The RTX3371 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 RTX3371 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) using standard wireless technologies.

The RTX3371 does not measure, interpret or make any decisions on the vital data that it conveys.

Device Description

The RTX3371 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 RTX3371, with its build-in GSM/GPRS module, transmits data using public wireless networks.

The RTX3371 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 RTX3371 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 Tunstall Healthcare RTX3371 device is a physiological signal transmitter and receiver intended for use in non-clinical settings (e.g., home) as a communication tool. It enables healthcare providers to receive historical patient information by serving as a remote communication link between compatible external devices and a healthcare facility. The device collects and transmits selected medical information (e.g., weight, blood pressure, blood glucose) using standard wireless technologies. It does not measure, interpret, or make decisions on vital data.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standards and Regulations)	Reported Device Performance
IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	Testing successfully conducted to meet requirements.
IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests)	Testing successfully conducted to meet requirements.
EN980 (Symbols for use in the labelling of medical devices)	Testing successfully conducted to meet requirements.
FCC Part 15 (Radio Frequency Devices)	Testing successfully conducted to meet requirements.
FCC Part 24 (Personal Communications Services)	Testing successfully conducted to meet requirements.
ISO14971:2000 (Medical devices - Application of risk management to medical devices)	Risk management performed using FMEA.

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

The document describes verification and internal validation testing activities. It explicitly states: "Based on the fact that the performance comparison of the predicate devices 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 are similar, it was early in the project decided to focus on verification and internal validation instead of large scale validation in form of clinical investigation."

This indicates that an external "test set" in the traditional sense of a clinical trial with human subjects for novel efficacy/performance testing was not performed. The primary testing focused on engineering verification and validation against specified standards. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) for clinical performance is not provided as a clinical study was deemed unnecessary for this device's 510(k) submission based on substantial equivalence to predicate devices.

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

As no large-scale clinical validation study with an independent test set was conducted (as per point 2), there is no information provided regarding the number or qualifications of experts used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set:

Given the lack of a traditional clinical test set (as per point 2), there is no adjudication method mentioned as it would not be applicable in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs without AI assistance:

The RTX3371 device is described as a communication tool for historical patient information and does not involve AI for interpretation or decision-making. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

The device's function is to transmit data; it does not involve an "algorithm only" performance for interpretation or diagnosis. Its performance is related to its ability to reliably transmit data and meet safety and electromagnetic compatibility standards. The verification and internal validation testing focused on these aspects, which can be considered "standalone" in the sense of the device functioning as intended.

7. The Type of Ground Truth Used:

For the technical performance of the device (communication, safety, EMC), the "ground truth" would be established by:

Compliance with published international standards (IEC 60601-1, IEC 60601-1-2, EN980, FCC Part 15 & 24).
Successful completion of risk management activities (ISO14971:2000 using FMEA).
Verification and validation against internal design specifications and requirements.

There is no ground truth based on expert consensus, pathology, or outcomes data as this device does not perform diagnostic or interpretive functions.

8. The Sample Size for the Training Set:

The device is a communication hardware device, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, information regarding a training set sample size is not applicable and not provided.

9. How the Ground Truth for the Training Set was Established:

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

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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
	Tunstall Healthcare
	Stroemmen 6
	DK-9400 Noerresundby
	Denmark
	Tel: +45 72 100 163
	Fax: +45 72 100 164
	Email: bf@tunstallhealthcare.com

APR 1 5 2009

Contact person: Niels Ole Andersen Director of Operations Email: noa@tunstallhealthcare.com

February 6, 2009 Date of summary:

Common Name: Physiological Transmitter and Receiver Trade name: RTX3371

Classification name:21 CFR 870.2910 Physiological Signal Transmitter and Receiver. Product code: DRG

Predicate Devices:

The RTX3371 device is substantially equivalent to the following predicate devices: 510(k) number: K071953 Device name: RTX3370 Applicant: Tunstall Healthcare

510(k) number: K072698 Device name: Confidant 2.5 Applicant: Confidant International, LLC

Submission Device Description:

The RTX3371, with its build-in GSM/GPRS module, transmits data using public wireless networks.

The RTX3371 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 RTX3371 device is not used directly on a patient, and poses no significant risk to the patient or other people within the patient's home.

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Intended use and indications for use:

The RTX3371 does not measure, interpret or make any decisions on the vital data that it conveys.

Item		Submission device	Predicate deviceK071953(Own product)	Predicate deviceK072698
1	Intended use /Indication foruse	See section 2.	See section 9.1.Same, except wayof communicationwith server	See section 9.2.
2	Intended users	Home users andhealthcare providers.	Same	Same
3	Site of use	Typically for use inpatient's home	Same	Same
4	Systemdescription	Telemedicine device thatis working as hub/gatewaysending measured datafrom compatible patientmonitors to a compatibledata server.	Same	Same
5	Appearance	Special designed unit withrelatively small display andpush buttons forinteraction.	Same	Standard Mobile Phoneplatform with arelatively small displayand push buttons forinteraction.
6	Connection topatientmonitors	Wireless and cableconnection between thepatient monitors and thedevice.	Same	Only Wirelessconnection between thepatient monitors andthe device.
7	Transmissionfrom device tothe server	Standard wirelesstechnologies	Residentialtelephone line	Standard wirelesstechnologies
8	PatientInteractions	Colour display and pushbuttons for collection ofpatient typed data.	Same	Same, but different sizeof display and buttons.
9	Measurements	Blood pressure, weight,	Same	Same

other measurements provided from compatible

monitor devices.

Substantial Equivalence Comparison table:

Tunstall Healthcare

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10a	Contraindications andwarnings	The device is not foremergency calls, and maynot be used to send anyreal-time alarms or time-critical data.	Same	The device is notintended for emergencycalls or for transmissionor indication of anyreal-time alarms ortime-critical data.
10b	Contraindications andwarnings	All patient medicaldiagnosis and treatmentare to be performed underthe supervision andoversight of an appropriatehealthcare professional.	Same	All patient medicaldiagnoses andtreatment are to beperformed under thesupervision andoversight of anappropriate healthcareprofessional.
10c	Contraindications andwarnings	The device is not for use insystems which substitutefor medical care.	Same	The device is notintended to provideautomated treatmentdecisions, or to be usedas a substitute forprofessional healthcarejudgment
10d	Contraindications andwarnings	The device is not for use insystems set up for patientswho need direct medicalsupervision or who mightneed emergencyintervention.	Same	The device is notintended as a substitutefor direct medicalsupervision oremergencyintervention.

Discussion of similarities and differences:

Item 1: The submission device and the predicate device K071953 have exactly the same intended use except the way of communication with the server. The products are identical seen from the user, with same functionalities and visual design except the color of the front cover. The way of communication is "Normal residential telephone line" for the predicate device K071953 but "standard wireless technologies" for the submission device and the predicate device K072698. The way of communication is discussed under Item 7. The overall intended use for the submission device and both predicate devices are the same. The minor differences are discussed in the items below.

Item 2: The submission device and the two predicate devices are all intended to be used by the same group of patients and health care providers.

Item 3: The submission device and the two predicate devices are all intended to be used by patients in their homes.

Item 4: The submission device and the two predicate devices are all collecting data from standard home monitoring devices and transmit the measurements to a database server.

Item 5: The submission device and the predicate device K071953 have identical appearance. The predicate device K072698 is a standard Mobile Phone platform, but seen from the user an almost identical appearance using a small display and a few buttons,

Tunstall Healthcare

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Item 6: The submission device and the predicate device K071953 use exactly the same way of communication technologies with the patient monitors. The predicate device K072698 does not support cable connections to patient monitors, but this does not change the intended use. It only limits the number of supported patient monitors.

Item 7: The predicate device K071953 use a standard residential telephone line as communication between the device and the database server, but both the submission device and the predicate device K072698 use standard wireless technologies. The submission device is based on GSM/GPRS wireless technology like the predicate device K072698.

Item 8: The submission device and the two predicate devices are all based on patient interactions using a relatively small color display and a few push buttons. The submission device and the predicate device K071953 are identical seen from user, and designed to be more user friendly than the predicate device K072698.

Item 9: The submission device and the two predicate devices are all interfacing the same type of home monitoring devices to collect measurements like blood pressure. blood glucose, weight etc.

Item 10: The contra indications and warnings are the same for the submission device and the predicate devices.

Performance data:

The RTX3371 device has been tested to meet the requirements of the following standards and requlations used as acceptance criteria:

IEC 60601-1. IEC 60601-1-2. EN980 and FCC part 15+24.

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

Based on the fact that the performance comparison of the predicate devices 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 are similar, 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.

Conclusion

The RTX3371 is substantially equivalent to the predicate devices cleared by FDA. Verification and validation activities demonstrate that safety and effectiveness are acceptable and comparable to the performance of the predicate devices, justifying 510(k) clearance of the device RTX3371.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 2009

Tunstall Healthcare c/o Mr. Niel Ole Anderson Director of Operations Stroemmen 6 DK-9400 Noerresundby Denmark

Re: K090886

Trade/Device Name: RTX3371 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: March 25, 2009 Received: March 31, 2009

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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Page 2 - Mr. Niel Ole Anderson

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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

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K090886

2. Indications for use statement

Indication for Use Statement

510(k) Number (if known):

Device name: RTX3371

The RTX3371 does not measure, interpret or make any decisions on the vital data that it conveys.

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)

Nathalie Zuckerman

4/14/09 (Division Slan-Off) Division of Cardiovascular Devices 510(k) Number 12090886

Page 1 of

Tunstall 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).