(34 days)
The Welch Allyn CP150TM Electrocardiograph is intended for use by trained operators in health facilities. The electrocardiograph provides the following diagnostic functions: Acquiring, viewing, storing and printing ECG waveforms using ECG Front-End modules (patient cables) and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.Using optional algorithms to generate measurements, data presentations and graphical presentations, and interpretative statements on an advisory basis. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the result of physical examination, the ECG tracings, and other clinical findings.
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
The Welch Allyn CP150™ Electrocardiograph is an electrocardiograph used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart. Its features include a 7" color touch screen display for ECG preview and user-friendly interface, full-size user-programmable reports, and the ability to operate on either battery or AC power.
The CP150™ Electrocardiograph is able to connect either via USB cable or via wired ethernet (RJ45 connector) across the ethernet network, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The USB port can also be used to connect other accessory devices.
The provided document describes the Welch Allyn CP150™ Electrocardiograph and its substantial equivalence to predicate devices (Welch Allyn CP100™ and CP200™ Electrocardiographs, K072449). The information focuses on non-clinical performance testing and device comparison, rather than a clinical study evaluating diagnostic accuracy or reader performance with an AI algorithm. Therefore, many aspects of your request (e.g., sample size for test set, number of experts, MRMC study, standalone performance for AI, training set details) are not directly addressed in the provided text.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents "Additional performance Bench Testing" with specific criteria and conclusions. These primarily relate to the device's physical and electrical reliability and compliance with various standards, not diagnostic accuracy of an interpretation algorithm.
| Report DIR -- Description | Objective of the Test | Pass/Fail Criteria (Acceptance Criteria) | Conclusions (Reported Device Performance) |
|---|---|---|---|
| 60048998 --- CP150 Connectors Reliability | To verify the reliability of all connectors of CP150. | • AC power inlet: 50 connect/disconnect cycles. • ECG (DB15): 50 connect/disconnect cycles. • Ethernet (RJ45): 100 connect/disconnect cycles. • mini USB (USB B): 100 connect/disconnect cycles. • USB: 400 connect/disconnect cycles. | PASS: The connectors meet the requirements of TRS and reliability plan. |
| 60048999 --- CP150 Battery Capacity Test | To verify the battery capacity for number of standard use cycles available without re-charging the battery. | The device shall have the capacity to complete 25 ECGs over a 12 hour period with a single fully charged battery. Each ECG test is assumed taken in 15 minutes cycle with two copies of ECG prints. | PASS: The battery meets the requirements of TRS. |
| 60049000 --- CP150 Battery Door & Connector | To verify the reliability of Battery Door and Battery Connector for number of standard use (insert/remove) cycles. | TRS 4.8 4.8: The battery connector shall have a useable life shall be at least 10 connect/disconnect cycles and the door needs to pass 230 cycles of opening/closing. | PASS: The battery door and battery connector meet the requirements of TRS. |
| 60049001 --- CP150 Power Button Test | To verify the reliability of Power Button by number of presses. | Reliability Plan 8.5: The test should meet zero failures for a total of 48,909 presses on 1 unit. | PASS: The Power Button meets the requirements of reliability plan. |
| 60049002 --- CP150 LCD Touchscreen Test | To verify the reliability of LCD Touchscreen by applying mechanical touches on the screen. | Reliability Plan 8.5: All the functional tests must pass for a total of 1,687,688 touches on 3 units. | PASS: The test results shows the LCD touchscreen meets the requirements of Reliability plan. |
| 60049003 --- CP150 Environment Test | To verify the device shall operate at temperature between 10.0C and 40.0C and at a relative humidity of 15% to 95% (non condensing). For printing the humidity is limited to 30% to 70% (non-condensing). | All the intermediate verification test was passed for following conditions: Acquiring ECG with Printing: • +5°C / 30% RH for 6 hours • +5°C / 70% RH for 6 hours • +45°C / 30% RH for 6 hours • +45°C / 30% RH for 6 hours Acquiring ECG without Printing: • +5°C / 10% RH for 6 hours • +5°C / 95% RH for 6 hours • +45°C / 10% RH for 6 hours • +45°C / 95% RH for 6 hours | PASS: The test results shows the CP150 meets the environmental test requirements of Reliability plan. |
| --- CP150 Barcode scanner verification | To verify that the device will have the ability to input barcode alphanumeric inputs via a bar code scanner. | Scanned results should match the sample serial number in the box. | PASS: The test results shows the bar code scanner meets the requirements of Reliability plan. |
| 50052441 --- 60601-1 Safety test | Test the device per 60601-1 to ensure that the device meets the safety requirements for medical devices. | Devices pass criteria of 60601-1. | PASS: Devices are compliant with 60601-1 standard. |
| 50052442 --- 60601-1-2 Electromagnetic Compatibility test | Test the device per 60601-1-2 to ensure that the device meets the requirements for Electromagnetic Compatibility. | Devices pass criteria of 60601-1-2. | PASS: Devices are compliant with 60601-1-2 standard. |
| 50052441 - 60601-1-4 Medical Electrical Equipment - Part 1-4 | Test the device per 60601-1-4 to ensure that the device meets the requirements for Programmable Electrical Medical Systems. | Devices pass criteria of 60601-1-4. | PASS: Devices are compliant with 60601-1-4 standard. |
| AAMI EC-11 Diagnostic electrocardiographic devices | Test the device per to ensure that the device meets the AAMI standard requirements for Diagnostic electrocardiographic devices. | Devices pass criteria of AAMI EC-11. | PASS: Devices are compliant with AAMI EC-11. |
| 60601-2-25 Medical electrical equipment - Part 2-25 | Test the device per to ensure that the device meets the 60601-2-25 requirements for the basic safety and essential performance of electrocardiographs. | Devices pass criteria of 60601-2-25. | PASS: Devices are compliant with 60601-2-25. |
| 60601-2-51 Particular Requirements For Safety | Test the device per to ensure that the device meets 60601-2-51 the requirements for Safety, Including Essential Performance, Of Recording And Analysing Single Channel And Multichannel Electrocardiographs. | Devices pass criteria of 60601-2-51. | PASS: Devices are compliant with 60601-2-51. |
| 14971 Medical Devices - Application of Risk Management to Medical Devices | Test the device per to ensure that the device meet the requirements for the Application of Risk Management to Medical Devices. | Devices pass criteria of 14971. | PASS: Risk Analysis Summary. |
| 60051724-- Welch Allyn mobile stand - Large Platform Cart (LPC) Safety test | To verify the LPC meet the safety requirements per 60601-1. | The device can be installed as per assembly instruction and the LPC pass criteria of 60601-1. | PASS: the LPC is compliant with 60601-1 standard and can be used with the subject device. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." The performance tests conducted are non-clinical bench tests (e.g., connector cycles, battery capacity, touchscreen presses) and compliance testing against various medical device standards (e.g., IEC 60601 series, AAMI EC-11). Therefore, there isn't a "test set" in the context of clinical data for diagnostic performance.
The provenance of non-clinical test data is implied to be internal Welch Allyn testing or third-party certified labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set or ground truth established by experts for diagnostic performance is described. The device is tested against engineering and safety standards. The "optional interpretation algorithm" mentioned is noted as providing "guidance for qualified physicians" and "must not be relied upon as diagnoses," implying that human expert interpretation remains the gold standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication process for diagnostic performance is described.
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
No MRMC comparative effectiveness study is mentioned. The submission focuses on the technical characteristics and safety of the device itself and its substantial equivalence to predicate devices, not on the comparative effectiveness of its optional interpretation algorithm with or without human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions an "optional interpretation algorithm" that "provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information." This indicates that the algorithm is not intended for standalone use as a diagnostic tool. No standalone performance study for the algorithm is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is defined by the technical specifications and regulatory standards (e.g., number of cycles for reliability tests, passing criteria for IEC 60601 standards). No clinical ground truth from expert consensus, pathology, or outcomes data is mentioned as being used for device validation in this submission.
8. The sample size for the training set
Not applicable. Since no clinical studies were used and the focus is on hardware and software updates for substantial equivalence, details about an algorithm's training set are not provided. The algorithm itself is noted to be "also used in Welch Allyn's Cardioperfect Workstation, and this modification to the PEDMEANS was covered in the submission K082478 for the Cardioperfect Workstation." This suggests the algorithm's development and validation (and likely training) occurred prior to this submission and was part of a different submission.
9. How the ground truth for the training set was established
Not applicable, for the same reasons as point 8. The document does not provide details about the training set for the interpretation algorithm.
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Welch
K131573 pg 1 of 13
Special 510(k) Premarket Notification Welch Allyn CP150TM Electrocardiograph
510(k) Summary
[As described in 21 CFR 807.92]
JUL 0 3 2013
| Submitted by: | Welch Allyn Inc. |
|---|---|
| 4341 State Street Road | |
| Skaneateles Falls, NY 13153-0220 | |
| Contact Person: | Kevin Crossen |
| Director Regulatory Affairs | |
| Phone: (315) 685-2609 | |
| Fax: (315) 685-2532 | |
| E-mail: Kevin.Crossen@welchallyn.com | |
| Date Prepared: | May 30, 2013 |
| Trade Name: | Welch Allyn CP150 TM Electrocardiograph |
| 901049 Electrocardiograph | |
| Common Name: | Electrocardiograph |
| Classification Reference: | Class II, Electrocardiograph (21 CFR 870.2340, Product Code DPS) |
| Predicate Device: | Welch Allyn CP100 TM and CP200 TM Electrocardiographs |
| 510(k) Number: K072449 | |
| Electrocardiograph, 21 CFR 870.2340 | |
| Class II, DPS |
Description of the Device:
The Welch Allyn CP150™ Electrocardiograph is an electrocardiograph used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart. Its features include a 7" color touch screen display for ECG preview and user-friendly interface, full-size user-programmable reports, and the ability to operate on either battery or AC power.
The CP150™ Electrocardiograph is able to connect either via USB cable or via wired ethernet (RJ45 connector) across the ethernet network, which in turn can connect with other electronic patient-information systems, such as billing and medical records. The USB port can also be used to connect other accessory devices,
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Image /page/1/Picture/1 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The words "Welch" and "Allyn" are next to each other, with a small registered trademark symbol after "Allyn".
Special 510(k) Premarket Notification Welch Allyn CP150"M Electrocardiograph
The CP150™ Electrocardiograph is specifically intended for acquiring and printing ECG signals from adults and pediatric patients. It will be used in clinical settings by trained healthcare providers.
The optional interpretation algorithm analyzes these ECG signals to generate measurements and interpretive statements. The interpretive results are intended only as guidance for qualified physicians and must not be relied upon as diagnoses.
Indications for Use:
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and measure patient cardiac function.
The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
Contraindications:
There are no known contraindications for use.
Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate; The hardware, software, and mechanical aspects of the CP150 have been updated to current technology equivalent to the cleared devices (CP100" and CP200™ Electrocardiographs, K072449, S.E. dated Nov. 29, 2007) as described below. The modification is to replace the display, i.e. 5.7 inches color LCD display, with a 7' color touch screen display for ECG preview. The physical QWERTY keyboard and other hard function keys used on CP100/CP200™ will be replaced by the touch screen interface. Additionally included are minor software and connectivity enhancements to improve performance and customer experience.
Non-Clinical Tests:
The Welch Allyn CP150" Electrocardiograph was tested to evaluate its safety and effectiveness based on the following standards:
| Standard | Version | Title |
|---|---|---|
| EN/IEC 60601-1 | 2nd Edition2000 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safetyand Essential Performance |
| EN/IEC 60601-1-2 | 2007 | Medical Electrical Equipment - Part 1-2: General Requirements for BasicSafety and Essential Performance - Collateral Standard: ElectromagneticCompatibility - Requirements and Tests |
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Image /page/2/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, serif font. The words "Welch" and "Allyn" are next to each other, with a small dot after the word "Allyn".
K131573 pg 3 of 13
Special 510(k) Premarket Notification
Welch Allyn CP150™ Electrocardiograph
| EN/IEC 60601-1-4 | 2000 | Medical Electrical Equipment - Part 1-4: General Requirements for Safety -Collateral Standard: General Requirements for Programmable ElectricalMedical Systems |
|---|---|---|
| AAMI EC-11 | 1991 (R2007) | Diagnostic electrocardiographic devices |
| IEC/EN60601-2-25 | 1993 AMD 11999 | Medical electrical equipment - Part 2-25: Particular requirements for the basicsafety and essential performance of electrocardiographs |
| IEC/EN60601-2-51 | 2003 | Particular Requirements For Safety, Including Essential Performance, OfRecording And Analysing Single Channel And MultichannelElectrocardiographs |
| EN/ISO 14971 | 2007/2007 | Medical Devices - Application of Risk Management to Medical Devices |
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:
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K131573 pg 4 of 13
VechAllyn.
Special 510(k) Premarket Notification
Welch Allyn CP150™ Electrocardiograph
Rench Testi Additional per
| Additional performance Bench Testing: | ||||
|---|---|---|---|---|
| Report DIR --Description | Objective of the Test | Test Method/ Procedure | Pass/Fail Criteria | Conclusions |
| 60048998 --- CP150ConnectorsReliability | To verify the reliability ofall connectors of CP150 asper CP150 TechnicalRequirements Specification(TRS) (DIR 60047341) andCP150 Reliability Plan(DIR 60046890) including:• AC power inlet• ECG (DB15)• Ethernet (RJ45)• mini USB (USB B)• USB | 1. Insert connector into the inlet2. Conduct an Interval Inspection afterevery 10 insert/remove cycles.3: Repeat steps 1-2 for greater than theminimum number of cycles listed inPass/Fail criteria | • AC power inlet; 50connect/disconnectcycles.• ECG (DB15), 50connect/disconnectcycles.• Ethernet (RJ45), 100connect/disconnectcycles.• mini USB (USB B)100connect/disconnectcycles.• USB, 400connect/disconnectcycles. | PASS: Theconnectorsmeet therequirements ofTRS andreliability plan |
| 60048999 --- CP150Battery Capacity Test | To verify the batterycapacity for number ofstandard use cyclesavailable without re-charging the battery | 1. Using only the battery (fully charged),perform 25x ECG print tests2. ECG test duration should take 15minutes3. Check battery capacity after each ECGprint test | The device shall have thecapacity to complete 25ECGs over a 12 hour periodwith a single fully chargedbattery. Each ECG test isassumed taken in 15 minutescycle with two copies ofECG prints | PASS: Thebattery meetstherequirementsof TRS |
| 60049000 --- CP150Battery Door &Connector | To verify the reliability ofBattery Door and BatteryConnector for number ofstandard use(insert/remove) cycles | 1. Unscrew the Battery Door. Removethe battery fully. Insert back the batteryand close the battery door and screw backto secure.2. Conduct an Interval Inspection afterevery 10 insert/remove cycles. | TRS 4.8 4.8: The batteryconnector shall have auseable life shall be at least10 connect/disconnect cyclesand the door needs to pass230 cycles ofopening/closing. | PASS: Thebattery doorand batteryconnector meettherequirementsof TRS |
| 60049001 --- CP150Power Button Test | To verify the reliability ofPower Button by numberof presses as per CP150Reliability Plan (DIR60046890) requirements | • Press the Power Button with a nominalforce as to power up the unit. Hold forone second then release.• Conduct an Interval Inspection afterevery 2,500 presses. | Reliability Plan 8.5: The testshould meet zero failures fora total of 48,909 presses on 1unit | PASS: ThePower Buttonmeets therequirementsof reliabilityplan |
| 60049002 --- CP150LCD Touchscreen Test | To verify the reliability ofLCD Touchscreen byapplying mechanicaltouches on the screen asper CP150 Reliability Plan(DIR 60046890)requirements | • Install the 'touch finger' with siliconerubber region above the LCDTouchscreen. Adjust the input force to be350g.• Set the same for the other 5 'touchfinger'• Setup test speed to 1 Hz and start thetest.• Conduct an Interval Inspection afterevery 60,000 touches.• Shift the 'touch finger' to other positions | Reliability Plan 8.5: All thefunctional tests must pass fortotal of 1,687688 touches on3 unites (please see therational on analysis columnon the right) | PASS: The testresults showsthe LCDtouchscreenmeets therequirementsof Reliabilityplan |
| 60049003 --- CP150Environment Test | To verify the device shalloperate at temperaturebetween 10.0C and 40.0Cand at a relative humidityof 15% to 95% (noncondensing) For printingthe humidity is limited to30% to 70% (non-condensing) | Device dwells for at least 6 hours at eachoperating conditionsAfter every 3 hours dwell at eachcondition, perform an intermediateverification test | All the intermediateverification test was passedfor following conditions:Acquiring ECG withPrinting• +5°C / 30% RH for 6 hours• +5°C / 70% RH for 6 hours• +45°C / 30% RH for 6hours• +45°C / 30% RH for 6hoursAcquiring ECG withoutPrinting• +5°C / 10% RH for 6 hours• +5°C / 95% RH for 6 hours• +45°C / 10% RH for 6hours• +45°C / 95% RH for 6hours | PASS: The testresults showsthe CP150meets theenvironmentaltestrequirementsof Reliabilityplan |
| --- CP150 Barcodescanner verification | To verify that the devicewill have the ability toinput barcodealphanumeric inputs via abar code scanner | 1. Connect barcode scanner to the device2. Scan the sample Serial number andverify the result3. Repeat step 2 for 58 times | Scanned results shouldmatch the sample serialnumber in the box | PASS: The testresults showsthe bar codescanner meetstherequirementsof Reliabilityplan |
| 50052441 ---60601-1 Safety test | Test the device per 60601-1 to ensure that the devicemeets the safetyrequirements for medicaldevices | Units delivered to independently certifiedtest lab for testing per compliance withstandard. | Devices pass criteria of60601-1 | PASS Devicesare compliantwith 60601-1standard |
| 50052442 --- 60601-1-2 ElectromagneticCompatibility test | Test the device per 60601-1-2 to ensure that thedevice meets therequirements forElectromagneticCompatibility | Units delivered to independently certifiedtest lab for testing per compliance withstandard. | Devices pass criteria of60601-1-2 | PASS Devicesare compliantwith 60601-1-2standard |
| 50052441 - 60601-1-4Medical ElectricalEquipment - Part 1-4:General RequirementsFor Safety - CollateralStandard: GeneralRequirements forProgrammableElectrical MedicalSystems | Test the device per 60601-1-4 to ensure that thedevice meets therequirements forProgrammable ElectricalMedical Systems | Units delivered to independently certifiedtest lab for testing per compliance withstandard. | Devices pass criteria of60601-1-4 | PASS Devicesare compliantwith 60601-1-4 |
| AAMI EC-11Diagnosticelectrocardiographicdevices | Test the device per toensure that the devicemeets the AAMI standardrequirements for Diagnosticelectrocardiographic devices | Units delivered to independently certifiedtest lab for testing per compliance withstandard. | Devices pass criteria ofAAMI EC-11 | PASS Devicesare compliantwith AAMI EC-11 |
| 60601-2-25 Medicalelectrical equipment -Part 2-25: Particularrequirements for thebasic safety andessential performanceof electrocardiographs | 60601-2-51 ParticularRequirements ForSafety, IncludingEssential Performance,Of Recording AndAnalysing SingleChannel AndMultichannelElectrocardiographs | 14971 Medical Devices- Application of RiskManagement to MedicalDevices | 60051724-- WelchAllyn mobile stand- Large Platform Cart(LPC) Safety test | |
| Test the device per toensure that the devicemeets the 60601-2-25requirements for the basicsafety and essentialperformance ofelectrocardiographs | Test the device per toensure that the devicemeets 60601-2-51 therequirements for Safety,Including EssentialPerformance, Of RecordingAnd Analysing SingleChannel And MultichannelElectrocardiographs | Test the device per toensure that the device meetthe requirements for theApplication of RiskManagement to MedicalDevices | To verify the LPC meet thesafety requirements per60601-1 | |
| Units delivered to independently certifiedtest lab for testing per compliance withstandard. | Units delivered to independently certifiedtest lab for testing per compliance withstandard. | Risk management review performedaccording to Welch Allyn procedures | The subject device is verifies to beassembled with the cart as per assemblyinstructions and the LPC is verified tomeet the safety requirements per 60601-1by third party | |
| Devices pass criteria of60601-2-25 | Devices pass criteria of60601-2-51 | Devices pass criteria of14971 | The device can be installedas per assembly instructionand the LPC pass criteria of60601-1 | |
| PASS Devicesare compliantwith 60601-2-25 | PASS Devicesare compliantwith 60601-2-51 | PASS RiskAnalysisSummary | PASS the LPCis compliantwith 60601-1standard andcan be usedwith thesubject device |
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WelchAllyn
K131573 pg 5 of 13
Special Special 510(k) Premarket Notification
Welch Allyn CP150™ Electrocardiograph
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Welch Allyn CP150™ Electrocardiograph
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K131573 pg 6 of 13
VectorAly
Special 510(k) Premarket Notification
Welch Allyn CP150™ Electrocardiograph
Page 8-7
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K131573 pg 7 of 13
Page 8-8
WelchAllyn
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K131573 pg 8 of 13
V
ely
Allyn
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Special 510(k) Premarket Notification
Welch Allyn CP150™ Electrocardiograph
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K131573 pg 9 of 13
Veatchlyn.
Special 510(k) Premarket Notification
Welch Allyn CP150™ Electrocardiograph
ge
8-10
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Image /page/9/Picture/1 description: The image shows the logo for Welch Allyn. The logo is in a bold, sans-serif font. The words "Welch Allyn" are written in black. There is a registered trademark symbol to the right of the word "Allyn".
Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety and effectiveness data.
Device Comparison Table:
The Welch Allyn CP150™ Electrocardiograph is substantially equivalent in operation and performance to the Welch Allyn CP100™ and CP200TM Electrocardiographs (K072449).
| Subject Device and Predicate Device Comparison | |||
|---|---|---|---|
| Characteristic | Subject Device | Predicate Devices | Differences |
| Device | CP150TMElectrocardiograph | CP100TM and CP200TMElectrocardiographs | Model number |
| Manufacturer | Welch Allyn, Inc. | Welch Allyn, Inc. | Same |
| 510(k) Number | N/A | K072449 | N/A |
| Product Code | DPS | DPS | Same |
| Classification Name | Electrocardiograph, ClassII | Electrocardiograph, ClassII | Same |
| Regulation Number: | 21 CFR 870.2340 | 21 CFR 870.2340 | Same |
| Intended Use | The Welch Allyn CP150TMElectrocardiograph isintended for use by trainedoperators in health facilities.The electrocardiographprovides the followingdiagnostic functions:Acquiring, viewing,storing and printing ECGwaveforms using ECGFront-End modules(patient cables) andassociated accessoriesthat provide signalacquisition for up totwelve (12) leads ofpatient ECG waveformsthrough surface electrodesadhered to the body.Using optional algorithmsto generatemeasurements, datapresentations, graphicalpresentations, and | The Welch Allynelectrocardiographs areintended for use by trainedoperators in health facilities.The electrocardiograph willprovide the followingdiagnostic functions:Acquiring, viewing,storing, and printingECG waveforms usingECG Front End modulesand associatedaccessories that providesignal acquisition for upto twelve (12) leads ofpatient ECG waveformsthrough surfaceelectrodes adhered to thebody.Using optionalalgorithms to generatemeasurements, datapresentations, graphicalpresentations and | Same |
| Subject Device and Predicate Device Comparison | |||
| Characteristic | Subject Device | Predicate Devices | Differences |
| interpretative statementson an advisory basis.These are presented forreview and interpretationby the clinician basedupon knowledge of thepatient, the result ofphysical examination, theECG tracings, and otherclinical findings. | interpretative statements onan advisory basis. Theseare presented for reviewand interpretation by theclinician based uponknowledge of the patient,the result of physicalexamination, the ECGtracings, and otherclinical findings. | ||
| Indications for Use | The electrocardiograph is oneof the tools that clinicians useto evaluate, diagnose, andmonitor patient cardiacfunction.The 12-lead interpretivealgorithm provides acomputer-generated analysisof potential patient cardiacabnormalities, which must beconfirmed by a physicianwith other relevant clinicalinformation. | The electrocardiograph isone of the tools thatclinicians use to evaluate,diagnose, and monitorpatient cardiac function.The 12-lead interpretivealgorithm provides acomputer-generated analysisof potential patient cardiacabnormalities, which mustbe confirmed by a physicianwith other relevant clinicalinformation. | Same |
| Target Population | Adult and pediatric patients | Adult and pediatric patients | Same |
| Where Used | Health care facilities | Health care facilities | Same |
| ECG Storage | 100 Adults ECG | 50 Adults ECG | Upgrading tohigher storagecapacity |
| Printer | Thermal printer (internal) | Thermal printer (internal) | Same |
| Display type | LCD color touch screen | Color LCD | Upgrading to colortouch screen |
| Alphanumeric keyboard | QWERTY keyboard - Onscreen | Physical QWERTYkeyboard | Same function |
| Sterility | Device not supplied sterile | Device not supplied sterile | Same |
| Power | The electrocardiograph canrun on AC or battery power | The electrocardiograph canrun on AC or battery power | Same |
| Subject Device and Predicate Device Comparison | Differences | ||
| Characteristic | Subject Device | Predicate Devices | Differences |
| Battery Operation | Yes | Yes | Same |
| 12 hours of continuous use orcontinuous printing of 250ECG pages. The continuoustest is based on performing25 ECG's in a period of 12hoursBattery recharge - 6 hours tofull capacity | 4 hours of continuous use orcontinuous printing of100ECG pages. Thecontinuous test is based onperforming 5 ECG's in aperiod of 4 hoursBattery recharge - 12 hoursto full capacity | Upgrading thebattery capacity | |
| Standard Compliance | EC 11 (AAMI/ANSI)IEC 60601-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-25IEC 60601-2-51EN/ISO 14971 | EC 11 (AAMI/ANSI)IEC 60601-1IEC 60601-1-1IEC 60601-1-2IEC 60601-1-4IEC 60601-2-25IEC 60601-2-51 | Same - except IEC60601-1-1 does notapply to theCP150. TheCP150 (like theCP100) does nothave spirometrylike the CP200. Itno longer meetsthe definition ofMedical System inIEC 60601-1-1 |
| Filters | - 0.5 Hz high-performancebase line filter- 35 Hz muscle-tremorfilter- AC interference filter | - 0.5 Hz high-performance base linefilter- 35 Hz muscle-tremorfilter- AC interference filter | Same |
| ECG acquisition | ECG signal acquisition of upto 12 leads | ECG signal acquisition of upto 12 leads | Same |
| ECG Interpretation | Optional algorithm for adult(MEANS) and pediatric(PEDMEANS) patients | Optional algorithm for adult(MEANS) and pediatric(PEDMEANS) patients | For the PEDMEANSanalysis - QTinterval corrected forheart rate accordingto Hodges' formula:QTc = QT + 1.75 ×(HR-60) was addedas a user selectableoption. This sameanalysis software isalso used in Welch |
| Subject Device and Predicate Device Comparison | |||
| Characteristic | Subject Device | Predicate Devices | Differences |
| Allyn'sCardioperfectWorkstation, andthis modification tothe PEDMEANSwas covered in thesubmission K082478for the CardioperfectWorkstation. | |||
| Weight | 9.9 lb | 11.6 lb | Slightly lighter |
| Dimensions | 15x14.1x5.4 in. | 16.2x15.6x6.2 in. | Slightly smaller |
| Connectivity | - 1 USB client,- 4 USB host ports,- 1 Ethernet port. | - 1 USB client- 1 SD slot- Wireless network | - Add 4 USB hostports- Remove the SDslot- Add 1 Ethernetport to replacewireless network |
| Accessories | - Patient Electrodes- Printer Paper- Patient Lead CablesDB15 connector toCP150 | - Patient Electrodes- Printer Paper- Patient Lead CablesDB9 connector toCP100/CP200 | All accessories arethe same with theexception of aminor change tothe connector typeon the Unitconnection end ofpatient lead cables |
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K131573 pg 11 of 13
Welch Allyn
Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph
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K131573 pg 12 of 13
Image /page/11/Picture/1 description: The image shows the logo for Welch Allyn. The logo is in a bold, sans-serif font. The words "Welch Allyn" are written in black. There is a registered trademark symbol to the right of the word "Allyn".
Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph
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Image /page/12/Picture/0 description: The image shows the logo for Welch Allyn. The logo is in a bold, serif font. The words "Welch Allyn" are written in black. There is a small circle after the word Allyn.
K131573 pg 13 of 13
Conclusion
Based on the information presented in this 510(k) premarket notification the Welch Allyn CP150™ Electrocardiograph is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed devices (K072449) citied in this submission. The differences noted between the CP150 and the predicate devices do not impact safety or effectiveness based on the successfully conducted testing of the modified device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
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July 3, 2013
Welch Allyn, Inc. C/O Kevin Crossen 4341 State St. Rd. P.o. Box 220 Skaneateles Falls, NY 13153-0220 US
Re: K131573
Trade/Device Name: Cp150 electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: May 30, 2013 Received: June 3, 2013
Dear Kevin Crossen:
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, 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 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.
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Page 2 - Kevin Crossen
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M.A. Lillehemen
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K131573
Indications for Use
510(k) Number (if known): K
Device Name: Welch Allyn CP150™ Electrocardiograph
Indications for Use:
The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function.
The 12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use, (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillemann
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).