(84 days)
No
The summary describes a standard multi-parameter physiological monitor with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is intended for monitoring, display, and recording physiological data and generation of alarms, not for treating a disease or condition.
No.
The device is intended to monitor, display, and record physiological data, and generate alarms, but it does not provide a diagnosis. Its function is to provide real-time patient physiological data for medical personnel to interpret.
No
The device description explicitly states it consists of hardware components including a color LCD touchscreen, multi-parameter input unit, and a removable battery pack, in addition to being software driven.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The description clearly states the device monitors, displays, and records physiological data directly from the patient. It measures things like ECG, heart rate, blood pressure, temperature, and respiratory rate. These are all measurements taken in vivo (within the living body).
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
Therefore, based on the provided information, this device falls under the category of a patient monitor or physiological monitor, not an In Vitro Diagnostic device.
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 within a medical facility. The device is intended to 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, carbon dioxide concentration (CO2 and EtCO2), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations.
Product codes
MHX
Device Description
The device is a multi-parameter monitor consisting of a color LCD touchscreen to display waveforms and numerics of monitored parameters, multi-parameter input unit (socket panel), and a removable battery pack. Options include a built-in thermal array recorder and network communication. The device is software driven.
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
Intended User / Care Setting
medical personnel on all patient populations / within a medical facility
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 device complies with IEC 601-1 subclause 56.3(c) implemented by 21 CFR Part 898 - Lead Wires and Patient Cables. The device is designed to comply with the standards: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), IEC 60601-1-2 (1993-05), CISPR11 Group 1, Amendment 1 (1998-09), IEC 60601-2-27 (1994), IEC 60601-2-30 (1995-03), IEC 60601-2-34 (1994-12).
The device is not sterile.
The device does not directly contact patients. Accessories that contact patients, such as probes and cables, are the same accessories as used with other legally marketed products or are comprised of the same component materials as the predicate accessories except as noted. The disposable SpO2 probes include No.1776 3M Nonwoven Medical Tape which may contact the surface of intact skin. According to the manufacturer, 3M, the material was tested in accordance with ISO 10993 and Good Manufacturing Practices and found to release acceptable levels of adhesive materials within historically acceptable levels.
The device was subjected to environmental testing including temperature/humidity stress testing, electromagnetic interference / electromagnetic compatibility testing and safety standards testing and performance testing procedures. Test criteria is established prior to testing based upon product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards.
Software verification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications. There are no significant changes in function, biocompatibility, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Koll918 P
NIHON KOHDEN AMERICA, INC. June 19, 2001
510(k) NOTIFICATION BSM-2300A Series Bedside Monitor
SEP 1 2 2001
SECTION 2 - 510(K) SUMMARY
Name and Address of Applicant
Nihon Kohden America, Inc. Contact: Regulatory Affairs Manager 90 Icon Street Foothill Ranch, CA 92610
Phone: (949) 580-1555 Fax: (949) 580-1550
Device Name: BSM-2300A Series Bedside Monitor. Common names for the device include Bedside Device Name: Dow 2007 Coence Bouttor, Cardiac Monitor and Vital Signs Monitor. The classification Monitor, F Gallerinention Patient Monitor with Arrhytmia Detection and Alarms
Legally Marketed Predicate: Nihon Kohden BMS-4100A Series Bedside Monitor per 510(k)# K001693.
Description and Intended Use: The device is a multi-parameter monitor consisting of a color LCD touchscreen to display waveforms and numerics of monitored parameters, multi-parameter input unit (socket Screen to display waronomic and namovable battery pack. Options include a built-in thermal array pailer, visual alanm lindications card. The device is software driven. Both the device and the starside of recorder and hetwork communitor, direr it is display and record physiological data to provide cardiac predicale have the same intention association and the is intended to monitor the electrocaciliogram and vital visible and/or audible 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 monitor mean rate, pulse fate, plood oxygon oataration (2) respiratory rate. The device may generate an blood pressure (fDT ); body tomporation of SS and SS (and St. This device may also condition addide and or visual alam who i modour calls Tato Talle Talle Taller will be available for use by medical personnel on all patient populations.
Performance Testing
- formanos Tooting
The device complies with IEC 601-1 subclause 56.3(c) implemented by 21 CFR Part 898 1 The donion of the read on " Sead Wires and Patient Cables. To date, no other special controls r enomance olandards are known or established for this device. The device is designed to comply or performance candards and the standards: IEC 60601-1 (1988-12), Amendment 1 (1991-11), Amendment 2 (1995-03), IEC 60601-1-1 (1992-06), IEC 60601-1-2 (1993-05), CISPR11 Group 1, Allianonent = (1000-00), 12-27 (1994), JEC 60601-2-30 (1995-03), IEC 60601-2-34 (1994-12) - The device is not sterile. 트
- The device does not directly contact patients. Accessories that contact patients, such as probes and ■ The device are the same accessories as used with other legally marketed products or are comprised of the same component materials as the predicate accessories except as noted below. The disposable SpO2 probes include No.1776 3M Nonwoven Medical Tape which may contact the surface of intact skin. According to the manufacturer, 3M, the material was tested in accordance with ISO 10993 and Good Aooorang to the manafactively of adhesive materials within historically acceptable levels.
- The device was subjected to environmental testing including temperature/humidity stress testing, . electromagnetic interference / electromagnetic compatibility testing and safety standards testing and performance testing procedures. Test criteria is established prior to testing based upon product specifications and applicable standards. The completed testing showed that the device met its product specifications and verified conformance to safety, reliability, and applicable standards. product operification and validation tested the operation of the software functions of the device. The results confirmed that the device performed within specifications.
There are no significant changes in function, biocompatibility, performance or manufacturability compared to the predicate device that would affect the safety and effectiveness of the device as intended for use. Therefore, Nihon Kohden believes that the new BSM-2300 Series, is substantially equivalent to the predicate BSM-4100A Series Bedside Monitor.
1
K011918 p.2/2
NIHON KOHDEN AMERICA, INC. June 19, 2001
510(k) NOTIFICATION BSM-2300A Series Bedside Monitor
SECTION 3 - PROPOSED LABELING
Intended Use A.
The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to monitor the vital signs monitoring withili a modical land/or audible 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, carbon nonimasive blood probodio (NBC) and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.
B. Device/Package Labels
The proposed product labels for the device are located in Attachment 2.
C. Proposed Packaging
Packaging for the device is depicted in Attachment 3.
D. Instructions for Use
The proposed instructions for use are provided with each packaged device and are presented in Attachment 9.
Advertisement/Promotional Literature E.
To date no advertisement or promotional literature for this device has been created for distribution in the United States.
Contraindications, Precautions & Warnings F.
Warnings and cautions are listed in the Operator's Manual as shown in Attachment 4.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2001
Ms. Bonnie Bishop Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, CA 92610
Re: K011918
Trade Name: Nihon Kohden BSM-2300A Series Bedside Monitor and Accessories Regulation Number: 21 CFR 870.1025 Regulatory Class: III (three) Product Code: MHX Dated: June 19, 2001 Received: June 20, 2001
Dear Ms. Bishop:
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 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
3
Page 2 - Ms. Bonnie Bishop
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.
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) 594-4646. 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" (21CFR 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,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
G. Indications for Use Statement
| 510(k) Number (if known): | K011918 |
|---|---|
| --------------------------- | --------- |
Device Name: BSM-2300A Series Bedside Monitors
Indications for Use:
The device is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to 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, carbon dioxide concentration (CO2 and EtCO2), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations.
Dale Tell
Division of Cardiovascular & Respiratory Devices
510(k) Number K011915
Prescription Use
(Per 21 CFR 801.109)