(83 days)
Not Found
No
The description details a standard CPAP device with fixed pressure and basic automatic features (on/off, softstart). There is no mention of adaptive algorithms, learning capabilities, or any terms associated with AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as treating Obstructive Sleep Apnea (OSA) in adult patients by generating a Continuous Positive Airway Pressure (CPAP), which is a therapeutic intervention.
No
The device is described as a treatment device (CPAP) for Obstructive Sleep Apnea, which generates and provides airflow at a set pressure. It does not mention any function for diagnosing or detecting OSA.
No
The device description clearly outlines hardware components such as a microprocessor controlled blower, radial compressor, patient tubing, external power supply, and an optional heated humidifier. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the WEINMANNcomfort 2 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients by generating a Continuous Positive Airway Pressure (CPAP). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a blower-based system that delivers air pressure to the patient's airway. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.) which is characteristic of IVD devices.
- Lack of IVD-related terms: The description does not mention any terms related to in vitro diagnostics, such as "sample," "reagent," "assay," "analyte," "diagnosis," or "testing of biological specimens."
The WEINMANNcomfort 2 is a medical device used for therapy, specifically for treating a respiratory condition.
N/A
Intended Use / Indications for Use
The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.
Product codes
BZD
Device Description
The WEINMANNcomfort 2 is a microprocessor controlled blower-based device that generates a Continuous Positive Airway Pressure (CPAP) from 4 to 20 cmH2O for the treatment of Obstructive Sleep Apnea (OSA).
The system includes the flow generator, patient tubing, external power supply, and an optional heated humidifier WEINMANNaqua.
A radial compressor draws in ambient air via a filter and conveys it to the unit outlet. From here the air flows through the hose system and the mask to the patient.
The WEINMANNcomfort 2 has one mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixed-pressure as set by the clinician. Automatic switch on/off can be activated on WEINMANNcomfort 2. The unit can then be switched on by breathing into the mask and will switch off when the mask is removed. The softstart automatic system is installed to help the patient fall asleep more easily.
The optional breath humidifier WEINMANNaqua can be snapped onto the therapy unit. The air from the flow generator is directed over a water surface in the humidifier, which functions according to the pass-over principle.
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
Intended User / Care Setting
Home and hospital use.
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)
Design verification testing was performed to ensure that the WEINMANNcomfort 2 based on risk analysis and product requirements met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
WEINMANN
medical technology
5. 510(k) Summary
WEINMANNcomfort 2
April 20, 2007
JUL 1 8 2007
Submitter Information:
Weinmann Gerate fur Medizin GmbH+Co. KG Kronsaalsweg 40 22525 Hamburg / Germany
| Submitter's Name: | Eckhardt Albers |
|---|---|
| Phone: | 011 49 40 54 70 2 - 180 |
| Fax: | 011 49 40 54 70 2 - 468 |
Device Name:
| Proprietary name: | WEINMANNcomfort 2 |
|---|---|
| Common Name: | CPAP Device |
| Classification Name: | Noncontinuous ventilator |
Device Classification:
.
21 CFR 868.5905, Class II, Product Code BZD
Predicate Device Equivalence:
Substantial equivalence is claimed to ResMed S7 Elite CPAP System, cleared for commercial distribution per K013909.
Device Description:
The WEINMANNcomfort 2 is a microprocessor controlled blower-based device that generates a Continuous Positive Airway Pressure (CPAP) from 4 to 20 cmH2O for the treatment of Obstructive Sleep Apnea (OSA).
The system includes the flow generator, patient tubing, external power supply, and an optional heated humidifier WEINMANNaqua.
A radial compressor draws in ambient air via a filter and conveys it to the unit outlet. From here the air flows through the hose system and the mask to the patient.
The WEINMANNcomfort 2 has one mode of operation (CPAP fixed-pressure mode). In this mode the flow generator provides a single fixed-pressure as set by the clinician. Automatic
1
Image /page/1/Picture/0 description: The image shows the logo for Weinmann Medical Technology. The logo is in black and white. The word "WEINMANN" is in large, bold letters, and the words "medical technology" are in smaller letters below it. There are two diagonal lines above the second N in Weinmann.
switch on/off can be activated on WEINMANNcomfort 2. The unit can then be switched on by breathing into the mask and will switch off when the mask is removed. The softstart automatic system is installed to help the patient fall asleep more easily.
The optional breath humidifier WEINMANNaqua can be snapped onto the therapy unit. The air from the flow generator is directed over a water surface in the humidifier, which functions according to the pass-over principle.
Intended Use:
The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.
Comparison of Technological Characteristics
The WEINMANNcomfort 2 has the same technological characteristics as the predicate device.
The new device has the following similarities to the previously cleared predicate device:
- . Same intended use
- . Same operating principle
- � Same technology
- Same manufacturing process .
The new device differs in having an external power supply. This change, as well as other minor changes, do not affect safety and effectiveness.
Summary of Device Testing:
Design verification testing was performed to ensure that the WEINMANNcomfort 2 based on risk analysis and product requirements met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used.
Conclusion:
Based on the above, we concluded that the WEINMANNcomfort 2 is substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use, and performs as well as or better than the predicate device.
End of section.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 8 2007
Mr. Eckhardt Albers Quality Assurance Manager Weinmann Gerate Fur Medizin GmbH + CO. KG Kronsaalsweg 40 22525 Hamburg, GERMANY
Re: K071163
Trade/Device Name: WEINMANNcomfort 2, Model WM 27600 and Weinmann Aqua Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: July 6, 2007 Received: July 11, 2007
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. Alberts
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Chih-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
510(k) Number (if known):
Device Name: WEINMANNcomfort 2
Indications For Use:
The WEINMANNcomfort 2 is for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (WEINMANNaqua) is indicated for the humidification and warming of air from the WEINMANNcomfort 2 flow generator device. The WEINMANNcomfort 2 and WEINMANNaqua are for home and hospital use.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Null R. Roff
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K071163