(226 days)
I'm sorry, but without text providing information about K/DEN numbers for predicate devices, I cannot fulfill your request. The input "Not Found" indicates that the necessary information is missing.
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts. The only information present is about predicate devices, which does not indicate the presence of AI/ML in the subject device.
No
The provided information only lists predicate devices, which are all types of ventilators or capnographs, indicating a likely diagnostic or monitoring function rather than a direct therapeutic one. There is no information in the text that directly identifies the device as therapeutic.
No
The information provided only lists predicate devices, which are medical devices. It does not contain any information about the device's intended use, description, or functions, making it impossible to determine if it is a diagnostic device.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device. The predicate devices listed are hardware-based ventilators and capnographs, which doesn't provide insight into the nature of the subject device.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
-
Lack of IVD-Specific Information: The document is completely devoid of any information typically found in an IVD submission, such as:
- Intended Use/Indications for Use: This is the most crucial piece of information for determining if a device is an IVD. IVD intended uses specifically describe the diagnostic purpose (e.g., detecting a disease, measuring a substance in a sample).
- Device Description: IVD descriptions detail how the device interacts with biological samples.
- Input Imaging Modality: While not all IVDs use imaging, if it did, this would be relevant.
- Anatomical Site: IVDs typically analyze samples taken from specific anatomical sites.
- Training/Test Set Descriptions and Performance Studies: These are essential for demonstrating the analytical and clinical performance of an IVD.
- Key Metrics: Sensitivity, specificity, etc., are standard performance metrics for IVDs.
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Predicate Devices: The listed predicate devices (Drager Evita 1, Drager Capnosat, Siemens Servo 300) are all ventilators and respiratory monitoring devices. These are generally considered medical devices used for patient support and monitoring, not for performing in vitro diagnostic tests on biological samples.
Conclusion:
The information provided strongly suggests that this device is a non-IVD medical device, likely related to respiratory support or monitoring, given the nature of the predicate devices. There is no indication that it is intended to be used for the in vitro examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
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
SUMMARY AND CERIFICATION 2.
Drager Inc. K96168 Dec. 13, 1996
Identification 2.1
Applicants Name and Address: Drager Inc. Critical Care Systems 4101-100 Pleasant Valley Rd. Chantilly, Virginia 22021 (703) 817 0100 phone: fax: (703) 817 0101
Contact Person:
Harald Kneuer Regulatory Affairs Manager (703) 817 0100 phone: (703) 817 0101 fax:
Manufacturers Address:
Dragerwerk AG Moislinger Allee 53-55 23542 Luebeck Germany
Date of Application:
Device Name:
Evita 4
April 24, 1996
Registration Number:
Owner/Operator ID No. Drager Inc .: 24 31 188 Registration No. Dragerwerk AG:
96 11 500
Classification:
Classification: Panel: Code: Classification Name: Device Listing #:
Class II
73
CBK
Ventilator, Continuous
A911151
Predicate Device(s):
| Drager Evita 1, | 510(k) Number: K92 49 30 |
|---|---|
| Drager Capnosat, | 510(k) Number: K92 28 49 |
| Siemens Servo 300; | 510(k) Number: K90 28 59 |
Drager EVITA 4 Premarket Notification Submission, 510(k)
00000