(64 days)
Not Found
No
The description focuses on microprocessor control and a "flex therapy feature" for comfort, with no mention of AI, ML, or related concepts.
Yes
The device is used to deliver positive airway pressure therapy for the treatment of Obstructive Sleep Apnea, which directly addresses a medical condition.
No
This device delivers positive airway pressure therapy for treatment; it does not diagnose a condition.
No
The device description clearly outlines a hardware system including a microprocessor-controlled blower, integrated heated humidifier, and patient circuit components (tubing, exhalation device, mask). While it mentions a "flex therapy feature cleared in K052110," which could potentially involve software control, the core device is a physical system delivering positive airway pressure.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Respironics REMstar Pro M-Series CPAP & Heated Humidifier System is a therapeutic device. It delivers positive airway pressure to treat Obstructive Sleep Apnea. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for delivering therapy for a specific condition, not for diagnostic testing of samples.
Therefore, based on the provided information, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Respironics REMstar Pro M-Series CPAP & Heated Humidifier 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 (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Respironics REMstar Pro M-Series CPAP & Heated Humidifier System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M-Series CPAP & Heated Humidifier System also includes the flex therapy feature cleared in K052110 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. The design of the humidifier has been adapted to be powered from DC. Like its predicate, the REMstar Pro M-Series CPAP & Heated Humidifier 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
Not Found
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 REMstar Pro M-Series CPAP & Heated Humidifier System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 | ||
|---|---|---|
| 510(K) SUMMARY OF SAFETY & EFFECTIVENESS | ||
| Official Contact | Zita A. Yurko | |
| Director, Regulatory Affairs | ||
| Respironics, Inc. | ||
| 1001 Murry Ridge Lane | ||
| Murrysville, PA 15668 |
724-387-4120
724-387-7490 (fax)
Email: Zita. Yurko@Respironics.com | K072996
DEC 27 2007 |
| Classification Reference | 21 CFR 868.5905 | |
| Product Code | BZD - Non-Continuous ventilator | |
| Common/Usual Name | CPAP System | |
| Proprietary Name | Respironics REMstar Pro M-Series CPAP & Heated Humidifier System | |
| Predicate Device(s) | Respironics MPAP Pro CPAP System (K052110) | |
| Reason for submission | Modified design | |
:
.
Image /page/0/Picture/5 description: The image shows a sequence of numbers, specifically "000030". The numbers are arranged horizontally, with five zeros followed by a three and then another zero. The numbers appear to be slightly distorted or aged, with some imperfections in the digits.
:
1
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- 0 Same intended use.
- Same operating principle. D
- 0 Same technology.
- Same manufacturing process. ට
Design verification tests were performed on the Respironics REMstar Pro M-Series CPAP & Heated Humidifier 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 2007.
Intended Use
The Respironics REMstar Pro M-Series CPAP & Heated Humidifier 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 Pro M-Series CPAP & Heated Humidifier System is a smaller and lighter microprocessor controlled blower based positive pressure system with integrated heated humidifier. The REMstar Pro M-Series CPAP & Heated Humidifier System also includes the flex therapy feature cleared in K052110 which provides the patient with additional comfort by easing the transition from the end of inspiration to the beginning of exhalation. The design of the humidifier has been adapted to be powered from DC. Like its predicate, the REMstar Pro M-Series CPAP & Heated Humidifier 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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines forming the wings and a base that resembles a staff with a snake winding around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
DEC 2 7 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Incorporated Ms. Zita A. Yurko Director, Regulatory Affairs Sleep & Home Respiratory Group 1740 Golden Mile Highway Monroeville, Pennsylvania 15146
Re: K072996
Trade/Device Name: Respironics REMstar Pro M-Series CPAP & Heated Humidifier System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 28, 2007 Received: November 29, 2007
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,
Robert S. Betz DDS for
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): K072996
Device Name: Respironics REMstar Pro M-Series CPAP & Heated Humidifier System
Indications for Use:
Intended Use/Indications for Use
The Respironics REMstar Pro M-Series CPAP & Heated Humidifier 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert S Betz for M. Husband
Page 1 of
(Posted November 13, 2003)
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