The intended use of the PLV Continuum II 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 II 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, ventilator that provides ventilatory support 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. The PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings. The 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, Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous 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

The provided document is a 510(k) Premarket Notification for a modification to the PLV Continuum Ventilator, now referred to as the PLV Continuum II Ventilator. This document concerns a medical device (ventilator) and its regulatory approval process, rather than a clinical study evaluating an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.

The document primarily focuses on establishing substantial equivalence to predicate devices rather than proving the performance against specific acceptance criteria in the context of an AI/ML algorithm.

However, I can extract information related to the performance testing conducted for the device.

Here's a summary of the information that can be extracted, with notes for the fields that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as a series of performance tests, rather than a single clinical study.

Study Name/Description: "Summary of Performance Testing" (Section 16.5)
Study Objective: To demonstrate that all design and system requirements for the modified PLV Continuum have been met and to support substantial equivalence to predicate devices.
Key Finding: "The results of all testing demonstrate that all design and system requirements for the modified PLV Continuum have been met." (Section 16.5) and "The technological characteristics of the modified 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." (Section 16.6)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This is a hardware/software medical device modification submission, not an AI/ML study with a distinct "test set" of patient data. The "testing" refers to engineering and regulatory compliance testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth, in the context of patient data adjudicated by experts, is not relevant to this type of device submission. Performance was assessed against engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-powered device, nor is it a diagnostic device being evaluated with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. While the device is microprocessor-controlled with software algorithms, the "standalone" performance requested typically refers to the performance of an AI algorithm in isolation from a human user, which is not the subject of this document. The device's performance was evaluated as a complete system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable as traditionally defined for AI/ML studies. The "ground truth" here is adherence to engineering specifications and regulatory standards (e.g., flow rates, pressure delivery, safety alarms, EMC compliance).

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of an AI/ML algorithm development described in this document. The software algorithms are described as "equivalent to those used on the currently marketed Respironics PLV Continuum ventilator (K022750)".

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K03403Z" in a bold, sans-serif font. The text is oriented diagonally, sloping upwards from left to right. The characters are large and clearly legible, with a slight distortion or blurriness that suggests the image may be a scan or photograph of a physical document.

Modification to PLV Continuum Ventilator 510(k) Premarket Notification

MAR 1 6 2004

510(k) SUMMARY 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:	December 3, 2003
Product Name:	PLV Continuum II Ventilator
Product Code:	73 CBK; 73 NOU
Common Name:	Ventilator
Classification:	Class IIContinuous Ventilator (per 21 CFR 868.5895)
PredicateDevices:	• Respironics PLVC Ventilator• Respironics Esprit Ventilator• Pulmonetics LTV 1000 Ventilator	K022750 K981072 K984056

Device Description: 16.1

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, The PLV Continuum ventilator is a mioroprobocour cannothing by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generalled by offware air to the patient. FLV Continuin untile Breath delivery is controlled by software compressed an for delivery to the patient. Broadm has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient Indicator Light Enlitting Diodos (EEB) for the continuum is capable of providing the following types of ventilatory support:

Positive Pressure Ventilation, delivered either invasively (via endotracheal or . r osltive 1 roosarely (via mask or mon-invasively (via mask or mouthpiece).
tracheolonny table/ intermittent Mandatory Ventilation (SIMV) or . Assist Control, "Opentanov 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. .

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16.2 Intended Use:

The intended use of the PLVC II is to provide continuous or intermittent ventilatory rno intention as a re of individuals who require mechanical ventilation. The intended Support for the our of increasiatric and adult patients who weigh at least 5 kg (11 pation: population ninuum ventilator is intended for use in home, institutional and 1007. He settings and may be used for invasive as well as non-invasive ventilation.

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.

Technological Characteristics: 16.3

Like other continuous ventilators, PLVC II 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 algontinus that the entilator (K022750). PLVC II does not incorporate any new technological characteristics.

Determination of Substantial Equivalence: 16.4

The modes of ventilation on PLVC II are the same as the current PLVC, K022750 as well as other currently marketed ventilators. PLVC II has similar performance characteristics to the predicate devices with the same intended use, the same environment of use and patient populations. The PLVC II labeling and instructional information, including warning and caution statements, is standard for critical care ventilators used in institutional and home care environments.

Summary of Performance Testing: 16.5

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 modified PLV Continuum have been met.

16.6 Conclusion:

The technological characteristics of the modified 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.

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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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

· Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2004

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

Re: K034032

Trade/Device Name: PLV Continuum II Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: NOU, CBK Dated: December 26, 2003 Received: December 29, 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.

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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 (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), 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,

for

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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Indications For Use Statement

Applicant:	Respironics California, Inc.2271 Cosmos CourtCarlsbad, CA 92009USA
510(k) Number:	K034032

PLV Continuum II Device Name:

Indications for use: The intended use of the PLV Continuum II 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 II ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

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 Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

KD 34032 510(k) Number

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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).