(283 days)
C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker.
The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.
C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is intended to be used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. Other parameters can be applied to adult, pediatric or neonate.
The provided text is a 510(k) Summary for the Shenzhen Comen Medical Instruments Co., Ltd. Multi-parameter Patient Monitor, Model C30. It describes the device's characteristics, intended use, and comparisons to legally marketed predicate devices.
However, the document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific clinical study for the device's performance in isolation. The testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and adherence to performance standards, along with some clinical verification for NIBP and respiration rate accuracy.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of an AI algorithm's performance (such as sensitivity, specificity, or reader improvement) is not directly available or applicable to this type of medical device submission. This document describes a traditional multi-parameter patient monitor, not an AI-powered diagnostic device.
Based on the provided text, here's what can be extracted and what cannot be provided:
1. A table of acceptance criteria and the reported device performance:
The document lists various performance characteristics for each parameter (ECG, Respiration, Temperature, SpO2, Pulse Rate, NIBP, CO2) as part of the technological comparison to predicate devices, including measurement ranges and accuracies. These can be considered the de facto performance criteria. While the document states the device was "tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards," it does not provide a specific table of acceptance criteria with corresponding measured performance for each parameter from a single comprehensive study report. Instead, it infers compliance through comparison to predicate device specifications and adherence to standards.
| Parameter | Acceptance Criteria (from predicate comparison/standards) | Reported Device Performance (Implied from substantial equivalence and compliance statements) |
|---|---|---|
| ECG Heart Rate (HR) | Neonate/Pediatric: 15 to 350 bpm; Adult: 15 to 300 bpm; Accuracy: ±1% or ±1 bpm (whichever is larger) | The document states the device has "similar" characteristics and "complies" with performance standards, implying it meets these ranges and accuracies, but no direct measured performance values are provided. |
| Respiration Rate (Resp) | Measurement range: Adult: 0 to 120 rpm; Neonate: 0 to 150 rpm; Accuracy: 7 to 150 rpm: ±1 rpm (for subject device, compared to predicate's ±2 rpm or ±2%); 0 to 6 rpm: Not specified. | Clinical study indicated to verify RR accuracy by comparing subject device RR to capnography. Implies accuracy within the stated/expected range, but no specific results are quantified in the summary. |
| Temperature (Temp) | Measurement range: 0 to 50°C (32 to 122°F); Accuracy: ±0.1°C or ±0.2°F (without probe) | No specific measured performance values provided, but implied to be compliant with these specifications. |
| SpO2 | Masimo SpO2: Measurement range: 1 to 100%; Accuracy: 70 to 100%: ±2% (adult/pediatric, no motion), ±3% (neonate, no motion, and with motion). Nellcor SpO2: Measurement range: 0 to 100%; Accuracy: 70 to 100%: ±2% (adult/pediatric), ±3% (neonate). 0 to 69%: Not specified. | No specific measured performance values provided, but implied to be compliant with these specifications as "Same" as predicate device for Masimo/Nellcor module characteristics. |
| Pulse Rate (PR) | From Masimo SpO2: Range 25 to 240 bpm; Accuracy: ±3 bpm (no motion), ±5 bpm (with motion). From Nellcor SpO2: Range 20 to 300 bpm (20-250 bpm: ±3 bpm, 251-300 bpm: not specified). | No specific measured performance values provided, but implied to be compliant with these specifications as "Same" as predicate device for Masimo/Nellcor module characteristics. |
| Non-Invasive Blood Pressure (NIBP) | Measurement range (Adult/Pediatric/Neonate systolic/mean/diastolic ranges vary as per table). Accuracy: Max mean error: ±5 mmHg; Max standard deviation: 8 mmHg. (These are performance requirements based on ISO 81060-2:2013). | "According to ISO 81060-2:2013, NIBP clinical accuracy was verified." This statement indicates testing was done according to the standard, implying it met the accuracy requirements specified by that standard, but explicit performance values are not provided. |
| Carbon Dioxide (CO2) | Respironics: Range 0-150 mmHg; Accuracy: 0-40 mmHg: ±2 mmHg, 41-70 mmHg: ±5%, 71-100 mmHg: ±8%, 101-150 mmHg: ±10%. awRR: 0-150 bpm, Accuracy: ±1 rpm. Masimo: Range 0-190 mmHg; Accuracy: 0-114 mmHg: ±1.52 mmHg + 2%. awRR: 0-150 bpm, Accuracy: ±1 rpm. | No specific measured performance values provided, but implied to be compliant with these specifications. |
2. Sample size used for the test set and the data provenance:
- NIBP Clinical Study: The document states "According to ISO 81060-2:2013, NIBP clinical accuracy was verified." This standard specifies requirements for Non-Invasive Sphygmomanometers, including clinical investigation procedures. However, the exact sample size for this specific study and the data provenance (country, retrospective/prospective) are not given in this summary.
- Respiration Rate Clinical Study: "To verify respiration rate (RR) accuracy, Clinical study was conducted comparing the RR from the subject device with that from capnography." The exact sample size and data provenance are not given.
- For other parameters, bench testing and compliance with standards are mentioned, but no specific clinical test sets or sample sizes are detailed.
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 as this is not an AI diagnostic device and does not inherently involve expert image interpretation or similar processes for ground truth establishment. Clinical studies mentioned (NIBP, RR) would likely use reference measurements from other validated medical devices as a "ground truth" or comparator, but details on expert involvement are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/provided. Adjudication methods are typically used in studies involving subjective assessments, especially common in AI diagnostic imaging where multiple readers reconcile disagreements. This device is a physiological monitor measuring objective parameters.
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. This is a physiological monitoring device, not an AI-powered diagnostic tool intended to assist human readers in interpreting complex medical data or images. Therefore, an MRMC study is beyond the scope of this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable/provided. This device is a multi-parameter patient monitor that measures physiological signals directly rather than an AI algorithm performing a standalone diagnostic function. The device's performance is its direct measurement output, which is then used by healthcare professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the NIBP and Respiration Rate clinical studies, the "ground truth" would likely be established through reference measurements from other validated medical devices or established clinical methods. For example, NIBP accuracy usually compares the device's readings to those obtained through an invasive arterial line or another highly accurate, validated NIBP device. For respiration rate, capnography (a precise measurement of CO2 in exhaled breath) was explicitly mentioned as the comparator.
8. The sample size for the training set:
The device described is a traditional patient monitor developed through engineering and design principles, not a machine learning or AI model that requires a "training set." Therefore, this concept is not applicable to this product.
9. How the ground truth for the training set was established:
As above, the concept of a "training set" and "ground truth for the training set" is not applicable to this traditional medical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2018
Shenzhen Comen Medical Instruments Co., Ltd. Hongbo Yan Registration Engineer South of Floor 7, Block 5 4th Industrial Area of Nanyou Nanshan District Shenzhen, 518052 CN
Re: K173454
Trade/Device Name: Multi-parameter Patient Monitor, Model C30 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: DRT, DPS, DSJ, DSK, DXN, DOA, DSB, FLL Dated: Julv 23, 2018 Received: July 23, 2018
Dear Hongbo Yan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jessica E. Paulsen -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K173454
Device Name
Multi-parameter Patient Monitor, Model C30
Indications for Use (Describe)
C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker.
The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510 (k) Summary C30 Multi-parameter Patient Monitor
This 510(k) Summary is provided in accordance with the requirements of 21 CER 807.92.
| Date: | Aug 14, 2018 |
|---|---|
| Submitter: | SHENZHEN COMEN MEDICAL INSTRUMENTS CO.,LTD |
| South of Floor 7, Block 5 4th Industrial Area of Nanyou, Nanshan District, | |
| Shenzhen, Guangdong, 518052, P.R.China | |
| No.2 of FIYTA Timepiece Building, Nanhuan Avenue, Gongming Sub-district, | |
| Guangming New District, Shenzhen, Guangdong, 518106, P.R.China. | |
| Contact: | Hongbo Yan |
| Registration Engineer | |
| Telephone: | +86-13424152596 |
| Facsimile: | +86-755-26431232 |
| Device Trade Name: | Multi-parameter Patient Monitor, Model C30 |
| Common Name: | Multi-parameter Patient Monitor |
Device Classification:
| Device Panel | Classification | ProCode | Description | |
|---|---|---|---|---|
| Cardiovascular | §870.2300, II | DRT | Cardiac Monitor (incl. Rate Alarm) | |
| §870.1110, II | DSK | Computer, Blood Pressure | ||
| Devices: | §870.1130, II | DXN | System, Measurement, Blood-Pressure,Non-Invasive | |
| §870.1100, II | DSJ | Alarm, Blood Pressure | ||
| §870.2300, II | DRT | Monitor, Cardiac (incl.Cardiotachometer& Rate Alarm) | ||
| §870.2340, II | DPS | Electrocardiograph | ||
| §870.2700, II | DQA | Oximeter | ||
| §870.2770, IT | DSB | Plethysmograph, Impedance | ||
| General Hospital | §880 .2910, II | FLL | Thermometer, Electronic, Clinical | |
| Predicate Devices: | K123074, BeneView T1 Patient monitor, Shenzhen Mindray Bio-medicalElectronics (The primary predicate device) | |||
| K112877, C80 COMEN Multi-parameter Patient Monitor, Shenzhen ComenMedical Instruments Co., Ltd | ||||
| Device description: | C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) isintended to be used for monitoring, reviewing and storing of multiple physiologicalparameters as following: ECG, heart rate (HR), respiration (Resp), temperature(Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of singlepatient. Other parameters can be applied to adult, pediatric or neonate. | |||
| Indications for Use: | C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) isindicated for use by health care professionals whenever there is a need formonitoring the physiological parameters of patients. It's used for monitoring,reviewing and storing of multiple physiological parameters as following: ECG,heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR),non-invasive blood pressure (NIBP) of single patient. All parameters can beapplied to adult, pediatric or neonate. The Patient Monitor is not intended to beused on the patients with pacemaker. The monitor is used for monitoring theclinical patients, so only the doctors and nurses who are qualified through trainingcan use these monitors. | |||
| The table below lists the patient population for each parameter as appropriate: | ||||
| PatientPopulationParameter | Adult | Pediatric | Neonate | |
| ECG | √ | √ | √ | |
| RESP | √ | √ | √ | |
| SpO2 | √ | √ | √ | |
| TEMP | √ | √ | √ | |
| NIBP | √ | √ | √ | |
| Et CO2 | √ | √ | √ | |
| Remark: | 1. The patient population for each parameter asappropriate is marked with '√';2. The neonatal patient type is not included in thepatient type of pediatrics for COMENmulti-parameter patient monitors. | |||
| Indications for UseComparison toPredicate Devices | The C30 and the predicate devices' indications for use are similar. The subjectand predicate devices are all patient monitors that are intended to be used inhealthcare facilities by physicians or clinical staff. The devices measure similarpatient parameters.The device provides single patient monitoring for parameters such as ECG,impedance respiration (Resp), temperature (TEMP),SpO2, pulse rate(PR),noninvasive blood pressure (NIBP), respiration rate (RR) and EtCO2. Allparameters can be applied to adult, pediatric or neonate..These minor differences between the predicate device and subject devices'indications for use do not constitute a new intended use and are not significantchanges in indications for use. | |||
| TechnologicalComparison toPredicate Devices: | Both the subject devices and the predicate devices provide a means forinterfacing with a patient, collecting parameter and specific physiological data,and processing the data for alarm generation and display of numeric values andwaveforms. |
{4}------------------------------------------------
{5}------------------------------------------------
{6}------------------------------------------------
| Feature | Subject Devices | Predicate Device(primary) K123074 | Predicate Device K112877 | |||
|---|---|---|---|---|---|---|
| Dimension | C30 | T1 | C80 | |||
| 190×82×105mm | 143×77×102mm | 344.5x291×165 mm | ||||
| Integrateddisplay andtouchscreen | 4.3"480*272 pixels | 5"same | 12.1"800*600 pixels | |||
| Powersupply | One standardrechargeablelithium-ion batteryor AC power | Same | Same | |||
| Battery | 11.1V, 2600mAh | 14.8V, 4400Ah | 12V, 2500mAh | |||
| ECG | 3-lead, 5-lead or12-lead selectable, | 3-lead, 5-lead or12-lead selectable,arrhythmiadetection, STsegment | 3-lead, 5-lead or12-leadselectable | |||
| ECGmeasurement range andaccuracy | HR:Neonate /Pediatric: 15 to350bpmAdult: 15 to300bpmAccuracy: ±1% or±1bpm, whicheveris the larger. | Same | Same | |||
| Respirationrate (Resp) | Measurementrange: Adult: 7 to120rpm, Neonate:7 to 150rpm.Accuracy: 7 to 150rpm: ±2rpm or±2%, whichever isgreater; 0 to 6rpm:Not specified. | Measurementrange: Adult: 0 to120rpm, Neonate:0 to 150rpm.Accuracy: same | Measurementrange: sameAccuracy:7 to 150rpm:±1rpm | |||
| Temperature(Temp) | Measurementrange: 0 to 50°C (32to 122°F )Accuracy: ±0.1 ℃ or | Same | Same | |||
| ±0.2°F (without probe) | ||||||
| Pulse oxygen saturation (SpO2) | Masimo SpO2 Module:Measurement range: 1 to 100%Accuracy: 70 to 100%: ±2% (measured without motion in adult/pediatric mode)Accuracy: 70 to 100%: ±3% (measured without motion in neonate mode)Accuracy: 70 to 100%: ±3% (measured with motion)1 to 69%: Not specifiedNellcorSpO2 module:Measurement range: 0 to 100%Accuracy: 70 to 100%: ±2% (adult/pediatric mode)Accuracy: 70 to 100%: ±3% (neonate mode)0 to 69%: Not specified | MindraySpO2 Module:Measurement range: 0 to 100%Accuracy: 70 to 100%: ±2% (adult/pediatric mode)70 to 100%: ±3% (neonate mode)0 to 69%: Not specifiedMasimo SpO2 Module: SameNellcorSpO2 module: Same | Masimo SpO2 Module: SameNellcorSpO2 module: Same | |||
| Pulse rate | PR from MasimoSpO2 module:Measurement | PR from MindraySpO2 module:Measurement | / | |||
| range: 25 to 240bpmAccuracy: ±3bpm(measured withoutmotion)±5 bpm (measuredwith motion)PR fromNellcorSpO2module:Measurementrange: 20 to 300bpmAccuracy: 20 to250bpm: ±3bpm,251 to 300bpm:notspecified. | range: 20 to 254bpmAccuracy: ±3bpmPR fromMasimoSpO2module: SamePR fromNellcorSpO2module: Same | |||||
| Non-invasive bloodpressure(NIBP) | Measurementrange:Adult:Systolic:40-270mmHgMean: /Diastolic:10-215mmHgPediatric:Systolic:40-200mmHgMean: /Diastolic:10-150mmHgNeonate:Systolic:40-135mmHgMean: /Diastolic:10-100mmHgAccuracy:Max mean error: | Measurementrange:Adult:Systolic: sameMean: 20-230Diastolic:10-210mmHgPediatric:Systolic: sameMean:20-165mmHgDiastolic: sameNeonate:Systolic: sameMean:20-110mmHgDiastolic:10-110mmHgAccuracy: Same | Measurementrange:Adult:Systolic: sameMean: 20-235Diastolic: samePediatric:Systolic: sameMean:20-165mmHgDiastolic:10-100mmHgNeonate:Systolic:40-150mmHgMean:20-110mmHgDiastolic: sameAccuracy:Same | |||
| Carbondioxide(CO2) | ±5mmHg | / | ||||
| Max standarddeviation: 8mmHg | ||||||
| RespironicsNovametrix CO2module: | Measurementrange: 0-99mmHg | |||||
| Measurementrange:0-150mmHg, | Accuracy: | |||||
| Accuracy: | 0 to 40 mmHg:±2mmHg | |||||
| 0-40mmHg:±2mmHg | 41 to 76mmHg:±5% of the reading | |||||
| 41-70mmHg: ±5%of the reading | 77 to 99mmHg:±10% of thereading | |||||
| 71-100mmHg: ±8%of the reading | awRRmeasurementrange: 0 to 120rpm | |||||
| 101-150mmHg:±10% of thereading | awRRmeasurementaccuracy: ±2rpm | |||||
| awRRmeasurementrange: 0 to 150 rpm | ||||||
| awRRmeasurementaccuracy: ±1rpm | ||||||
| Masimo CO2module: | ||||||
| Measurementrange: 0-190mmHg | ||||||
| Accuracy: | ||||||
| 0-114mmHg:±1.52mmHg+2% | ||||||
| 114mmHg-190mmHg: Not specified | ||||||
| awRRmeasurementrange: 0 to 150 rpm | ||||||
| awRRmeasurementaccuracy: ±1rpm | ||||||
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
| The differences do not raise questions of safety and effectiveness | |
|---|---|
| Summary ofPerformance Testing: | The C30 Multi-parameter Patient Monitor has been tested and found to be incompliance with recognized safety, performance and electromagneticcompatibility standards.The risk analysis has been developed to identify potential hazards anddocuments the mitigation of the hazards. The device's software has been verifiedand validated in accordance with the appropriate test requirements. Clinicaland/or bench performance testing are also provided.The C30 Multi-parameter Patient Monitor has been evaluated by end-users andfound to meets performed within its intended use and met their specific needs.The C30 Multi-parameter Patient Monitor has been tested and found to be incompliance with the following safety, performance and electromagneticcompatibility standards:Electrical Safety and Electromagnetic Compatibility:ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012IEC 60601-1-2:2007Bench testing:IEC 60601-1-8 Edition 2.0 2006-10IEC60601-2-27 Edition 3.0 2011-03IEC 80601-2-30 Edition 1.1 2013-07IEC 80601-2-56 First Edition 2009-10-01IEC 80601-2-61 First Edition 2011-04-01IEC 62366-1 Edition 1.0 2015-01ISO 80601-2-55 First Edition 2011-12-15Clinical testing: |
| According to ISO 81060-2:2013, NIBP clinical accuracy was verified. | |
| To verify respiration rate (RR) accuracy, Clinical study was conducted comparing | |
| the RR from the subject device with that from capnography. | |
| Software Verification and Validation Testing: | |
| The software was developed according to IEC 62304 First Edition 2006-05. | |
| Testing was conducted to verify and validate the software performs according to | |
| the requirements. Documentation in accordance with FDA's guidance document | |
| "Guidance for the Content of Premarket Submissions for Software Contained in | |
| Medical Devices" was provided. | |
| Conclusion: | Based on similarities in intended use and technological characteristics, results of |
| performance and validation/verification testing, and conformance with applicable | |
| standards, the C30 Multi-parameter Patient Monitor is considered substantially | |
| equivalent to the predicate devices. |
{11}------------------------------------------------
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.