(53 days)
Not Found
No
The summary describes a mechanical oxygen blender with no mention of AI or ML capabilities.
No
The device delivers blended air and oxygen but explicitly states it is "not intended as a life supporting device" and focuses on delivery rather than actively treating a condition.
No
The device is described as a "Blender Oxygen System" intended to "deliver blended air and oxygen." Its function is therapeutic (delivery of gases) rather than diagnostic (identifying medical conditions or diseases).
No
The device description clearly states it is an "Air and Oxygen blender," which is a hardware device used to mix gases. The performance studies also mention "Mechanical / Climatic Device Performance," further indicating a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver blended air and oxygen in a Hospital setting." This describes a device used to provide respiratory support, not to perform tests on samples taken from the body (which is the definition of an IVD).
- Device Description: The description reinforces its use in delivering air/oxygen mixtures, not in analyzing biological samples.
- Lack of IVD Characteristics: The document 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 those samples
- Providing diagnostic information based on sample analysis
The device is clearly a medical device used for respiratory therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Precision Medical Inc. Air and oxygen blender is designed to dispense a continuous and precise blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients. The exact FIO2 blend of gases corresponds to the dialed in Fractional Concentration of Oxygen (FiO2) setting indicated by the control face.
The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. The blender is not intended as a life supporting device.
Product codes
BYJ, BZR
Device Description
The Precision Medical, Inc. Air and Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required.
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
infant, pediatric, and adult patients.
Intended User / Care Setting
qualified and trained personnel under the direction of a physician in institutional environments, Hospital setting.
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
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Summary of Performance Studies
The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance.
In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. oxygen blender is safe and effective. The combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use.
Key Metrics
Not Found
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
510(k) Summary
Precision Medical, Inc. Blender
Submitter Information
| Submitter | Precision Medical, Inc.
300 Held Drive
Northampton, Pa.
18067 |
|-------------------------------------|------------------------------------------------------------------------|
| Contact | James Parker
Quality Assurance Manager |
| Tel:
Fax: | (610)-262-6090 Extensions 228
(610)-262-6080 |
| Preparation Date: | November 17, 2005 |
| Device Name | |
| Proprietary Name: | Precision Blender |
| Common Name: | Oxygen Blender |
| Classification Name:
Two models: | Blender, Oxygen Unit (73 BYJ) as per CFR 868.5330 |
| Low flow Blender | PM 5300 flow, range 0 to 30 liters per minute |
High flow blender PM 5200 flow, range 2 to 120 liters per minute
Predicate Device Equivalence
Precision Medical, Inc. is claiming substantial equivalence to the Bio-Med Blender 510K # K925982
Device Description
The Precision Medical, Inc. Air and Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required.
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Intended Use
The Precision Medical Inc. Air and oxygen blender is designed to dispense a continuous and precise blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients. The exact FIO2 blend of gases corresponds to the dialed in Fractional Concentration of Oxygen (FiO2) setting indicated by the control face.
| Manufacturer | BIO-Med Blender | Precision Medical, Inc. |
|---|---|---|
| Dimensions | H 3 ½ "x W 2 ¼" D 2 ⅞ " | H 3 ½ " W 2 ¼ " 5 ¼ " |
| Weight | 2 ¼ lbs | 2 ¼ lbs |
| Oxygen % Range | 21 to 100% | 21 to 100% |
| Accuracy | ± 3% of full scale | ± 3% of full scale |
| Supply Pressure | 30-75 psi air + O2 must be within 10 psi of each other | 30-75 psi air + O2 must be within 10 psi of each other |
| Max Flow (High Flow) | ≥ 120 lpm @60% setting at 50psi inlet pressures | ≥ 120 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (high flow) | ≤ 6 psi at 50 psi inlet pressure and 40 lpm flow | ≤ 6 psi at 50 psi inlet pressure and 40 lpm flow |
| Alarm/Bypass Reset | When inlet gas pressure differential is ≤ 6 psi | When inlet gas pressure differential is ≤ 6 psi |
| Alarm intensity | 80 db at 1 foot | 80 db at 1 foot |
| Operating temperature | 59° to 104°F | 59°F to 104°F |
Table of Comparisons to Predicate Device
The low flow model has the same characteristics as listed above, with the Max flow and the pressure drop being the only differences.
| Manufacturer | BIO-Med Blender | Precision Medical, Inc. |
|---|---|---|
| Max Flow ( Low Flow) | $\geq$ 30 lpm @60% setting at 50psi inlet pressures | $\geq$ 30 lpm @60% setting at 50psi inlet pressures |
| Pressure Drop (low flow) | $\leq$ 6 psi at 50 psi inlet pressure and 10 lpm flow | $\leq$ 6 psi at 50 psi inlet pressure and 10 lpm flow |
2
Summary of Performance Testing
The Precision Medical, Inc. Blender will successfully pass tests in the following areas; Mechanical / Climatic Device Performance
Conclusions
In Summary, Precision Medical, Inc. has demonstrated that the Precision Medical, Inc. oxygen blender is safe and effective. The combined testing and analysis of results provides assurance that the device meets the specifications and is safe and effective for the intended use.
Risk Analysis
Precision Medical, Inc. is using International Standard ISO 14971 Medical Devices Application of Risk management to medical devices Risk analysis has been completed for this device. This document will be updated and released as part of design control.
Design control
Precision Medical, Inc. is in compliance with 21 CFR 820.30 for design control. The design inputs/outputs matrix has been developed using form PMF 202. These documents will be completed before the release of the product.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN I 0 2006
Mr. James Parker Quality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067
Re: K053232
Trade/Device Name: Precision Medical, Inc Blender Regulation Number: 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: November 17, 2005 Received: November 18, 2005
Dear Mr. Parker:
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. Parker
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,
Sygite Y. Michael Oms.
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 (if known)
Device Name: Precision Medical, Inc.Blender
Indications for use:
The Precision Medical, Inc. Blender Oxygen System is intended to deliver blended air and oxygen in a Hospital setting. Oxygen concentrations can be dialed in from 21% to 100%. The blender is not intended as a life supporting device.
Prescription Use X (Per 21 CFR 801.109) Or
Over the counter use (Optional Format 1-2-9)
(Please do not write below this line- continue on another page if needed) Concurrence of CDRH, office of device Evaluation (ODE)
Smitte Y. Michie Omd.
Oral, Dental Devices