K Number

Device Name

ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000

Manufacturer

RESPIRONICS CALIFORNIA, INC.

Date Cleared

2007-07-30

(90 days)

Product Code

CBK

Regulation Number

868.5895

Intended Use

The ESPRIT ventilatory 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 Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

Device Description

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 Speaking Mode software option allows tracheostomized adult and pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K981072

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as "microprocessor controlled," which is a standard term for non-AI/ML devices.

Therapeutic

Yes
A therapeutic device is one that treats or alleviates a medical condition. This device provides ventilatory support, which directly addresses a respiratory need or problem in patients.

Diagnostic

No
The device is a mechanical ventilator used to provide ventilatory support. It does not mention any diagnostic functions.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "mechanical ventilator" and "electrically powered," indicating it is a hardware device with software control, not a software-only device. The "Speaking Mode software option" is a feature of the hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states the ESPRIT ventilator is a "mechanical ventilator" intended for "providing continuous or intermittent ventilatory support." This is a life-support device that assists with breathing, not a test performed on a biological sample.
Intended Use: The intended use is to provide ventilatory support to patients, not to diagnose or monitor a condition through analysis of biological samples.

The information provided describes a medical device used for respiratory support, which falls under a different regulatory category than in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

CBK

Device Description

The ESPRIT ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. There have been no changes to the operating principle of the equipment.

The breathing system is under microprocessor control
The user interface is under microprocessor control, featuring a touch screen and graphical user interface technology.
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.
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
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

The currently marketed Esprit ventilator and the Esprit ventilator with Speaking Mode option both analyze pressure to trigger and cycle the ventilator. In currently marketed ventilators, an external (closed) Speaking Valve is installed to allow the exhaled gas to flow past the vocal cords. In the Speaking Mode option, the Esprit exhalation valve is closed, so that the exhaled gas is allowed to flow past the vocal cords. The exhaled gas pressure is measured to evaluate if (a) the tracheostomy tube has become disconnected or (b) if the tracheostomy tube has become occluded.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and pediatric.

Intended User / Care Setting

Qualified medical personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Substantial equivalence was established by performance testing. The performance testing included:

Speaking Mode (SM) operability: SM operates with VCV with A/C, SIMV, and CPAP; is not functional with NPPV; operates with Flow-Trak; operates with Pressure Support; operates on both adult and pediatric patient types. (Pass)
Speaking Mode operability: SM is not available for Neonatal patients; is not active after power cycling; is not available when specific alarms are active. (Pass)
Speaking mode and I-trigger: I-trigger will automatically adjust to pressure triggering if flow triggering is the current trigger type; that only pressure triggering is allowed while in SM; test the accuracy of pressure triggering. (Pass)
Speaking Mode graphical user interface: Test the ventilator behavior when SM is not installed; confirm the SM related dialogs; test the ventilator behavior when SM is deactivated; confirm that PEEP is always set to zero when SM is active. (Pass)
Speaking Mode alarms and settings: Confirm alarm performance, including patient disconnect. (Pass)
Speaking Mode alarms and settings: Confirm alarm performance, including occlusion alarm. (Pass)
Apnea alarm: Confirm that if apnea alarm occurs while in SM, exhalation valve opens during exhalation. (Pass)
Maneuvers not available: Confirm that Respiratory Mechanics and expiratory Hold Maneuvers are not available when SM is active. (Pass)
Displayed patient data: Confirm that data displays are appropriate. (Pass)
Trending: Confirm that trending values are trended/not trended when SM is active. (Pass)
Breath delivery: Confirm that exhalation valve is closed during inhalation and exhalation while in SM. (Pass)
Communications: Confirm that RS 232 and Vuelink communications are operable. (Pass)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Esprit Ventilator, K981072

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Ko71212

Image /page/0/Picture/1 description: The image shows the word "RESPIRONICS" in all caps. Above the word, there are two curved lines. To the right of the word, there is a small circle with an R inside, indicating a registered trademark.

JUL 3 0 2007

510(k) Summary

Submitter: Respironics Inc. Address: 2271 Cosmos Court Carlsbad, CA 92011 Contact: Mara Caler Telephone: 760 918 7458 Fax: 760 918 0169 Email: mara.caler(@Respironics.com Date: 30 April 2007

Trade name: Esprit Ventilator Speaking mode 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)

Indications for Use:

Substantial Equivalence to Predicate Devices:

Predicate device: Esprit Ventilator, K981072 The proposed Esprit Ventilator is identical to the existing Esprit Ventilator with the exception of the addition of the Speaking Mode option.

List of Similarities:

Similar intended use the intended use is unchanged .
- The Esprit Ventilator is intended for use by qualified medical personnel in o 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.

Similar patient circuit the patient circuit is unchanged .
- o The patient circuit is unchanged.
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.
  - The breathing system is under microprocessor control 트
  - The user interface is under microprocessor control, featuring a touch screen and graphical user interface technology.
  - The integral air source is built into the ventilator, eliminating the 피 requirement for a central compressor and piped, medical grade wall air and/or an individual stand alone compressor for each ventilator.
  - The ability to provide variable oxygen concentrations (21% to 해 100% O2) from a 35 to 80 PSIG medical oxygen gas source, including medical grad gas cylinders with suitable regulators
  - The ability to operate on a re-chargeable primary battery for 30 트 minutes (nominal)
  - The ability to be powered by a secondary DC power source (24 L VDC) for up to 3 hours
Same technology the technology is unchanged ●
- The ESPRIT ventilator 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.

List of Differences:

Indications for Use ●
- The Speaking mode software option allows tracheostomized adult and o pediatric patients who meet the assessment criteria to vocalize without the need of a speaking valve (e.g., the Passy-Muir valve).
Breathing modes: .
- The breathing modes available during active Speaking Mode include ০ pressure control and volume control in A/C, SIMV and CPAP, Pressure Support and Flow Trak. Speaking Mode option is not available while in the NPPV mode. Neonatal option are not available when in Speaking Mode.

Substantial equivalence was established by performance testing. The Table describing the performance testing follows:

Parameter	Purpose	Pass/Fail
Speaking Mode (SM)
operability	SM operates with VCV with A/C,
SIMV, and CPAP; is not functional
with NPPV; operates with Flow-Trak;
operates with Pressure Support;
operates on both adult and pediatric
patient types	Pass
Speaking Mode
operability	SM is not available for Neonatal
patients; is not active after power
cycling; is not available when specific
alarms are active	Pass
Speaking mode and I-
trigger	I-trigger will automatically adjust to
pressure triggering if flow triggering is
the current trigger type; that only
pressure triggering is allowed while in
SM; test the accuracy of pressure
triggering	Pass
Speaking Mode
graphical user interface	Test the ventilator behavior when SM
is not installed; confirm the SM
related dialogs; test the ventilator
behavior when SM is deactivated;
confirm that PEEP is always set to
zero when SM is active	Pass
Speaking Mode alarms
and settings	Confirm alarm performance, including
patient disconnect	Pass
Speaking Mode alarms
and settings	Confirm alarm performance, including
occlusion alarm	Pass
Apnea alarm	Confirm that if apnea alarm occurs
while in SM, exhalation valve opens
during exhalation	Pass
Maneuvers not available	Confirm that Respiratory Mechanics
and expiratory Hold Maneuvers are
not available when SM is active	Pass
Parameter	Purpose	Pass/Fail
Displayed patient data	Confirm that data displays are
appropriate	Pass
Trending	Confirm that trending values are
trended/not trended when SM is active	Pass
Breath delivery	Confirm that exhalation valve is
closed during inhalation and
exhalation while in SM	Pass
Communications	Confirm that RS 232 and Vuelink
communications are operable	Pass

Summary of Validation Testing

Conclusion:

This testing demonstrates that the device is as safe, as effective and performs as well as or better than the predicate device.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 3 0 2007

Re: K071212

Trade/Device Name: Esprit Ventilator Speaking Mode Option Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 12, 2007 Received: July 16, 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.

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 vour 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 vours.

Suttie G. Michael DMD.

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

Indications for use

510(k) Number (if known): K071212

Device Name: Esprit Ventilator (Speaking Mode Option)

Indications for Use:

X Prescription Use (Part 21 CFR 801, Subpart D) Over-the-Counter Use (Part 21 CFR 801, Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

ch (acting)
(Division Sign-Off)

Page 1 of 1

vision of Anesthesiology, General Hospital. tion Control. Dental Devices

510(k) Number: K071212