(106 days)
No
The document mentions "on-board ECG arrhythmia detection algorithms" but does not provide any details suggesting these algorithms utilize AI or ML. The lack of mention of AI/ML terms, training/test data, or performance metrics typically associated with AI/ML models further supports this conclusion.
No.
The device is used for monitoring and transmitting physiological data for display or analysis, not for treatment or therapy.
Yes
The device is designed to detect and record physiological data, including ECG and respiration signals, and specifically mentions "on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event," which indicates a diagnostic function for heart conditions.
No
The device description explicitly lists hardware components including a monitor, electrode array, and battery charger, in addition to software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Intelesens Aingeal Activity device directly monitors physiological data (ECG, respiration, heart rate, skin temperature, activity levels) from the patient's body using electrodes applied to the torso. It does not analyze samples taken from the body.
- Intended Use: The intended use is to monitor and transmit physiological data for display or analysis by a clinician, supporting routine observations or unmonitored situations. This is a direct physiological monitoring function, not an in vitro diagnostic test.
The device is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The Intelesens Aingeal Activity is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine or when a patient would otherwise be in an unmonitored or unobserved situation.
This re-usable device is intended to be used on the patient for short term periods only.
The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.
The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.
The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device also detects and records respiration, skin temperature and activity. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia or threshold breach).
The Intelesens Aingeal Activity is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.
This re-usable device is intended to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.
The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.
The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device also detects and records respiration, skin temperature and activity. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).
Product codes
MHX
Device Description
The Aingeal Activity System is a modification of the Intelesens Aingeal (VS200) 510(k) cleared under 510(k) K110015. Details of the modifications can be found in Section 11.
The Aingeal Activity system includes the following components:
- Aingeal Activity Monitor a wireless (Wi-Fi) monitoring device with a rechargeable lithium polymer battery
- Adherent electrode array
- Battery charger
- Compatible monitoring software such as CPC Bernoulli (FDA 510(k) clearance # K130208)
The Aingeal Activity device is battery powered. The battery is removed from the device prior to charging in the standalone battery charger station. Charging does not occur when the Aingeal Activity device is connected to a patient. Aingeal Activity is a reusable, nonsterile device to be used with a single use disposable electrode.
The battery is charged in a separate charger, charging does not / cannot occur when the Aingeal Activity Device is connected to a patient.
The Aingeal Activity monitor clips on the adherent electrode array and is worn on-body. In conjunction with the array it collects, stores and transmits user physiological data. The electrode array and device, when enabled and applied to the user's torso will measure ECG, heart rate, respiration rate, skin temperature and activity levels with on board software algorithms. This data is transmitted periodically to the compatible third party server for display such as the CPC Bernoulli software (server). ECG signals recorded by the electrode array and device will also be transmitted on a heart rate trigger basis with thresholds adjustable by the user, or arrhythmia. Respiration signals recorded by the electrode array and device will also be transmitted on a respiration rate trigger basis with thresholds adjustable by the user. Skin temperature is recorded by the electrode array and device will also be transmitted on a temperature level trigger basis with thresholds adjustable by the user. The ECG, respiration signals, skin temperature value and activity metrics are also transmitted periodically and can be displayed via the server.
The device also contains on-board ECG arrhythmia recognition to automatically record and send ECG data on detection of one or more of the following arrhythmias:
- asystole,
- ventricular fibrillation, (VF)
- bradycardia
- tachycardia (Ventricular or Supraventricular)
The Aingeal Activity electrode array is a patient worn adhesive sensor that facilitates the acquisition of ECG, respiration and temperature measurement.
The array is placed onto the patient following the instructions detailed in the user manual.
The array consists of two electrodes and magnetic studs for connecting to the device.
The electrode array has the same patient contact materials as the zensor electrode array cleared under 510(k) K151027.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso
Indicated Patient Age Range
Adults
Intended User / Care Setting
Healthcare 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)
Bench:
The Aingeal Activity System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market.
- Compliance with AAMI ANSI ES60601-1:2005 (+C1:09+A2:10).
- Compliance with IEC 60601-2-49:2011
- Compliance with ISO 80601-2-56:2009
- Compliance with AAMI EC 57:2012
- Compliance with IEC 60601-1-8:2006
- Compliance with IEC 60601-2-27:2011
- Compliance with IEC 60601-1-2:2007
- Hardware Verification
- System Validation
- Electrode Validation Summary inclusive of AAMI EC12:2000(R)2010 compliance
- Electrode Storage test
- Wireless Coexistence Testing.
Testing is documented in Sections 16 - Software, 17 Electrical Safety and 18 -Performance Testing - Bench of this submission.
Animal:
No animal testing was performed.
Clinical:
No human clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Intelesens Aingeal (VS-200) K110015
Reference Device(s)
CPC Bernoulli K130208, zensor K151027
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized graphic of three human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Intelesens. Ltd. Paul Dryden Consultant 17 Heron Road Belfast, BT3 9LE GB
Re: K153275
Trade/Device Name: Aingeal Activity System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX Dated: January 28, 2016 Received: January 29, 2016
Dear Paul Dryden:
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 device
1
related 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
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K153275
Device Name
Aingeal Activity System
Indications for Use (Describe)
The Intelesens Aingeal Activity is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine or when a patient would otherwise be in an unmonitored or unobserved situation.
This re-usable device is intended to be used on the patient for short term periods only.
The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.
The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.
The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device also detects and records respiration, skin temperature and activity. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia or threshold breach).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
3
| Premarket Notification 510(k)
| Section 5 - 510(k) Summary | Intelesens Aingeal System |
|---|---|
| 510(k) Summary | |
| November 10, 2015 | |
| Page 1 of 9 | |
| Date Prepared | November 10, 2015 |
| Official Contact: | Patricia Pepper |
| Regulatory Affairs Officer | |
| Intelesens Ltd. | |
| 17 Heron Road | |
| Belfast BT3 9LE UK | |
| Tel – 44 (0) 28 9073 6801 | |
| Fax - 44 (0) 28 9099 2433 | |
| Proprietary or Trade Name: | Aingeal Activity System |
| Common/Usual Name: | Physiological Patient Monitor |
| Classification Name: | Arrhythmia detector and alarm (including ST-segment |
| measurement and alarm) | |
| MHX, Class II, CFR 870.1025 | |
| Predicate Device: | Intelesens Aingeal (VS-200) K110015 |
Device Description:
Aingeal Activity System
The Aingeal Activity System is a modification of the Intelesens Aingeal (VS200) 510(k) cleared under 510(k) K110015. Details of the modifications can be found in Section 11.
The Aingeal Activity system includes the following components:
- Aingeal Activity Monitor a wireless (Wi-Fi) monitoring device with a ● rechargeable lithium polymer battery
- Adherent electrode array ●
- Battery charger
- Compatible monitoring software such as CPC Bernoulli (FDA 510(k) clearance # ● K130208)
The Aingeal Activity device is battery powered. The battery is removed from the device prior to charging in the standalone battery charger station. Charging does not occur when the Aingeal Activity device is connected to a patient. Aingeal Activity is a reusable, nonsterile device to be used with a single use disposable electrode.
The battery is charged in a separate charger, charging does not / cannot occur when the Aingeal Activity Device is connected to a patient
4
510(k) Summary November 10, 2015 Page 2 of 9
Aingeal Activity Monitor
The Aingeal Activity monitor clips on the adherent electrode array and is worn on-body. In conjunction with the array it collects, stores and transmits user physiological data. The electrode array and device, when enabled and applied to the user's torso will measure ECG, heart rate, respiration rate, skin temperature and activity levels with on board software algorithms. This data is transmitted periodically to the compatible third party server for display such as the CPC Bernoulli software (server). ECG signals recorded by the electrode array and device will also be transmitted on a heart rate trigger basis with thresholds adjustable by the user, or arrhythmia. Respiration signals recorded by the electrode array and device will also be transmitted on a respiration rate trigger basis with thresholds adjustable by the user. Skin temperature is recorded by the electrode array and device will also be transmitted on a temperature level trigger basis with thresholds adjustable by the user. The ECG, respiration signals, skin temperature value and activity metrics are also transmitted periodically and can be displayed via the server.
The device also contains on-board ECG arrhythmia recognition to automatically record and send ECG data on detection of one or more of the following arrhythmias:
-
- asystole,
-
- ventricular fibrillation, (VF)
-
- bradycardia
- tachycardia (Ventricular or Supraventricular 4.
Image /page/4/Figure/11 description: The image shows a white medical device with rounded edges. The front of the device has a blue section with indicator lights and symbols labeled A, B, and C. The side of the device is labeled D. The back of the device has regulatory information and is labeled E.
Controls Indicators and Labeling of Aingeal Activity
5
510(k) Summary November 10, 2015 Page 3 of 9
Figure 1: Aingeal user interface
| A | On/Off button |
|---|---|
| B | Connection LED: orange or green indicates monitor status |
| C | Blue LED indicates Leads off or ECG and respiration have |
| not yet been detected. | |
| D | Aingeal Activity battery pack |
| E | Connecting studs |
Table 10.1 Specifications
| Function/Characteristic | Intelesens
Aingeal Activity |
|--------------------------|------------------------------------------------------|
| ECG/Heart Rate | |
| Number of leads | Single |
| Sample Rate | 360 Hz |
| Bandwidth | 40 Hz |
| Resolution | 12 bit |
| Respiration | |
| Sample Rate | 120 Hz |
| Resolution | 12 bit |
| Accelerometer | |
| Number of axes | 3 |
| Sensitivity | $+/-2G$ |
| Sample rate | 100 Hz |
| Skin Surface Temperature | |
| Accuracy | $+ / - 0.2 °C$ |
| Range | $30 °C to 45 °C$ |
| Sample Rate | 10 Hz |
| Power | |
| Battery | Rechargable Poliflex 3.7 V Li
Polymer battery x 1 |
6
| Premarket Notification 510(k) |
|---|
| Section 5 – 510(k) Summary |
| | 510(k) Summary
November 10, 2015
Page 4 of 9 |
|----------------------|-----------------------------------------------------------------------------------|
| Operational Life | 24 hours at 1 minute reporting
frequency;
Longer for less frequent readings |
| Physical Properties | |
| Dimensions | 96mm (H) x 71mm (W) x 19 mm
(D) |
| Weight | 85g |
| Environmental rating | IPx7 |
| Data Transmission | |
| Type | Wi-Fi 802.11 b/g |
| Range | 50 m |
When fully charged the life of the battery pack is 24 hours when set to 1 minute update interval.
Electrode Array:
- The Aingeal Activity electrode array is a patient worn adhesive sensor that ● facilitates the acquisition of ECG, respiration and temperature measurement.
- The array is placed onto the patient following the instructions detailed in the user ● manual.
- The array consists of two electrodes and magnetic studs for connecting to the ● device.
The electrode array has the same patient contact materials as the zensor electrode array cleared under 510(k) K151027
7
510(k) Summary November 10, 2015 Page 5 of 9
Image /page/7/Picture/4 description: In the image, a shirtless man is shown with medical devices attached to his torso. The devices are connected by a thin wire. The man is looking down, and his face is partially visible. The image is in black and white.
Aingeal electrode and device applied to patient
System:
The functional diagram of the system is as follows:
Image /page/7/Picture/8 description: The image shows a diagram of a hospital network. On the left side of the image, there are three patients with wireless devices attached to them. The wireless devices are connected to a WLAN access point, which is connected to a server in the hospital network. The text in the image labels the different components of the network.
8
Image /page/8/Figure/2 description: This image shows the Intelesens Aingeal System. The system includes the Aingeal Activity Device, the Aingeal Activity Battery, the Aingeal Activity Charger, and the Aingeal Activity Electrode. The document is a Premarket Notification 510(k) Section 5 - 510(k) Summary, dated November 10, 2015, and is page 6 of 9.
Indications for Use:
The Intelesens Aingeal Activity is used to monitor and transmit physiological data to a remote application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.
This re-usable device is intended to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting.
The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful.
The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device also detects and records respiration, skin temperature and activity. The device transmits the data to the remote application at user defined intervals or upon the detection of an arrhythmia event (arrhythmia or threshold breach).
Patient Population:
Adults
9
510(k) Summary November 10, 2015 Page 7 of 9
Environment of Use:
Healthcare environment
Contraindications:
No contraindications exist
Technology:
The Aingeal Activity System is an electronic device that contains software. It conforms to the applicable performance requirements contained in and referenced in this 510(k). The Aingeal Activity System conforms to the following standards:
- AAMI / ANSI ES60601-1:2005 (+C1:09+A2:10) Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: 2007 Collateral standard: Electromagnetic Compatibility -Requirements and Tests
- IEC 60601-1-8: 2006 collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC 60601-2-27: 2011 particular requirements for the basic safety and essential ● performance of electrocardiographic monitoring equipment
- . IEC 60601-2-49: 2011 Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment.
- ISO 80601-2-56: 2009 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- AAMI / ANSI EC12:2000/(R)2010, Disposable ECG electrodes. ●
- AAMI / ANSI EC57: 2012, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
Summary of Performance Data
Bench
The Aingeal Activity System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market.
- Compliance with AAMI ANSI ES60601-1:2005 (+C1:09+A2:10) .
- Compliance with IEC 60601-2-49:2011
10
510(k) Summary
November 10, 2015
Page 8 of 9
- Compliance with ISO 80601-2-56:2009 ●
- Compliance with AAMI EC 57:2012 ●
- Compliance with IEC 60601-1-8:2006 ●
- Compliance with IEC 60601-2-27:2011 ●
- Compliance with IEC 60601-1-2:2007
- Hardware Verification ●
- System Validation
- . Electrode Validation Summary inclusive of AAMI EC12:2000(R)2010 compliance
- Electrode Storage test
- Wireless Coexistence Testing .
Testing is documented in Sections 16 - Software, 17 Electrical Safety and 18 -Performance Testing - Bench of this submission
Animal
No animal testing was performed
Clinical:
No human clinical testing was performed
Risk Analysis:
Risk analyses identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Intelesens' product development procedure. Intelesens' Quality System conforms to 21CFR820 and is certified by SGS UK Ltd. to ISO13485:2003 and ISO13485:2012.
Substantial Equivalence
Indications -
The indications for use are equivalent.
Prescriptive - The Aingeal Activity System and predicate are both prescription devices.
Design and Technology - The Aingeal Activity System and predicate have equivalent design features and technology
Performance and Specifications - The Aingeal Activity System has equivalent specifications of performance as the predicate.
Patient Population -
The Aingeal Activity System and predicate are indicated for adults
11
510(k) Summary November 10, 2015 Page 9 of 9
Environment of Use – Aingeal Activity System and predicate are for healthcare environments
Differences -There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.
Substantial Equivalence Conclusion-
It is Intelesens' opinion that the Aingeal Activity System is substantially equivalent to the predicate device, and is safe and effective.