(71 days)
K9622203, K993094
Not Found
No
The summary describes a mechanical exhalation system and does not mention any AI or ML components or functionalities.
No.
The Weinmann Silentflow 2 Exhalation System is an accessory that enables exhalation during CPAP or bi-level pressure therapy, but it is not a direct therapeutic device itself. It facilitates the function of therapeutic devices (CPAP/bi-level machines) that deliver the actual therapy.
No.
The device description indicates it is an exhalation system that allows a patient to exhale during CPAP or bi-level pressure therapy, which is a therapeutic function, not a diagnostic one. It does not mention any function for identifying or analyzing a condition.
No
The device description explicitly states it "consists of two components assembled together," indicating a physical, hardware-based system, not software only.
Based on the provided information, the Weinmann Silentflow 2 Exhalation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use with nasal masks in CPAP or bi-level pressure therapy for adult patients. This is a therapeutic device used directly on a patient for respiratory support.
- Device Description: The description confirms it's a system that allows a patient to exhale during therapy. This is a mechanical function related to breathing, not a diagnostic test performed on a sample from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the body (blood, urine, tissue, etc.), performing diagnostic tests, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Weinmann Silentflow 2 Exhalation System does not fit this description.
N/A
Intended Use / 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.
Product codes
73 BZD
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.
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
adult patients (> 30 kg)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional and environmental testing was conducted to ensure that the device would perform as described in its specifications
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K9622203, K993094
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
NOV 1 4 2002
WEINM/ANN
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.
1
Image /page/1/Picture/0 description: The image shows the word "WEINMANN" in a bold, sans-serif font. A diagonal line cuts through the middle of the word, starting from the top right of the "I" and extending to the bottom left of the second "N". The text is black and the background is white.
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.
2
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.
3
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
4
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.
Image /page/4/Picture/5 description: The image shows a black and white drawing of an abstract symbol. The symbol is composed of curved and straight lines. The lines intersect and overlap, creating a complex and somewhat chaotic design. The overall impression is one of movement and energy.
Prescription
use
- Over-the-counter
use
Ullhan A noé
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, De
510(k) Number: K022934