The RTX3320 device is for use by patients at home. It is intended to be used in combination with a variety of patient monitors upon the prescription of a licensed physician or other authorized healthcare provider. RTX3320 serves as the remote communication link between compatible patient monitors, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management center, or with the healthcare/wellness provider or other out-of-hospital caregivers.

The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

RTX3320 is a "black box" device – it is not connected to the patient and not operated by the patient. The installation must be performed by or under supervision of an authorized professional healthcare company.

This device does not measure, interpret or make any decisions on the vital data that it conveys.

Device Description

The RTX3320 telemedicine device perform transmission of physiological patient information to and from wireless patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols.

The RTX3320, with its build-in modem, transmits data using the public switched telephone network. It is designed not to interfere with the normal use of phones on the same telephone line.

The RTX3320 device is not operated by, or used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

AI/ML Overview

The RTX3320 device is a "black box" telemedicine device designed to transmit physiological patient information from wireless patient monitors to a remote healthcare facility using standard digital communication technologies and protocols. It uses a built-in modem to transmit data over the public switched telephone network. The device is not operated by or used directly on a patient and is not intended for emergency calls or time-critical data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Safety Standards:
IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety)	The device has been tested to meet the requirements of IEC 60601-1. This standard ensures the fundamental safety and essential performance of medical electrical equipment.
IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic Compatibility - Requirements and Tests)	The device has been tested to meet the requirements of IEC 60601-1-2. This standard ensures that the device is electromagnetically compatible, meaning it does not interfere with other electronic devices and is not unduly affected by them.
Communication Standards:
FCC Part 15 (Radio Frequency Devices)	The device has been tested to meet the requirements of FCC Part 15. This standard governs unintentional and intentional radiators of radio frequency energy, ensuring that the device's wireless communication (Bluetooth) does not cause harmful interference.
FCC Part 68 (Connection of Terminal Equipment to the Telephone Network)	The device has been tested to meet the requirements of FCC Part 68. This standard ensures that the device, with its built-in modem, can be safely connected to and used with the public switched telephone network without causing harm to the network.
Risk Management:
ISO 14971:2000 (Medical Devices - Application of Risk Management to Medical Devices)	Risk management is performed according to ISO 14971:2000. This standard provides a process for a manufacturer to identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The document states that the performance comparison of the predicate and submission device showed minor differences causing no harm, and that because of this and the similar intended use, they focused on verification and internal validation.
Functional Equivalence	The device is deemed substantially equivalent to the predicate device (Philips Telemonitoring System with TeleStation K023749) based on similar intended use/indications, users, site of use, prescription requirements, and general system functionality. Differences, such as the submission device being a "black box" without user interaction and using Bluetooth for wireless connectivity, are evaluated not to add additional risks, especially given its role as a communication hub and the need for compatible, validated patient monitors and servers. Verification and validation testing activities were conducted to establish performance and reliability characteristics, implicitly demonstrating functional and safety adherence to its intended purpose as a communication link.

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

The provided document does not specify a distinct "test set" sample size or data provenance in terms of patient data or clinical cases for the RTX3320 device. The focus of the substantiation is on:

Conformance to standards: This involves testing the device against specific technical and safety standards (IEC, FCC). These tests typically involve laboratory setups and simulated environments, not patient data sets.
Comparison to a predicate device (K023749): The assessment largely relies on demonstrating substantial equivalence by comparing the technical characteristics, intended use, and safety profiles with an already cleared device.
Verification and internal validation: The document states that "Verification and validation testing activities [were] conducted to establish performance and reliability characteristics of the device." This implies internal testing of the device's hardware, software, and communication capabilities, likely through engineering tests and non-clinical scenarios rather than a clinical "test set" with patient data.

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

Given that the substantiation is primarily based on standards conformance, risk management, and comparison to a predicate device, and not on the evaluation of medical images or diagnostic outputs from a clinical test set, there is no mention of experts establishing a "ground truth" for a test set in the traditional sense of clinical studies.

The "ground truth" in this context is established by:

Regulatory bodies and standards organizations: The standards (IEC, FCC, ISO) themselves represent a form of "ground truth" for device safety and performance.
Engineering and quality assurance personnel: Internal experts at RTX Healthcare would have conducted the verification and validation tests against these standards.
The predicate device's established safety and effectiveness: The predicate device (Philips M3810A) serves as a benchmark for equivalence.

4. Adjudication Method for the Test Set

As there is no specific clinical "test set" involving human interpretation of medical data, there is no mention of an adjudication method (like 2+1 or 3+1). The "adjudication" is implicitly handled by the adherence to established engineering standards and regulatory requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed and is not applicable to this device. The RTX3320 is a communication gateway, not a diagnostic or interpretive device. It explicitly states: "This device does not measure, interpret or make any decisions on the vital data that it conveys." Therefore, there is no human-in-the-loop performance to improve with or without AI assistance, and no effect size regarding human reader improvement is relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of an algorithm's diagnostic accuracy was not performed and is not applicable. The device's primary function is data transmission, not data analysis or diagnosis. Its "performance" is assessed by its ability to reliably transmit data according to communication standards and safety requirements.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Compliance with recognized international and national standards (IEC, FCC): These standards define acceptable levels of safety, electromagnetic compatibility, and communication performance.
Risk management principles (ISO 14971:2000): Ensures that identified risks are mitigated to acceptable levels.
Substantial equivalence to a legally marketed predicate device: The functional and safety characteristics of the predicate device (Philips M3810A) serve as a benchmark for the RTX3320.
Verification and internal validation testing: This involves engineering tests to confirm the device meets its design specifications and performs reliably in its intended environment.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device. The RTX3320 is a hardware device designed for data transmission, not for machine learning or AI models that require training data.

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

Since there is no training set, this question is not applicable.

Summary

{0}------------------------------------------------

KC4816
page 1 of 4

JUL 1 9 2004

Image /page/0/Picture/2 description: The image shows the logo for RTX Healthcare. The logo consists of the letters "RTX" in a bold, sans-serif font. To the right of the letters, there is a stylized arrow pointing to the right. Below the logo, the words "RTX Healthcare" are printed in a smaller, sans-serif font.

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirement of 21 CFR 807.92

Submitter:	Bjarne Flou
	Managing Director
	RTX Healthcare
	Stroemmen 6
	DK-9400 Noerresundby
	Denmark
	Tel: +45 96322300
	Fax: +45 96322310
	Email: bf@rtx.dk
Contact person:	Niels Ole Andersen
	Engineering Manager
	Email: noa@rtx.dk
Date of summary:	04/15/2004

Physiological Transmitter and Receiver Common Name: Trade name: RTX3320 Wireless Telehealth Gateway

Classification name:21 CFR 870.2910 Physiological Signal Transmitter And Receiver. Classification no: DRG

Predicate Device:

The RTX3320 device is substantially equivalent to the following predicate device: 510(k) number: K023749 Device name: M3810A Philips Telemonitoring System with M3812B TeleStation. Applicant: Philips Medical Systems

Submission Device Description:

The RTX3320, with its build-in modem, transmits data using the public switched telephone network. It is designed not to interfere with the normal use of phones on the same telephone line.

The RTX3320 device is not operated by, or used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

Intended use and indications for use:

{1}------------------------------------------------

The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

This device does not measure, interpret or make any decisions on the vital data that it conveys.

Contraindications, precautions and warnings

This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data.

Clinical judgement and experience are required to check and interpret the measurements collected and transmitted.

This device is not for use in systems which substitute for medical care.

This device is not intended for patients requiring direct medical supervision or emergency intervention.

Item	Predicate device	Submission device
1	Intended use / Indication for use	See section 6.	See section 2.
2	Intended users	Home users and healthcare providers.	Home users and healthcare providers.
3	Site of use	Typically for use in patient's home, placed on a normal table.	Typically for use in patient's home, placed on a normal table.
4	Prescription	The device is intended to be used upon prescription of a licensed physician or authorized healthcare provider.	The device is intended to be used upon prescription of a licensed physician or authorized healthcare provider.
5	System description	Telemedicine system consisting of a device that is working as hub/gateway sending data measured by the system patient monitors to a system data server.	Telemedicine device that is working as hub/gateway sending measured data from compatible patient monitors to a compatible data server.
6	Wireless patient monitors	Wireless connection between the patient monitors and the hub/gateway.	Wireless connection between the patient monitors and the hub/gateway.
7	Transmission	Residential telephone lines	Residential telephone lines
8	Patient Interactions	Display and push buttons for collection of patient typed data	No patient interaction. ("Black box")
9	Measurements taken	Blood pressure, weight, ECG and Blood glucose	Blood pressure, weight, ECG, Blood glucose and other measurements provided from compatible monitor devices.
10a	Contra indications and warnings	The device does not send any real time alarms.	The device is not for emergency calls, and may not be used to send any real-time alarms or time-critical data

Substantial Equivalence Comparison table

{2}------------------------------------------------

KC41816
Page 3 of 4

10b	Contra indicationsand warnings	Clinical judgment andexperience are required tocheck and interpret theinformation delivered.	Clinical judgment andexperience are required tocheck and interpret themeasurements that are taken,collected, and delivered bysystems using a RTX3320device.
10c	Contra indicationsand warnings	The device is not intended as asubstitute for medical care.	The device is not for use insystems which substitute formedical care.
10d	Contra indicationsand warnings	The device is not for use insystems set up for patients whoneed direct medical supervision	The device is not for use insystems set up for patients whoneed direct medical supervisionor who might need emergencyintervention.
11	Wireless linkbetween patientmonitors and thegateway	Short range radio system.	Short range radio system usingBluetooth technology.
12	Environmentalspecifications	Proprietary information	See section 5.
11	Wireless linkbetween patientmonitors and thegateway	Short range radio system.	Short range radio system usingBluetooth technology.
12	Environmentalspecifications	Proprietary information	See section 5.

Discussion on differences:

ltem 1: The intended use / Indications for use for the predicate device and submission device is generally the same. The exact use is for both devices to be decided and supervised by a licensed physician or an authorized healthcare provider, but limited to be within the intended use and with respect to the contra indications and warnings which are also generally the same for both devices.

ltem 5 The predicate device is a system consisting of patient monitor devices, a hub/gateway device and a system server software. The Submission device is a hub/gateway device with a specified generic protocol interface to any compatible patient monitor, and with a specified generic protocol interface to any compatible system server. The protocols are validated against existing compatible patient monitors and servers, and in the labeling it is stated that only compatible and system validated patient monitors and servers must be used with the hub/gateway.

Verfication and validation done on the compatible patient monitors ensure that no extra safety or performance risks are added when using the submission device compared with the predicate device.

The server side and database management must always be validated by the responsible system operator or provider, and using the generic and properly documented protocol adds no extra safety or performance risks to a system using the submission device compared to the predicate device.

{3}------------------------------------------------

Kc41816
page 4 of 4

It is very important to state that both the predicate and the submission device may only be n is very important to other that both the presence is used to check and interpret the measurements that are taken, collected and transmitted by the devices.

that are taken, bonoots and is fitted with a display and some push buttons for patient interaction. The purpose is to collect some additional information from the patient. The interaction device is not fitted with a display, and no user interaction is possible or necessary to perform the intended use.

hecossary to portom the internable assess physiological parameters as the predicate device r to oubmibolon as now over otheraction on the device. If additional information is needed this may be achieved by a normal voice phone call.

may be arrithe predicate device the measurements taken are defined by the patient momitors that are a part of the system. For the submission device the measurements taken mention and by the specific compatible patient monitors. Because of the similar intended use and indication for use for both the predicate device and the submission device, the measurements will typically be the same.

Inoded.omomonik thir typecifications about the wireless link between the patient monitors and the Gateway for the predicate device are proprietary and not available for RTX Healthcare. Based on the knowledge available as a leading company within wireless connectivity RTX Healthcare has evaluated that many different short range radio solutions are suitable for this type of devices without adding any additional risks to the patient. RTX Healthcare has chosen the Bluetooth wireless technology used in other medical devices like the Nonin Pulseoximeter (FDA-K041156 ) developed by RTX Healthcare. The general radio signal safety requirements and FCC Part 15 rules are regulatory requirements that are equal for both the predicate device and the submission device. Since the only purpose using a wireless radio link is to replace a cable, the wireless link in the submission device is evaluated not to add any additional risks within the intended use compared to the predicate device.

Item 12: Detailed environmental specifications for the predicate device are proprietary and not available for RTX Healthcare. This is evaluated not to add any additional risks to the patient since both the predicate device and the submission device, according to the intended use, are designed for use by patients at home. The environmental specifications for the submission device are defined according to IEC60601-1 and specifications available for other medical devices for home use.

Performance data:

The RTX3200 device has been tested to meet the requirements of the following standards and regulations used as acceptance criteria:

IEC 60601-1, IEC 60601-1-2, FCC part 15 and FCC Part 68.

Risk management is performed according to ISO14971:2000.

Based on the fact that the performance comparison of the predicate device and the submission device show that the differences are minor and causes no harm to the user, and the fact that the intended use and indication for use is the same, it was early in the project decided to focus on verification and internal validation instead of large scale validation in form of clinical investigation.

Verification and validation testing activities is conducted to establish performance and reliability characteristics of the device.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2004

RTX Healthcare A/S c/o Dr. J.A. van Vugt Certification Manager KEMA Quality B.V. Utrechtseweg 310, NL-6812 AR Arnhem P.O. Box 5185, 6802 ED Arnhem THE NETHERLANDS

Re: K041816

Trade Name: RTX3320 Wireless Telehealth Gateway Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: July 2, 2004 Received: July 6, 2004

Dear Dr. van Vugt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bocurity is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosuly to regars and ment date of the Medical Device Amendments, or to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices mat have occh recultion in assee approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not requent of the general controls provisions of the Act. The I ou may, merclore, maniel the Act include requirements for annual registration, listing of general controls provisions of the rees, 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 IT your device is classified (500 abs. 19) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations may be subject to suer additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oode of Peachar Singerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Dr. J.A. van Vugt

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); 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), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Neil McOglin

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

Enclosure

{6}------------------------------------------------

3. Indications for use statement

Indication for Use Statement

510(k) Number (if known):

Device name: RTX3320 Wireless Telehealth Gateway

Indications for Use:

The purpose is to transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

This device does not measure, interpret or make any decisions on the vital data that it conveys.

Contraindications, precautions and warnings

This device is not intended for emergency calls, and may not be used for transmission or indication of any real-time alarms or time-critical data.

Clinical judgement and experience are required to check and interpret the measurements collected and transmitted.

This device is not for use in systems which substitute for medical care.

This device is not intended for patients requiring direct medical supervision or emergency intervention.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Ogle

+N DDZ

(Division Sian-Off

Division of Cardiovascular Devices

510(k) Number

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).