(159 days)
Not Found
No
The summary describes a standard ECG acquisition and data transmission device. There is no mention of AI, ML, or any form of automated interpretation or analysis of the ECG data beyond basic processing for display and storage. The device explicitly states it provides "un-interpreted 12-lead ECG data".
No
The device is described as an electrocardiograph intended for acquiring, processing, displaying, storing, and printing diagnostic 12-lead ECGs. Its purpose is diagnostic, providing "un-interpreted 12-lead ECG data" and explicitly stating it is "not to be a sole means of diagnosis." It does not provide any form of therapy or treatment to the patient.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to acquire a resting, diagnostic 12-lead ECG".
No
The device description explicitly mentions the "Spaulding Electrocardiograph 2100iQ device" which collects and uploads ECG information, indicating a hardware component beyond just software.
Based on the provided information, the Spaulding Electrocardiograph is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Spaulding Electrocardiograph Function: The Spaulding Electrocardiograph acquires a resting, diagnostic 12-lead ECG. This involves placing electrodes on the patient's skin to measure electrical activity of the heart within the body. It is a non-invasive procedure.
- Intended Use: The intended use clearly states it acquires and processes ECG data for display and upload, enabling clinicians to acquire, process, display, store, and print diagnostic 12 lead ECGs. This is related to physiological measurement, not analysis of specimens.
Therefore, the Spaulding Electrocardiograph falls under the category of a medical device used for physiological measurement, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spaulding Electrocardiograph is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to a Medical Device Data System (MDDS). This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs.
The Spaulding Electrocardiograph is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use in highly invasive environments, or as a vital signs physiological monitor.
The Spaulding Electrocardiograph provides un-interpreted 12-lead ECG data and is not to be a sole means of diagnosis.
Product codes
DPS
Device Description
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device collects and uploads a dedicated patient's ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythm data to a iOS device using Bluetooth wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Clinical Client Application software (Spaulding ECG) to collect a 12-lead ECG.
The Spaulding ECG application then communicates to the Spaulding webECG server to upload ECG data through an Internet connection.
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 populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years).
Intended User / Care Setting
clinicians, or trained care personnel who are acting on the orders of a licensed physician
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)
A comparison test between the Spaulding Electrocardiograph 2100iQ and the predicate was completed. Wireless transmission functionality (via Bluetooth) performance testing compared the data captured from the predicate Spaulding IQ Electrocardiograph 1000, against the data captured from the Spaulding Electrocardiograph 2100iQ utilizing a calibrated simulator with arrhythmia capabilities for both devices. The results from the acquired and transferred data was compared to ensure there was no discrepancy. Tests were performed with varying beats per minute, ventricular tachycardia and ventricular fibrillation conditions. The Spaulding Electrocardiograph 2100iq used an iOS device, and the predicate Spaulding IQ Electrocardiograph 1000 utilized a windows laptop to collect the data. The results of the testing showed that the devices produce comparable results.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three heads, representing the department's focus on health, well-being, and human services. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2015
Spaulding Clinical Research, LLC Mr. Andre Leak Manager of Regulatory Affairs 525 South Silverbrook Drive West Bend, Wisconsin 53095
Re: K150564
Trade/Device Name: Spaulding Electrocardiograph 2100iO Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: July 10, 2015 Received: July 13, 2015
Dear Mr. Leak:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh - S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known):
K150564
Device Name: Spaulding Electrocardiograph 2100iQ
Indications for Use:
The Spaulding Electrocardiograph is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to a Medical Device Data System (MDDS). This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs.
The Spaulding Electrocardiograph is for use on adult and pediatric populations, diseased or non-diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use in highly invasive environments, or as a vital signs physiological monitor.
The Spaulding Electrocardiograph provides un-interpreted 12-lead ECG data and is not to be a sole means of diagnosis.
x Prescription Use (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for Spaulding Clinical. The logo consists of a grid of small squares in various shades of brown and tan on the left, followed by the words "spaulding clinical" in black. Below the words "spaulding clinical" is the phrase "RESEARCH BEYOND RESULTS" in a smaller, sans-serif font.
Spaulding Electrocardiograph 510(k) Summary
Submitter:
Date: July 6, 2015
Andre Leak, Manager of Regulatory Affairs
Owner:
Spaulding Clinical Research, LLC 525 South Silverbrook Drive West Bend, WI 53095
FAX: | (262) 334-6067 |
---|---|
Phone: | (262) 306-3086 ext. 129 |
Contact: | Andre Leak |
Trade Name: | Spaulding Electrocardiograph 2100iC |
Common Name: | Electrocardiograph |
Classification Name: | Electrocardiograph |
(Per 21 CFR 870.2340) |
Legally marketed device to which Substantial Equivalence is claimed:
The Spaulding Electrocardiograph 2100iQ is substantially equivalent to the legally marketed device presently in distribution:
- Spaulding IQ Electrocardiograph (K110065) .
Description:
The Spaulding Electrocardiograph Model 2100iQ works with the Spaulding webECG Diagnostic ECG management solution. (Medical Device Data System) The light weight and portable Spaulding Electrocardiograph 2100iQ device collects and uploads a dedicated patient's ECG (electrocardiograph) information to the WebECG system and receives a report back from the WebECG system.
The Spaulding Electrocardiograph 2100iQ streams ECG heart rhythm data to a iOS® mobile device using Bluetooth® wireless communication. Using the Spaulding Patient Cable and strategically placed electrodes, it allows the Spaulding Clinical Client Application software (Spaulding ECG) to collect a 12-lead ECG.
The Spaulding ECG application then communicates to the Spaulding webECG server to upload ECG data through an Internet connection.
Intended use:
The Spaulding Electrocardiograph is intended to acquire a resting, diagnostic 12-lead ECG for display and subsequent upload to a Medical Device Data System (MDDS). This enables clinicians, or trained care personnel who are acting on the orders of a licensed physician, to acquire, process, display, store, and print diagnostic 12 lead ECGs.
The Spaulding Electrocardiograph is for use on adult and pediatic populations, diseased and is not intended for use on neonatal (birth to 28 days) or infants (29 days up to 2 years). The device is not for use in highly invasive environments, or as a vital signs physiological monitor.
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Image /page/4/Picture/0 description: The image shows the logo for Spaulding Clinical. The logo consists of a grid of small squares in various shades of brown and gold, followed by the words "spaulding clinical" in black, with "spaulding" in a bold, sans-serif font and "clinical" in a lighter, sans-serif font. Below the company name, the words "RESEARCH BEYOND RESULTS" are written in a smaller, sans-serif font.
The Spaulding Electrocardiograph provides un-interpreted 12-lead ECG data and is not to be a sole means of diagnosis.
Technical Comparison to predicate:
The Spaulding Electrocardiograph 2100iQ is the next version of the Spaulding IQ Electrocardiograph predicate device. Most design features, and technical components are shared between the two devices. The development of the Spaulding Electrocardiograph 2100iQ used the Spaulding IQ Electrocardiograph predicate as the base design and all added improvements / modifications / features were made using the base design. The hardware for ECG acquisition has not changed from the predicate device.
| Feature | Predicate Spaulding
IQ
Electrocardiograph | Spaulding
Electrocardiograph
2100iQ | Comparison Summary | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Patient Cable | Proprietary 12-Lead
Patient Cable | Proprietary 12-Lead
Patient Cable | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same patient cable as the predicate
Spaulding IQ Electrocardiograph | |
| Electrocardiograph | Round shape, single
button, portable, LED
display | Round shape, single
button, portable,
LED display | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same casing, circuit board, LED
display as the predicate Spaulding IQ
Electrocardiograph device. | |
| Leads | 12-Lead | 12-lead | Same - The Spaulding
Electrocardiograph 2100iQ is a 12-
lead electrocardiograph the same as
the predicate Spaulding IQ
Electrocardiograph. | |
| Circuit Board | Cased in Printed
Circuit Board | Cased in Printed
Circuit Board | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same printed circuit board component
as the predicate Spaulding IQ
Electrocardiograph. | |
| Daughter Board | None | Daughter board
contains Bluetooth®
Chip and Apple
Coprocessor. | Different - The Spaulding
Electrocardiograph has an additional
daughter circuit board affixed which
contains the Bluetooth® radio and
Apple coprocessor. | |
| Microcontroller | AVR 8 bit
Microcontroller | AVR 8 bit
Microcontroller | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same microcontroller component as
the predicate Spaulding IQ
Electrocardiograph. | |
| Battery | Device is powered by
an internal polymer
lithium ion 3.7V
rechargeable battery. | Device is powered
by an internal
polymer lithium ion
3.7V rechargeable
battery. | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same battery as the predicate
Spaulding IQ Electrocardiograph
device. | |
| ECG Waveform
Acquisition | Electrodes to patient
cable to
electrocardiograph | Electrodes to patient
cable to
electrocardiograph | Same - The Spaulding 2100iQ
acquires signal from electrodes thru
the patient cable to the
electrocardiograph the same way as
the predicate Spaulding IQ
electrocardiograph. | |
| ECG Data Transfer | Data Transfer via
standard USB Cable | Data Transfer via
Bluetooth®
Technology | Different - The Spaulding
Electrocardiograph 2100iQ transfers
data wirelessly to the receiving client
application software.
The predicate Spaulding IQ
Electrocardiograph transfers data via
USB cable to the client application
software. | |
| Software
Component | Spaulding Client
Application Software | Spaulding Client
Application Software | Same - The Spaulding
Electrocardiograph 2100iQ requires
the use of the Spaulding Client
Application Software running on a
computer/display device, which is also
required with the predicate Spaulding
IQ Electrocardiograph. | |
| Client Software
platform | Personal Computer | Mobile device | Different - The Spaulding
Electrocardiograph 2100iQ interfaces
with the Spaulding Client Application
Software running on a Mobile Device.
The predicate Spaulding IQ
Electrocardiograph interfaces with the
Spaulding Client Application Software
running on a personal computer. | |
| ECG Interpretation | No | No | Same - The Spaulding
Electrocardiograph 2100iQ provides
un-interpreted ECG data the same as
the predicate Spaulding IQ
Electrocardiograph. | |
| ECG Display | ECG data display
occurs on personal
computer screen after
acquisition and data
upload using
Spaulding Client
Application software | ECG data is
displayed on mobile
screen in real-time
before, during, and
after acquisition.
Acquired ECG
displayed before
and after upload. | Different - The Spaulding
Electrocardiograph 2100iQ streams
data to the Spaulding Client
Application Software. The software
allows the data to be displayed as it is
received, it will also allow user to see
the acquired ECG data before or after
upload. The predicate Spaulding IQ
Electrocardiograph only allows the
Spaulding Client Application software
to display the ECG data after
acquisition and upload. | |
| Pacemaker
Interaction | Has ability to acquire
ECG data in the
presence of
pacemaker pulses. | Has ability to
acquire ECG data in
the presence of
pacemaker pulses
and identify that a
pacemaker pulse is
present. | Different - The Spaulding
Electrocardiograph 2100iQ, in
conjunction with the Spaulding Client
Application software, has the
additional ability to give a visual
notification on the computing/display
device when a pacemaker pulse is
detected. | |
| Internet access | Internet access is
required for ECG data
upload and retrieval. | Internet access is
required for ECG
data upload and
retrieval. | Same - The Spaulding
Electrocardiograph 2100iQ requires
internet access to upload and retrieve
data from an MDDS, the same as the
predicate Spaulding IQ
electrocardiograph device. | |
| Device Charging | Device battery is
charged by USB
connection to
personal computer or
medical grade USB
charger. | Device battery is
charged by USB
connection to
personal computer
or medical grade
USB charger. | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same charging method as the
predicate Spaulding IQ
Electrocardiograph device. | |
| | | Materials | | |
| Patient Cable | Elastolan | Elastolan | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same patient cable as the predicate
Spaulding IQ Electrocardiograph
device. | |
| Device enclosure
(plastic casing) | ABS Polycarbonate | ABS Polycarbonate | Same - The Spaulding
Electrocardiograph 2100iQ device
enclosure is the same device
enclosure as the predicate Spaulding
IQ Electrocardiograph device. | |
| | Software & Settings Comparison | | | |
| Lead Markers | Spaulding Client
Application Software
displays lead markers | Spaulding Client
Application Software
displays lead
markers | Same - The Spaulding Client
Application software used in
conjunction with the Spaulding
Electrocardiograph 2100iQ can be
configured to display lead markers the
same as the predicate Spaulding IQ
Electrocardiograph device. | |
| Sensitivity, mm/mV
(Gain) | 2.5,5,10,20,40 | 2.5,5,10,20,40 | Same - The Spaulding
Electrocardiograph 2100iQ has the
same gain options as the predicate
Spaulding IQ Electrocardiograph
device. | |
| Chart Speed, mm/s | 5,10,12.5,25,50 | 5,10,12.5,25,50 | Same - The Spaulding
Electrocardiograph 2100iQ has the
same chart speeds as the predicate
Spaulding IQ Electrocardiograph
device. | |
| ECG display
formats | User Selectable
12-lead, 3+1, 3+3 | User Selectable
12-lead, 12x1, 6x1,
4x1, 3x1, 2x1, 1x1,
6x2, 4x2, 3x2, 2x2,
1x2 | Different - The Spaulding
Electrocardiograph 2100iQ allows for
ECGs to be displayed in a wider
range of display formats than the
predicate Spaulding IQ
Electrocardiograph device. | |
| Safety / Standards Comparison | | | | |
| Performance | AAMI
EC11:1991/2001/2007
Diagnostic
Electrocardiograph
Devices
IEC 60601-2-51:2003
Medical Electrical
Equipment - Particular
requirements for the
safety, including
essential
performance, of
recording and
analyzing single
channel and
multichannel
electrocardiographs. | IEC 60601-2-
25:2011 Particular
requirements for the
basic safety and
essential
performance of
electrocardiographs. | Equivalent - The Spaulding
Electrocardiograph 2100iQ essential
performance is comparable to
performance compliance of the
predicate Spaulding IQ
Electrocardiograph. | |
| Biocompatibility
Safety | ISO 10993 Part 1,
Part 5, Part 10 | ISO 10993 Part 1,
Part 5, Part 10 | Same - The Spaulding
Electrocardiograph 2100iQ uses the
same patient cable and the same
device enclosure of the predicate
Spaulding IQ Electrocardiograph
device. | |
| Environmental
Safety | IEC 60601-2-25:2011
Particular
requirements for the
safety of
electrocardiographs | ISO 60601-1:2005
ed 3.1
Medical electrical
equipment - Part 1:
General
requirements for
basic safety and
essential
performance
IEC 60601-2-25:2011 Particular | Different - The Spaulding
Electrocardiograph 2100iQ has been
tested in a wider range of
environmental conditions than the
predicate Spaulding IQ
Electrocardiograph device. The
Spaulding Electrocardiograph 2100iQ
can be used in transit settings as a
portable device. | |
| | | | requirements for the
basic safety and
essential
performance of
electrocardiographs. | |
| Water ingress and
particulate matter
rating | IEC 60529:2001
Degrees of protection
provided by
enclosures
IPX21 | IEC 60529: 2013
Degrees of
protection provided
by enclosures
IP22 | Different - The Spaulding
Electrocardiograph 2100iQ has been
tested and complies with a higher
water ingress and particulate matter
rating than the predicate Spaulding IQ
Electrocardiograph device. | |
| Thermal safety | IEC 60601-2-25:2011
Particular
requirements for the
safety of
electrocardiographs | ISO 60601-1:2005
ed 3.1
Medical electrical
equipment - Part 1:
General
requirements for
basic safety and
essential
performance
IEC 60601-2-
25:2011 Particular
requirements for the
basic safety and
essential
performance of
electrocardiographs. | Equivalent - The Spaulding
Electrocardiograph 2100iQ has been
tested in a wider range of temperature
conditions than the predicate
Spaulding IQ Electrocardiograph
device. The Spaulding
Electrocardiograph 2100iQ extends
use temperatures to those found in
home settings and transit settings as
a portable device. | |
| Electrical Safety | ISO 60601-1 ed 2.0 | ISO 60601-1:2005
ed 3.1
Medical electrical
equipment - Part 1:
General
requirements for
basic safety and
essential
performance
IEC 60601-2-
25:2011 Particular
requirements for the
basic safety and
essential
performance of
electrocardiographs. | Equivalent - The Spaulding
Electrocardiograph 2100iQ has been
tested in a wider range of electrical
tests than the predicate Spaulding IQ
Electrocardiograph device. It complies
with the current 60601-1 ed 3.0. The
Spaulding Electrocardiograph 2100iQ
extends use environments to home
settings and transit settings as a
portable device. | |
| | | | | |
| Applied Part
Classification | TYPE CF | TYPE CF | Same - The Spaulding
Electrocardiograph 2100iQ's applied
part classification is the same as the
predicate Spaulding IQ
Electrocardiograph device applied
part classification. | |
| Patient Cable
Safety | 21 CFR Part 898.12
Lead Sets | 21 CFR Part 898.12
Performance
standard for
electrode and lead
wire sets
AAMI/ANSI
EC53:2013 ECG
Trunk Cables and
Patient Leadwires | Same - The Spaulding
Electrocardiograph 2100iQ patient
cable performance testing completed
is the same and more extensive as
the predicate Spaulding IQ
Electrocardiograph device. | |
| Mechanical Safety | IEC 60601-2-25:2011
Particular
requirements for the
safety of
electrocardiographs | ISO 60601-1:2005
ed 3.1
Medical electrical
equipment - Part 1:
General
requirements for
basic safety and
essential
performance
IEC 60601-2-
25:2011 Particular
requirements for the
basic safety and
essential
performance of
electrocardiographs. | Equivalent - The Spaulding
Electrocardiograph 2100iQ has been
tested in a wider range of impact and
vibration tests than the predicate
Spaulding IQ Electrocardiograph
device. The Spaulding
Electrocardiograph 2100iQ extends
use environments to home settings
and transit settings as a portable
device. | |
| EMC safety | ISO 60601-1-2:2001-
09 Medical Electrical
Equipment - Part 1:
General requirements
for safety Subpart
2:Collateral standard:
Electromagnetic
Compatibility -
Requirements and
tests | IEC 60601-1-2:2007
ED. 3.0 Medical
electrical equipment
- Part 1-2: General
requirements for
basic safety and
essential
performance -
Collateral Standard:
Electromagnetic
disturbances -
Requirements and
tests
Class B | Different - The Spaulding
Electrocardiograph 2100iQ has been
tested for electromagnetic
disturbances the same as the
predicate Spaulding IQ
Electrocardiograph device, however
the Spaulding Electrocardiograph
2100iQ can be used in transit settings
as a portable device. | |
| Chemical safety | Not Applicable – The
Spaulding IQ
Electrocardiograph is
not designed to be
used with or contain
hazardous chemicals. | Not Applicable –
The Spaulding
Electrocardiograph
2100iq is not
designed to be used
with or contain
hazardous
chemicals. | Same – The Spaulding
Electrocardiograph 2100iQ does not
contain and is not to be used with
hazardous chemicals which is the
same as the predicate Spaulding IQ
Electrocardiograph. | |
| Radiation safety | Not Applicable – The
Spaulding IQ
Electrocardiograph
does not emit
radiation. | Not Applicable –
The Spaulding
Electrocardiograph
2100iq does not
emit radiation | Same – The Spaulding
Electrocardiograph 2100iQ does not
emit radiation same as the predicate
Spaulding IQ Electrocardiograph
device. | |
| Sterility | Not Applicable – The
Spaulding IQ
Electrocardiograph is
not provided sterile. | Not Applicable –
The Spaulding
Electrocardiograph
2100iq is not
provided sterile. | Same – The Spaulding
Electrocardiograph 2100iQ is not
designed to be provided sterile same
as the predicate Spaulding IQ
Electrocardiograph device. | |
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Image /page/8/Picture/0 description: The image contains the logo for Spaulding Clinical. The logo consists of a grid of small squares in various shades of brown and yellow on the left, followed by the words "spaulding clinical" in a bold, sans-serif font. Below the company name, in smaller letters, is the phrase "research beyond results."
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Image /page/10/Picture/0 description: The image shows the logo for Spaulding Clinical. The logo consists of a grid of small squares in various shades of brown and orange on the left, followed by the words "spaulding clinical" in black, with "spaulding" in a bold, sans-serif font and "clinical" in a lighter, handwritten-style font. Below the company name is the tagline "RESEARCH BEYOND RESULTS" in a smaller, sans-serif font.
A comparison test between the Spaulding Electrocardiograph 2100iQ and the predicate was completed. Wireless transmission functionality (via Bluetooth) performance testing compared the data captured from the predicate Spaulding IQ Electrocardiograph 1000, against the data captured from the Spaulding Electrocardiograph 2100iQ utilizing a calibrated simulator with arrhythmia capabilities for both devices. The results from the acquired and transferred data was compared to ensure there was no discrepancy. Tests were performed with varying beats per minute, ventricular tachycardia and ventricular fibrillation conditions. The Spaulding Electrocardiograph 2100iq used an iOS device, and the predicate Spaulding IQ Electrocardiograph 1000 utilized a windows laptop to collect the data. The results of the testing showed that the devices produce comparable results.
Based on the above comparison data, it can be concluded that the Spaulding Electrocardiograph 2100iQ is as safe, effective, and performs as well as the predicate Spaulding iQ Electrocardiograph device. Testing has been completed regarding the differences between the two devices and the differences do not adversely affect safety and effectiveness.