(15 days)
No
The device description focuses on hardware modifications and data transmission, with no mention of algorithmic analysis or interpretation of the ECG data using AI/ML. The performance studies also focus on hardware and basic functionality validation against standards.
No
The device is described as an ECG monitoring device used for "diagnostic evaluation" and provides "information used for the diagnosis of cardiac arrhythmias," indicating its purpose is to aid in diagnosis rather than provide therapy.
Yes
The 'Intended Use / Indications for Use' states: "Diagnostic evaluation of patients with asymptomatic disturbances of cardiac rhythm..." and "The recorder provides physicians with information used for the diagnosis of cardiac arrhythmias." This clearly indicates its purpose is for diagnosis.
No
The device description explicitly states it is a "recorder" and describes hardware components like battery operation and the difference between models being the activation of channels by software, implying the presence of underlying hardware. The performance studies also mention testing to hardware-related standards like IEC 60601-1.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Diagnostic evaluation of patients with asymptomatic disturbances of cardiac rhythm". This indicates the device is used to provide information for diagnosis.
- Device Description: The description states the device "provides physicians with information used for the diagnosis of cardiac arrhythmias."
- Nature of the Data: The device records and transmits ECG data, which is physiological data collected from the patient's body. While not a traditional "in vitro" sample like blood or urine, the collection and analysis of this physiological data for diagnostic purposes falls under the broader scope of IVD regulations in many jurisdictions.
While the device doesn't process biological samples in a lab setting, the collection and analysis of physiological data for diagnostic purposes is often regulated under the same framework as IVDs, especially when the output is used to inform a medical diagnosis. The focus is on the diagnostic purpose of the information provided by the device.
N/A
Intended Use / Indications for Use
Diagnostic evaluation of patients with asymptomatic disturbances of cardiac rhythm such as: -Dizziness -Heart race -Palpitation -Syncopes of unknown cause
Product codes
DXH
Device Description
The ECG monitoring devices are post-event recorders, also called tele-ECG devices, which realize one-channel (100BT) or three- channel (300BT) recordings of short ECG sections, their memorization as well as the preparation of the transmission. Therefore, the purpose of the recorders is the derivation and memorization of an ECG section in combination with a compatible telemedicine system. The recorder provides physicians with information used for the diagnosis of cardiac arrhythmias. The Post Event 300BT device is a modification to Vitaphone's previously cleared Post Event 110BT device cleared pursuant to K100383. The modification consists of the availability of three recording channels rather than one recording channel. There is no change to intended use, patient contact materials or core technology. The hardware of the 100BT and the 300BT is basically the same. The differences between both devices is the activation of the channels by the software. The device supports the transmission of the data. The recorders are battery operated devices. The recorders do not possess a separate on/off switch.
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
Healthcare Professionals
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)
Every specification of the modified device has been validated according to the documented development and test procedures. The verification and validation testing included testing to applicable standards including: - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1; 2005, MOD) - Medical electrical equipment Part 1-2: General requirements for basic safety ● and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests - Medical electrical equipment-Part 2-47; Particular requirements for the safety , ● including essential performance; of ambulatory electrocardiographic systems ISO 14971 Medical devices - application of risk management to medical devices . Verification and validation testing were completed in accordance with the company's design control process in compliance with 21 CFR Part 820.30. Results of performance testing demonstrated that the 300BT model is substantially equivalent to the 100BT and that the 300BT meets all performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2015
Vitasystems Gmbh % Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K151013
Trade/Device Name: Vitaphone Post-Event Recorder 300 BT Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitters and Receivers Regulatory Class: II (two) Product Code: DXH Dated: April 13, 2015 Received: April 15, 2015
Dear Mr. Mark Job,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 vours,
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
Page 1 of__1__1__
510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________
Device Name : ___ Vitaphone Post-Event Recorder 300 BT________________________________________________________________________________________________________________________
Indications For Use:
Diagnostic evaluation of patients with asymptomatic disturbances of cardiac rhythm such as: -Dizziness -Heart race -Palpitation -Syncopesof unknown cause
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
3
510(k) Summary Prepared June 30, 2014
| Sponsor: | Vitasystems GmbH |
|---|---|
| Address: | Staderstralle 14 |
| D-09126 Chemnitz, Germany | |
| Contact Person: | Michael Rothhaar |
| Telephone: | 49 621 178918174 |
| Fax: | 49 621 178918101 |
| Submission Date: | June 30, 2014 |
| Device Name: | Vitaphone Post-Event Recorder 300BT |
| Common Name: | Tele-ECG System, Cardiac Event Recorder |
| Classification: | |
| Regulatory Class: | II |
| Review Category: | Tele-ECG System, Cardiac Event Recorder |
| 21CFR 870.2920 (DXH) | |
| Classification Panel: | Cardiology |
A. Legally Marketed Predicate Devices
The Post Event 300BT device is substantially equivalent to Vitaphone's Post Event Recorder 100BT (K100383) with regard to both its intended use and its core technological characteristics. The 300BT represents a modification to the predicate device.
B. Device Description:
The ECG monitoring devices are post-event recorders, also called tele-ECG devices, which realize one-channel (100BT) or three- channel (300BT) recordings of short ECG sections, their memorization as well as the preparation of the transmission. Therefore, the purpose of the recorders is the derivation and memorization of an ECG section in combination with a compatible telemedicine system. The recorder provides physicians with information used for the diagnosis of cardiac arrhythmias. The Post Event 300BT device is a modification to Vitaphone's previously cleared Post Event 110BT device cleared pursuant to K100383.
The modification consists of the availability of three recording channels rather than one recording channel. There is no change to intended use, patient contact materials or core
4
technology. The hardware of the 100BT and the 300BT is basically the same. The differences between both devices is the activation of the channels by the software. The device supports the transmission of the data. The recorders are battery operated devices. The recorders do not possess a separate on/off switch.
C. Intended Use
Diagnostic evaluation of patients with asymptomatic and symptomatic disturbances of the cardiac rhythm such as:
-Dizziness
-Heart race
-Palpatations
-Syncopes of unknown cause
D. Substantial Equivalence
The Post Event 300BT device is substantially equivalent to Vitaphone's previously cleared Post Event 100BT device cleared pursuant to K100383. There is only one difference between the original and the modified device: the 300BT provides 3 recording channels whereas the 100BT had only one recording channel. There is not change to the intended use, materials or core technology. A comparison between the predicate and the modified device and an analysis of the differences demonstrated that the devices are substantially equivalent.
5
| Feature | Predicate Device
Vitaphone 100BT Event Recorder
(K100383) | Subject Device
Vitaphone 300BT Event Recorder |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Diagnostic evaluation of patients with
asymptomatic and
symptomatic disturbances of the
cardiac rhythm
such as:
– Dizziness
– Racing heart beat
– Palpitations
– Syncopes of unknown cause | Diagnostic evaluation of patients with
asymptomatic and symptomatic
disturbances of the cardiac rhythm such
as:
– Dizziness
– Racing heart beat
– Palpitations
– Syncopes of unknown cause |
| Intended Users | Healthcare Professionals | Healthcare Professionals |
| Class | II | II |
| Regulation
number
Code | 21CFR 870.2920 | 21CFR 870.2920 |
| Device
Description | The Vitaphone 100 BT device is a one
channel cardiac event recorder for
transmitting multiple ECG recordings
via land-line or GSM telephony
networks to a compatible ECG
receiving system, such as REMOS
ECG Receiving Software (510(k)
K050670) or compatible ECG
receivers.
The Vitaphone 100 BT device is
intended for patient activated event
recordings. It is battery operated and
Utilizes a Flash memory to store ECG
data with and adjustable event time. | The Vitaphone 300 BT device is a three
channel cardiac event recorder for
transmitting multiple ECG recordings
via land-line or GSM telephony
networks to a compatible ECG
receiving system, such as REMOS
ECG Receiving Software (510(k)
K050670) or compatible ECG
receivers.
The Vitaphone 300 BT device is
intended for patient activated event
recordings. It is battery operated and
utilizes a Flash memory to store ECG
data with an adjustable event time. |
6
K151013
Page 4 of 5
| Comparison Table – Technological Characteristics | ||
|---|---|---|
| Feature | Predicate Device | |
| Vitaphone 100BT Event Recorder | ||
| (K100383) | Subject Device | |
| Vitaphone 300BT Event Recorder | ||
| ECG Channels | 1 | 3 |
| Safety | Compliant with ISO 60601-1 | Compliant with ISO 60601-1 |
| Display | Yes | Yes |
| Buttons | 2 | 2 |
| Audible feedback | Yes | Yes |
| Setup | Use of buttons and display | Use of buttons and display |
| Transmission method | Bluetooth / GSM; transtelephonic | Bluetooth / GSM; transtelephonic |
| Audio trigger | No | No |
| Arythmia detection | No | No |
| Auto send | Yes | Yes |
| Electrode type | Metal | Metal |
| Looping memory | No | No |
| Pacemaker detection | Yes | Yes |
| Applied part class | BF | BF |
| ECG memory | 10800s | 10800s |
| Max events | 120 | 120 |
| Batteries | 2 x AAA | 2 x AAA |
| Battery lifetime | 100 ECG transmissions | 100 ECG transmissions |
| Backup battery | Yes | Yes |
| Weight | 95 gr | 95 gr |
| Width | 74 mm | 74mm |
| Thickness | 23mm | 23mm |
| Cover material | Molded plastic | Molded plastic |
| Operating temperature | 5-45°C | 5-45°C |
| Storage temperature | -20 - +60° C | -20 - +60° C |
| Relative humidity | 10-95% | 10-95% |
| Memory type | Flash | Flash |
| Data retention | 10 years | 10 years |
| Sampling rate | 200 Hz | 200 Hz |
| A/D Converter | 12 bit | 12 bit |
| Input impedance | 10 MOhm | 10 MOhm |
| Frequency range | 0.5 - 40 Hz | 0.5 - 40 Hz |
| Signal input range AC | +/- 3mV | +/- 3mV |
| Signal input range DC | +/- 300 mV | +/- 300 mV |
| Common mode ejection | 80dB | 80dB |
| Amplitude | 1 mV | 1 mV |
| calibration | ||
| Minimum feature | ||
| size | 50μV p-v@10Hz | 50μV p-v@10Hz |
7
E. Performance Data
Every specification of the modified device has been validated according to the documented development and test procedures. The verification and validation testing included testing to applicable standards including:
- Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (IEC 60601-1; 2005, MOD)
- Medical electrical equipment Part 1-2: General requirements for basic safety ● and essential performance - Collateral standard: Electromagnetic compatibility Requirements and tests
- Medical electrical equipment-Part 2-47; Particular requirements for the safety , ● including essential performance; of ambulatory electrocardiographic systems
ISO 14971 Medical devices - application of risk management to medical devices . Verification and validation testing were completed in accordance with the company's design control process in compliance with 21 CFR Part 820.30. Results of performance testing demonstrated that the 300BT model is substantially equivalent to the 100BT and that the 300BT meets all performance specifications.