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. .

The ventilator is suitable for use in institutional, home, or 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 addition intended to be cleared by this submission is:

The addition of the Automobile Lighter Power Cord to be externally attached . to the LTV Series to power the LTV Ventilator while operating in an automobile. The power cord is designed to connect to +12V automobile cigarette lighter or auxiliary power outlets capable of supplying as least 20 amperes of current.

AI/ML Overview

The provided document is a 510(k) summary for the "Automobile Lighter Power Cord" for the LTV 1000 ventilator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria in the context of AI/ML or diagnostic applications.

Therefore, many of the requested elements (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance with AI, ground truth types) are not applicable to this particular submission.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this specific 510(k) submission revolve around demonstrating substantial equivalence to an existing legally marketed device (the predicate device) and ensuring the new accessory (Automobile Lighter Power Cord) does not raise new questions of safety or effectiveness.

The "study" conducted for this submission is a comparison to a predicate device to establish substantial equivalence based on intended use and technical characteristics.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Summary)
Intended Use: Device's intended use must be the same as the predicate device.	Same intended use as the predicate device (LP-6 Ventilator with Cigarette Lighter Cable).
Technological Characteristics: Device must have similar technological characteristics, or differences must not raise new questions of safety or effectiveness.	The Automobile Lighter Power Cord allows the LTV 1000 Ventilator to be powered from a 12V automotive power outlet.
Safety and Effectiveness: Demonstrate that the device is as safe and effective as the predicate device, or that differences do not affect safety/effectiveness.	Implied by "Same intended use" and the nature of the accessory (power cord). No specific safety/effectiveness study details related to the cord's primary function are provided in this summary.

Additional Requested Information (Not Applicable or Not Provided in this Document)

The document is a 510(k) summary for a ventilator accessory, not a diagnostic device or an AI/ML-driven device. As such, information typically found in studies for AI/ML or diagnostic performance is not present.

Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or an AI/ML algorithm on a test set of data. The "test" is the comparison to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of diagnostic performance is being established for this type of device.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this submission is primarily the regulatory standard of substantial equivalence to a predicate device.
The sample size for the training set: Not applicable. There is no AI/ML algorithm being trained.
How the ground truth for the training set was established: Not applicable.

Summary

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K 060549

MAY 4 2006

1. 510(K) SUMMARY

1.1 SUBMITTER

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

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

1.2 DEVICE / TRADE NAME

Trade Name: Automobile Lighter Power Cord

Common Name: Ventilator Accessory

Classification Name: Ventilator, Continuous (Respirator) 868.5895

1.3 SUBMISSION DATE

Submission Date: March 1, 2006

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 addition intended to be cleared by this submission is:

The addition of the Automobile Lighter Power Cord to be externally attached . to the LTV Series to power the LTV Ventilator while operating in an automobile. The power cord is designed to connect to +12V automobile cigarette lighter or auxiliary power outlets capable of supplying as least 20 amperes of current.

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1.5 INTENDED USE

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 Automobile Lighter Power Cord is substantially equivalent to the following listed devices:

Predicate Device	510(k) Clearance	Manufacturer
LP-6 Ventilator withCigarette LighterCable Y-CG1230	K905244	Puritan BennettPleasanton, CA 94588

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SUBSTANTIAL EQUIVALENCE SUMMARY TABLE

Predicate Device	Modified Device	Discussion of Differences andSimilarities
LP-6 Ventilator withCigarette Lighter CableP/N Y-CG1230 (K905244)	LTV 1000 Ventilator withAutomobile Lighter Power CordP/N 11544	Same intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

4 2006 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert C. Samec Vice President, Product Assurance Pulmonetic Systems, Incorporated 17400 Medina Road, Suite 100 Minneapolis, Minnesota 55447-1341

Re: K060549

Trade/Device Name: Ventilator, Continuous (Respirator) Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: March 1, 2006 Received: March 2, 2006

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 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.

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 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 - 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. 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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 vour 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 (240) 276-0120. 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/industry/support/index.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):

Device Name: Ventilator, Continuous (Respirator)

Indications for 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, or transport settings.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Tim Sullivan

ion of Anesthesioloo eneral Hos Infection Control. D

510(k) Number:

Page _ of _/

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).