(120 days)
No
The summary describes a software option that amplifies patient inspiratory effort based on a clinician-specified setting. There is no mention of AI, ML, or any learning or adaptive algorithms. The performance studies focus on system-level testing, clinical simulation, and hospital setting evaluations, not on training or testing of AI/ML models.
Yes.
The device is a ventilator, which is a medical device used to support or replace the breathing function, directly treating a patient's respiratory system.
No
Explanation: The device is described as a software option for a ventilator designed to assist spontaneously breathing patients, not to diagnose medical conditions. Its purpose is to provide respiratory support.
No
The device is described as a software option for a physical ventilator (Puritan Bennett 840 Ventilator), indicating it is part of a hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to assist breathing in spontaneously breathing patients through mechanical ventilation. This is a life support and respiratory therapy function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a software option for a ventilator that amplifies the patient's inspiratory effort. This is a therapeutic intervention, not a diagnostic process.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is a medical device used for respiratory support, falling under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Puritan Bennett 840 Ventilator with Proportional Assist Ventilation® Plus software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (IBW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive. PAV+ is intended for use in hospitals and hospital-type facilities.
Product codes
CBK
Device Description
Proportional Assist Ventilation Plus is a software option for the Puritan Bennett 840 Ventilator that includes a spontaneous breath type called, Proportional Assist. PAV+ is designed to assist the spontaneous breathing patient with an active neural drive. Proportional Assist amplifies the patient's inspiratory effort. A control function allows the clinician to specify an amplification setting.
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
Intended User / Care Setting
hospitals and hospital-type facilities
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)
Performance data includes results from testing at the system level and conducting testing on controls. Clinical simulation testing was conducted to evaluate the PAV+ software in the hands of respiratory therapists. Evaluations of the software were also conducted in a hospital setting.
The performance data demonstrates substantial equivalence between the 840 Ventilator with the PAV+ software option and the legally marketed predicates; the 840 Ventilator with Volume Ventilation Plus and the Dräger EvitaXL with SmartCare/PS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Puritan Bennett 840 Ventilator with Volume Ventilation Plus (VV+), K021573, Dräger EvitaXL with SmartCare/PS Software Option, K051263
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
APR 4 2006
510(k) Summary of Safety and Effectiveness
| Submitted by: | Puritan Bennett Corporation
5931 Priestly Drive, Suite 100
Carlsbad, CA 92008
FAX: (925) 463-4020 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------|
| Company Contact: | Sarah Harrington, Regulatory Affairs Manager
(925) 463-4151
sarah.harrington@tycohealthcare.com |
| Date Prepared: | Dec. 1, 2005 |
| Trade Name: | Puritan Bennett 840 Ventilator with Proportional Assist
Ventilation® Plus (PAV+) |
| Common/Usual Name: | Continuous ventilator |
| Classification Name: | Continuous Ventilator
21 CFR 868.5895 |
| Substantially Equivalent
Devices: | Puritan Bennett 840 Ventilator with Volume Ventilation
Plus (VV+), K021573. |
| | Dräger EvitaXL with SmartCare/PS Software Option,
K051263 |
Device Description:
Proportional Assist Ventilation Plus is a software option for the Puritan Bennett 840 Ventilator that includes a spontaneous breath type called, Proportional Assist. PAV+ is designed to assist the spontaneous breathing patient with an active neural drive. Proportional Assist amplifies the patient's inspiratory effort. A control function allows the clinician to specify an amplification setting.
1
Intended Use
The Puritan Bennett 840 Ventilator with Proportional Assist Ventilation® Plus software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (IBW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive. PAV+ is intended for use in hospitals and hospital-type facilities.
Technological Characteristics
As with other commercially available modes of ventilation, PAV+ provides ventilatory support according to the measured characteristics of the patient. PA is also comparable to other spontaneous breath types already available on the 840 Ventilator, such as Volume Support.
PAV+ calculates the pulmonary compliance and total pulmonary resistance of a spontaneously breathing patient and applies a proportional pressure augmentation throughout the inspiratory phase of the ventilation. The amount of pressure augmentation is determined by the clinician.
Performance Data
Performance data includes results from testing at the system level and conducting testing on controls. Clinical simulation testing was conducted to evaluate the PAV+ software in the hands of respiratory therapists. Evaluations of the software were also conducted in a hospital setting.
The performance data demonstrates substantial equivalence between the 840 Ventilator with the PAV+ software option and the legally marketed predicates; the 840 Ventilator with Volume Ventilation Plus and the Dräger EvitaXL with SmartCare/PS.
Conclusion
The technological characteristics and the results of the performance data demonstrate that the PAV+ option for the 840 Ventilator is safe and effective and is substantially equivalent to the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 4 2006
Mr. James Bonds Puritan Bennett Corporation 4280 Hacienda Drive Pleasanton, California 94588-2719
Re: K053388
Trade/Device Name: Puritan Bennett 840 Ventilator with Proportional Assist Ventilation® Plus (PAV+) Software Option Regulation Number: 868.5895 Regulation Name: Continuous ventilator
Regulatory Class: Class II Product Code: CBK Dated: March 23, 2006 Received: March 24, 2006
Dear Mr. Bonds:
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. James Bonds
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- __ 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Suitt y. Michael Om-s.
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
4
Statement of Indications for Use
510(k) Number (if known):
K 053388
Puritan Bennett 840 Ventilator with Proportional Assist Device Name: Ventilation® Plus (PAV+) Software Option
Indications For Use:
The Puritan Bennett 840 ventilator with Proportional Assist Ventilation® Plus (PAV+) software option is intended for use in spontaneously breathing adult patients whose ventilator ideal body weight (IBW) is at least 25.0 kg. Patients must be intubated with either endotracheal or tracheostomy tubes of internal diameter of 6.0 mm to 10.0 mm. Patients must have satisfactory neural-ventilatory coupling, and stable, sustainable inspiratory drive.
PAV+ is intended for use in hospitals and hospital-type facilities.
Prescription Use __ X_ (Part 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
Aun Solom
Seneral Hospital Hospital, Truction Dental Devices
840 Ventilator PAV+ 510(k)
CONFIDENTIAL