(217 days)
Hudson RCI AQUAPAK
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No
The device is sterile water for inhalation therapy and the description focuses on its sterility, packaging, and intended use, with no mention of AI or ML.
No
The device is Sterile Water for Inhalation Therapy, which is a consumable used in a therapeutic process but is not a therapeutic device itself. Its function is to provide sterile water for humidification during inhalation therapy.
No
Explanation: The device is sterile water for inhalation and humidification, used in therapy. It is not described as being used to identify or diagnose a disease or condition.
No
The device description clearly states the product is "Sterile Water for Inhalation Therapy" packaged in a "closed system" and is "disposable". This indicates a physical product, not software.
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 derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is "Sterile Water for Inhalation Therapy." This is a substance administered to the patient, not a tool for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is clearly intended for direct patient care during inhalation therapy, which falls outside the scope of In Vitro Diagnostics.
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
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Device Description
This product is Sterile Water 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Test Data: Sterile Water according to the USP Endotoxin free 3 year and 5 year Stability Testing Closed system and disposable, single use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Hudson RCI AQUAPAK
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K96872
FEB 2 5 1997
510(K) SUMMARY
RESPIFLO
Applicant:
Kendall GmbH Raffinieristrasse 18 93333 Neustadt an der Donau Germany
Contact: Mr. Konrad Schmitt
Telephone: 09445/959/160 FAX: 09445/959/189
Submitted by:
.. .. .. .. ..
Curtin & Associates International, Inc. 1200 East Street Dedham, MA 02026
Contact: Mr. William D. Curtin
Telephone: 1.617.329.1955 FAX: 1.617.329.2529
Date this Summary was prepared: July 16, 1996
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Trade Name: RESPIFLO Common Name: Sterile Water for Inhalation Therapy
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1
Legally Marketed Devices in Which Substantial Equivalence is claimed:
Hudson RCI AQUAPAK
Description of the Device: This product is Sterile Water 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 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."