(159 days)
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.
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.
The document provided outlines the K150564 submission for the Spaulding Electrocardiograph 2100iQ. The study performed is a non-inferiority comparison study against a predicate device (Spaulding IQ Electrocardiograph 1000). The focus of the comparison appears to be on specific technical changes and overall performance rather than clinical diagnostic accuracy per se.
Here's an breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or a direct performance table for measures like sensitivity, specificity, or accuracy for diagnosing specific conditions. Instead, it focuses on demonstrating equivalence to the predicate device across various features and safety standards. The reported device performance is summarized as "comparable results" to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate equivalence) | Reported Device Performance (Spaulding Electrocardiograph 2100iQ) |
|---|---|---|
| ECG Data Acquisition | Ability to acquire 12-lead ECG data accurately. | Acquires 12-lead ECG data. |
| ECG Data Transfer | Reliable transfer of ECG data without discrepancy. | Data transferred wirelessly (Bluetooth®) was compared to predicate's USB transfer; "no discrepancy" found in acquired and transferred data. |
| Arrhythmia Detection (for signal integrity) | Accurate representation of various cardiac rhythms, including arrhythmias. | Tested with varying beats per minute, ventricular tachycardia, and ventricular fibrillation conditions, showing "comparable results" to the predicate. |
| Safety - Electrical | Compliance with electrical safety standards (e.g., ISO 60601-1 ed 3.1, IEC 60601-2-25:2011). | "Tested in a wider range of electrical tests than the predicate... Complies with the current 60601-1 ed 3.0." |
| Safety - Environmental | Compliance with environmental operational conditions. | "Tested in a wider range of environmental conditions than the predicate... Can be used in transit settings as a portable device." Significantly wider range of temperature conditions covered. |
| Safety - Water Ingress/Particulate Matter | Compliance with IP rating (e.g., IEC 60529). | "Tested and complies with a higher water ingress and particulate matter rating (IP22) than the predicate (IPX21)." |
| Safety - Mechanical | Compliance with mechanical safety standards (e.g., ISO 60601-1 ed 3.1). | "Tested in a wider range of impact and vibration tests than the predicate... Extends use environments to home settings and transit settings as a portable device." |
| Safety - EMC | Compliance with electromagnetic compatibility standards (e.g., IEC 60601-1-2:2007 ED. 3.0 Class B). | "Tested for electromagnetic disturbances the same as the predicate... Can be used in transit settings as a portable device." |
| Pacemaker Interaction | Ability to acquire ECG data in the presence of pacemaker pulses. | "Has ability to acquire ECG data in the presence of pacemaker pulses" and "additional ability to give a visual notification...when a pacemaker pulse is detected." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size (e.g., number of patients, number of ECGs) for the test set used in the comparison study.
The data provenance is from a comparison test against a predicate device using a calibrated simulator with arrhythmia capabilities. This implies the data is generated in a controlled environment using simulated cardiac signals, not from human subjects. The country of origin for this simulation data is not specified, but the applicant is based in West Bend, Wisconsin, USA. The study is a prospective comparison of the new device against the predicate under various simulated conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No human experts were used to establish the ground truth for this simulator-based comparison test. The "ground truth" for the test set was the known outputs of the calibrated simulator.
4. Adjudication Method for the Test Set
Not applicable. As the ground truth was based on a calibrated simulator, no human adjudication was described or needed for this specific comparison test. The comparison involved checking if the device's output matched the simulator's pre-programmed signals.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided text. The study described is a technical comparison of the device's signal acquisition and transfer capabilities against a predicate, using a simulator, not a study of human reader performance or diagnostic accuracy.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a form of standalone performance was demonstrated through the comparison test. The device (Spaulding Electrocardiograph 2100iQ) was tested directly against a calibrated simulator to acquire and transfer data, without human interpretation as part of the data acquisition/transfer performance comparison. The device provides "un-interpreted 12-lead ECG data".
7. The Type of Ground Truth Used
The ground truth used for the comparison test was the known, pre-programmed signals and conditions from a calibrated ECG simulator.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set. This type of 510(k) submission (for an ECG device) often focuses on technical equivalence and safety rather than a machine learning algorithm's performance requiring a separate training set. The device provides "un-interpreted 12-lead ECG data," implying it's not performing automated diagnoses that would typically involve a vast training dataset for pattern recognition.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or machine learning algorithm requiring such a set is described in the provided text.
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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
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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 (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
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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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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 SpauldingIQElectrocardiograph | SpauldingElectrocardiograph2100iQ | Comparison Summary | |
|---|---|---|---|---|
| Patient Cable | Proprietary 12-LeadPatient Cable | Proprietary 12-LeadPatient Cable | Same - The SpauldingElectrocardiograph 2100iQ uses thesame patient cable as the predicateSpaulding IQ Electrocardiograph | |
| Electrocardiograph | Round shape, singlebutton, portable, LEDdisplay | Round shape, singlebutton, portable,LED display | Same - The SpauldingElectrocardiograph 2100iQ uses thesame casing, circuit board, LEDdisplay as the predicate Spaulding IQElectrocardiograph device. | |
| Leads | 12-Lead | 12-lead | Same - The SpauldingElectrocardiograph 2100iQ is a 12-lead electrocardiograph the same asthe predicate Spaulding IQElectrocardiograph. | |
| Circuit Board | Cased in PrintedCircuit Board | Cased in PrintedCircuit Board | Same - The SpauldingElectrocardiograph 2100iQ uses thesame printed circuit board componentas the predicate Spaulding IQElectrocardiograph. | |
| Daughter Board | None | Daughter boardcontains Bluetooth®Chip and AppleCoprocessor. | Different - The SpauldingElectrocardiograph has an additionaldaughter circuit board affixed whichcontains the Bluetooth® radio andApple coprocessor. | |
| Microcontroller | AVR 8 bitMicrocontroller | AVR 8 bitMicrocontroller | Same - The SpauldingElectrocardiograph 2100iQ uses thesame microcontroller component asthe predicate Spaulding IQElectrocardiograph. | |
| Battery | Device is powered byan internal polymerlithium ion 3.7Vrechargeable battery. | Device is poweredby an internalpolymer lithium ion3.7V rechargeablebattery. | Same - The SpauldingElectrocardiograph 2100iQ uses thesame battery as the predicateSpaulding IQ Electrocardiographdevice. | |
| ECG WaveformAcquisition | Electrodes to patientcable toelectrocardiograph | Electrodes to patientcable toelectrocardiograph | Same - The Spaulding 2100iQacquires signal from electrodes thruthe patient cable to theelectrocardiograph the same way asthe predicate Spaulding IQelectrocardiograph. | |
| ECG Data Transfer | Data Transfer viastandard USB Cable | Data Transfer viaBluetooth®Technology | Different - The SpauldingElectrocardiograph 2100iQ transfersdata wirelessly to the receiving clientapplication software.The predicate Spaulding IQElectrocardiograph transfers data viaUSB cable to the client applicationsoftware. | |
| SoftwareComponent | Spaulding ClientApplication Software | Spaulding ClientApplication Software | Same - The SpauldingElectrocardiograph 2100iQ requiresthe use of the Spaulding ClientApplication Software running on acomputer/display device, which is alsorequired with the predicate SpauldingIQ Electrocardiograph. | |
| Client Softwareplatform | Personal Computer | Mobile device | Different - The SpauldingElectrocardiograph 2100iQ interfaceswith the Spaulding Client ApplicationSoftware running on a Mobile Device.The predicate Spaulding IQElectrocardiograph interfaces with theSpaulding Client Application Softwarerunning on a personal computer. | |
| ECG Interpretation | No | No | Same - The SpauldingElectrocardiograph 2100iQ providesun-interpreted ECG data the same asthe predicate Spaulding IQElectrocardiograph. | |
| ECG Display | ECG data displayoccurs on personalcomputer screen afteracquisition and dataupload usingSpaulding ClientApplication software | ECG data isdisplayed on mobilescreen in real-timebefore, during, andafter acquisition.Acquired ECGdisplayed beforeand after upload. | Different - The SpauldingElectrocardiograph 2100iQ streamsdata to the Spaulding ClientApplication Software. The softwareallows the data to be displayed as it isreceived, it will also allow user to seethe acquired ECG data before or afterupload. The predicate Spaulding IQElectrocardiograph only allows theSpaulding Client Application softwareto display the ECG data afteracquisition and upload. | |
| PacemakerInteraction | Has ability to acquireECG data in thepresence ofpacemaker pulses. | Has ability toacquire ECG data inthe presence ofpacemaker pulsesand identify that apacemaker pulse ispresent. | Different - The SpauldingElectrocardiograph 2100iQ, inconjunction with the Spaulding ClientApplication software, has theadditional ability to give a visualnotification on the computing/displaydevice when a pacemaker pulse isdetected. | |
| Internet access | Internet access isrequired for ECG dataupload and retrieval. | Internet access isrequired for ECGdata upload andretrieval. | Same - The SpauldingElectrocardiograph 2100iQ requiresinternet access to upload and retrievedata from an MDDS, the same as thepredicate Spaulding IQelectrocardiograph device. | |
| Device Charging | Device battery ischarged by USBconnection topersonal computer ormedical grade USBcharger. | Device battery ischarged by USBconnection topersonal computeror medical gradeUSB charger. | Same - The SpauldingElectrocardiograph 2100iQ uses thesame charging method as thepredicate Spaulding IQElectrocardiograph device. | |
| Materials | ||||
| Patient Cable | Elastolan | Elastolan | Same - The SpauldingElectrocardiograph 2100iQ uses thesame patient cable as the predicateSpaulding IQ Electrocardiographdevice. | |
| Device enclosure(plastic casing) | ABS Polycarbonate | ABS Polycarbonate | Same - The SpauldingElectrocardiograph 2100iQ deviceenclosure is the same deviceenclosure as the predicate SpauldingIQ Electrocardiograph device. | |
| Software & Settings Comparison | ||||
| Lead Markers | Spaulding ClientApplication Softwaredisplays lead markers | Spaulding ClientApplication Softwaredisplays leadmarkers | Same - The Spaulding ClientApplication software used inconjunction with the SpauldingElectrocardiograph 2100iQ can beconfigured to display lead markers thesame as the predicate Spaulding IQElectrocardiograph device. | |
| Sensitivity, mm/mV(Gain) | 2.5,5,10,20,40 | 2.5,5,10,20,40 | Same - The SpauldingElectrocardiograph 2100iQ has thesame gain options as the predicateSpaulding IQ Electrocardiographdevice. | |
| Chart Speed, mm/s | 5,10,12.5,25,50 | 5,10,12.5,25,50 | Same - The SpauldingElectrocardiograph 2100iQ has thesame chart speeds as the predicateSpaulding IQ Electrocardiographdevice. | |
| ECG displayformats | User Selectable12-lead, 3+1, 3+3 | User Selectable12-lead, 12x1, 6x1,4x1, 3x1, 2x1, 1x1,6x2, 4x2, 3x2, 2x2,1x2 | Different - The SpauldingElectrocardiograph 2100iQ allows forECGs to be displayed in a widerrange of display formats than thepredicate Spaulding IQElectrocardiograph device. | |
| Safety / Standards Comparison | ||||
| Performance | AAMIEC11:1991/2001/2007DiagnosticElectrocardiographDevicesIEC 60601-2-51:2003Medical ElectricalEquipment - Particularrequirements for thesafety, includingessentialperformance, ofrecording andanalyzing singlechannel andmultichannelelectrocardiographs. | IEC 60601-2-25:2011 Particularrequirements for thebasic safety andessentialperformance ofelectrocardiographs. | Equivalent - The SpauldingElectrocardiograph 2100iQ essentialperformance is comparable toperformance compliance of thepredicate Spaulding IQElectrocardiograph. | |
| BiocompatibilitySafety | ISO 10993 Part 1,Part 5, Part 10 | ISO 10993 Part 1,Part 5, Part 10 | Same - The SpauldingElectrocardiograph 2100iQ uses thesame patient cable and the samedevice enclosure of the predicateSpaulding IQ Electrocardiographdevice. | |
| EnvironmentalSafety | IEC 60601-2-25:2011Particularrequirements for thesafety ofelectrocardiographs | ISO 60601-1:2005ed 3.1Medical electricalequipment - Part 1:Generalrequirements forbasic safety andessentialperformanceIEC 60601-2-25:2011 Particular | Different - The SpauldingElectrocardiograph 2100iQ has beentested in a wider range ofenvironmental conditions than thepredicate Spaulding IQElectrocardiograph device. TheSpaulding Electrocardiograph 2100iQcan be used in transit settings as aportable device. | |
| requirements for thebasic safety andessentialperformance ofelectrocardiographs. | ||||
| Water ingress andparticulate matterrating | IEC 60529:2001Degrees of protectionprovided byenclosuresIPX21 | IEC 60529: 2013Degrees ofprotection providedby enclosuresIP22 | Different - The SpauldingElectrocardiograph 2100iQ has beentested and complies with a higherwater ingress and particulate matterrating than the predicate Spaulding IQElectrocardiograph device. | |
| Thermal safety | IEC 60601-2-25:2011Particularrequirements for thesafety ofelectrocardiographs | ISO 60601-1:2005ed 3.1Medical electricalequipment - Part 1:Generalrequirements forbasic safety andessentialperformanceIEC 60601-2-25:2011 Particularrequirements for thebasic safety andessentialperformance ofelectrocardiographs. | Equivalent - The SpauldingElectrocardiograph 2100iQ has beentested in a wider range of temperatureconditions than the predicateSpaulding IQ Electrocardiographdevice. The SpauldingElectrocardiograph 2100iQ extendsuse temperatures to those found inhome settings and transit settings asa portable device. | |
| Electrical Safety | ISO 60601-1 ed 2.0 | ISO 60601-1:2005ed 3.1Medical electricalequipment - Part 1:Generalrequirements forbasic safety andessentialperformanceIEC 60601-2-25:2011 Particularrequirements for thebasic safety andessentialperformance ofelectrocardiographs. | Equivalent - The SpauldingElectrocardiograph 2100iQ has beentested in a wider range of electricaltests than the predicate Spaulding IQElectrocardiograph device. It complieswith the current 60601-1 ed 3.0. TheSpaulding Electrocardiograph 2100iQextends use environments to homesettings and transit settings as aportable device. | |
| Applied PartClassification | TYPE CF | TYPE CF | Same - The SpauldingElectrocardiograph 2100iQ's appliedpart classification is the same as thepredicate Spaulding IQElectrocardiograph device appliedpart classification. | |
| Patient CableSafety | 21 CFR Part 898.12Lead Sets | 21 CFR Part 898.12Performancestandard forelectrode and leadwire setsAAMI/ANSIEC53:2013 ECGTrunk Cables andPatient Leadwires | Same - The SpauldingElectrocardiograph 2100iQ patientcable performance testing completedis the same and more extensive asthe predicate Spaulding IQElectrocardiograph device. | |
| Mechanical Safety | IEC 60601-2-25:2011Particularrequirements for thesafety ofelectrocardiographs | ISO 60601-1:2005ed 3.1Medical electricalequipment - Part 1:Generalrequirements forbasic safety andessentialperformanceIEC 60601-2-25:2011 Particularrequirements for thebasic safety andessentialperformance ofelectrocardiographs. | Equivalent - The SpauldingElectrocardiograph 2100iQ has beentested in a wider range of impact andvibration tests than the predicateSpaulding IQ Electrocardiographdevice. The SpauldingElectrocardiograph 2100iQ extendsuse environments to home settingsand transit settings as a portabledevice. | |
| EMC safety | ISO 60601-1-2:2001-09 Medical ElectricalEquipment - Part 1:General requirementsfor safety Subpart2:Collateral standard:ElectromagneticCompatibility -Requirements andtests | IEC 60601-1-2:2007ED. 3.0 Medicalelectrical equipment- Part 1-2: Generalrequirements forbasic safety andessentialperformance -Collateral Standard:Electromagneticdisturbances -Requirements andtestsClass B | Different - The SpauldingElectrocardiograph 2100iQ has beentested for electromagneticdisturbances the same as thepredicate Spaulding IQElectrocardiograph device, howeverthe Spaulding Electrocardiograph2100iQ can be used in transit settingsas a portable device. | |
| Chemical safety | Not Applicable – TheSpaulding IQElectrocardiograph isnot designed to beused with or containhazardous chemicals. | Not Applicable –The SpauldingElectrocardiograph2100iq is notdesigned to be usedwith or containhazardouschemicals. | Same – The SpauldingElectrocardiograph 2100iQ does notcontain and is not to be used withhazardous chemicals which is thesame as the predicate Spaulding IQElectrocardiograph. | |
| Radiation safety | Not Applicable – TheSpaulding IQElectrocardiographdoes not emitradiation. | Not Applicable –The SpauldingElectrocardiograph2100iq does notemit radiation | Same – The SpauldingElectrocardiograph 2100iQ does notemit radiation same as the predicateSpaulding IQ Electrocardiographdevice. | |
| Sterility | Not Applicable – TheSpaulding IQElectrocardiograph isnot provided sterile. | Not Applicable –The SpauldingElectrocardiograph2100iq is notprovided sterile. | Same – The SpauldingElectrocardiograph 2100iQ is notdesigned to be provided sterile sameas the predicate Spaulding IQElectrocardiograph device. |
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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.
§ 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).