(34 days)
No
The document mentions "optional algorithms to generate measurements, data presentations and graphical presentations, and interpretative statements on an advisory basis" and a "12-lead optional interpretation algorithm". While these are algorithms, the description does not provide any indication that they utilize AI or ML techniques. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for diagnostic purposes (acquiring, viewing, storing, and printing ECG waveforms and providing interpretive statements on an advisory basis), not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "diagnostic functions" and is "one of the tools that clinicians use to evaluate, diagnose, and monitor patient cardiac function." It also mentions "Using optional algorithms to generate measurements, data presentations and graphical presentations, and interpretative statements on an advisory basis" and a "12-lead optional interpretation algorithm provides a computer-generated analysis of potential patient cardiac abnormalities".
No
The device description explicitly mentions hardware components such as a 7" color touch screen display, battery or AC power operation, USB cable and wired ethernet connectivity, and the use of ECG Front-End modules (patient cables) and surface electrodes. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Welch Allyn CP150™ Electrocardiograph is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Welch Allyn CP150™ Electrocardiograph directly measures the electrical activity of the heart through surface electrodes placed on the body. It processes and displays this electrical signal.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It is a non-invasive device that measures a physiological signal on the body.
Therefore, the Welch Allyn CP150™ Electrocardiograph falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes
DPS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
trained operators in health facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were utilized for the purpose of obtaining safety and effectiveness data.
Non-Clinical Tests: The Welch Allyn CP150™ Electrocardiograph was tested to evaluate its safety and effectiveness based on the following standards: EN/IEC 60601-1, EN/IEC 60601-1-2, EN/IEC 60601-1-4, AAMI EC-11, IEC/EN60601-2-25, IEC/EN60601-2-51, EN/ISO 14971.
Additional performance Bench Testing was conducted for:
- CP150 Connectors Reliability: PASS: The connectors meet the requirements of TRS and reliability plan.
- CP150 Battery Capacity Test: PASS: The battery meets the requirements of TRS.
- CP150 Battery Door & Connector: PASS: The battery door and battery connector meet the requirements of TRS.
- CP150 Power Button Test: PASS: The Power Button meets the requirements of reliability plan.
- CP150 LCD Touchscreen Test: PASS: The test results shows the LCD touchscreen meets the requirements of Reliability plan.
- CP150 Environment Test: PASS: The test results shows the CP150 meets the environmental test requirements of Reliability plan.
- CP150 Barcode scanner verification: PASS: The test results shows the bar code scanner meets the requirements of Reliability plan.
- 60601-1 Safety test: PASS Devices are compliant with 60601-1 standard.
- 60601-1-2 Electromagnetic Compatibility test: PASS Devices are compliant with 60601-1-2 standard.
- 60601-1-4 Medical Electrical Equipment - Part 1-4: General Requirements For Safety - Collateral Standard: General Requirements for Programmable Electrical Medical Systems: PASS Devices are compliant with 60601-1-4 standard.
- AAMI EC-11 Diagnostic electrocardiographic devices: 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: PASS Devices are compliant with 60601-2-25.
- 60601-2-51 Particular Requirements For Safety, Including Essential Performance, Of Recording And Analysing Single Channel And Multichannel Electrocardiographs: PASS Devices are compliant with 60601-2-51.
- 14971 Medical Devices - Application of Risk Management to Medical Devices: PASS Risk Analysis Summary.
- 60051724-- Welch Allyn mobile stand - Large Platform Cart (LPC) Safety test: PASS the LPC is compliant with 60601-1 standard and can be used with the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 |
- 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 - ECG test duration should take 15
minutes - 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. - 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
- 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
- Scan the sample Serial number and
verify the result - 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
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6
K131573 pg 7 of 13
Page 8-8
WelchAllyn
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K131573 pg 8 of 13
V
ely
Allyn
.
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 | 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 according
to Hodges' formula:
QTc = QT + 1.75 ×
(HR-60) was added
as a user selectable
option. This same
analysis software is
also used in Welch |
| Subject Device and Predicate Device Comparison | | | |
| Characteristic | Subject Device | Predicate Devices | Differences |
| | | | Allyn's
Cardioperfect
Workstation, and
this modification to
the PEDMEANS
was covered in the
submission K082478
for the Cardioperfect
Workstation. |
| 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 host
ports - Remove the SD
slot - Add 1 Ethernet
port to replace
wireless network |
| Accessories | - Patient Electrodes - Printer Paper
- Patient Lead Cables
DB15 connector to
CP150 | - Patient Electrodes - Printer Paper
- Patient Lead Cables
DB9 connector to
CP100/CP200 | All accessories are
the same with the
exception of a
minor change to
the connector type
on the Unit
connection end of
patient lead cables |
10
K131573 pg 11 of 13
Welch Allyn
Special 510(k) Premarket Notification Welch Allyn CP150™ Electrocardiograph
.
11
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
"
12
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.
13
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
Image /page/13/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
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.
14
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
15
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