(190 days)
No
The device description focuses on the physical components of a nasal mask for CPAP/Bi-level therapy and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The document describes a face mask and its components used to deliver therapy, but it is not the therapeutic device itself. It is an accessory to a CPAP or Bi-level therapy device.
No
The device description indicates it is a face mask used for delivering CPAP or Bi-level Positive Pressure therapy, which is a treatment, not a diagnostic procedure.
No
The device description clearly outlines multiple physical components made of plastic, such as nasal pillows, mask body, forehead cushion, headgear, etc., indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The NP15 is a nasal mask used to deliver positive airway pressure therapy (CPAP or bi-level) to patients. It is a physical interface between the patient and a therapy device.
- Intended Use: The intended use describes the delivery of therapy, not the analysis of biological samples.
- Device Description: The description details the physical components of a mask and its function in delivering air pressure.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the NP15 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NP15 is intended for
- adult patients (> 30 kg) prescribed continuous positive airway pressure . (CPAP) or bi-level therapy,
- multiple-patient use in a hospital or clinic environment after high-level . disinfection,
- single-patient use in a home environment. .
Product codes
BZD
Device Description
The NP15 is a plastic face mask sealing the patient's nose around the nares and including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy.
It consists of nasal pillows, mask body, forehead cushion, forehead support, headgear clip, elbow, tube adapter, pressure measurement port with plug, mask tube, rotating sleeve, exhalation system, headgear (including crossband, forehead strap and cheek strap), and tube anchoring clip.
The mask has an integrated exhalation system and provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.
The NP15 is available as one unit with a set of three different pillow sizes (small, medium, large). It has removable nasal pillows.
The NP15 is secured to the patient's head with a 4-point headgear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's nose around the nares
Indicated Patient Age Range
adult patients (> 30 kg)
Intended User / Care Setting
multiple-patient use in a hospital or clinic environment after high-level disinfection, single-patient use in a home environment.
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)
Bench testing was performed to ensure that the NP15 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)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for WEINMANN medical technology. Above the logo is the text "K10 2515". The logo is in black and white and features the company name in bold letters. Below the company name is the text "medical technology" in a smaller font.
5. 510(k) Summary
MAR 1 1 2011
NP15
August 31, 2010
Submitter Information:
Weinmann Gerate fur Medizin GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg / Germany
| Submitter's Name: | Dr. Ralf Egenolf |
|---|---|
| Phone: | 011 49 40 54 70 2 370 |
| Fax: | 011 49 40 54 70 2 468 |
Device Name:
| Proprietary name: | NP15 |
|---|---|
| ------------------- | ------ |
Nasal mask Common Name:
Accessory to non-continuous ventilator Classification Name:
Device Classification:
21 CFR 868.5905, Class II, Product Code BZD
Predicate Device Equivalence:
Substantial equivalence is claimed to Respironics ComfortLite Nasal Mask, cleared for commercial distribution per K082558. An additional predicate, the Weinmann SOYALA Full Face Mask, cleared for commercial distribution per K061653, is referred to in this submittal as a basis for comparison to certain features, as well as materials other than those used in K082558.
1
Image /page/1/Picture/0 description: The image shows the logo for WEINMANN medical technology. The logo is in black and white, with the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" is the phrase "medical technology" in smaller letters. There are two vertical lines that intersect the two N's in the word WEINMANN.
Device Description:
The NP15 is a plastic face mask sealing the patient's nose around the nares and including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy.
It consists of nasal pillows, mask body, forehead cushion, forehead support, headgear clip, elbow, tube adapter, pressure measurement port with plug, mask tube, rotating sleeve, exhalation system, headgear (including crossband, forehead strap and cheek strap), and tube anchoring clip.
The mask has an integrated exhalation system and provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.
The NP15 is available as one unit with a set of three different pillow sizes (small, medium, large). It has removable nasal pillows.
The NP15 is secured to the patient's head with a 4-point headgear.
Intended Use:
The NP15 is intended for
- adult patients (> 30 kg) prescribed continuous positive airway pressure . (CPAP) or bi-level therapy,
- multiple-patient use in a hospital or clinic environment after high-level . disinfection,
- single-patient use in a home environment. .
Comparison of Technological Characteristics
The NP15 has the same technological characteristics as the predicate device Respironics ComfortLite Nasal Mask, K082558.
The new device has the following similarities to the previously cleared predicate device:
- Same intended use ●
- Same operating principle ◆
- Same technology ●
2
Image /page/2/Picture/0 description: The image shows the logo for WEINMANN medical technology. The logo is in black and white and features the company name in bold, sans-serif font. Below the company name, the words "medical technology" are written in a smaller font.
Some materials of the new device are different from the predicate device. The changed materials represent secondary support or incidental contact. Safety and effectiveness are not affected by these changes.
Summary of Device Testing:
Bench testing was performed to ensure that the NP15 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 NP15 is substantially equivalent to the legally marketed predicate devices Respironics ComfortLite Nasal Mask, K082558, it is safe and effective for its intended use; and performs as well as or better than the predicate devices.
End of section.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Ralf Egenolf Head of Quality Management and Regulatory Affairs Weinmann Gerate fur Medizin GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg GERMANY
MAR 1 1 2011
Re: K102515
Trade/Device Name: NP15 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 21, 2011 Received: February 28, 2011
Dear Dr. Egenolf:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Dr. Egenolf
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
James I. Robertson
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and
· Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for WEINMANN medical technology. The logo is in black and white, with the word "WEINMANN" in large, bold letters. Below the word "WEINMANN" is the phrase "medical technology" in smaller letters. The logo has a stylized design.
4. Indications for Use Statement
510(k) Number (if known):
Device Name: NP15
The NP15 is intended for
- adult patients (> 30 kg) prescribed continuous positive airway pressure . (CPAP) or bi-level therapy,
- multiple-patient use in a hospital or clinic environment after high-level . disinfection,
- single-patient use in a home environment. .
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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)
ul.y. Rel.