(80 days)
No
The document describes standard ventilator functions and a CO2 analyzer, with no mention of AI or ML technologies.
Yes
The device is described as "intended for treatment and monitoring of patients... with respiratory failure or respiratory insufficiency," indicating a therapeutic purpose.
Yes
Explanation: The device includes a CO2 analyzer that measures the concentration of carbon dioxide to aid in determining the patient's ventilatory, circulatory, and metabolic status, which is a diagnostic function.
No
The device description explicitly states "The ventilator is the same as described in the notification K010925" and describes hardware components like a CO2 analyzer, indicating it is a physical device with software, not a software-only device.
Based on the provided information, the Servo Ventilator System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment and monitoring of patients with respiratory failure or insufficiency. This is a direct interaction with the patient's physiological state, not the analysis of samples taken from the body.
- Device Description: The core function is ventilation (providing breathing support). While it includes a CO2 analyzer, the purpose of this analyzer is to measure CO2 in expired air from the patient, not to analyze a sample taken from the patient's body (like blood or urine). The CO2 analysis is used to aid in determining the patient's ventilatory, circulatory, and metabolic status in real-time, which is part of the overall patient monitoring and treatment.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on samples.
The CO2 analyzer component, while measuring a biological parameter, is integrated into a system for direct patient support and monitoring of their respiratory function, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.
Product codes
CBK, CCK
Device Description
The ventilator is the same as described in the notification K010925. This application if for the following options to the Servo-i ventilator family.
The Bi-Vent mode is a Pressure controlled mode with added possibility to allow unrestricted spontaneous breathing, also at high level pressure.
The CO2 analyzer displays continuous CO2 curves of mainstream expired air and etCO2 figures. The aim is to measure the concentration of carbon dioxide to aid in determining the patient's ventilatory, circulatory, and metabolic status.
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
neonates, infants and adults
Intended User / Care Setting
professional health care providers who have sufficient experience in ventilator treatment in hospitals or health care facilities and for in-hospital transport.
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)
The technology used is assessed, verification and design validation on animals show that the Servo? Ventilator System has the equivalent clinical performance with the above options.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K010925, K001646, K980642, K001686, K984407, K003075
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SIEMENS
Object/Subject
SEP 1 9 2002
Document Type Special 510(k)
Special
Section-Page E-2 Doc-ID Issue no. EVU-111 163 - 00
Servo Ventilator System -510(k) Summary
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 986190 Contact Person for this submission: Anders Palm Richard Flynn Official Correspondent:
Manager Regulatory Affairs/Quality Assurance Siemens Medical Solutions USA, Inc. / S.S.G. R.A. 16 Electronics Avenue Danvers, MA USA 01923
Trade Names
Siemens Predicate device Servos Ventilator System (K0100925)
Options : Bi-Vent ventilation mode and CO2 analyzer
Device Classification
| Common Name | Classification
Number | Class | Regulation Number |
|-------------------------------------|--------------------------|-------|-------------------|
| Ventilator, Continuous (Respirator) | 73 CBK | II | 868.5895 |
| Carbon dioxide gas analyser | CCK | II | 868.1400 |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # | |
|---|---|---|
| Bi- Vent spontaneous mode breathing; | ||
| PB840 | Puritan Bennet | K001646 |
| Evita 4 | Dräger | K980642 |
| Galileo | Hamilton | K001686 |
| Harmony S/T | Respironics | K984407 |
| KnightStar 330 | Nellcor | K003075 |
| CO2 Analyzer; | ||
| Infnity etCO2 pod | Siemens | K003550 |
1
| | Document Type
Special 510(k) | Section-Page |
|----------------|-----------------------------------------|-----------------|
| Object/Subject | Servo/Ventilator System –510(k) Summary | |
| | Doc-ID
EVU-111 163 | Issue no.
00 |
Device Description (for detailed description see Section F)
The ventilator is the same as described in the notification K010925. This application if for the following options to the Servo-i ventilator family.
The Bi-Vent mode is a Pressure controlled mode with added possibility to allow unrestricted spontaneous breathing, also at high level pressure.
The CO2 analyzer displays continuous CO2 curves of mainstream expired air and etCO2 figures. The aim is to measure the concentration of carbon dioxide to aid in determining the patient's ventilatory, circulatory, and metabolic status.
Intended Use of the Device:
The indented use is the same as in K010925 (Servo-i application) including the;
- Bi-Vent mode a pressure controlled ventilation that allows the patient the opportunity of unrestricted spontaneous breathing.
- CO2 analyzer displaying continuous CO2 curves of mainstream expired air to measure the concentration of carbon dioxide to aid in determining the patient's ventilatory, circulatory, and metabolic status.
The indented use is the same as in K010925 application.
Intended Use of the Device:
The Servo-i Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo-i is a ventilator system to be used only by health care providers in hospitals or health care facilities and for in-hospital transport.
Note: The Servo-i Ventilator System is not intended to be used with any anesthetic agents.
Intended operator:
Servo-i is a ventilator system with advanced functionality. It may be used only by professional health care providers who have sufficient experience in ventilator treatment.
Intended Patient Populations:
Servo-i Infant for patient weight 0.5-30 kg Servo-i Adult for patient weight 10-250 kg Servo-i Universal for patient weight 0.5 - 250 kg.
Intended Use Environment:
The Servo' Ventilator System is designed to be used at the bedside and for in-hospital transport. The Servo? Ventilator System is not intended to be used with any anesthetic agents. The Servo Ventilator System is not compatible for use in a MRI magnetic field
2
| SIEMENS | Document Type
Special 510(k) | Section-Page
E-4 | |
|------------------------------------------|---------------------------------|---------------------|-----------|
| Object/Subject | | Doc-ID | Issue no. |
| Servo Ventilator System – 510(k) Summary | | EVU-111 163 | - 00 |
Summary of technological characteristics of Device and Predicate Device:
Carbon dioxide analyzer.
The CO2 functionality uses the Servo-i screen for presentation of mainstream CO2 measurements. The airway adapter is placed at the Y-piece and the sensor is snapped on to the airway adapter. The CO2 Analyser module receives signals from the sensor that reflects the variations of CO2 in expiratory gas. This allows for continuously monitoring shown in a waveform indicating the CO2 concentration and numerical presentations of EtCO2 and VCO2.
The CO2 functionality for the Servo-i CO2 module is equivalent to the CO2 analyzer in Siemens Infinity CO2 pod (file number K003550), an accessory item employed with the Siemens Servo Ventilator 300A, which also is technologically based and componentry sourced as Sensor and input electronics card from Novametrix. (file number K963380)
Bi-Vent mode
Bi-Vent is a Biphasic positive airway pressure (BIPAP™) which is equivalent to airway pressure release ventilation (APRV) which has been designed to provide ventilatory support with unrestricted, spontaneous breathing, These modalities operate by periodic switching between two levels of continuous positive airway pressure while allowing spontaneous breathing in any phase of the ventilatory cycle. However, in the absence of spontaneous breathing, airway pressure release ventilation/biphasic positive airway pressure is identical to conventional pressure-limited. time-cycled, mechanical ventilation, eg Pressure Control.
Bi-Vent ventilator mode is used on many ventilators for both critical care and home care. The Bi Vent mode is substantially equivalent to Puritan Bennet 840 ventilator with NeoMode option (K001646), Dräger Evita 4 - (K980642) for adult and with Neo flow for neonates , Savina (Dräger – K003068), Galileo (Hamilton - K001686), and Harmony S/T Respironics - K984407 and KnightStar 330 (Nellcor - K003075)
The technology used is assessed, verification and design validation on animals show that the Servo? Ventilator System has the equivalent clinical performance with the above options.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
Mr. Richard M. Flynn Manager, RA/QA Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923
Re: K022132
Trade/Device Name: Servo Ventilator System Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 23, 2002 Received: August 27, 2002
Dear Mr. Flynn:
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.
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.
4
Page 2 - Mr. Flynn
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| SIEMENS | Document Type
Special 510(k) | Section-Page
H-8 | |
|--------------------------------------------------------------------|---------------------------------|----------------------------|-----------|
| Object/Subject
Servo/Ventilator System -Indicated Use Statement | | Doc-ID
EVU-111 163 - 00 | Issue no. |
510(k) Number (if known): K022132
Device Name: Servoi Ventilator System-
Indications For Use:
The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency. Servo is a ventilator system to be used only by healthcare providers in hospitals or healthcare facilities and for in-hospital transport.
(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
Lg. Roberts
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K022132