(255 days)
No
The document describes a servo-controlled, closed-loop system based on pressure and flow signals, which is a traditional control system, not explicitly mentioning or implying the use of AI/ML.
Yes
The device description and intended use clearly state that it provides "continuous or intermittent mechanical ventilatory support" and offers various "modes of ventilation" to patients, which are therapeutic interventions.
No
The device is described as a ventilator, providing mechanical ventilatory support. Its function is to support breathing, not to diagnose a medical condition.
No
The device description explicitly states it is composed of an airflow generator, a valve, and a self-adapting drive system, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "continuous or intermittent mechanical ventilatory support of patients." This describes a device that directly interacts with a patient's respiratory system to provide breathing assistance.
- Device Description: The description details an "airflow generator," "valve enabling piloting of the expiration valve," and a "self-adapting drive system governed by a closed loop flow generator." These are components of a mechanical ventilator, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide mechanical ventilation, which is a therapeutic intervention, not a diagnostic test.
N/A
Intended Use / Indications for 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.
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.
Product codes
CBK
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients weighing at least 5kg
adult and pediatric patients
Intended User / Care Setting
The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician.
institutional, home, or transport settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TBird Legacy (K003770), Pulmonetic Systems LTV 1000 (K051767)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 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 -
1
- 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.
2
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.
3
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
4
510(k) Number:
Device Name: Puritan Bennett Legendair XL2 Ventilator
Indications for Use
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.
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)
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510(k) Submission
510(k) Submission Page 12