The REMstar SE delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg (66 lbs). It is for use in the home or hospital/institutional environment.

Device Description

The REMstar SE is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).

The REMstar SE includes a CPAP mode only. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session.

In addition to the CPAP therapy mode, the REMstar SE incorporates several optional features to aid with patient comfort. These features include ramp, adjustable pressure relief (FLEX technologies), and humidification. Humidification options include both a heated humidifier and heated tubing. The heated humidifier adjusts the level of humidification by varying the temperature of a heated plate used to heat up a chamber of water. Optional heated tubing can then be used to maintain that air at a desired temperature until it reaches the patient's mask.

The REMstar SE is intended for use with a patient circuit that connects the device to a patient interface device (mask). A typical patient circuit consists of patient tubing (15mm, or heated tubing) and an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.

AI/ML Overview

The provided text describes modifications to an existing CPAP system (REMstar SE) and confirms its substantial equivalence to predicate devices. It does not present a study with detailed acceptance criteria and reported device performance in the format requested, nor does it provide information relevant to AI/ML device studies.

The document states that "Design verification tests were performed on the REMstar SE as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." However, it does not enumerate these criteria or provide specific performance metrics in a table. It also explicitly states, "Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar SE. Product functionality has been adequately assessed by non-clinical tests." This indicates that the device's performance was evaluated through non-clinical or bench tests rather than studies involving human subjects or complex data analysis as typically seen with AI/ML devices.

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

Here is what can be inferred or explicitly stated from the document, with limitations highlighted:

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

Acceptance Criteria Category	Reported Device Performance
Flex performance	Verified to meet product specifications for each level of control.
Pressure stability	Verified across all environmental conditions including altitude, temperature, and humidity.
Humidifier performance	Verified to meet product specifications for humidity output.
Standards compliance	Designed to meet requirements of ISO 14971, ISO 10993-1, IEC 60601-1, IEC 62304, ISO 5356-1.
General safety & effectiveness	Modifications have no impact on safety and effectiveness; device is substantially equivalent to predicate devices.

Limitations: The text does not provide quantitative acceptance criteria (e.g., "Pressure stability within X mmHg") or specific numerical performance results. It only states that specifications were met.

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

Sample Size: Not applicable/Not provided. The text mentions "design verification tests" and "non-clinical tests" but does not specify sample sizes for these tests, as they are likely bench tests on the device hardware and software, not data points in a clinical study.
Data Provenance: Not applicable/Not provided. No clinical data or patient data is mentioned as being used for testing.

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. Ground truth as typically understood in AI/ML performance evaluation (e.g., expert consensus on medical images or diagnoses) is not described. The "ground truth" here would be the physical and functional specifications of the device, verified through engineering tests.

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

Not applicable. This concept pertains to resolving discrepancies in expert labeling for clinical studies, which were not performed.

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. This is a non-AI/ML device. No MRMC study was performed.

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

Not applicable. This is a non-AI/ML device. Its function is to deliver positive airway pressure, not to interpret data or perform diagnostic tasks.

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

The "ground truth" for this device's performance is its designed product specifications and compliance with relevant industry standards (e.g., ISO, IEC). These are engineering and performance specifications.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

Not applicable. See point 8.

Summary

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Tectiveness

Official Contact

Date Prepared

Trade Name

Common Name

Classification Name

Predicate Device(s)

Reason for Submission

Frank Kadi Senior Regulatory Affairs Engineer Respironics, Inc. 1740 Golden Mile Highway Monroeville, PA 15146

30 January 2012

REMstar SE

CPAP System

ventilator, non-continuous (respirator) (21 CFR 868.5905, Product Code BZD)

Respironics REMstar Auto A-Flex HT (K113068) Respironics SleepEasy CPAP System (K091112) Respironics REMstar Plus CPAP System (K010263)

The REMstar SE is the result of modifications made to the REMstar Auto A-Flex HT (K113068). The goal of these modifications is to combine the updated platform design of the REMstar Auto A-Flex HT (K113068) with both the feature set and performance aspects of the SleepEasy CPAP System (K091112) and the REMstar Plus CPAP System (K010263). In addition, modifications have been made in regards to flow detection, and humidity control. The necessary modifications have been accomplished via a combination of software, electrical and mechanical design changes.

קען ק

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

. Same Intended Use
. Same operating principle
. Same technology
Same manufacturing process

Design verification tests were performed on the REMstar SE 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 devices.

The modified device complies with the requirements of the following FDA Guidance Documents:

FDA Reviewers Guidance for Premarket Notification Submissions (November 1993) ●
FDA Reviewers Guidance for the Content of Premarket Submissions for Software Contained in . Medical Devices (May 11, 2005)

Intended Use

The REMstar SE is a microprocessor controlled blower based positive pressure system which is comprised of the therapy device, a heated humidifier and patient tubing (15mm, 22mm, or heated tubing).

The REMstar SE includes a CPAP mode only. While in CPAP mode, the device delivers a continuous positive airway pressure throughout the entire therapy session.

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an exhalation device (if one is not present in the mask). When a heated humidifier is attached to the therapy device, the patient circuit connects to the air outlet port of the heated humidifier.

Verification activities performed to verify that the device modifications did not affect the safety and effectiveness of the subject device included the following:

Flex Performance

Flex performance has been verified to meet product specifications for each level of control.

Pressure Stability

Pressure stability performance for the REMstar SE has been verified across all environmental conditions including altitude, temperature, and humidity.

Humidifier Performance

Humidifier performance has been verified to meet product specifications for humidity output.

Standards Evaluation

The REMstar SE has been designed to meet the requirements of the following FDA Recognized Consensus Standards:

ISO 14971 Medical devices Application of risk management to medical devices .
ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within . a risk management process
. IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements of Safety
IEC 62304 Medical device software Software life cycle processes .
ISO 5356-1 Anaesthetic and respiratory equipment Conical connectors: Part 1L Cones and . sockets

Clinical tests were not required to demonstrate the safety and effectiveness of the REMstar SE. Product functionality has been adequately assessed by non-clinical tests.

clusions

The REMstar SE has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that the REMstar SE is substantially equivalent to the predicate device in terms of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

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

OCT

2012

Respironics, Incorporated

Mr. Frank Kadi

Senior Regulatory Affairs Engineer

1740 Golden Mile Highway

Monroeville, Pennsylvania 15146

Re: K122769 Trade/Device Name: REMstar SE Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 7, 2012 Received: September 11, 2012

Dear Mr. Kadi:

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. Kadi

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/ucm115809.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,

Nh 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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510(k) Number (if known):

KIZZ 769

Device Name:

REMstar SE

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schuler

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

K12276 510(k) Number:

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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).