(171 days)
The InvisionECG System is intended to acquire, display and record electrocardiographic information from adult and pediatric patients.
The InvisionECG System is intended to be used in a clinical or home environment by trained healthcare professionals.
The InvisionECG System is a hand-held, battery powered, 12 lead electrocardiograph (ECG) system. The InvisionECG System acquires ECG information via a patient-attached lead set, and processes and transmits the ECG information to a mobile device where the ECG waveform may be viewed in near real-time. A 12 second snapshot of the waveform can be acquired, and then uploaded to an medical device data system (MDDS) from where these records can be retrieved and analyzed by trained medical professionals. Patient data is also transmitted with the ECG waveform.
The primary functions of the InvisionECG System are to:
• Acquire ECG signals from the patient's body and display the near real-time ECG waveform.
The displayed waveform is intended to provide the bedside care provider with a preliminary view of the ECG and additional opportunity to control the quality of captured ECGs.
- Capture a 12-second ECG waveform. .
- Associate the captured ECG waveform to the patient. .
- . Forward captured ECG waveform to an MDDS for later retrieval. analysis and diagnosis by a trained professional.
The InvisionECG System is a hand-held, battery-powered 12-lead electrocardiograph (ECG) system. It acquires ECG information, processes and transmits it to a mobile device for near real-time viewing. It can capture a 12-second ECG waveform and associate it with the patient, then forward it to an MDDS for later retrieval, analysis, and diagnosis by trained professionals.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a discrete table explicitly outlining acceptance criteria alongside device performance metrics for diagnostic accuracy. Instead, the performance testing section details compliance with various standards related to safety, electrical performance, and software. The "Conclusion" states that the device "performs as well as or better than the predicate device," implying that the performance of the predicate device (Midmark IQecg, K103640) set the de facto acceptance benchmark.
Below is a table summarizing the types of performance testing mentioned and their outcomes:
| Performance Area | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials with patient contact to comply with ISO 10993-1: 2009. | Complies with ISO 10993-1: 2009 for appropriate component materials. |
| Software | Compliance with FDA guidance documents for "MODERATE level of concern" software, including robust software development process, verification, and validation. | Complies with predetermined specifications and applicable FDA guidance documents. Software was rigorously verified and validated. |
| Electrical Safety | Compliance with ANSI/AAMI ES60601-1: 2005/(R)2012 (incl. amendments) and ANSI/AAMI HA60601-1-11: 2011 (home healthcare). | Complies with ANSI/AAMI ES60601-1 and ANSI/AAMI HA60601-1-11. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2007. | Complies with IEC 60601-1-2. |
| Performance Testing – Bench | Compliance with ANSI/AAMI EC53: 2013 (ECG Trunk Cables and Lead Wires), IEC 60601-2-25: 2011 (Basic safety & essential performance of electrocardiographs), IEC 62366: 2007 (Usability engineering), MIL-STD-810E (Environmental), ISTA Procedure 2a (Packaging). | Complies with its predetermined specifications and the applicable standards (ANSI/AAMI EC53, IEC 60601-2-25, IEC 62366, MIL-STD-810E, ISTA Procedure 2a). |
| Clinical Performance | Implied "as safe, as effective, and performs as well as or better than the predicate device" (Midmark IQecg, K103640). Specific metrics like sensitivity, specificity for disease detection are not stated in this document. | The conclusion states the device "is as safe, as effective, and performs as well as or better than the predicate device," but no specific clinical performance metrics (e.g., diagnostic accuracy) or studies are detailed in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention any clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating diagnostic performance. The testing described is primarily for safety, electrical performance, software validation, and biocompatibility, which are typically bench or engineering tests, not clinical studies involving patient data for diagnostic accuracy.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no clinical test set for diagnostic performance is described, there is no information provided regarding experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set for diagnostic evaluation, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study. The focus is on demonstrating substantial equivalence to a predicate device through technical and safety performance, not on comparing reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not describe a standalone performance study for an algorithm in terms of diagnostic accuracy. The device "acquires, displays and records electrocardiographic information" and "forwards captured ECG waveform to an MDDS for later retrieval, analysis and diagnosis by a trained professional." This indicates that the device facilitates human diagnosis rather than providing an automated diagnosis itself, at least within the scope of this 510(k) summary. The "Technology Comparison" mentions "ECG Analysis and Measurement" for both predicate and proposed devices, but does not detail a standalone algorithm for automated diagnosis in the proposed device that would require such a study.
7. Type of Ground Truth Used
Given the absence of clinical diagnostic performance studies in the provided text, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
The document does not mention any machine learning or AI models that would require a training set. The described device functions as an ECG acquisition and display system.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI/ML model is mentioned, there is no information provided on how ground truth for a training set was established.
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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 21, 2015
InvisionHeart Inc. % Thomas Kroenke Principal Consultant Speed To Market, Inc. P.O. Box 3018 Nederland. Colorado 80466
Re: K143436
Trade/Device Name: InvisionECG System Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 16, 2015 Received: April 20, 2015
Dear Thomas Kroenke,
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
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,
Mitchell Stein
forBram 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): | K143436 |
|---|---|
| Device Name: | InvisionECG System |
| Indications for Use: | The InvisionECG System is intended to acquire, display and record electrocardiographic information from adult and pediatric patients.The InvisionECG System is intended to be used in a clinical or home environment by trained healthcare professionals. |
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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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510(k) Summary
| Submission Date: | 20 May 2015 | ||
|---|---|---|---|
| Submitter: | InvisionHeart Inc.121 17th Avenue SouthNashville, TN 37203 | ||
| SubmitterCorrespondent | Mr. Michael WurstPhone: +1 (615) 943-4926Email: michael.wurst@invisionheart.com | ||
| ApplicationCorrespondent: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 | ||
| Manufacturing Site: | InvisionHeart Inc.121 17th Avenue SouthNashville, TN 37203 | ||
| Trade Name: | InvisionHeart InvisionECG System | ||
| Common andClassificationName: | Electrocardiograph | ||
| ClassificationRegulation: | 21 CFR §870.2340 | ||
| Product Code: | DPS | ||
| SubstantiallyEquivalent Devices: | New InvisionHeartModel | Predicate510(k) Number | PredicateManufacturer / Model |
| InvisionHeartInvisionECG System | K103640 | Midmark DiagnosticsGroup / Midmark IQecg |
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| Device Description: | The InvisionECG System is a hand-held, battery powered, 12 lead electrocardiograph (ECG) system. The InvisionECG System acquires ECG information via a patient-attached lead set, and processes and transmits the ECG information to a mobile device where the ECG waveform may be viewed in near real-time. A 12 second snapshot of the waveform can be acquired, and then uploaded to an medical device data system (MDDS) from where these records can be retrieved and analyzed by trained medical professionals. Patient data is also transmitted with the ECG waveform.The primary functions of the InvisionECG System are to:• Acquire ECG signals from the patient's body and display the near real-time ECG waveform.The displayed waveform is intended to provide the bedside care provider with a preliminary view of the ECG and additional |
|---|---|
| --------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
opportunity to control the quality of captured ECGs.
- Capture a 12-second ECG waveform. .
- Associate the captured ECG waveform to the patient. .
- . Forward captured ECG waveform to an MDDS for later retrieval. analysis and diagnosis by a trained professional.
- The InvisionECG System is intended to acquire, display and record Intended Use: electrocardiographic information from adult and pediatric patients.
The InvisionECG System is intended to be used in a clinical or home environment by trained healthcare professionals.
Technology The InvisionECG System employs the same technological characteristics Comparison: as the predicate device.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Intended Use | The Midmark IQecg is indicated foruse, under the supervision of aPhysician, to obtainelectrocardiograms from the adultand pediatric human body surface.The process of taking anelectrocardiogram is non-invasive,painless, without direct risk to thepatient and is reproducible. | The InvisionECG System isintended to acquire, display andrecord electrocardiographicinformation from adult and pediatricpatients.The InvisionECG System isintended to be used in a clinical orhome environment by trainedhealthcare professionals. |
| PatientConnection | Ten (10) lead patient cable with RFIfilter, defibrillator protection andpatient isolation | Same |
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510(k) Summary
Technology
Comparison (continued):
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Connection toDisplay Device | USB or serial wired | Bluetooth wireless |
| ECG Analysisand Measurement | Midmark 12-lead RestingElectrocardiogram AnalysisProgram, personal computer (PC)-based | InvisionHeart InvisionConnectMobile App, tablet-based |
| Lead Wires | AHA 12 lead wires | Same |
| Required LeadWire Accessories | Electrode clipsDisposable electrodes | Same |
| Battery Type | AA alkaline cells - serial versionNo batteries required for USBversion | LiOnRechargeable |
Summary of Performance Testing:
| Biocompatibility | The InvisionMD12, InvisionCC12, and Mobile Device have no patientcontact materials, and therefore this section does not apply to them. |
|---|---|
| The InvisionLW12, electrode connector clips, and electrodes have patientcontact materials and are made from medical grade biocompatiblematerials. | |
| The appropriate InvisionECG system component materials were testedfor biocompatibility in accordance with the following standard: | |
| • ISO 10993-1: 2009, Biological evaluation of medical devices – Part1: Evaluation and testing within a risk management process. | |
| Test results indicate that the appropriate InvisionECG system componentmaterials comply with the applicable standard. | |
| Software | The InvisionECG System contains MODERATE level of concernsoftware. Software was designed and developed according to a robustsoftware development process, and was rigorously verified and validated.Software information is provided in accordance with internalrequirements and the following FDA guidance documents: |
| • The content of premarket submissions for software contained inmedical devices, 11 May 05. | |
| • Off-the-shelf software use in medical devices, 09 Sep 99. | |
| • General principles of software validation; Final guidance for industryand FDA staff, 11 Jan 02. | |
| • Content of premarket submissions for management of cybersecurity inmedical devices, 02 Oct 14. | |
| Test results indicate that the InvisionECG System complies with itspredetermined specifications and the applicable guidance documents. |
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510(k) Summary
| Electrical Safety | The InvisionECG System was tested for performance in accordance with the following standard: | ANSI/AAMI ES60601-1: 2005/(R)2012, A1:2012, C1:2009/(R)2012, A2:2010/(R)2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. ANSI/AAMI HA60601-1-11: 2011, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment. Test results indicate that the InvisionECG System complies with the applicable standards. |
|---|---|---|
| Electromagnetic Compatibility | The InvisionECG System was tested for performance in accordance with the following standard: | 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. Test results indicate that the InvisionECG System complies with the applicable standards. |
| Performance Testing – Bench | The InvisionECG System was tested for performance in accordance with internal requirements and the following standards: | ANSI/AAMI EC53: 2013, ECG Trunk Cables and Lead Wires. IEC 60601-2-25: 2011, Medical electrical equipment – Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs. IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices. MIL-STD-810E, Environmental Test Methods and Engineering Guidelines ISTA Procedure 2a, Partial simulation performance test procedure – Packaged-products 150 lb (68 kg) or less. Test results indicate that the InvisionECG System complies with its predetermined specifications and the applicable standards. |
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Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the device modifications made to the InvisionECG System. The results of these activities demonstrate that the InvisionECG System is as safe, as effective, and performs as well as or better than the predicate device.
Therefore, the InvisionECG System is considered substantially equivalent to the predicate device.
§ 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).