(50 days)
The patient monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.
The proposed device, PM50 Patient Monitor, is a portable device, which is intended for measuring and/or cont pulse oxygen saturation (SpO2), pulse rate (PR), systolic pressure (SYS), diastolic pressure (DIA) and mean arterial pressure (MAP) on adult and pediatric.
Acceptance Criteria and Device Performance Study for Contec Medical Systems PM50 Patient Monitor
This report details the acceptance criteria and the study conducted to demonstrate that the Contec Medical Systems PM50 Patient Monitor meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the PM50 Patient Monitor are based on recognized international standards for SpO2 and NIBP measurement accuracy. The reported device performance is stated to meet these accuracy requirements.
| Measurement Parameter | Acceptance Criteria Standard | Reported Device Performance | Comments |
|---|---|---|---|
| SpO2 | ISO 9919:2005 (Annex EE) | Met accuracy requirements | Specific accuracy values (e.g., RMS error) are not provided in this summary but are referenced as meeting the standard. |
| NIBP | ANSI/AAMI SP10:2002+A1:2003+A2:2006 | Met accuracy requirements | Specific accuracy values (e.g., mean difference, standard deviation) are not provided in this summary but are referenced as meeting the standard. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the specific sample sizes used for the SpO2 and NIBP clinical accuracy evaluation studies.
Data Provenance:
- Country of Origin: The clinical investigation for both SpO2 and NIBP was conducted in Qinhuangdao Maternal and Child Health Hospital, China.
- Retrospective or Prospective: The summary describes "clinical test discussion" and states that the device "was tested," implying a prospective clinical study conducted during the device development and validation phase.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided 510(k) summary does not specify the number of experts or their qualifications used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The provided 510(k) summary does not mention any specific adjudication method used for the test set. The clinical studies were conducted to evaluate the device's measurement accuracy against the respective standards.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed as this device is a patient monitor performing physiological measurements, not an AI/imaging diagnostic device requiring human interpretation alongside an algorithm. Therefore, the effect size of human readers improving with or without AI assistance is not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, a standalone performance study was conducted. The clinical accuracy evaluations for both SpO2 and NIBP are standalone studies, assessing the device's ability to accurately measure these physiological parameters independently, without human intervention or interpretation of the device's output.
7. Type of Ground Truth Used
- SpO2: The ground truth for SpO2 was established by evaluating the device "in accordance with Annex EE of ISO 9919." Annex EE specifies a method for evaluating the accuracy of pulse oximeters, typically involving inducing a range of arterial oxygen saturations in healthy volunteers and comparing the oximeter's readings against a co-oximeter (which provides gold-standard arterial blood gas analysis for oxygen saturation). Therefore, the ground truth would be based on co-oximetry readings (reference measurements against a gold standard).
- NIBP: The ground truth for NIBP was established by evaluating the device "in accordance with AAMI Sp10." AAMI SP10 outlines requirements for automated sphygmomanometers, which typically involves comparing the device's measurements against auscultatory readings taken by trained observers using a mercury sphygmomanometer (or a validated equivalent) in a clinical setting. Therefore, the ground truth would be based on trained observer auscultatory measurements (reference measurements against a gold standard).
8. Sample Size for the Training Set
The provided 510(k) summary does not provide information regarding a separate training set or its sample size. For patient monitors like the PM50, the device's core algorithms for SpO2 and NIBP measurement are typically developed and validated against established physiological principles and data, often through extensive internal testing and calibration, rather than a distinct "training set" in the context of machine learning. The clinical studies described are for validation of the finalized device.
9. How the Ground Truth for the Training Set Was Established
As noted above, the 510(k) summary does not describe a "training set" in the context of the PM50's development and validation. The ground truth for internal development and calibration would typically be established through controlled experiments using reference devices (e.g., co-oximeters, calibrated pressure transducers) and simulated physiological signals within laboratory settings, based on the principles outlined in the relevant ISO and AAMI standards. The clinical studies documented here are for proving the finalized device's performance against these standards.
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510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K101127 |
|---|---|
| -------------------------------- | --------- |
| Sponsor: | Contec Medical Systems Co., Ltd |
|---|---|
| No. 24, West Huanghe Road | |
| Qinhuangdao, Hebei, 066000, China | |
| Establishment Registration Number: 3006979678 | |
| Contact Person: Mr. Li Xueyong, Quality Manager | |
| Tel:+86-335-8015490 | |
| Fax: +86-335-8015505 | |
| Email: Ixyong1011@163.com | |
| Correspondent: | Ms. Diana Hong |
| Mr. Tarzan. Wang | |
| Shanghai Mid-Link Business Consulting Co., Ltd | |
| Suite 5D, No. 19, Lane 999, Zhongshan No.2 | |
| Road(S) | |
| Shanghai, 200030, China | |
| Tel: +86-21-64264467 | |
| Fax: (240)238-7587 | |
| Email: Diana.hong@mid-link.net | |
| Proposed Device Information | |
| Trade Name | Patient Monitor; |
| Model: | PM50; |
| Classification Name: | monitor, physiological, patient; |
| Product Code: | MWI; |
| Subsequent Product Codes: | DQA,DXN |
| Regulation Number: | 870.2300; |
| Device Class: | II |
| Intended Use: | The patient monitor is a portable device indicated for use in non-invasively measuring and displaying |
functional
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oxygen
of
arterial
saturation
haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult
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| Predicate Device: | VS-800 Vital Signs MonitorK Number: K063055 |
|---|---|
| Device Description: | The proposed device, PM50 Patient Monitor, is aportable device, which is intended for measuringand/or cont pulse oxygen saturation (SpO2), pulserate (PR), systolic pressure (SYS), diastolicpressure (DIA) and mean arterial pressure (MAP)on adult and pediatric. |
| Testing Conclusion: | Performance testing including clinical andlaboratory testing was conducted to validate andverify that the proposed device, PM50 PatientMonitor met all design specifications and wassubstantially equivalent to the predicate device. |
| Clinical Test Discussion | The proposed device. PM50 Patient Monitor wastested in accordance Annex EE of ISO 9919 toevaluate SpO2 measurement accuracy. The test wassponsored by Contec Medical Systems Co., Ltd.and investigated in Qinhuangdao Maternal andChild Health Hospital.The proposed device. PM50 Patient Monitor wastested in accordance AAMI Sp10 to evaluate NIBPmeasurement accuracy. The test was sponsored byContec Medical Systems Co., Ltd. and investigatedin Qinhuangdao Maternal and Child HealthHospital.There are no any adverse effects and complicationsduring test, the data obtained in the test meet theaccuracy requirements of ISO 9919:2005 andANSI/AAMI SP10:2002+A1: 2003+A2:2006. |
| SE Conclusion: | The proposed device, PM50 Patient Monitor is |
.
.
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substantially equivalent (SE) to the predicate device, VS-800 Vital Signs Monitor.
and the comments of the comments of the comments of
1
Comments of the country
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
JUN 1 1 2010
Contec Medical Systems Co., Ltd. c/o Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D. No. 19, Lane 999, Zhongshan No. 2 Road (S) Shanghai, 200030 CHINA
K101127 Re:
Trade/Device Name: Patient Monitor, PM50 Regulatory Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: MWI Dated: April 15, 2010 Received: April 22, 2010
Dear Ms. Hong:
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.
ﺍﻟﻘﺎﺩﺭ
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Page 2 - Ms. Diana Hong
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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Indication For Use
510(k) Number (if known): =
Device Name: __ Patient Monitor, PM50
Indications for Use:
The Patient Monitor is a portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult patients in hospitals, medical facilities, and sub-acute environments. The patient monitor is intended for spot-checking and/or continuous monitoring of patients.
Prescription Use _ _ _ J (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)
W.W. West.
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(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).