(459 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
Yes
The device is used to administer anesthesia and control ventilation for patients, indicating its role in treating or managing a medical condition.
No
The KION Anesthesia Workstation is indicated for the provision of anesthesia and assisting patient breathing during anesthesia, not for diagnosing medical conditions.
No
The device description explicitly refers to an "Anesthesia Workstation," which is a complex medical device that includes hardware components for delivering anesthesia and controlling ventilation. The submission describes adding "Extended Modes Functionality" to this existing hardware, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to administer anesthesia and assist with patient breathing. This is a direct interaction with the patient's physiological processes, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the functionality of an anesthesia workstation, including ventilation modes. This aligns with a life support or therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The KION Anesthesia Workstation's function is to support and control a patient's breathing during anesthesia, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The KION Anesthesia Workstation is intended for general anaesthesia use. The KION Anesthesia Workstation will deliver operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a decelerating flow pattern. KION Anesthesia Workstation is also intended to allow for the provision of manual ventilation and spontaneous ventilation.
Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a device is required to assist the breathing of a patient undergoing anesthesia. The device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breath, as well as supporting patients with reduced ability to breath.
Product codes
BSZ, ELI, DSI, CBP
Device Description
The KION Anesthesia Workstation - Extended Modes Functionality, adds primarily new functions for Pressure Support and Non-rebreathing to the already cleared KION Anesthesia Workstation with Pressure Control Functionality.
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
The KION Anesthesia Workstation is intended for use on the neonatal to adult patient populations in all ventilation modes. The exception is in Volume Control in the Circle System, where it is not intended for use on neonates.
Intended User / Care Setting
Intended Operator: The KION Anesthesia Workstation is intended for use by Healthcare professionals who are trained in the administration of anesthesia
Intended Use Environment: The KION Anesthesia Workstation is intended to be used in the environments where anesthesia is to be administered by Healthcare professionals trained in administering anesthesia. It is not intended for transport use in ambulances or helicopters. It is not intended for use in Magnetic Resonance Imaging Suites.
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)
K973971, K001315, K010923, K811102, K902859, K893786
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
MAR 2 3 2004
| | Document Type
Traditional 510(k) | Section-Page
E-2 | |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------|-------------|
| Object/Subject
KION Anesthesia Workstation - Extended Modes Functionality -
510(k) Summary & Certification | | Doc-ID
EVU 113 905 | Issue
00 |
510 (k) Summary as required by section 807.92(c)
Subscribers Name & Address
Siemens-Elema AB Electromedical Systems Division, Life Support Systems Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: (011) 46 8 7307000 Fax: (011) 46 8 986017
Contact Person for this submission:
Mikael K. Johansson, Regulatory Affairs Anesthesia
Official Correspondent:
Timothy W Capehart Manager Regulatory Submissions, Siemens Medical Solutions USA, Inc. 51 Valleystream Parkway, Malvern PA 19355
Trade Name
KION Anesthesia Workstation - Extended Modes Functionality
Device Classification
| Common Name | Classification
Number | Class | Regulation Number |
|-------------------------------|--------------------------|-------|-------------------|
| Gas machine, Anesthesia | 73 BSZ | II | 21 CFR 868.5160 |
| Gas machine, Analgesia | 73 ELI | II | 21 CFR 868.5160 |
| Arrhythmia detector and alarm | 74 DSI | III | 21 CFR 870.1025 |
| Non-rebreathing valve | CBP | II | 21 CFR 868.5870 |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| KION Anesthesia Workstation | K973971 |
| Modification to KION Anesthesia Workstation | K001315 |
| KION Anesthesia Workstation - Pressure Control Functionality | K010923 |
| Servo Ventilator 300A | K970839 |
| Servo Ventilator 900C Siemens-Elema AB | K811102 |
| Servo Anesthesia Circle 985 Siemens-Elema AB | K893786 |
Other relevant submissions
| Devices | 510(k) # |
|---|---|
| Servo-I | K010925 |
| Servo Ventilator 300 Auto Mode | K970839 |
1
| SIEMENS | Document Type | Section-Page |
|---|---|---|
| Traditional 510(k) | E-3 | |
| Object/Subject | Doc-ID | Issue no. |
| KION Anesthesia Workstation - Extended Modes Functionality - | ||
| 510(k) Summary & Certification | EVU 113 905 - 00 |
Device Description (for detailed description see Section F)
The KION Anesthesia Workstation - Extended Modes Functionality, adds primarily new functions for Pressure Support and Non-rebreathing to the already cleared KION Anesthesia Workstation with Pressure Control Functionality.
Intended Use:
The KION Anesthesia Workstation is intended for general anaesthesia use. The KION Anesthesia Workstation will deliver operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a decelerating flow pattern. KION Anesthesia Workstation is also intended to allow for the provision of manual ventilation and spontaneous ventilation.
Intended Operator:
The KION Anesthesia Workstation is intended for use by Healthcare professionals who are trained in the administration of anesthesia
Intended Patient Populations:
The KION Anesthesia Workstation is intended for use on the neonatal to adult patient populations in all ventilation modes. The exception is in Volume Control in the Circle System, where it is not intended for use on neonates.
Intended Use Environment:
The KION Anesthesia Workstation is intended to be used in the environments where anesthesia is to be administered by Healthcare professionals trained in administering anesthesia. It is not intended for transport use in ambulances or helicopters. It is not intended for use in Magnetic Resonance Imaging Suites.
Summary of technological characteristics of Device and Predicate Device:
The KION Anesthesia Workstation - Extended Modes Functionality is substantially equivalent to it's previous versions KION Anesthesia Workstation (K973971), Modification to KION Anesthesia Workstation (K001315) and KION Anesthesia Workstation with Pressure Control Functionality (K010923) as well as to the predicate devices, the Siemens Servo Ventilator 900 C (K811102), Siemens Servo Ventilator 300 (K902859), and Servo Anesthesia Circle 985 (K893786).
The technical differences are more of physical dimensions (compared to the SV900 and SV300), simplified user interaction for fast and reliable user operation, and use of modern components. The technology used is assessed and the results show that the KION anesthesia Workstation. Extended Modes functionality has the equivalent clinical performance.
Siemens-Elema AB
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 circular design with the department's name around the perimeter. In the center is a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes coiled around it.
MAR 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jamie Yieh Manager, Regulatory Affairs Maquet Inc. c/o Siemens Medical Solutions USA, Inc. 1140 Route 22 East, Suite 202 Bridgewater, NJ 08807
Re: K024213
Trade/Device Name: Siemens Kion Anesthesia Workstation Regulation Number: 870.1025 Regulation Name: Physiological Patient Monitor w/ Arrhythmia Detection or Alarms Regulatory Class: III Product Code: DSI, BSZ Dated: December 23, 2003 Received: December 24, 2003
Dear Mr. Yich:
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. Jamie Yieh
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
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
| SIEMENS | Document Type
Traditional 510(k) | Section-Page
H-2 |
|----------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------|
| Object/Subject
KION Anesthesia Workstation - Extended Modes Functionality-
Indicated Use Statement | | Doc-ID
EVU 113 905 - 00 |
510(k) Number (if known): KOZYZ 3
Device Name: KION Anesthesia Workstation
Indications For Use:
Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a device is required to assist the breathing of a patient undergoing anesthesia. The device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breath, as well as supporting patients with reduced ability to breath.
MRI Compatibility Statement:
Siemens KION anesthesia Workstation is not compatible for use in a MRI magnetic field. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
GAmth
Division of Anesthesiology, General Hospital,
5.10(k) Number: K024213
COMPANY CONFIDENTIAL
Siemens-Elema AB
extended modes 510k file (evu 113 905) 17
)62(568)