(75 days)
Not Found
No
The document describes a standard vital signs monitor with NIBP, SpO2, and temperature measurement capabilities. There is no mention of AI, ML, or any advanced algorithms beyond basic signal processing for vital sign extraction. The performance studies focus on comparing the device's measurements to predicate devices and simulators, not on evaluating the performance of any AI/ML models.
No.
This device is described as a noninvasive blood pressure monitor with optional pulse oximetry and electronic thermometry, intended for "spot checking or monitoring" of vital signs, which are diagnostic or monitoring functions rather than therapeutic.
Yes
Explanation: The device measures various physiological parameters such as blood pressure, pulse rate, SpO2, and temperature to provide information about a patient's health status, which are used for diagnostic purposes (spot-checking or monitoring).
No
The device description clearly outlines a physical hardware device (monitor, charger, display, keypad, ports, etc.) that performs measurements using physical sensors (cuff, SpO2 sensor, temperature probe). While it has software components, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a monitor for measuring physiological parameters (blood pressure, pulse rate, SpO2, temperature) directly from the patient. This is in vivo measurement, not in vitro (testing samples outside the body).
- Device Description: The description details a monitor with connections for cuffs, sensors, and probes that attach to the patient. It does not mention any components for handling or analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as reagents, assays, sample collection methods, or analysis of biological fluids or tissues.
Therefore, the device described is a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 6004 NIBP monitor is a low cost portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO3, optional oral/rectal temperature, and/or inter. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpO2 and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpO3 and pulse rate data on adult patients using the Nellcor DS 100A sensor. The electronic thermometry option is intended for intermittent "spot checks" of oral or rectal temperature for patients neonate through adult and requires WelchAllyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.
Product codes (comma separated list FDA assigned to the subject device)
DQA, DXN
Device Description
The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional pulse oximeter, electronic thermometer and printer has been updated to include an additional Nellcor pulse oximeter option which uses the same technology as existing legally marketed devices. The BCI 6004 NIBP monitor with Nellcor pulse oximetry uses the Nellcor MP506 pulse oximetry module. This same module is used in the Nellcor Oximax N-550 Pulse Oximeter (K021090). The Nellcor MP506 board uses the same technology in a very similar design to that found in the Nellcor N-595 Pulse Oximeter.
This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power, start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
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
neonate to adults
Intended User / Care Setting
health care professionals in both clinical and ground EMS environments. It is not intended for home use.
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)
Comparison testing of the new 6004 with Nellcor pulse oximetry option and the predicate 6004 was done to show that the performance of the NIBP and electronic thermometry parameters of the two devices are the same (systolic, and mean arterial pressures, NIBP heart rate, oral and rectal temperature). Comparison testing of the new 6004 with Nellcor pulse oximetry option and the Nellcor® N-595 Pulse Oximeter (K012891) was done to show that the performance of the SpO2 measurements made by the two devices is the same. Bench-top performance testing of the BCI 6004 NIBP monitor were performed by Nellcor using their proprietary simulators. They show that their MP506 pulse oximetry board when contained in the BCI 6004 monitor performs to its specifications. A full software validation test of the BCI 6004 NIBP monitor with new Nellcor pulse oximetry option was completed. These tests showed that the device modifications operate as intended and that the changes made do not compromise the overall performance of the monitor. The testing described above indicate that there is no functional difference between the operation of the new 6004 NIBP monitor with Nellcor pulse oximetry option and the original 6004 NIBP monitor or Nellcor N-595 Pulse Oximeter.
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.
BCI® 6004 NIBP monitor (K984618, K983796, K970801), Nellcor® Oximax N-550 Pulse Oximeter (K021090), Nellcor® N-595 Pulse Oximeter (K012891)
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
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the text 'K031742' written in a handwritten style, angled diagonally from the bottom left to the upper right. To the right of this text is a logo that includes a circular graphic with vertical lines, followed by the letters 'BCI' in a bold, sans-serif font. The logo appears to be a company or brand identifier.
AUG 1 8 2003
Summary of Safety and Effectiveness
| Submitter: | BCI, Inc. |
|---|---|
| Address: | N7 W22025 Johnson Road Waukesha, WI 53186 |
| Telephone: | (262) 542-3100 |
| Contact: | VP Regulatory Affairs |
| Prepared: | May 16, 2003 |
| Proprietary Name: | BCI® MiniTorr Plus® NIBP monitor (model 6004) with new Nellcor pulse oximetry option. |
| Common/Classification Name: | Non-invasive blood pressure monitor/pulse oximeter |
| Predicate Devices: | BCI® 6004 NIBP monitor (K984618, K983796, K970801) |
| Nellcor® Oximax N-550 Pulse Oximeter (K021090) | |
| Nellcor® N-595 Pulse Oximeter (K012891) |
New Device Description:
The currently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with optional pulse oximeter, electronic thermometer and printer has been updated to include an additional Nellcor pulse oximeter option which uses the same technology as existing legally marketed devices. The BCI 6004 NIBP monitor with Nellcor pulse oximetry uses the Nellcor MP506 pulse oximetry module. This same module is used in the Nellcor Oximax N-550 Pulse Oximeter (K021090). The Nellcor MP506 board uses the same technology in a very similar design to that found in the Nellcor N-595 Pulse Oximeter.
This device is designed to provide full featured monitoring capabilities in a light weight, transportable design. The system consists of a small table top NIBP monitor with a desk top charger. Features include an NIBP cuff hose connection, an optional SpO2 sensor interface, an optional temperature probe interface and holder, an optional internal printer, display of patient data via an LED display (systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature), system status LEDs (battery, sensor, alarm silence, alarm, and alert), and the function keypad area consisting of eleven keys (power,
1
start, cancel, stat, up and down arrows, interval, recall, manual/auto, alarm set, and alarm silence). The monitor has a serial port that is used for data communication.
Intended Use:
The 6004 NIBP monitor is a low cost portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO2, optional oral/rectal temperature, and/or integral printer. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpO2 and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpO2 and pulse rate data on adult patients using the Nellcor DS 100A sensor. The electronic thermometry option is intended for intermittent "spot checks" of oral or rectal temperature for patients neonate through adult and requires WelchAllyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.
Performance Data:
The design of this device utilizes currently available technology found in many legally marketed devices. Testing was done to ensure that the BCI 6004 monitor would perform within the environment(s) for which it is to be marketed. Testing was performed in accordance with the guidelines and standards found in the reviewer's guides for respiratory devices. Electromagnetic compatibility testing to IEC 60601-1-2: 2001 has been completed and demonstrated that the BCI 6004 monitor was in compliance.
Comparison testing of the new 6004 with Nellcor pulse oximetry option and the predicate 6004 was done to show that the performance of the NIBP and electronic thermometry parameters of the two devices are the same (systolic, and mean arterial pressures, NIBP heart rate, oral and rectal temperature). Comparison testing of the new 6004 with Nellcor pulse oximetry option and the Nellcor® N-595 Pulse Oximeter (K012891) was done to show that the performance of the SpO2 measurements made by the two devices is the same.
Bench-top performance testing of the BCI 6004 NIBP monitor were performed by Nellcor using their proprietary simulators. They show that their MP506 pulse oximetry board when contained in the BCI 6004 monitor performs to its specifications.
A full software validation test of the BCI 6004 NIBP monitor with new Nellcor pulse oximetry option was completed. These tests showed that the device modifications operate as
2
Image /page/2/Picture/0 description: The image shows the logo for BCI. The logo consists of a circle made of vertical lines on the left, followed by the letters "BCI" in bold, sans-serif font. There is a small dot to the right of the letter "I". The logo is black and white.
intended and that the changes made do not compromise the overall performance of the monitor.
The testing described above indicate that there is no functional difference between the operation of the new 6004 NIBP monitor with Nellcor pulse oximetry option and the original 6004 NIBP monitor or Nellcor N-595 Pulse Oximeter. On the basis of these results, it is our determination that the device is safe, effective, and performs as well as the legally marketed predicate device(s).
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Respectfully,
Donald D. Alyward
Donald Alexander VP Regulatory Affairs
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Image /page/3/Picture/1 description: The image is a black and white circular logo. The logo features a stylized bird-like symbol with three curved lines representing its body and wings. The bird is facing towards the right. Encircling the bird symbol is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged along the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 2003
Mr. Donald Alexander Vice President of Regulatory Affairs BCI, Incorporated N7 W22025 Johnson Road Waukesha, Wisconsin 53186-1856
Re: K031742
Trade/Device Name: BCI 6004 NIBP Monitor with Nellcor Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II (Two) Product Code: DQA, DXN Dated: May 23, 2003 Received: June 4, 2003
Dear Mr. Alexander:
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. Alexander
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 (QS) 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Susan Russoni
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications For Use
510(k) Number (if known): KO31742
Device Name: BCI 6004 NIBP Monitor with Nellcor Pulse Oximeter.
Indications For Use:
Intended Use
The 6004 NIBP monitor is a low cost portable NIBP monitor for spot checking or monitoring of a patient's systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rate, with optional SpO3, optional oral/rectal temperature, and/or inter. The device will provide NIBP measurements on patients ranging from neonate to adults when using the appropriate BCI blood pressure cuff. The monitor has two modes for NIBP monitoring: neonate and adult. An LED indicator illuminates when the monitor is configured for NIBP neonate mode. The BCI oximetry options work with all BCI oximetry sensors when providing SpO2 and pulse rate on all patients from neonate to adult in both NIBP adult and neonate mode. The Nellcor oximetry option provides SpO3 and pulse rate data on adult patients using the Nellcor DS 100A sensor. The electronic thermometry option is intended for intermittent "spot checks" of oral or rectal temperature for patients neonate through adult and requires WelchAllyn thermometry probes and probe covers. The temperature option works for all patients in NIBP adult or neonate mode. The device is intended for use in both clinical and ground EMS environments by health care professionals. It is not intended for home use.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital, |
| Infection Control, Dental Devices |
| 510(k) Number: | K031242 |
|---|---|
| ---------------- | --------- |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
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