The intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 – 4.0 mm.

Device Description

The Neonatal Option is a software modification to the currently marketed Esprit Ventilator. Once the software is enabled and the neonatal patient type is selected on the Esprit, it provides the following types of ventilatory support to neonatal patients in invasive applications only: Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CPAP) modes of ventilation. Pressure-Controlled (PC). Available in A/C and SIMV. Pressure Support (PS). Available in SIMV and SPONT. Apnea Ventilation

AI/ML Overview

The provided text describes a software modification to the Esprit Ventilator, called the "Neonatal Option," but it does not contain acceptance criteria or a study proving that the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary for a medical device modification, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

Here's an breakdown of what is and isn't available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	"Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met."

Comment: The document states that "performance testing was successfully completed" and "all design and system level requirements...have been met," but it does not explicitly list what those acceptance criteria (e.g., specific metrics like accuracy, precision, or reliability thresholds) were, nor does it provide the quantitative results of the performance testing against such criteria. It's a high-level statement of success.

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

Sample Size: Not specified.
Data Provenance: Not specified. The testing described is "Software verification and validation testing," implying internal testing rather than clinical study data from a specific country or retrospective/prospective collection.

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

Number of Experts: Not applicable. The document is about a ventilator's software modification, not an AI or diagnostic device that typically requires expert-established ground truth from medical images or clinical observations.
Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This type of testing (software verification and validation for a ventilator) does not typically involve expert adjudication of results in the way an AI diagnostic tool would.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study: No. This document does not describe an MRMC study. The device is a ventilator, not an imaging or diagnostic AI tool that would typically involve human readers.
Effect Size of Human Readers: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

Standalone Study: Yes, indirectly. The "Software verification and validation testing" is conducted on the device's software algorithms to ensure they meet design and system-level requirements. This inherently refers to the algorithm's performance in controlling ventilation parameters. However, specific metrics or a detailed standalone performance study report are not provided. The phrase "Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator" suggests that the technical characteristics and performance of these algorithms were deemed equivalent to a previously cleared device.

7. Type of Ground Truth Used:

Type of Ground Truth: "Design and system level requirements." For a ventilator, ground truth would typically be established based on engineering specifications, physiological models, and regulatory standards for delivering specific pressure, volume, and flow characteristics accurately and safely. It would not typically be pathology, expert consensus on images, or outcomes data in the way an AI diagnostic device would.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is a software modification for a ventilator, not a machine learning or AI model trained on a data set.

9. How Ground Truth for Training Set was Established:

How Ground Truth was Established: Not applicable, as there is no training set in the context of an AI model for this device.

Summary of what the document does provide regarding performance:

It states that the Neonatal Option is a software modification to an existing ventilator.
It claims the addition does not result in the use of any new technological characteristics.
It explicitly states: "Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator."
It indicates that "Software verification and validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998)."
It concludes that "Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met."
The primary method for determining substantial equivalence relies on the similarity of performance characteristics, intended use, and patient populations to predicate devices, implying that the performance meets expectations set by already approved devices.

In essence, the document serves as a regulatory submission arguing for substantial equivalence based on the software's adherence to established design requirements and equivalency to existing technology, rather than detailing a specific experimental study with statistical results against explicit numerical acceptance criteria.

Summary

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JUL. - 8 2005

Modification to the Esprit Ventilator 510(k) Premarket Notification for the Neonatal Option

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:	May 12, 2005
Product Name:	Esprit Ventilator Neonatal Option
Common Name:	Ventilator
Classification:	Class IIContinuous Ventilator (per 21 CFR 868.5895)
PredicateDevices:	P-B 840 Ventilator NeoMode Option K001646 Event Medical Inspiration Ventilator K021112 Siemens Servo 300 Ventilator K970839 Dräger Evita 4 Ventilator NeoFlow Option K983219

16.1 Device Description:

Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or . Continuous Positive Airway Pressure (CPAP) modes of ventilation.
Pressure-Controlled (PC). Available in A/C and SIMV. .
Pressure Support (PS). Available in SIMV and SPONT. .
. Apnea Ventilation

Note: certain features of the currently marketed Esprit are not available to neonatal patient types. Refer to the Neonatal Option instructional information for details.

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Intended Use: 16.2

The currently marketed Esprit ventilator is intended for use by qualified medical rne ourrelity many many or intermittent ventilatory support for adult and performer and prescribed by a physician. It is intended for use in either invasive or non-invasive applications.

With the Neonatal Option, the intended patient population is expanded to include intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 - 4.0 mm.

The Esprit Ventilator 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

The addition of the Neonatal Option to the currently marketed Esprit does not result in the use of any new technological characteristics. Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator (reference K981072).

Determination of Substantial Equivalence: 16.4

The modes/types of ventilation on the Esprit Ventilator with Neonatal Option are similar to those on other currently marketed continuous ventilators. The modified Esprit has similar performance characteristics, similar intended use and similar patient populations to the predicate devices. The addition of the Neonatal Option does not raise new questions of safety or effectiveness. The labeling and instructional information for the Neonatal Option is similar to that of the predicate devices.

16.5 Summary of Performance Testing:

Software verification and validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met.

16.6 Conclusion:

The addition of the Neonatal Option to the Esprit Ventilator does not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures connected by flowing lines, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 8 2005

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

Re: K051262

Trade/Device Name: Esprit Ventilator with Neonatal Option Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 12, 2005 Received: May 16, 2005

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 I Tease be advisod that 12 a determination that your device complies with other requirements mean that I DA mas made statutes and regulations administered by other Federal agencies. or the Fet of all , a vary - eath s requirements, including, but not limited to: registration 1 ou intiles comprise to Part 807); labeling (21 CFR Part 801); good manufacturing practice and ifsung (21 es reas of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quartify tion 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 and if your even 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), If you desite of the Office of Compliance at (240) 276-0115. 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 may of any 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/industry/support/index.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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Modification to the Esprit Ventilator Mountcation to the Esphe For the Neonatal Option

INDICATIONS FOR USE STATEMENT

Applicant:	Respironics California, Inc.2271 Cosmos CourtCarlsbad, CA 92009USA
510(k) Number:	K051262
Device Name:	Esprit Ventilator with Neonatal Option
Indications for use:	The intended use of the Esprit Ventilator Neonatal Option is to providecontinuous or intermittent ventilatory support for the care of individualswho require mechanical ventilation.The intended patient population includes intubated neonatal patientswith an ideal body weight range from 0.5 kg to 6.5 kg and anendotracheal tube I.D. range from 2.5 – 4.0 mm.
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)

Oeen Sulam K051262

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General Devices Division of Anesthesion Control, Devices

510(k) Number -

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).