(70 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on microprocessor control and existing cleared technologies like "flex therapy". There is no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is described as delivering "positive airway pressure therapy for the treatment of Obstructive Sleep Apnea," which directly indicates a therapeutic function.
No
The device is described as delivering positive airway pressure therapy for the treatment of Obstructive Sleep Apnea, indicating a therapeutic rather than diagnostic function.
No
The device description explicitly states it is a "microprocessor controlled blower based positive pressure system with integrated heated humiditier," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea in spontaneously breathing patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a blower-based system that provides air pressure. It does not involve the analysis of biological samples.
- No mention of IVD activities: The description does not mention any activities related to collecting, preparing, or analyzing samples like blood, urine, or tissue, which are characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly treats a condition by providing mechanical support to the airway.
N/A
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. For use in the home or hospital/institutional environment.
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
TAB 3
Premarket Notification -- Special 510(k)
JUN 2 3 2006
0(K) SUMMARY OF SAFETY & EFFECTIVENES
| Official Contact | Zita A. Yurko
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
724-387-4120
724-387-4206 (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. |
.
-- -. ...... . ... .. . . . . . . .
1
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.
2
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized human figure with three overlapping profiles, representing the department's focus on people and health. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple and recognizable, conveying the department's mission to protect the health of all Americans.
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.
3
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
4
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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