(87 days)
The ECG Telemedicine Option for the GEMS Series 4000 Communications Console is indicated for use when it is desired to communicate with distant medical devices in an EMS pre-hospital setting and to acquire and present information, such as single/12lead ECG and physiologic/non-physiologic data, or other physiologic information which has been gathered by these devices.
The EMS Telemedicine Option is an optional element of the GEMS Series 4000 communications console which provides the means for performing telemedicine functions, namely, communicating with and presenting information acquired from distant medical devices. The GEMS Series 4000 communications console is a standard radio/telephony communications console used for voice and data communications. The GEMS Series 4000 communications console, without the EMS Telemetry Option is marketed for non-medical applications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e.; 2-way radio equipment, landline and wireless telephone) as which are commonly used for commercial and public safety (i.e.: police, fire and EMS) communications purposes. With the EMS Telemedicine Option, the console can perform medical functions, such as communicating physiologic information (i.e .: single/12-Lead ECG and physiologic/non-physiologic data) with distant medical devices. The signal processing means employed for this includes: frequency modulation (FM), which is commonly used in EMS ECG telemetry applications; DTMF (touch-tone) signaling, which is commonly used for telecommunications signaling: Frequency Shift Keying (FSK), which is commonly used for data communications; as well as standard digital communications schemes such as modulation/demodulation (modem) communications. It also provides for the display and printing of physiologic information, such as single and 12-Lead ECG, and non-physiologic data, such as EMS Run ID, patient name, time of day, etc. The EMS Telemedicine Option consists of hardware and software elements that are installed into the GEMS Series 4000 communications console. These hardware & software elements convert received information into a digital form compatible with standard PC functions, such as information presentation by a CRT monitor and hardcopy printouts. Signal processing is performed by a printed circuit board (PCB) that plugs into the console's PC Mother Board. The EMS Telemedicine Option's features and functions are similar to those found in this type of equipment, including the predicate devices (GEMS Series 2000 and Rosetta-Rx). The digital and analog technologies employed by the above stated purposes are commonly employed for this purpose and are well understood. The functioning of the heart rate meter and the performance of the demodulator/signal processing and display elements conform to ANSI/AAMI EC11-1991.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EMS Telemedicine Option:
It's important to note that the provided text is a 510(k) premarket notification summary from 2002. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical trial data with detailed acceptance criteria and performance metrics typically seen in studies for novel high-risk devices.
Based on the information given, here's a breakdown:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a dedicated table. Instead, it describes general performance requirements that are met by the device. The reported performance refers to the successful outcome of these non-clinical tests.
| Acceptance Criteria (Implied from Study Goals) | Reported Device Performance (as stated in the document) |
|---|---|
| Ability to correctly and accurately communicate desired information from the acquisition device under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Ability to correctly convert gathered information to the desired communications scheme under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Efficacy of the intended transmission schemes under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Ability to correctly and accurately acquire information from the transmission means under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Ability to correctly convert gathered information for presentation by the desired presentation means and accurately present this information under simulated use conditions | System successfully performs the intended task under normal use conditions, demonstrating reliable and accurate reception and reconstruction of physiologic information. |
| Conformity to ANSI/AAMI EC11-1991 for heart rate meter functioning and demodulator/signal processing/display elements | The functioning of the heart rate meter and the performance of the demodulator/signal processing and display elements conform to ANSI/AAMI EC11-1991. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "simulated use conditions" and "non-clinical testing" but does not quantify the number of tests performed or any data points.
- Data Provenance: The study was a "non-clinical testing" under "simulated use conditions." This implies it was conducted internally by the manufacturer. The country of origin for the data is not explicitly stated. The nature of the tests suggests it was prospective testing of the device's functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. This was a non-clinical, functional and performance test against established engineering standards (ANSI/AAMI EC11-1991) and expected behavior, not an expert-driven diagnostic study.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. Since this was a non-clinical performance and functional verification study, there was no need for human adjudication of results in the diagnostic sense. The "ground truth" was the expected correct functioning according to design specifications and relevant standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This document describes a non-clinical performance evaluation of a communication and display system for physiological data, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a sense. The testing described primarily focuses on the standalone performance of the device's components (hardware and software) in accurately receiving, demodulating, converting, and displaying physiological information. The "human-in-the-loop" would be using the display, but the core functionality being tested is the automated processing by the device itself to conform to standards and reconstruct the received data correctly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth: The ground truth for the non-clinical tests appears to be:
- Established engineering standards: Specifically, ANSI/AAMI EC11-1991 for the heart rate meter and demodulator/signal processing/display elements.
- Expected correct output/behavior: The device was tested to ensure it "correctly and accurately" communicated, converted, acquired, and presented information as designed, implying comparison against a known, accurate input signal or data.
8. The sample size for the training set
- Sample Size: Not applicable. This type of device (an ECG demodulator/display) is not typically "trained" in the way a machine learning or AI model would be. Its functions are based on fixed algorithms and hardware components.
9. How the ground truth for the training set was established
- Ground Truth for Training: Not applicable. As mentioned, this device does not use a training set in the context of machine learning. Its functionality is based on established engineering principles and protocols for signal processing and communication.
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'JAN 1 8 2002
K013533
p. 1/4
510(k) SUMMARY
| Applicant: | Michael SmithPresident, General Devices1000 River St.Ridgefield, NJ 07657 |
|---|---|
| Contact Person(s): | Applicant and/orCurtis BashfordVice-President, General Devices1000 River St.Ridgefield, NJ 07657 |
| Telephone & Fax No.: | Tel. (201) 313-7075Fax (201) 313-5671E-Mail cbashford@general-devices.com |
| Date Prepared: | October 19, 2001 |
Device Information:
| Trade/Proprietary Name: EMS Telemedicine Option (for GEMS Series 4000 | |
|---|---|
| Common Name: | ECG Demodulator/Display |
| Classification: | Class II |
| Panel: | Cardiovascular Devices Classification |
| Product Code: | Not Applicable |
Predicate Device Information:
| Trade/Proprietary Name: | GEMS Series 2000 (Modified DR-2C/PMC 100) |
|---|---|
| Common Name: | EMS Communications Console |
| Manufacturer | General Devices (same as applicant) |
| Classification: | Class II |
| 510(k) No. | K896153 |
| Trade/Proprietary Name: | Rosetta-Rx |
| Common Name: | Demodulator, Data Translator |
| Manufacturer | General Devices (same as applicant) |
| Classification: | Class II |
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DESCRIPTION OF DEVICE
The EMS Telemedicine Option is an optional element of the GEMS Series 4000 communications console which provides the means for performing telemedicine functions, namely, communicating with and presenting information acquired from distant medical devices.
The GEMS Series 4000 communications console is a standard radio/telephony communications console used for voice and data communications. The GEMS Series 4000 communications console, without the EMS Telemetry Option is marketed for non-medical applications. Personal Computer (PC) based, it contains various means to interface to and control communications elements (i.e.; 2-way radio equipment, landline and wireless telephone) as which are commonly used for commercial and public safety (i.e.: police, fire and EMS) communications purposes.
With the EMS Telemedicine Option, the console can perform medical functions, such as communicating physiologic information (i.e .: single/12-Lead ECG and physiologic/non-physiologic data) with distant medical devices. The signal processing means employed for this includes: frequency modulation (FM), which is commonly used in EMS ECG telemetry applications; DTMF (touch-tone) signaling, which is commonly used for telecommunications signaling: Frequency Shift Keying (FSK), which is commonly used for data communications; as well as standard digital communications schemes such as modulation/demodulation (modem) communications. It also provides for the display and printing of physiologic information, such as single and 12-Lead ECG, and non-physiologic data, such as EMS Run ID, patient name, time of day, etc.
The EMS Telemedicine Option consists of hardware and software elements that are installed into the GEMS Series 4000 communications console. These hardware & software elements convert received information into a digital form compatible with standard PC functions, such as information presentation by a CRT monitor and hardcopy printouts. Signal processing is performed by a printed circuit board (PCB) that plugs into the console's PC Mother Board. The EMS Telemedicine Option's features and functions are similar to those found in this type of equipment, including the predicate devices (GEMS Series 2000 and Rosetta-Rx). The digital and analog technologies employed by the above stated purposes are commonly employed for this purpose and are well understood. The functioning of the heart rate meter and the performance of the demodulator/signal processing and display elements conform to ANSI/AAMI EC11-1991.
INTENDED USE
The intended use of the GEMS Series 4000 EMS Telemetry Option is to provide a means to communicate with distant medical devices in an EMS pre-hospital setting and to acquire and present information, such as single/12-lead ECG and physiologic/non-physiologic data which has been gathered by these devices.
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K013533 2314
COMPARISON WITH PREDICATE DEVICES
| Function orSpecification | New Device | Predicate Devices | |
|---|---|---|---|
| ECG Telemetry Option | GEMS Series 2000 | ROSETTA-Rx | |
| Form Factor | PC Option Card (for PC cabinet) | Desktop/rack mount cabinet | Option Card (for GEMSSeries 2000) or Stand-Alonedevice |
| ECG Presentation Means | CRT Display (PC monitor), strip-chart recorder, laser printer | CRT Display (Vectored BeamCRT), strip-chart recorder, laserprinter (w/Rosetta Option) | Stand-Alone: Laser printerOption Card: GEMS 2000display and record features |
| Communication Means | Radio, landline telephone,wireless telephone | Radio, landline telephone,wireless telephone | Radio, landline telephone,wireless telephone |
| Digital CommunicationInterface | Serial (RS232), PC Modem | Serial (RS232) | Serial (RS232) |
| ECG & physiologic/non-physiologic data Formats | FM, DTMF, FSK, Modem | FM, DTMF | FM, DTMF, & FSK |
| Demodulation Means | Hardware/Software | Hardware | Hardware/Software |
| ECG DemodulationFormat | 1400 Hz Center frequency, 50 &250 mV/Hz deviation | 1400 Hz Center frequency, 50mV/Hz deviation | 1400 Hz Center frequency,50 & 250 mV/Hz deviation |
| Data DemodulationFormat | FSK 1.2kHz/1.6kHz | FSK 1.2kHz/1.6kHz(w/RosettaOption) | FSK 1.2kHz/1.6kHz |
| User Controls | Pointing Device (mouse) | Mechanical front panelswitches | Mechanical front panelswitches |
| Power | +3.3, +/- 12 VDC from PC powersupply | 115Volt AC, 60Hz | Stand alone: External 9VDCadapterOption Card: +5, +/- 12VDC from GEMS Series2000 power supply |
SUMMARY OF DIFFERENCES
The differences between the predicate and the new device relate primarily to: the form of system integration, in that the EMS Telemetry Option is an "add-on" to a nonmedical device; the use of a modem to communicate information; the use of a pointing device, rather than mechanical control keys, an lastly, minor differences, such as formfactor, size, appearance and minor operating features.
SUMMARY OF NON-CLINICAL TESTS
The EMS Telemetry Option was subjected to non-clinical testing to insure proper performance. The testing consisted of the following parts:
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- · A determination of the ability of the EMS Telemetry Option to correctly and accurately communicate desired information from the acquisition device under simulated use conditions
- · A determination to the ability of the EMS Telemetry Option to correctly convert the gathered information to the desired communications scheme under simulated use conditions
- · A determination of the efficacy of the intended transmission schemes under simulated use conditions
- · A determination of the ability of the EMS Telemetry Option to correctly and accurately acquire the information from the transmission means under simulated use conditions
- · A determination of the ability of the EMS Telemetry Option to correctly convert the gathered information for presentation by the desired presentation means and accurately present this information under simulated use conditions
DISCUSSION OF HOW TEST RESULTS SUPPORT SUBSTANTIAL EQUIVALENCY
The testing that was performed on the EMS Telemetry Option demonstrates that the system is substantially equivalent to the predicate devices in that physiologic information acquired by an external source was reliably and accurately received and reconstructed for presentation at the far end.
CONCLUSION DRAW BY NON-CLINICAL TESTING
The conclusions draw by the non-clinical testing indicate that the EMS Telemetry Option/EMS Telemetry Option successfully perform the intended task under normal use conditions. The system behaved as expected and demonstrates the application of well-understood technology as well as the absence of any electrical risk factors to the patient.
END OF SUMMARY
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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
'JAN 1 8 2002
Mr. Michael Smith President General Devices 1000 River St. Ridgefield, NJ 07657
Re: K013533
Trade Name: EMS Telemedicine Option (for GEMS Series 4000) Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: October 19, 2001 Received: October 23, 2001
Dear Mr. Smith:
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
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Page 2 - Mr. Michael Smith
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); 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 equivalence 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
h. D. Zeller, M.D.
Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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6.2
INDICATIONS FOR USE STATEMENT
PMN 510(k) Number: _ KO1333
Device Name: ECG Telemedicine Option (for GEMS Series 4000)
Indications For Use:
.
The ECG Telemedicine Option for the GEMS Series 4000 Communications Console is indicated for use when it is desired to communicate with distant medical devices in an EMS pre-hospital setting and to acquire and present information, such as single/12lead ECG and physiologic/non-physiologic data, or other physiologic information which has been gathered by these devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number: KA3533
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).