The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilation is a restricted medical device intension of individuals who require incomment venture direction of a physician. Specifically, the ventilator is applicable for adult and petiative weighing at least 5 kg (1 1 lbs), who require the following types of ventilatory support:

Positive Pressure Yentilation, delivered invasively (via ET tube) or non-invasively (via mask).
Assist/Control, SIMV, CPAP, or NPPV modes of ventilation.
The ventilator is suitable for use in institutional, home, or transport settings.

Device Description

The LTV 1200 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, CPAP, or NPPV modes of ventilation. .
Breath types including Volume, Pressure Control and Pressure Support. .
The modifications intended to be cleared by this submission are:
Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator.
해 The addition of a Low PEEP alarm.
The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters.
I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation.
I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement.
g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission).
The LTV 1000 Ventilator, previously cleared for homecare, institutional and transport use is now being submitted for clearance with the listed modifications.

AI/ML Overview

This 510(k) premarket notification (K060647) is for the Pulmonetic Systems, Inc. LTV 1200 Ventilator. The submission describes modifications to the previously cleared LTV 1000 Ventilator. However, the document does not contain information regarding specific acceptance criteria for performance metrics or a detailed study proving the device meets those criteria, as one would typically find for AI/ML-based medical devices.

Instead, this submission is a typical medical device 510(k) for a hardware device with software components, focusing on demonstrating substantial equivalence to predicate devices and adherence to general controls and good manufacturing practices. The "acceptance criteria" discussed are implicitly related to the device functioning as intended for ventilation, meeting safety standards, and performing comparably to the predicate LTV 1000 and other listed ventilators (iVent 201 Portable Ventilator, AVEA Ventilator).

Here's a breakdown of the requested information based on the provided document, with notes on what is not applicable or not present in a traditional hardware device submission like this:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Implied from Modifications and Equivalence)
Functional Equivalence to Predicate Devices: Device performs its intended ventilatory support functions comparably to the LTV 1000, iVent 201, and AVEA Ventilators.	The LTV 1200 Ventilator is stated to be "substantially equivalent" to predicate devices, including the LTV 1000, iVent 201, and AVEA Ventilators. This implies that its overall performance in delivering ventilatory support (e.g., breath types, modes, pressure/volume delivery) meets similar standards. Specific performance metrics are not quantitative stated in this summary.
Proper function of new features/modifications: - Optional internal PEEP control - Low PEEP alarm - Optional Patient Setting Control Presets - NPPV mode setting enhancements - Externally accessibility to the device internal battery	The modifications are listed, and the 510(k) clearance implies that the FDA found these modifications do not raise new questions of safety or effectiveness and function as intended. However, specific quantitative performance data for these new features (e.g., alarm accuracy, preset efficacy) is not provided in this summary.
Safety and Effectiveness: Device meets general safety and effectiveness requirements for ventilators for adult and pediatric patients (>5 kg) in institutional, home, and transport settings.	The FDA's clearance (K060647) indicates that after review, the device is deemed substantially equivalent, which includes an implicit determination of sufficient safety and effectiveness for its stated indications for use. Compliance with general controls and GMP is also required.

Note: For a hardware device like a ventilator, acceptance criteria typically involve detailed engineering specifications, performance against recognized standards (e.g., ISO 80601-2-12 for critical care ventilators), and verification/validation testing covering aspects like:

Pressure/volume/flow accuracy and stability
Alarm performance (accuracy, response time)
Battery life and management
Durability and environmental testing
Electromagnetic compatibility (EMC)
Biocompatibility (if applicable to patient contact parts)
Software validation (for embedded software)

This 510(k) summary does not include such detailed technical specifications or test results. It focuses on the regulatory aspect of demonstrating substantial equivalence.

The following information is not present in the provided 510(k) summary, as it is typically relevant for AI/ML-based medical devices or more specific clinical trials, which are not the focus of this hardware device submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided: This type of information is generally for studies involving data analysis, particularly for AI/ML models. For a ventilator, testing involves engineering verification and validation testing, not typically a "test set" in the context of data-driven models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided: This is specific to establishing ground truth for diagnostic or prognostic AI/ML applications. For a ventilator, "ground truth" is established by physical measurements and engineering standards, not expert consensus on data interpretation.

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

Not Applicable/Not Provided: This relates to expert review processes for ground truth establishment in data-driven studies.

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/Not Provided: MRMC studies are used for evaluating diagnostic performance of AI-assisted human readers, which is not relevant for a ventilator's functional clearance.

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

Not Applicable/Not Provided: This also pertains to AI/ML algorithm performance. The LTV 1200 is a device operated by a human, not a standalone diagnostic algorithm.

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

Not Applicable/Not Provided, but inferred through engineering standards: For a ventilator, the "ground truth" for its performance is derived from physical laws of gas exchange, pressure/flow measurements, and established medical standards for ventilatory support. This is verified through engineering tests, rather than expert consensus on data labels, pathology, or outcomes data in the traditional sense of AI/ML studies.

8. The sample size for the training set

Not Applicable/Not Provided: This refers to data used to train AI/ML models.

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

Not Applicable/Not Provided: This also refers to AI/ML model training data.

Summary of the Study (as described in the 510(k) summary):

The "study" for the LTV 1200 Ventilator, as presented in this 510(k) summary, is not a clinical trial or a data-driven performance study in the AI/ML context. Instead, it is a regulatory submission process aimed at demonstrating substantial equivalence to legally marketed predicate devices (LTV 1000, iVent 201 Portable Ventilator, AVEA Ventilator).

Evidence for Equivalence: The submission implicitly relies on:
- Description of modifications: The document details the changes from the LTV 1000, which are primarily related to convenience, alarms, and internal components, not fundamental changes to the core ventilation mechanism.
- Intended Use comparison: The intended use of the LTV 1200 is identical to the LTV 1000 (continuous or intermittent ventilatory support for adults and pediatric patients >5kg in various settings).
- Technological Characteristics Comparison (implied): While not explicitly detailed in the summary, a full 510(k) submission would include a comparison of technological characteristics between the new device and the predicates, demonstrating that any differences do not raise new questions of safety and effectiveness. This often involves engineering verification and validation testing, which is assumed to have been performed even if not detailed in the public summary.

The FDA's clearance (K060647) signifies that they reviewed the provided information and concluded that the LTV 1200 Ventilator, with its modifications, is substantially equivalent to the predicate devices and can therefore be marketed without requiring a premarket approval application (PMA) or more extensive clinical trials typical for novel devices.

Summary

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Ko60647

510(K) SUMMARY

SUBMITTER

MAY 2 5 2006

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

Trade Name: LTV 1200 Ventilator

Common Name: Ventilator

Ventilator, Continuous (Respirator) 868.5895 Classification Name:

SUBMISSION DATE

Submission Date: March 9, 2006

DESCRIPTION

Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
Assist/Control, SIMV, CPAP, or NPPV modes of ventilation. .
Breath types including Volume, Pressure Control and Pressure Support. .

The modifications intended to be cleared by this submission are:

Incorporation of optional internal PEEP control, replacing the optional external 록 mechanical PEEP valve used with the previously cleared LTV 1000 Ventilator.
해 The addition of a Low PEEP alarm.

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The addition of optional Patient Setting Control Presets to assist clinicians in initially setting patient ventilation set parameters.
I The addition of NPPV mode setting enhancements to assist the clinician in setting up NPPV mode ventilation.
I The addition of externally accessibility to the device internal battery for trained service personnel battery replacement.
g The designation of the modified LTV 1000 Ventilator as the VIASYS LTV 1200 Ventilator. (Note: The previously cleared Pulmonetic Systems LTV 1000 will continue to be marketed without the modifications listed in this submission).

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

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,CPAP, or NPPV 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)

The modified LTV 1000 with the modifications listed is substantially equivalent to the predicate device(s) listed.

Predicate Device	510(k) Clearance	Manufacturer
iVent 201 PortableVentilator	K011957	Versamed Corporation2 Blue Hill PlazaPearl River, NY 10965
AVEA Ventilator	K022674	Bird Products Corporation1100 Bird Center DrivePalm Springs, CA 92262
LTV 1000 Ventilator	K051767	Pulmonetic Systems, Inc.17400 Medina Road, Suite 100Minneapolis, MN 55447

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

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

Re: K060647

Trade/Device Name: Ventilator, Continuous (Respirator), Model LTV 1200 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 9, 2006 Received: May 10, 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 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 (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

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Indications for Use

510(k) Number (if known):

Device Name: Ventilator, Continuous (Respirator)

Indications for Use:

Positive Pressure Yentilation, delivered invasively (via ET tube) or non-invasively (via mask).
Assist/Control, SIMV, CPAP, or NPPV 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)

Aunselum

Anesthesiology, General Hospital,
Control, Dental Devices

K060647

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).