(58 days)
Not Found
No
The summary describes a standard multi-parameter patient monitor that acquires, processes, and displays physiological signals and provides alarms. There is no mention of AI, ML, or any related technologies in the intended use, device description, or other sections. The processing described is standard signal processing for vital signs.
No.
The device is a patient monitor used to measure and display various physiological parameters, not to treat a condition.
Yes
The device monitors multiple patient parameters (ECG, HR, PR, RESP, NIBP, SpO2, TEMP) and processes the signals to identify alarm conditions, which is indicative of its use in assessing and identifying health states.
No
The device description explicitly states it is a "battery or line-powered patient monitor" that "acquires the physiological signals" and "converts into digital data and processed," indicating it includes hardware components for signal acquisition and processing, not just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices analyze samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- The PMS8210A Multi Parameter Patient Monitor directly monitors physiological signals from the patient's body (ECG, respiration, blood pressure, SpO2, temperature, heart rate, pulse rate). It does not analyze samples taken from the body.
The description clearly states it "acquires the physiological signals" and "displays the data," which is characteristic of a patient monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The PMS8210A Multi Parameter Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Patient Monitor has certain features and functions.
The patient parameters that can be monitored by PMS8210A Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The PMS8210A Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PMS8210A Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
Product codes (comma separated list FDA assigned to the subject device)
DQA, MWI, FLL, DXN, MWI
Device Description
PMS8210A Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), Heart rate (HR) and Pulse Rate (PR), The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user.
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 neonatal patients.
Intended User / Care Setting
The patient monitor is intended to be used in a hospital clinical area such as intensive care units, cardiac care units, operation room, emergency department, to provide additional information to the medical and nursing staff about the physiological condition of the patient. The PMS8210A patient monitor is intended to be used only under reqular supervision of clinical personnel. The intended location of use is clinics.
It is intended for use by qualified medical personnel trained in the use of the equipment.
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 PMS8210A has undergone Third Party safety testing in accordance with IEC standards and completed performance testing in accordance with IEC standards. In that this device has software of Moderate concern; the appropriate level of Software evaluation was performed.
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 summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: January 27, 2010
- Company and Correspondent making the submission:
Name - Shanghai 3F Electronics Co., Ltd. Address - Building 3, No. 128, Jiujing Road, Shanghai, China Telephone -- +86-21-67696500/51695200 ext: 8022 Fax - +86-21-67696296 Contact - Mr. Lu Yulin Email - rmdlu@3fmedical.cn
2. Device :
Trade/proprietary name: PMS8210A (IRIS) Patient Monitor/ Multi-Parameter
Patient Monitor
Common Name : Multi-parameter Patient Monitor
Classification of the device: Class II
Panels: Cardiovascular, General Hospital, Anesthesiology
Product code: 21CFR870.2700, Oximeter, DQA
21CFR870.2300, Monitor, Physiological, MWI
21CFR880.2910, Thermometer, Electronic, Clinical, FLL
21CFR871.1130, System, Measurement, Blood Pressure,
DXN
Establishment Registration Number : None Yet Predicate Devices:
1
| Predicate Model | Manufacturer | K Number | Submitted Device |
|---|---|---|---|
| PM-9000 | |||
| EXPRESS PATIENT | |||
| MONITOR | Shenzhen | ||
| Mindtay Bio- | |||
| medical | |||
| Electronics Co., | |||
| LTD | K053234 | PMS8210A (Iris) Patient | |
| Monitor/ Multi-Parameter | |||
| Patient Monitor |
3. Description :
3.1 General
PMS8210A Patient Monitor is a battery or line-powered patient monitor. The Patient Monitor acquires the physiological signals such as ECG, respiration (RESP), Non-Invasive blood pressure (NIBP), Saturation of pulse oxygen (SPO2), Temperature (TEMP), Heart rate (HR) and Pulse Rate (PR), The signals are converted into digital data and processed, examines the data for alarm conditions and displays the data. The monitor also provides operating control for the user.
The patient monitor is intended to be used in a hospital clinical area such as intensive care units, cardiac care units, operation room, emergency department, to provide additional information to the medical and nursing staff about the physiological condition of the patient. The PMS8210A patient monitor is intended to be used only under reqular supervision of clinical personnel. The intended location of use is clinics.
- Indication for use :
The PMS8210A Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Patient Monitor has certain features and functions.
The patient parameters that can be monitored by PMS8210A Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP),
2
Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The PMS8210A Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PMS8210A Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
-
- Comparison with predicate device: Please see next page for the comparison table.
3
Table of Comparison to Predicate Device 出来ないからない。 「
- General Specifications (i.e. physical/electrical)
| Characteristics
| (i.e. physical/electrical) | Subject Device | Claimed SE Device 510(K) No. |
|---|---|---|
| Name and model | PMS8210A Multi-parameter Patient Monitor | PM-9000 EXPRESS PATIENT MONITOR (K053234) |
| Physical dimension/weight | Dimensions: 250 (W)×180 (H)× 180 (D) (mm) | |
| Weight: 2.0kg | Dimensions: 318(W)×270(H)×137(D) (mm) | |
| Weight: Trade/Device Name: PMS8210A (IRIS) Multi-parameter Patient Monitor Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI Dated: February 7, 2010 Received: February 16, 2010 |
Dear Mr. Mack:
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. Iisting 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.
:
13
Page 2 - Mr. Charles Mack
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 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/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely vo
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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Indications for Use
Indications for Use
510(k) Number (if known):
Device Name: PMS8210A (IRIS) Multi-parameter Patient Monitor
Indications for Use:
The PMS8210A Multi Parameter Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Patient Monitor has certain features and functions.
になってきましたができ
The patient parameters that can be monitored by PMS8210A Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs.
The PMS8210A Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment.
The PMS8210A Patient Monitor is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
Prescription Use __
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
W. M
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices |
27 of 866
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