(221 days)
Use of the Servo Ventilator 300A is indicated for adult, pediatric or neonatal patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician), when the professional determines that a device is required to assist the breathing of the patient. The device can be used both for controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability.
The Servo Ventilator 300A is a modification of the Servo Ventilator 300 which was found Substantially Equivalent on October 25, 1996 (Premarket Notification K960010). The physical differences between the Servo Ventilator 300 and the Servo Ventilator 300A consist of a software change and adding of a new printed circuit board as well as a new switch and two LED's on the front panel.
In the Servo Ventilator 300A a new functionality called Automode has been added, which is a method that, by using functionality from existing breathing modes, allows the patient to better interact with the ventilator. Each controlled mode has a corresponding supported mode. This gives the possibility for the ventilator to react on patient effort - triggering, and lack of effort - apnea. Essentially the ventilator can be set in two states, support or control. Which of these states that are active is determined by a pre-defined algorithm.
This document describes the Siemens Servo Ventilator 300A, a modification of the Servo Ventilator 300. The primary change is the addition of "Automode" functionality, which allows the ventilator to automatically switch between controlled and supported breathing modes based on patient effort.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a specific table of acceptance criteria with quantitative targets (e.g., a specific percentage of accurate mode switches or a defined range for response times). Instead, the acceptance criteria are described qualitatively as ensuring the "Automode" functionality improves patient adaptation and ease of use without adversely affecting safety.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety: Device operates without adversely affecting patient safety. | "Analysis and tests has shown that the new functionality Automode ... without adversely affecting patient safety." (Page 3) |
| Effectiveness/Performance: Improves adaptation to patient needs. | "Analysis and tests has shown that the new functionality Automode improves the adaptation of the ventilator to the patient needs..." (Page 3) "This software and hardware enhancement will adapt the ventilator status to the patient's breathing efforts, by automatic switching between controlled and supported breathing." (Page 4) "The switching between controlled and supported modes that is done automatically with Automode has always been possible to do manually on the Servo Ventilator 300. For some of the supported modes in Servo Ventilator 300, the Automode functionality improves the safety for the patient, by doing an automatic switch to a controlled mode in case of apnea, instead of just giving an alarm." (Page 2) |
| Ease of Use: Improves ease of use. | "...as well as the ease of use of the device..." (Page 3) |
| Functionality: All new features (Automode) function correctly. | "All different settings of the new functionality was tested, as well as all the ventilation modes and the complete alarm system. All test were passed according to criteria that are equal or more stringent than the test criteria which were applied to the predicate device." (Page 2) |
| Equivalence to Predicate Device (Servo Ventilator 300): Maintain or exceed safety and effectiveness of the predicate device. | "Therefor, we conclude that the requirements specifications and validation testing show that the modified device is as safe and effective, and performs as well or better as the predicate device." (Page 3) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a "clinical test has also been performed to evaluate the automatic switching between controlled and supported ventilation" (Page 2). However, it does not specify the sample size used for this clinical test (number of patients, number of events, etc.).
The data provenance (country of origin, retrospective/prospective) is not explicitly stated for this clinical test. Given the submitter's address (Sweden), it's possible the test was conducted there, but this is not confirmed. The document only mentions the intended use in the U.S. market.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. There is no mention of experts establishing ground truth for the clinical test data.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study is mentioned. This device is not an AI-assisted diagnostic tool, but rather an automated feature within a medical device (ventilator). The "Automode" functionality is a direct automation of a clinical decision, not an aid for human interpretation. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not directly apply here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The "Automode" functionality is inherently a standalone algorithmic feature. It automatically switches between modes based on pre-defined algorithms and patient effort, without continuous human intervention for each switch. The clinical test evaluated this automated switching.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document does not explicitly state how "ground truth" was established for the clinical test of automatic switching. It's implied that the success of the automatic switching was evaluated based on its clinical appropriateness and effect on patient ventilation, likely against established physiological responses or clinical standards, but the specific method (e.g., expert review of ventilator logs, patient outcomes, direct observation) is not detailed. Crucially, it speaks to whether the system "improves the adaptation of the ventilator to the patient needs," suggesting clinical observation or physiological measurements as the basis for evaluation.
8. The Sample Size for the Training Set
The document refers to the "Automode" as a "software change and adding of a new printed circuit board" based on "functionality from existing breathing modes" (Page 1). This implies that the underlying algorithms and logic were primarily designed based on existing knowledge of ventilator operation and clinical practice, rather than trained on a large dataset in the sense of machine learning. Therefore, a "training set" in the context of deep learning or statistical model training is not applicable or mentioned. The "design" of the device was validated, not "trained."
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, a "training set" in the modern AI sense is not explicitly used or described. The "ground truth" for the device's design implicitly comes from established medical and engineering principles of ventilation, rather than a data-driven training process with established ground truth labels. The "design" itself reflects clinicians' understanding of optimal ventilation strategies.
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Section 2 - Summary & Certification
Submitter's Name and Address
Siemens-Elema AB Röntgenvägen 2 S-171 95 Solna Sweden
OCT 1 4 1997
Official Correspondent
Mr. David Simard
Telephone (508) 750 7500 (508) 777 3391 Telefax
Contact Person for this Submission
Ms. Ann-Christine Jönsson
Telephone 011-46 8 730 77 74 Telefax 011-46 8 98 61 90
Device Name
| Trade/Proprietary Name: | Servo Ventilator 300A |
|---|---|
| Common Name: | Ventilator |
| Classification Name: | Ventilator, Continuous (Respirator) |
Predicate Device
The legally marketed device to which equivalence is being claimed is:
Siemens Servo Ventilator 300 (K960010)
1- - - - -- --
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Device Description
The Servo Ventilator 300A is a modification of the Servo Ventilator 300 which was found Substantially Equivalent on October 25, 1996 (Premarket Notification K960010). The physical differences between the Servo Ventilator 300 and the Servo Ventilator 300A consist of a software change and adding of a new printed circuit board as well as a new switch and two LED's on the front panel.
In the Servo Ventilator 300A a new functionality called Automode has been added, which is a method that, by using functionality from existing breathing modes, allows the patient to better interact with the ventilator. Each controlled mode has a corresponding supported mode. This gives the possibility for the ventilator to react on patient effort - triggering, and lack of effort - apnea. Essentially the ventilator can be set in two states, support or control. Which of these states that are active is determined by a pre-defined algorithm.
Coupled modes:
| Volume Control (VC) | $ \Leftrightarrow $ | Volume Support (VS) |
|---|---|---|
| Pressure Control (PC) | $ \Leftrightarrow $ | Pressure Support (PS) |
| Pressure Regulated Volume Control (PRVC) | $ \Leftrightarrow $ | Volume Support (VS) |
When Automode is activated and the ventilator is in PC, VC or PRVC, a switch from the controlled breathing pattern to supported will be induced if the patient triggers two consecutive breaths. In the case of apnea lasting longer than 5 seconds for Neonate, 8 seconds for Pediatric or 12 seconds for Adult, the ventilator will switch back to controlled ventilation with the current settings now applicable to the controlled mode.
A possibility for the patient to interrupt the inspiration and initiate an exhalation is added during controlled breaths in Automode PRVC or PC. This change is made to further adapt the ventilation to the patient.
Intended Use
The Servo Ventilator 300A is intended for general and critical ventilatory care for use on Adult, Pediatric, Infant and Neonatal patients. The unit is designed to be used at the bedside and for in-hospital transport. It is not intended for transport use in ambulances or helicopters in the U.S. market.
The intended use for Servo Ventilator 300A is the same as for the Servo Ventilator 300.
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Comparison of Technological Characteristics
The hardware modification, compared to the original Servo Ventilator 300, is that a new knob has been added on the front panel, to make it possible to switch the Automode functionality on and off. If the Automode switch is in the off position, the functionality of the Servo Ventilator 300A is identical to the functionality of the Servo Ventilator 300.
The switching between controlled and supported modes that is done automatically with Automode has always been possible to do manually on the Servo Ventilator 300. For some of the supported modes in Servo Ventilator 300, the Automode functionality improves the safety for the patient, by doing an automatic switch to a controlled mode in case of apnea, instead of just giving an alarm.
Tests Used in Determination of Substantial Equivalence
The design of the Servo Ventilator 300A has been thoroughly validated at the unit, subsystem and system level. All different settings of the new functionality was tested, as well as all the ventilation modes and the complete alarm system. All test were passed according to criteria that are equal or more stringent than the test criteria which were applied to the predicate device.
A clinical test has also been performed to evaluate the automatic switching between controlled and supported ventilation.
Conclusion
Analysis and tests has shown that the new functionality Automode improves the adaptation of the ventilator to the patient needs, as well as the ease of use of the device, without adversely affecting patient safety.
Therefor, we conclude that the requirements specifications and validation testing show that the modified device is as safe and effective, and performs as well or better as the predicate device.
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Section 3 - Proposed Labeling
Labeling of the Device
All labeling of the device itself can be found in the mechanical drawings "Mont. Instr" (Mounting Instruction) #60 40 476 E380E and "Panel Printing) #64 19 191 E398E, provided as APPENDIX B-1. Other labeling can be found in the accompanying documentation, i.e. the Operating Manual, provided as APPENDIX A-1.
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Below is an example of a package label for the Servo Ventilator 300A.
Image /page/3/Figure/5 description: The image shows a label with the text "SIEMENS SERVO VENTILATOR 300A ENGLISH 120V". The label also includes the part number "64 24 704 E398E" and the serial number "08747". The label also mentions "Life Support Systems. Sweden".
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Intended Use Statement
Purpose and function of the Servo Ventilator 300A:
The Servo Ventilator 300A is intended for general and critical ventilatory care. This software and hardware enhancement will adapt the ventilator status to the patient's breathing efforts, by automatic switching between controlled and supported breathing.
The ventilator will deliver controlled or supported breaths to the patient, with either constant flow or constant pressure, using a set oxygen concentration. The operator can choose to either set the desired pressure or the desired minute volume. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings.
Intended Operator:
The Servo Ventilator 300A is intended to be used by Healthcare providers, i.e. Physicians, Nurses and Technicians.
Intended Patient Populations:
The Servo Ventilator 300A is intended to be used on Adult, Pediatric, Infant and Neonatal populations.
Intended Use Environment:
The Servo Ventilator 300A is intended to be used in the environment where patient care is provided by Healthcare Professionals. The unit is designed to be used at the bedside and for inhospital transport. It is not intended for transport use in ambulances or helicopters in the U.S. market.
Substantial Equivalence:
The enhanced functionality for the Servo Ventilator 300A is equivalent to the Siemens Servo Ventilator 300. The Siemens Servo Ventilator 300 was granted pre-market approval under 510(k) file number K960010.
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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine. The caduceus is depicted with three intertwined snakes and a staff.
OCT 1 4 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ann-Christine Jönsson Siemens-Elema AB Röntgenvägen 2 Solna SWEDEN
Re: K970839 Servo Ventilator 300A Regulatory Class: II (two) Product Code: 73 CBK Dated: July 19, 1997 Received: July 23, 1997
Dear Ms. Jönsson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Ann-Christine Jönsson
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statment:
510(k) Number (if known):
Device Name: Servo Ventilator 300A
Indications For Use:
Use of the Servo Ventilator 300A is indicated for adult, pediatric or neonatal patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician), when the professional determines that a device is required to assist the breathing of the patient. The device can be used both for controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
============================================================================================================================================================================== Concurrence of CDRH, Office of Device Evaluation (ODE)
Charles C. Ad. In. Mac
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices ×970839 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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).