(110 days)
M80: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The 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.
MSO: The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
M50/M80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
M50 Patient Monitor can monitor parameters including SpO2, NIBP. ECG, RESP, TEMP, CO2, IBP.
M80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, CO2, IBP, C.O. and AG.
M50 is outfitted with a 8.4-inch display screen, M80 is 15-inch, as well as an equal large touch screen. which enables the operation by touching the screen, thus offering convenience for doctors and nurses.
M50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG RESP. CO2, IBP and Ouick Temp.
M80 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SpO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, CO2, CO, IBP, AG
The provided 510(k) submission for the Edan Instruments Patient Monitor (Models M50 and M80) describes the device and claims substantial equivalence to predicate devices. However, it does not contain the specific details required to answer all your questions regarding acceptance criteria and performance studies.
This type of 510(k) summary focuses on demonstrating equivalence to existing devices rather than presenting detailed scientific studies with acceptance criteria and specific performance metrics for the new device. The document mentions "Verification and validation testing" and "similar performance specifications" to predicate devices, but does not provide the results of these tests or explicit acceptance criteria.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given document. The submission claims "similar performance specifications" to predicate devices, but no specific performance metrics or acceptance criteria are listed for the M50/M80 Patient Monitor itself. It only references that certain modules used within the M50/M80 were cleared under their own 510(k)s, implying that those modules met their respective performance criteria.
2. Sample size used for the test set and the data provenance
This information is not provided in the given document. The submission mentions "Software testing," "Hardware testing," "Safety testing," "Environment test," and "Final validation," but does not detail the methodologies, sample sizes, or data provenance for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the given document. This device is a patient monitor, not an AI diagnostic tool, so an MRMC study with human readers assisting AI would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly provided in the given document. The "Verification and validation testing" and "Final validation" mentioned likely included testing of the device's algorithms and functions in a standalone capacity, as is typical for medical devices. However, no specific details of such studies are presented.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the given document.
8. The sample size for the training set
This information is not provided in the given document. As this is a traditional patient monitor rather than a machine learning/AI device, the concept of a "training set" in the context of supervised learning algorithms might not directly apply in the same way. The device's internal algorithms would be developed and validated against established physiological models and sensor data, but these are typically not referred to as "training sets" in the context of a 510(k) for such devices.
9. How the ground truth for the training set was established
This information is not provided in the given document. (See point 8 regarding the applicability of "training set" for this device type).
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence through comparison of indications for use, operating principles, testing modules, and general performance specifications to predicate devices. It does not present the detailed results of performance studies, specific acceptance criteria, or the methodologies for establishing ground truth or testing populations for the M50/M80 Patient Monitor itself. This level of detail is typically found in the full 510(k) submission, not just the summary.
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JUL 2 0 2011
Patient Monitor Traditional 510K Submission
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 Contact person: Randy Jiang
Date of Preparation:
2011-03-20
Proprietary Name:
Patient Monitor (Models M50 and M80)
- Classification:
| Description | Classification | Productcode |
|---|---|---|
| 21 CFR 870.1025 Arrhythmia detector and alarm (Including ST-segment measurement and alarm) | II | MHX |
| 21 CFR 870.2300 Cardiac monitor (including cardiotachoment and rate alarm) | II | DRT |
| 21 CFR 870.1130 Non-Invasive blood pressure measurement System | II | DXN |
| 21 CFR 870.1110 Blood pressure computer | II | DSK |
| 21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with Probe | II | FLL |
| 21 CFR 870.2700 Oximeter, Pulse | II | DQA |
| 21 CFR 870.1400 Carbon Dioxide Gas Analyzer | II | CCK |
| 21 CFR 868.1500 Enflurane gas analyzer | II | CBQ |
| 21 CFR 868.1620 Halothane gas analyzer | II | CBS |
| 21 CFR 868.1700 Nitrous Oxide gas analyzer | II | CBR |
| 21 CFR 868.1720 Oxygen gas analyzer | II | CCL |
| 21 CFR 868.2900 cable, transducer and electrode, patient, (including connector) | II | DSA |
| 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) | II | DRT |
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | II | DSI |
| 21 CFR 870.1025 Monitor, ST Segment with Alarm | II | MLD |
Regulatory Class: Class II
K110922
pi/4
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Section 1
Patient Monitor Traditional 510K Submission
Legally Marketed Predicate Devices: :
| Manufacturer | Predicate Device | 510(k) number | Cleared date |
|---|---|---|---|
| Shenzhen Mindray Bio-medicalElectronics co., LTD | PM-8000 Express | K053193 | Oct.25.2005 |
| Edan Instruments, Inc | M3B | K083821 | May. 14.2009 |
| Colin Medical Instruments Corp | BX-10 | K032857 | April.21.2003 |
| Shenzhen Mindray Bio-medicalElectronics co., LTD | BeneView T5 | K073280 | Nov.8.2007 |
Device Description:
.. `
M50/M80 Patient Monitor provides the following primary features:
M50/M80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
M50 Patient Monitor can monitor parameters including SpO2, NIBP. ECG, RESP, TEMP, CO2, IBP.
M80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG RESP, TEMP, CO2, IBP, C.O. and AG.
M50 is outfitted with a 8.4-inch display screen, M80 is 15-inch, as well as an equal large touch screen. which enables the operation by touching the screen, thus offering convenience for doctors and nurses.
M50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG RESP. CO2, IBP and Ouick Temp.
M80 Patient Monitor has parameter modules including SpO2 with EDAN SpO2 module or Nellcor SPO2 module, NIBP with EDAN NIBP module or Omron M3600, TEMP, ECG, RESP, CO2, CO, IBP, AG
The EDAN SpO2 module used in M80 and M50 is also used by H100B Pulse Oximeter which has been cleared by FDA under K092727. The CO2 module and Nellcor SpO2 module used in M80 are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.
M80 could be configured with two different NIBP modules, one is EDAN NIBP module, the other one is Omron M3600 NIBP module; M3600 module used in M80 is the same to that used in BX-10. which has been cleared by K032857 in April.21.2003.
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Patient Monitor Traditional 510K Submission
Section 1
CO2 module and Nellcor SpO2 module used in M50 are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.
Arrhythmia and ST Analysis used in M80 is the same to that in PC ECG which has been cleared by FDA under K102854 and K092010
Comparison with predicate device
The M50 and M80 Patient Monitors have the following similarities to that which previously received 510(k) concurrence:
· have the same indications for use,
· use the similar operating principle,
- · have the same testing module, e.g. EDAN SpO2 module and Nellcor NELL-1
module.
· have the same or similar performance specifications
In summary, the M50 and M80 Patient Monitor described in this submission is, in our opinion, substantially equivalent to the predicate device
Intended Use:
| M80: | The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The 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. |
|---|---|
| M50: | The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature (Quick TEMP. The 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. The arrhythmia detection and ST Segment analysis are not intended for neonatal patients. |
| Contraindications: | It is not intended for use in patient's home or residence, or when it has not been ordered by a physician. |
| Test Summary: | The following quality assurance measures were applied to the development of the Patient Monitor |
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Section 1
Patient Monitor Traditional 510K Submission
| · Software testing | ||
|---|---|---|
| -- | -------------------- | -- |
- · Hardware testing
- Safety testing
- Environment test
- Risk analysis
- Final validation
Conclusion:
Verification and validation testing was done on the Patient Monitor. This premarket notification submission demonstrates that Patient Monitor is substantially equivalent to the predicate device.
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Image /page/4/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the upper half of the circle, following its curvature. The emblem is positioned in the center of the circle, with the text surrounding it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Edan Instruments, Inc. c/o Mr. Randy Jiang Certificate Engineer 3/F-B, Nanshan Medical Equipments Park, Nanhai RD1019 Shenzhen, Guangdong CHINA 518067
JUL 20 2011
Re: K110922
Trade/Device Name: Patient Monitor Models M50 and M80 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX, DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, DSA, . DRT, DSF, and MLD Dated: June 25, 2011 Received: June 27, 2011
Dear Mr. Jiang:
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 Amendmouts, or to devices that have been reclassified in accordance with the provisions of the Federal Foond, Orug 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, issue 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 additional controls. Existing major regulations affecting your device ann be
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Page 2 - Mr. Randy Jiang
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. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or.at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 1
Indication for Use
510(k) Number (if known):
Device Name: Patient Monitor Models M50 and M80
M80:
The monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG), The 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.
MSO:
The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
Prescription Use × (21 CFR Part 801 Subpart D)
And/Or Over the Counter Use (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluatio
Atith De for B. Zuckerman
(Division Sign-Off)
7/20/201
Division of Cardiovascular Devices
510(k) Number K110922
§ 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.