(58 days)
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.
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 provided text does not contain detailed information about specific studies, acceptance criteria, or performance data for the PMS8210A (IRIS) Multi-parameter Patient Monitor. Instead, it focuses on comparing the device's technical specifications and adherence to various medical standards with a predicate device (PM-9000 EXPRESS PATIENT MONITOR).
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information.
The document primarily acts as a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics, or different technological characteristics that do not raise different questions of safety and effectiveness and are as safe and effective as the predicate device.
The study described is a comparison of the PMS8210A Multi-parameter Patient Monitor's specifications and compliance with relevant medical standards against a predicate device, the PM-9000 EXPRESS PATIENT MONITOR (K053234). The intent is to demonstrate that the subject device is substantially equivalent to the predicate device.
Here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various technical specifications and accuracy claims for the PMS8210A device (Subject Device) and compares them to the predicate device. While these are performance characteristics, they are not explicitly labeled as "acceptance criteria" through a formal study results table. The implication is that meeting or being comparable to the predicate's performance, and adhering to referenced standards, constitutes meeting acceptance criteria for substantial equivalence.
| Parameter | Acceptance Criteria (Implied by Predicate/Standard) | PMS8210A Reported Performance |
|---|---|---|
| ECG | ||
| Gain | Predicate: ×0.125; ×0.25; ×0.5; ×1; ×2; auto. | ×0.5; ×1. |
| Range of Heart Rate Monitoring | Adult: 15 | Adult: 20 |
| Resolution (HR) | 1 bpm (Predicate) | 1 bpm |
| Precision (HR) | 1 bpm or ±1% (Predicate) | 20 |
| CMRR | Diagnostic mode: ≥90dB; Monitoring mode: ≥105dB; Surgical mode: ≥105dB (Predicate) | ≥89 dB |
| Frequency Characteristic (Mode 1) | 0.05Hz-100Hz (Diagnostic), 0.5Hz-40Hz (Monitoring), 1Hz-20Hz (Surgical) (Predicate) | Mode 1: 0.1Hz-40Hz; Mode 2: 0.67Hz-40Hz; Mode 3: 1Hz-25Hz |
| Respiration | ||
| Measuring Range | Adult: 0 | 15 ~ 120 rpm |
| Resolution | 1 rpm (Predicate) | 1 rpm |
| Precision | 0 | The bigger one between ±2 rpm or ±2% |
| NIBP | ||
| BP Accuracy | Arithmetic mean values: ±5 mmHg; Standard deviation no greater than 8 mmHg (Predicate, also stated by ANSI/AAMI SP10:2002; EN1060-4) | Arithmetic mean values: ±5 mmHg; Standard deviation no greater than 8 mmHg |
| SpO2 | ||
| SpO2 Measurement Range | 0~100% (Predicate) | 0~100% |
| SpO2 Measurement Accuracy | Adult/Pediatric: 70 | Adult/Pediatric: 70 |
| Pulse Rate Measurement | 20 to 250 BPM (Predicate) | 20~250bpm |
| Temperature | ||
| Measurement Range | 0°C | 0°C |
| Measurement Accuracy | ±0.1°C (±0.2°F) (Predicate, also stated by ASTM E1112:00) | ±0.1°C (±0.2°F) |
2. Sample size used for the test set and the data provenance:
This information is not provided in the given text. The document refers to "performance testing in accordance with IEC standards" but does not detail the size or nature of the test set or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. The document focuses on technical specifications and standard compliance, not clinical ground truth establishment by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the given text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable/provided. The device is a multi-parameter patient monitor, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device itself is a standalone monitor. Its performance is assessed against technical specifications and standards (e.g., IEC, AAMI, EN, ISO). The document states the device has "software of Moderate concern" and that "the appropriate level of Software evaluation was performed," but does not detail the standalone performance study specific to an algorithm. The overall product performance is standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for evaluating the device's technical specifications and accuracy is largely based on measurements against established reference standards and calibrated equipment, as implied by adherence to standards like ANSI/AAMI SP10 for NIBP accuracy and ASTM E1112 for temperature accuracy. For SpO2, it leverages the Nellcor SpO2 module, implying its proven accuracy. There is no mention of expert consensus, pathology, or outcomes data as ground truth in this document.
8. The sample size for the training set:
This information is not provided in the given text. As a patient monitor rather than an AI/ML algorithm requiring a training set in the typical sense, this concept might not directly apply or is not detailed. The "software of Moderate concern" does not imply a classical AI/ML model.
9. How the ground truth for the training set was established:
This information is not provided in the given text, and likely not applicable in the context of this traditional medical device.
{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-9000EXPRESS PATIENTMONITOR | ShenzhenMindtay Bio-medicalElectronics Co.,LTD | K053234 | PMS8210A (Iris) PatientMonitor/ Multi-ParameterPatient 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: <7.5kg |
| Display | 7 segment LED + 3.2" colorful TFT LCD (320×240) | 10.4" color TFT LCD(800×600) |
| Button | keys – front panel | Soft keys – front panel |
| Type, Degree of protectionagainst electric shock | AC power adapterElectr. Class I and internal power supply | AC power adapterElectr. Class I and internal power supply |
| Power supply | 100~240VAC(±10%),50/60Hz(±3Hz),45VA | 100~240VAC(± 10%),50/60Hz(±3Hz),140VA |
| Internal power source | Insetting sealed lithium batter: 2200mAh and 4400mAh | Sealed Lead acid battery(for 2 pieces)And insetting li-ion battery (for 2 pieces) |
| Battery charging indicator | Yes | Yes |
| Low battery indicator | Yes | Yes |
| Battery charge time, typ. | 2200mAh: approx. 3 hours4400mAh: approx. 6 hours | Acid battery: approx. 12 hoursAnd li-ion battery: approx. 6.5 hours |
| Flammable anesthetics | not suitable | not suitable |
| Operating condition | Temperature: 0°C to 40°C (32°F to 104°F)Relative Humidity: ≤95% (non-condensing) | Temperature: 0°C to 40°C (32° F to 104° F)Relative Humidity: 15%~95% (non-condensing) |
| Storage condition | Temperature: -40°C to 55°C (-40°F to 131°F)Relative Humidity: ≤95% (non-condensing) | Temperature: -20°C to 60°C (-4°F to 140°F)Relative Humidity: 10%~95% (non-condensing) |
| EMC | IEC 60601-1-2:2007 | IEC 60601-1-2:2001+A1:2004 |
| Power on self test | Yes | Yes |
| Optional printer | Yes | Yes |
| Characteristics | Subject Device | Claimed SE Device 510(K) No. |
| Name and model | PMS8210A Multi-parameter Patient Monitor | PM-9000 EXPRESS PATIENT MONITOR (K053234) |
| Lead | 3lead(RA,LA,LL);5lead(RA, RL, LA, LL,V)). | 3lead(RA, LA,LL);5lead(RA, RL, LA, LL,V));10lead(RA, RL, LA,LL,V1-V6)). |
| Lead option | Monitor lead(3 lead) / standard lead(5 lead) | 3 lead/ 5 lead/ 12 lead |
| Gain | ×0.5; x1. | ×0.125; ×0.25; ×0.5; ×1; ×2;auto. |
| Sweep speed | 12.5mm/s, 25mm/s, 50mm/s | 12.5mm/s, 25mm/s, 50mm/s |
| Range of heart rate monitoring | Adult: 20 | Adult: 15 |
| Resolution | 1 bpm | 1 bpm |
| Precision | 20 | 1 bpm or ±1% |
| Alarm setting | The limit of alarm (setup range: 20~350 bpm), and leads-off alarm display. | 15~350 bpm |
| Input resistance | ≥5 MΩ | ≥5 MΩ |
| CMRR | ≥89 dB | Diagnostic mode: ≥90dBMonitoring mode: ≥105dBSurgical mode: ≥105dB |
| Heart disorder analysis | NO | NO |
| Anti-polarized voltage | ≤±500 mV | 3/5 lead ≤±300mV;12 lead ≤±500mV. |
| Baseline renewing time | <5 s after the defibrillation | <5 s after the defibrillation |
| ECG mode | Mode 1 (Monitoring mode), mode 2(Monitoring mode), mode 3 (Surgical mode) | Diagnostic mode, Monitoring mode, Surgical mode. |
| Frequency characteristic | Mode 1: 0.1Hz-40Hz;Mode 2: 0.67Hz-40HzMode 3: 1Hz-25Hz | Diagnostic mode: 0.05Hz-100HzMonitoring mode: 0.5Hz-40HzSurgical mode: 1Hz-20Hz |
| Safeguard | 4000V high voltage isolation, anti-defibrillation | Withstand 4000VAC/50Hz voltage in isolation; |
{4}------------------------------------------------
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||\n
- ECG
バイト (
32 of 866
{5}------------------------------------------------
| Respiration |
|---|
| તં |
נייר ל
| Characteristics | Subject Device | Claimed SE Device 510(K) No. |
|---|---|---|
| Name and model | PMS8210A Multi-parameter Patient Monitor | PM-9000 EXPRESS PATIENT MONITOR (K053234) |
| Measuring method | The thorax impedance method (used with ECG lead) | Thoracic impedance |
| Measuring range | 15 ~ 120rpm | Adult: 0 |
| Resolution | 1 rpm | 1 rpm |
| Precision | The bigger one between ±2 rpm or ±2% | 0 |
| Alarm setup | Yes | Yes |
| Alarm method | Audible and visual alarm, alarm events recallable | Audible and visual alarm, alarm events recallable |
4. Non-Invasive Blood Pressure (NIBP)
| Characteristics | Subject Device | Claimed SE Device 510(K) No. |
|---|---|---|
| Name and model | PMS8210A Multi-parameter Patient Monitor | PM-9000 EXPRESS PATIENT MONITOR (K053234) |
| Method | Oscillometric | Oscillometric |
| Patient type | Neonatal, pediatric and adult patients | Neonatal, pediatric and adult patients |
| Unit of measure | mmHg & kPa | mmHg & kPa |
| Pressure measurementrange - Systolic | Adult: 40 ~ 260mmHgpediatric: 40 ~ 160mmHgNeonate: 40 ~ 130mmHg | Adult: 40 ~ 270mmHgpediatric: 40~200mmHgNeonate: 40 ~ 135mmHg |
| Pressure measurementrange - Diastolic | Adult: 20 ~ 200mmHgpediatric: 20 ~ 120mmHgNeonate: 20 ~ 100mmHg | Adult: 10 ~ 210mmHgpediatric: 10 ~ 150mmHgNeonate: 10 ~ 100mmHg |
| Pressure measurement | Adult: 26 ~ 220mmHg | Adult: 20 ~ 230mmHg |
33 of 866
ri
{6}------------------------------------------------
| Range-Dean pressure | pediatric: 26 ~ 133mmHgNeonate: 26 ~ 110mmHg | pediatric: 20 ~ 165mmHgNeonate: 20 ~ 110mmHg |
|---|---|---|
| BP accuracy | Arithmetic mean values:±5 mmHg;Standard deviation no greater than 8 mmHg | Arithmetic mean values:±5 mmHg;Standard deviation no greater than 8 mmHg |
| BP measurement accuracy | ANSI/AAMI SP10:2002;EN1060-4 | Meets ANSI/AAMI SP10:1992+A1:2002 |
| Cuff pressure range | 0 to 300mmHg | 0 to 300mmHg |
| Auto zero CAL | Yes | Yes |
| Over pressure protector | Adult/ Pediatric: 300mmHg;Neonate: 150mmHg | Adult: 297±3mmHgPediatric: 240±3mmHgNeonate: 147±3mmHg |
| Alarm setup | The range is the same as parameter measurementrange of SYS、DIA、MAP | The range is the same as parameter measurementrange of SYS、DIA、MAP |
| Alarm method | Sound light alarm, and record the alarm status forreview | Sound light alarm, and record the alarm status forreview |
5. Pulse Oximetry. (SpO2)
| Characteristics | Subject Device | Claimed SE Device 510(K) No. |
|---|---|---|
| Name and model | PMS8210A Multi-parameter Patient Monitor | PM-9000 EXPRESS PATIENT MONITOR (K053234) |
| SpO2 module | Nellcor SpO2 | Nellcor SpO2 |
| Patient type | Adult, Pediatric & Neonate | Adult, Pediatric & Neonate |
| SpO2 measurement range | 0~100% | 0~100% |
| adult/ Pediatric: | adult/ Pediatric: | |
| 70~100%: ±2%; | 70~100%: ±2%; | |
| SpO2 measurement accuracy | 0~69%: Unspecified. | 0~69%: Unspecified. |
| neonate | neonate | |
| 70~100%: ±3%; | 70~100%: ±3%; | |
| 0~69%: Unspecified. | 0~69%: Unspecified. | |
| Alarm range(%) | 0~100% | 0~100% |
| Pulse rate measurement | 20~250bpm | 20 to 250 BPM |
34 of 866
Page 4 of 5
{7}------------------------------------------------
K100394 p8/12
:
| No. | Category | Directives/Standards | Title & Comments |
|---|---|---|---|
| 1 | General | 93/42/EEC | Medical Device Directive |
| 21CFR820 | Code of Federal Regulations | ||
| 91/157/EEC | Battery Declaration Directive | ||
| 93/86/EEC | Battery Disposal Directive | ||
| IEC60601-1:1988 | General requirements for Safety and | ||
| A1:1991,+ A2:1995 | Essential Performance | ||
| IEC60601-1-1:2000 | Medical electrical equipment -- Part 1:General requirements for safety- Collateralstandard-Safety requirements for medicalelectrical systems | ||
| IEC60601-1-4:2000 | Programmable medical systems | ||
| IEC 60601-1-6:2006 | Medical electrical equipment - Part 1-6:General requirements for safety - Collateralstandard: Usability | ||
| IEC 60601-1-8: 2006 | Medical electrical equipment - Part 1-8:General requirements for safety - Collateralstandard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystems | ||
| IEC 60601-2-25 | Medical electrical equipment, Part 2-25:Particular requirements for the safety ofelectrocardiographs | ||
| IEC 60601-2-27: 2005 | Medical electrical equipment -- Part 2-27:Particular requirements for the safety,including essential performance, ofelectrocardiographic monitoringequipment. (Cardiovascular) | ||
| IEC 60601-2-49:2001 | Medical electrical equipment --- Part 2-49:Particular requirements for the safety ofmultifunction patient monitoring equipment | ||
| ISO14971:2007 | Medical devices-Application of riskmanagement to medical devices | ||
| 2 | Alarm | IEC60601-1-8 2006 | Medical electrical equipment - Part 1-8:General requirements for safety - Collateralstandard: General requirements, tests andguidance for alarm systems in medicalelectrical equipment and medical electricalsystems |
| 3 | NIBP | AAMI SP 10:2002 | Electronic or AutomatedSphygmomanometers |
| EN1060-1:1995 | Non-invasive sphygmomanometers - Part 1:General requirements | ||
| EN1060-3:1997 | Non-invasive sphygmomanometers - Part 3supplementary requirements for | ||
| EN1060-4: 2004 | Non-invasive sphygmomanometers - Part 4:Test procedures to determine the overallsystem accuracy of automated non-invasivesphygmomanometers. | ||
| IEC60601-2-30:1999 | Medical Electrical Equipment-Part 2-30:Particular requirements for safety ofautomatic cycling indirect blood pressuremonitoring equipment. | ||
| 5 | SpO2 | EN 865:1997ISO 9919:2005 | Pulse oximeters, Particular requirementsMedical electrical equipment -- Part 2-34:Particular requirements for the basic safetyand essential performance of pulse oximetersequipment for medical use |
| 6 | Temperature | ASTM E1112:2000ASTM E1104-03EN 12470-4:2000 | Electronic thermometer for intermittentdetermination of patient temperatureStandard Specification for ClinicalThermometer Probe Covers and SheathsClinical thermometers-Part 4: Performance ofelectrical thermometers for continuousmeasurement. |
| 7 | ECGMeasurement | ANSI/AAMIEC11:1991/(R)2001AAMI/ANSI EC13:2002/(R)2007ANSI/AAMI EC12:2000/(R) 2005AAMI EC53/(R) 2001 | Diagnostic electrocardiographic devicesCardiac monitors, heart rate meters, andalarmsDisposable ECG electrodesECG cables and leadwires. (Cardiovascular) |
| 8 | EMC | IEC60601-1-2:2007 | Medical Electrical Equipment-Part1-2:General Requirements for Safety -2.Collateral Standard-Electromagneticcompatibility - Requirements and tests |
| IEC61000-3-2 | Harmonic Emission | ||
| IEC61000-3-3 | Voltage Fluctuations/Flicker Emission | ||
| IEC61000-4-2 | Electrostatic Discharge (ESD) | ||
| IEC61000-4-3 | Radiated RF electromagnetic field | ||
| IEC61000-4-4 | Electrical fast Transient/Burst (EFT) | ||
| IEC61000-4-5 | Surge current | ||
| IEC61000-4-6 | Conducted disturbances, induced by RF field | ||
| IEC61000-4-8 | Power frequency (50/60Hz) Magnetic field | ||
| IEC61000-4-11 | Voltage dips, short interruptions, and voltagevariation on power supply input lines | ||
| CISPR 11, EN55011 | RF emissions | ||
| 9 | Biocompatibility | ISO10993-1 | Biological evaluation of medical devices - |
| Part 1: Evaluation and testing | |||
| 15010993-2 | Biological evaluation of medical devices - | ||
| Part 5: Tests for In Vitro cytotoxicity. | |||
| ISO10993-10 | Biological evaluation of medical devices - | ||
| Part 10: Tests for irritation and delayed-type | |||
| hypersensitivity | |||
| 10 | Labeling | EN1041:1998 | Terminology, symbols and information |
| provided with medical devices - information | |||
| supplied by the manufacturer with medical | |||
| devices. | |||
| 11 | Marking | IEC60878, EN980, | Graphical Symbols for use in the labeling of |
| ISO7000, EN60417-1, | Medical Devices | ||
| EN60417-2 | |||
| 12 | Package | ISTA: Pre-Shipment Test | Pre-Shipment Test Procedures (Package) |
| Procedures | |||
| (Procedure 1A, 1994 | |||
| Rev.) | |||
| 13 | Reliabilityi | IEC60068-2-1 | Environmental testing - Part 2-1: Tests - Test |
| A: Cold | |||
| IEC60068-2-2 | Environmental testing - Part 2-2: Tests - Test | ||
| B: Dry heat | |||
| IEC 60068-2-6 | Environmental testing - Part 2-6: Tests - Test | ||
| Fc: Vibration (sinusoidal) | |||
| IEC 60068-2-27 | Environmental testing - Part 2-27: Tests - Te | ||
| st Ea and guidance: Shock | |||
| IEC60068-2-30 | Environmental testing- Part 2-30: Tests - Tes | ||
| t Db: Damp heat, cyclic | |||
| IEC 60068-2-64 | Environmental testing - Part 2-64: Tests - Te | ||
| st Fh: Vibration, broadband random and guid | |||
| ance | |||
.
1
・
:
:
s
、、 .
35 of 866
.
Page 1 / 3
:
{8}------------------------------------------------
K100394
p9/12
··············································································································································································
・
{9}------------------------------------------------
K100394
p10/12
.
{10}------------------------------------------------
| ·m (GeostationsOr ±5 bpm (Campa20~250bpn3bpm ({------------------------------------------------------------------------------------------------------------------------------------------------------------------------------aleUlleeange-PulPulse rate accurar | |
|---|---|
| AND AND A CLASS OF A | |
| AND of the first of the country of can and other free for the first for for------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Or ±5 bpm (Campar±3bpm (Geostationa20~250bpm------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Note: Because the same NELLCOR SPO2 module and the sensors and cables are used in PM-9000 EXPRESS PATIENT MONITOR (K053234 Alarm
(bpm)
the Characteristics are same
dictive 6. Tempera
| ature (Predictive & Monitor) | ||
|---|---|---|
| Characteristics | Subject Device | Claimed SE Device 510(K) No. |
| Name and model | PMS8210A Multi-parameter Patient Monitor | PM-9000 EXPRESS PATIENT MONITOR (K053234) |
| Temperature parameter | Optional parameter | Optional parameter |
| Patient type | Adult, Pediatric & Neonate | Adult, Pediatric & Neonate |
| Unit of measure | °C & °F | °C & °F |
| Measurement site | Oral, Rectal & Axillary | Oral, Rectal & Axillary |
| Temperature measurementrange | 0°C | 0°C |
| Temperature measurementaccuracy | ±0.1°C (±0.2°F) | ±0.1°C (±0.2°F) |
| ASTM E1112:00 | ASTM E1112:00 | |
| Probe cross contaminationcontrol | Single use | Single use |
| Disposable cover | Disposable cover |
38 of 866
Page 5 of 5
{11}------------------------------------------------
-
- Safety and Performance Data :
Please refer to the Declaration of Conformity for the comprehensive list of testing performed on the PMS8210A Multi-parameter Patient Monitor. 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.
- Safety and Performance Data :
8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shanghai 3F Electronics Co., Ltd. concludes that the Patient Monitor, Model PMS8210A, is safe and effective and substantially equivalent to predicate devices as described herein.
-
- Shanghai 3F Electronics Co., Ltd.will update and include in a summary any other information deemed seasonably necessary by the FDA.
END
- Shanghai 3F Electronics Co., Ltd.will update and include in a summary any other information deemed seasonably necessary by the FDA.
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 1 5 2010
Shanghai 3F Electronics Co., Ltd. c/o Mr. Charles Mack Principal Engineer International Regulatory Consultants (IRC) 77325 Joyce Way Echo, OR 97826
Re: K100394
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
{14}------------------------------------------------
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
Page 1 of 1
§ 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).