(63 days)
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.
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.
This document is a 510(k) summary for the BiPAP Harmony Ventilatory Support System. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance and does not detail specific acceptance criteria or a dedicated study with specific performance metrics as one might find in a clinical trial report for AI/ML devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria regarding device performance (e.g., accuracy of a measurement, sensitivity/specificity of a diagnosis, etc.) and corresponding reported performance values. Instead, it states:
"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."
This indicates that internal design verification tests were conducted against established criteria, but the criteria themselves and the detailed results are not presented in this summary.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes design verification tests for a ventilatory support system, not a study involving a "test set" of patient data in the context of an AI/ML device. The "tests" mentioned are likely engineering and functional tests of the hardware and software for safety and performance, rather than an evaluation on a dataset of patient cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document pertains to the regulatory clearance of a medical device (a ventilator), not a study evaluating an AI/ML algorithm that requires expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. As above, this is not a study evaluating an AI/ML algorithm on a test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document makes no mention of an MRMC study or any comparison of human readers with or without AI assistance. The device is a ventilatory support system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is not an AI/ML algorithm in the context of a diagnostic or predictive tool, but a medical device that provides ventilatory support. The "standalone" performance would refer to the device's functional operation in delivering therapy, which is verified through design tests.
7. Type of Ground Truth Used
Not applicable in the context of a dataset for an AI/ML algorithm. For the design verification tests, the "ground truth" would be established engineering specifications, performance standards, and safety requirements. Compliance with these established criteria would be the "ground truth" for verifying device function.
8. Sample Size for the Training Set
Not applicable. The BiPAP Harmony is a microprocessor-controlled medical device, not an AI/ML system that undergoes "training" on a dataset in the modern sense. The "design verification tests" mentioned are likely based on engineering principles and regulatory standards, not statistical training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device.
Summary of the Study Mentioned in the Document:
The document states: "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."
- Acceptance Criteria: These were established based on "risk analysis and product requirements." The specific criteria are not detailed in this summary but would likely include parameters related to pressure delivery accuracy, flow rates, alarm functionality, system stability, electrical safety, biocompatibility of patient-contacting materials, software validation, and adherence to relevant industry standards (e.g., ISO, IEC).
- Study That Proves the Device Meets Acceptance Criteria: This refers to the "design verification tests." These tests were internal to Respironics, Inc. and were conducted to confirm that the modified device (BiPAP Harmony) met its specified design requirements and safety/effectiveness standards. The document asserts that these tests were successful.
- Data Provenance: The 'data' from these design verification tests would be internal engineering and testing reports, likely conducted in Respironics' facilities in the USA (given the company's address).
- Nature of the Study: This was a set of engineering and functional verification tests, not a clinical trial or a study evaluating an AI/ML algorithm on patient data. The purpose was to demonstrate that the modifications to the device had "no impact on the safety and effectiveness" compared to the predicate devices, thereby establishing substantial equivalence for regulatory clearance.
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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. YurkoManager, Regulatory Affairs/Product AssuranceRespironics, Inc.1001 Murry Ridge LaneMurrysville, 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
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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.
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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.
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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
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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.
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| 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 |
|---|---|
| ---------------- | --------- |
§ 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).