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 for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or noninvasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically adjusts I-Triggers and E-Cycles breathing without the need for useradjustment of I-trigger (sensitivity) and E-cycle thresholds under changing leak conditions. The Auto-Trak option provides leak-compensated ventilation for leaks up to 60L/min.

Device Description

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Respironics Esprit Ventilator Auto-Trak Sensitivity Option, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The document presents software testing results and performance testing results. The acceptance criteria for the software tests appear to be a simple "Pass/Fail" determination, where all listed parameters must pass. The performance testing section mentions a clinical trial for Auto-Trak performance and evaluation of other parameters, but it doesn't explicitly state quantitative acceptance criteria for these. The overall conclusion for the clinical investigation is qualitative: "at least equivalent performance and patient preference and no increase in adverse events over the predicate device."

Acceptance Criteria / Software Parameter	Reported Device Performance
Software Testing
Flow Triggering: Validate accuracy of flow-triggered breaths during Auto-Trak triggering	Pass
Auto-Trak Triggering - Bias Flow: Validate accuracy of bias flow used during Auto-Trak triggering; check for Auto-Trak triggering with constant and changing leaks	Pass
Auto-Trak Triggering - Back up Pressure Trigger: Validate that breaths can also be triggered using the back up pressure trigger when Auto-Trak is active	Pass
Auto-Trak Triggering - Mask Off Test: Validate that in CPAP or non-invasive modes, breaths will not auto-cycle if a patient's mask is taken off, then returned to the patient, when Auto-Trak is active	Pass
Auto-Trak Triggering - High Leak Test: Validate that when Auto-Trak is active, and a large leak is suddenly blocked, the ventilator will not truncate more than one breath	Pass
Exhalation Sensitivity with and without Auto-Trak active: Validate the Auto-Trak performance when Auto-Trak is active and not active	Pass
Exhalation Sensitivity decreasing with Auto-Trak active: Validate Auto-Trak sensitivity when Exhalation is not detected, compensating by decreasing exhaled flow sensitivity for the next breath	Pass
Exhalation Sensitivity Increasing with Auto-Trak: Validate Auto-Trak performance when Auto-Trak is active and not active	Pass
Clinical Investigation (Primary Efficacy Objective)
Equivalence in the proportion of subjects in Auto-Trak (test) and Flow Triggering (control) treatment groups	Shown to be substantially equivalent in performance
Clinical Investigation (Primary Safety Objective)
Evaluate the rate of adverse events during the intervention	No increase in adverse events over the predicate device
Patient Preference (Clinical Investigation)
Not explicitly stated as a separate criterion, but included in the overall conclusion.	Substantially equivalent in patient preference

Study Information

Due to the nature of the 510(k) summary, specific details about sample size for test and training sets, and expert qualifications are limited.

Sample Size and Data Provenance (Test Set):
- Sample Size: The document does not explicitly state the sample size (number of patients) for the clinical trial. It refers to "the proportion of subjects."
- Data Provenance: Not specified, but generally, clinical trials submitted for U.S. FDA 510(k) clearance are often conducted in the U.S. or international sites adhering to GCP. The document does not specify if the data was retrospective or prospective, but clinical investigation implies prospective.
Number of Experts and Qualifications (Ground Truth for Test Set):
- The document does not provide information on the number or qualifications of experts used to establish the ground truth for the clinical trial.
Adjudication Method (Test Set):
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical trial data.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not explicitly described as such. The clinical investigation was a comparison between the "Auto-Trak (test)" and "Flow Triggering (control)" treatment groups to show equivalence. This is more of a comparative clinical trial of two device functionalities rather than an MRMC study assessing human reader improvement with AI assistance.
- Effect Size: Not applicable, as an MRMC study was not described. The study aimed for equivalence rather than an effect size of human improvement with AI.
Standalone Performance (Algorithm Only without Human-in-the-loop):
- Yes, a standalone study was done in the form of "Software testing" and "Performance Testing Results" tables (Table 1 and Table 2). These tests evaluated the device's algorithmic and mechanical functions independently of direct human interaction with the real-time AI. The "Auto-Trak Sensitivity option automatically triggers and cycles breathing without the need for user-adjustment of I-trigger (sensitivity) and E-cycle thresholds," which indicates its autonomous operation in those aspects.
Type of Ground Truth Used:
- For the Software Testing and Performance Testing Results (mechanical parameters): The ground truth was based on pre-defined engineering and software specifications, and measured directly from the device's output against expected values (e.g., accuracy of flow-triggered breaths, bias flow).
- For the Clinical Investigation: The ground truth for efficacy would be patient breathing patterns, comfort levels, and ventilator performance metrics (triggering, cycling). The ground truth for safety would be the occurrence and rate of adverse events. These would be derived from clinical observations and patient outcomes.
Sample Size for Training Set:
- The document does not provide any information on the sample size used for the training set (if any explicit machine learning 'training' was involved beyond deterministic algorithm development). The "Auto-Trak" option likely relies on rule-based algorithms or pre-programmed logic derived from extensive engineering and physiological knowledge, rather than a machine learning model trained on a large dataset in the modern sense.
How Ground Truth for Training Set Was Established:
- As with the training set size, the document does not describe how ground truth was established for a training set. Given the context of a 2007 510(k) for a ventilator option, it's highly probable that the "training" involved:
  - Physiological models and simulations: Using established respiratory mechanics and patient models to design and refine the algorithms for triggering and cycling.
  - Bench testing & phantom lungs: Extensive testing with artificial lungs and leak generators to validate the algorithms' responses across various scenarios.
  - Clinical experience and expert input: The design of the algorithms would have incorporated extensive knowledge from respiratory therapists and physicians on effective ventilation strategies and patient interaction.

Summary

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K072450
page 1/5

RESPIRONICS®

510(k) Summary

Submitter: Respironics Inc. Address: 2271 Cosmos Court Carlsbad, CA 92011 Telephone: 760 918 7458 Fax: 760 918 0169

DEC 1 2 2007

Contact: Mara Caler Regulatory Affairs Telephone: 760 918 7458 Fax: 760 918 0169 Email: mara.caler(@respironics.com

Date Prepared: 15 August 2007

Trade name: Esprit Ventilator Auto-Trak Sensitivity Option Common Name (Device Type): Continuous Ventilator Classification Regulation (CFR): 21 CR 868.5895 Class: 2 Product Code: 73 - CBK Panel: Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (73)

Predicate Device:

Esprit Ventilator (K981072) Vision Ventilator with Auto-Trak (K982454) Evita XL Ventilator with "Option Mask Ventilation NIV" (K980642)

Indications for 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 for adult and pediatric patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications. The Auto-Trak option is intended for adult and pediatric patients, and automatically triggers and cycles breathing without the need for user-adjustment of Itrigger (sensitivity) and E-cycle thresholds.

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Substantial Equivalence to Predicate Devices:

The predicate device is the Esprit Ventilator Flow Triggering option and the Esprit Ventilator Auto Trak Sensitivity option ..

The proposed Esprit Ventilator Auto-Trak is identical to the existing Esprit . Ventilator with the exception of the addition of the Auto-Trak option.
The Esprit Ventilator Auto-Trak is similar to the Vision Ventilator with Auto-. Trak as identified in Table 3, Section 12, page 31 and to the Drage Evita (included because is it is similarly classified device (73-CBK)).
Bench performance testing was performed for the new option and clinical . performance was compared between the Respironics Esprit Flow Triggering option and the Respironics Esprit Auto-Trak option.

List of Similarities:

Similar intended use the intended use is unchanged .
- o The Esprit Ventilator is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support for adult, pediatric and neonatal patients as prescribed by a physician. The ESPRIT Ventilator is intended for use in either invasive or non-invasive applications.
Similar patient circuit the patient circuit is unchanged .
- The patient circuit is unchanged. o
Same operating principle the operating principle is unchanged .
- The ESPRIT ventilatory is a microprocessor controlled, electrically o powered, mechanical ventilator. There have been no changes to the operating principle of the equipment.
  - M The breathing system is under microprocessor control
  - . The user interface is under microprocessor control, featuring a touch screen and graphical user interface technology.
  - 트 The integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade wall air and/or an individual stand alone compressor for each ventilator.
  - 트 The ability to provide variable oxygen concentrations (21% to 100% O2) from a 35 to 80 PSIG medical oxygen gas source, including medical grad gas cylinders with suitable regulators
  - 프 The ability to operate on a re-chargeable primary battery for 30 minutes (nominal)
  - The ability to be powered by a secondary DC power source (24 VDC) for up to 3 hours
. Same technology - the technology is unchanged
- The ESPRIT ventilatory is a microprocessor controlled, electrically O powered, mechanical ventilator. There have been no changes to the technology or equipment hardware.
Same manufacturing process the manufacturing process is unchanged .
- There have been no changes to the manufacturing processes for the o equipment.

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Breathing modes there are no new breath types or breathing modes required. .
List of Differences:
. Indications for Use
- The Auto-Trak Sensitivity option automatically triggers and cycles o breathing without the need for user-adjustment of I-trigger (sensitivity) and E-cycle thresholds.
Algorithms used to determine triggering and cycling sensitivity thresholds .
- o Triggering: Auto-Trak monitors changes in pressure and flow patterns throughout exhalation, applying compensation for circuit leaks and triggering an inspiration.
  - Automatically adjusts I-Trigger and E-cycle in the face of . changing leaks
  - Provides leak-compensated ventilation .
    - · Compensation for leaks up to 60 L/min
- O Reduces auto-triggering and I-time too long alarms/conditions
- Cycling: Auto-Trak automatically cycles breathing based on the pressure and flow patterns at the end of inspiration and beginning of expiration. The threshold used to cycle each breath changes with the patient's breathing pattern and lung dynamics.
. Improved patient comfort especially in NIV
Makes it easier to set up the patient (no need to set triggering and cycling criteria) .

Software Parameter	Purpose	Pass/Fail
Breath Delivery
Flow Triggering	To validate the accuracy of the flowtriggered breaths during Auto-Traktriggering	Pass
Auto-Trak Triggering -Bias Flow	To validate the accuracy of the biasflow used during Auto-Traktriggering; to check for Auto-Traktriggering when leaks are constant andduring changes of pt Leak duringExhalation and Inhalation	Pass
Auto-Trak Triggering -Back up Pressure Trigger	To validate that breaths can also betriggered using the back up pressuretrigger when Auto-Trak is active	Pass

		Table 1: Software testing results:
--	--	------------------------------------	--	--

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Software Parameter Purpose 24 4 %		Pass/Fail
Auto-Trak Triggering -Mask Off Test	To validate that in CPAP or non-invasive modes, breaths will not auto-cycle if a patient's mask is taken off,then returned to the patient, whenAuto-Trak is active	Pass
Auto-Trak Triggering -High Leak Test	To validate that when Auto-Trak isactive, and a large leak is suddenlyblocked, the ventilator will nottruncate more than one breath	Pass
Exhalation Sensitivitywith and without Auto-Trak active	To validate the Auto-Trakperformance when Auto-Trak is activeand not active	Pass
Exhalation Sensitivitydecreasing with Auto-Trak active	To validate the Auto-Trak Sensitivitywhen Exhalation is not detected.When flow is not detected at theexhalation flow sensor at the start ofexhalation, Auto-Trak willcompensate by decreasing the exhaledflow sensitivity for the next breath	Pass
Exhalation SensitivityIncreasing with Auto-Trak	To validate the Auto-Trakperformance when Auto-Trak is activeand not active.	Pass

Table 2: Performance Testing Results

Test Parameter	Purpose
Auto-Trak triggering andcycling performance	Auto-Trak performance was evaluated in the clinicaltrial.
Leak Compensated BiasFlow	To evaluate the accuracy of the bias flow at theventilator output for 6 leak conditions
High Leak Alarm	To evaluate the new high leak alarm
Patient Leak Display	To evaluate the number of breaths before a newdisplayed value is stabilized and the accuracy of thedisplayed value

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Clinical Investigation:

The primary efficacy objective of this study was to show equivalence in the proportion of subjects in the Auto-Trak (test) and Flow Triggering (control) treatment groups. The primary safety objective of this study was to evaluate the rate of adverse events during the intervention.

Based on the success criteria (at least equivalent performance and patient preference and no increase in adverse events over the predicate device), Auto-Trak was shown to be substantially equivalent in performance, patient preference and no increase in adverse events.

Conclusion:

Performance testing and clinical data demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is positioned to the right of the seal. Encircling the caduceus is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 2 2007

Ms. Mara Caler Regulatory Affairs Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92011

Re: K072450

Trade/Device Name: Esprit Ventilator Auto-Trak Sensitivity Option Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 5, 2007 Received: November 6, 2007

Dear Ms. Caler:

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. Caler

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Smitte Y. Michie Omis.

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

K072450 510(k) Number (if known)

Device Name: Esprit Ventilator Auto-Trak Sensitivity Option

Indications for Use:

Prescription Use X (Part 21 CFR 801, Subpart D)

And/or

Over-the-Counter Use (Part 21 CFR 807, Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K072450

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).