The Legendair XL2 is indicated for the continuous or intermittent mechanical ventilatory support of patients weighing at least 5 kg 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 who require the following general types of ventilatory support, as prescribed by an attending physician:
. Positive Pressure ventilation
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. It is not intended for use as an emergency transport ventilator.

Device Description

The LEGENDAIR® XL2 ventilator is composed of an airflow generator capable of supplying a range of flow rates and pressures and a valve enabling piloting of the expiration valve. The operation of the device is based on a self-adapting drive system governed by a closed loop flow generator. The speed of the flow generator (turbine) is servo-controlled to the patient pressure signal or the inspired flow signal.
The ventilation modes available are:

-Pressure Support Ventilation
. Pressure Support Ventilation with Back Up Rate
CPAP mode -
Pressure Controlled Ventilation ﮯ
Pressure Assisted Controlled Ventilation -
Volume Controlled Ventilation -
Volume Assisted Controlled Ventilation -
Synchronous Intermittent Mandatory Ventilation with either volume or pressure ﮮ targeted mandatory breaths

AI/ML Overview

The provided text does not contain acceptance criteria or study details in the format typically used for AI/ML device submissions. This document is a 510(k) summary for a ventilator, a type of electro-mechanical medical device, not an AI/ML diagnostic or predictive tool.

Therefore, many of the requested fields are not applicable to the information provided in this document.

Here's an analysis based on the information available and how it relates to the questions, with an explanation of why other fields are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on "substantial equivalence" to predicate devices rather than specific quantitative performance metrics against predefined acceptance criteria for an AI/ML model.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Equivalence to predicate devices (TBird Legacy, Pulmonetic Systems LTV 1000) in performance modes, ranges of operation, and compliance with electrical and mechanical safety standards.	The Legendair XL2 demonstrated equivalence through detailed comparison, showing it is safe and effective and performs equivalently to the predicate devices.
No new questions of safety or effectiveness when compared to legally marketed predicate devices.	The technological characteristics and testing results did not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

Not Applicable. This is not an AI/ML device where a "test set" of data samples (e.g., images, patient records) is used to evaluate an algorithm's performance. The "testing" referred to for this ventilator would involve engineering and functional tests on the physical device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. See point 2. Ground truth in the context of an AI/ML device is typically established by medical experts reviewing data, which is not relevant here.

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

Not Applicable. See point 2.

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. An MRMC study is relevant for AI-assisted diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This is a ventilator, not a diagnostic AI tool.

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

Not Applicable. This device is a ventilator, not an algorithm, so the concept of standalone performance does not apply in the AI/ML sense. Its "performance" is inherent to its mechanical and software operation.

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

Not Applicable. The "ground truth" for a ventilator would be its adherence to specified operational parameters (e.g., delivered pressure, flow rates, alarms functioning correctly) validated through engineering tests against known standards, not expert consensus on medical data or pathology. The document explicitly states "compliance with external electrical and mechanical safety standards" and "detailed comparison of performance modes, ranges of operation."

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device that requires a "training set" of data to learn patterns. The ventilator's operation is based on coded logic and physical engineering, not machine learning.

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

Not Applicable. See point 8.

Summary

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K070899

tyco Healthcare

Nellcor uritan Bennett

4280 Hacienda Drive
Pleasanton, CA 94588-2719

Fax: 925 463-4020

Page 1 of 2

510(k) Summary

Submitted by: Nellcor Puritan Bennett 4280 Hacienda Drive DEC 1 3 2007 Pleasanton, CA 94588 Company Contact: James Bonds Senior Director Regulatory Affairs (925) 463-4371 Fax (925) 463-4020 Date Summary Prepared: March 30, 2007 Trade Name: Puritan Bennett Legendair XL2 Common/Usual Name: Continuous Ventilator Classification Name: Ventilator (CBK) per 21 CFR §868.5895 Substantially Equivalent Devices: TBird Legacy (K003770) and Pulmonetic Systems LTV 1000 (K051767)

DEVICE DESCRIPTION

The ventilation modes available are:

-Pressure Support Ventilation
. Pressure Support Ventilation with Back Up Rate
CPAP mode -

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Pressure Controlled Ventilation ﮯ
Pressure Assisted Controlled Ventilation -
Volume Controlled Ventilation -
Volume Assisted Controlled Ventilation -
Synchronous Intermittent Mandatory Ventilation with either volume or pressure ﮮ targeted mandatory breaths

INTENDED USE

The Legendair XL2 is intended to provide continuous or intermittent mechanical I ne Dogendan TEL 10 patients weighing at least 5kg. The ventilator provides assist/control, SIMV, and CPAP modes of ventilation, and is intended for use in institutional, home, or transport settings. The Legendair XL2 is not intended for use as an emergency transport ventilator.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The performance is the Legendair XL2 is equivalent to the Bird Products Corporation TBird Vela Ventilator (K032451). Equivalence has been shown through a detailed comparison of performance modes, ranges of operation, and compliance with external electrical and mechanical safety standards. The results of these comparisons have demonstrated that the Legendair XL2 is safe and effective and performs equivalently to the TBird Legacy Ventilator and the Pulmonetic Systems LTV 1000 Ventilator

CONCLUSIONS

The technological characteristics of the Legendair XL2 ventilator and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices.

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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 human figure with three arms reaching upwards, representing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2007

Mr. James Bonds Senior Director Regulatory Affairs Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588

Re: K070899

Trade/Device Name: Puritan Bennett Legendair XL2 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 30, 2007 Received: December 6, 2007

Dear Mr. Bonds

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. Bonds

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clore

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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510(k) Number:

Device Name: Puritan Bennett Legendair XL2 Ventilator

Indications for Use

. Positive Pressure ventilation
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. It is not intended for use as an emergency transport ventilator.

Mh thl

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K070899

Prescription Use X (Per 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

510(k) Submission

510(k) Submission Page 12

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).