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.

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.

AI/ML Overview

This document is a 510(k) summary for a Special 510(k) submission for the Siemens Servo Ventilator System, seeking clearance for two new options: Bi-Vent ventilation mode and a CO2 analyzer. The submission claims substantial equivalence to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria (e.g., accuracy percentages, error margins) for the CO2 analyzer or performance metrics for the Bi-Vent mode. Instead, it relies on claiming technological and clinical equivalence to predicate devices, implying that if the new options perform similarly to cleared devices, they meet implicit acceptance criteria.

The "reported device performance" is described through the lens of this equivalence:

Acceptance Criterion (Implicit)	Reported Device Performance
CO2 Analyzer Functional Equivalence: Measures CO2 concentration to aid in determining ventilatory, circulatory, and metabolic status; continuous CO2 curves, EtCO2, and VCO2 display.	"The CO2 functionality for the Servo-i CO2 module is equivalent to the CO2 analyzer in Siemens Infinity CO2 pod (file number K003550)... which also is technologically based and componentry sourced as Sensor and input electronics card from Novametrix (file number K963380)." This implies the Servo-i CO2 analyzer performs these functions with similar accuracy and reliability as the predicate device.
Bi-Vent Mode Functional Equivalence: Pressure-controlled ventilation with unrestricted spontaneous breathing; periodic switching between two levels of continuous positive airway pressure; allowing spontaneous breathing in any phase.	"Bi-Vent is a Biphasic positive airway pressure (BIPAP™) which is equivalent to airway pressure release ventilation (APRV)... 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." "The Bi Vent mode is substantially equivalent to Puritan Bennet 840 ventilator with NeoMode option (K001646), Dräger Evita 4 – (K980642)... Savina (Dräger – K003068), Galileo (Hamilton - K001686), and Harmony S/T Respironics - K984407 and KnightStar 330 (Nellcor - K003075)." This implies the Bi-Vent mode provides the intended ventilation support with equivalent clinical performance to these predicate devices.
Clinical Performance Equivalence: Safe and effective for intended patient populations (neonates, infants, adults) and use environments (hospitals, in-hospital transport).	"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." This statement broadly confirms the clinical performance of the entire system with the new options.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for "test sets" in the typical sense of a clinical trial with a defined number of patients or samples.
Data Provenance: The document mentions "verification and design validation on animals." This indicates that some form of pre-clinical testing data was used.
- Country of Origin: Not specified for the animal studies.
- Retrospective/Prospective: Animal studies are typically prospective by design.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The submission relies on technological and clinical equivalence to predicate devices. It doesn't describe a process of establishing ground truth on a new dataset by experts.

4. Adjudication Method

Not applicable as the submission does not detail a study involving expert review or adjudication of a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or implied in this submission. The focus is on device function and equivalence, not on human reader performance with or without AI assistance (as this is a ventilator, not an AI-assisted diagnostic tool).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, for a ventilator and CO2 analyzer, the performance is inherently "standalone" in the sense that the device performs its functions and measurements independently. The clinical use involves a human operator (healthcare provider), but the performance metrics of the device itself (e.g., CO2 measurement accuracy, pressure delivery) are evaluated for the device alone. The "verification and design validation on animals" would assess this standalone performance.

7. Type of Ground Truth Used

The ground truth is not explicitly defined as pathology, expert consensus, or outcomes data in the context of a new study on the Servo-i. Instead, the "ground truth" for the new options is essentially the performance of the legally marketed predicate devices. The new options are deemed to meet acceptance criteria if they exhibit "equivalent clinical performance" and "technological basis" to these established devices. For the animal study, the "ground truth" would be physiological measurements and observations in the animal model.

8. Sample Size for the Training Set

This document does not refer to a "training set" as it would for a machine learning or AI algorithm. A ventilator's design and engineering are based on medical, physiological, and engineering principles rather than a data-driven training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of this device and submission type. The design and validation are based on established engineering principles, regulatory standards, and comparative performance to predicates.

Summary

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K022132

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	ClassificationNumber	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

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	Document TypeSpecial 510(k)	Section-Page
Object/Subject	Servo/Ventilator System –510(k) Summary
	Doc-IDEVU-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.

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

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SIEMENS	Document TypeSpecial 510(k)	Section-PageE-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.

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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.

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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

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SIEMENS	Document TypeSpecial 510(k)	Section-PageH-8
Object/SubjectServo/Ventilator System -Indicated Use Statement		Doc-IDEVU-111 163 - 00	Issue no.

510(k) Number (if known): K022132

Device Name: Servoi Ventilator System-

Indications For Use:

(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)

Over-The-Counter Use

Lg. Roberts

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022132

Regulation Number and Section

§ 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).