The intended use of the PLV Continuum ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

Device Description

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PLV Continuum is capable of providing the following types of ventilatory support:

Positive Pressure Ventilation, delivered either invasively (via endotracheal or . tracheostomy tube) or non-invasively (via mask or mouthpiece).
Assist/Control. Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
Volume-Controlled (VC). Available in A/C and SIMV. .
Pressure-Controlled (PC). Available in A/C and SIMV. .
Pressure Support (PS). Available in SIMV and SPONT. ●

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PLV Continuum Ventilator:

Acceptance Criteria and Device Performance for PLV Continuum Ventilator

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Performance Testing	The results of all testing demonstrate that all design and system requirements for the PLV Continuum have been met per ASTM F 1100-90 and F 1246-91.*
EMC Testing	Performed per IEC 60601-1-2.
Electrical, Mechanical, and Environmental Testing	Performed in accordance with the FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993).
Software Validation Testing	Performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998).
Substantial Equivalence	PLVC has similar performance characteristics to the predicate devices, the same intended use, same environment of use and patient populations. PLVC does not raise new questions of safety or effectiveness.
Technological Characteristics	Utilizes an internal compressor and software algorithms equivalent to currently marketed Respiratory Esprit ventilator (K981072). Does not incorporate new technological characteristics.
Intended Use Alignment	Provides continuous or intermittent ventilatory support for pediatric and adult patients (at least 5kg) in home, institutional, and portable settings, for invasive and non-invasive ventilation.

Note: The document states that the results "demonstrate that all design and system requirements...have been met," implying successful adherence to the standards. Specific numerical performance data against acceptance thresholds from ASTM F 1100-90 and F 1246-91 are not explicitly detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document refers to "Performance testing," "EMC testing," "Electrical, mechanical and environmental testing," and "Software validation testing" as being conducted, but typical details like the number of devices tested, number of patients, or specific test scenarios are not included in this high-level summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. Performance testing for a ventilator typically involves engineering and functional tests against specifications, rather than expert-established ground truth in the same way a diagnostic imaging AI might.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The document describes performance testing against established standards and guidance, not an adjudication process of expert opinions.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic AI devices where human readers interpret medical images or data. The PLV Continuum Ventilator is a mechanical ventilator, and its evaluation focuses on its functional performance, safety, and equivalence to predicate devices, not on human-in-the-loop diagnostic accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Given that the device is a mechanical ventilator, the "standalone" performance would encompass the various performance tests mentioned (e.g., breath delivery accuracy, alarm functionality, power consumption) without direct human intervention in its core mechanical operation. The summary states: "Breath delivery is controlled by software algorithms." This implies algorithmic function is evaluated as part of the overall device performance. However, there isn't a separate "algorithm only" study specifically described as it would be for an AI diagnostic device. The performance testing evaluates the device's functions, which are driven by its algorithms.

7. The Type of Ground Truth Used

The "ground truth" for the PLV Continuum Ventilator's performance testing is based on established engineering standards and regulatory guidance. This includes:

ASTM F 1100-90 and F 1246-91: These are standards for ventilators, providing the criteria against which the device's mechanical and functional performance (e.g., volume delivery, pressure control, alarm thresholds) would be measured.
FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993): This guidance dictates the requirements for electrical, mechanical, and environmental testing.
FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998): This guidance sets the "ground truth" for software validation.

Essentially, the "ground truth" is defined by compliance with these recognized safety and performance standards for medical devices.

8. The Sample Size for the Training Set

The concept of a "training set" is usually applicable to machine learning or AI models that learn from data. The PLV Continuum Ventilator is described as a "microprocessor controlled" device with "software algorithms" that are "equivalent to those used on the currently marketed Respironics Esprit ventilator." This suggests that the software algorithms were developed based on established engineering principles for ventilator function, possibly iteratively tested and refined, rather than being "trained" on a large dataset in the sense of a deep learning model. Therefore, a "training set" in the context of an AI model driven by data is not explicitly mentioned or directly applicable here.

9. How the Ground Truth for the Training Set Was Established

As the device relies on established software algorithms and engineering principles rather than a data-driven AI model, the concept of a "training set" with established ground truth as it applies to AI/ML is not relevant here. The ground truth for the development of such a device's software would stem from physiological requirements for ventilation, mechanical engineering principles, and the performance characteristics of predicate devices, which were then codified into algorithms. The testing described then verifies that these algorithms, as implemented in the device, meet the specified performance and safety requirements.

Summary

{0}------------------------------------------------

KOZZ750

NOV 2 0 2003

SUMMARY OF SAFETY AND EFFECTIVENESS 16

CompanyInformation:	Respironics, California Inc.2271 Cosmos CourtCarlsbad, CA. 92009
ContactInformation:	Mary FunkRegulatory Affairs Project Manager
	Phone Number: (760) 918-7328Fax Number: (760) 918-0169
Date Prepared:	June 25, 2002
Product Name:	PLVC Ventilator
Common Name:	Ventilator
Classification:	Class IIContinuous Ventilator (per 21 CFR 868.5895)
PredicateDevices:	• Respironics PLV-102 Ventilator K842876• Respironics Esprit Ventilator K981072• Pulmonetic Systems LTV 1000 K984056

Device Description: 16.1

Positive Pressure Ventilation, delivered either invasively (via endotracheal or . tracheostomy tube) or non-invasively (via mask or mouthpiece).
Assist/Control. Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
Volume-Controlled (VC). Available in A/C and SIMV. .
Pressure-Controlled (PC). Available in A/C and SIMV. .
Pressure Support (PS). Available in SIMV and SPONT. ●

{1}------------------------------------------------

16.2 Intended Use:

PLVC is not intended for use as an emergency transport ventilator. It is not intended for use in the presence of flammable anæsthetics. PLVC is a prescription use device that is intended for sale by or on the order of a physician.

16.3 Technological Characteristics:

Like other continuous ventilators, PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator (reference K981072). PLVC does not incorporate any new technological characteristics.

16.4 Determination of Substantial Equivalence:

The modes of ventilation on PLVC are similar to those on other currently marketed continuous ventilators. PLVC has similar performance characteristics to the predicate devices, the same intended use, same environment of use and patient populations. PLVC does not raise new questions of safety or effectiveness. The PLVC labeling and instructional information, including warning and caution statements, is similar to that of the predicate devices.

16.5 Summary of Performance Testing:

Performance testing was conducted per the applicable sections of ASTM F 1100-90 and F 1246-91. EMC testing was performed per IEC 60601-1-2. Electrical, mechanical and environmental testing was performed in accordance with the FDA Draft Reviewer Guidance for Premarket Notification Submissions (1993). Software validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all testing demonstrate that all design and system requirements for the PLV Continuum have been met.

16.6 Conclusion:

The technological characteristics of the PLV Continuum ventilator and the results of the performance testing do not raise new questions of safety and effectiveness when compared 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Respironics, California Incorporated Ms. Mary Funk Regulatory Affairs Project Manager Hospital Division 2271Cosmos Court Carlsbad, California 92009-1517

Re: K022750

Trade/Device Name: PLV Continuum Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: NOU, CBK Dated: August 25, 2003 Received: August 26, 2003

Dear Ms. Funk:

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.

{3}------------------------------------------------

Page 2 - Ms. Funk

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 (OS) 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 (301) 594-4646. 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.

Ole

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}------------------------------------------------

Respironics PLV Continuum Ventilator 510(k) Premarket Notification

Indications For Use Statement

Applicant:

Respironics (California) Inc. 2271 Cosmos Court Carlsbad, CA 92009 USA

K022750 510(k) Number:

PLV Continuum Ventilator Device Name:

Indications for use:

Prescription Use:

Yes (Per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022750

Prescription Use V

OTC Use

Regulation Number and Section

§ 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).