The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of 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 (via ET tube) or non-invasively (via mask).
. Assist/Control, SIMV, or CPAP modes of ventilation.
The ventilator is suitable for use in institutional, home, and transport settings.

Device Description

The LTV 1000 is a self-contained mechanical ventilator suitable for continuous life support in institutional, home, and transport settings. The ventilator is slightly larger than a "laptop computer" and is self-contained in that it can be operated without the need for externally supplied compressed air. The unit may be operated from external AC power through the use of an external AC/DC converter, or may be operated for approximately one hour using an internal rechargeable battery pack.
The following major features are included:

. Modes: Assist/Control, SIMV, CPAP, Apnea Backup
Breath Types: Volume Control, Pressure Control, Pressure Support, Spontaneous .
. Flow Triggering
. Oxygen Blending
. PEEP
Monitors: Calculated Peak Flow, Exhaled Tidal Volume, I:E Ratio, Mean Airway Pressure, Real . Time Airway Pressure, Peak inspiratory Pressure, PEEP, Total Breath Rate, Total Minute Volume
. Alarms: Apnea, High Pressure Limit, Low Peak Pressure, Low Minute Volume, Disconnect, Low & Lost External Power, Low & Empty Internal Battery, Oxygen Inlet Pressure
The ventilator uses an internal flow generator to provide the pressurized gas source. All breath types are delivered by an electromechanical inspiratory flow valve. An oxygen blender meters oxygen as required to meet the current setting of the O2% control. Mechanical valves are provided internally for overpressure relief and sub-ambient relief functions.
The patient circuit is comprised of a single leg inspiratory tube connected to an exhalation system located proximal to the patient connection. The exhalation valve system will consist of a piloted exhalation valve, a PEEP valve, and a flow transducer combined in a compact package. Additional small bore tubing is included to transmit the flow, pressure and exhalation drive signals.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LTV 1000 ventilator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines a non-clinical performance test program to ensure the LTV 1000 meets its stated specifications and standards. This effectively serves as the acceptance criteria. The reported device performance is that the "ventilator was found to perform to specifications with exceptions as noted in the validation report."

Acceptance Criteria Category	Specific Acceptance Criteria (from text)	Reported Device Performance
ASTM Tests	Ventilator meets ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care. Ventilator meets ASTM F 1246-91 Standard Specification for Electrically Powered Home Care Ventilators.	"The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user." (Implies general compliance, with specific deviations addressed and mitigated).
Performance Tests	Ventilator meets performance specifications, including tolerance and accuracy issues. (Example: Set Tidal Volume function tested over its entire range (50-2000 ml) and worst-case combinations of patient compliance, patient resistance, temperature/humidity of breathing gas, and ventilator operating temperature).	"The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user." (Implies general compliance, with specific deviations addressed and mitigated). The example specifically mentions testing "over the entire range of operation while varying other relevant parameters."
Functional Tests	Ventilator meets behavioral specifications (Primarily Software).	"The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user." (Implies general compliance, with specific deviations addressed and mitigated).

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

Sample Size: The document states that "Test procedures were written for individual tests specifying: the requirement being tested, the number of units to be tested." However, the exact sample size (the specific number of units tested) is not explicitly provided in the given text. It mentions testing "worst case combinations" for parameters like tidal volume, implying comprehensive testing.
Data Provenance: The data is retrospective in the sense that it's generated from internal testing of the manufactured device. The country of origin of the data is not explicitly stated but is implicitly the USA, where Pulmonetic Systems, Inc. is located.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for this device's performance is established through adherence to engineering specifications, industry standards (ASTM), and internal validation procedures, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to this type of device testing. This method is typically used in clinical studies where subjective human interpretation (e.g., image reading) requires consensus from multiple experts. For a mechanical ventilator, the tests are objective, comparing measurements against predefined specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and their performance with and without AI assistance is evaluated. The LTV 1000 is a therapeutic device, a ventilator, and its performance is assessed against technical specifications, not human interpretive accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The entire non-clinical performance testing described is essentially a standalone (algorithm/device only) performance study. The testing validates the ventilator's functional and performance specifications independently, without human intervention as part of the evaluated performance metric. The "human-in-the-loop" would be the clinician operating the device, but the device's inherent performance is assessed on its own.

7. Type of Ground Truth Used

The ground truth used for validating the LTV 1000 is based on engineering specifications, industry standards (ASTM F 1100-90, ASTM F 1246-91), and internal requirements (System Specification, Software Requirements Specification, System Hazards Analysis). These define the expected or correct behavior and output of the device.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a mechanical device, and its design and development likely involved traditional engineering and testing, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set in the context of AI/ML, the question of how its ground truth was established is not applicable to this document. The "ground truth" for the device's design and function would have been established through engineering principles, regulatory requirements, and clinical needs analysis.

Summary

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K984056

510 K

SUBMITTER

Pulmonetic Systems, Inc 930 S. Mt. Vernon Ave. Suite 100 Colton, CA 92324-3928 Ph. (909) 783-2280 Fax (909) 783-2975 Douglas DeVries Contact Person: November 11, 1998 Date Prepared:

DEVICE NAME

Trade Name:	LTV 1000
Common Name:	Ventilator
Classification Name:	Ventilator, Continuous (Respirator)

PREDICATE DEVICE

The primary predicate device is the TBird Homecare Ventilator (K981971), manufactured by Bird Products Corp. of Palm Springs, CA.

DESCRIPTION

The LTV1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home, and transport settings, and 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 (via ET tube) or non-invasively (via mask). .
. Assist/Control, SIMV, or CPAP modes of ventilation.
Breath types including Volume, Pressure Control, and Pressure Support .

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The following major features are included:

. Modes: Assist/Control, SIMV, CPAP, Apnea Backup
Breath Types: Volume Control, Pressure Control, Pressure Support, Spontaneous .
. Flow Triggering
. Oxygen Blending
. PEEP
Monitors: Calculated Peak Flow, Exhaled Tidal Volume, I:E Ratio, Mean Airway Pressure, Real . Time Airway Pressure, Peak inspiratory Pressure, PEEP, Total Breath Rate, Total Minute Volume
. Alarms: Apnea, High Pressure Limit, Low Peak Pressure, Low Minute Volume, Disconnect, Low & Lost External Power, Low & Empty Internal Battery, Oxygen Inlet Pressure

The ventilator uses an internal flow generator to provide the pressurized gas source. All breath types are delivered by an electromechanical inspiratory flow valve. An oxygen blender meters oxygen as required to meet the current setting of the O2% control. Mechanical valves are provided internally for overpressure relief and sub-ambient relief functions.

The patient circuit is comprised of a single leg inspiratory tube connected to an exhalation system located proximal to the patient connection. The exhalation valve system will consist of a piloted exhalation valve, a PEEP valve, and a flow transducer combined in a compact package. Additional small bore tubing is included to transmit the flow, pressure and exhalation drive signals.

INTENDED USE

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

The ventilator is suitable for use in institutional, home, and transport settings.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO THE PREDICATE DEVICE

The following table sets forth a comparison of the major technological characteristics of the TBird Ventilator (K981971), manufactured by Bird Products Corp. of Palm Springs, CA.

Characteristic	LTV 1000 Vent	Predicate Device	Discussion of Differences and Similarities
		Bird TBird Ventilator(K981971)
Compressed Air Source	Internal, Flow Generator driven by abrushless DC motor.	Internal, Flow Generator driven by abrushless DC motor.	The flow generator is similar in that both devices usea rotating element driven by a brushless DC motor.The LTV differs in that the flow generator operatesat a constant speed and is not used to control thebeginning and end of inspiration as does thepredicate device. This constant speed operation isequivalent to the operation of other ventilators, suchas the Quantum (K962517) mfg by HealthdyneTechnologies.
Inspiratory Flow Control	Variable poppet valve positioned by arotary actuator.	No separate valve, breath control iseffected through variable speed controlof the flow generator.	The rotary actuator driven flow control valve usedon the LTV 1000 is similar to flow valves used onother currently marketed ventilators the ServoVentilator 900C ( K811102) mfg by Siemens. Eventhough the 900C is not a home care ventilator, thisflow control method is approved for use incomparable clinical settings.
Exhalation Valve	External Piloted balloon type.	Internal, diaphragm driven by a linearactuator.	The external piloted exhalation valve used on theLTV 1000 is similar to types used on other currentlymarketed ventilators, for example the NellcorPuritan Bennet LP 10 ventilator, (K905244).

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Characteristic	LTV 1000 Vent	Predicate DeviceBird TBird Ventilator(K981971)	Discussion of Differences and Similarities
PEEP Valve	External, spring loaded diaphragmtype.	Internal, controlled by closed loopcontrol of the linear actuator.	The external spring loaded PEEP valve used on theLTV 1000 is similar to types used on other currentlymarketed ventilators, for example the NellcorPuritan Bennet LP 10 ventilator, (K905244).
Exhalation Flow Xducer	Differential Pressure Type, fixedorifice.	Differential Pressure Type, variableorifice.	Transducer is similar.
Control System	Microprocessor based analog anddigital electronics.	Microprocessor based analog anddigital electronics.	Control system is similar.
Package	Sheetmetal and thermoplasticelastomer.	Sheetmetal, thermoplastic, andthermoplastic elastomer.	The LTV 1000 employs a sheetmetal chassis,protected by elastomeric side panels to provideenhanced durability.
Displays	7-segment, alpha-numeric, and singlelamp LEDs.	7-segment, alpha-numeric, and singlelamp LEDs.	Displays are similar

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. .

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NON-CLINICAL PERFORMANCE TESTING

Pursuant to establishing functional and technical equivalence to the predicate device, a non clinical test program was completed to insure that the device met its stated specifications. Validation activities included running test procedures written to validate the requirements as specified in the following documents:

. System Specification
. Software Requirements Specification
. System Hazards Analysis
ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care
ASTM F 1246-91 Standard Specification for Electrically Powered Home Care Ventilators .

The test procedures were divided into 3 primary categories:

ASTM tests	Tests that verify the ventilator meets ASTM standards
Performance Tests	Tests that verify the ventilator meets performance specifications includingtolerance and accuracy issues.
Functional Tests	Tests that verify the ventilator meets behavioral specifications (PrimarilySoftware)

Test procedures were written for individual tests specifying: the requirement being tested, the number of units to be tested, the equipment to be used, test set-up instructions, the data to be recorded. In general, test procedures were written to test each parameter over the entire range of operation while varying other relevant parameters such as patient lung condition and environment. For example, the Set Tidal Volume function was tested over its entire range (50 - 2000 ml) and over worst case combinations of the following parameters:

. Patient Compliance
Patient Resistance
. Temperature/Humidity of Patient breathing gas.
Ventilator Operating Temperature.

A validation report was written that summarizes the results of these tests. The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user.

CONCLUSION

The comparison analysis and validation test results demonstrate the device is substantially equivalent to the predicate device and appropriate for the intended use.

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three parallel lines that curve and taper to suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 2 1999

Mr. Douglas DeVries Chief Executive Officer Pulmonetic Systems 930 S. Mt. Vernon Avenue, Suite 100 Colton, CA 92324

Re: K984056 Trade Name: LTV 1000 Regulatory Class: II (two) Product Code: CBK Dated: February 18, 1999 Received: February 23, 1999

Dear Mr. DeVries:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements

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Page 2 - Mr. Douglas DeVries

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, " Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities

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Page 3 - Mr. Douglas DeVries

under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Athr A. Carlaw L.

/ . Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INTENDED USE

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

The ventilator is suitable for use in institutional, home, and transport settings.

Ath. A. Cizlowski.

Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number

Prescription Use X
(Per 21 CFR 801.109)

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).