(120 days)
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.
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.
The provided text describes a 510(k) submission for the Puritan Bennett 840 Ventilator with Proportional Assist Ventilation® Plus (PAV+) software option, which is a continuous ventilator.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or specific performance metrics that were established as targets for the PAV+ software. However, it indicates a qualitative acceptance criterion: "substantial equivalence" to legally marketed predicate devices.
| Acceptance Criteria (Qualitative) | Reported Device Performance |
|---|---|
| Substantial equivalence to legally marketed predicate devices (Puritan Bennett 840 Ventilator with Volume Ventilation Plus and Dräger EvitaXL with SmartCare/PS) in terms of safety and effectiveness. | Performance data (system level, controls, clinical simulation, hospital setting) "demonstrates substantial equivalence" in technological characteristics and safety/effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Clinical simulation testing" and "Evaluations... conducted in a hospital setting" but does not provide specific sample sizes for these test sets. The provenance of the data (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document states that "Clinical simulation testing was conducted to evaluate the PAV+ software in the hands of respiratory therapists." This implies that respiratory therapists were the users and evaluators, acting as a form of "expert" group. However, the exact number of these respiratory therapists and their specific qualifications (e.g., years of experience) are not provided. It's also unclear if they established a formal "ground truth" or simply provided feedback and assessments of the software's performance.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set. It broadly refers to "evaluations."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study is mentioned. The device is a ventilator software option, not an imaging analysis tool that typically involves "readers" in the context of MRMC studies. The focus is on the software's performance and its interaction with a human operator (respiratory therapist) rather than improving human "reading" performance. Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document states, "Performance data includes results from testing at the system level and conducting testing on controls." This suggests some level of standalone testing of the algorithm's components or the overall system without direct human interaction at all times. However, the exact nature and extent of this standalone testing are not detailed. The "clinical simulation testing" and "evaluations... in a hospital setting" clearly involved human-in-the-loop performance.
7. The Type of Ground Truth Used
The document doesn't explicitly define a "ground truth" in the sense of a gold standard (like pathology or outcome data) for the PAV+ software's performance. Instead, the "ground truth" appears to be implicitly established by:
- Comparison to predicate devices: The functionality and performance of the PAV+ software were assessed against the known characteristics and performance of the Puritan Bennett 840 Ventilator with Volume Ventilation Plus and the Dräger EvitaXL with SmartCare/PS.
- Clinical judgment/experience of respiratory therapists during simulation and hospital evaluations.
- Measured characteristics of the patient (pulmonary compliance and total pulmonary resistance) as inputs for the PAV+'s proportional pressure augmentation, implying that the algorithm's calculations and subsequent actions were verifiable.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This submission is for a medical device software, and while software development typically involves training and testing, the regulatory filing focuses on the final performance demonstration. The term "training set" is usually associated with machine learning models, and while PAV+ involves complex algorithms, it's not explicitly framed as an AI/ML product requiring a distinct "training set" description in this 2006 K05.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or detailed, the method for establishing its ground truth is also not provided.
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APR 4 2006
510(k) Summary of Safety and Effectiveness
| Submitted by: | Puritan Bennett Corporation5931 Priestly Drive, Suite 100Carlsbad, CA 92008FAX: (925) 463-4020 |
|---|---|
| Company Contact: | Sarah Harrington, Regulatory Affairs Manager(925) 463-4151sarah.harrington@tycohealthcare.com |
| Date Prepared: | Dec. 1, 2005 |
| Trade Name: | Puritan Bennett 840 Ventilator with Proportional AssistVentilation® Plus (PAV+) |
| Common/Usual Name: | Continuous ventilator |
| Classification Name: | Continuous Ventilator21 CFR 868.5895 |
| Substantially EquivalentDevices: | Puritan Bennett 840 Ventilator with Volume VentilationPlus (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.
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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.
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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
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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
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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
§ 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).