(143 days)
Not Found
No
The summary describes a mechanical gas blender with no mention of AI or ML capabilities.
No
The device delivers blended gases for respiration, which is a therapeutic function. However, the "Intended Use" specifically states, "The blender is not intended as a life supporting device," indicating it is not designed to treat, prevent, or diagnose a disease or condition in a primary therapeutic manner.
No
The device is a heliox/oxygen blender used to deliver blended gases in a hospital setting for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "Heliox/oxygen blender," which is a physical hardware device used to mix gases. The summary does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver blended Helium and oxygen to a patient in a hospital setting. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description reinforces its use in delivering gas mixtures to patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is to provide a specific gas mixture for respiration.
N/A
Intended Use / Indications for Use
The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.
The blender is not intended as a life supporting device.
Product codes (comma separated list FDA assigned to the subject device)
BZR
Device Description
The Precision Medical, Inc. Heliox/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 Heliox/oxygen mixtures are 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
Not Found
Intended User / Care Setting
qualified and trained personnel under the direction of a physician in institutional environments where delivery of Heliox/oxygen mixtures are required.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 | AUG 1 3 2009 |
|-----------------------|---------------------------------------------------------------------------------|--------------|
| Contact | James Parker
Quality Assurance Manager | |
| Tel:
Fax:
Email | (610)-262-6090 Extensions 228
(610)-262-6080
jparker@precisionmedical.com | |
| Preparation Date: | March 20, 2009 | |
| Device Name | | |
| Proprietary Name: | HeliO2 Blender |
|---|---|
| Common Name: | Helium- Oxygen Blender |
| Classification Name: | Blender, HeliO2 Unit (BZR) as per CFR 868.5330 |
| Two models: | |
| Low flow Blender | PM 5470/5480 flow, range 2 to 30 liters per minute |
| High flow blender | PM 5580/5570 flow, range 15 to 120 liters per minute |
Predicate Device Equivalence
510K # K053232
Precision Medical, Inc. is claiming substantial to Precision Medical, Inc. oxygen blender same as oxygen blender except air fitting has been replaced with helium male fitting and scale on dial has been altered to add the Helium to the concentration.
Four models will be marketed
-
- Low flow HeliO2 uses 70/30 helium to oxygen mixture
-
- Low Flow HeliO2 uses 80/20 helium to oxygen mixture
-
- Hi Flow HeliO2 uses 70/30 helium to oxygen mixture
-
- Hi Flow HeliO2 uses 80/20 helium to oxygen mixture.
1
Device Description
The Precision Medical, Inc. Heliox/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 Heliox/oxygen mixtures are required.
2
Intended Use
The Precision Medical, Inc. Heliox Blender Oxygen System is intendcd to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.
The blender is not intended as a life supporting device.
| Manufacturer | Precision Medical, Inc.
Heliox/oxygen blender | Precision Medical, Inc.
air/oxygen blender |
|---------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Dimensions | H 3 ½ " W 2 ¼ " 5 ¼ " | H 3 ½ " W 2 ¼ " 5 ¼ " |
| Weight | 2 ¾ lbs | 2 ¾ lbs |
| Oxygen % Range | 20 to 100% and 30 to 100% | 21 to 100% |
| Accuracy | ± 3% of full scale | ± 3% of full scale |
| Supply Pressure | 30-75 psi Heliox + 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) | ≤ 3 psi at inlet pressures
from 30-90 psi and at
30lpmflow rate at 60%
FiO2 | ≤ 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°F 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 | Precision Medical, Inc.
Heliox/oxygen blender | Precision Medical, Inc.
air/oxygen blender |
|--------------------------|-------------------------------------------------------------------------------|---------------------------------------------------------|
| Max Flow ( Low Flow) | $\ge$ 30 lpm @60% setting at
50psi inlet pressures | $\ge$ 30 lpm @60% setting at
50psi inlet pressures |
| Pressure Drop (low flow) | $\le$ 2 psi at 30-90 psi inlet
pressure and 10 lpm flow
Rate at 60%FiO2 | $\le$ 6 psi at 50 psi inlet
pressure and 10 lpm flow |
3
Image /page/3/Picture/1 description: The image shows a close-up of the words "HEALTH & HUMAN SER". The text is in a bold, sans-serif font and appears to be part of a larger document or heading. The words are black against a white background, and there is a horizontal line underneath the text.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. James Parker Quality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067
AUG 1 3 2009
Re: K090781
Trade/Device Name: Helium-Oxygen Blender Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: August 10, 2009 Received: August 11, 2009
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 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Arthur Dimock
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
()
510 (k) number K090781
Device Name: Precision Medical, Inc. Helium-Oxygen Blender
Indications for use:
The Precision Medical, Inc. Heliox Blender Oxygen System is intended to deliver blended Helium and oxygen in a hospital setting. Oxygen concentrations can be dialed in from 20% to 100% for heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox tank mixtures of 30% oxygen / 70% helium.
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)
L. Schutter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090781