(51 days)
No
The document describes standard ventilator modes (CPAP, S/T) and does not mention any AI/ML terms, image processing, or data sets related to training or testing AI/ML models.
Yes
The device is used to augment breathing in patients with respiratory insufficiency, respiratory failure, or obstructive sleep apnea, directly treating or managing their medical conditions.
No
The device is described as a non-invasive, pressure support ventilator used to augment breathing or maintain airway patency, not to diagnose a condition.
No
The device description clearly describes a hardware device (a ventilator) with specific ventilation modes and pressure delivery mechanisms, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "non-invasive, pressure support ventilator used to augment the breathing of patients". This describes a device that directly interacts with the patient's respiratory system to provide support, not a device that analyzes samples from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The description details the ventilation modes (CPAP and S/T) and how they deliver positive pressure to the patient. This further reinforces its function as a respiratory support device.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the BiPAP Focus ventilator is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.
Product codes
MNS
Device Description
The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes:
- Continuous positive airway pressure (CPAP) which provides a single level of positive pressure to the patient
- Spontaneous/Timed (S/T) which provides two levels of positive pressure (one during inspiration - IpAp and one during expiration - EvAp) and delivers timed breaths if the patient does not initiate a breath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Adults > 30 kg
Intended User / Care Setting
Hospital, sub-acute and intra-hospital transport under qualified clinician direction and supervision; Home, Hospital, Sub-acute Institutions
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)
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2006
Dr. John O'Dea General Manager Respironics (Ireland) Limited Parkmore Business Park, Parkmore West Galway, Ireland
Re: K053168
Trade/Device Name: BiPAP Focus Regulation Number: 21 CFR 868.5895 Regulation Name: Ventilator, Continuous, Non-Life-Supporting Regulatory Class: II Product Code: MNS Dated: November 10, 2005 Received: November 14, 2005
Dear Dr. O'Dea:
This letter corrects our substantially equivalent letter of January 4, 2006.
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 narketed 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 (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 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.
1
Page-2 Dr. O'Dea
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 continue 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/dsma/dsmamain.html
Sincerely yours,
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
2
Premarket Notification 510(k) Section 4 - Indications for Use Statement Respironics BiPAP Focus
Page 1 of i
510(k) Number: (To be assigned)
Device Name:
BiPAP Focus
Indications for Use:
The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.
Intended Population
Adults > 30 kg
Environments of use
Hospital, sub-acute and intra-hospital transport under qualified clinician direction and supervision
Prescription Use XX (Part 21 CFR 80 ! Subpart D)
or
Over-the-counter use (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)
Tim Johnson
Page 4.1
3
Premarket Notification 510(k) Section 5 - 510(k) Summary
JAN 4 2006
Non-Confidential Summary of Safety and Effectiveness Page 1 of 2
10-Nov-05 Respironics Ireland Ltd. Parkmore Business Centre Tel - [353] (91) 709011 Parkmore West Fax - [353] (91) 758929 Galway, Ireland Official Contact: John O'Dea, Ph.D. - General Manager Proprietary or Trade Name: BiPAP Focus Common/Usual Name: Noninvasive ventilator Classification Name: ventilator, continuous, minimal ventilatory support, facility use (MNT) Device: Model - BiPAP Focus Predicate Devices: Respironics - Vision - K982454 Harmony K984407 and K031656
Device Description:
The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes:
- Continuous positive airway pressure (CPAP) which provides a single level of positive 1. pressure to the patient
- Spontaneous/Timed (S/T) which provides two levels of positive pressure (one during 2. inspiration - IpAp and one during expiration - EvAp) and delivers timed breaths if the patient does not initiate a breath.
Image /page/3/Picture/9 description: The image shows a piece of medical equipment sitting on a stand. The equipment has a screen and several buttons. The stand has wheels, which makes it easy to move the equipment around. The equipment is likely used to monitor a patient's vital signs.
Indications for use - The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventil support to patients who experience obstructive sleep apnea. It is not intended to romaid? } ventilatory requirements of the patient.
4
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 10-Nov-05
Patient Population - For use with patients > 30 kg
Environment of Use - Home, Hospital, Sub-acute Institutions
Differences Between Other Legally Marketed Predicate Devices
The differences between the new device, BiPAP Focus, and the predicate devices are -
- An Internal battery and associated charging circuit is being added; .
- . The existing Buzzer on Harmony 2 will become the backup Buzzer;
- The existing Remote Alarm will be reconfigured to go through an internal relay to isolate t the circuit. A ¼ Screen VGA will be used instead of the current LCD;
- The Alarm LEDs will be supplemented with Battery Status LEDs; .
- The "Vent Inop" LED will be replaced by a High Priority Text based alarm; and .
- The Industrial Design of the unit will cater for additional GUI circuitry. .
The BiPAP Focus is viewed as having a non-invasive ventilation capability substantially equivalent to the following predicate devices -
Respironics - Vision - K982454 and Harmony K984407 and K031656
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.