(56 days)
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Not Found
No
The provided text describes a standard oxygen conserver with fixed flow settings and no mention of adaptive or learning capabilities.
Yes
The device is described as providing supplemental oxygen to patients who have difficulty breathing, directly addressing a health condition.
No
The device is an oxygen conserver, which is a therapeutic device for delivering supplemental oxygen, not a diagnostic device used to identify or analyze a medical condition.
No
The device description explicitly states it is an "Oxygen Conserver" and describes the delivery of 100% oxygen at different flow settings, indicating a physical hardware component for oxygen delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients. It delivers oxygen directly to the patient via a nasal cannula.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is to deliver a therapeutic gas.
Therefore, this device falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.
Product codes
NFB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines that resemble an abstract bird in flight. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2003
Mr. James Parker Ouality Assurance Manager Precision Medical, Incorporated 300 Held Drive Northampton, Pennsylvania 18067
Re: K032018
Trade/Device Name: Easy Pulse II Oxygen Conserver Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NFB Dated: June 26, 2003 Received: June 30, 2003
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 ensctment 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.
1
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Susan Ruoary
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Easy Pulsc II
510 (k) number (if known) KO32 2 0 18
Device Name: Precision Medical, Inc.Easy Pulse II Oxygen Conserver
Indications for use:
The Precision Medical, Inc. Easy Pulse II Oxygen Conserver is intended to provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. The patients would normally receive the oxygen via a nasal cannula. The system delivers 100% oxygen at 5 different flow settings. It is intended to be used as ambulatory source of oxygen both inside and out side of the patient's home. It is not intended as a life supporting device. The device has no contraindications.
(Please do not write below this line- continue on another page if needed)
Concurrence of CDRH, office of device Evaluation (ODE)
Prescription Use
OrOver the counter use
(Per 21 CFR 801.109)
(Optional Format 1-2-9)
(Per 21
sthesiology, General Hospital
510(k) Number: K032018