The Tasman is indicated for the treatment of obstructive sleep apnea (OSA) in adult patients weighing more than 66 lb (>30 Kg). The Tasman mask system delivers airflow noninvasively to a user from the integrated Continuous Positive Airway (CPAP) device. The Tasman is intended for single-patient re-use in the home environment and while travelling.

Device Description

The Tasman is a portable CPAP device where the blower, mask and tubing are integrated and mounted to the headgear. The blower generates the required CPAP pressure to maintain an "air splint" for effective treatment of OSA.

AI/ML Overview

The ResMed Tasman device is a noncontinuous ventilator (IPPB) intended for the treatment of obstructive sleep apnea (OSA) in adult patients. The acceptance criteria and the study performed to demonstrate its performance are described below based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria in a general sense, stating that "All tests confirmed the product met the predetermined acceptance criteria." However, specific numerical targets for each criterion are not provided in the summary. The performance is reported in terms of meeting these criteria rather than providing specific measurements.

Acceptance Criterion	Reported Device Performance
Pressure stability	Met predetermined acceptance criteria
Jitter	Met predetermined acceptance criteria
Swings (pressure fluctuations)	Met predetermined acceptance criteria
ISO 17510-1 pressure performance	Met predetermined acceptance criteria
Functional dead space	Met predetermined acceptance criteria
Safety and effectiveness	New device has not altered the safety and effectiveness of CPAP treatment for adult OSA patients.
Compliance with FDA guidance	Complies with FDA Draft Reviewer Guidance for Ventilators (July 1995)

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

The document does not explicitly state the sample size used for the test set of the verification activities. It generally refers to "Design and Verification activities" and "All tests."

The data provenance is not specified. It is likely internal testing conducted by ResMed, but the country of origin of the data or whether it was retrospective or prospective is not mentioned.

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

The document does not mention the use of experts to establish ground truth for a test set. The verification activities seem to be based on engineering and performance tests against predetermined criteria and predicate devices, rather than expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set

No adjudication method is described, as the verification appears to be based on objective performance measurements rather than subjective assessments requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. This device is a hardware device (CPAP machine) and not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a hardware CPAP machine, not an algorithm or AI system. Its performance is inherent to its mechanical and electronic function, which is assessed standalone.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on established engineering and medical device standards (e.g., ISO 17510-1) and comparison against predicate devices. This represents an objective, regulatory-defined "ground truth" for technical performance and safety, rather than clinical outcomes or pathology.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning. The device is a traditional medical device, not an AI/ML-based algorithm that requires training data.

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

This question is not applicable, as there is no "training set" for this type of device.

Summary

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, n° ﺮ ﻣﺮ

RESMED

Tasman Traditional 510(k)

	K112393Traditional 510(k) SUMMARY[As required by 21 CFR 807.92(c)]
Date Prepared	16th Aug, 2011
Submitter Name	Mr. Kim Kuan Lee
Official Contact	Mr. David D'Cruz
	V.P., Medical & Regulatory Affairs
	9001 Spectrum Center Blvd
	San Diego CA 92123 USA
	Tel: (858) 836-5984
Device Trade Name	Tasman
Device Common Name	Non continuous Ventilator (IPPB)
Classification	21 CFR 868.5905 (Class II)
Product Code	73 BZD
Predicate Device	S8 Prime (K033841)
	Ultra Mirage II Nasal Mask (K050359)
Reason for submission	New Device
Intended Use	The Tasman is indicated for the treatment of obstructivesleep apnea (OSA) in adult patients weighing more than66 lb (>30 Kg). The Tasman mask system delivers airflownoninvasively to a user from the integrated ContinuousPositive Airway (CPAP) device. The Tasman is intendedfor single-patient re-use in the home environment andwhile travelling.
Substantial Equivalence	The new device has the following similarities to thepreviously cleared predicate devices.• Same intended use• Similar operating principle• Similar technologies• Similar manufacturing processDesign and Verification activities were performed on theTasman System as a result of the risk analysis anddesign requirements. All tests confirmed the product met

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the predetermined acceptance criteria. This included pressure stability, jitter, swings, ISO 17510-1 pressure performance and functional dead space tests against the predicate devices using common protocols for both devices. ResMed has determined that the new device has not altered the safety and effectiveness of CPAP treatment for adult patients with Obstructive Sleep Apnoea (OSA) who weigh more than 66 lb (>30 kg). The new device complies with the applicable requirements referenced in the FDA guidance documents:

FDA Draft Reviewer Guidance for Ventilators (July . 1995)
The Tasman is a portable CPAP device where the blower, Device Description mask and tubing are integrated and mounted to the headgear. The blower generates the required CPAP pressure to maintain an "air splint" for effective treatment of OSA.
The Tasman is substantially equivalent to the Predicate Conclusion devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ResMed Limited C/O Mr. David D'Cruz Vice President, Medical & Regulatory Affairs Resmed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123

NOV 1 6 2011

Re: K112393.

Trade/Device Name: Tasman Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 16, 2011 Received: August 19, 2011

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. D'Cruz

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hn for

Anthony D. Watson, B.S., M.S., M.B.A. 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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RESMED

Tasman Traditional 510(k)

Indication for Use

1112393 510(k) Number (if known):

Device Name:

Tasman

Indication for Use

Prescription Use	X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(Part 21 CFR 807 Subpart C)

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

Copcurrence of CDRH; Office of Device Evaluation (ODE)

(Division Sign-Off Thurth

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

16th Aug, 2011

Page 22

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).