(130 days)
General Patient Monitors is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (BP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
The proposed device, M Series Patient Monitor (M66, M69, M8000 and M9000) is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. It has the physical and technical alarming function with audio and visual alarming, The device can driven by AC or DC power supply.
The provided text is a 510(k) summary for a general patient monitor. It describes the intended use and states that performance testing was conducted. However, the document does not contain the specific details required to answer your questions about acceptance criteria and the study proving the device meets them.
The summary only states: "Performance testing including clinical and bench testing was conducted to validate and verify that the proposed device, General Patient Monitors met all design specifications." It then concludes with a statement of substantial equivalence to a predicate device.
Therefore, for each of your requested points, the answer is: Not provided in the given text.
Here's a breakdown of why each piece of information is missing:
- A table of acceptance criteria and the reported device performance: This level of detail about specific performance metrics and their acceptance thresholds is not included in the 510(k) summary.
- Sample size used for the test set and the data provenance: The summary mentions "clinical and bench testing" but does not provide any sample sizes, nor does it specify the origin or nature (retrospective/prospective) of any clinical data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of experts, ground truth establishment, or their qualifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No information on adjudication is provided.
- 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 device is a general patient monitor, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study in that context would not be applicable, and no such study is mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a monitor, meaning its primary function involves displaying physiological parameters. While it has algorithms for processing data (e.g., heart rate calculation from ECG), the concept of "standalone performance" in the context of an AI diagnostic algorithm is not directly applicable here, and no specific algorithmic performance metrics are detailed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No information about the type of ground truth is provided.
- The sample size for the training set: The document does not discuss any "training set." This type of detail typically applies to machine learning or AI-driven devices, which this patient monitor is not described as.
- How the ground truth for the training set was established: As there is no mention of a training set, there is no information on how its ground truth might have been established.
In summary, the provided 510(k) summary is a high-level document stating that performance testing occurred and the device met design specifications, but it lacks the granular details about the studies and acceptance criteria you are requesting.
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K092970
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Premarket Notification Section 510{k) Submission Section III 510(k) Summary
Section III 510(k) Summary
FEB - 2 2010
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.
Date of Submission September 21, 2009 Sponsor General Meditech, Inc Registration No .: 3006147705 4/F, South Office, No.1, Kezhi Road (W), Nanshan District, Shenzhen, Guangdong, 518057, China Contact Person: Carter Wu, Management of Representative Correspondent Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite SD, No.19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China Proposed Device General Patient Monitors, G3C / G3D / G3F / G3G / G3H Common Name Patient Monitor Classification Monitor, Physiological, Patient , MHX , 21 CFR 870.1025 Panel Cardiovascular Subsequent Code DRT, DXN, DSK, DQA, BZQ, CCK, FLL The proposed device, M Series Patient Monitor (M66, M69, M8000 and M9000) is intended to be Device Description used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters. It has the physical and technical alarming function with audio and visual alarming, The device can driven by AC or DC power supply. Intended Use General Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient. The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance. Performance testing including clinical and bench testing was conducted to validate and verify that Testing the proposed device, General Patient Monitors met all design specifications. The proposed device, General Patient Monitors, is Substantially Equivalent (SE) to the Predicate SE Conclusion
Device, PM-7000 Patient Monitor, K072346
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
FEB - 2 2010
General Meditech, Inc. c/o Mr. Lee Fu Regulatory Consultant Suite 5D, No. 19, Lane 999, Zhongshan Road (S-2) Shanghai, 200030 CHINA
K092970 Re:
Trade/Device Name: General Patient Monitors; Models: G3C/G3D/G3F/G3G/G3H Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MHX Dated: December 22, 2009 Received: December 24, 2009
Dear Mr. Fu:
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 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.
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Page 2 - Mr. Lee Fu
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 (OS) 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,
W. Md
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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Premarket Notification Section 510(k) Submission Section II Indication for Use Statement
Section II Indication for Use Statement
510(k) Number: Device Name: General Patient Monitors Model: G3C / G3D / G3F / G3G
Indications for Usc:
General Patient Monitors is intended to be used for monitoring, displaying, reviewing, storing and alaming of multiple physiological parameters including ECG, Heart Rate (HR), Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (BP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.
The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K082970
Page 1 of __ 1_
§ 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.