(111 days)
Not Found
No
The description focuses on standard microcontroller-based control, digital and analog process control, and safety features. There is no mention of AI, ML, or related concepts.
Yes.
The device is intended to augment the breathing of patients suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea, which are therapeutic uses.
No
The device is an assist ventilator intended to augment breathing and provide therapy, not to diagnose medical conditions.
No
The device description explicitly details hardware components such as a microcontroller, LCD screen, keys, and a rotary adjustment knob, and the performance studies include electrical, electromagnetic, and mechanical testing, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided text, the Respironics BiPAP Vision® Ventilatory Support System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "assist ventilator intended to augment the breathing of spontaneously breathing adult patients". This describes a device that directly interacts with the patient's respiratory system to provide therapy.
- Device Description: The description details a system that delivers pressurized air, monitors respiratory variables, and has a user interface for controlling ventilation settings. This aligns with the function of a respiratory support device.
- Lack of IVD Characteristics: The text does not mention any of the key characteristics of an IVD device, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on the analysis of samples.
- Performing tests outside of the body (in vitro).
Instead, the device is a therapeutic device used to support a patient's breathing in vivo (within the body).
N/A
Intended Use / Indications for Use
The Respironics BiPAP Vision® Ventilatory Support System is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non-invasive applications.
Product codes (comma separated list FDA assigned to the subject device)
73 MNT
Device Description
The BiPAP Vision can provide therapy in the modes of continuous positive airway pressure (CPAP), and pressure support ventilation, with preset, machine assisted breaths available as a backup to the patient's respiratory spontaneity, i.e., the Spontaneous/Timed (S/T) mode. Both modes of operation of the BiPAP Vision provide accurate and reliable delivery of pressurized air, at flows sufficient to accommodate the needs of adult patients (≥ 30 kg). The BiPAP Vision is a microcontroller-based, pressure assist, critical care, continuous ventilator that has been provided with digital and analog process control and variable monitoring capabilities, and a comprehensive array of alarms, engineered safety features and self diagnostic functions. The BiPAP Vision architecture, and the electrical, mechanical and material specifications of all system components were selected to optimize performance and reliability. The BiPAP Vision also incorporates a number of safety features and self-diagnostic testing capabilities.
A Liquid Crystal Display (LCD) video screen mounted on the front of the unit, together with an array of keys and a rotary adjustment knob, provide the primary user interface with the BiPAP Vision. The display includes waveform or bargraph representation of the process variables, and a digital display of the control settings and any alarm conditions. User interaction with the device is accomplished by keystrokes and rotation of the adjustment knob while observing the results of this manipulation on the display. The information provided on the display varies depending on the operating mode and/or the operations being performed.
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 kgs)
Intended User / Care Setting
The BiPAP Vision is intended for use in a hospital environment (including sleep labs, respiratory care units) or alternate care site (e.g., transitional care centers, skilled nursing homes, ambulatory care centers) by respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician.
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)
The safety of the BiPAP Vision Ventilatory Support System, i.e., the BiPAP Vision with the Respironics-approved circuits and accessories, was verified through performance testing that consisted of Electrical Safety, Electromagnetic Compatibility, and Mechanical and Environmental testing. The BiPAP Vision was found compliant and has been certified to the applicable sections of the following standards: IEC 601-1, IEC 801-1, IEC 801-2, IEC 801-3, IEC 801-4, CISPR 11, IEC 68-2-6, IEC 68-2-27, IEC 68-2-34, MIL-STD-461D, MIL-STD-462D, and MIL-STD-810E. The safety and effectiveness of the BiPAP Vision was verified by a comparative analysis of the predicate devices; functional testing of the device against product specifications; and, testing to ASTM F 1100-90, and the performance requirements of the FDA Reviewers Guidance.
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
§ 868.5895 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
NOV 3 1998
RESPIRONICS INC.
1001 Murry Ridge Lane, Murrysville, PA 15668
Official Contact
David J. Vanella Manager, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
Telephone: (724) 733-0200
Classification Name
Common/Usual Name
Proprietary Name
Predicate Devices
21 CFR 868.5895,73 MNT
Ventilator, Continuous
BiPAP Vision® Ventilatory Support System
Respironics BiPAP S/T-D 30 - K955324 Respironics, Inc.
BiPAP and BiPAP Vision are registered trademarks of Respironics, Inc.
1
Substantial Equivalence to Predicate Devices
The SE Comparative Analysis performed in the Section 510(k) Premarket Notification for the BiPAP Vision demonstrates that it compares favorably with the two predicate devices in the provision of engineered safety features and alarm functions, and that it is substantially equivalent to them, both in its intended use, and in its safety and effectiveness for the comparable operating modes, viz., CPAP and Spontaneous with Timed breaths as a backup (S/T). The SE Analysis, thus, allows the conclusion that the BiPAP Vision presents no additional concerns regarding safety or effectiveness.
Furthermore, testing was performed to demonstrate that the performance of the BiPAP Vision in its intended environment is as safe and effective as that of each of the legally marketed predicate devices. The BiPAP Vision has been found to be in compliance with, and has been certified to, the standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications, November 1993." The effectiveness of the BiPAP Vision has been further established through testing to the performance requirements of ASTM F 1100-90 and the "Draft Reviewers Guidance For Ventilators", July 1995.
Intended Use
The BiPAP Vision Ventilatory Support System is an assist ventilator and is intended to augment patient breathing. It is not intended to provide the total ventilatory requirements of the patient. The BiPAP Vision Ventilatory Support System is intended for spontaneously breathing adult patients suffering from acute respiratory failure, acute or chronic respiratory insufficiency, or obstructive sleep apnea in hospitals, or other institutional settings, under the direction of a physician. It may also be indicated for intubated patients meeting the same selection criteria as the noninvasive applications. Operators of the BiPAP Vision are expected to be physicians, nurses and respiratory therapists. The patient would not be responsible for ventilator control. The BiPAP Vision is used with various combinations of Respironics-approved patient circuit accessories, such as patient interface devices (masks and headgear assemblies, endotracheal tube elbow adapter), humidifiers, and circuit tubing.
2
Device Description
Introduction
The BiPAP Vision can provide therapy in the modes of continuous positive airway pressure (CPAP), and pressure support ventilation, with preset, machine assisted breaths available as a backup to the patient's respiratory spontaneity, i.e., the Spontaneous/Timed (S/T) mode. Both modes of operation of the BiPAP Vision provide accurate and reliable delivery of pressurized air, at flows sufficient to accommodate the needs of adult patients (≥ 30 kg). The BiPAP Vision is a microcontroller-based, pressure assist, critical care, continuous ventilator that has been provided with digital and analog process control and variable monitoring capabilities, and a comprehensive array of alarms, engineered safety features and self diagnostic functions. The BiPAP Vision architecture, and the electrical, mechanical and material specifications of all system components were selected to optimize performance and reliability. The BiPAP Vision also incorporates a number of safety features and self-diagnostic testing capabilities.
A Liquid Crystal Display (LCD) video screen mounted on the front of the unit, together with an array of keys and a rotary adjustment knob, provide the primary user interface with the BiPAP Vision. The display includes waveform or bargraph representation of the process variables, and a digital display of the control settings and any alarm conditions. User interaction with the device is accomplished by keystrokes and rotation of the adjustment knob while observing the results of this manipulation on the display. The information provided on the display varies depending on the operating mode and/or the operations being performed. The Vision is shown in Figure 12.1
3
Premarket Notification Section 510(k) Section 12 - Summary of Safety & Effectiveness
Image /page/3/Figure/2 description: The image shows a medical ventilator machine. The ventilator has a screen displaying waveforms, likely representing respiratory parameters such as pressure, volume, or flow over time. There are also several buttons and knobs on the front panel, which are used to control the ventilator's settings and modes. The ventilator is a compact, portable device designed for use in hospitals or other medical settings.
Figure 12.1 -- The BiPAP Vision Ventilator
Principles of Operation
Ambient air is drawn in through an integral air intake filter, and pressurized in a centrifugal blower assembly. System total flow and pressure are regulated by means of a valve assembly located in the blower discharge manifold.
As mentioned previously, a Liquid Crystal Display (LCD) video screen mounted on the front panel of the unit is the primary user interface with the BiPAP Vision. It provides a continuous display of total gas flow, temperature, generated pressure, and patient circuit pressure to ensure prescribed therapy to the patient.
4
Premarket Notification Section 510(k)
Section 12 - Summary of Safety & Effectiveness
Image /page/4/Figure/3 description: This image shows a BiPAP Vision machine with various labeled components. The machine features a graphic display showing waveforms and numerical data, including IPAP at 15, EPAP at 6, and Rate at 12. The device also includes soft keys with descriptors, alarm hard keys, and lights indicating ventilator operation and checks, along with pressure line and patient interface ports.
Figure 12.2 -- BiPAP Vision Front Panel: Controls and Displays
The front panel, shown in Figure 12.2, has a rotary adjustment knob, eight hardkeys, and ten soft-keys to establish the ventilatory parameters, alarm settings and the ventilator graphics. The hard-keys are mechanical key switches dedicated to specific functions regardless of the mode of operation. They become active or inactive based on the screen currently displayed in the Graphic Display Area. The hard key functions are: Monitoring, Mode, Parameters, Alarms, Scale, Freeze/Unfreeze, Alarm Silence, and Alarm Reset. The soft-keys are dome-key switches, the functions of which change depending upon the displayed screen or the current mode. The soft-key function is displayed in the soft-key descriptor area that is immediately adjacent to the key. The Rotary Adjustment Knob allows the user to adjust the values of the ventilatory parameter that has been "activated" with a soft-keystroke. The knob is "active" only when a soft-key is used to select a parameter.
Triggering and Cycling Logic
In the S/T operating mode the BiPAP Vision employs enhanced triggering/cycling logic that accommodates variable leak conditions and patient breathing patterns, thereby minimizing early triggering and delays in cycling, and resulting in improved patient-ventilator synchrony. The BiPAP Vision senses when to trigger and cycle in accordance with established rule sets.
5
F.03
System Configurations
The Phoenix BiPAP Vision Basic Unit is equipped with the standard alarm package (i.e., High Pressure, Low Pressure and Delay, and Apnea).
Options
(Available as product "upgrades")
- Oxygen Module
- Mobile Stand
Patient Circuit Configurations
The BiPAP Vision Ventilator is intended for use with a patient circuit specifically approved by Respironics, Inc. All the patient circuits that Respironics has approved for use with the BiPAP Vision are illustrated in Figure 1.4(a) - (c).
Image /page/5/Figure/11 description: The image shows a diagram of a vision unit with various components. The vision unit is connected to a bacteria filter and 72" smooth inner lumen tubing. Other components include a proximal pressure line, disposable exhalation port, mouthpiece adaptor, contour nasal mask, plateau exhalation valve, whisper swivel, and spectrum full face mask.
the exhalation port or to the mask (when
Figure 1.4(a) -- Typical Approved BiPAP Vision Patient Circuit For Noninvasive Patient Interfaces
Section 12, Page 6
6
Image /page/6/Figure/2 description: This image shows a diagram of a Vision Unit connected to various components. The Vision Unit is connected to a bacteria filter, which is then connected to 18" smooth inner lumen tubing. The tubing connects to a low resistance HC 100 heated humidifier and 72" smooth inner lumen tubing. The diagram also shows a proximal pressure line, a disposable exhalation port, a mouthpiece adaptor, a contour nasal mask, a plateau exhalation valve, a whisper swivel, and a spectrum full face mask.
- The proximal pressure line may connect to either the exhalation port or to the mask (when a mask is used).
Figure 1.4(b) -- Approved BiPAP Vision Patient Circuit With Optional Humidifier
Image /page/6/Figure/5 description: This image shows a diagram of a vision unit connected to a series of tubes and components. The vision unit is on the left side of the image, and it is connected to a proximal pressure line with a bacteria filter. The proximal pressure line is connected to a low resistance heated humidifier, a water trap, a temperature probe adapter, and a disposable exhalation port. The disposable exhalation port is connected to a right angle trach elbow and a patient connection.
Figure 1.4(c) -- Approved BiPAP Vision Patient Circuit For Invasive Applications
As depicted in Figure 1.4, the Respironics-approved patient circuit consists of the following components:
- a bacteria filter; ●
- a transparent proximal pressure line (1/8" I.D.) with a smooth inner ● lumen;
- a patient circuit tube with smooth inner lumen;
7
- an exhalation device such as the Whisper Swivel, Respironics Disposable ● Exhalation Port assembly, or Plateau Exhalation Valve; and
- a Respironics noninvasive or invasive patient interface. .
Also, as an option,
- a Heated humidifier .
Patient Circuit Components and Accessories
-
Disposable Noninvasive Circuit: .
Includes 72 inch tubing, exhalation port, 84 inch proximal pressure line, hanger, and hose clips. -
Disposable Invasive Circuit: ●
Includes circuit tubing, exhalation port, water trap, humidifier, proximal pressure line, hanger, hose clips, and airway adapter. -
Circuit Tubing:
72 inch disposable circuit tubing 18 inch disposable circuit tubing 36 inch disposable humidifier tubing Disposable proximal pressure line with tee -
O2 enrichment attachment .
-
Disposable bacteria filter
-
Water Trap, Model No. 073-0072-95, manufactured by Marquest, Inc ●
-
Exhalation Ports: ●
Disposable exhalation port Whisper Swivel® exhalation port Plateau™ exhalation port
- Patient Interfaces
Masks:
Disposable vinyl masks Reusable contour nasal masks Spectrum™ disposable full face mask Comfort Flap® mask accessory Disposable mouthpiece adapter
8
Mask Accessories:
Disposable headgear Reusable headgear Chin strap Softcap™ Slip-on spacers
Endotracheal Tube Interface:
Marquest Tracheal Tube Elbow Adapter
Humidifiers: ●
Fisher & Paykel MR730 Respiratory Humidifier disposable chambers recommended for invasive applications
Hardware: ●
Circuit Support Arm Mobile Stand Humidifier Pole Mount
9
Summary of the Functional and Performance Testing Conducted
As mentioned previously, in addition to the SE Comparative Analyses, the determination of substantial equivalence of the Vision with its predicate devices is based on performance testing that was conducted to demonstrate it to be safe and effective in its intended environment. Thus, the safety of the BiPAP Vision Ventilatory Support System, i.e., the BiPAP Vision with the Respironics-approved circuits and accessories, was verified through performance testing that consisted of Electrical Safety, Electromagnetic Compatibility, and Mechanical and Environmental testing. Again, the BiPAP Vision was found compliant and has been certified to the applicable sections of the following standards, as referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications, November 1993":
- IEC 601-1: General Requirements for Safety of Medical Electrical ● Equipment;
- IEC 801-1: Electromagnetic Compatibility for Industrial Process and . Measurement and Control Equipment, Part 1;
- IEC 801-2: Electrostatic Discharge Requirements; ●
- IEC 801-3: Radiated Electromagnetic Field Requirements; .
- IEC 801-4: Electrical Fast Transients/Burst Requirements; .
- CISPR 11: Limits and Methods of Measurement of Radio Interference ● Characteristics of Industrial, Scientific, and Medical Equipment;
- IEC 68-2-6: Basic Environment Test Procedures, Part 2: Tests. Test Fc ● and Guidance: Vibration (Sinusoidal);
- . IEC 68-2-27: Basic Environment Test Procedures, Part 2: Tests. Test Ea and Guidance: Shock;
- IEC 68-2-34: Basic Environment Test Procedures, Part 2: Tests. Test ● Fdc: Random Vibration Wide Band - Reproducibility Low;
- MIL-STD-461D: Requirements for Control of Electromagnetic ● Interference Emissions and Susceptibility;
- MIL-STD-462D: Measurements of Electromagnetic Interference . Characteristics; and
- MIL-STD-810E: Environmental Test Methods .
Thus, the safety and effectiveness of the BiPAP Vision was verified by a comparative analysis of the predicate devices; functional testing of the device against product specifications; and, testing to ASTM F 1100-90, and the performance requirements of the FDA Reviewers Guidance.
10
Image /page/10/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 NOV
Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550
Re: K982454 BiPAP Vision Ventilatory Support System Regulatory Class: II (two) Product Code: 73 MNT Dated: October 14, 1998 Received: October 15, 1998
Dear Mr. Vanella:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, r other Federal laws or regulations.
11
Page 2 -- Mr. David J. Vanella
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
12
Page 1 of 1
510(k) Number (if known): _ 1982454
Device Name: BiPAP Vision ® Ventilatory Support System
Indications for Use:
Intended Use/Indications for Use
The Respironics BiPAP Vision® Ventilatory Support System is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients (>30 kgs) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient. It is intended to be used for both invasive and non-invasive applications.
The BiPAP Vision is intended for use in a hospital environment (including sleep labs, respiratory care units) or alternate care site (e.g., transitional care centers, skilled nursing homes, ambulatory care centers) by respiratory therapists, sleep lab technicians or nurses under the supervision or direction of a physician.
The BiPAP Vision is used with various combinations of Respironics-approved patient circuit accessories, such as patient interface devices (masks and tracheal tube adapter), humidifiers, and circuit tubing.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kramer
Division of Cardiovascular, Respiratory, and Neurological D 510(k) Number
i.
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)