(50 days)
Not Found
No
The summary describes a standard patient monitor measuring vital signs and does not mention any AI/ML terms or capabilities.
No
The device is a patient monitor intended for measuring and displaying vital signs (SpO2, PR, NIBP), not for treating or preventing diseases.
No
Explanation: The device measures and displays physiological parameters (SpO2, PR, NIBP) but does not interpret these measurements to diagnose a condition. It is a monitoring device.
No
The device description explicitly states it is a "portable device" and mentions measuring SpO2, PR, and NIBP, which are typically measured using hardware sensors and components. The performance studies also refer to testing the "proposed device, PM50 Patient Monitor" in accordance with standards for hardware-based vital signs monitors (ISO 9919 and AAMI Sp10).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is described as a "patient monitor" that non-invasively measures physiological parameters (SpO2, pulse rate, NIBP) directly from the patient's body. IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description reinforces that it's a portable device for measuring vital signs on the patient.
- Lack of Mention of Specimens: There is no mention of collecting or analyzing any biological specimens.
- Performance Studies: The performance studies described involve testing the device's accuracy in measuring SpO2 and NIBP directly on patients, not on laboratory specimens.
Therefore, the PM50 Patient Monitor falls under the category of a non-invasive physiological monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DXN
Device Description
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.
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
Intended User / Care Setting
hospitals, medical facilities, and sub-acute environments.
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)
Performance testing including clinical and laboratory testing was conducted to validate and verify that the proposed device, PM50 Patient Monitor met all design specifications and was substantially equivalent to the predicate device.
The proposed device. PM50 Patient Monitor was tested in accordance Annex EE of ISO 9919 to evaluate SpO2 measurement accuracy. The test was sponsored by Contec Medical Systems Co., Ltd. and investigated in Qinhuangdao Maternal and Child Health Hospital.
The proposed device. PM50 Patient Monitor was tested in accordance AAMI Sp10 to evaluate NIBP measurement accuracy. The test was sponsored by Contec Medical Systems Co., Ltd. and investigated in Qinhuangdao Maternal and Child Health Hospital.
There are no any adverse effects and complications during test, the data obtained in the test meet the accuracy requirements of ISO 9919:2005 and ANSI/AAMI SP10:2002+A1: 2003+A2:2006.
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
§ 870.2300 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).
0
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
Page 1 of 3
oxygen
of
arterial
saturation
haemoglobin (SpO2), pulse rate(PR), Non-invasive measurement of blood pressure(NIBP) of adult
1
| Predicate Device: | VS-800 Vital Signs Monitor
K Number: K063055 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | 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. |
| Testing Conclusion: | Performance testing including clinical and
laboratory testing was conducted to validate and
verify that the proposed device, PM50 Patient
Monitor met all design specifications and was
substantially equivalent to the predicate device. |
| Clinical Test Discussion | The proposed device. PM50 Patient Monitor was
tested in accordance Annex EE of ISO 9919 to
evaluate SpO2 measurement accuracy. The test was
sponsored by Contec Medical Systems Co., Ltd.
and investigated in Qinhuangdao Maternal and
Child Health Hospital.
The proposed device. PM50 Patient Monitor was
tested in accordance AAMI Sp10 to evaluate NIBP
measurement accuracy. The test was sponsored by
Contec Medical Systems Co., Ltd. and investigated
in Qinhuangdao Maternal and Child Health
Hospital.
There are no any adverse effects and complications
during test, the data obtained in the test meet the
accuracy requirements of ISO 9919:2005 and
ANSI/AAMI SP10:2002+A1: 2003+A2:2006. |
| SE Conclusion: | The proposed device, PM50 Patient Monitor is |
.
.
Page 2 of 3
2
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
.
Page 3 of 3
3
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
4
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
5
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.
Page 1 of 1
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number.