(119 days)
Not Found
No
The description focuses on the mechanical mixing of gases and standard performance testing, with no mention of AI or ML.
No
The device primarily blends gases to produce Medical Air and supplies it to a hospital's central system rather than directly treating a patient's medical condition.
No
This device is described as a mixer that blends oxygen and nitrogen to provide Medical Air for hospital central supply systems. Its function is to produce medical air, not to diagnose medical conditions.
No
The device description clearly states it is a "system which mixes oxygen and nitrogen from hospital bulk supply systems," indicating it is a hardware device with physical components for gas mixing and delivery. The summary also mentions "bench and environmental testing" and compliance with standards related to electrical safety and EMI/EMC, which are typical for hardware devices. While software is mentioned in the context of compliance with FDA software guidelines, the core function and description point to a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide Medical Air to patients through a hospital's central supply system. This is a therapeutic or life-support function, not a diagnostic one.
- Device Description: The device mixes gases (oxygen and nitrogen) to create Medical Air. This is a manufacturing/supply process, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly intended to provide a medical gas for patient use, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Praxair Medical Air mixer blends oxygen USP and nitrogen NF in order to provide Medical Air, USP having an oxygen concentration ranging between 19.5% and 23.5%. The device is to be used to supply Medical Air at a specific delivery pressure to the central supply system of a hospital/ healthcare facility for delivery through the hospital wall outlets to patients for purposes under the direction of a physician.
The mixer will be located outside of the patient care area of the hospital, in a location such as the hospital mechanical room.
Product codes
BZR
Device Description
The PROGENAIRE™ Compressor-free Medical Air system is a device which mixes The FROOLNAINE - Oomprogen from hospital bulk supply systems to provide a product Medical Air USP.
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
Not Found
Intended User / Care Setting
hospital/healthcare facility
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
Bench and environmental testing were performed. These tests confirmed that the mixer produces Medical Air within USP limits for oxygen concentration, 19.5 % - 23.5%. The Mcdical I in Within OD-massing and use-related parameters to the mixer performance was also evaluated. Alarm verification was also performed. The device complies with was also evaluation. Thankiple standards, including ASTM 1462-93, the FDA guidance apprically obections of mical safety and EMI/EMC, and FDA software guidelines. The on effectiven and more the Praxair Medical Air Mixer is as safe and effective as the predicate device and performs as intended.
Key Metrics
oxygen concentration, 19.5 % - 23.5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).
0
SEP - 6 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
PRAXAIR, INC.
Proprietary and Confidential Information
COMPANY INFORMATION Praxair, Inc. 175 East Park Drive Tonawanda, NY 14150 Tonawanda, Fromara Brown, Associate Project Manager, Healthcare R&D Phone; 716-879-7465 Fax: 716-879-7275
PREPARATION DATE April 19, 2005
DEVICE NAME PROGENAIRE™ Compressor-free Medical Air system
COMMON NAME Mixer, Breathing Gases, Anesthesia Inhalation
PRODUCT CLASSIFICATION Class II, 21 C.F.R. § 868.5330 Product Code: BZR
PREDICATE DEVICE M202 Monitoring Mixer K031860
DESCRIPTION
The PROGENAIRE™ Compressor-free Medical Air system is a device which mixes The FROOLNAINE - Oomprogen from hospital bulk supply systems to provide a product Medical Air USP.
INTENDED USE
The Praxair Medical Air system is designed to provide Medical Air on demand up to a The I flaxan Mechour An Brother is abe used to supply Medical Air only to the central peak now fac of 400 bom. "It is to to es oe facility for delivery to patients for purposes under supply system of a nospital neatinations of the Medical Air produced by the mixer are the direction and calibration of medical devices for respiratory applications.
Both the Praxair Medical Air system and the predicate device are intended to blend two Dolli the Fraxan Modicate device blends independent streams of oxygen and ufficion gasos. "White Medical Air mixer blends independent streams of oxygen and Medical Air, the Praxair Medical Air system is intended to provide Medical mirogen. Addinonally, the Prailer a hospital/health care facility for delivery to multiple All to the contral bapply by steather as the predicate device provides mixed gas to a single
Summary Page 1 of 2
1
patient. These differences between the Praxair mixer and the predicate device do not raise new issues of safety or effectiveness.
TECHNOLOGY CHARACTERISTICS
TLCHNOLOG I Onlinel Air system and the predicate device provide continuous monitoring of oxygen concentration and pressure levels and alarms to signal when these and other critical operating parameters are outside specified ranges. The Praxair blender and other entral operating paramessure sufficient to provide Medical Air at a pressure of 50-55 psig to hospital outlets. Pneumatic pressure regulators and flow control are used to 50-55 psig to noophal vation in the product mixture. Unlike the predicate device, the oontrol orggen of the product air is not selectable by the user.
A visual alarm system and shutdown is provided with the Praxair system to alert the user A visual marm byeten and out of range. Alarms are also activated when critical should ortgen ochroman and onforming. In addition, backup system(s) activate during operating paramerers and visual alarms are provided in case of back-up system activation.
TESTING
I LDTHTS
In order to verify that the Praxair system does not raise new issues of safety or m order to 10113 mark is substantially equivalent to the predicate device, bench and environmental testing were performed. These tests confirmed that the mixer produces Medical Air within USP limits for oxygen concentration, 19.5 % - 23.5%. The Mcdical I in Within OD- massing and use-related parameters to the mixer performance was also evaluated. Alarm verification was also performed. The device complies with was also evaluation. Thankiple standards, including ASTM 1462-93, the FDA guidance apprically obections of mical safety and EMI/EMC, and FDA software guidelines. The on effectiven and more the Praxair Medical Air Mixer is as safe and effective as the predicate device and performs as intended.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
SEP - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Praxair, Incorporated C/O Ms. Tamara Brown Associate Project Manager Healthcare Applications R&D 175 East Park Drive, 2/144 Tonawanda, New York 14150
Re: K051192
Trade/Device Name: PRAXAIR MEDICAL AIR MIXER Regulation Number: 21 CFR 868.5330 Regulation Name: Medical Air Mixer/Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: August 22, 2005 Received: August 24, 2005
Dear Ms. Brown:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becalent 910(4) ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ referenced above and have determined the as a regionate devices marketed in
indications for use stated in the enclosure) to legally marketed in the Unice I indications for use stated in the enclosed of the enactment date of the Medical Device interstate comments, or to thay 20, 1978, and entired in accordance with the provisions of Amendments, of to devices that have book former of the approval of a prematice the premarket the Federal Food, Drug, and Cosment 110 (110) ................................................................................................................................ approval application (1177). controls provisions of the Fet. - The girling of devices, good manufacturing practice, lequirements for anilud reagainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 899. In the Federal your device can be found in the Cours of the concerning your device in the Federal Register.
3
Page 2 - Ms. Brown
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issuance of a sassammation with other requirements
mean that FDA has made a determination that your device complies with other consiss mean that FDA has made a decernmance water Jatin Jatin Federal agencies. of the Act of ally receital statutes and regarates . including, but not limited to: registration You must comply with an the Fice break 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gED Box 800); and and listing (21 CFR Part 607), laooling (21 cm (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality Systems (Sections 531-542 of the Act), 21 CFR 1000-1050.
21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailering of substantial equivalence of your device a premarket notification. THE PDF Intalling on 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), If you desire specific advice for your de at (240) 276-0120. Also, please note the regulation
Please contact the Office of Compliance at (240) 276-0120. Also, please of Com 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 may obtain other general miormation on your a and Consumer Assistance at its toll-free Division of Binas-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sulate Y. Michael O.M.D
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Device and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K051192
Device Name: Praxair PROGENAIRE™ Compressor-free Medical Air System
Indications For Use:
The Praxair Medical Air mixer blends oxygen USP and nitrogen NF in order to provide Medical Air, USP having an oxygen concentration ranging between 19.5% and 23.5%. The device is to be used to supply Medical Air at a specific delivery pressure to the central supply system of a hospital/ healthcare facility for delivery through the hospital wall outlets to patients for purposes under the direction of a physician.
The mixer will be located outside of the patient care area of the hospital, in a location such as the hospital mechanical room.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suitte Y. Michaud
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K051192
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