The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.

It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond & S8 Series CPAP Systems, positive airway pressure flow generators.

Device Description

The performance and functional characteristics of the ResTraxx Data Center System includes all the performance and functional characteristics of the predicate device, SomnoTraxx System (K030797).

The ResTraxx Data Center System is designed to function with ResMed's S7™ Elite, AutoSet™ Respond and AutoSet Spirit™ CPAP Systems and S8 Series CPAP Systems for the transfer, storage, retrieval and display of stored information from the flow generators to the clinician, via wireless transmission and display of stored information from the flow generators to the clinician. There is no patient access to the system.

The ResTraxx Data Center System comprises two distinct components, ResTraxx or S8 ResTraxx and the Server System. Data taken from the flow generator is transmitted via a wireless network, stored in the Server System and displayed on the Clinical reviewer's PC.

ResTraxx™ and S8 ResTraxx™ are optional wireless modules designed to attach to ResMed S7™ Elite, AutoSet Respond and AutoSet® Spirit or S8 Series flow generators respectively using a docking mechanism. This mechanism allows the device to be electrically connected with the existing expansion port located at the rear of the flow generator. When attached, the ResTraxx can automatically collect patient and machine information stored within the flow generator's memory.

The ResTraxx and S8 ResTraxx sends information utilizing existing messaging networks providing wireless coverage to large portions of the US population.

Server System – The Server System consists of several functional software modules that are designed to retrieve information from ResMed flow generators through the ResTraxx or S8 ResTraxx and a secure into the wireless messaging network, store the information in a database and provide a secure into the wireless messaging network, store the information in a database and provide of the information.

AI/ML Overview

This document (K051314) is a 510(k) premarket notification for the ResTraxx Data Center System, which is a device intended to augment the standard follow-up care of adult patients diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a predicate device, rather than to prove safety and effectiveness through extensive clinical trials. Therefore, the information provided relates to design verification and validation rather than a typical clinical study with acceptance criteria for device performance.

Here's an analysis of the provided information based on your request:

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

The document does not provide a specific table of detailed acceptance criteria for particular performance metrics and their corresponding reported device performance values. Instead, it states:

Criterion Type	Details
Design & Verification	"Design and Verification activities were performed on the ResTraxx Data Center System as a result of the Design and product requirements. All tests confirmed the product met the acceptance criteria."
Risk & Product Req.	"All tests confirmed the product to the product risk and product requirements." (This appears to be a slight typo in the original document, likely meaning "product met the product risk and product requirements.")
Substantial Equiv.	"ResMed has determined that the new device is Substantially Equivalent to the predicate device... The new device complies with the FDA guidance documents: FDA Draft Reviewer Guidance for Ventilators (July 1995) and FDA reviewer's and industry, Guidance for the content of premarket submissions for software contained in medical devices, May 1998."

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

The document does not provide information about a specific "test set" in the context of clinical data for performance evaluation. The "tests" mentioned are related to design verification and validation, as typically performed during medical device development. There is no information regarding sample size, country of origin, or retrospective/prospective nature of data for a clinical test set.

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 is not applicable to the provided document. The submission focuses on demonstrating substantial equivalence through design and functional testing, not through a study involving expert-established ground truth for a clinical "test set."

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

This is not applicable. The document does not describe a clinical study requiring an adjudication method for ground truth.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. The ResTraxx Data Center system is a data transmission and display system, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is not an algorithm-only diagnostic tool. It's a system for collecting and displaying existing data from CPAP devices to clinicians.

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

The concept of "ground truth" in the context of clinical data (like expert consensus or pathology) is not described in this document. The "truth" for the device's functionality is its ability to accurately transmit and display data as intended, which would be verified through engineering and functional testing.

8. The sample size for the training set

This is not applicable. The device is not a machine learning or AI model that requires a training set of data.

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

This is not applicable, as there is no training set for an AI model.

Summary of what the document indicates for "proving device meets acceptance criteria":

The document states that "Design and Verification activities were performed on the ResTraxx Data Center System as a result of the Design and product requirements. All tests confirmed the product met the acceptance criteria" and "All tests confirmed the product to the product risk and product requirements." This indicates a standard medical device development process where the device's design and functionality were verified against predefined engineering and product requirements. The "acceptance criteria" here refer to internal design specifications, performance standards, and risk mitigation requirements rather than the performance against a clinical ground truth dataset. The primary "proof" of meeting requirements for this 510(k) submission is the demonstration of substantial equivalence to the predicate device (SomnoTraxx System K030797) based on similar intended use, operating principle, technologies, and manufacturing process, and compliance with relevant FDA guidance documents.

Summary

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Image /page/0/Picture/0 description: The image shows the word "RESMED" in bold, black letters. The letters are capitalized and evenly spaced. The font appears to be sans-serif.

Section 4(6) Rule 506(b) Private Placement Notification

ResTraxx Data Center Traditional 510(k) Premarket Notification

510(k) Summary - ResTraxx Data Center
	JUL 1 5 2005
Date Prepared	5th April, 2005
Official Contact	Dr Lionel KingV.P., Quality Assurance & Regulatory AffairsResMed Ltd97 Waterloo RoadNorth Ryde, NSW 2113AustraliaTel: +61 (2) 9886 5000Fax: +61 (2) 9878 5517
Classification Reference	21 CFR 868.5905
Product Code	73 BZD
Common/Usual Name	CPAP System / Non continuous Ventilator (with accessory)
Proprietary Name	ResTraxx Data Center System
Predicate Device(s)	SomnoTraxx System (K030797)
Reason for submission	New Device
Indications for Use	The ResTraxx Data Center system is intended to augment the standardfollow-up care of adult patients diagnosed with obstructive sleep apnea byproviding wireless transmission and display of usage and therapeuticinformation.It is intended to be used in the home only and with compatible S7 Elite,AutoSet Spirit, AutoSet Respond & S8 Series CPAP Systems, positiveairway pressure flow generators.

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RESMED

Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device.

Similar intended use A
Same operating principle A
Same technologies A
Same manufacturing process A

Design and Verification activities were performed on the ResTraxx Data Center System as a result of the Design and product requirements. All tests confirmed the product met the acceptance criteria.
risk and product requirements. All tests confirmed the product to the prodicat risk and product requirements. 7 in tots sommitally Equivalent to the predicate device.
ResMed has determined that the new device is Substantially Equivalent used in the Reswed has delemined that the new oction to safety and effectiveness when used in the Res irax Data Center System nas not allery and outly antients. The new device complies with the
management of Obstructive Sleep Apnea (OSA) in adult patients. management of Obstructive Gloop Aprila (Coop) in the FDA guidance documents:

FDA Draft Reviewer Guidance for Ventilators (July 1995) A
FDA reviewer's and industry, Guidance for the content of premarket submissions for software A contained in medical devices, May 1998.

Intended Use

The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients The Res Fraxx Data Center System is intended to dagment the Standard of usage and therapeutic information.

lt is intended to be used in the home only and with compatible ResMed S7 Elite, AutoSet Spirit, AutoSet It is intended to be used in the nomo sing ative airway pressure flow generators.

Device Description

The performance and functional characteristics of the ResTraxx Data Center System includes all the The performance an the predicate device, SomnoTraxx System (K030797).

The ResTraxx Data Center System is designed to function with ResMed's S7™ Elite, AutoSet" Respond The Res Halx Dala Cellier Systems and S8 Series CPAP Systems for the transfer, storage, retireval and AutoSet Spint™ CPAF Systems and Oo Generators to the clinician, via wireless transmission and
and display of stored information from the flow generators to the care no and display of stored mornation from the liew generations of the system. There is no patient access to the system.

The ResTraxx Data Center System comprises two distinct components, ResTraxx or S8 ResTraxx and The ResTrax Data Center System comprises two also is transmitted via a wireless network, stored in the Server System. Data taken from the now gonorator is thanks and displayed on the Clinical reviewer's PC.

ResTraxx™ and S8 ResTraxx™ are optional wireless modules designed to attach to ResMed S7™ ResTraxx™ and 30 Nes Haxx__ are optional wirersos mow generators respectively using a Ellie, AutoSet Respond and AutoSel® Opine or So Senally connected watte existing
docking mechanism. This mechanism allows the device to be existing and SS Post docking filectialism. This nechanism anows and concerner works. When attached, the Res Traxx
expansion port located at the rear of the flow generator. When attached, the Re expansion port located at the rear of the now generator - within the flow generator's memory.
can automatically collect patient and machine information stored within the flow

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Image /page/2/Picture/2 description: The image shows the word "RESMED" in bold, black font. The letters are capitalized and evenly spaced. The font appears to be sans-serif.

The ResTraxx and S8 ResTraxx sends information utilizing existing messaging networks providing wireless coverage to large portions of the US population.

Server System – The Server System consists of several functional software modules that are designed a Server System – The Server Official or of SesTraxx or SesTraxx or S8 ResTraxx and a
to retrieve information from ResMed flow generators through the ResTraxx and a to retrieve information from the information in a database and provide a secure into the wireless messaging network, store the mornation in a datababe and provide of the enternation.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 5 2005

ResMed Limited c/o Mr. David D'Cruz 14040 Danielson St. Poway, California 92064-6857

Re: K051314

Trade/Device Name: Res Traxx Data Center Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 5, 2005 Received: May 20, 2005

Dear Mr. D'Cruz:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premaine 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 encrosule) to regally manation in the Medical Device American on to commerce prior to May 20, 1970, the enaounce with the provisions of the Federal Food. Drug, devices that have been recials.ned in acceraanse was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosmelle Act (Act) that to not require approvine capprovisions of the Act. The Y ou may, therefore, market the devices, books of the coursements for annual registration, listing of general controls provisions of the Fist 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 If your device is Classifica (SCC above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major research and li may be subject to such additional controller "Little 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pouch Snowning your device in the Federal Register.

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Page 2 - Mr. D'Cruz

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a subscribe with other requirements of the Act
that FDA has made a determination that your device of a cranice. You must that FDA has made a delerimiation that your are reas by other Federal agencies. You must or any Federal statures and regulations administed to: registration and listing (21
comply with all the Act's requirements, including, but not regultements as set comply with all the Act S requirements; mercements and in the practice requirements as set CFR Part 807); labeling (21 CFX 1 at 601); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicab forth in the quality systems (Q5) regalatesin (Sections 531-542 of the Act); 21 CFF 1000-1050.
product radiation control provisions (Sections 531-542 of the Acchae Section S product radiation control provisions (occtions our device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a le This letter will anow you to begin manxemily of substantial equivalence of your device to a legally premarket notification. The PDA midning of succements of the more 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 If you desire specific advice for your de need on Also, please note the regulation entitled, and the move obtain contact the Office of Compliance at (210) 216 of Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reference to premarket itstitutions of the Act from the Division of Small
other general information on your responsibilities under the Act from pumber (800) 6 other general information on your responsible and at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Assistance of to corport/industry/support/index.html.

Sincerely yours,

Suytte of. Michael Onis

Chiú Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

... ..

Enclosure

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ResTraxx Data Center Traditional 510(k) Premarket Notification

RESMED

Indication for Use

510(k) Number (if known):

・、 ResTraxx Data Center

Scale
1:24,000

Device Name:

Indication for Use

The ResTraxx Data Center system is intended to augment the standard follow-up care of adult patients I he Hes Faxx Data Center system is inchient to dagment of the starter.
diagnosed with obstructive sleep apnea by providing wireless transmission and display of usage and therapeutic information.

It is intended to be used in the home only and with compatible S7 Elite, AutoSet Spirit, AutoSet Respond It is intended to be used in the norms shy any any pressure flow generators.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(Part 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)

Qum Sylon

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, De

510(k) Number:

Page 1 of_ 1_

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).