(41 days)
Not Found
No
The summary explicitly states that the collected data is not interpreted by the BT device, and there is no mention of AI, ML, or related concepts in the description or performance studies.
No
Explanation: The device is for cardiac monitoring and diagnosis, and the text explicitly states, "No therapy or drugs can be administered based solely on ECG data derived from the BT devices."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the BT devices acquire and transmit EKGs "for the purpose of cardiac monitoring and diagnosis performed by medical professionals."
No
The device description explicitly details hardware components such as a battery-powered device worn on the body, cables, electrode clips, an integrated LCD display, and radio data transmission technology. It is not solely software.
Based on the provided text, the BT devices are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The BT devices acquire and transmit electrocardiogram (EKG) data, which is a measurement of electrical activity of the heart, not a specimen derived from the body.
- The intended use is for cardiac monitoring and diagnosis based on electrical signals. This is a physiological measurement, not an in vitro test.
- The device description focuses on acquiring and transmitting electrical signals. It does not mention any reagents, assays, or analysis of biological samples.
Therefore, the BT devices fall under the category of medical devices used for physiological monitoring and diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. The collected data is processed by the BT device and then transmitted via a standard wireless link to a monitoring device, such as a PC or handheld device for display, review, printing, saving and post event processing by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.).
Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. BT devices are not intended for monitoring critical patients and are not intended for intracardial use.
Product codes
DXH
Device Description
BT3/6. BT12 is a compact ECG device which is worn on the body and is capable of wireless data transmission. With the BT3/6 type, 2 ECG leads (II - III according to Einthoven) can be measured via a 4-pin cable. The receiving unit can calculate four additional leads (lead I according to Einthoven, aVL, aVR, aVF according to Goldberger).Type BT12 has a 10-pin cable, which, in addition to the leads of the BT3/6 variant, can also measure the 6 leads according to Wilson. With this cable, one can select among 3-, 6- or 12-channel ECG measurements. The cables of the BT are pluggable and therefore can be easily changed.
The electrode clips on the patient cables are suitable for connection to button and tab electrodes. It has an integrated electrode contact detector and a heart rate meter, the results of which are displayed on an integrated LCD display. Thanks to the integrated radio data transmission technology, BT3/6, BT12 is able to transmit ECG data online over a range of up to 10 m to a monitor or recording unit for further evaluation.
BT3/6, BT12 can be used in all medical applications where the long, stiff trunk cables are a problem due to their weight, their motion artifacts or their electromagnetic susceptibility or because they limit the patient in his freedom of motion. Especially significant are the applications in which it is necessary for the patient to move around freely, for example when the patient is undergoing a stress electrocardiogram.
BT3/6, BT12 is compact and simple to operate. A clip allows the device to the patient's clothing. BT3/6, BT12 is powered by two standard AA cells.
Patient contacting components are the electrodes. BT3/6, BT12 is intended for use with approved. biocompatible electrodes only.
A user manual with detailed description of the device is submitted in section 13 "Proposed Labeling".
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
Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.).
Intended User / Care Setting
medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical 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
The BT3/6, BT12 has been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and has shown full compliance to these standards and the standards listed in chapter 9 of this 510(k).
BT3/6, BT12 fulfils only those parts of the standards ANSI/AAMI EC11:1991, and ANSI/AAMI EC38:1998 that relate to hardware requirements. In case the device is used in combination with appropriate software and the user manual is adapted to the standards, it is possible to completely comply with these standards. Since the BT3/6, BT12 is supplied without diagnostic/interpreting software, the manufacturer cannot claim full compliance to ANSI/AAMI EC11:1991, and EC38:1998.
The software was tested as described in section 16 "Software". The corresponding FDA software quidelines were followed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
| Title | Premarket Notification for BT |
|---|---|
| Document Name | BT_510(k).doc |
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG |
SEP - 2 2008
5 510(K) SUMMARY
General Information
5.1 Applicant
June 13, 2008 Date:
- Corscience GmbH & Co. KG Name:
- Address: Henkestr. 91 D-91052 Erlangen Germany
Contact person in the U.S .: Address
Telephone: FAX: E-Mail:
Contact person in Germany: Telephone: FAX: E-Mail:
rpkarem@somnotech.com Christine Baumann 01149 9131 977986 - 25 01149 9131 977986 - 59
Patrik R. Karem SOMNO TECH, L.L.C.
700-706 Seco Rd. Monroeville, PA 15146
412 — 372 — 8571
412 - 372 - 8575
Signature:
. Baumann
5.2 Trade Name
BT3/6, BT12
5.3 Common Name or Classification Name
Wireless electrocardiograph
Establishment Registration Number 5.4
3005488716
1
| Title | Premarket Notification for BT |
|---|---|
| Document Name | BT_510(k).doc |
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG |
K082077 p2/6
5.5 Facility Address
Corscience GmbH & Co. KG Henkestr. 91 D-91052 Erlangen Germany
5.6 Device Classification
5.6.1 Classification
This is a class II device
5.6.2 Classification panel
Panel: cardiovascular Product Code DXH
5.6.3 Regulation Number
870.2920
Reason for Premarket Notification 5.7
Approval of new ECG device.
5.8 Predicate Device Description
5.8.1
CG-7000DX-BT
5.8.2 Predicate Device Company
Card Guard Scientific Survival, LTD.
ર-8.3 Predicate Device 510(k)#
2
| Document Name | BT_510(k).doc |
|---|---|
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG | K082077 |
| 3/6 |
5.9 Device Description
BT3/6. BT12 is a compact ECG device which is worn on the body and is capable of wireless data transmission. With the BT3/6 type, 2 ECG leads (II - III according to Einthoven) can be measured via a 4-pin cable. The receiving unit can calculate four additional leads (lead I according to Einthoven, aVL, aVR, aVF according to Goldberger).Type BT12 has a 10-pin cable, which, in addition to the leads of the BT3/6 variant, can also measure the 6 leads according to Wilson. With this cable, one can select among 3-, 6- or 12-channel ECG measurements. The cables of the BT are pluggable and therefore can be easily changed.
The electrode clips on the patient cables are suitable for connection to button and tab electrodes. It has an integrated electrode contact detector and a heart rate meter, the results of which are displayed on an integrated LCD display. Thanks to the integrated radio data transmission technology, BT3/6, BT12 is able to transmit ECG data online over a range of up to 10 m to a monitor or recording unit for further evaluation.
BT3/6, BT12 can be used in all medical applications where the long, stiff trunk cables are a problem due to their weight, their motion artifacts or their electromagnetic susceptibility or because they limit the patient in his freedom of motion. Especially significant are the applications in which it is necessary for the patient to move around freely, for example when the patient is undergoing a stress electrocardiogram.
BT3/6, BT12 is compact and simple to operate. A clip allows the device to the patient's clothing. BT3/6, BT12 is powered by two standard AA cells.
Patient contacting components are the electrodes. BT3/6, BT12 is intended for use with approved. biocompatible electrodes only.
A user manual with detailed description of the device is submitted in section 13 "Proposed Labeling".
5.10 Intended Use Statement
The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are battery powered devices capable of acquiring and transmitting a standard electrocardiogram (EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and diagnosis performed by medical professionals. The collected data is not interpreted by the BT device as this is done by the monitoring device operated by medical professionals. The collected data is processed by the BT device and then transmitted via a standard wireless link to a monitoring device, such as a PC or handheld device for display, review, printing, saving and post event processing by medical professionals. Use of the BT devices is not restricted to adult population, but is also intended for infants weighing less than 10 kg (22 lbs.).
Measurements taken by the BT devices are only significant if considered in connection with other clinical findings. No therapy or drugs can be administered based solely on ECG data derived from the BT devices. BT devices are not intended for monitoring critical patients and are not intended for intracardial use.
5.11 Required Components
- BT3/6, BT12 .
- . User manual
- Batteries .
- Cable 4-lead (BT3/6 only) �
- Cable 10-lead (BT12 only) .
3
| | Parameter | BT3/6, BT12 | Predicate Device
CG-7000DX-BT
12 Lead ECG
Recorder/ Transmitter | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--|
| Intended Use | The BT3/6 (3/6-lead) and BT12 (12-
lead), hereafter referred to as the
"BT devices", are battery powered
devices capable of acquiring and
transmitting a standard
electrocardiogram (EKG) to be
applied by medically trained persons
for the purpose of cardiac monitoring
and diagnosis performed by medical
professionals. The collected data is
not interpreted by the BT device as
this is done by the monitoring device
operated by medical professionals.
The collected data is processed by
the BT device and then transmitted
via a standard wireless link to a
monitoring device, such as a PC or
hand-held device for display, review,
printing, saving and post event
processing by medical professionals.
Use of the BT devices is not
restricted to adult population, but is
also intended for infants weighing
less than 10 kg (22 lbs.).
Measurements taken by the BT
devices are only significant if
considered in connection with other
clinical findings. No therapy or drugs
can be administered based solely on
ECG data derived from the BT
devices. BT devices are not intended
for monitoring critical patients and
are not intended for intracardial use. | 12-Lead ambulatory electrocardiograph
capable of recording and transmitting
up to 40 standard ECGs for the purpose
of cardiac monitoring and diagnosis,
incorporates recording/ transmitting
circuitry, graphic LCD, a package of
firmware tools and is intended for use
by a medical professional:
a. The ECG is recorded and transmitted
to a remote receiving station
for consultation with a cardiologist.
b. The ECG is recorded and transferred
to a remote hand held
device/PC/printer for viewing and
processing. | | |
| ECG interpretation
software | No interpretation | No interpretation | | |
| Input dynamic range | +/- 5 mV | +/- 5mV | | |
| Frequency response
bandwidth | 0,05-150Hz / according to EC11 and
IEC 60601-2-51 | | | |
| Resolution | 24 bit A/D converter
(15 bit transmitted)
2,58 µV/bit | 10 bit | | |
| Leads | 3/6 or 12 | 12 | | |
| CMRR | >94 dB | 60 dB | | |
4
082077 P 5/6
| Title | Premarket Notification for BT |
|---|---|
| Document Name | BT_510(k).doc |
| Issue | 1.1 |
| Date | 11.08.2008 |
| Corscience GmbH & Co. KG |
| Parameter | BT3/6, BT12 | Predicate Device
CG-7000DX-BT
12 Lead ECG
Recorder/ Transmitter |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Pacemaker
detection | Yes | Yes |
| Current consumption | For BT12:
Operation (incl. transmission):
148 mA
stand-by: 37 mA | Record: 55 mA
Transmit: 75 mA |
| Battery type | 2 x 1,5V alkaline or
2 x 1,2V rechargeable | 9V alkaline |
| Input impedance | 20 MΩ | > 10 MΩ |
| DC offset correction | ± 190 mV | ± 75 mV |
| ECG storage
capacity | 5 min/12 channel when transmission
is interrupted | 4-20 s length, 40-10 recordings (event
recorder) |
| Temperature range | Operation: 0...50°C
Storage: -20...70°C | Operation: 0...40°C
Storage: -20...65°C |
| Display | LCD | LCD |
| Weight | 260 g incl. batteries and cable
154 g without batteries, incl. cable | 274 g incl. batteries
228 g (without batteries and cable) |
| Dimensions in mm | 61 x 106 x 23 | 168 x 78 x 40 |
| A to D sampling rate | 500 samples/sec | 500 samples/sec |
| data transmission | wireless | wireless |
| Degree of protection
against penetration
of water | IPX3 | IPX0 |
| Classification | BF | BF |
| Defibrillation
protection | Device itself is not defibrillation
proof, but ECG patient cable
supplied with the device by
manufacturer has defibrillation
protection circuit. Note in manual
that guarantee of defibrillation
protection can be given only in
combination with original cable | The CG-7000DX-BT is not a
defibrillation-proof device (optional
cable available for defibrillation proof
use). |
Both devices are intended for continuous wireless transmission of ECG signals and both are portable due to battery-supply and light weight. Both devices are capable of acquiring the ECGs at remote sites and transmitting them via radio transmission to an appropriate receiving station. Therefore, the device under consideration and the predicate device are very similar in their basic functions. The predicate device claims conformance with the ECG standards ANSI/AAMI EC11:1991, and ANSI/AAMI EC38:1998. BT3/6, BT12 is conform with hardware requirements of EC11 and EC38. Exception is the offset-voltage requirement of ±300mV. With BT3/6, BT12 an offset of up to ±190mV does not influence the baseline of the ECG signal. But performance is better than that of the predicate device which states DC offset of only ±75 mV.
The differences in technological characteristics between BT3/6, BT12 and the predicate device can be summarized as follows:
5
The resolution of the BT devices is higher than that of the predicate (15 bit compared to 10 bit) which results in a better ECG signal quality.
The predicate device is available only for the acquisition of 12-lead ECGs, whereas the device under consideration is available for measuring either a 12- or a 3/6-lead ECG (BT12 and BT3/6).
CMRR of the BT devices is higher than with the predicate (>94 db compared to 60 db). This results in a better ECG signal quality in the presence of interference signals.
Input impedance is specified higher with the BT devices (20 MΩ compared to >10 MΩ). Therefore, ECG signal quality is less dependent on electrode contact quality with the BT as with the predicate.
The two devices differ in their data storage functionality. The BT stores data only when the wireless radio connection is interrupted, e.g. when the patient leaves the transmission range. After the connection is re-established the stored data is transmitted to the receiving unit. Interruption of the transmission is indicated on the device. The BT devices are not intended for use as Holter monitors. The CG-7000X-BT has a limited event storage capability of up to 40 ECG recordings.
The BT devices and the predicate are capable of continuously transmitting ECG data.
The graphic display of the CG-7000DX-BT is able to display the measured ECG, while the BT devices can display the ECG on the receiving unit only. But, the predicate is of low resolution and should not be used to make a diagnosis.
The BT devices have a higher degree of protection against penetration of water (IPX3).
5.13 Summary of Device Testing
The BT3/6, BT12 has been tested according to IEC 60601-1 and IEC 60601-1-2 by accredited laboratories and has shown full compliance to these standards and the standards listed in chapter 9 of this 510(k).
BT3/6, BT12 fulfils only those parts of the standards ANSI/AAMI EC11:1991, and ANSI/AAMI EC38:1998 that relate to hardware requirements. In case the device is used in combination with appropriate software and the user manual is adapted to the standards, it is possible to completely comply with these standards. Since the BT3/6, BT12 is supplied without diagnostic/interpreting software, the manufacturer cannot claim full compliance to ANSI/AAMI EC11:1991, and EC38:1998.
The software was tested as described in section 16 "Software". The corresponding FDA software quidelines were followed.
5.14 Conclusions
Based on the above, Corscience GmbH & Co. KG concludes, that BT3/6, BT12 is substantially equivalent to a legally marketed predicate device and iffective for its intended use, and performs as well as or better than the predicate device.
6
Image /page/6/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 2 2008
TUV SUD America c/o Mr. Olaf Teichert Third Party Reviewer 1775 Old Highway 8, NW Ste. 104 New Brighton, MN 55112-1891
Re: K082077
Trade/Device Name: BR3/6, BR12 Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II Product Code: DXH Dated: August 13, 2008 Received: August 18, 2008
Dear Mr. Teichert:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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);
7
Page 2 - Mr. Olaf Teichert
labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510/k)
premarket notification. The FDA finding of substantial cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
8
Food and Drug Administration
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
Indications for Use
| 510(k) Number (if known): | 082077 |
|---|---|
| --------------------------- | -------- |
BT3/6 BT12 Device Name:
1999 1. 16
Indications for Use:
| to adult population, but is also intended for infants weighing less than 10 kg (22 lbs. | | The BT3/6 (3/6-lead) and BT12 (12-lead), hereafter referred to as the "BT devices", are
battery powered devices capable of acquiring and transmitting a standard electrocardiogram
(EKG) to be applied by medically trained persons for the purpose of cardiac monitoring and
diagnosis performed by medical professionals. The collected data is processed by the B1
device and then transmitted via a standard wireless link to a monitoring device, such as a P
or hand-held device for display, review, printing, saving and post event processing by medical
professionals. The collected data is not interpreted by the BT device as this is done by the
monitoring device operated by medical professionals. Use of the BT devices is not restricted |
|-----------------------------------------------------------------------------------------|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| and are not intended for intracardial use. | | Measurements taken by the BT devices are only significant if considered in connection with
other clinical findings. No therapy or drugs can be administered based solely on ECG data
derived from the BT devices. The BT devices are not intended for monitoring critical patients |
| Federal law restricts this device to sale by or on the order of a physician. | | |
| | | |
| | | |
| Prescription Use
Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 801 Subpart C) |
| | NEFIDED | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF |
| Concurrence of CDRH | | vice Evaluation (ODE) |
| | (Division Siant
Division of Cardiovascular Device | |
| | 510(k) Number_ | K082077 |
| http://www.fda.gov/cdrh/ode/indicate.html | | 15 .
07.08.2008 |