(63 days)
Not Found
No
The document describes a microprocessor-controlled blower/valve system with a pressure relief feature. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
Yes.
The device is intended to treat respiratory insufficiency or obstructive sleep apnea, conditions affecting the body.
No
The device is a ventilator used to deliver therapy for respiratory insufficiency or sleep apnea, not to diagnose these conditions.
No
The device description clearly states it is a "microprocessor controlled blower/valve based bi-level positive pressure system," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided text, the BiPAP Harmony is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing non-invasive ventilation to treat respiratory insufficiency and obstructive sleep apnea. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a system that delivers positive pressure to the patient's airway. This is consistent with a respiratory support device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The BiPAP Harmony is a medical device used for respiratory therapy.
N/A
Intended Use / Indications for Use
The BiPAP Harmony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea.
The BiPAP Harmony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Product codes
MNS
Device Description
The Respironics BiPAP Harmony Ventilatory Support System is a microprocessor controlled blower/valve based bi-level positive pressure system that delivers two different positive pressure levels (IPAP/EPAP). To improve comfort of the therapy being delivered, Respironics is adding an additional therapy feature to the CPAP and S modes only to provide pressure relief during exhalation. The BiPAP Harmony 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, a method of venting exhaled gases, 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
adult patients (>30 kg)
Intended User / Care Setting
Home or hospital/institutional environments
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 Harmony Ventilatory Support 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.
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
iPAP Harmony Ventilatory Support System
TAB 3
JUL 3 0 2003
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
中國國際。
| Official Contact | Zita A. Yurko
Manager, Regulatory Affairs/Product Assurance
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 868.5895
- Product Code MNS – Non-Continuous ventilator
- Common/Usual Name Ventilator, continuous, non-life supporting
- Respironics BiPAP Harmony Ventilatory Support System Proprietary Name
- Respironics BiPAP Synchrony Ventilatory Support System (K012323) Predicate Device(s)
- Respironics BiPAP BiPAP Pro Bi-Level System (K011714)
- Modified design, enhanced mode; change in environment of use. Reason for submission
1
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate devices:
- O Same intended use.
- Same operating principle. ර
- O Same technology.
- D Same manufacturing process.
Design verification tests were performed on the Respironics BiPAP Harmony Ventilatory Support 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 1998.
Intended Use
The BiPAP Harmony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea. The BiPAP Harmony may be used in the home or hospital/institutional environments.
The BiPAP Harmony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Device Description
The Respironics BiPAP Harmony Ventilatory Support System is a microprocessor controlled blower/valve based bi-level positive pressure system that delivers two different positive pressure levels (IPAP/EPAP). To improve comfort of the therapy being delivered, Respironics is adding an additional therapy feature to the CPAP and S modes only to provide pressure relief during exhalation. The BiPAP Harmony 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, a method of venting exhaled gases, and a patient interface device.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2003
Ms. Zita A. Yurko Manager, Regulatory Affairs Respironics, Incorporated 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
Re: K031656
Trade/Device Name: BiPAP Harmony Ventilator Support System Regulation Number: 868.5895 Regulation Name: Non-Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: May 27, 2003 Received: May 28, 2003
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.
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.
3
Page 2 - Ms. Zita A. Yurko
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 vour 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 (301) 594-4646. 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/dsma/dsmamain.html.
Sincerely yours,
Patricia Cincente/fo
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Respironics BiPAP Harmony Ventilatory Support System
Intended Use/Indications for Use
The BiPAP Harmony is intended to provide non-invasive ventilation in adult patients (>30 kg) for the treatment of respiratory insufficiency (a condition in which the patient can continue without ventilation for some period, such as overnight) or obstructive sleep apnea.
The BiPAP Harmony is intended for use with nasal masks and full-face masks as recommended by Respironics.
Environment of Use/Patient Population
For use in the home or hospital/institutional environment on adult patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
(Division Sign-Off
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K031656 |
|---|---|
| ---------------- | --------- |