The V200 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 ventilator is intended for use in either invasive or non-invasive applications.

The intended use is identical to that of the predicate the currently marketed Esprit Ventilator.

The V200 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 V200 Ventilator is intended for use in either invasive or noninvasive applications and contains the following modes of ventilation:

. Assist/Control (A/C)
Synchronized Intermittent Mandatory Ventilation (SIMV) .
Continuous Positive Airway Pressure (CPAP)
Spontaneous (Spont) .
. Spontaneous/Timed (Spont/T)
Apnea (Backup Mode) .

Device Description

The V200 Ventilator is a hardware modification to the currently marketed Esprit that upgrades the look of the Esprit through minor changes to some of the external hardware components, as follows:

The position of the encoder knob changed, as well as the attachment method .
Material changes were made to the top and bottom enclosure .
Dimensional, material, and attachment method changes were made to the bezel . assembly
The resins and color of the Heated Filter Assembly were changed ●
Dimensional changes were made to the Overlay, as well as positioning of the hard . keys, indicator lights, and icons

Ventilators with this updated look are sold under the brand name of the V200 Ventilator.

All electrical components, internal hardware components, firmware, and software are physically and functionally identical to those on the currently marketed Esprit Ventilator.

The V200 Ventilator technological characteristics with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, software, environmental specifications, and performance specifications are identical to that of the currently marketed Esprit Ventilator.

The V200 ventilator contains the identical software as the currently marketed Esprit Ventilator. The software options are enabled by downloading the operational software and installing the software option. They are integrated into the V200 Ventilator in the same manner as they are on the currently marketed Esprit Ventilator. The options can be installed either in the factory or in the field as an upgrade to existing V200 Ventilators.

All available options on the Esprit cleared subsequent to the original 510(k) (K981072) are also available on the V200 Ventilator.

AI/ML Overview

This 510(k) summary explains that the V200 Ventilator is a hardware modification of the already-marketed Esprit Ventilator. The submission focuses on demonstrating substantial equivalence rather than presenting new performance data against specific acceptance criteria for a novel device. Therefore, many standard elements of acceptance criteria and a study proving those criteria are not explicitly present in the provided text.

Here's a breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance:

Since the V200 Ventilator is presented as a hardware modification of an existing device (Esprit Ventilator) with identical technological characteristics, the acceptance criteria are implicitly that the V200 Ventilator performs identically to the Esprit Ventilator in all functional and safety aspects.

Acceptance Criteria Category	Reported Device Performance (V200 Ventilator)
Intended Use	Identical to the predicate (Esprit Ventilator): providing continuous or intermittent ventilatory support for adult, pediatric, and neonatal patients by qualified medical personnel, in invasive or non-invasive applications.
Technological Characteristics	Identical to the predicate (Esprit Ventilator) with respect to control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, software, environmental specifications, and performance specifications.
Hardware Components	External hardware components changed (encoder knob position, enclosure materials, bezel, heated filter assembly, overlay dimensions and positioning of keys/lights/icons). Internal hardware components are physically and functionally identical.
Electrical Components	Physically and functionally identical to the predicate (Esprit Ventilator).
Firmware/Software	Physically and functionally identical to the predicate (Esprit Ventilator), including all available options cleared for the Esprit.
Safety & Effectiveness	"These changes do not raise any new questions regarding safety and effectiveness." (Implies no degradation from predicate).
Electromagnetic Compatibility (EMC)	Test data provided to support substantial equivalence.
Safety Testing	Test data provided to support substantial equivalence.
Shock and Vibration Testing	Test data provided to support substantial equivalence.

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

The document does not specify a "sample size" for a clinical test set in the traditional sense, nor does it mention data provenance (country, retrospective/prospective). This is because the submission primarily relies on demonstrating that the hardware modifications did not alter the performance of the existing, cleared device. The testing mentioned in "Substantial Equivalence/Performance Testing" relates to engineering and regulatory compliance testing rather than clinical performance testing with patient data.

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. This submission concerns hardware changes to a medical device, not a diagnostic algorithm that requires expert ground truth for a test set.

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

Not applicable. This submission concerns hardware changes to a medical device, not a diagnostic algorithm that requires expert adjudication for a test set.

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. The V200 Ventilator is a mechanical ventilator, not an AI-assisted diagnostic tool.

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

Not applicable. The V200 Ventilator is a mechanical ventilator, not an algorithm.

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

Not applicable in the typical sense for a diagnostic device. For the V200 Ventilator, "ground truth" likely refers to the established performance specifications and safety profile of the predicate Esprit Ventilator. The "study" (testing) aims to show that the V200 maintains this "ground truth" and that the hardware changes did not introduce deviations.

8. The sample size for the training set:

Not applicable. The V200 Ventilator is a mechanical ventilator with identical firmware and software to its predicate. There is no mention of a "training set" as would be relevant for machine learning algorithms.

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

Not applicable, as there is no mention of a training set.

Summary

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510(k) Summary

K1.02054/

[Refer to 21 CFR 807.92]

Owner:	Respironics California, Inc.2271 Cosmos CourtCarlsbad, CA 92011
Contact Person:	Tamatha LeyRegulatory Affairs SpecialistPhone: (760) 918-1026Fax: (760) 918-0169
Date Prepared:	November 8, 2010
Proprietary Name:	V200 Ventilator
Common Name:	Ventilator
ClassificationName:	Continuous Ventilator (21 CR 868.5895, Product Code 73 CBK)
Predicate Devices:	ManufacturerRespironics California, Inc.	Device NameEsprit Ventilator	510(k) NumberK981072

Intended Use of the Device:

The intended use is identical to that of the predicate the currently marketed Esprit Ventilator.

Respironics California, Inc.

Device Description:

The V200 Ventilator is a hardware modification to the currently marketed Esprit that upgrades the look of the Esprit through minor changes to some of the external hardware components, as follows:

The position of the encoder knob changed, as well as the attachment method .
Material changes were made to the top and bottom enclosure .
Dimensional, material, and attachment method changes were made to the bezel . assembly
The resins and color of the Heated Filter Assembly were changed ●
Dimensional changes were made to the Overlay, as well as positioning of the hard . keys, indicator lights, and icons

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Ventilators with this updated look are sold under the brand name of the V200 Ventilator.

All electrical components, internal hardware components, firmware, and software are physically and functionally identical to those on the currently marketed Esprit Ventilator.

All available options on the Esprit cleared subsequent to the original 510(k) (K981072) are also available on the V200 Ventilator. The table below identifies those options. Options that may be used in conjunction with each other are denoted by an 'X'. Options that may not be used together are denoted by "NA".

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	Graphics	RespiratoryMechanics	DemandFlow	NICO-Esprit	Neonatal	SpeakingMode	Auto-Trak
SOFTWARE OPTIONS
Graphics Option (K001208)Enhances the display screens with graphical data ofthe patient's flow, pressure, and volume.	X		X	X	X	X	X
Respiratory Mechanics (K023350)A diagnostic tool that provides the clinician theability to measure and monitor a patient'srespiratory condition while that patient is receivingventilatory support. It consists for four maneuvers(Vital Capacity, Maximum Inspiratory Pressure,Occlusion Pressure at 100ms, & Static C&R) andcalculates Dynamic C&R, Ti/Ttot, and Peak LungFlow.		X	X	X	NA	NA	X
VCV Demand Flow (K034040)Provides additional flow/volume to patients whenoperator settings do not satisfy patient demand. Itis available only in VCV mode for mandatory andassist breaths.	X	X		X	NA	X	X
NICO-Esprit Interface (K041412)Enables the ventilator to receive information from aNICO monitor and trend and display thatinformation on the ventilator's User Interface	X	X	X		X	X	X
Neonatal Option (K051262)Provides support for intubated neonatal patientswith an ideal body weight range from 0.5kg to6.5kg	X	NA	NA	X		NA	NA
	Graphics	RespiratoryMechanics	DemandFlow	NICO-Esprit	Neonatal	SpeakingMode	Auto-Trak
Speaking Mode (K071212)allows tracheostomized adult and pediatric patientsto meet the assessment criteria to vocalizewithout the need of a speaking valve.	X	NA	X	X	NA	X	NA
Auto-Trak (K072450)automatically adjusts I-Triggers and E-Cyclesbreathing without the need for user adjustment of I-Trigger and E-Cycle Thresholds under changingconditions.		X	X	X	NA	X	X
BREATH TYPES
Volume Control Ventilation	X	X	X	X	NA	X	X
Pressure Control Ventilation	X	X	NA	X	X	X	X
Non-Invasive Positive Pressure Ventilation	X	NA	NA	X	NA	NA	X
VENTILATION MODES
Assist/Control (A/C)	X	X	X	X	X	X	X
SIMV	X	X	X	X	X	X	X
CPAP	X	X	X	X	X	X	X
Spont/T	X	NA	NA	X	NA	NA	X
Spont	X	NA	NA	X	NA	NA	X
Apnea Backup	X	NA	X	X	X	NA	X
FEATURES
Expiratory Hold (Auto-PEEP)	X	X	X	X	NA	NA	X

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Substantial Equivalence/Performance Testing:

The V200 Ventilator technological characteristics are identical to that of the currently marketed Esprit Ventilator with respect to the control mechanism, operating principle, energy type, ergonomics of the patient interface, firmware, software, environmental specifications, and performance specifications.

This hardware modification has no affect on intended use, intended patient population, clinical benefit to the user or patient, operating principle, operating mechanism, operating algorithm, ventilation modes, functionality, features, or performance.

This submission contains comparative information and test data related to Electromagnetic Compatibility (EMC), Safety, and Shock and Vibration Testing to support the conclusion that the V200 Ventilator is substantially equivalent to currently marketed Esprit Ventilator.

These changes do not raise any new questions regarding safety and effectiveness.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Ms. Tamatha Ley Regulatory Affairs Specialist Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92011

DEC 2 2 2010

Re: K102054 Trade/Device Name: V200 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 14, 2010 Received: December 16, 2010

Dear Ms. Ley:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Ley

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Wh for

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K102054

Device Name: V200 Ventilator

Indications for Use:

The V200 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 V200 Ventilator is intended for use in either invasive or noninvasive applications and contains the following modes of ventilation:

. Assist/Control (A/C)
Synchronized Intermittent Mandatory Ventilation (SIMV) .
Continuous Positive Airway Pressure (CPAP) �
Spontaneous (Spont) .
. Spontaneous/Timed (Spont/T)
Apnea (Backup Mode) .

Prescription Use (Part 21 CFR 801, Subpart D)

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)

L. Schuston.

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).