The RTX3370 is for use in non-clinical settings (such as the home), as an accessory device that is intended to be a communication tool to enable health care providers to receive historical patient information. It is intended to be used in combination with a variety of external devices. The RTX3370 serves as the remote communication link between compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys.

Device Description

The RTX3370 telemedicine device performs transmission of physiological patient information to and from wireless, infrared and cabled patient monitors, and a remote data server healthcare facility using standard digital communication technologies and protocols. The RTX3370, with its build-in modem, transmits data using the public switched telephone network.

The RTX3370 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons

The RTX3370 device is not 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 provided text describes a 510(k) submission for the RTX3370 telemedicine device and its substantial equivalence to a predicate device (DLM112 Daylink Monitor, K062304). The submission focuses on demonstrating that the new device meets the same safety and effectiveness criteria as the predicate device, primarily through verification and validation activities guided by relevant standards, rather than a clinical trial with specific performance metrics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria / Standard	Reported Device Performance / Compliance
Safety and Effectiveness (General)	Demonstrated through verification and validation activities. Claimed to be acceptable and comparable to predicate device.
IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance)	The RTX3370 device has been tested to meet the requirements of this standard.
IEC 60601-1-2 (Medical electrical equipment - Electromagnetic compatibility)	The RTX3370 device has been tested to meet the requirements of this standard.
EN980 (Graphical symbols for use in the labelling of medical devices)	The RTX3370 device has been tested to meet the requirements of this standard.
FCC Part 15 (Radio Frequency Devices)	The RTX3370 device has been tested to meet the requirements of this standard.
FCC Part 68 (Connection of Terminal Equipment to the Telephone Network)	The RTX3370 device has been tested to meet the requirements of this standard.
ISO 14971:2000 (Medical devices - Application of risk management to medical devices)	Risk management is performed according to this standard using FMEA.
Substantial Equivalence (Features & Functionality)	Minor differences in specifications (dimensions, weight, display type), but same intended use, indications for use, and functionality. Changes are addressed in risk analysis and do not bring additional or new risks.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document does not detail specific sample sizes for a "test set" in the context of a clinical performance study. The evaluation focused on verification and internal validation in contrast to "large scale validation in form of clinical investigation." Therefore, it's highly likely that the testing involved laboratory-based verification of compliance with established standards and internal validation protocols conducted by the manufacturer.

Sample size: Not specified, as it was not a traditional clinical study but rather engineering verification and validation.
Data provenance: Not explicitly stated, but given it's manufacturer-conducted verification and validation, it would be internal data from the company (RTX Healthcare, Denmark). The tests would be prospective in nature, as they are conducted on the device to prove compliance.

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):

This information is not applicable and not provided in the document. The device is a physiological signal transmitter and receiver, a communication tool, and not a diagnostic device that interprets medical data or requires expert-established ground truth for its performance assessment in the way a diagnostic AI would. Its "performance" is assessed against technical standards and its ability to accurately transmit data, not against clinical expert interpretations of medical conditions.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This type of adjudication method is used in clinical studies, particularly in radiology or pathology, where human expert disagreement needs to be resolved for ground truth establishment. This is not relevant for the type of device and testing described.

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:

No, an MRMC comparative effectiveness study was not performed. This type of study would be relevant for AI-powered diagnostic or assistive tools where human performance is being evaluated and potentially augmented by AI. The RTX3370 is a communication device and does not involve "human readers" or "AI assistance" in the diagnostic sense.

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

The device itself is a "standalone" communication device in the sense that its primary function (data transmission) does not involve a human-in-the-loop for its direct operation. However, its purpose is to transmit data to healthcare providers. The performance data discussed relates to its compliance with technical standards (e.g., electrical safety, EMC, radio frequency emissions, telephone network connectivity) and internal validation of its communication functions. It's not an algorithm that performs a diagnostic task, so the concept of "standalone" performance for an algorithm isn't directly applicable in the same way as for AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The concept of "ground truth" for this device's performance relies on compliance with established technical and safety standards (e.g., IEC 60601-1, FCC Part 15, etc.) and successful execution of its intended communication functions as verified by internal testing. There is no biological or clinical "ground truth" (like pathology or outcomes data) involved for this specific type of device, as it does not make diagnostic or treatment decisions.

8. The sample size for the training set:

Not applicable. The RTX3370 is not an AI/ML device, so there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for RTX Healthcare. The logo consists of the letters "RTX" in bold, black font, with a stylized arrow pointing to the right. Below the letters, the words "RTX Healthcare" are printed in a smaller, less bold font. The logo is simple and modern, and the use of black and white gives it a clean and professional look.

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 FlouManaging DirectorRTX HealthcareStroemmen 6DK-9400 NoerresundbyDenmarkTel: +45 96322300Fax: +45 96322310Email: bf@rtx.dk
Contact person:	Niels Ole AndersenEngineering ManagerEmail: noa@rtx.dk
Date of summary:	July 10, 2007
Common Name:	Physiological Transmitter and Ro

Transmitter and Receiver ommon Name: RTX3370 Trade name:

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

Predicate Device:

The RTX3370 device is substantially equivalent to the following predicate device: 510(k) number: K062304 Device name: DLM112 Daylink Monitor Applicant: RTX Healthcare

Submission Device Description:

The RTX3370 screen, displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons

The RTX3370 device is not 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;

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compatible external devices, and the compatible healthcare facility at another location. The healthcare facility could be at a disease management centre or with the healthcare/wellness provider or other out of hospital caregivers. The purpose is to collect and transmit selected medical information (such as weight, blood pressure, blood glucose) over a normal residential telephone line.

The RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys.

Item	Submission device	Predicate device K062304(RTX Healthcare)
1	Intended use /Indication for use	See section 3	Same
2	Intended users	Home users and healthcareproviders.	Same
3	Site of use	Typically for use in patient'shome, placed on a normaltable.	Same
4	Systemdescription	Telemedicine device that isworking as hub/gatewaysending measured data fromcompatible patient monitors toa compatible data server.	Same
5	Connection topatient monitors	Wireless and cable connectionbetween the patient monitorsand the hub/gateway.	Same
6	Transmission	Residential telephone line	Same
7	PatientInteractions	Monochrome display and pushbuttons for collection of patienttyped data	Colour display and push buttons forcollection of patient typed data.
8	Measurementstaken	Blood pressure, weight, ECG,Blood glucose and othermeasurements provided fromcompatible monitor devices.	Same
9a	Contra indicationsand warnings	The device is not foremergency calls, and may notbe used to send any real-timealarms or time-critical data.	Same
9b	Contra indicationsand warnings	All patient medical diagnosisand treatment are to beperformed under thesupervision and oversight ofan appropriate healthcareprofessional.	Same
9c	Contra indicationsand warnings	The device is not for use insystems which substitute formedical care.	Same
9d	Contra indicationsand warnings	The device is not for use insystems set up for patientswho need direct medicalsupervision or who might needemergency intervention.	Same
10	Wireless linkbetween patientmonitors and thegateway	Short range radio systemusing Bluetooth technology.	Same
11	Devicespecifications	See section 7	Dimensions and weight changed.

Substantial Equivalence Comparison table:

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Discussion of similarities and differences:

Item 1 to 6: No differences.

Item 7: The submission device is equipped with a colour display instead of the monochrome display on the predicate device. The size of the visible display area is almost the same and the use of the display in interaction with the user is based on the same principles.

The push button layout is different on the submission device compared to the predicate device, but with the same functionality seen from the user. An extra Info key is added to support the user interaction.

Item 8 to 10: No differences.

Item 11: The submission device and the predicate device are different on the following specifications:

Specification	Submission device	Predicate device
Dimensions	(W x L x H): 145 x 125 x 75 mm / 5.7 x 4.9 x 2.9 inches	(W x L x H): 156 x 145 x 70 mm / 6.2 x 5.7 x 2.8 inches
Weight	295 g / 11 oz including power supply adapter	425 g / 15 oz including power supply adapter

The visual design on the submission device is different than the predicate device. Mechanics materials used in both the submission device and the predicate device are common materials used in house hold electronic, mobile phones etc. The mechanic parts in the submission device are addressed in the risk analysis, and does not bring additional or new risks compared to the predicate device.

Performance data:

The RTX3370 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, EN980, FCC part 15 and FCC Part 68.

Risk management is performed according to ISO14971:2000 using FMEA.

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 are successfully conducted according to the company's design control processes to establish performance and reliability characteristics of the device.

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Conclusion

The RTX3370 is substantially equivalent in technology, features, labeling and indications for use compared to the predicate device cleared by FDA.

Verification and validation activities demonstrate that safety and effectiveness are acceptable and comparable to the performance of the predicate device, justifying 510(k) clearance of the modified device RTX3370

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Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2007

RTX Healthcare A/S c/o Mr. Niels O. Anderson Engineering Manager Stroemmen 6 Noerresundby DK-9400, Denmark

Re: K071953

RTX3370 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II (two) Product Code: DRG Dated: July 10, 2007 Received: July 16, 2007

Dear Mr. Anderson:

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.

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Page 2 - Mr. Niels O. Anderson

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Blumimo for

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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4. Indications for use statement

Indication for Use Statement

510(k) Number (if known):

Device name: RTX3370

The RTX3370 does not measure, interpret or make any decisions on the vital data that it conveys.

Prescription Use × (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)

Blummenmor
Division Sign-Off

Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K071953

Page 1 of

RTX Healthcare

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).