson RCI AQUAPAK/S
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
FEB 2 5 1997
510(K) SUMMARY
RESPIFLO/S
Applicant:
Kendall GmbH Raffinieristrasse 18 93333 Neustadt an der Donau Germany
Contact: Mr. Konrad Schmitt
Telephone: 09445/959/160 09445/959/189 FAX:
Submitted by:
Curtin & Associates International, Inc. 1200 East Street Dedham, MA 02026
Contact: Mr. William D. Curtin
Telephone: 1.617.329.1955 1.617.329.2529 FAX:
Date this Summary was prepared: July 16, 1996
| Trade Name: | RESPIFLO/S |
|---|---|
| Common Name: | Sterile Water with Saline for Inhalation Therapy |
| Classification Name: | Sterile Water with Saline for Inhalation Therapy |
1
Legally Marketed Devices in Which Substantial Equivalence is claimed:
Hudson RCI AQUAPAK/S
Description of the Device: This product is Sterile Water with Saline for Inhalation Therapy. It is packaged in a closed system and it is disposable after one use. The water is sterile and endotoxin free according to the USP. The product is used for Inhalation and Humidification during Inhalation Therapy.
Intended Use of the Device: For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.
Summary of Technological Characteristics: This product is the exact same in nature and design as a currently marketed in the United States as the product used for Inhalation and Humidification during Inhalation Therapy.
Summary of Test Data:
Sterile Water with Saline according to the USP Endotoxin free 3 year and 5 year Stability Testing Closed system and disposable, single use
See Test Data Results in Section 11, "Confidential Testing, Methods and Results."