(285 days)
Not Found
No
The summary mentions "automated arrhythmia analysis algorithms" but does not provide any details or keywords (like AI, ML, DNN) that would indicate the use of AI/ML technology. The description of performance studies also lacks information about training or test sets typically associated with AI/ML development.
Yes
The device is intended to monitor patients for cardiac arrhythmias and aid in the diagnosis and management of cardiac diseases, which are therapeutic purposes.
Yes
The device's intended use is to monitor individuals at risk of cardiac disease and those with intermittent symptoms indicative of cardiac disease, with ECG recordings being analyzed by healthcare professionals. It employs automated arrhythmia analysis algorithms to detect events and mentions analysis, measurement, and reporting of QT interval, all of which are diagnostic functions.
No
The device description explicitly states it is composed of "patient (ECG) leads, monitor, and charging wall board adapter," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 about a person's health.
- Device Function: The described device, the Aera CT, is an ECG device. It captures electrical signals directly from the patient's body (specifically, the heart) via leads placed on the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for monitoring cardiac electrical activity in individuals at risk of or with symptoms of cardiac disease. This is a direct physiological measurement, not an in vitro test.
Therefore, the Aera CT falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.
Patients include, but at are not limited to, those requiring monitoring for
a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT) and ventricular ectopy,
b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and
c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
Patients with symptoms that may be due to cardiac arrhythmias. These may include, but are not limited to, symptoms such as a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded, c) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms.
Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation).
Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze , measure or report QT interval . The device is not intended to sound any alarms for QT interval changes.
Product codes
DSI
Device Description
The Aera CT is an ECG Device with auto trigger capability using MCOT compliant wireless technology for monitoring ambulatory patients with non-life threatening conditions.
The device is composed of patient (ECG) leads, monitor, and charging wall board adapter.
A sensor captures the ECG signal from the patient's body and transmits the signal to the small (hand sized) monitor where data is stored and analyzed by automated arrhythmia analysis algorithms. When events are detected by the arrhythmia analysis algorithm or when the event processing event key is depressed, the data is transmitted by RF to a data storage location monitored by receiving center. The transmission may occur via Cellular RF modem, RF, or TTL via a landline telephone. The data is received and reviewed by the appropriately trained healthcare professionals or technicians. Request for additional data can be sent to MCT device via SMS text formatted message that will originate from the receiving software.
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
Not Found
Intended User / Care Setting
Ambulatory, Outpatient. Interpretation and diagnosis is the responsibility of a trained healthcare professional or physician.
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)
TZ Medical will compile and analyze clinical test data at a trial site prior to use. Results of data will be used as part of the validation and verification data submitted with the design file. Clinical test will be conducted at facilities that are familiar with predicate devices and will submit reports verifying substantial equivalence to competitive products and on performance to specifications.
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
§ 870.1025 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
Aera CT
10250
Abbreviated 510(k)
JUN 1 3 2011
Summary of Safety and Effectiveness
1. General
- A) Submitter Name and Address:
- TZ Medical, Inc. 7272 SW Durham Rd, Suite #800 Portland, OR 97224
- B) Contact Name and Phone Number: John Lubisich 800-944-0187 or 503-639-0282
2. Device Identification
| Trade name/Proprietary: | Aera CT
TZ Medical MCOT ECG Monitor and Arrhythmia Detector |
|-------------------------|----------------------------------------------------------------|
| Common Name: | Arrhythmia Detector and Alarm |
| Classification Name: | Arrhythmia Detector and Alarm |
| Product Code: | DSI (21 CFR Part 870.1025) |
| Class: | Class II with Special Controls |
| Panel: | 74 Circulatory System Devices |
3. Predicate Devices
K072558 CardioNet ECG Monitor with Arrhythmia Detector Model CN1005
Biomedical Systems Inc. Monitor with Arrhythmia Detector Model TruVue K100155
4. Indications for Use and Contraindications
Indications for Use:
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.
Patients include, but at are not limited to, those requiring for a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT)
1
and ventricular ectopy, b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
Patients with symptoms that may be due to cardiac arrhythmias. These may include, but are not limited to, symptoms such as a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded, c) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms.
Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation).
Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze , measure or report QT interval . The device is not intended to sound any alarms for QT interval changes.
Contraindications:
Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
Patients who the attending physician thinks should be hospitalized.
Note:
The Aera CT system does not provide interpretive or diagnostic statements. Interpretation and diagnosis is the responsibility of a trained healthcare professional or physician.
5. Device Description
The Aera CT is an ECG Device with auto trigger capability using MCOT compliant wireless technology for monitoring ambulatory patients with non-life threatening conditions.
The device is composed of patient (ECG) leads, monitor, and charging wall board adapter.
A sensor captures the ECG signal from the patient's body and transmits the signal to the small (hand sized) monitor where data is stored and analyzed by automated arrhythmia analysis algorithms. When events are detected by the arrhythmia analysis algorithm or when the event
2
processing event key is depressed, the data is transmitted by RF to a data storage location monitored by receiving center. The transmission may occur via Cellular RF modem, RF, or TTL via a landline telephone. The data is received and reviewed by the appropriately trained healthcare professionals or technicians. Request for additional data can be sent to MCT device via SMS text formatted message that will originate from the receiving software.
Image /page/2/Picture/2 description: The image shows a black and white picture of a device labeled "Aera CT". The device has a rectangular shape with rounded edges. A cable is connected to the device on the left side. There are some markings and labels on the top surface of the device.
Image /page/2/Figure/3 description: The image shows a diagram of a system with several components. A stick figure labeled 'Patient' is connected via 'Patient Cable' to a rounded rectangle labeled 'Aera-Ct'. 'Aera-Ct' is connected to a cylinder labeled 'Data Storage' via a line labeled 'Digital/RF', and to a square labeled 'Service Receiving Software' via a line labeled 'Analog'. There is also a wireless signal icon connected to 'Aera-Ct' and 'Service Receiving Software' via a line labeled 'SMS'.
6. Comparison to Predicate Devices
There is no primary technological difference between TZ Medical's Aera CT device and the predicate devices (K072558) CardioNet CN1005S and (K100155) Biomedical Systems Inc TruVue System.
The following chart describes further comparison.
3
| Subject Device | Predicate Device 1 | Predicate Device 2 | |
|---|---|---|---|
| Characteristics | Aera CT | ||
| TZ Medical | CN1005 | ||
| CardioNet | |||
| (K072558) | TruVue | ||
| Biomedical Systems | |||
| (K100155) | |||
| Patient population | Patients requiring cardiac | ||
| monitoring who are ambulatory | |||
| and without life-threatening | |||
| arrhythmia conditions | Same | Same | |
| Environment for | |||
| Intended Use | Ambulatory, Outpatient | Same | Same |
| Basic Technology | Analog Front end, MCU running | ||
| detection Algorithm, Flash Storage, | |||
| Modem for transmission | Same | Same | |
| System | |||
| communication / | |||
| Transmission | RF Modem, Cellular RF Modem, | ||
| Transtelephonic Transmissions | Cellular RF Modem, | ||
| RF Modem to Base, | |||
| Transtelephonic | |||
| Transmission via | |||
| landline | Cellular RF Modem, | ||
| Transtelephonic | |||
| Transmission | |||
| Ambulatory ECG | |||
| performance | |||
| standards | EC 38 compliant | Same | Same |
| Algorithm | Proprietary / Device side | Proprietary / Device | |
| Side | Proprietary /Server | ||
| Side | |||
| Indicators / Alarms | NONE | NONE | NONE |
Element 807.92 (6)(b)(1)
The TZ Medical has developed tests using the same requirements that CardioNet (K072558) and (K100155) have used and stated that their devices comply with in their respective 510k submission. The TZ Medical device and the two predicated devices are tested to and comply with all applicable tests and requirements in the relevant standards as stated in this submission.
Element 807.92 (6)(b)(2)
TZ Medical will compile and analyze clinical test data at a trial site prior to use. Results of data will be used as part of the validation and verification data submitted with the design file. Clinical test will be conducted at facilities that are familiar with predicate devices and will submit reports verifying substantial equivalence to competitive products and on performance to specifications.
4
MCT
K102507 Aera CT
page 5 OF 5
7. Substantial Equivalence Conclusion
TZ Medical's Aera CT, monitor with arrhythmia detection has the same intended use, similar operating principles and technological characteristics as the predicate devices. Based on the descriptive information and the performance testing and validation, the Aera CT is as safe and effective as the predicate devices. Therefore, the Aera CT is substantially equivalent to the predicate devices.
8. Referenced Standards
FDA Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm
(IEC) 60601-1-1:1998 Medical Electrical Equipment-Part 1 General Requirements for Safety
- (IEC) 60601-1-2:2001,Second edition Medical Electrical Equipment Part 1: General Requirements for Safety: Electromagnetic Compatibility
(AAMI) EC 38:2007 Ambulatory Electrocardiographs
(ANSI/ AAMI) EC 57:1998 Testing & reporting performance results of cardiac and ST-segment measurement algorithms
IEC 60601-1-4 + A1:1999 : General Requirements for safety 4. Collateral Standard: Programmable Electrical Medical Systems
IEC 14971-2007: Application of risk management to medical devices
ISO 15223-1:2007 Medical devices – Symbols to be used with medical device labels, labeling, and information to be supplied.
Note: AAMI EC 11 and EC 13 Do not apply to this device.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
TZ Medical Inc. c/o Mr. John Lubisich VP of Operations 7272 SW Durham Road, Suite #800 Portland, OR 97224
JUN 1 3 2011
- Re: K102507
Device Name: Aera CT Regulation Number: 21 CFR 870.1025 Regulation Name: Patient physiological monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (Two) Product Codes: DSI Dated: June 7, 201 Received: June 9, 2010
Dear Mr. Lubisich:
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. Ilsting 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
6
Page 2 – Mr. John Lubisich
CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Artur Wist
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name: Aera CT
Indications For Use:
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.
Patients include, but at are not limited to, those requiring monitoring for
a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT) and ventricular ectopy,
b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and
c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
(Continued on Second page)
Prescription Use X (Part 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)
for B Zuckerman
6/13/2011
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K102507
Page 1 of 2
8
Patients with symptoms that may be due to cardiac arrhythmias.
These may include, but are not limited to, symptoms such as
a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded.
b) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms.
Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation).
Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze , measure or report QT interval . The device is not intended to sound any alarms for QT interval changes.
Contraindications:
Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
Patients who the attending physician thinks should be hospitalized.
Note:
The Aera CT system does not provide interpretive or diagnostic statements. Interpretation and diagnosis is the responsibility of a trained healthcare professional or physician.
Arthur for B. Zuckerman
10 vision Sign-Division of C 510/ki Number
Page 2 of 2