(217 days)
For Inhalation and Humidification by way of Sterile Water in a closed system during Inhalation Therapy.
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.
The provided text describes a 510(k) summary for the RESPIFLO/S device, which is a "Sterile Water with Saline for Inhalation Therapy." However, the document does not contain information relevant to the acceptance criteria or study design for an AI/algorithm-based medical device as requested in the prompt.
The document discusses:
- The product name and classification.
- A legally marketed device to which substantial equivalence is claimed (Hudson RCI AQUAPAK/S).
- A description and intended use of the RESPIFLO/S device (Sterile Water with Saline for Inhalation Therapy).
- A summary of technological characteristics, stating it's "the exact same in nature and design as a currently marketed" product.
- A summary of test data, mentioning sterile water with saline according to USP, endotoxin-free, 3-year and 5-year stability testing, and a closed/disposable system. It refers to "Confidential Testing, Methods and Results" in Section 11, which is not provided.
Therefore, I cannot provide the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as the document pertains to a physical medical product (sterile water with saline) and not an AI or algorithm-based device.
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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 |
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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."
§ 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).