Who is the manufacturer of CP150 ELECTROCARDIOGRAPH?

Welch Allyn, Inc. filed the 510(k) submission for CP150 ELECTROCARDIOGRAPH (K131573).

What is the FDA product code for CP150 ELECTROCARDIOGRAPH?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CP150 ELECTROCARDIOGRAPH?

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

What are the predicate devices for CP150 ELECTROCARDIOGRAPH?

Welch Allyn CP100™ and CP200™ Electrocardiographs (K072449).

Who can help prepare an FDA 510(k) submission like CP150 ELECTROCARDIOGRAPH?

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

CP150 ELECTROCARDIOGRAPH

K131573 · Welch Allyn, Inc. · DPS · Jul 3, 2013 · Cardiovascular

Device Facts

Record ID	K131573
Device Name	CP150 ELECTROCARDIOGRAPH
Applicant	Welch Allyn, Inc.
Product Code	DPS · Cardiovascular
Decision Date	Jul 3, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Welch Allyn CP150™ 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, 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.

Device Story

CP150 Electrocardiograph acquires, displays, stores, and prints 12-lead ECG signals via surface electrodes; used in clinical settings by trained healthcare providers. Device features 7-inch color touch screen for preview and interface; replaces physical keyboard of predicate. Optional interpretation algorithms (MEANS for adults, PEDMEANS for pediatrics) analyze signals to generate measurements and interpretive statements. Output serves as guidance for physicians to confirm diagnoses alongside clinical findings. Connectivity includes USB and Ethernet for integration with patient information systems. Benefits include improved user interface, increased storage (100 ECGs), and enhanced battery capacity (12 hours/250 pages) compared to predicates.

Clinical Evidence

No clinical studies were utilized. Safety and effectiveness were established through bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance standards for electrocardiographs (AAMI EC-11, IEC 60601-2-25, IEC 60601-2-51).

Technological Characteristics

12-lead ECG acquisition; 7-inch color LCD touch screen; thermal printer; battery or AC power. Connectivity: 1 USB client, 4 USB host ports, 1 Ethernet port. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-25, IEC 60601-2-51, AAMI EC-11, ISO 14971. Software includes optional interpretation algorithms.

Indications for Use

Indicated for adult and pediatric patients to evaluate, diagnose, and monitor cardiac function. Includes optional 12-lead interpretation algorithm for computer-generated analysis of potential cardiac abnormalities, requiring physician confirmation.

Regulatory Classification

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.

Predicate Devices

Welch Allyn CP100™ and CP200™ Electrocardiographs (K072449)

Reference Devices

Welch Allyn Cardioperfect Workstation (K082478)

Related Devices

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K020708 — PHILIPS PAGEWRITER TOUCH CARDIOGRAPH, MODEL M5000A SERIES · Philips Medical Systems, Inc. · Apr 25, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ 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, {1}------------------------------------------------ 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 Edition 2000 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | | EN/IEC 60601-1-2 | 2007 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | {2}------------------------------------------------ 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 Electrical Medical Systems | |------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | AAMI EC-11 | 1991 (R2007) | Diagnostic electrocardiographic devices | | IEC/EN60601-2-25 | 1993 AMD 1 1999 | Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | | IEC/EN60601-2-51 | 2003 | Particular Requirements For Safety, Including Essential Performance, Of Recording And Analysing Single Channel And Multichannel Electrocardiographs | | EN/ISO 14971 | 2007/2007 | Medical Devices - Application of Risk Management to Medical Devices | . : · {3}------------------------------------------------ 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 --- CP150 Connectors Reliability | To verify the reliability of all connectors of CP150 as per CP150 Technical Requirements Specification (TRS) (DIR 60047341) and CP150 Reliability Plan (DIR 60046890) including: • AC power inlet • ECG (DB15) • Ethernet (RJ45) • mini USB (USB B) • USB | 1. Insert connector into the inlet 2. Conduct an Interval Inspection after every 10 insert/remove cycles. 3: Repeat steps 1-2 for greater than the minimum number of cycles listed in Pass/Fail criteria | • 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 | 1. Using only the battery (fully charged), perform 25x ECG print tests 2. ECG test duration should take 15 minutes 3. Check battery capacity after each ECG print test | 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 | 1. Unscrew the Battery Door. Remove the battery fully. Insert back the battery and close the battery door and screw back to secure. 2. Conduct an Interval Inspection after every 10 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 as per CP150 Reliability Plan (DIR 60046890) requirements | • Press the Power Button with a nominal force as to power up the unit. Hold for one second then release. • Conduct an Interval Inspection after every 2,500 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 as per CP150 Reliability Plan (DIR 60046890) requirements | • Install the 'touch finger' with silicone rubber region above the LCD Touchscreen. Adjust the input force to be 350g. • Set the same for the other 5 'touch finger' • Setup test speed to 1 Hz and start the test. • Conduct an Interval Inspection after every 60,000 touches. • Shift the 'touch finger' to other positions | Reliability Plan 8.5: All the functional tests must pass for total of 1,687688 touches on 3 unites (please see the rational on analysis column on the right) | 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) | Device dwells for at least 6 hours at each operating conditions After every 3 hours dwell at each condition, perform an intermediate verification test | 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 | 1. Connect barcode scanner to the device 2. Scan the sample Serial number and verify the result 3. Repeat step 2 for 58 times | 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 | Units delivered to independently certified test lab for testing per compliance with standard. | 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 | Units delivered to independently certified test lab for testing per compliance with standard. | 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: General Requirements For Safety - Collateral Standard: General Requirements for Programmable Electrical Medical Systems | Test the device per 60601- 1-4 to ensure that the device meets the requirements for Programmable Electrical Medical Systems | Units delivered to independently certified test lab for testing per compliance with standard. | Devices pass criteria of 60601-1-4 | PASS Devices are compliant with 60601-1-4 | | AAMI EC-11 Diagnostic electrocardiographic devices | Test the device per to ensure that the device meets the AAMI standard requirements for Diagnostic electrocardiographic devices | Units delivered to independently certified test lab for testing per compliance with standard. | Devices pass criteria of AAMI EC-11 | PASS Devices are compliant with AAMI EC- 11 | | 60601-2-25 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs | 60601-2-51 Particular Requirements For Safety, Including Essential Performance, Of Recording And Analysing Single Channel And Multichannel Electrocardiographs | 14971 Medical Devices - Application of Risk Management to Medical Devices | 60051724-- Welch Allyn mobile stand - Large Platform Cart (LPC) Safety test | | | Test the device per to ensure that the device meets the 60601-2-25 requirements for the basic safety and essential performance of electrocardiographs | 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 | Test the device per to ensure that the device meet the requirements for the Application of Risk Management to Medical Devices | To verify the LPC meet the safety requirements per 60601-1 | | | Units delivered to independently certified test lab for testing per compliance with standard. | Units delivered to independently certified test lab for testing per compliance with standard. | Risk management review performed according to Welch Allyn procedures | The subject device is verifies to be assembled with the cart as per assembly instructions and the LPC is verified to meet the safety requirements per 60601-1 by third party | | | Devices pass criteria of 60601-2-25 | Devices pass criteria of 60601-2-51 | Devices pass criteria of 14971 | The device can be installed as per assembly instruction and the LPC pass criteria of 60601-1 | | | PASS Devices are compliant with 60601-2- 25 | PASS Devices are compliant with 60601-2- 51 | PASS Risk Analysis Summary | PASS the LPC is compliant with 60601-1 standard and can be used with the subject device | | {4}------------------------------------------------ WelchAllyn K131573 pg 5 of 13 Special Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph . Welch Allyn CP150™ Electrocardiograph {5}------------------------------------------------ K131573 pg 6 of 13 VectorAly Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph Page 8-7 . {6}------------------------------------------------ K131573 pg 7 of 13 Page 8-8 WelchAllyn {7}------------------------------------------------ K131573 pg 8 of 13 V ely Allyn . Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph . {8}------------------------------------------------ K131573 pg 9 of 13 Veatchlyn. Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph ge 8-10 {9}------------------------------------------------ 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 | CP150TM Electrocardiograph | CP100TM and CP200TM Electrocardiographs | 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, Class II | Electrocardiograph, Class II | Same | | Regulation Number: | 21 CFR 870.2340 | 21 CFR 870.2340 | Same | | Intended Use | 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, graphical presentations, and | The Welch Allyn electrocardiographs are intended for use by trained operators in health facilities. The electrocardiograph will provide the following diagnostic functions: Acquiring, viewing, storing, and printing ECG waveforms using ECG Front End modules 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, graphical presentations and | Same | | Subject Device and Predicate Device Comparison | | | | | Characteristic | Subject Device | Predicate Devices | Differences | | | 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. | 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. | | | Indications for Use | The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function. The 12-lead interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. | The electrocardiograph is one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function. The 12-lead interpretive algorithm provides a computer-generated analysis of potential patient cardiac abnormalities, which must be confirmed by a physician with other relevant clinical information. | 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 to higher storage capacity | | Printer | Thermal printer (internal) | Thermal printer (internal) | Same | | Display type | LCD color touch screen | Color LCD | Upgrading to color touch screen | | Alphanumeric keyboard | QWERTY keyboard - On screen | Physical QWERTY keyboard | Same function | | Sterility | Device not supplied sterile | Device not supplied sterile | Same | | Power | The electrocardiograph can run on AC or battery power | The electrocardiograph can run 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 or continuous printing of 250 ECG pages. The continuous test is based on performing 25 ECG's in a period of 12 hours Battery recharge - 6 hours to full capacity | 4 hours of continuous use or continuous printing of 100ECG pages. The continuous test is based on performing 5 ECG's in a period of 4 hours Battery recharge - 12 hours to full capacity | Upgrading the battery capacity | | Standard Compliance | EC 11 (AAMI/ANSI) IEC 60601-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-2-25 IEC 60601-2-51 EN/ISO 14971 | EC 11 (AAMI/ANSI) IEC 60601-1 IEC 60601-1-1 IEC 60601-1-2 IEC 60601-1-4 IEC 60601-2-25 IEC 60601-2-51 | Same - except IEC 60601-1-1 does not apply to the CP150. The CP150 (like the CP100) does not have spirometry like the CP200. It no longer meets the definition of Medical System in IEC 60601-1-1 | | Filters | - 0.5 Hz high-performance base line filter - 35 Hz muscle-tremor filter - AC interference filter | - 0.5 Hz high- performance base line filter - 35 Hz muscle-tremor filter - AC interference filter | Same | | ECG acquisition | ECG signal acquisition of up to 12 leads | ECG signal acquisition of up to 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 PEDMEANS analysis - QT interval corrected for heart rate accordin…

CP150 ELECTROCARDIOGRAPH

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

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Submission Summary (Full Text)

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CP150 ELECTROCARDIOGRAPH

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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