(171 days)
Not Found
No
The description focuses on basic ECG acquisition, display, and transmission, with no mention of AI/ML for analysis or interpretation. The analysis is explicitly stated to be performed by trained medical professionals.
No
The device is used to acquire, display, and record electrocardiographic information for analysis and diagnosis, not to provide therapy or treatment.
Yes
The device acquires, displays, and records electrocardiographic information, and the captured waveforms are forwarded for analysis and diagnosis by a trained professional, which aligns with the function of a diagnostic device.
No
The device description explicitly states it is a "hand-held, battery powered, 12 lead electrocardiograph (ECG) system" that "acquires ECG information via a patient-attached lead set". This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the InvisionECG System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- InvisionECG System Function: The InvisionECG System acquires and records electrical signals directly from the patient's body (electrocardiographic information). It does not perform tests on samples taken from the body.
- Intended Use: The intended use is to acquire, display, and record ECG information from patients, and to forward this information for later analysis and diagnosis. This is a direct measurement of a physiological signal, not a test on a biological sample.
Therefore, the InvisionECG System falls under the category of a medical device that measures physiological parameters directly from the patient, rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DPS
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 a 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
trained healthcare professionals in a clinical or home environment
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)
Biocompatibility:
The InvisionMD12, InvisionCC12, and Mobile Device have no patient contact materials, and therefore this section does not apply to them.
The InvisionLW12, electrode connector clips, and electrodes have patient contact materials and are made from medical grade biocompatible materials.
The appropriate InvisionECG system component materials were tested for biocompatibility in accordance with the following standard:
• ISO 10993-1: 2009, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
Test results indicate that the appropriate InvisionECG system component materials comply with the applicable standard.
Software:
The InvisionECG System contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following FDA guidance documents:
• The content of premarket submissions for software contained in medical devices, 11 May 05.
• Off-the-shelf software use in medical devices, 09 Sep 99.
• General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02.
• Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14.
Test results indicate that the InvisionECG System complies with its predetermined specifications and the applicable guidance documents.
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.
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
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
1
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
2
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)
3
510(k) Summary
| Submission Date: | 20 May 2015 | ||
|---|---|---|---|
| Submitter: | InvisionHeart Inc. | ||
| 121 17th Avenue South | |||
| Nashville, TN 37203 | |||
| Submitter | |||
| Correspondent | Mr. Michael Wurst | ||
| Phone: +1 (615) 943-4926 | |||
| Email: michael.wurst@invisionheart.com | |||
| Application | |||
| Correspondent: | Thomas Kroenke | ||
| Principal Consultant | |||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| 303 956 4232 | |||
| Manufacturing Site: | InvisionHeart Inc. | ||
| 121 17th Avenue South | |||
| Nashville, TN 37203 | |||
| Trade Name: | InvisionHeart InvisionECG System | ||
| Common and | |||
| Classification | |||
| Name: | Electrocardiograph | ||
| Classification | |||
| Regulation: | 21 CFR §870.2340 | ||
| Product Code: | DPS | ||
| Substantially | |||
| Equivalent Devices: | New InvisionHeart | ||
| Model | Predicate | ||
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| InvisionHeart | |||
| InvisionECG System | K103640 | Midmark Diagnostics | |
| Group / Midmark IQecg |
4
| 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 for | |
| use, under the supervision of a | ||
| Physician, to obtain | ||
| electrocardiograms from the adult | ||
| and pediatric human body surface. | ||
| The process of taking an | ||
| electrocardiogram is non-invasive, | ||
| painless, without direct risk to the | ||
| patient and is reproducible. | 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. | ||
| Patient | ||
| Connection | Ten (10) lead patient cable with RFI | |
| filter, defibrillator protection and | ||
| patient isolation | Same |
5
510(k) Summary
Technology
Comparison (continued):
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Connection to | ||
| Display Device | USB or serial wired | Bluetooth wireless |
| ECG Analysis | ||
| and Measurement | Midmark 12-lead Resting | |
| Electrocardiogram Analysis | ||
| Program, personal computer (PC)- | ||
| based | InvisionHeart InvisionConnect | |
| Mobile App, tablet-based | ||
| Lead Wires | AHA 12 lead wires | Same |
| Required Lead | ||
| Wire Accessories | Electrode clips | |
| Disposable electrodes | Same | |
| Battery Type | AA alkaline cells - serial version | |
| No batteries required for USB | ||
| version | LiOn | |
| Rechargeable |
Summary of Performance Testing:
| Biocompatibility | The InvisionMD12, InvisionCC12, and Mobile Device have no patient
contact materials, and therefore this section does not apply to them. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The InvisionLW12, electrode connector clips, and electrodes have patient
contact materials and are made from medical grade biocompatible
materials. |
| | The appropriate InvisionECG system component materials were tested
for biocompatibility in accordance with the following standard: |
| | • ISO 10993-1: 2009, Biological evaluation of medical devices – Part
1: Evaluation and testing within a risk management process. |
| | Test results indicate that the appropriate InvisionECG system component
materials comply with the applicable standard. |
| Software | The InvisionECG System contains MODERATE level of concern
software. Software was designed and developed according to a robust
software development process, and was rigorously verified and validated.
Software information is provided in accordance with internal
requirements and the following FDA guidance documents: |
| | • The content of premarket submissions for software contained in
medical devices, 11 May 05. |
| | • Off-the-shelf software use in medical devices, 09 Sep 99. |
| | • General principles of software validation; Final guidance for industry
and FDA staff, 11 Jan 02. |
| | • Content of premarket submissions for management of cybersecurity in
medical devices, 02 Oct 14. |
| | Test results indicate that the InvisionECG System complies with its
predetermined specifications and the applicable guidance documents. |
6
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. |
7
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.