(70 days)
The Respironics BiPAP Plus M Series Bi-level 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 BiPAP Plus M Series Bi-level System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humiditier. The device platform and fundamental technology is based on the Respironics REMstar Pro M Series CPAP System (K052110). The BiPAP Plus M Series Bi-level System includes the flex therapy feature cleared in K043607, which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicate, the BiPAP Plus M Series Bilevel System 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Respironics BiPAP Plus M Series Bi-level System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include a specific table of acceptance criteria or detailed reported device performance. It broadly states: "Design verification tests were performed on the Respironics BiPAP Plus M Series Bi-level System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria."
Therefore, I cannot populate the table with specific metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Design verification tests."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts or the establishment of ground truth for any specific test set. The submission focuses on device design verification rather than clinical outcomes or diagnostic accuracy studies.
4. Adjudication Method
No information is provided about an adjudication method, as there's no mention of expert review or clinical studies requiring such a process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. This submission is for a modified respiratory therapy device, not a diagnostic or AI-assisted system that would typically involve such studies.
6. Standalone Performance Study
The document does not explicitly describe a standalone performance study in terms of algorithm-only performance. The "Design verification tests" are likely related to the device's functional and safety specifications, not its standalone interpretative accuracy.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used. Given the nature of a 510(k) for a modified respiratory device, "ground truth" would likely refer to engineering specifications, performance standards, and safety requirements met through design verification.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This type of information is typically provided for AI/ML-based devices, which this BiPAP system is not described as.
9. How Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how ground truth for a training set was established.
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TAB 3
Premarket Notification -- Special 510(k)
JUN 2 3 2006
0(K) SUMMARY OF SAFETY & EFFECTIVENES
| Official Contact | Zita A. YurkoManager, Regulatory AffairsRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668724-387-4120724-387-4206 (fax)Email: Zita. Yurko@Respironics.com |
|---|---|
| Classification Reference | 21 CFR 868.5905 |
| Product Code | BZD - Non-Continuous ventilator |
| Common/Usual Name | CPAP System |
| Proprietary Name | Respironics BiPAP Plus M Series Bi-level System |
| Predicate Device(s) | Respironics REMstar Pro M Series CPAP System (K052110)Respironics BiPAP Pro 2 Bi-level System (K43607) |
| Reason for submission | Modified design. |
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Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- O Same intended use.
- Same operating principle. ロ
- 0 Same technology.
- D Same manufacturing process.
Design verification tests were performed on the Respironics BiPAP Plus M Series Bi-level 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 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 BiPAP Plus M Series Bi-level 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 BiPAP Plus M Series Bi-level System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humiditier. The device platform and fundamental technology is based on the Respironics REMstar Pro M Series CPAP System (K052110). The BiPAP Plus M Series Bi-level System includes the flex therapy feature cleared in K043607, which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. Like its predicate, the BiPAP Plus M Series Bilevel System 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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JUN 2 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Incorporated C/O Ms. Zita A. Yurko Manager, Regulatory Affairs Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K061034
Trade/Device Name: BiPAP Plus M-Series Bi-Level System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 25, 2006 Received: May 26, 2006
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 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 -- 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); 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours.
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): K061034
Device Name: BiPAP Plus M-Series Bi-level System
Indications For Use:
Intended Use/Indications for Use
The Respironics BiPAP Plus M Series Bi-level 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
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ion of Anesthesiology, General Hospital,
ion Control, Dental Devices
. Number:
§ 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).