Who is the manufacturer of PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

Shanghai 3f Electronics Co, Ltd. filed the 510(k) submission for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500 (K113183).

What is the FDA product code for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

PMS8210A (Iris) Patient Monitor/Multi-Parameter Patient Monitor (K100394).

Who can help prepare an FDA 510(k) submission like PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500

K113183 · Shanghai 3f Electronics Co, Ltd. · MWI · Feb 9, 2012 · Cardiovascular

Device Facts

Record ID	K113183
Device Name	PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500
Applicant	Shanghai 3f Electronics Co, Ltd.
Product Code	MWI · Cardiovascular
Decision Date	Feb 9, 2012
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Indications for Use

Indicated for adult, pediatric, and neonatal patients in healthcare facilities for monitoring ECG, HR, PR, RESP, NIBP, SpO2, TEMP, and EtCO2. Not for home use or without physician order.

Regulatory Classification

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)

Related Devices

K100394 — MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A · Shanghai 3f Electronics Co, Ltd. · Apr 15, 2010
K031124 — POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR · Datex-Ohmeda, Inc. · Dec 4, 2003
K053193 — PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 18, 2006
K032733 — PM-8000 PATIENT MONITOR, MODEL 8000 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 3, 2004
K102040 — PATIENT MONITOR · Guangdong Biolight Meditech Co., Ltd. · Sep 24, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ 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}------------------------------------------------ osive ອ້າງວ່ານອາ9 ot nozinequo 10 ອາໄດ້ຮັ The state of the first the first the (ໄຣວເາງ່ວອໄອ)ໄຣວເຮຣ(dq .ອ.i) ຂໍ້ແດງໄຊວເປີຣິເວທີໄວ້ອອຸຣິ ໄຣາອົກອ | របរុវជន្ម (elqsiC oma Optional printe sən qalınmışdır. Bu yarın və bir və bir və bir mən ipisips le dimension/weig ອານ ໄວ ຣາ ແນຣ they of themging indicato lıqdan sənədlər Rəmaniya Rəsmin Film Alanmada Alanmada Alanmada Şamar Alanmada Şamar Alanmada Şamar Şamar Şamar Şamar Şamar Şamar Şamar Şamar onos rewod lemet əqmədə (qalınmışdır. 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