The ResControl II is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResControl II displays data, relays data to a polysomnograph and acts as a manometer. ResControl II also provides functionality for setting flow generator parameters.

Device Description

The performance and functional characteristics of the ResControll II system includes all the user friendly features of the predicate device. UCU. ResControl II is designed to transfer data from a CPAP or birevel Flow Generator to a polysomnograph display system such as Sommitigica (K971813). ResControl 11 also provides parameter setting of Flow Generators within the hospital or sleep lab facilities.

AI/ML Overview

The provided 510(k) summary for ResControl™ II (K040944) focuses on establishing substantial equivalence to a predicate device (ResMed UCU, K961783) through similar intended use, operating principles, technologies, and manufacturing processes. It states that "Design and Verification activities were performed on the ResControl II as a result of the risk and product requirements. All tests confirmed the product met the acceptance criteria."

However, this submission does not contain specific details about the acceptance criteria nor the study that proves the device meets them. It asserts that such testing was done, but gives no quantitative data, sample sizes, or methods used to establish performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the available information, with specific notes where information is missing:

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

Acceptance Criteria	Reported Device Performance
Not provided. The submission states "All tests confirmed the product met the acceptance criteria."	Not provided. No specific performance metrics or values are reported.

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

Test Set Sample Size: Not provided.
Data Provenance: Not provided.

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)

Not applicable as no specific test set or ground truth establishment method is described for device performance. The submission discusses compliance with guidance documents and risk/product requirements for design and verification.

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

Not applicable as no specific test set or adjudication method for performance evaluation is 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 MRMC comparative effectiveness study is mentioned. This device is a measurement and control device, not one involving AI for image interpretation or diagnosis.

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

The device functions as a data display, relay, manometer, and parameter setting tool for clinicians using flow generators. The concept of "standalone algorithm only" performance as typically applied to diagnostic AI is not directly relevant here. However, the submission implies that the device's functional performance (displaying data, relaying data, acting as a manometer, setting parameters) was verified to meet its specified requirements. No specific standalone performance metrics are provided.

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

N/A. The "ground truth" for a device of this nature would likely refer to engineering specifications, accuracy of measurements against calibrated standards, and successful execution of its intended functions. No details on how this "ground truth" was established are provided.

8. The sample size for the training set

Not applicable. This device is not an AI/ML diagnostic algorithm that would typically require a training set.

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

Not applicable. This device is not an AI/ML diagnostic algorithm that would typically require a training set.

Summary

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Ko40944

510(k) Summary - ResControl™ II

Date Prepared	30th March, 2004
Official Contact	Dr Lionel KingV.P., Regulatory AffairsResMed Ltd97 Waterloo RoadNorth Ryde, NSW 2113AustraliaTel: +61 (2) 9886 5000Fax: +61 (2) 9878 5517
Classification Reference	21 CFR 868.5905
Product Code	BZD
Common/Usual Name	CPAP System / Non continuous Ventilator (with accessory)
Proprietary Name	ResControl™ II
Predicate Device(s)	ResMed UCU (K961783)
Reason for submission	New Device
Indications for Use	The ResControl II is intended to be used by clinicians withResMed flow generators that have software incorporatingResMed's proprietary communication protocol. ResControl IIdisplays data, relays data to a polysomnograph and acts as amanometer. ResControl II also provides functionality for settingflow generator parameters.

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Substantial Equivalence

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

Same intended use

Similar operating principle

Similar technologies

Same manufacturing process

Design and Vertification activities were performed on the ResControl II as a result of the risk and product requirements. All tests confirmed the product met the acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate device. ResControl II has not altered the safety and effectiveness when used in treatment studies for Chronic Obstructive Pulmonary Disease (COPD) or Obstructive Sieep Apnea (OSA) in adult patients. The new device complies with the applicable standards and requirements referenced in the FDA quidance documents:

FDA Reviewer Guidance for Premarket Notifications, November 1993 关
મુ FDA Draft Reviewer Guidance for Ventilators (July 1995)
ﺮ FDA reviewer's and industry. Guidance for the content of premarket submissions for software contained in madical devices. May 1998.

Intended Use

The ResControl II is intended to be used by clinicians with ResMed flow generators that have software ncorporating ResMed's proprietary communication protocol. ResControl II displays data to a polysomnograph and acts as a manometer. ResControl II also provides functionality for setting flow generator parameters.

Device Description

LL88

Dr Lionel King V P Regulatory Affairs ResMed.

30" March, 2004

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Image /page/2/Picture/1 description: The image is a seal or logo, likely representing a government or organizational entity. It features a circular design with text wrapping around the top half, reading 'HUMAN SERVICES - USA'. Inside the circle is a stylized emblem resembling a bird or abstract shape, composed of three curved lines. The bottom half of the circle also contains text, but it is less clear.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 0 3 2004

Resmed Limited c/o David D'Cruz Resmed Corporation 14040 Danielson St. Poway, CA 92064-6857

Re: K040944

Trade/Device Name: ResControl II Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 4, 2004 Received: April 12, 2004

Dear Mr. D'Cruz:

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.

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.

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Page 2 – David D'Cruz

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) 594-4646. 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,

Carl
Chiu Lin, Ph.D.

Chiu 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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Indication for Use

510(k) Number (if known):

Device Name:

ResControl II

Indications for Use:

The ResControl II is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResControl II displays data, relays data to Incolporating Roomos of Prophoury Commeter. ResControl II also provides functionality for setting flow generator parameters.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X 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)

Cum Sulom

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esiology, General Hospital

510(k) Number

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).