← Product Code [MWI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI) · K113183
# PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 (K113183)
_Shanghai 3f Electronics Co, Ltd. · MWI · Feb 9, 2012 · Cardiovascular · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI/K113183
## Device Facts
- **Applicant:** Shanghai 3f Electronics Co, Ltd.
- **Product Code:** [MWI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI.md)
- **Decision Date:** Feb 9, 2012
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 870.2300
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Pediatric
## Indications for Use
PMS8210A Model Code 500 is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Model Code 500 has certain features and functions. The patient parameters that can be monitored by PMS8210A Model Code 500 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), Temperature (TEMP) and End-tidal CO2 (EtCO2) . 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 Model Code 500 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 Model Code 500 is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
## Device Story
Battery or line-powered multi-parameter patient monitor; acquires physiological signals (ECG, RESP, NIBP, SpO2, TEMP, EtCO2) via sensors; converts signals to digital data; processes data for alarm conditions; displays real-time physiological data. Used in hospital clinical areas (ICU, CCU, OR, emergency department) by qualified medical/nursing staff. Provides audible/visual alarms for parameter excursions to notify clinicians of patient status changes; aids clinical decision-making by providing continuous physiological monitoring. Benefits include real-time patient status awareness.
## Clinical Evidence
Bench testing only. Device underwent third-party safety and performance testing in accordance with IEC standards, including environmental, vibration, shock, and water ingress testing. Software of moderate concern evaluated.
## Technological Characteristics
Battery or line-powered; multi-parameter monitoring; ECG (3/5-lead), NIBP, SpO2, TEMP, EtCO2. Standards: IEC 60601-1-2, ISO 81060-2:2009 (NIBP), ISO 9919:2005 (SpO2), ASTM E1112:2000/E1104-03 (TEMP). High voltage isolation (4000V), anti-defibrillation protection.
## Regulatory 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.
## Predicate Devices
- PMS8210A (Iris) Patient Monitor/Multi-Parameter Patient Monitor ([K100394](/device/K100394.md))
## Submission Summary (Full Text)
> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).
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Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of letters and numbers. On the left side, the text reads 'K113183'. To the right of this, there is a fraction written as '1/4'. The handwriting is somewhat stylized, with variations in stroke thickness and letter formation.
## 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.
ـ ﺃ- .
Date: October 14, 2011
1. Company and Correspondent making the submission:
Name - Shanghai 3F Electronics Co., Ltd. Address – 77325 Joyce Way Echo, Oregon 97826 Telephone - 931-625-4938 Fax - 541-376-5063 Contact - Charles Mack Email - charliemack@irc-us.com
# 2. Device :
Trade/proprietary name: PMS8210A (IRIS) Multi-Parameter Patient Monitor Model Code 500
Common Name : Multi-parameter Patient Monitor
Classification of the device: Class II
Panels: Cardiovascular, General Hospital, Anesthesiology 21CFR870.2300, Monitor, Physiological, MWI Product code:
Establishment Registration Number : 3008383116
{1}------------------------------------------------
K113183 2/14
Predicate Devices:
| Predicate Model | Manufacturer | K Number | Submitted Device |
|---------------------------------------------------------------------------|-----------------------------------------|----------|------------------------------------------------------------------------------------------|
| PMS8210A (Iris)
Patient Monitor/
Multi-Parameter
Patient Monitor | Shanghai 3F
Electronics Co.,
Ltd. | K100394 | PMS8210A Model Code
500 (Iris) Patient
Monitor/ Multi-Parameter
Patient Monitor |
# 3. Description :
- 3.1 General
PMS8210A Model Code 500 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), End-tidal (etCO₂). 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 submitted device is the same as the predicate with two differences. The new model has added an etCO2 function and the Temp module has been changed. The new Temp module is a previously FDA cleared device.
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 Model Code 500 patient monitor is intended to be used only under regular supervision of clinical personnel. The intended location of use is clinics.
{2}------------------------------------------------
- 4. Indication for use :
PMS8210A Model Code 500 is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Model Code 500 has certain features and functions.
The patient parameters that can be monitored by PMS8210A Model Code 500 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), Temperature (TEMP) and End-tidal CO2 (EtCO2) . 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 Model Code 500 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 Model Code 500 is not recommended for use in a patient's home or residence, or when it has not been ordered by a physician.
- 5. Comparison with predicate device: Please see next page for the comparison table.
{3}------------------------------------------------
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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI/K113183](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI/K113183)
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