The REMstar Auto Continuous Positive Airway Pressure (CPAP) System is a microprocessorcontrolled, blower-based system that generates positive airway pressures from 4 to 20 cmH₂O. The device is intended for use with a patient circuit that is used to connect the device to the patient interface (mask). The previously cleared REMstar Auto has been modified to include a Split-Night with Auto-CPAP mode to simplify spilt night studies and to add a Non Responsive Apnea Hypopnea (NRAH) flag for clinical use. The basic functional and performance characteristics of the REMstar Auto CPAP System is unchanged from its device predicate (REMstar Auto CPAP System K012554).

AI/ML Overview

The provided text describes a 510(k) summary for the Respironics REMstar Auto CPAP System (K031460). This submission focuses on modifications to an existing device and aims to demonstrate substantial equivalence to its predicates. The information required to fulfill the request, particularly regarding specific acceptance criteria, device performance, and details of a clinical study, is NOT present in the provided document.

The document states:

"Design verification tests were performed on the REMstar Auto CPAP System in accordance with of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
"The basic functional and performance characteristics of the REMstar Auto CPAP System is unchanged from its device predicate (REMstar Auto CPAP System K012554)."

This indicates that internal design verification tests were conducted, but the specifics of what those acceptance criteria were and what the reported performance results were are not detailed. It also does not describe a clinical study in the format requested.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document

Reasoning: The document states that "All tests were verified to meet the required acceptance criteria," but it does not list these criteria or the specific results. The focus of this 510(k) is on demonstrating substantial equivalence primarily through design modifications and compliance with standards, rather than presenting novel performance data from a clinical trial.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. (The document mentions "Design verification tests" but no specific clinical "test set" with patient data).
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a human-reviewed "ground truth" test set.

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

Not applicable. There is no mention of a clinical "test set" requiring adjudication.

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:

MRMC Study Done: No. This document describes a CPAP device, not an AI-assisted diagnostic tool that would typically involve human readers.
Effect Size of AI Improvement: Not applicable.

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

This is not an AI algorithm. It's a medical device. The "standalone performance" refers to the device's functional and performance characteristics, which are stated to be "unchanged from its device predicate."

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

Not applicable in the context of typical AI device ground truth. For a CPAP device, performance is typically verified against engineering specifications, simulated physiological conditions, and potentially sleep lab data if new therapeutic efficacy claims were made (which they are not in this submission, as it's a modification to an already cleared device).

8. The sample size for the training set:

Not applicable. This is not an AI/Machine Learning device that undergoes a "training set" process.

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

Not applicable.

Summary

{0}------------------------------------------------

TAB 3

510(K) SUMMARY OF SAFETY & EFFECTIVENESS

Official Contact	Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668	K031460
Classification Reference	21 CFR 868.5905
Product Code	BZD - Non-Continuous ventilator
Common/Usual Name	CPAP System
Proprietary Name	Respironics REMstar Auto CPAP System
Predicate Device(s)	Respironics REMstar Auto CPAP System (K012554)
	Respironics Virtuoso LX Smart CPAP System (K993433)
Reason for submission	Modified design, additional accessories.

Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

0 Same intended use.
D Same operating principle.
O Same technology.
O Same manufacturing process.

Design verification tests were performed on the REMstar Auto CPAP System in accordance with of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.

{1}------------------------------------------------

The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of premarket Submissions for Software Contained in Medical Devices", May 1998.

Intended Use

The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea. This device is intended for use in the home or hospital/institutional environment on adult patients.

Device Description

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2003

Ms. Zita A. Yurko Manager, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K031460

Trade/Device Name: REMstar Auto CPAP System Regulation Number: 868.5905 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: BZD Dated: June 5, 2003 Received: June 6, 2003

Dear Ms. Yurko:

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 vour 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.

{3}------------------------------------------------

Page 2 -- Ms. Zita A. Yurko

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 (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 vours.

Susan Rann

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of__1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Respironics® REMstar Auto CPAP System

Intended Use/Indications for Use

The REMstar Auto CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea.

Environment of Use/Patient Population

For use in the home or hospital/institutional environment on adult patients.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------	--

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
------------------------------------------	----	--------------------------------------------------

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

510(k) Number:	K031460
----------------	---------

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).