The TelEnable EMS System provides a mechanism to transmit 12-lead ECGs from a portable ECG monitor to a central location such as a hospital. This system connects to the ECG via a standard POTS (Plain Old Telephone System) interface and communicates to the ECG via standard Group 3 facsimile (fax) protocol.

Device Description

The TelEnable EMS System provides a means of transmitting snapshots of physiologic waveforms and data over standard communications means such as the public switched telephone, analog cellular, or digital cellular networks. Such information is transmitted from a remote location using the EMS-Enable component to a receiving EMS Hub component located in a hospital.

The EMS-Enable component connects to portable ECG & standard monitor/defibrillator devices that can output their data via a standard fax modulator (modem). The EMS-Enable decodes the touch tone dialing digits output by the monitor to determine which hospital to call. This analog information is converted into encrypted data packets that are suitable for transmission over digital and analog networks. The EMS-Enable is a self-contained, battery-powered device that is connected to a cell phone via a standard data cable compatible with the phone and a standard telephone adapter cable.

Standard fax output from the ECG monitor/defibrillator device is received by the EMS-Enable (as if was a standard telephone wall plug). The data is encrypted and converted into data packets to be transmitted over the digital cellular or other standard communication network. The EMS-Enable transmits the data packets over the communication network to the EMS Hub where the ECG fax can be printed out on a standard printer, saved in a data file, or printed out on a standard fax machine.

The EMS Hub component is located in the hospital and provides the interface between the remote EMS-Enable devices and the hospital. It is connected to the Public Switched Telephone Network (PSTN or standard telephone network) via standard telephone patch cables. It communicates with the EMS-Enable and depacketizes and decrypts the ECG fax into a format compatible with a printer, file, or standard fax machine.

The transmission formats supported by the EMS-Enable and EMS Hub include standard group 3 fax modulation formats, touch-tone signaling (DTMF), and standard interface protocols and schemes utilized by cell phones and cell phone carriers to transmit data.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the TelEnable EMS System:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be >95%"). Instead, the testing focuses on functional verification and reliability under simulated conditions. The reported "performance" is a qualitative statement of successful operation.

Acceptance Criteria (Implied)	Reported Device Performance
EMS-Enable:
Correctly and reliably receive standard fax formatted information.	Verified: "EMS-Enable could correctly and reliably received standard fax formatted information. These tests were performed under simulated use conditions and using standard fax machines as input devices."
Correctly and reliably connect to and communicate with standard communication devices (digital cell phone, land line).	Verified: "EMS-Enable can correctly and reliably connect to and communicate with the standard communication devices. The specific devices tested were digital cell phone and land line connection."
Correctly and reliably transmit packetized and encrypted fax information.	Verified: "EMS-Enable can correctly and reliably transmit the packetized and encrypted fax information. These tests were performed under simulated use conditions."
Reliably receive, encrypt, packetize, and send received fax information in a format compatible with EMS Hub.	Verified: "EMS-Enable can reliably received, encrypt, packetize, and send the received fax information in the format compatible with the EMS Hub. These tests were performed under simulated use conditions."
EMS Hub:
Correctly receive packetized and encrypted data.	Verified: "EMS Hub can correctly receive the packetized and encrypted data. These tests were performed under simulated use conditions."
Correctly and reliably decrypt and output fax data to standard printer, file, and fax machines.	Verified: "EMS Hub can correctly and reliably decrypt and output the fax data transmitted from the EMS-Enable. The outputs were to standard printer, file, and fax machines. These tests were performed under simulated use conditions."
System (EMS-Enable & EMS Hub):
Efficacy under simulated wireless signal dropout and signal-corruption conditions.	Determined: "Determined the efficacy of the EMS-Enable and EMS Hub under simulated wireless signal dropout and signal-corruption conditions. These tests were performed under simulated use conditions." (Efficacy is not explicitly stated but implied as satisfactory to meet substantial equivalency).
Reliable and correct transmission and faithful reproduction of physiologic information.	Verified: "The testing... demonstrates that the system is substantially equivalent to the predicate devices in that the physiologic information (snapshots are encoded by an external monitor and output as a standard fax) was reliably and correctly transmitted and faithfully reproduced on the output device."
Successful performance of intended tasks under normal use conditions.	Concluded: "The TellEnable EMS System can successfully perform the intended tasks under normal use conditions; that the system behaved as expected; that the application of standard communication technologies in this environment can achieve predictable results; and the absence of electrical risk factors to the patient."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The description only states "these tests were performed under simulated use conditions" and mentions using "standard fax machines as input devices" and specific communication devices like "digital cell phone and land line connection." It doesn't quantify the number of transmissions, runs, or specific data points used for these tests.
Data Provenance: The data appears to be prospective as it involves non-clinical trials conducted specifically for this submission. The "country of origin of the data" is not explicitly stated but is implied to be within the United States, given the submitter's location and FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The tests described are functional and reliability validations of data transmission and reproduction, not diagnostic performance. There is no mention of human expert review being used to establish a "ground truth" for the test set in the context of medical interpretation. The device's function is to transmit ECG faxes, not to interpret them. The "ground truth" for these tests would essentially be the original fax data input to the EMS-Enable and its accurate reproduction by the EMS Hub.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are functional and reliability validations. There's no mention of conflicting interpretations requiring adjudication. The assessment would likely have been against the expected output data.

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

Not applicable. This device is a communication system for transmitting faxes, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance improvement are not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The non-clinical trials describe the performance of the TelEnable EMS System purely as a standalone system (EMS-Enable and EMS Hub) transmitting data. There is no human intervention or interpretation within the system's function itself. The "human-in-the-loop" would be the initial operator sending the ECG fax and the recipient viewing/printing it, but the device's performance evaluation focuses on the automated transmission process itself.

7. The Type of Ground Truth Used

The ground truth used for these functional tests would be the original standard fax output from the ECG monitor/defibrillator device. The verification checks would compare the received and outputted fax data (printed, filed, or faxed) against this original content for fidelity and accuracy of transmission and reproduction. It is not pathology, outcomes data, or expert consensus in a diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware and software system for data transmission, not a machine learning or artificial intelligence algorithm that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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K040663

JUN 3 0 2004

MOLEX INCORPORATED 2222 WELLINGTON CT LISLE, IL 60532 +1 630.969.4747

510(k) SUMMARY

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR Part 870.2910, Molex Incorporated is hereby submitting the 510(k) Summary for the EMS-Enable (formerly known as Orange Box) and EMS-Hub (formerly known as Orange Crate). Please note that Molex Incorporated has acquired Strategis Technologies LLC assets in regard to the Orange Box/ Orange Crate and is applying for the 510(k) as a result of a 513(g) request made by Strategis Technologies LLC and responded to by Dr. Daniel G. Schultz (reference C040001).

Submitter:	Randall B. JonesStrategic Product ManagerMolex IncorporatedIntegrated Products Division2222 Wellington CtLisle, IL 60532
Contact Person(s):	Applicant and/orRandall B. JonesStrategic Product ManagerMolex IncorporatedIntegrated Products Division2222 Wellington CtLisle, IL 60532
Telephone & Fax No:	Tel: +1 630.527.4334Fax: +1 630.512.8630
Date Prepared:	February 16, 2004
Device Information:	Trade/Proprietary Name:	TelEnable EMS System comprised ofEMS-Enable or Orange Box andEMS-Hub or Orange Crate
	Common Name:	Data and Fax Modulator/Demodulatorand Receiving Station
	Classification:	Class II (See FDA Ref C040001)
Predicate Device Information:	Trade/Proprietary Name:	Rosetta-LT/Rosetta-Rx
	Common Name:	Modulator/Demodulator, Data Translator
	Manufacturer:	General Devices
	Classification:	Class II
	510(k) No:	K002089

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1.1. Description of TelEnable EMS System

1.2. Intended use

The TelEnable EMS System is intended to provide reliable transmission of ECG faxes acquired from a standard monitor/defibrillator. The EMS-Enable is designed to work remotely from the hospital and transmit ECG faxes (captured and formatted by the monitor/defibrillator). The transmission mechanism can be via any standard communication such as a landline, analog cell phone, digital cell phone, Bluetooth device, 802.11 device, or satellite phone,

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The communication devices are off-the-shelf devices which have received the necessary FCC certifications and/or approvals to operate as radio devices. Examples of such devices include: cell phone handsets, Bluetooth modules with a serial interface, or standard serial modems.

In addition, the EMS Hub component of the system is capable of receiving standard faxes from any device, including EOG monitors, which may be transmitting such images over a standard PSTN (landline) circuit. Such images will not meet the quality of images transmitted using the EMS-Enable component, but will meet the quality of most laser fax machines.

The EMS-Enable component is not designed to interface directly to a PSTN through its RJ11 jack. This interface is the principle interface mechanism to portable ECG monitors/ defibrillators.

1.3. Performance Comparison with Predicate Device(s)

Several devices, which are functionally similar, have previously been granted Class II, 510(k) approval from the FDA. While these predicate devices do not exactly match the functionally of the TelEnable EMS System, they are similar enough to be classified as legitimate predicate devices. These are listed in Table 1 and Table 2.

FUNCTIONSPECIFICATION	(PREDICATE DEVICE)ROSETTA-LT	EMS-ENABLE
Function	Modulates EOG waveforms & datainto FM & FSK transmission format.	Modulates ECG fax output intoencrypted digital data packets
Communication Means	Radio, landline telephone, wirelesstelephone	Landline, analog and digital cellphone, digital wireless devices
Acquisition Device Connection	Hardwire (digital and analog)	Hardwire (digital and analog)
Transmission Device Connection	Hardwire and acoustic coupling forradio, landline, or wireless telephone	Hardwire for landline or data-enabled cell or wirelesstelephone
Modulation Means	Hardware/Software	Hardware/ Software
ECG Modulation Format	1400 Hz Center frequency, 50 & 250mV/Hz deviation	Standard fax output using anymodulation format provided bythe monitor.
Data & Signaling Format	DTMF, FSK & Serial	DTMF, V.92, Fax Group 3,Serial
Self-Calibrating	YES	Not necessary
Form Factor	Hand-held	Hand-held
Power Source	Internal 9V Battery, External 12V	Internal 12V Battery, External12V

Table 1 EMS-Enable and Predicate Comparison

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FUNCTIONSPECIFICATION	(PREDICATE DEVICE)ROSETTA-RX	EMS HUB
Function	Demodulates FM ECG waveforms &FSK data.	Demodulates and decryptsdigital packets into a file, printer,or standard fax output formats
Presentation Means	GEMS 2000 & laser printer	Standard Group 3 fax orstandard laser printer
PC Interface	RS-232	RS-232, POTS, Ethernet, USB
Transmission Device Connection	Hardwire and acoustic coupling forradio, landline, or wireless telephone	Hardwire
Demodulation Means	Hardware/ Software	Hardware/ Software
ECG Modulation Format	1400 Hz Center frequency, 50 & 250mV/Hz deviation	Standard fax output using anymodulation format provided bythe monitor.
Data & Signaling Format	DTMF, FSK & Serial	DTMF, V.92, Fax Group 3,Serial
Self-Calibrating	YES	Not necessary
Form Factor	Desktop cabinet	Desktop cabinet
Power Source	120 VAC, 50/60 Hz	90-220 VAC, 50/60Hz

Table 2 EMS Hub and Predicate Comparison

1.4. Summary of Differences

The primary difference between the predicate devices (system) and the TelEnable EMS System (TES) is that TES only transports ECG fax formatted snapshots from a remote location to a hospital. TES does not reformat the output (other than formatically performed by fax machines to fit the image onto a page). TES provides data encryption (above that provided by the communications network) so that a casual interceptor of the data will not be able to read the information. Other differences relate to the packaging, circuits, software, battery type, appearance, brand name, manufacturer, and interface cables.

1.5. Summary of Non-clinical Trials

The TelEnable EMS System and its components were subjected to non-clinical testing to insure proper operation and performance. These tests included the following:

트 Verification that the EMS-Enable could correctly and reliably received standard fax formatted information. These tests were performed under simulated use conditions and using standard fax machines as input devices.
보 Verification that the EMS-Enable can correctly and reliably connect to and communicate with the standard communication devices. The specific devices tested were digital cell phone and land line connection.
Ventication that the EMS-Enable can correctly and reliably transmit the packetized and encrypted fax information. These tests were performed under simulated use conditions.

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. Verification that the EMS-Enable can reliably received, encrypt, packetize, and send the received fax information in the format compatible with the EMS Hub. These tests were performed under simulated use conditions.
발 Determined the efficacy of the EMS-Enable and EMS Hub under simulated wireless signal dropout and signal-corruption conditions. These tests were performed under simulated use conditions.
트 Verification that the EMS Hub can correctly receive the packetized and encrypted data. These tests were performed under simulated use conditions.
. Verification that the EMS Hub can correctly and reliably decrypt and output the fax data transmitted from the EMS-Enable. The outputs were to standard printer, file, and fax machines. These tests were performed under simulated use conditions.

1.6. How Test Results Support Substantial Equivalency

The testing that was performed on the TelEnable EMS System demonstrates that the system is substantially equivalent to the predicate devices in that the physiologic information (snapshots are encoded by an external monitor and output as a standard fax) was reliably and correctly transmitted and faithfully reproduced on the output device.

1.7. Conclusion Drawn by Non-Clinical Testing

The conclusions drawn by the non-clinical testing indicate that the TellEnable EMS System can successfully perform the intended tasks under normal use conditions; that the system behaved as expected; that the application of standard communication technologies in this environment can achieve predictable results; and the absence of electrical risk factors to the patient.

* END OF SUMMARY *

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an abstract eagle design with three stylized wing shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

JUN 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Molex Incorporated c/o Mr. Randall B. Jones Strategic Product Manager Integrated Products Division 2222 Wellington Ct Lisle, IL 60532

Re: K040663

Trade Name: TelEnable EMS System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: June 1, 2004 Received: June 7, 2004

Dear Mr. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the we have ferrenced above and have determined the device is substantially equivalent (for do recordinous for use stated in the enclosure) to legally marketed predicate devices the indications for are commerce prior to May 28, 1976, the enactment date of the marketed in meetstate ovents, 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 while proval 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 (1 will in they be ide found in the Code of Federal Regulations, Title 21, Parts and to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Randall B. Jones

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 I carrar agestration 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.

(Scottons 331-542 or the to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your s rote 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, 2Misbranding by reference to premarket notification2 (21CFR Part 807.97) you may obtain. 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 vours.

Nil R. Ogle

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K040663

TelEnable EMS System Device Name:

Indications For Use:

All information received by the TelEnable EMS System's mobile component (EMS-Enable) is relayed wirelessly to a central receiving station (EMS Hub). Such a station can be co-located in a hospital or at an EMS dispatch center.

The ECGs received may either be printed locally or forwarded, via fax, to the destination specified by the ECG operator.

No component of the TelEnable EMS System is connected directly to a patient. The TelEnable EMS System is non-invasive. The ECG monitor operator shall observe all the same precautions when connecting the ECG monitor to the EMS-Enable component as when connecting the ECG monitor directly to the PSTN (Public Switch Telephone Network).

Prescription Use_

AND/OR

Over-the-Counter Use_

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Device Evaluation (ODE) Concurrence of CDHR

Page 1 of 1

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K040663

Regulation Number and Section

§ 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).

JUN 3 0 2004

510(k) SUMMARY

1.1. Description of TelEnable EMS System

1.2. Intended use

1.3. Performance Comparison with Predicate Device(s)

Table 2 EMS Hub and Predicate Comparison

1.4. Summary of Differences

1.5. Summary of Non-clinical Trials

1.6. How Test Results Support Substantial Equivalency

1.7. Conclusion Drawn by Non-Clinical Testing

*** END OF SUMMARY ***

Indications for Use

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

* END OF SUMMARY *