(221 days)
No
The description mentions a "pre-defined algorithm" for switching between ventilation states, which is characteristic of traditional rule-based programming, not AI/ML. There is no mention of learning, training data, or adaptive algorithms based on patient data.
Yes
Explanation: The device is described as assisting or controlling the breathing of a patient, which directly addresses a physiological function and provides therapy.
No
Explanation: The device description and intended use clearly state its function as assisting or controlling patient breathing, which is a therapeutic function, not a diagnostic one. While it reacts to patient effort, this is part of its therapeutic control, not intended for diagnosing a condition.
No
The device description explicitly states that the Servo Ventilator 300A includes a software change and the addition of a new printed circuit board, a new switch, and two LEDs on the front panel. This indicates the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "assist the breathing of the patient." This is a therapeutic function, directly interacting with the patient's respiratory system.
- Device Description: The description details a ventilator, a device that provides mechanical ventilation. This is a life support device, not a diagnostic tool.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on in vitro testing.
- Using reagents or assays.
In summary, the Servo Ventilator 300A is a medical device used for respiratory support, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
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.
Product codes
73 CBK
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.
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
Adult, Pediatric, Infant and Neonatal patients.
Intended User / Care Setting
Healthcare providers, i.e. Physicians, Nurses and Technicians.
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Siemens Servo Ventilator 300 (K960010)
Reference Device(s)
Not Found
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
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- - - - -- --
1
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.
2
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.
3
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.
8
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".
4
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.
5
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.
6
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
7
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