Spaulding Electrocardiograph 2100iQ

K150564 · Spaulding Clinical Research, LLC · DPS · Aug 12, 2015 · Cardiovascular

Device Facts

• Record ID: K150564
• Device Name: Spaulding Electrocardiograph 2100iQ
• Applicant: Spaulding Clinical Research, LLC
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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 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.

Device Story

Portable 12-lead ECG device; collects heart rhythm data via patient cable and electrodes; streams data via Bluetooth to iOS mobile device running Spaulding ECG application; uploads data to webECG server. Used by clinicians or trained personnel; provides un-interpreted ECG data for display/storage. Enables remote diagnostic review; aids clinical decision-making; not sole diagnostic tool. Includes pacemaker pulse detection with visual notification on display.

Clinical Evidence

Bench testing only. Performance compared against predicate using calibrated simulator with arrhythmia capabilities (varying BPM, ventricular tachycardia, ventricular fibrillation). Results confirmed comparable data acquisition and transfer between subject (iOS-based) and predicate (PC-based) devices.

Technological Characteristics

Portable 12-lead ECG; ABS polycarbonate enclosure; 3.7V internal polymer lithium-ion battery. Connectivity: Bluetooth wireless to mobile device, Internet for MDDS upload. Applied part: Type CF. Standards: IEC 60601-1 ed 3.1, IEC 60601-2-25:2011, AAMI/ANSI EC53:2013, ISO 10993. IP22 rating. Software: Spaulding Client Application.

Indications for Use

Indicated for adult and pediatric patients, diseased or non-diseased, requiring resting 12-lead ECG acquisition. Contraindicated for neonates (birth to 28 days) and infants (29 days to 2 years). Not for use in highly invasive environments or as a vital signs monitor.

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

• Spaulding IQ Electrocardiograph (K110065)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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: | [phone] |
|----------------------|---------------------------------------------|
| Phone: | [phone] ext. 129 |
| Contact: | Andre Leak |
| Trade Name: | Spaulding Electrocardiograph 2100iC |
| Common Name: | Electrocardiograph |
| Classification Name: | Electrocardiograph<br>(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<br>IQ<br>Electrocardiograph | Spaulding<br>Electrocardiograph<br>2100iQ | Comparison Summary | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Patient Cable | Proprietary 12-Lead<br>Patient Cable | Proprietary 12-Lead<br>Patient Cable | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same patient cable as the predicate<br>Spaulding IQ Electrocardiograph | |
| Electrocardiograph | Round shape, single<br>button, portable, LED<br>display | Round shape, single<br>button, portable,<br>LED display | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same casing, circuit board, LED<br>display as the predicate Spaulding IQ<br>Electrocardiograph device. | |
| Leads | 12-Lead | 12-lead | Same - The Spaulding<br>Electrocardiograph 2100iQ is a 12-<br>lead electrocardiograph the same as<br>the predicate Spaulding IQ<br>Electrocardiograph. | |
| Circuit Board | Cased in Printed<br>Circuit Board | Cased in Printed<br>Circuit Board | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same printed circuit board component<br>as the predicate Spaulding IQ<br>Electrocardiograph. | |
| Daughter Board | None | Daughter board<br>contains Bluetooth®<br>Chip and Apple<br>Coprocessor. | Different - The Spaulding<br>Electrocardiograph has an additional<br>daughter circuit board affixed which<br>contains the Bluetooth® radio and<br>Apple coprocessor. | |
| Microcontroller | AVR 8 bit<br>Microcontroller | AVR 8 bit<br>Microcontroller | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same microcontroller component as<br>the predicate Spaulding IQ<br>Electrocardiograph. | |
| Battery | Device is powered by<br>an internal polymer<br>lithium ion 3.7V<br>rechargeable battery. | Device is powered<br>by an internal<br>polymer lithium ion<br>3.7V rechargeable<br>battery. | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same battery as the predicate<br>Spaulding IQ Electrocardiograph<br>device. | |
| ECG Waveform<br>Acquisition | Electrodes to patient<br>cable to<br>electrocardiograph | Electrodes to patient<br>cable to<br>electrocardiograph | Same - The Spaulding 2100iQ<br>acquires signal from electrodes thru<br>the patient cable to the<br>electrocardiograph the same way as<br>the predicate Spaulding IQ<br>electrocardiograph. | |
| ECG Data Transfer | Data Transfer via<br>standard USB Cable | Data Transfer via<br>Bluetooth®<br>Technology | Different - The Spaulding<br>Electrocardiograph 2100iQ transfers<br>data wirelessly to the receiving client<br>application software.<br>The predicate Spaulding IQ<br>Electrocardiograph transfers data via<br>USB cable to the client application<br>software. | |
| Software<br>Component | Spaulding Client<br>Application Software | Spaulding Client<br>Application Software | Same - The Spaulding<br>Electrocardiograph 2100iQ requires<br>the use of the Spaulding Client<br>Application Software running on a<br>computer/display device, which is also<br>required with the predicate Spaulding<br>IQ Electrocardiograph. | |
| Client Software<br>platform | Personal Computer | Mobile device | Different - The Spaulding<br>Electrocardiograph 2100iQ interfaces<br>with the Spaulding Client Application<br>Software running on a Mobile Device.<br>The predicate Spaulding IQ<br>Electrocardiograph interfaces with the<br>Spaulding Client Application Software<br>running on a personal computer. | |
| ECG Interpretation | No | No | Same - The Spaulding<br>Electrocardiograph 2100iQ provides<br>un-interpreted ECG data the same as<br>the predicate Spaulding IQ<br>Electrocardiograph. | |
| ECG Display | ECG data display<br>occurs on personal<br>computer screen after<br>acquisition and data<br>upload using<br>Spaulding Client<br>Application software | ECG data is<br>displayed on mobile<br>screen in real-time<br>before, during, and<br>after acquisition.<br>Acquired ECG<br>displayed before<br>and after upload. | Different - The Spaulding<br>Electrocardiograph 2100iQ streams<br>data to the Spaulding Client<br>Application Software. The software<br>allows the data to be displayed as it is<br>received, it will also allow user to see<br>the acquired ECG data before or after<br>upload. The predicate Spaulding IQ<br>Electrocardiograph only allows the<br>Spaulding Client Application software<br>to display the ECG data after<br>acquisition and upload. | |
| Pacemaker<br>Interaction | Has ability to acquire<br>ECG data in the<br>presence of<br>pacemaker pulses. | Has ability to<br>acquire ECG data in<br>the presence of<br>pacemaker pulses<br>and identify that a<br>pacemaker pulse is<br>present. | Different - The Spaulding<br>Electrocardiograph 2100iQ, in<br>conjunction with the Spaulding Client<br>Application software, has the<br>additional ability to give a visual<br>notification on the computing/display<br>device when a pacemaker pulse is<br>detected. | |
| Internet access | Internet access is<br>required for ECG data<br>upload and retrieval. | Internet access is<br>required for ECG<br>data upload and<br>retrieval. | Same - The Spaulding<br>Electrocardiograph 2100iQ requires<br>internet access to upload and retrieve<br>data from an MDDS, the same as the<br>predicate Spaulding IQ<br>electrocardiograph device. | |
| Device Charging | Device battery is<br>charged by USB<br>connection to<br>personal computer or<br>medical grade USB<br>charger. | Device battery is<br>charged by USB<br>connection to<br>personal computer<br>or medical grade<br>USB charger. | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same charging method as the<br>predicate Spaulding IQ<br>Electrocardiograph device. | |
| | | Materials | | |
| Patient Cable | Elastolan | Elastolan | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same patient cable as the predicate<br>Spaulding IQ Electrocardiograph<br>device. | |
| Device enclosure<br>(plastic casing) | ABS Polycarbonate | ABS Polycarbonate | Same - The Spaulding<br>Electrocardiograph 2100iQ device<br>enclosure is the same device<br>enclosure as the predicate Spaulding<br>IQ Electrocardiograph device. | |
| | Software & Settings Comparison | | | |
| Lead Markers | Spaulding Client<br>Application Software<br>displays lead markers | Spaulding Client<br>Application Software<br>displays lead<br>markers | Same - The Spaulding Client<br>Application software used in<br>conjunction with the Spaulding<br>Electrocardiograph 2100iQ can be<br>configured to display lead markers the<br>same as the predicate Spaulding IQ<br>Electrocardiograph device. | |
| Sensitivity, mm/mV<br>(Gain) | 2.5,5,10,20,40 | 2.5,5,10,20,40 | Same - The Spaulding<br>Electrocardiograph 2100iQ has the<br>same gain options as the predicate<br>Spaulding IQ Electrocardiograph<br>device. | |
| Chart Speed, mm/s | 5,10,12.5,25,50 | 5,10,12.5,25,50 | Same - The Spaulding<br>Electrocardiograph 2100iQ has the<br>same chart speeds as the predicate<br>Spaulding IQ Electrocardiograph<br>device. | |
| ECG display<br>formats | User Selectable<br>12-lead, 3+1, 3+3 | User Selectable<br>12-lead, 12x1, 6x1,<br>4x1, 3x1, 2x1, 1x1,<br>6x2, 4x2, 3x2, 2x2,<br>1x2 | Different - The Spaulding<br>Electrocardiograph 2100iQ allows for<br>ECGs to be displayed in a wider<br>range of display formats than the<br>predicate Spaulding IQ<br>Electrocardiograph device. | |
| Safety / Standards Comparison | | | | |
| Performance | AAMI<br>EC11:1991/2001/2007<br>Diagnostic<br>Electrocardiograph<br>Devices<br>IEC 60601-2-51:2003<br>Medical Electrical<br>Equipment - Particular<br>requirements for the<br>safety, including<br>essential<br>performance, of<br>recording and<br>analyzing single<br>channel and<br>multichannel<br>electrocardiographs. | IEC 60601-2-<br>25:2011 Particular<br>requirements for the<br>basic safety and<br>essential<br>performance of<br>electrocardiographs. | Equivalent - The Spaulding<br>Electrocardiograph 2100iQ essential<br>performance is comparable to<br>performance compliance of the<br>predicate Spaulding IQ<br>Electrocardiograph. | |
| Biocompatibility<br>Safety | ISO 10993 Part 1,<br>Part 5, Part 10 | ISO 10993 Part 1,<br>Part 5, Part 10 | Same - The Spaulding<br>Electrocardiograph 2100iQ uses the<br>same patient cable and the same<br>device enclosure of the predicate<br>Spaulding IQ Electrocardiograph<br>device. | |
| Environmental<br>Safety | IEC 60601-2-25:2011<br>Particular<br>requirements for the<br>safety of<br>electrocardiographs | ISO 60601-1:2005<br>ed 3.1<br>Medical electrical<br>equipment - Part 1:<br>General<br>requirements for<br>basic safety and<br>essential<br>performance<br>IEC 60601-2-25:2011 Particular | Different - The Spaulding<br>Electrocardiograph 2100iQ has been<br>tested in a wider range of<br>environmental conditions than the<br>predicate Spaulding IQ<br>Electrocardiograph device. The<br>Spaulding Electrocardiograph 2100iQ<br>can be used in transit settings as a<br>portable device. | |
| | | | requirements for the<br>basic safety and<br>essential<br>performance of<br>electrocardiographs. | |
| Water ingress and<br>particulate matter<br>rating | IEC 60529:2001<br>Degrees of protection<br>provided by<br>enclosures<br>IPX21 | IEC 60529: 2013<br>Degrees of<br>protection provided<br>by enclosures<br>IP22 | Different - The Spaulding<br>Electrocardiograph 2100iQ has been<br>tested and complies with a higher<br>water ingress and particulate matter<br>rating than the predicate Spaulding IQ<br>Electrocardiograph device. | |
| Thermal safety | IEC 60601-2-25:2011<br>Particular<br>requirements for the<br>safety of<br>electrocardiographs | ISO 60601-1:2005<br>ed 3.1<br>Medical electrical<br>equipment - Part 1:<br>General<br>requirements for<br>basic safety and<br>essential<br>performance<br>IEC 60601-2-<br>25:2011 Particular<br>requirements for the<br>basic safety and<br>essential<br>performance of<br>electrocardiographs. | Equivalent - The Spaulding<br>Electrocardiograph 2100iQ has been<br>tested in a wider range of temperature<br>conditions than the predicate<br>Spaulding IQ Electrocardiograph<br>device. The Spaulding<br>Electrocardiograph 2100iQ extends<br>use temperatures to those found in<br>home settings and transit settings as<br>a portable device. | |
| Electrical Safety | ISO 60601-1 ed 2.0 | ISO 60601-1:2005<br>ed 3.1<br>Medical electrical<br>equipment - Part 1:<br>General<br>requirements for<br>basic safety and<br>essential<br>performance<br>IEC 60601-2-<br>25:2011 Particular<br>requirements for the<br>basic safety and<br>essential<br>performance of<br>electrocardiographs. | Equivalent - The Spaulding<br>Electrocardiograph 2100iQ has been<br>tested in a wider range of electrical<br>tests than the predicate Spaulding IQ<br>Electrocardiograph device. It complies<br>with the current 60601-1 ed 3.0. The<br>Spaulding Electrocardiograph 2100iQ<br>extends use environments to home<br>settings and transit settings as a<br>portable device. | |
| | | | | |
| Applied Part<br>Classification | TYPE CF | TYPE CF | Same - The Spaulding<br>Electrocardiograph 2100iQ's applied<br>part classification is the same as the<br>predicate Spaulding IQ<br>Electrocardiograph device applied<br>part classification. | |
| Patient Cable<br>Safety | 21 CFR Part 898.12<br>Lead Sets | 21 CFR Part 898.12<br>Performance<br>standard for<br>electrode and lead<br>wire sets<br>AAMI/ANSI<br>EC53:2013 ECG<br>Trunk Cables and<br>Patient Leadwires | Same - The Spaulding<br>Electrocardiograph 2100iQ patient<br>cable performance testing completed<br>is the same and more extensive as<br>the predicate Spaulding IQ<br>Electrocardiograph device. | |
| Mechanical Safety | IEC 60601-2-25:2011<br>Particular<br>requirements for the<br>safety of<br>electrocardiographs | ISO 60601-1:2005<br>ed 3.1<br>Medical electrical<br>equipment - Part 1:<br>General<br>requirements for<br>basic safety and<br>essential<br>performance<br>IEC 60601-2-<br>25:2011 Particular<br>requirements for the<br>basic safety and<br>essential<br>performance of<br>electrocardiographs. | Equivalent - The Spaulding<br>Electrocardiograph 2100iQ has been<br>tested in a wider range of impact and<br>vibration tests than the predicate<br>Spaulding IQ Electrocardiograph<br>device. The Spaulding<br>Electrocardiograph 2100iQ extends<br>use environments to home settings<br>and transit settings as a portable<br>device. | |
| EMC safety | ISO 60601-1-2:2001-<br>09 Medical Electrical<br>Equipment - Part 1:<br>General requirements<br>for safety Subpart<br>2:Collateral standard:<br>Electromagnetic<br>Compatibility -<br>Requirements and<br>tests | IEC 60601-1-2:2007<br>ED. 3.0 Medical<br>electrical equipment<br>- Part 1-2: General<br>requirements for<br>basic safety and<br>essential<br>performance -<br>Collateral Standard:<br>Electromagnetic<br>disturbances -<br>Requirements and<br>tests<br>Class B | Different - The Spaulding<br>Electrocardiograph 2100iQ has been<br>tested for electromagnetic<br>disturbances the same as the<br>predicate Spaulding IQ<br>Electrocardiograph device, however<br>the Spaulding Electrocardiograph<br>2100iQ can be used in transit settings<br>as a portable device. | |
| Chemical safety | Not Applicable – The<br>Spaulding IQ<br>Electrocardiograph is<br>not designed to be<br>used with or contain<br>hazardous chemicals. | Not Applicable –<br>The Spaulding<br>Electrocardiograph<br>2100iq is not<br>designed to be used<br>with or contain<br>hazardous<br>chemicals. | Same – The Spaulding<br>Electrocardiograph 2100iQ does not<br>contain and is not to be used with<br>hazardous chemicals which is the<br>same as the predicate Spaulding IQ<br>Electrocardiograph. | |
| Radiation safety | Not Applicable – The<br>Spaulding IQ<br>Electrocardiograph<br>does not emit<br>radiation. | Not Applicable –<br>The Spaulding<br>Electrocardiograph<br>2100iq does not<br>emit radiation | Same – The Spaulding<br>Electrocardiograph 2100iQ does not<br>emit radiation same as the predicate<br>Spaulding IQ Electrocardiograph<br>device. | |
| Sterility | Not Applicable – The<br>Spaulding IQ<br>Electrocardiograph is<br>not provided sterile. | Not Applicable –<br>The Spaulding<br>Electrocardiograph<br>2100iq is not<br>provided sterile. | Same – The Spaulding<br>Electrocardiograph 2100iQ is not<br>designed to be provided sterile same<br>as the predicate Spaulding IQ<br>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.