(143 days)
Not Found
No
The summary describes a standard vital signs monitor with basic monitoring and alarm functions, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is a vital signs monitor designed for monitoring physiological parameters (SpO2 and CO2), not for providing therapeutic treatment.
No
Explanation: The device is described as a "Vital Signs Monitor" that provides continuous monitoring of physiological parameters like oxygen saturation and CO2. While monitoring is crucial for patient assessment, the text does not indicate that the device diagnoses diseases or conditions; rather, it tracks vital signs and alerts clinical personnel to deviations.
No
The device description explicitly lists hardware components such as an LCD display, built-in battery, and mentions SpO2 and CO2 measurement capabilities which typically involve hardware sensors.
Based on the provided information, 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. They are used to examine these samples outside of the body.
- Device Function: The Vital Signs Monitor described here performs non-invasive continuous monitoring of oxygen saturation (SpO2) and CO2. This is done by applying sensors to the patient's body (e.g., a finger clip for SpO2, a nasal cannula or mask for CO2).
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly measures physiological parameters in vivo (within the living body).
Therefore, the function and intended use of this Vital Signs Monitor fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.
The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital, hospital type facilities environment and intra-hospital moves.
The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
Product codes (comma separated list FDA assigned to the subject device)
DQA, CCK
Device Description
M3B Vital Signs Monitor supplies the following features:
- 5.7 inch LCD display .
- Sp02, Pulse Rate, and Respironics CO2 measurement .
- Nellcor OxiMax SpO2 .
- Display numeric and waveform information simultaneously .
- Nurse call .
- Powerful storage capacity .
- Built-in Lithium-ion Battery ●
- Suitable for adult, pediatric and neonate patients .
- Visual and audible alarm .
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, and neonate
Intended User / Care Setting
clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital, hospital type facilities environment and intra-hospital moves.
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 following quality assurance measures were applied to the development of the Fetal & Maternal Monitor
- Software testing
- . Safety testing
- . Risk analysis
- . Final validation
Verification and validation testing was done on the M3B Vital Signs Monitor. This premarket notification submission demonstrates that M3B Vital Signs Monitor is substantially equivalent to the predicate device.
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
§ 870.2700 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
Attachment A
510 (K) Summary of Safety and Effectiveness
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807:92
| Submitter: | Edan Instruments, Inc
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: 86-755-26882220
Fax:86-755-26882223
Responsible person: Jiang Yucai | MAY 14 2009 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Official correspondent: | William Stern | |
Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 X27 Fax: 914 376 6111
Proprietary Name: Vital Signs Monitor (Model M3B)
Classification Name: 21 CFR 870.2700 Oximeter DQA
21 CFR 868.1400 analyzer, gas, carbon-dioxide, gaseous-p CCK
Predicate Devices:
| Predicate devices | Capnostream 20 | TidalWave SP,
Model 710/715 |
|-------------------|-----------------------------|-------------------------------------------|
| Manufacturer | Oridion 1987
Medical Ltd | Respironics
ovametrix,
Incorporated |
| K # | K060065 | K032971 |
Device Description:
M3B Vital Signs Monitor supplies the following features:
- 5.7 inch LCD display .
- Sp02, Pulse Rate, and Respironics CO2 measurement .
- Nellcor OxiMax SpO2 .
- Display numeric and waveform information simultaneously .
- Nurse call .
- Powerful storage capacity .
- Built-in Lithium-ion Battery ●
- Suitable for adult, pediatric and neonate patients .
- Visual and audible alarm .
Comparison with predicate device
1
Attachment A
| Monitoring
functions | M3B Vital
Signs Monitor | Capnostream
20 | Tidal Wave
SP, Model
710/715 |
|-------------------------|----------------------------|-------------------|------------------------------------|
| SpO2,
Pulse Rate | yes | yes | yes |
| CO2
measurement | yes | yes | yes |
Intended Use:
The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.
The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal usage in a hospital, hospital type facilities environment and intra-hospital moves.
The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
Test Summary:
The following quality assurance measures were applied to the development of the Fetal & Maternal Monitor
- Software testing
- . Safety testing
- . Risk analysis
- . Final validation
Conclusion:
Verification and validation testing was done on the M3B Vital Signs Monitor. This premarket notification submission demonstrates that M3B Vital Signs Monitor is substantially equivalent to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
MAY 14 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edan Instruments, Incorporated C/o Mr. William Stern Multigon Industries, Incorporated 1 Odell Plaza Yonkers, New York 10701
Re: K083821
Trade/Device Name: Vital Signs Monitor (Model M3B) Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, CCK Dated: May 5, 2009 Received: May 6, 2009
Dear Mr. Stern:
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 cither class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2- Mr. Stern
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Quares
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use
KO83821 . 510(k) Number (if known):
Device Name:
Vital Signs Monitor (Model M3B)
The Vital Signs Monitor is indicated for use for non-invasive continuous monitoring of oxygen saturation of the blood (SpO2) and CO2.
The Vital Signs Monitor is intended to be used only under regular supervision of clinical personnel. It is adaptable to adult, pediatric, and neonatal psage in a hospital environment and intra-hospital moves.
The Vital Signs Monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
Prescription Use (21 CFR Part 801 Subpart D)
Over the Counter Use _______ (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Or
y Lhuta
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k08382
1