(95 days)
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No
The document describes a non-invasive ventilation mask and its accessories. There is no mention of AI or ML technology in the intended use, device description, or any other section. The focus is on the physical components and function of the mask.
No.
The device is a mask intended to provide a patient interface for the application of noninvasive ventilation, acting as an accessory to ventilators which administer CPAP or positive pressure ventilation for treatment. It does not perform therapy itself.
No
The device is described as a patient interface for noninvasive ventilation, acting as an accessory to ventilators for administering CPAP or positive pressure ventilation. Its function is to deliver therapy, not to diagnose conditions.
No
The device description clearly describes physical masks and associated hardware components (elbows, valves, headgears) used for noninvasive ventilation, with no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a noninvasive ventilation mask. Its function is to provide a physical interface between a patient and a ventilator to deliver air or oxygen. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states that the masks are "intended to provide a patient interface for application of noninvasive ventilation." This is a therapeutic and supportive function, not a diagnostic one.
The device is a medical device used for respiratory support, not for diagnosing conditions through in vitro testing.
N/A
Intended Use / Indications for Use
The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment.
The mask ClassicStar NV, with standard elbow is disposable and for single patient use.
The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.
The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.
Product codes (comma separated list FDA assigned to the subject device)
73CBK
Device Description
Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.
The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure.
A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.
The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory.
All noninvasive ventilation masks are available in three different sizes (S, M, L),
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Adult patients (>30 kg/66 lbs)
Intended User / Care Setting
Hospital, institutional and in the home environments.
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)
Not Found
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
510(k) Summary
Summary of Safety and Effectiveness
Applicants Name and Address:
Dräger Medical AG & Co. KG Moislinger Allee 53-55 23542 Lübeck Germany
Establishment Registration Number: 9611500
Contact Person:
Dr. Karin Luebbers Senior Manager Regulatory Affairs
Tel. No.: + 49 (451) 882-5367 Fax No .: + 49 (451) 882-7-5367
Applicants US Contact Person
Ms. Jovce Kilrov VP Processes, Quality & Regulatory Affairs
Tel. No .: (215) 660-2626 Fax No .: (267) 885-9989
Date submission was prepared:
2008-09-09
Device Name:
ClassicStar™, NV, Full Face Mask, SE Trade Name: Common Name: Full Face Mask, Noninvasive ventilation Trade Name: NovaStar™, NV, Full Face Mask, SE Common Name: Full Face Mask, Noninvasive ventilation NovaStar™, NV, Full Face Mask, AAV Trade Name: Common Name: Full Face Mask, Noninvasive ventilation
1
Noninvasive Ventilation Masks
Classification:
| Class II | ||
|---|---|---|
| Regulation No. | Device | Product Code |
| 868.5895 | Ventilator, continuous, facility use | 73CBK |
Legally Marketed Device to which Substantial Equivalence is claimed:
| 510(k) number | Trade name | Company |
|---|---|---|
| K023135 | Image3 SE Disposable Full Face Mask | Respironics Inc. |
| K063806 | SleepNet MoJoTM -NV Full Face Mask | |
| nonvented | SleepNet Corp. | |
| K060273 | SleepNet MoJoTM Full Face Mask | SleepNet Corp. |
Device Description:
Within the medical device family "Noninvasive Ventilation Masks" are devices to provide a patient interface for the application of noninvasive ventilation.
The masks ClassicStar and NovaStar are Full-Face masks which cover the mouth and the nose and are available with a standard elbow (SE) or an anti-asphyxia valve (AAV). Masks with a standard elbow (SE) may only be used on ventilation devices, which incorporate adequate alarm and safety systems for ventilation failure.
A mask with an anti-asphyxia valve (AAV) incorporates the anti-asphyxia valve in the mask elbow.
The ClassicStar Masks are disposable, while the NovaStar Masks are reusable up to 5 times for multiple patients. Further differences are the headgears, which are similar in materials but differ in means of connection to the mask. The headgears are generally provided with the masks, for the reusable masks further headgears are available as optional accessory.
All noninvasive ventilation masks are available in three different sizes (S, M, L),
Intended Use:
ClassicStar™, NV, Full Face Mask, SE (with standard elbow), size S-L:
The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to he used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. It is intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment. The mask is disposable and for single patient use. NovaStar™, NV, Full Face Mask, SE (with standard elbow), size S-L:
The mask NovaStar noninvasive ventilation (NV) with standard elbow (SE) is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
SEP 2 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karin Lübbers Senior Manger Regulatory Affairs Draeger Medical AG & Co. KG 53/55 Moislinger Allee Luebeck GERMANY 23542
Re: K081743
Trade/Device Name: ClassicStar™, NV, Full Face Mask, SE NovaStar™, NV, Full Face Mask, SE NovaStarTM, NV, Full Face Mask, AAV Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 10, 2008 Received: September 15, 2008
Dear Ms. Lübbers:
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 - Ms. Lübbers
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ThAnnuele Yendms foell
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
Indications for Use
510(k) Number (if known): K
Device Name:
ClassicStar ™, NV, Full Face Mask, SE Star TM, NV, Full Face Mask, SE
NovaStar TM, NV, Full Face Mask, AAV
Indications for Use:
The mask ClassicStar noninvasive ventilation (NV) with standard elbow (SE) and the mask NovaStar noninvasive ventilation (N); with standard elbow (SE) are intended to provide a patient interface for application of noninvasive ventilation. The masks are to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The masks are intended for use on adult patients (>30 kg/66 lbs), who are appropriate candidates for noninvasive ventilation in the hospital or institutional environment.
The mask ClassicStar NV, with standard elbow is disposable and for single patient use.
The mask NovaStar NV, with standard elbow can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.
The full face mask NovaStar, noninvasive ventilation (NV), with anti-asphyxia valve (AAV) is intended to be used with positive airway pressure devices, operating at or above 3 mbar (3 cmH2O). The mask contains exhalation ports and does not require the use of a separate exhalation device. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation in the hospital, institutional and in the home environments. The mask can be used multiple times on multiple patients. Reuse, however, is limited up to 5 times.
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. The
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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Ko81743 510(k) Number: -