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, 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 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 is a summary of a 510(k) premarket notification for a medical device (REMstar SE CPAP system), not a study report. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials or performance studies with specific acceptance criteria that would typically be found in a study for a novel device.

The information necessary to fill out many parts of your request (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, standalone performance with metrics) is not present in the provided document. This is because the submission is for a material modification to an already cleared device, and the demonstration of safety and effectiveness relies heavily on non-clinical tests and substantial equivalence.

Here's an attempt to extract and infer information based on the provided text, with clear indications where the information is not available:

REMstar SE CPAP System - Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Biocompatibility	Acceptable for use with human contact (implied by ISO 10993-1 compliance) through specific tests.	Passed:- Implantation (per ISO 10993-6)- Genotoxicity (per ISO 10993-3)- Irritation (per ISO 10993-10)- Cytotoxicity (per ISO 10993-5)- Sensitization (per ISO 10993-10)
Cleaning and Disinfection Validation	Device is safe and effective for single-patient reuse and multi-patient use after maximum recommended cycles. Disinfection methods are effective.	Passed:- Device withstood maximum recommended cleaning and disinfection cycles.- Disinfection methods were found to be effective, meeting acceptance criteria for performance tests after maximum cycles.
Volatile Organic Compounds (VOC) Testing	Meet established guidelines for the output of VOCs, carbon dioxide, and carbon monoxide.	Passed:- Demonstrated ability of modified device to meet established guidelines for VOCs, carbon dioxide, and carbon monoxide output.
Overall Safety & Effectiveness	Substantially equivalent to predicate device (K122769). Material modification has no impact on safety and effectiveness.	Confirmed:- Modified device determined to be substantially equivalent to the predicate (K122769).- All design verification tests verified to meet required acceptance criteria as a result of risk analysis and product requirements. (Specific criteria for these "design verification tests" are not detailed.)

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

Sample Size (Test Set): Not specified. The document refers to "new materials," "device," and "disinfection methods" without detailing the number of units or materials tested.
Data Provenance: Not specified. It can be inferred that the testing was conducted by Respironics, Inc., likely in the US, but no explicit statement on country of origin of data or whether it was retrospective/prospective is made. Given it's verification testing for a device modification, it would inherently be prospective testing for the modified components.

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

Not Applicable / Not Specified. This submission focuses on non-clinical (engineering and biocompatibility) testing, not on clinical performance where expert ground truth might be needed (e.g., for image interpretation or diagnosis). The "ground truth" here is compliance with established standards (like ISO 10993) and internal product requirements, which are typically assessed by qualified technical personnel rather than clinical experts assigning "ground truth" to patient data.

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

Not Applicable / Not Specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices, where there might be disagreement among experts. This document describes non-clinical engineering and material verification tests, which do not involve such adjudication processes.

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 CPAP system, not an AI-assisted diagnostic device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance was not conducted.

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

Not Applicable. This device is a CPAP system, not an algorithm or AI system, so the concept of "standalone algorithm performance" does not apply. The device's "standalone" performance would be its functional operation in delivering positive airway pressure, which is assessed through the non-clinical tests mentioned (e.g., pressure output, safety features).

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

Standards/Regulatory Requirements and Internal Product Specifications. For biocompatibility, the "ground truth" is compliance with ISO 10993 standards. For cleaning/disinfection effectiveness, the "ground truth" is the predefined efficacy criteria (e.g., reduction in microbial load) and the ability of the device to withstand repeated cycles without degradation. For VOC testing, the ground truth is established guidelines for acceptable emissions. For overall device function, it's the internal product requirements and specifications. There is no clinical "ground truth" from pathology or outcomes data presented here, as no clinical study was performed.

8. The sample size for the training set

Not Applicable / Not Specified. This device is not an AI/ML algorithm that requires a "training set."

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

Not Applicable. Since there is no training set for an AI/ML algorithm, this question is not relevant to the provided submission.

Summary

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

K130077

Premarket Notification – Special 510(k)

MAY 2 1 2013

Official Contact	Frank KadiSenior Regulatory Affairs EngineerRespironics, Inc.1740 Golden Mile HighwayMonroeville, PA 15146
Date Prepared	11 January 2013
Trade Name	REMstar SE
Common Name	CPAP System
Classification Name	ventilator, non-continuous (respirator) (21 CFR 868.5905,Product Code BZD)
Predicate Device	Respironics REMstar SE (K122769)
Reason for Submission	The modified device is the result of a material modificationsmade to the REMstar SE (K122769).

・

ーデ

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

Substantial Equivalence

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 material modification has 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 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

Comments of the controlled of the consideration of the consideration of the more of the more of the more of the more of the more of the more of the more of the more of the ma
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, 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 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

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

REMstar SE

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.

Non-Clinical Tests

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

Material Evaluation

New materials used in the air flow path of the device have been verified to be acceptable for use through the following biocompatibility tests, in accordance with ISO 10993-1:

Implantation (per ISO 10993-6) .
. Genotoxicity (per ISO 10993-3)
. Irritation (per ISO 10993-10)
Cytotoxicity (per ISO 10993-5) .
Sensitization (per ISO 10993-10) ●

The cleaning and disinfection methods identified in the product labeling were validated in order to demonstrate that the device is safe and effective for single-patient reuse and multi-patient use. Performance testing was completed to demonstrate the ability of the device to withstand the maximum number of recommended cleaning and disinfection cycles, and disinfection efficacy testing was performed to demonstrate the ability of the disinfection methods to disinfect the device met the acceptance criteria for the performance tests after the maximum recommended cycles of cleaning and disinfection, and the disinfection methods were found to be effective.

Volatile Organic Compounds (VOC) testing was performed and demonstrated ability of modified device to meet established guidelines for the output of Volatile Organic Compounds (VOCs), carbon dioxide and carbon monoxide.

привается приверсии со приведение со преднество в селение по предната на подарение на подарение по подательно по полнения с составника с составника с составника с сединание к

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.

Conclusion

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.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 21, 2013

Mr. Frank Kadi Senior Regulatory Affairs Engineer Respironics, Incorporated 1740 Golden Mile Highway MONROEVILLE PA 15146

Re: K130077

Trade/Device Name: REMstar SE Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: April 24, 2013 Received: April 25, 2013

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.

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

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer for
-S FDA

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

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known):

30077

Device Name:

REMstar SE

Indications for Use:

Prescription Use J V (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)

Paul H. Shin
2013.05.16 1:48:30 -04'00'

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

510(k) Number: K130677

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).