The Esprit Ventilator with VCV Demand Flow Option is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Device Description

The VCV Demand Flow Option is a software option for the currently marketed Esprit Ventilator. It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand. VCV Demand Flow is available only in volume controlled mandatory and assist breaths. Once the software is enabled, the VCV Demand Flow feature is always available.

AI/ML Overview

The provided text describes a 510(k) submission for a device modification (VCV Demand Flow Option) to an existing Esprit Ventilator. The document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, comprehensive performance metrics, or the specific study design typically associated with a complete clinical trial or a full standalone performance evaluation of a new device.

Therefore, many of the requested categories cannot be fully answered based on the provided text. However, I will extract all available information that aligns with your request.

Acceptance Criteria and Device Performance (Limited Information Available)

The document states: "The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met." However, it does not provide a table of specific acceptance criteria (e.g., specific thresholds for flow rate accuracy, response time, etc.) nor does it report detailed device performance against such criteria. The focus is on demonstrating that the new software option for demand flow provides additional flow/volume when operator settings do not satisfy patient demand, and that this does not raise new questions of safety and effectiveness.

Performance Metric Category	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Not Explicitly Stated)
Software Functionality	Implied: All design and system requirements met	"The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met."
Demand Flow Provision	Implied: Provides additional flow/volume to patients when operator settings do not satisfy patient demand.	"It represents an enhancement intended to provide additional flow/volume to patients when operator settings do not satisfy patient demand."
Safety and Effectiveness	Implied: No new questions of safety and effectiveness compared to predicate devices.	"The addition of this new feature does not raise new questions of safety and effectiveness for the Esprit." and "The technological characteristics of the Esprit ventilator with the VCV Demand Flow and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices."

Study Details (Limited Information Available)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "Software validation testing was performed," but does not specify a sample size for a test set, nor does it provide information on data provenance (country of origin, retrospective/prospective). This typically refers to patient data, which is not mentioned in the context of this software modification.
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):
- This information is not provided. The testing described appears to be software verification and validation, not a study involving expert-adjudicated ground truth on patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided, as the study described is not a clinical or image-based adjudication study.
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:
- No MRMC comparative effectiveness study is mentioned. The device is a ventilator, not an AI diagnostic tool primarily evaluated by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone testing of the software modification ("Software validation testing was performed... The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met."). However, it does not isolate "algorithm only" performance from the overall system performance, nor does it quantify it explicitly. The VCV Demand Flow option is a software feature that enhances the ventilator's automatic response.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The concept of "ground truth" (in the sense of clinical accuracy against a definitive reference standard) is not explicitly discussed for this type of software modification. The ground truth for software validation would be defined by the design requirements and specifications themselves, against which the software's functionality is tested.
The sample size for the training set:
- Not applicable. The document describes a software modification to an existing ventilator, not a machine learning or AI model trained on a dataset.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for a machine learning model.

Summary of Study Information Available in the Document:

The study described is primarily software verification and validation testing.

Objective: To demonstrate that the VCV Demand Flow option, a software enhancement, meets all design and system requirements and does not raise new questions of safety and effectiveness compared to predicate devices.
Methodology: "Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998)."
Outcome: "The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met." and "The technological characteristics... and the results of the performance testing do not raise new questions of safety and effectiveness."

This submission is a "Special 510(k): Device Modification," which typically focuses on demonstrating that the changes do not adversely affect safety or effectiveness, often through engineering analysis and in-house testing rather than extensive clinical trials or complex AI performance studies with broad datasets and expert adjudication.

Summary

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ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification

510(k) SUMMARY

JAN 2 1 2004

Company:	Respironics California, Inc.
Address:	2271 Cosmos CourtCarlsbad, CA-92009
Contact:	Anil BhalaniManager, QA/RA
Date prepared:	December 26, 2003
Product Common Name:	Continuous Ventilator
Product Proprietary Name:	Esprit VentilatorModel Number: V1000
Device Classification:	Class II (Special Controls) and 840Continuous Ventilator per 21 CFR 868.5895 andDiagnostic Spirometer per 21 CFR 868.1Procode: CBK and BZG
Predicate Devices:	Esprit Ventilator (K023350/K981072)Bear 1000 Ventilator (K912619/A)Servoi Ventilator System (K022132)

Description of Device Modification:

Intended Use:

The Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

Esprit is not intended for use in the presence of flammable anesthetics. Esprit is a prescription use device that is intended for sale by or on the order of a physician.

Technological Characteristics:

The Esprit ventilator does not incorporate any new technological characteristics with the addition of the VCV Demand Flow option.

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KB4040

ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification

Determination of Substantial Equivalence:

The Esprit Ventilator with the VCV Demand Flow option has similar performance characteristics, the same intended use, the same environment of use and patient populations as currently marketed predicate devices. The labeling and instructional information, including warning and caution statements, is similar to that of the predicate devices. The addition of this new feature does not raise new questions of safety and effectiveness for the Esprit.

Summary of Performance Testing:

Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with VCV Demand Flow have been met.

Conclusion:

The technological characteristics of the Esprit ventilator with the VCV Demand Flow 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 is a seal for the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health, with a double helix representing DNA. The caduceus is composed of three wavy lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

Mr. Anil Bhalani Manager of QA/RA Respironics, Incorporated 2271 Cosmos Court Carlsbad, CA 92009-1517

Rc: K034040

Trade/Device Name: Esprit Ventilator, Model V1000 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 26, 2003 Received: December 29, 2003

Dear Mr. Bhalani:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your became of 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 interstate conmisive prior to tray been reclassified in accordance with the provisions of Amendinens, of to devroos and nave ooch (Act) that do not require approval of a premarket the rederal Food, Drag, and Commens , therefore, market the device, subject to the general approval appreation (1 Million). The general controls provisions of the Act include controls 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 (FMA), it may be subject to sace of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Cours nouncements concerning your device in the Federal Register.

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Page 2 - Mr. Bhalani

Please be advised that I DA's issuance of a substantial equivalence determination does not Fleast be advisod that I Dr. determination that your device complies with other requirements mean that I Dr mai maal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal babet's requirements, including, but not limited to: registration 1 our must comply with and are reveling (21 CFR Part 801); good manufacturing practice and fisting (21 CF A real of 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) This letter will are .. The FDA finding of substantial equivalence of your device to a premaired 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), If you desire spleetive at 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 Inter 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

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ESPRIT VENTILATOR WITH VCV DEMAND FLOW SPECIAL 510(k): Device Modification

Indications for Use

510(k) Number (if known): K034040

Esprit Ventilator with VCV Demand Flow Option Device Name:

Indications for Use:

The Esprit Ventilator with VCV Demand Flow Option is a microprocessor controlled, The Espit Pennancel was ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.

MB 20/04

Prescription Use(Per 21 CFR 801.109)	OR Over-The-Counter Use
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

BHWunderhauer

on Sign-C of Anesthesiology, General Hospital,

510(k) Number: K034040

Page 1 of 1

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).