(50 days)
Not Found
No
The summary describes standard physiological monitoring and ECG interpretation software, with no mention of AI or ML technologies.
No.
The device is intended for monitoring, display, and recording physiological data, not for treating or preventing a disease or condition.
Yes
The device "is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis" and monitors vital signs to "generate audible and/or visible alarms when an arrhythmia exists" or when "a measured rate falls outside preset limits," all of which point to its use in identifying medical conditions.
No
The device description explicitly lists multiple hardware components and functions beyond software, such as monitoring blood pressure, temperature, and gas concentrations, and transmitting signals via radio frequency. It is a comprehensive patient monitor system that includes software but 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 clearly states that the device is for monitoring, displaying, and recording physiological data from the patient. This involves measuring vital signs and electrical signals directly from the body.
- Device Description: The device is described as a "Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor and Anesthesia monitor." These are all terms associated with devices that monitor the patient's physiological state in real-time.
- Measured Parameters: The device measures parameters like ECG, heart rate, blood pressure, SpO2, temperature, respiratory rate, and anesthetic gases. These are all directly measured from the patient's body or breath.
- Classification: The device is classified under regulations related to physiological patient monitors, ECG analysis systems, cardiac monitors, oximeters, blood pressure measurement systems, thermometers, breathing frequency monitors, gas analyzers, and radio frequency physiological signal transmitters. These classifications are for devices that interact directly with the patient or their physiological outputs, not with in vitro samples.
In vitro diagnostics (IVDs) are devices that are used to examine specimens (such as blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis on such specimens.
N/A
Intended Use / Indications for Use
The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring as well as gas monitoring. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO>), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CQ), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and qases including NxO, Halothane, Isoflurane, Sevoflurane, and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals yia radio frequency. The device will be available for use by medical personnel on all patient populations within a medical facility.
The series of device are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, Cardiac Output (CO ), oxygen concentration (FiO2), carbon dioxide concentration (CO2 and EtCO2), and respiratory rate, CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including NJO, Halothane, Isoflurane, Sevoflurane, and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
Product codes (comma separated list FDA assigned to the subject device)
MHX, LOS, DRT, DQA, DXN, DSK, DSJ, FLL, BZQ, CCL, CCK, DRG
Device Description
Common names for the BSM-5130A device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor and Anesthesia 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
all patient populations within a medical facility.
adults, children and infants.
The ECAPS 12 interpretive ECG software program of the device is limited for use with patients age 3 years to adult.
Intended User / Care Setting
medical personnel on all patient populations within a medical facility.
medical personnel on patients within a medical facility.
physician
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 BSM-5130A series Bedside Monitor was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of the results confirmed that the device performed within specifications.
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
NIHON KOHDEN AMERICA, INC.
510(k) NOTIFICATION BSM-5130A Series Bedside Monitor
MAR 0 4 2003
SECTION 2 - 510(K) SUMMARY
Name and Address of Applicant Nihon Kohden America, Inc. Attn: Regulatory Affairs 90 Icon St. Foothill Ranch, Ca 92610
Phone: (949) 580-1555 Fax: (949) 580-1550
Indications for Use:
The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring as well as gas monitoring. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO>), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CQ), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and qases including NxO, Halothane, Isoflurane, Sevoflurane, and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals yia radio frequency. The device will be available for use by medical personnel on all patient populations within a medical facility.
The device complies with IEC 601-1 sub-clause 56.3(c) implemented by 21 CFR Part 898 Performance Standard for Electrode Lead Wires and Patient Cables. To date, no other special controls or performance standards are known or established for this device.
The BSM-5130A series devices are not sterile.
The device does not directly contact patients. Accessories that contact patients, such as probes and thermistors, are the same accessories as used with other legally marketed products or are comprised of the same component materials as the predicate accessories. Therefore, qood laboratory practice studies were not required per 21 CFR Part 58.
The BSM-5130A series Bedside Monitor was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the software functions of the results confirmed that the device performed within specifications.
Therefore, Nihon Kohden believes that the device is substantially equivalent to the combination of two Nihon Kohden predicate devices as stated.
1
510(k) NOTIFICATION BSM-5130A Series Bedside Monitor
Common names for the BSM-5130A device include Bedside Monitor, Patient Monitor, Cardiac Monitor and Vital Signs Monitor and Anesthesia monitor. The device has been classified as Class III per Cardiovascular Device Classification Panel under 21 CFR Part 870.1025, "Physiological Patient Monitor with Arrhytmia Detection and Alarms" as MHX and under 21 CFR 870.2340. "ECG Analysis System" as LOS. Functions of the device have also been classified as Class II by the Anesthesiology Device Classification Panel and the General Hospital and Personal Use Classification Panel as follows: under 21 CFR 870.2300, "Cardiac Monitor (including cardiotachometer and rate alarms)" per DRT: under 21 CFR 870.2700, "Oximeter" per DQA; under 21 CFR 870.1130, "Noninvasive Blood Pressure Measurement System" per DXN; under 21 CFR 870.1110 and 21 CFR 870.1100, "Blood Pressure Computer and Alarm" per DSK and DSJ; under 21 CFR 880.2910, "Thermometer. Electronic, Clinical" per FLL; under 21 CFR 868.2375, "Breathing Frequency Monitor" per BZQ; under 21 CFR 868.1720, "Oxygen Gas Analyzer" per CCL; under 21 CFR 868.1400, "Carbon Dioxide Gas Analyzer" per CCK; under 21 CFR 870.2910, "Radio Frequency Physiological Signal Transmitter" per DRG.
The predicate devices are the Nihon Kohden BSM-4100A Monitor per 510(k) #K001693, commercial distribution certification dated October 24, 2000 and the Nihon Kohden Multigas Unit, Ag-920RA per 510(k) #K020046, commercial distribution certification dated July 25, 2002. The new device is a combination of the two devices. The predicate device, marketed by other companies, include: Anesthesia Monitor by Datex-Ohmeda, 510k #K022485, which is similar in intended use,
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 4 2003
Nihon Kohden America, Inc. c/o Mr. Serrah Namini Regulatory Affairs Associate Director 90 Icon Street Foothill Ranch, CA 92610
Re: K030105
Trade Name: BSM-5130A Series Bedside Monitors Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: January 12, 2003 Received: January 13, 2003
Dear Mr. Namini:
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.
3
Page 2 -- Mr. Serrah Namini
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. 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.
K. Deletuh
ram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NIHON KOHDEN AMERICA, INC.
510(k) NOTIFICATION BSM-5130A Series Bedside Monitor
G. Indications for Use Statement
KO30105 510(k) Number (if known):
Device Name: BSM-5130A Series Bedside Monitors
Indications for Use:
The series of device are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, Cardiac Output (CO ), oxygen concentration (FiO2), carbon dioxide concentration (CO2 and EtCO2), and respiratory rate, CO2 and EtCO2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including NJO, Halothane, Isoflurane, Sevoflurane, and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency.
The device will be available for use by medical personnel on patients within a medical facility including adults, children and infants.
The ECAPS 12 interpretive ECG software program of the device is limited for use with patients age 3 years to adult. The interpretation is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis and is not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.
Prescription Use Only
N. Celentano
510(k) Number K030105