SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650

K022934 · Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits · BZD · Nov 14, 2002 · Anesthesiology

Device Facts

• Record ID: K022934
• Device Name: SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650
• Applicant: Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

The Weinmann Silentflow 2 Exhalation System is a two-component accessory designed for use with nasal masks in CPAP or bi-level pressure therapy. It functions as an exhalation port for patients whose masks lack an integrated exhalation device. The system allows for patient exhalation during therapy. It is intended for prescription use in clinical or home settings. The device is operated by the patient or caregiver as part of the mask assembly. It does not involve electronic processing or software.

Clinical Evidence

Bench testing only.

Technological Characteristics

Two-component mechanical exhalation assembly. Passive airflow design. No energy source, software, or electronic components.

Indications for Use

Indicated for adult patients (> 30 kg) undergoing CPAP or bi-level pressure therapy using nasal masks lacking integrated exhalation ports.

Regulatory Classification

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.

Predicate Devices

• Respironics Whisper Swivel II Exhalation Port (K9622203)
• MAP Aero-Click (K993094)

Submission Summary (Full Text)

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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:

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.

#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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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