(95 days)
The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.
The Respironics REMstar M-Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar M-Series Auto with AFLEX System also includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the device includes an AFLEX therapy feature which provides added comfort for the user. As stated in the submission, the purpose of this modification is to provide enhanced event detection and algorithm response to these new event types. Like its predicate, this device 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, an exhalation device, and a patient interface device.
The provided text does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria with the requested level of detail. The document is a 510(k) summary for a CPAP system, primarily focusing on its substantial equivalence to a predicate device and its intended use.
However, based on the statement: "Design verification tests were performed on the Respironics REMstar M-Series Auto with AFLEX 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." we can infer that acceptance criteria and verification tests were indeed conducted.
Given the available information, I can only provide a general interpretation based on the statements made:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify a table of acceptance criteria or numerical performance metrics for the device. The only performance-related statement is a general assertion that "All tests were verified to meet the required acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not provided in the document, as the "ground truth" concept as typically applied in AI/ML performance evaluation studies (e.g., expert consensus on medical images) is not relevant to this type of device modification submission.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned or implied. The device is a CPAP system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
While "enhanced event detection and algorithm response" are mentioned as a purpose of modification, the document does not describe a standalone performance study with specific metrics, methodology, or results. The focus is on the device as a whole and its substantial equivalence to a predicate device, not on isolated algorithm performance.
7. Type of Ground Truth Used
Given that this is a CPAP device and the context of a 510(k) for a modified device, the "ground truth" would likely refer to objective engineering and clinical performance metrics measured against established standards and internal specifications, rather than expert consensus on diagnostic interpretations or pathology. Examples of such "ground truth" would be:
- Engineering Specifications: Pressure accuracy, flow rate, leak detection, alarm functionality, power consumption, sound levels.
- Clinical Performance (inferred): The device's ability to effectively deliver positive airway pressure for Obstructive Sleep Apnea, as measured through clinical trials or simulated use conditions against established physiological parameters.
- Risk Analysis Outcomes: Verification that identified risks are mitigated and safety requirements are met.
However, the document does not explicitly describe how this "ground truth" was established or measured with specific details.
8. Sample Size for the Training Set
This information is not provided. Given that the document refers to "design verification tests" and "risk analysis and product requirements" rather than an AI/ML development process, the concept of a "training set" in the context of machine learning is not directly applicable here. The device likely underwent traditional engineering design and testing, not a machine learning model training process that would require a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" with established ground truth in the AI/ML sense is not directly applicable to this document. The "ground truth" for verifying the device's performance (as inferred from point 7) would have been established through a combination of industry standards, regulatory requirements, internal design specifications, and potentially pre-clinical or clinical testing protocols for CPAP devices.
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Image /page/0/Picture/2 description: The image shows the title "TAB 3" and "510(K) SUMMARY OF SAFETY & EFFECTIVENESS". There is also a handwritten annotation that appears to be a tracking or identification number. The image is a close-up shot of the text, with a slightly blurred background.
| Official Contact | Zita A. YurkoDirector, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668Zita.yurko@respironics.com724-387-4120 t724-882-4120 c724-387-4216 f |
|---|---|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - - ventilator, non-continuous (respirator) |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics REMstar M-Series Auto with AFLEX CPAP System |
| Predicate Device(s) | Respironics REMstar AFLEX CPAP System (K063830) |
| Reason for submission | modified device |
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- ロ Same intended use.
- Same operating principle. ට
- D Same technology.
- Same manufacturing process.
Design verification tests were performed on the Respironics REMstar M-Series Auto with AFLEX 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
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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 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 2006.
Intended Use
The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg. For use in the home or hospital/institutional environment.
Device Description
The Respironics REMstar M-Series Auto with AFLEX CPAP System is a microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar M-Series Auto with AFLEX System also includes the auto mode and the flex therapy feature cleared in K063830 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. In addition the device includes an AFLEX therapy feature which provides added comfort for the user. As stated in the submission, the purpose of this modification is to provide enhanced event detection and algorithm response to these new event types. Like its predicate, this device 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, an exhalation device, and a patient interface device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract human figure.
Public Health Service
MAY - 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Zita A. Yurko Director, Regulatory Affairs Respironics Incorporated, Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K090243
Trade/Device Name: Respironics REMstar M-Series Auto with AFLEX CPAP System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 9, 2009 Received: April 10, 2009
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 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 vour device in the Federal Register.
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Page 2 Ms. Yurko
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Ronder.
Susan Runner, D.D.S., MA Acting 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): _
Device Name: Respironics REMstar M-Series Auto with AFLEX CPAP System
Intended Use/Indications for Use
The Respironics REMstar M-Series Auto with AFLEX CPAP System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients weighing over 30kg.
Environment of Use/Patient Population
For use in the home or hospital/institutional environment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseXXXXX (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Susan Rosen
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090243
§ 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).