BIPAP AUTOSV

K063540 · Respironics, Inc. · MNS · Feb 22, 2007 · Anesthesiology

Device Facts

Record IDK063540
Device NameBIPAP AUTOSV
ApplicantRespironics, Inc.
Product CodeMNS · Anesthesiology
Decision DateFeb 22, 2007
DecisionSESE
Submission TypeAbbreviated
Regulation21 CFR 868.5895
Device ClassClass 2
AttributesTherapeutic

Intended Use

The BIPAP AutoSV is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Device Story

Microprocessor-controlled, blower-based bi-level positive pressure system; delivers IPAP/EPAP pressure levels. Inputs: flow and pressure data from patient airway sensors. Operation: microprocessor regulates blower assembly based on sensor feedback to normalize ventilation during sleep-disordered breathing. Output: automated pressure support between IPAP Min and IPAP Max settings; clinical data displayed on user interface. Used in home or clinical settings; operated by patient or clinician. Benefits: provides non-invasive ventilatory support to treat central/mixed apneas and periodic breathing; improves patient comfort via dual pressure levels.

Clinical Evidence

Bench testing only. No clinical data presented. Bench testing compared waveform performance, triggering, alarms, and event detection/control data against the Resmed VPAP Adapt predicate to confirm equivalent performance.

Technological Characteristics

Microprocessor-controlled blower-based bi-level positive pressure system. Includes flow and redundant pressure sensors. Delivers IPAP/EPAP pressure support. User interface for parameter adjustment and data display. Fixed and user-adjustable alarms. Uses standard 22mm patient circuit tubing.

Indications for Use

Indicated for adult patients with OSA and respiratory insufficiency caused by central and/or mixed apneas and periodic breathing.

Regulatory Classification

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.

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Abbreviated 510(k) Tab 5 - 510(k) summary K063540 Date of Submission 22 November 2006 Official Contact Zita A. Yurko Manager, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 Zita.yurko@respironics.com > 724-387-4120 t 724-882-4120 с 724-387-4216 f Classification Reference 21 CFR 868.5895 Product Code Common/Usual Name Ventilator, continuous, non-life supporting Proprietary Name Respironics BiPAP AutoSV Ventilatory Support System MNS – Non-Continuous ventilator Predicate Device(s) Respironics BiPAP Synchrony HC (K992530) Respironics BiPAP Synchrony S/T (K012323) Respironics BiPAP Harmony (K031656) Resmed VPAP III ST-A / Kidsta system (K060105) Reason for submission new device # Substantial Equivalence The BiPAP AutoSV has the following similarities to the previously cleared predicate device: - 0 Same intended use. - Same operating principle. D - Same technology. 0 {1}------------------------------------------------ Tab 5 – 510(k) summary O Same manufacturing process. The BiPAP Synchrony was cleared in K992530/K012323/K020777. The VPAP Adapt was cleared in K051364. Respironics has performed a risk analysis to identify the consideration of using the existing BiPAP Synchrony electromechanical platform with the AutoSV algorithm to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. To determine equivalence between the Respironics BiPAP AutoSV and the Resmed VPAP Adapt, comprehensive bench testing was performed. This testing including collecting waveform performance data, triggering data, alarms data, and overall event diction and control data for comparison to the VPAP Adapt. Bench testing has confirmed that the BiPAP AutoSV performs equivalently to the device predicate VPAP Adapt (K051364). All tests were verified to meet the required acceptance criteria. # Intended Use The BIPAP AutoSV is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. # Device Description The Respironics BiPAP AutoSV is a microprocessor controlled blower based Bi-level positive pressure system that delivers two positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. A flow sensor and redundant pressure sensors in the patient airway feed data on measured flow and pressure into a microprocessor controller, which in turn regulates the blower assembly. A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters. The BiPAP AutoSV pressure control that contains various which are used to configure positive pressure therapies. With these controls, the device delivers minimum pressure support determined by the EPAP and IPAP Min controls. The device may automatically provide additional pressure support with inspiratory pressures between IPAP Min and IPAP Max to normalize patient ventilation during sleep disordered breathing events. Note: When EPAP < IPAP Min = IPAP Max, this is equivalent to traditional bi-level therapy. The BiPAP AutoSV is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable. {2}------------------------------------------------ ... ..... Tab 5 – 510(k) summary The BiPAP AutoSV Ventilatory Support 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, a method of venting exhaled gases.. (End of Tab.) 000021 {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the eagle. The logo is black and white. 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 FEB 2 2 2007 Re: K063540 Trade/Device Name: BiPAP AutoSV Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: November 22, 2006 Received: November 24, 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. {4}------------------------------------------------ #### 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, Clare Ellis-Lain, Ph.D. 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): _ Device Name: ____BiPAP AutoSV The BiPAP AutoSV is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing. Over-The-Counter Use _ Prescription Use __ × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Will Maler for M. Husband Anesthestology Concral Hospital Control. Dental Devices
Innolitics
510(k) Summary
Decision Summary
Classification Order
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