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 and transport settings.

Device Description

The LTV 1000 is a self-contained mechanical ventilator suitable for continuous life support in institutional and attended transport settings. The ventilator is slightly larger than a "laptop computer" and is selfcontained 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

The provided document is a 510(k) premarket notification for a medical device, the LTV 1000 Ventilator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. Therefore, several requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in terms of quantitative performance metrics with pre-defined thresholds. Instead, it describes a non-clinical performance testing program designed to ensure the device met its "stated specifications" and demonstrated "functional and technical equivalence" to the predicate device. The "reported device performance" is essentially that the ventilator "was found to perform to specifications."

Acceptance Criteria Category	Reported Device Performance
ASTM Tests	Ventilator meets ASTM standards
Performance Tests	Ventilator meets performance specifications, including tolerance and accuracy issues
Functional Tests	Ventilator meets behavioral specifications (primarily software)
Overall	Device found to perform to specifications (with exceptions noted and addressed in a validation report)

Note: The document explicitly states: "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." This suggests that any deviations from specifications were either minor or had a documented mitigation plan.

Study Details

The study described is a non-clinical performance testing program aimed at demonstrating substantial equivalence to a predicate device (TBird Ventilator, K950484).

Sample size used for the test set and the data provenance:
- Sample Size: The document states that test procedures were written specifying the "number of units to be tested." However, the exact number is not specified in this document. It only mentions "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."
- Data Provenance: The testing was retrospective in the sense that it was conducted on the manufactured device to verify its specifications. The data origin is internal testing by Pulmonetic Systems, Inc. There is no mention of external data or patient data from a specific country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. This was a non-clinical technical performance study. "Ground truth" in this context refers to the defined specifications and standards (e.g., ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care). The "experts" involved would be the engineers and quality assurance personnel who designed the tests and evaluated the results against the established specifications. Their specific number and qualifications are not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None specified. As this was a technical validation against specifications, an adjudication method in the clinical sense (e.g., for image interpretation) is not relevant. The validation report would likely have involved review and approval by relevant engineering and quality management personnel.
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:
- No. This device is a mechanical ventilator and does not involve AI or human "readers" in the context of diagnostic interpretation. Therefore, an MRMC study is not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, analogous to standalone performance. The non-clinical performance testing assesses the device (including its software and mechanical components) in isolation, against its stated specifications and relevant standards. This is essentially a standalone performance evaluation of the device's functional and technical characteristics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this non-clinical study consists of:
  - System Specifications: Internal design requirements.
  - Software Requirements Specifications: Internal software design requirements.
  - System Hazards Analysis: Requirements derived from risk assessment.
  - ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care: External, recognized industry standard for ventilator performance.
The sample size for the training set:
- Not applicable / Not specified. This device is a mechanical ventilator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The development of the device would have involved engineering design, prototyping, and iterative testing, but not a "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable. As there is no "training set" for an algorithm, this question is not relevant. The ground truth for the testing related to device specifications was established through internal design requirements (System, Software Requirements, Hazards Analysis) and external industry standards (ASTM F 1100-90).

Summary

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510(4) K 18,371

OCT 30 1998

Submitter

Pulmonetic Systems, Inc
1016 E. Cooley Drive, Suite B
Colton, CA 92324
Ph.	(909) 783-2280
Fax	(909) 783-2975
Contact Person:	Douglas DeVries
Date Prepared:	April 15, 1998

DEVICE NAME

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

PREDICATE DEVICE

The primary predicate device is the TBird Ventilator (K950484), manufactured by Bird Products Corp. of Palm Springs, CA.

DESCRIPTION

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilator is suitable for use in institutional and attended 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 and 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 (K950484), manufactured by Bird Products Corp. of Palm Springs, CA.

Characteristic	LTV 1000 Vent	Predicate DeviceBird TBird Ventilator(K950484)	Discussion of Differences and Similarities
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 devicesa 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 operationequivalent to the operation of other ventilators,as 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 usesthe LTV 1000 is similar to flow valves used on othercurrently marketed ventilators the Servo Ventilator900C ( K811102) mfg by Siemens.
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 NellcorBennet LP 10 ventilator, (K905244).
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 NellcorBennet LP 10 ventilator, (K905244).

Pulmonetic Systems, Inc.

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Characteristic	LTV 1000 Vent	Predicate DeviceBird TBird Ventilator(K950484)	Discussion of Differences and Similarities
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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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 Specification1 .
. Software Requirements Specification
. System Hazards Analysis
. ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care

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.

See Section 15: Software.

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Image /page/5/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. Below the profiles are three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 30 1998

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

Re: K981371 LTV 1000 Ventilator Regulatory Class: II (two) Product Code: 73 CBK August 26, 1998 Dated: Received: August 27, 1998

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 your 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 requlations affecting your device can be found in the Code of Federal Regulations, 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements 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.

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Page 2 - Mr. Douglas DeVries

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, 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 leqally 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) 594-4648. 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 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,

, Ath. A. Giall.

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

Enclosures

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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 and transport settings.

revised 8/5/98.

Mark Kram

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K98i371

Prescription Use ✓
(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).