(90 days)
Not Found
No
The description details a communication interface using standard data transmission protocols and a microprocessor for data conversion and routing. There is no mention of learning, pattern recognition, or complex algorithms characteristic of AI/ML.
No
The device is described as an interface that communicates information from existing ventilators to patient monitoring systems, but it does not directly treat or diagnose a patient's condition.
No
The device is an interface that communicates data from a ventilator to a patient monitoring system; it does not perform diagnostic functions itself.
No
The device description explicitly details hardware components such as a stand-alone unit, fiber optic interfaces, RS-232 interfaces, a microprocessor, RAM, EPROM, and a power indicator. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Bird Monitor Interface (BMI) is described as a communication interface between ventilators and patient monitoring systems. Its purpose is to transmit data from the ventilator to the monitoring system. It does not analyze biological samples or perform any diagnostic tests on bodily fluids or tissues.
- Lack of IVD Characteristics: The description does not mention any interaction with biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
The BMI is a medical device, but its function is related to data communication and integration within a patient care setting, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Bird Monitor Interface (BMI) is a stand-alone unit providing a means of communicating information from Bird ventilators to patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin and SpaceLab's PDMS are provided. as well as a Bird proprietary interface for use with other systems. The purpose of BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
The Bird Monitoring Interface (BMI) is a stand-alone unit providing a communications interface between the Bird ventilators, 8400STi, VIP and TBird, and patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin (via Hewlett-Packard's Vuelink proprietary interface) and SpaceLab's PDMS (via Spacelab's Universal Flexport proprietarv interface) are provided as well as a Bird proprietary interface, the General Purpose Computer Protocol (GPCP), for use with other systems. The purpose of the BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.
The BMI has no user-operated controls or displays. This device is activated when it is attached to a 9 to 15 Volt power supply and fully functional when attached to the ventilator and patient monitoring system. Indicators are limited to a power indicator.
The BMI is installed between the ventilator and the Patient Monitoring System. Figure 3-1 illustrates a tvpical BMI installation. Connection between the ventilator and the BMI is Fiber Optic. Connection between the BMI and the Patient Monitoring System is RS-232 compatible. The BMI also contains a fiber optic feed-through for connection to Bird accessories, particularly the Bird Graphics Monitor and The Partner Volume Monitor.
Serial data is received from the ventilator over the fiber optic interface. The fiber optic signal is converted to an electrical signal by a fiber optic receiver. The electrical signal then routes to a fiber optic driver for connection to an accessory device as described above.
The electrical signal also routes to the serial input of the microprocessor where the serial data is converted to parallel data. The parallel data is then stored in random access memory (RAM) for future use. Program code for the microprocessor is contained in an electrically programmable read only memory (EPROM) and is accessed as necessary for program execution.
Requests from the monitoring system are received as serial RS-232 signals. These signals are converted to logic levels by RS-232 receivers. These logic levels then are processed bv a universal asynchronous receiver transmitter (UART). The UART converts the serial data to parallel data and then notifies the microprocessor by using the interrupt signal. The microprocessor reads the data from the UART, forming a request packet from the monitor. Following receipt of a complete request packet from the monitor, the processor generates the appropriate response packet from the ventilator data stored in RAM. This data is written to the UART, which converts the data to serial form. The serial data is then converted to RS-232 signals and transmitted to the monitor.
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
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing was conducted in the laboratory to confirm input and output of data to and from the Bird Monitor Interface. Testing to Environmental, EMI/RFI and Electrical Safety Standards were performed by certified test facilities. All functions were verified to operate as designed and intended. Hardware and software performance testing verified that the Bird Monitor Interface meets all of it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(K) SUMMARY
Bird Monitor Interface
Bird Products Corporation
Neil Battiste Regulatory Affairs Manager Bird Products Corporation 1100 Bird Center Drive Palm Springs, CA 92262-6267
760.778.7341 (voice) 760.778.7274 (fax)
July 21, 1998
1
General Information
Bird Monitor Interface Device Trade Name:
Device Common/Classification Name:
The Bird Monitor Interface is an accessory to Bird Products Corporation ventilator products classified under 73 CBK "Continuous Ventilators"
| Predicate Device: | Bird RS-232 Interface Module |
|---|---|
| FDA 510(k) No: | K880721 |
| Option 20-26 of Puritan Bennett 7200 Volume Ventilator | |
| FDA 510(k) No: | K841757 |
Intended Use:
The Bird Monitor Interface (BMI) is a stand-alone unit providing a means of communicating information from Bird ventilators to patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin and SpaceLab's PDMS are provided. as well as a Bird proprietary interface for use with other systems. The purpose of BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.
2
Device Description
The Bird Monitoring Interface (BMI) is a stand-alone unit providing a communications interface between the Bird ventilators, 8400STi, VIP and TBird, and patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin (via Hewlett-Packard's Vuelink proprietary interface) and SpaceLab's PDMS (via Spacelab's Universal Flexport proprietarv interface) are provided as well as a Bird proprietary interface, the General Purpose Computer
Protocol (GPCP), for use with other systems. The purpose of the BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.
The BMI has no user-operated controls or displays. This device is activated when it is attached to a 9 to 15 Volt power supply and fully functional when attached to the ventilator and patient monitoring system. Indicators are limited to a power indicator.
Image /page/2/Picture/5 description: The image shows a close-up of a device with several labels and indicators. The device has labels such as "DATA IN", "DATA OUT", "POWER INDICATOR", "DYAD", "MONITOR INTERFACE", "TO MONITOR", and "INPUT 9/16VDC". The device also has a few ports and indicators on the top and bottom.
The BMI is installed between the ventilator and the Patient Monitoring System. Figure 3-1 illustrates a tvpical BMI installation. Connection between the ventilator and the
BMI is Fiber Optic. Connection between the BMI and the Patient Monitoring System is RS-232 compatible. The BMI also contains a fiber optic feed-through for connection to Bird accessories, particularly the Bird Graphics Monitor and The Partner Volume Monitor.
Image /page/2/Figure/8 description: The image shows a diagram of a bird monitoring system. The system consists of a graphics monitor, a bird ventilator, a bird monitor interface, and a monitoring system. The graphics monitor and bird ventilator are connected to the bird monitor interface via fiber optic cables, and the bird monitor interface is connected to the monitoring system via an RS-232 cable.
Figure 3-1 Bird Monitor Interface Installation
3
Serial data is received from the ventilator over the fiber optic interface. The fiber optic signal is converted to an electrical signal by a fiber optic receiver. The electrical signal then routes to a fiber optic driver for connection to an accessory device as described above.
The electrical signal also routes to the serial input of the microprocessor where the serial data is converted to parallel data. The parallel data is then stored in random access memory (RAM) for future use. Program code for the microprocessor is contained in an electrically programmable read only memory (EPROM) and is accessed as necessary for program execution.
Requests from the monitoring system are received as serial RS-232 signals. These signals are converted to logic levels by RS-232 receivers. These logic levels then are processed bv a universal asynchronous receiver transmitter (UART). The UART converts the serial data to parallel data and then notifies the microprocessor by using the interrupt signal. The microprocessor reads the data from the UART, forming a request packet from the monitor. Following receipt of a complete request packet from the monitor, the processor generates the appropriate response packet from the ventilator data stored in RAM. This data is written to the UART, which converts the data to serial form. The serial data is then converted to RS-232 signals and transmitted to the monitor.
Image /page/3/Figure/4 description: The image shows a block diagram of a ventilator interface system. The system consists of several main components, including a ventilator interface, a processor, memory, a monitor interface, and a voltage regulator. The ventilator interface includes an optical receiver and transmitter for fiber optic communication. The processor contains a microprocessor and a latch, while the memory consists of 8K RAM and 64K EPROM. The monitor interface includes a UART and an RS-232 driver/receiver for communication with a patient monitoring system.
Image /page/3/Figure/5 description: The image shows the title of a diagram. The title reads "Bird Monitor Interface Block Diagram". The image also includes the text "Figure 3-2".
4
Comparison to Predicate Device
The Bird Monitor Interface™, (referred to as BMI), is a stand-alone unit providing a means of communicating information from Bird ventilators to patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin and SpaceLab's PDMS are provided, as well as, a
Image /page/4/Picture/3 description: The image shows a cassette tape with a white label on top of a black cassette. The label has the word "SWITCH" in large, bold letters. Below the word "SWITCH" is the word "ENTERPRISES" in smaller letters. The cassette tape has a few buttons and holes on the bottom.
Bird Monitor Interface
Bird proprietary interface for use with other systems. The purpose of the Bird Monitor Interface is to deliver ventilator settings. monitored values. alarm information, and waveform data to the patient monitoring system.
The BMI is not significantly different from the predicate device the Bird RS 232 Interface. Both devices are microprocessor controlled systems that accept the fiber optic output
from the 8400STi® and V.I.P Bird® ventilators. Both interfaces act as intermediaries
linking a Bird ventilator with a central computer. The means of communicating the data between the devices is a commonly used platform.
Image /page/4/Picture/9 description: The image shows a piece of electronic equipment, possibly a computer or server. The device has a boxy shape with a front panel that includes several slots or bays. There is a logo or label on the top right of the device. The device is sitting on a surface with a grid pattern.
RS-232 Interface Module
The development of the BMI involves four changes to the currently marketed Interface Module RS232:
-
- The BMI interfaces directly with the Hewlett-Packard Merlin and SpaceLab's PDMS systems;
-
- The BMI accepts input from the TBird ventilator family;
-
- The BMI does not contain any alarms or indicate any alarm conditions;
-
- The BMI does not interface directly to a printer
First Modification:
Direct output to the Hewlett-Packard Merlin and SpaceLabs PDMS systems. Both the Hewlett-Packard Merlin and SpaceLab's PDMS are popular patient monitoring svstems with an established hospital customer base.
Each system employs a unique, proprietary communications protocol (Hewlett-Packard VueLink and SpaceLab's Universal Flexport). The protocol, maintained and supplied by each company, describes the exact structure and hierarchy for transmitted data. Information received in the proper format can be displayed on the monitor's display screen.
The BMI functions as a data organizer for each of these monitoring systems. The Bird ventilator sends out a stream of data in a format designed by Bird. The BMI gathers this
5
information and structures it into the required format, one that is acceptable to the monitoring system. This does not entail substantive modification of the data. Rather, the BMI describes the data in terms that are understandable and usable by the monitoring system before sending it on.
The Data Interface-RS232 performed a similar function but formatted the data for printing or into a more universal format call the General Purpose Computer protocol. The Data Interface-RS232 could not be connected directly to a monitoring system.
Second Modification;
The BMI accepts information from the TBird family of ventilators.
The Data Interface-RS232 was designed to accept information from the 6400ST, 8400STi, and the VIP Bird. The product scope of the BMI is enhanced in comparison. The BMI can accept and transmit information from the following list of Bird ventilators: 8400STi, VIP Bird, and the TBird Series. The TBird family of ventilators use the same fiber optic output as was used in the previously listed models. All of the connections, cables, and protocols are common to the entire line.
Third Modification;
The BMI does not contain any alarms or indicate any alarm conditions.
In addition to receiving information on alarm conditions, the Data Interface-RS232 contained the means of displaying this information. The front panel of the Data Interface-RS232 housed LED indicators for an alarm condition and an alarm disable. There is an audible alarm generator located inside of the Data Interface-RS232's housing. Any of the ventilator's alarm conditions would engage the Data Interface-RS232's slave alarm system. An alarm condition would trigger a red indicator lamp and sound the audible alarm. The user could manually disable these remote alarm functions. When operating in this condition a yellow indicator lamp would be illuminated.
The BMI acts solely as a means of communicating data from the Bird ventilator to the monitoring system or hospital computer system. All alarm information and alarm conditions are relayed through the BMI to the patient monitoring system for visual and audible display by the monitoring system. The BMI does not contain any audible alarm generators or visual alarms LED indicators. The single LED indicator on the BMI indicates that a power source has been successfully attached.
Fourth Modification - The BMI does not interface directly to a printer.
The Data Interface-RS232 contained the ability to send the ventilator information to a serial printer. The user had to select the proper DIP switch position prior to activating the printer switch. A serial printer and cable were also required.
The BMI does not contain the software or hardware to interface with a printer. The information being transmitted from the BMI can only go to the specified monitoring systems or a computer.
6
Summary of Performance Testing
Performance testing was conducted in the laboratory to confirm input and output of data to and from the Bird Monitor Interface. Testing to Environmental, EMI/RFI and Electrical Safety Standards were performed by certified test facilities. The following table specifies all Bird Monitor Interface functions. All functions were verified to operate as designed and intended, as denoted by the checkmark.
| Specification | Requirement |
|---|---|
| BMI interface to the T-Bird, 8400STi and VIP ventilators | |
| The following data is received from the T-Bird ventilator: | |
| Settings | |
| Mode | ☑ Pressure Support ☑ |
| Tidal Volume | ☑ %02 ☑ |
| Peak Flow | ☑ Pressure Control ☑ |
| Breath Rate | ☑ Inspiratory Pause ☑ |
| Sensitivity | ☑ Inspiratory Time ☑ |
| PEEP | ☑ Waveform type ☑ |
| Vol. Assured Press. Support | ☑ Low Peak Pressure Alarm ☑ |
| High Pressure Limit Alarm | ☑ Low Minute Volume Alarm ☑ |
| Monitored Values | |
| Flow | ☑ Mean Airway Pressure ☑ |
| Proximal Pressure | ☑ Exhaled Minute Volume ☑ |
| Exhaled Tidal Volume | ☑ PEEP ✔ |
| Breath Rate | ☑ Inspiratory Time ☑ |
| Peak Inspiratory Pressure | ☑ |
| Alarm Status | |
| High Pressure Limit | ☑ Apnea ☑ |
| Low Minute Volume | ☑ Low Peak Pressure ✔ |
| The following data is received from the 8400 ventilator: | |
| Settings | |
| Mode | ☑ Pressure Support ☑ |
| Tidal Volume | ☑ Waveform type ☑ |
| Peak Flow | ☑ High Pressure Limit Alarm ☑ |
| Breath Rate | ☑ Low Peak Pressure Alarm ☑ |
| Sensitivity | ☑ Low Minute Volume Alarm ☑ |
| PEEP | ☑ Low PEEP/CPAP Alarm ☑ |
| Apnea Interval | ☑ High Breath Rate Alarm ☑ |
| Back Up Breath Rate | ☑ |
| Monitored Values | |
| Flow | ☑ Peak Inspiratory Pressure ☑ |
| Proximal Pressure | ☑ Mean Airway Pressure ☑ |
| Exhaled Tidal Volume | ☑ Exhaled Minute Volume ☑ |
| Breath Rate | ☑ PEEP ☑ |
| I:E Ratio | ☑ Inspiratory Time ☑ |
| Alarm Status | |
| High Pressure Limit | ☑ Low Peak Pressure ☑ |
| Low Minute Volume | ☑ Low PEEP/CPAP ☑ |
| Apnea | ☑ |
| The following data is received from the VIP ventilator: | |
| Settings | |
| Tidal Volume | ☑ Pressure Support ☑ |
| Peak Flow | ☑ Termination Sensitivity ☑ |
| Breath Rate | ☑ High Pressure Limit ☑ |
| Sensitivity | ☑ Low Peak Pressure Alarm ☑ |
| PEEP | ☑ Low PEEP/CPAP Alarm ☑ |
| Monitored Values | |
| Flow | ☑ Peak Inspiratory Pressure ☑ |
| Proximal Pressure | ☑ Total Breath Rate ☑ |
| Exhaled Tidal Volume | ☑ Exhaled Minute Volume ☑ |
| I:E Ratio | ☑ Mean Airway Pressure ☑ |
| Inspiratory Time | ☑ |
| Alarm Status | |
| High Pressure Limit | ☑ Low Peak Pressure ☑ |
| Apnea | ☑ Low PEEP/CPAP ☑ |
7
| Specification | Requirement | ||
|---|---|---|---|
| BMI interface to the Hewlett-Packard VueLink and SpaceLabs Universal Flexport | |||
| Hewlett-Packard VueLink | |||
| The following data | |||
| is transmitted to the | |||
| Hewlett-Packard monitor: | Total Breath Rate | ☑ | Exhaled Tidal Volume ☑ |
| Peak Inspiratory Pressure | ☑ | Exhaled Minute Volume ☑ | |
| Mean Airway Pressure | ☑ | Inspiratory Time ☑ | |
| Inspiratory Tidal Volume | ☑ | PEEP/CPAP ☑ | |
| SpaceLabs Universal Flexport | |||
| The following data | |||
| is transmitted to the | |||
| SpaceLabs monitor: | Total Breath Rate | ☑ | Exhaled Minute Volume ☑ |
| Inspiratory Time | ☑ | Mean Airway Pressure ☑ | |
| Peak Inspiratory Pressure | ☑ | Exhaled Tidal Volume ☑ | |
| PEEP/CPAP | ☑ | Inspiratory Tidal Volume ☑ | |
| Proprietary Interface | |||
| All TBird data listed below is available through the proprietary interface. | |||
| Settings | Mode | ☑ | Pressure Support ☑ |
| Tidal Volume | ☑ | %02 ☑ | |
| Peak Flow | ☑ | Pressure Control ☑ | |
| Breath Rate | ☑ | Inspiratory Pause ☑ | |
| Sensitivity | ☑ | Inspiratory Time ☑ | |
| PEEP | ☑ | Waveform type ☑ | |
| Vol. Assured Press. Support | ☑ | Low Peak Pressure Alarm ☑ | |
| High Pressure Limit Alarm | ☑ | Low Minute Volume Alarm ☑ | |
| Monitored Values | Flow | ☑ | Peak Inspiratory Pressure ☑ |
| Proximal Pressure | ☑ | Mean Airway Pressure ☑ | |
| Exhaled Tidal Volume | ☑ | Exhaled Minute Volume ☑ | |
| Breath Rate | ☑ | PEEP ☑ | |
| Inspiratory Time | ☑ | ||
| Alarm Status | High Pressure Limit | ☑ | Apnea ☑ |
| Low Minute Volume | ☑ | Low Peak Pressure ☑ | |
| All 8400 data listed in below is available through the proprietary interface. | |||
| Settings | Mode | ☑ | Pressure Support ☑ |
| Tidal Volume | ☑ | Waveform type ☑ | |
| Peak Flow | ☑ | High Pressure Limit Alarm ☑ | |
| Breath Rate | ☑ | Low Peak Pressure Alarm ☑ | |
| Sensitivity | ☑ | Low Minute Volume Alarm ☑ | |
| PEEP | ☑ | Low PEEP/CPAP Alarm ☑ | |
| Apnea Interval | ☑ | High Breath Rate Alarm ☑ | |
| Back Up Breath Rate | ☑ | ||
| Monitored Values | Flow | ☑ | Peak Inspiratory Pressure ☑ |
| Proximal Pressure | ☑ | Total Breath Rate ☑ | |
| Exhaled Tidal Volume | ☑ | Exhaled Minute Volume ☑ | |
| I:E Ratio | ☑ | PEEP ☑ | |
| Alarm Status | High Pressure Limit | ☑ | Low Peak Pressure ☑ |
| Low Minute Volume | ☑ | Low PEEP/CPAP ☑ | |
| Apnea | ☑ | High Breath Rate ☑ | |
| All VIP data listed below is available through the proprietary interface. | |||
| Settings | Mode | ☑ | PEEP ☑ |
| Tidal Volume | ☑ | Pressure Support ☑ | |
| Peak Flow | ☑ | High Pressure Limit ☑ | |
| Breath Rate | ☑ | Low Peak Pressure Alarm ☑ | |
| Sensitivity | ☑ | Low PEEP/CPAP Alarm ☑ | |
| Monitored Values | Flow | ☑ | Peak Inspiratory Pressure ☑ |
| Proximal Pressure | ☑ | Total Breath Rate ☑ | |
| Exhaled Tidal Volume | ☑ | Exhaled Minute Volume ☑ | |
| I:E Ratio | ☑ | ||
| Alarm Status | High Pressure Limit | ☑ | Low Peak Pressure ☑ |
| Apnea | ☑ | Low PEEP/CPAP ☑ |
8
| Specification | Requirement | ||
|---|---|---|---|
| Power On Self Test | Runs at power application | ||
| verifies processor operation | verifies EPROM operation | verifies RAM operation | |
| Electrical Requirements | |||
| Electrical Safety | IEC601-1:1988 | ||
| Dielectric Withstand | IEC 601-1:1988, clause 20 | ||
| AC Power Grounding and Polarity | output cable, connector cannot be reversed | ||
| reverse polarity will not damage the BMI | |||
| Leakage Current | In accordance with IEC601-1, 1988 | ||
| Electromagnetic Compatibility | |||
| Emissions | IEC 601-1-2 | ||
| Radiated and Conducted EMI | In accordance with CISPR11 | ||
| Magnetic Fields | In accordance with MIL-5TD462D, RE101 | ||
| Immunity | IEC 601-1-2 | ||
| Electrostatic Discharge | In accordance with IEC801-2, FDA | ||
| Radiated Electromagnetic Fields | FDA Reviewer's Guidance | ||
| Fluctuations, Transients, Surges | |||
| Steady State Voltage | 120VAC +10%,-20% | ||
| Dropout | FDA Reviewer's Guidance | ||
| Slow Sags and Surges | FDA Reviewer's Guidance | ||
| Fast Transient Bursts | IEC801-4 for table top equipment | ||
| Fast Surges | FDA Reviewer's Guidance | ||
| Conducted EMC | In accordance with MIL-5TD461 D | ||
| Magnetic Fields | In accordance with RS101 of MIL-5TD462D | ||
| Quasi-Static Electric Fields | FDA Reviewer's Guidance | ||
| Mechanical and Environmental Requirements | |||
| Shock | In accordance with IEC 68-2-27 | ||
| Sinusoidal Vibration | In accordance with IEC 68-2-6 | ||
| Random Vibration | In accordance with IEC 68-2-34 | ||
| Fluid Spill Resistance | In accordance with IEC 601-1, Clause 44.6 | ||
| Operating Temperature | +10 to +40°C, 30 to 75% RH | ||
| Storage Temperature | -20 to +60°C, up to 95% RH | ||
| Surface Temperature | Less than 41 °C while in an ambient of 35°C |
Hardware and software performance testing verified that the Bird Monitor Interface meets all of it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States.
9
Image /page/9/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other. The faces are abstract and appear to be connected by a flowing line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1998
Mr. Neil Battiste Bird Products Corporation 1100 Bird Center Drive Palm Springs, CA 92262-8099
K982580 Re: Bird Monitor Interface Regulatory Class: II (two) Product Code: 73 CBK Dated: July 22 1998 Received: July 24, 1998
Dear Mr. Battiste:
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 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). 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 (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 requlation (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 requlation may result in In addition, FDA may publish further announcements regulatory action. 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.
10
Page 2 -- Mr. Neil Battiste
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 requlation (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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
11
Statement of Indications for Use
The Bird Monitor Interface (BMI) is a stand-alone unit providing a means of communicating information from Bird ventilators to patient monitoring systems. Specific interfaces to the Hewlett-Packard Merlin and SpaceLabs PDMS are provided, as well as a Bird proprietary interface for use with other systems. The purpose of BMI is to deliver ventilator settings, monitored values, alarm information and waveform data to the patient monitoring system.
Kramer