The REMstar Auto with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Auto with C-Flex may be used in the home or hospital/institutional environment.
The REMstar Auto with C-Flex CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only. The device is for use in the home or hospital/institutional environment.

Device Description

The Respironics REMstar Auto with C-Flex CPAP System is a microprocessor controlled blower based continuous positive pressure system. Respironics is adding an additional therapy feature to provide pressure relief during exhalation. The REMstar Auto with C-Flex CPAP System provides CPAP or Auto CPAP therapy with or without the C-Flex function and is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, a method of venting exhaled gases, and a patient interface device.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for the device's performance, nor does it describe a specific study proving the device meets acceptance criteria with quantitative results. Instead, it makes a general statement that "Design verification tests were performed on the Respironics REMstar Auto with C-Flex CPAP System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."

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

Here's a breakdown of what can be inferred or explicitly stated:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics or thresholds. The text only mentions "required acceptance criteria" in a general sense.
- Reported Device Performance: Not provided in quantitative terms. The document focuses on demonstrating substantial equivalence rather than presenting detailed performance data against specific criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not mentioned. The text refers to "Design verification tests" but does not specify the sample size of the devices or any patient data used for these tests. Data provenance is also not provided.
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/Not mentioned. The submission describes a medical device (CPAP system) that directly provides therapy, not a diagnostic imaging or AI-driven system that requires expert ground truth for a test set in the traditional sense of a clinical or image-based study.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. This typically relates to expert review of diagnostic assessments, which is not the focus of this device submission.
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 study was done. This device is a therapeutic CPAP system and does not involve "human readers" or "AI assistance" in the context of diagnostic interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of "algorithm only." The device is a "microprocessor controlled blower based continuous positive pressure system" with a C-Flex function. Performance would be assessed for the device's function in delivering pressure and managing C-Flex, not as a standalone AI algorithm. The text implies the device's overall performance was tested, but details are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated. For a therapeutic device like this, "ground truth" would likely refer to engineering specifications, physiological measurements (e.g., pressure delivery accuracy, response to exhalation), and potentially clinical outcomes in broader studies (though not detailed here for this submission).
The sample size for the training set:
- Not applicable/Not mentioned. This device does not describe an AI that learns from a "training set" in the machine learning sense. The device is "microprocessor controlled" but operates based on defined algorithms and parameters.
How the ground truth for the training set was established:
- Not applicable/Not mentioned for the same reasons as #8.

Summary based on available information:

The submission confirms that "Design verification tests were performed" and "All tests were verified to meet the required acceptance criteria." However, it does not provide the specific details of these acceptance criteria or the quantitative results of the tests. The focus of the provided text is on establishing substantial equivalence to predicate devices based on intended use, operating principle, technology, and manufacturing process, rather than presenting detailed performance data from a clinical or diagnostic study.

Table of Acceptance Criteria and Reported Device Performance (as much as can be inferred):

Acceptance Criteria Category	Specific Criteria (Inferred from general statement)	Reported Device Performance (Inferred from general statement)
Device Functionality	Meets "required acceptance criteria" for design verification tests related to safety and effectiveness.	All performed tests were "verified to meet the required acceptance criteria."
Safety and Effectiveness	Modifications have "no impact on the safety and effectiveness of the device."	The manufacturer has "determined that the modifications have no impact on the safety and effectiveness of the device."
Standard Compliance	Complies with "applicable standards referenced in the Guidance for FDA Reviewers and Industry 'Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices', May 1998."	The modified device "complies with the applicable standards."

Summary

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MAY - 5 2004

Date	April 19, 2004
Official Contact	Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
	Phone: 724-387-4120Fax: 724-387-4216Email: Zita. Yurko@Respironics.com
Classification Reference	21 CFR 868.5905
Product Code	BZD – Non-Continuous ventilator
Common/Usual Name	CPAP System
Proprietary Name	Respironics REMstar Auto with C-Flex CPAP System
Predicate Device(s)	Respironics REMstar Auto CPAP System (K012554/K031460)Respironics REMstar Pro with C-Flex CPAP System (K021861)
Reason for submission	Modified design, enhanced mode.

· ·· ··· ·····

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Substantial Equivalence

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

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

Design verification tests were performed on the Respironics REMstar Auto with C-Flex CPAP System as a result 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 device.

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

Intended Use

Device Description

(End of Tab.)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 5 2004

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

Re: K041010

Trade Name: REMstar Auto with C-Flex CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 19, 2004 Received: April 20, 2004

Dear Ms. Yurko:

We have reviewed your Section 510(k) promarket 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 gencral 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 complics 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

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Page 2 -- Ms. Zita A. Yurko

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 yours,

CluR

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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Indications for Use

510(k) Number (if known): סוסום

Device Name:

Indications for Use:

The REMstar Auto with C-Flex CPAP System is a CPAP (Continuous Positive Airway Pressure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only. The device is for use in the home or hospital/institutional environment.

Prescription Usc 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF)

Aurse

(Division Division r thesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K04070

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).