The LTV 1000 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 5 kg (11 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. .

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

Device Description

The LTV 1000 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 5 kg (11 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. ●

The modifications intended to be cleared by this submission are:

. The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition.
. The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters.
The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period.
The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air.
A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.

AI/ML Overview

The provided text describes a 510(k) summary for the LTV 1000 Ventilator, focusing on modifications to an existing device rather than a study proving the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and performance studies for a device which normally would involve data from human or phantom subjects, ground truth, expert opinions, or statistical analysis of algorithmic performance.

The text details:

Device Trade Name: LTV 1000 Ventilator
Common Name: Ventilator
Classification Name: Ventilator, Continuous (Respirator) 868.5895
Intended Use: To provide continuous or intermittent ventilatory support for individuals requiring mechanical ventilation (adult and pediatric patients weighing at least 5 kg). Suitable for institutional, home, and transport settings.
Modifications: Addition of High Breath Rate Alarm, O2 cylinder duration monitoring, 100% O2 flush feature, Automatic High O2 Switchover, and improved maximum allowable oxygen input pressure.
Equivalence to Predicate Devices: The modified LTV 1000 Ventilator is deemed substantially equivalent to the previously cleared LTV 1000 Ventilator (K032226) and the T-Bird AVS Ventilator (K981971).

Without information on a performance study specific to the modifications and their impact on clinical outcomes or diagnostic accuracy, I cannot fill out the requested table or answer the questions related to acceptance criteria, sample size, ground truth, or expert involvement.

The information provided in this 510(k) summary is focused on demonstrating substantial equivalence to a predicate device for device modifications, which is a regulatory pathway for marketing new medical devices in the US. This regulatory process typically relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, often through engineering tests and comparison of technical specifications, rather than new clinical effectiveness studies as would be seen for novel device types or those requiring PMA.

Summary

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510(K) SUMMARY

1.1 SUBMITTER

Pulmonetic Systems, Inc. 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341

Contact Person:	Robert C. Samec	Telephone
	(763) 398-8305
	(763) 398-8400	Facsmilie

DEVICE / TRADE NAME 1.2

LTV 1000 Ventilator Trade Name:

Ventilator Common Name:

Classification Name: Ventilator, Continuous (Respirator) 868.5895

SUBMISSION DATE 1.3

Submission Date: April 1. 2004

1,4 DESCRIPTION

The LTV 1000 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 5 kg (11 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. ●

The modifications intended to be cleared by this submission are:

. The addition of a High Breath Rate Alarm to alert operators to a patient's high breath rate condition.
. The addition of O2 cylinder duration monitoring to provide a reference indicator of the approximate remaining usable time of an external O2 cylinder based on operator entered input parameters.

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The addition of a 100% O₂ flush feature allowing the operator to elevate delivered FIO₂ . for a preset time period.
The addition of Automatic High O₂ Switchover to alert operators that a high O₂ pressure . source is attached to the ventilator when a low O2 pressure source has been selected. In this condition, the ventilator will switch to a high O2 pressure source mode and set O2 delivery to 21% or room air.
A change in maximum allowable oxygen input pressure from 70 psig to allow . broader compatibility with institutional oxygen sources.

INTENDED USE 1.5

The LTV 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 5 kg (11 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. .

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

EQUIVALENCE TO PREDICATE DEVICE(S) 1.6

The LTV 1000 Ventilator listed modifications are substantially equivalent to the following listed devices:

Predicate Device	510(k) Clearance	Manufacturer
LTV 1000 Ventilator	K981371 - Initial clearance forInstitutional and Transportsettings.K984056 - Homecare settings.K002881 - Enhancements.K010608 - Lap Top Monitor.K032226 - 5 kg Patient Application.	Pulmonetic Systems, Inc.Colton, CA/Mpls., MN
T-Bird AVS	K981971	Bird Products, PalmSprings, CA

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The LTV 1000 ventilator, previously cleared for homecare use and for institutional and transport settings, is now being submitted for clearance with the listed modifications.

The table on the following pages compares the modifications/features of the LTV to the previously cleared LTV 1000 ventilator and the T-Bird AVS ventilator.

The LTV 1000 ventilator with the modifications listed is substantially equivalent to the predicate LTV 1000 (K032226) and the T-Bird AVS Ventilator (K981971) manufactured by Bird Products.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing left. The eagle is composed of three thick, curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2004

Mr. Robert C. Samec Vice President-Regulatory Affairs Pulmonetic System, Incorporated 17400 Medina Road Suite 100 Minneapolis, Minnesota 55447

Re: K040540

Trade/Device Name: LTV 1000 Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 1, 2004 Received: April 2, 2004

Dear Mr. Samec:

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 apper (a) sprovisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will ), it hay ob of of the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Lederal Register.

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Page 2 - Mr. Samec

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. or the receir any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and inning (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rins leter 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K040540

Device Name: Ventilator, Continuous (Respirator)

Indications For Use:

The LTV 1000 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 5 kg (11lbs.), 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, or transport settings.

Prescription Use X ___________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

sthmil

on of Anesthesiology, General Hospital, Infection Control Dental Device

Page 1 of

510(k) Number: K040540

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).