LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use environment is for institutional use. Institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.

TheLTV2 Series Ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lbs.), who require the following types of ventilatory support:

. Positive Pressure Ventilation, delivered invasively or non-invasively (via mask).
. Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.
The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.

Device Description

The LTV2 Series ventilator supports adult and pediatric patients weighing at least 10 kg (22 lb) in professional healthcare facilities response with invasive or noninvasive ventilation presets. These settings can be easily refined using the touch-turn-touch interface on the LED display. The ventilator also provides a wide range of ventilation therapies to meet demanding patient needs, including volume control, pressure control, pressure support and spontaneous breath types. Combined with the spontaneous breathing trial function, the ultra-sensitive flow trigger facilitates weaning patients weighing at least 10 kg (22lb).

AI/ML Overview

The provided document is an FDA 510(k) premarket notification for the LTV2 Series Ventilators. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a study with a test set, expert ground truth, and statistical analysis as would be done for a novel AI/ML device.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for performance metrics (like sensitivity, specificity, F1 score), sample sizes for test and training sets, expert adjudication, MRMC studies, and ground truth establishment is not present in this document because it's not relevant to a 510(k) submission for a non-AI/ML medical device like a ventilator.

The document describes the device's technical specifications and compares them to predicate devices, along with listing applicable performance standards and verification testing (e.g., waveform, alarms, endurance). The conclusion explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject, predicate and reference devices, no clinical studies were deemed to needed to support this submission."

To address your request, I will explain why your specific questions are not applicable to this document and provide the information that is available.

Reasoning for Inapplicability of AI/ML-focused Questions:

The LTV2 Series Ventilator is a mechanical device, not an AI/ML diagnostic or prognostic tool. Therefore, the regulatory pathway (510(k)) and the evidence required to demonstrate safety and effectiveness for this type of device differ significantly from what would be expected for an AI/ML device.

Acceptance Criteria & Reported Performance (Table A): For a mechanical device, performance is evaluated against engineering specifications, industry standards (e.g., IEC 60601 series, ISO 80601-2-12 for ventilators), and comparison with predicate devices. There isn't a "test set" in the sense of a dataset of medical images or patient records, or metrics like sensitivity/specificity for a diagnosis. Performance is about meeting physical parameters (e.g., tidal volume range, breath rate range, pressure control range, alarm specifications, electrical safety).
Sample Sizes, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth (Questions 2-7): These questions are highly specific to the validation of AI/ML algorithms, particularly in medical imaging or diagnostic contexts. They relate to how a model's output is compared against a clinical "truth" established by human experts or other definitive sources. For a ventilator, "performance" is demonstrated through non-clinical testing (e.g., mechanical testing, software V&V, endurance testing) confirming it adheres to its design specifications and relevant safety/performance standards.
Training Set & Ground Truth Establishment (Questions 8-9): These apply to the development and training of machine learning models. A mechanical ventilator does not have "training data" in this sense. Its design and functionality are based on engineering principles and verified through physical testing.

Information Available from the Document (Addressing Relevant Aspects):

The document demonstrates the device's safety and effectiveness by showing substantial equivalence to existing predicate devices and compliance with recognized performance standards.

1. Table of "Acceptance Criteria" (derived from technical specifications and standards) and "Reported Device Performance" (implied by meeting standards and equivalence to predicates):

For a mechanical ventilator, "acceptance criteria" are typically defined by engineering specifications and compliance with relevant international standards. "Reported device performance" is confirmed through design verification and validation testing, ensuring these specifications and standards are met. The document states:

"Successful test results (electrical safety testing, mechanical testing, software V&V, and waveform verification tests) ensured the proposed ventilator does not raise any different questions of safety and effectiveness."

Criteria/Element of Comparison	Acceptance/Target Performance (as per standards/predicates)	Reported Device Performance (as demonstrated by testing and equivalence)
Intended Use	Continuous or intermittent ventilator support for individuals requiring mechanical ventilation. Institutional use (ICU, hospital, intra-hospital transport).	Meets: Same as predicate devices.
Indications for Use (Patient Population)	Adult and pediatric patients weighing at least 10 kg (22 lbs.) (Proposed Device). Predicates were for 5 kg (11 lbs.).	Meets (within specified range): Targeted for adult and pediatric patients weighing at least 10 kg (22 lbs.). Discussion notes: "Substantial equivalent, increase in lower weight limit." Implies the device functions safely and effectively for this patient group.
Principles of Operation	Positive pressure mechanical ventilator.	Meets: Same as predicate.
Environment of Use	Healthcare institutional settings (Proposed Device). Predicates included home/transport.	Meets: Suitable for use in healthcare institutional settings. Discussion notes: "Substantial equivalent for healthcare institutional settings."
Compatibility (Temperature, Humidity, EMC, Sound)	Storage Temp: -20 to +60 C. Operating Temp: +5 to +40 C. Humidity: 10-95% non-condensing. EMC: IEC 60601-1-2. Sound: Not exceed 55 dBA (RMS) at one meter (proposed); 50 dBA (predicates).	Meets: Designed and tested to latest EMC standards (IEC 60601-1-2 Ed 3/4). Storage/Operating temps & humidity are consistent. Sound level of 55 dBA is within acceptable limits for the environment. Discussion notes: "Substantial equivalent, designed and tested to latest EMC standards."
Electrical Safety	Class II Type BF (IEC 60601-1-2).	Meets: Same as predicate.
Internal PEEP/PEEP Compensation	Range: 0-20 cmH2O ± 1 cmH2O or 10%, whichever is greater, within 3 breaths. (Mechanical/pneumatic control).	Meets: Same as predicate.
Bias Flow	Off or 5 to 15 LPM. Predicates were Off or 10 LPM ± 10% or 1 LPM.	Meets: Off or 5 to 15 LPM. Discussion notes: "Substantially Equivalent (Reference device K032451, K070594)"
Ventilation Mode & Breath Types	Control Mode, Assist/Control Mode, SIMV Mode, CPAP, NPPV, Apnea Backup. Breath types: Pressure Control, Volume Control, Pressure Support, Spontaneous.	Meets: Same as predicate.
Breath Rate	0-80 BPM.	Meets: Same as predicate.
Tidal Volume	50-2,000 mL.	Meets: Same as predicate.
Inspiratory Time	0.3 - 9.9 seconds.	Meets: Same as predicate.
Pressure Control (for applicable modes)	4 – 98 cmH20 (Assist/Control & SIMV/CPAP); Off - 60 cmH2O (NPPV). Predicate was 1-99 cmH2O.	Meets: Range specified. Discussion notes: "Substantially equivalent."
Pressure Support	1-60 cmH2O.	Meets: Same as predicate.
Sensitivity	Off, 1-9 LPM.	Meets: Same as predicate.
O2%	21–100%; oxygen bleed flow (for LTV 2150 and LTV 2200).	Meets: Same as predicate.
O2 Flush	1-3 min (LTV 2200 only).	Meets: Same as predicate.
PEEP/CPAP	0 – 20 cmH2O.	Meets: Same as predicate.
Blender	LTV2 2200: High and low oxygen inlet pressure. LTV2 2150: Low oxygen inlet pressure.	Meets: Same as predicate.
Software Functionality (VOXP)	VOXP (VENTILATOR OPEN XML PROTOCOL) present (Proposed Device). Not present in predicates.	Meets: Present. Discussion notes: "Substantially equivalent," implying this added feature does not raise new safety/effectiveness questions and has been validated.
Compliance with Standards	Adherence to a range of relevant medical device standards (e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62304, ISO 80601-2-12, ISO 14971).	Meets: "The LTV2 Series Ventilators was designed and tested in accordance with the following and FDA guidance documents and international standards." Implies successful testing against all listed standards.
Verification Testing	Successful completion of design verification tests.	Meets: Design Verification included: Waveform, Alarms, Ventilation Controls, Ventilation Displays, Endurance, Patient Circuit Testing. "Successful test results... ensured the proposed ventilator does not raise any different questions of safety and effectiveness."

2. Sample Sized used for the test set and the data provenance:

Not Applicable in the AI/ML sense. For this mechanical device, performance is evaluated through design verification and validation testing, and compliance with standards. There is no "test set" of patient data or images. Performance is based on physical property testing, software validation, and electrical safety testing.
The data provenance for such tests are typically in-house lab reports and compliance certificates from testing bodies, not clinical data from specific countries or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. "Ground truth" established by experts is a concept for AI/ML diagnostic or prognostic devices. For a ventilator, the "truth" is whether the device meets its engineered specifications and performs reliably according to intended use and recognized standards. This is assessed by engineers, quality control personnel, and regulatory specialists.

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

Not Applicable. Adjudication methods are used in studies involving human interpretation or labeling of data, typically for AI/ML validation. This is a mechanical device.

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. MRMC studies are for evaluating the impact of AI assistance on human performance in diagnostic tasks. This is a mechanical ventilator.

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

Not Applicable. This refers to the performance of an AI algorithm on its own. While the ventilator has internal algorithms for control, its "performance" is inherently tied to its mechanical function, and its safety/effectiveness is not evaluated as a standalone AI system.

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

Not Applicable in the AI/ML sense. The "ground truth" for a mechanical ventilator's performance is its adherence to its design specifications, established engineering principles, and compliance with international performance and safety standards for ventilators. This is verified through objective measurements, calibrations, and stress tests.

8. The sample size for the training set:

Not Applicable. A mechanical ventilator does not have a "training set" in the context of machine learning.

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

Not Applicable. As there's no training set, this question is not relevant.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

Vyaire Medical Inc Colleen Watson Director, Regulatory Affairs 26125 N. Riverwoods Blvd. Mettawa. Illinois 60045

Re: K201082

Trade/Device Name: LTV2 Series Ventilators Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK Dated: November 5, 2021 Received: November 8, 2021

Dear Colleen Watson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Brandon Blakely, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory, and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201082

Device Name

LTV2 Series Ventilator (LTV2 model 2200 and 2150)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the "Vyaire Medical" logo. The logo features a stylized graphic on the left, consisting of overlapping red and blue shapes. To the right of the graphic is the company name, "Vyaire," in a bold, dark blue font, with the trademark symbol (™) next to it. Below "Vyaire" is the word "MEDICAL" in a smaller, lighter font.

Summary of Safety and Effectiveness

510k summary complying with 21 CFR 807.92.

1. SUBMITTER [21 CFR § 807.92(a)]

VYAIRE MEDICAL INC. 26125 North Riverwoods Blvd. Mettawa, IL 60045. USA

Colleen Watson. MSc. RAC. Contact Person: Alternate Contact Person: Jayme Yamaguchi-Owens

Date Prepared: November 10, 2021

2. Device [21 CFR § 807.92(a)(2)]

Product Name:	LTV2 Series Ventilator (LTV2 model 2200 and 2150)
Device Name:	Ventilator, Continuous
Common Name:	Continuous or intermittent Ventilator
Classification Name:	Ventilator, continuous, facility use (21CFR 868.5895)
Regulatory Class:	II
Product Code:	CBK

3. Predicate Device [21 CFR § 807.92(a)(3)]

This submission demonstrates substantial equivalence to the LTV 1200 Ventilator K060647 cleared on May 25th, 2006 and LTV 1100 cleared under K101643 on January 26th, 2011.

Predicate Device Information
Predicate Device	Manufacturer	510(k) Number	Cleared Device
LTV 1200 Ventilator	Pulmonetic Systems, Inc.(Vyaire Medical, Inc.)	K060647	25 May 2006
LTV 1100 Ventilator	Carefusion (VyaireMedical, Inc.)	K101643	26 January 2011

Table 1: Predicate Device Information

Table 2: Reference Device Information

Reference Device Information

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Predicate Device	Manufacturer	510(k) Number	Cleared Device
TBird Vela Ventilator	Bird Product Corporation(Vyaire Medical, Inc.)	K032451	17 March 2004
PALMTop PTV Models8/10	Pulmonetic Systems, Inc.(Vyaire Medical, Inc.)	K070594	01 August 2007
bellavista 1000/1000e	Imtmedical AGGewerbestrasse 8Buchs Sg, CH 9470	K183364	13 September 2019

Device Description [21 CFR § 807.92(a)(4)] 4.

Intended Use [21 CFR § 807.92(a)(5)] 5.

LTV2 model 2200 and 2150 ventilators are intended to provide continuous or intermittent ventilator support for the care of the individuals who require mechanical ventilation. The use of environment is for institutional use includes ICU or other hospital environments including intra-hospital transport. The model 2200 can operate with high pressure O2. The model 2150 operates with low pressure oxygen.

Indication for use

. Positive Pressure Ventilation, delivered invasively or non-invasively (via mask).
. Assist/Control, SIMV, CPAP, and NPPV modes of ventilation.

The ventilator is suitable for use in professional healthcare facilities, including during intrahospital transport.

6. Summary of Substantial Equivalence [21 CFR § 807.92(a)(6)]

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The fundamental scientific technology is the same for both proposed and predicate devices. It is based on mechanical control of breathing gas with a predetermined percentage of oxygen to provide control ventilation or to assist patient breathing. The LTV2 Series Ventilators are substantially equivalent to the predicate LTV1200 Ventilator and LTV 1100 regarding safety, design materials and intended use.

The proposed ventilator is designed to operate the same as the predicate devices. Successful test results (electrical safety testing, mechanical testing, software V&V, and waveform verification tests) ensured the proposed ventilator does not raise any different questions of safety and effectiveness. The table below outlines the similarities and differences between the device and predicate device.

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Element ofComparison	Proposed DeviceLTV2 SeriesVentilators(LTV2 2150 & LTV22200)	PrimaryPredicate DeviceLTV 1200 - (K060647)	SecondaryPredicate DeviceLTV 1100 - (K101643)	Discussion ofDifferences
Intended Use	Intended to providecontinuous orintermittent ventilatorsupport for the care ofindividuals who requiremechanical ventilation.	Intended to providecontinuous or intermittentventilator support for the careof individuals who requiremechanical ventilation.	Intended to providecontinuous or intermittentventilator support for thecare of individuals whorequire mechanicalventilation.	Same
Indications forUse	The LTV2 SeriesVentilators are intendedto provide continuousor intermittentventilatory support forthe care of theindividuals who requiremechanical ventilation.The ventilator is arestricted medicaldevice intended for useby qualified, trainedpersonnel under thedirection of a physician.Specifically, theventilator is applicablefor adult and pediatricpatients weighing atleast 10kg (22 lbs.), whorequire the followingtypes of ventilatorysupport:Positive PressureVentilation,delivered invasivelyor non-invasively. Assist/Control,SIMV, CPAP, andNPPV modes ofventilation. The ventilator issuitable for use inhealthcare institutionalsettings.	The LTV 1200 ventilator isintended to providecontinuous or intermittentventilatory support for thecare of the individuals whorequire mechanicalventilation. The ventilator is arestricted medical deviceintended for use by qualified,trained personnel under thedirection of a physician.Specifically, the ventilator isapplicable for adult andpediatric patients weighing atleast 5kg (11 lbs.), whorequire the following types ofventilatory support:Positive PressureVentilation, deliveredinvasively (via ET tube) ornon-invasively (via mask). Assist/Control, SIMV,CPAP, and NPPV modesof ventilation. The ventilator is suitable foruse in institutional, home, ortransport settings.	The LTV 1100 ventilator isintended to providecontinuous or intermittentventilatory support for thecare of the individuals whorequire mechanicalventilation. The ventilatoris a restricted medicaldevice intended for use byqualified, trainedpersonnel under thedirection of a physician.Specifically, the ventilatoris applicable for adult andpediatric patients weighingat least 5kg (11 lbs.), whorequire the following typesof ventilatory support:Positive PressureVentilation, deliveredinvasively (via ETtube) or non-invasively (via mask). Assist/Control, SIMV,CPAP, and NPPVmodes of ventilation. The ventilator is suitablefor use in institutional,home, or transportsettings.	Same
Element ofComparison	Proposed DeviceLTV2 SeriesVentilators(LTV2 2150 & LTV22200)	PrimaryPredicate DeviceLTV 1200 - (K060647)	SecondaryPredicate DeviceLTV 1100 - (K101643)	Discussion ofDifferences
Principles ofOperation	Positive pressuremechanical ventilator	Positive pressure mechanicalventilator	Positive pressuremechanical ventilator	Same
Patientpopulation	Targeted for adult andpediatric patientsweighing at least 10kg(22 lbs.).	Targeted for adult andpediatric patients weighing atleast 5kg (11 Ibs.).	Targeted for adult andpediatric patients weighingat least 5kg (11 Ibs.).	Substantialequivalent, increasein lower weightlimit
Environment	The ventilator issuitable for use inhealthcare institutionalsettings.	The ventilator is suitable foruse in institutional, home, ortransport settings.	The ventilator is suitablefor use in institutional,home, or transportsettings.	Substantialequivalent forhealthcareinstitutionalsettings
Compatibilitywith theenvironmentand otherdevices;	Storage:Temperature: -20degrees C withoutrelative humiditycontrol to + 60 degreesC at 93% relativehumidity, non-condensing.	Storage:Temperature: -20 to+60 degrees C.Humidity: 10% to95% Relative, non-condensing	Storage:Temperature: -20 to +60degrees C. Humidity: 10%to 95% Relative, non-condensing	Substantialequivalent,designed and testedto latest EMCstandards
	Operating:Temperature:+5 to +40degrees CHumidity: 15%to 95% non-	Operating:Temperature: +5 to+40 degrees CHumidity: 15% to95% non-condensing	Operating:Temperature: +5 to +40degrees CHumidity: 15% to 95%non-condensing
	condensingEMC:IEC 60601-1-2Issue2007/03/30Edition 3 classB for Emissions,Immunity forLife SupportingEquipment	EMC:60601-1-2IEC:2001(E)Sound level:	EMC:60601-1-2 IEC:2001(E)Sound level:
	Sound level:Not exceed 55dBA (RMS) atone meter	Not exceed 50 dBA(RMS) at one meter	Not exceed 50 dBA (RMS)at one meter
Electricalsafety	Class IIType BF	Class IIType BF	Class IIType BF	Same
Battery	Internal batteryRemovable batteryoptional	Internal battery: lower paneldoor access for trained servicetechnician.	Internal battery: lowerpanel door access fortrained service technician.	Substantialequivalent
Element ofComparison	Proposed DeviceLTV2 SeriesVentilators(LTV2 2150 & LTV22200)	PrimaryPredicate DeviceLTV 1200 - (K060647)	SecondaryPredicate DeviceLTV 1100 - (K101643)	Discussion ofDifferences
InternalPEEP/PEEPCompensation	Range: 0-20 cmH2O ± 1cmH2O or 10%,whichever is greater,within 3 breaths.(Mechanical/pneumaticcontrol)	Range: 0-20 cmH2O ± 1cmH2O or 10%, whichever isgreater, within 3 breaths.(Mechanical/pneumaticcontrol)	Range: 0-20 cmH2O ± 1cmH2O or 10%, whicheveris greater, within 3breaths.(Mechanical/pneumaticcontrol)	Same
Bias Flow	Off or 5 to 15 LPM inincrements of 1 LPM.	Off or 10 LPM 10% or 1 LPM,whichever is greater	Off or 10 LPM 10% or 1LPM, whichever is greater	SubstantiallyEquivalent(Reference deviceK032451, K070594)
VentilationMode	Control ModeAssist/Control ModeSIMV ModeCPAPNPPVApnea Backup	Control ModeAssist/Control ModeSIMV ModeCPAPNPPVApnea Backup	Control ModeAssist/Control ModeSIMV ModeCPAPNPPVApnea Backup	Same
Breath types	Pressure ControlVolume ControlPressure SupportSpontaneous	Pressure ControlVolume ControlPressure SupportSpontaneous	Volume ControlPressure SupportSpontaneous	Same as predicate
Breath rate	0-80 BPM	0-80 BPM	0-80 BPM	Same
Tidal volume	50-2,000 mL	50-2,000 mL	50-2,000 mL	Same
Inspiratorytime	0.3 - 9.9 seconds	0.3-9.9 sec	0.3-9.9 sec	Same
Pressurecontrol	4 – 98 cmH20(assist/Control &SIMV/CPAP)Off - 60 cmH2O (NPPV)	1-99 cmH2O	Pressure control notpresent	Substantiallyequivalent
Pressuresupport	1-60 cmH2O	1-60 cmH2O	1-60 cmH2O	Same
Sensitivity	Off, 1-9 LPM	Off, 1-9 LPM	Off, 1-9 LPM	Same
02%	21–100% (LTV2200);oxygen bleed flow (LTV2150 and LTV 2200)	21-100%; oxygen bleed flow	oxygen bleed flow%	Same as predicate
O2 flush	1-3 min (LTV 2200 only)	1-3 min	N/A	Same as predicate
PEEP/CPAP	0 – 20 cmH2O	0-20 cmH2O	0–20 cmH2O	Same
Element ofComparison	Proposed DeviceLTV2 SeriesVentilators(LTV2 2150 & LTV22200)	PrimaryPredicate DeviceLTV 1200 - (K060647)	SecondaryPredicate DeviceLTV 1100 - (K101643)	Discussion ofDifferences
Blender	LTV2 2200: High andlow oxygen inletpressureLTV2 2150: Low oxygeninlet pressure	High and low oxygen inletpressure	Low oxygen inlet pressure	Same
VOXP(VENTILATOROPEN XMLPROTOCOL)	Present	Not present	Not present	Substantiallyequivalent

Table 3: Substantial Equivalence Comparison

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Image /page/8/Picture/0 description: The image shows the logo for "Vyaire Medical". The logo consists of two overlapping circles, one red and one blue, followed by the word "Vyaire" in a dark blue sans-serif font. Below the word "Vyaire" is the word "MEDICAL" in a smaller, red sans-serif font.

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7. Performance Data [21 CFR § 807.92(b)(1)]

The LTV2 Series Ventilators was designed and tested in accordance with the following and FDA guidance documents and international standards

Standards / FDA guidance

Standard #	Title
ANSI AAMI ES60601-1:2005 + A1:2012 +C1:2009 + A2:2010	Medical electrical equipment — part 1: General requirementsfor basic safety and essential performance
IEC 60601-1:2005 +A1:2012	Medical electrical equipment — part 1: General requirementsfor basic safety and essential performance
IEC 60601-1-2 Edition3.0 2007-03IEC 60601-1-2:2014	Medical electrical equipment — part 1-2: general requirementsfor basic safety and essential performance — collateralstandard: electromagnetic compatibility — requirements andtests. (General II (ES/EMC))
IEC 60601-1-2 Edition4.0 2014-02	Medical electrical equipment — part 1-2: general requirementsfor basic safety and essential performance — collateralstandard: electromagnetic compatibility — requirements andtests. (General II (ES/EMC))
IEC 60601-1-6 Edition3.0 2010-01	Medical electrical equipment — part 1-6: general requirementsfor basic safety and essential performance — collateralstandard: usability. (General I (QS/RM)

Table 4: List of Standards

{10}------------------------------------------------

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IEC 60601-1-8 Edition2.1 2012-11	Medical electrical equipment - part 1-8: general requirementsfor basic safety and essential performance – collateralstandard: general requirements, tests and guidance for alarmsystems in medical electrical equipment and medical electricalsystems. (General I (QS/RM))
IEC 62304 First edition2006-05IEC Edition 1.1 2015-08	Medical device software - software life cycle processes.(Software/Informatics)
IEC 62366:2007ANSI AAMI IEC 62366-1:2015	Medical devices – Application of usability engineering tomedical devices
ISO 80601-2-12 FirstEdition: 2011	Medical electrical equipment – part 2-12: particularrequirements for the safety of lung ventilators - critical careventilators [including: technical corrigendum 1 (2011)
ISO 5356-1 Third edition2004-05-15	Anaesthetic and respiratory equipment – Conical connectors:Part 1: Cones and sockets
ISO 5367:2014	Anaesthetic and respiratory equipment -- Breathing sets andconnectors
ISO 10993-1:2009	Biological evaluation of medical devices - Part 1: Evaluationand testing
ISO 14971:2007	Medical devices - Applications of risk management to medicaldevices

Design Verification included:

Waveform
Alarms
Ventilation Controls
Ventilation Displays ●
Endurance
Patient Circuit Testing

Clinical Data [21 CFR § 807.92(b)(2)]

Based on the similarities in the safety and effectiveness profiles of the subject, predicate and reference devices, no clinical studies were deemed to needed to support this submission.

8. Conclusion [21 CFR § 807.92(b)(2)]

The non-clinical data support the safety and effectiveness of the proposed device. Also, test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device.

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).