The Weinmann Silentflow 2 Exhalation System is intended for prescription use to be used with nasal masks which are used in CPAP or bi-level pressure therapy for adult patients (> 30 kg) and do not have a built-in exhalation device.

Device Description

The Weinmann Silentflow 2 Exhalation System consists of two components assembled together. It allows for a patient to exhale during CPAP or bi-level pressure therapy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Weinmann Silentflow 2 Exhalation System. It does not contain information about acceptance criteria, device performance metrics, or a study that evaluates a device based on such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional and environmental testing.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can and cannot be answered:

A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The text states "Functional and environmental testing was conducted to ensure that the device would perform as described in its specifications," but no specific criteria or performance numbers are given.
Sample size used for the test set and the data provenance: This information is not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is not applicable. The device is an exhalation system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This is not applicable as it's not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided. The testing mentioned is "functional and environmental," implying engineering or physical performance standards, rather than medical ground truth as typically understood in diagnostic studies.
The sample size for the training set: This is not applicable as there is no mention of a training set for an algorithm.
How the ground truth for the training set was established: This is not applicable as there is no mention of a training set for an algorithm.

Summary of available information related to testing:

The device underwent:

Functional testing: To ensure it performs as described in its specifications.
Environmental testing: To ensure it performs as described in its specifications.

The conclusion drawn from this testing was that the device is "substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use." However, specific acceptance criteria and reported numerical performance data are not detailed in this document.

Summary

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NOV 1 4 2002

WEINM/ANN

K022934

510(k) SUMMARY

Weinmann Silentflow 2 Exhalation System

August 27, 2002

Submitter Information:

Gottlieb Weinmann Geraete für Medizen und Arbeitsschutz GmbH+Co. Kronsaalsweg 40 22525 Hamburg Germany

Submitter's Name:	Eckhardt Albers
Phone:	011 49 40 54 70 2 - 180

Device Name:

Proprietary name:	Weinmann Silentflow 2 Exhalation System
Common Name:	Exhalation Device
Classification Name:	Accessory to non-continuous ventilator

Predicate Device Equivalence:

Substantial equivalence is claimed to the Respironics Whisper Swivel II Exhalation Port and the MAP Aero-Click®, cleared for commercial distribution per K9622203 and K993094, respectively.

Device Description:

The Weinmann Silentflow 2 Exhalation System consists of two components assembled together. It allows for a patient to exhale during CPAP or bi-level pressure therapy.

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Intended Use:

Comparison of Technological Characteristics:

The Weinmann Silentflow 2 Exhalation System has the same technological characteristics as the predicate devices.

Summary of Device Testing:

Functional and environmental testing was conducted to ensure that the device would perform as described in its specifications

Conclusions:

Based on the above, we concluded that the Weinmann Silentflow 2 Exhalation System is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2002

Mr. Eckhardt Albers Quality Assurance Manager Gottlieb Weinmann Geraete für Medizin und Arbeitsschutz GmbH + Co. Kronsaalsweg 40 22525 Hamburg, GERMANY

Re: K022934

Trade Name: Weinmann Silentflow 2 Exhalation System Regulation Number: 868.5905 Regulation Name: Non-continuous Ventilator, Accessory Regulatory Class: II Product Code: 73 BZD Dated: August 27, 2002 Received: September 4, 2002

Dear Mr. Albers:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Albers

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Kumres

Timothy A. Ulatowski 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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WEINMANN

Device Name:

Weinmann Silentflow 2 Exhalation System

Indications for Use:

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Prescription
use

Over-the-counter
use

Ullhan A noé

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, De

510(k) Number: K022934

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).