(104 days)
Not Found
No
The description focuses on conventional pressure adsorption technology and mechanical features, with no mention of AI or ML. The "automatic cylinder filling restart feature" is described as a simple purity threshold check, not an AI/ML algorithm.
Yes
The device is intended to treat respiratory diseases by supplying supplemental oxygen.
No
This device is described as an oxygen delivery system, intended to supply supplemental oxygen and fill oxygen cylinders for the treatment of respiratory diseases. It does not mention any function for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as pressure adsorption technology, a nasal cannula, an intensifier, and a unique cylinder fill mechanism. It also mentions mechanical and electromagnetic compatibility testing, which are typically associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to supply supplemental oxygen for the treatment of respiratory diseases and to fill oxygen cylinders. This is a therapeutic and oxygen delivery function, not a diagnostic one.
- Device Description: The description details the mechanism for generating and delivering oxygen and filling cylinders. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- 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 specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly focused on providing a therapeutic intervention (oxygen delivery) and facilitating ambulatory use of that therapy.
N/A
Intended Use / Indications for Use
The Omni-5 Total O2 Delivery System is intended to supply low-pressure supplemental oxygen for the treatment of Respiratory Diseases in children through adults in the home, health care facility or hospital and to supply pressurized oxygen to fill oxygen cylinders for patient’s ambulatory use.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Omni 5 Total O2 Delivery System addresses several needs of patients and homecare providers. The Total O- Delivery System has been designed to reduce the need for bulk storage and transport of liquid oxygen as well as the storage and transport of high-pressure oxygen tanks. The Ornni 5 Total O2 Delivery System is comprised of conventional pressure adsorption technology which supplies low pressure oxygen to a nasal cannula and/or an intensifier which compresses a small portion of the gas to pressures up to 2015 psig in an oxygen gas cylinder for ambulatory use.
The Omni 5 Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily and safely connected to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O₂ oxygen cylinders can o̲nly be filled through the unique fill port with the Total O₂ Delivery System.
The original Total O2 Delivery System allowed for continuous oxygen flows and settings from 0 - 3 liters per minute, the modified Total O2 Delivery System (Omni 5 Total O2 Delivery System) allows for continuous oxygen flows and settings from 0 - 5 liters per minute. Additionally, the Omni 5 Total O2 Delivery System incorporates an automatic cylinder filling restart feature, should the oxygen purity fall below acceptable limits (cylinder filling stopped), then recover above the acceptable limits (cylinder filling restarted).
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
children through adults
Intended User / Care Setting
home, health care facility or hospital
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)
Performance, mechanical, electromagnetic compatibility, environmental testing and software verification and validation were conducted to demonstrate that the Omni 5 Total O2 Delivery System would perform as intended.
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
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
JUL 2 3 2009
Image /page/0/Picture/2 description: The image shows the title "TAB 3" and "510(K) SUMMARY OF SAFETY & EFFECTIVENESS". The text is in black font and is located in the top left corner of the image. The background of the image is a light gray color.
Official Contact
Zita A. Yurko Director, Regulatory Affairs Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668
724-387-4120 724-387-7490 (fax) Email: Zita.Yurko@Respironics.com
Classification Reference 21 CFR 868 5440
CAW - Portable Oxygen Generator Product Code
Common/Usual Name Portable Oxygen Generator
Proprietary Name Respironics Omni 5 Total O2 Delivery System
Chad Therapeutics Total O2 Delivery System (K013472/K971889) Predicate Device(s)
Reason for submission
Modified design.
1
Substantial Equivalence
The modified device has the following similarities to the previously cleared predicate device:
- O Same intended use.
- D Same operating principle.
- O Same technology.
- D Same manufacturing process.
Design verification tests were performed on the Respironics Omni 5 Total O2 Delivery System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.
The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices," May 2005.
Predicate Device Equivalence:
Substantial equivalence is claimed to the Total O2 Delivery System, cleared for commercial distribution per K013472.
Device Description
The Omni 5 Total O2 Delivery System addresses several needs of patients and homecare providers. The Total O- Delivery System has been designed to reduce the need for bulk storage and transport of liquid oxygen as well as the storage and transport of high-pressure oxygen tanks. The Ornni 5 Total O2 Delivery System is comprised of conventional pressure adsorption technology which supplies low pressure oxygen to a nasal cannula and/or an intensifier which compresses a small portion of the gas to pressures up to 2015 psig in an oxygen gas cylinder for ambulatory use.
The Omni 5 Total O2 Delivery System has a unique cylinder fill mechanism, which allows it to be easily and safely connected to the patient's Total O2 oxygen cylinder. The unique cylinder fill mechanism ensures that Total O₂ oxygen cylinders can o̲nly be filled through the unique fill port with the Total O₂ Delivery System.
2
The original Total O2 Delivery System allowed for continuous oxygen flows and settings from 0 - 3 liters per minute, the modified Total O2 Delivery System (Omni 5 Total O2 Delivery System) allows for continuous oxygen flows and settings from 0 - 5 liters per minute. Additionally, the Omni 5 Total O2 Delivery System incorporates an automatic cylinder filling restart feature, should the oxygen purity fall below acceptable limits (cylinder filling stopped), then recover above the acceptable limits (cylinder filling restarted).
Indications for Use:
The Omni-5 Total O2 Delivery System is intended to supply low-pressure supplemental oxygen for the treatment of Respiratory Diseases in children through adults in the home, health care facility or hospital and to supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use.
Intended Use:
The oxygen supplied by the Omni 5 Total O2 Delivery System is supplemental and is not considered to be life supporting and not intended to be used with air or any life support applications or in the presence of flammable anesthetics. Geriatric, pediatic or other patients unable to communicate discomfort may require additional monitoring as with the case with oxygen concentrators currently in use. The device is not sold sterile or intended to be sterilized.
. Comparison of Technological Characteristics:
The Omni 5 Total O2 Delivery System has the same technological characteristics as the predicate device.
The hardware portions of the device are identical except for the following:
-
The continuous oxygen outlet flow meter has changed from 0 3 liters per minute to 0 5 liters per t minute (Modification #1 in the submittal).
The software was modified to include: -
. An automatic cylinder filling restart feature, should the oxygen purity fall below acceptable limits (cylinder filling stopped), then recover above the acceptable limits (cylinder filling restarted) (Modification #2 in the submittal).
3
Summary of Testing:
Performance, mechanical, electromagnetic compatibility, environmental testing and software verification and validation were conducted to demonstrate that the Omni 5 Total O2 Delivery System would perform as intended.
Conclusions:
Based on the above, we concluded that the Omni 5 Total O2 Delivery System is substantially equivalent to the Total O₂ Delivery System and is safe and effective for its intended use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Zita A. Yurko Director of Regulatory Affairs Respironics, Incorporated Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
JUL 2 3 2009
Re: K091028
Trade/Device Name: Respironics Omni 5 Total O2 Delivery System Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 19, 2009 Received: June 22, 2009
Dear Ms. Yurko:
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.
5
Page 2 - Ms. Yurko
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 (OS) 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 vours.
for.
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K091028
Device Name: Respironics Omni 5 Total O2 Delivery System
Indications for Use:
The Omni-5 Total O2 Delivery System is intended to supply low-pressure supplemental oxygen for the treatment of Respiratory Diseases in children through adults in the home, health care facility or hospital and to supply pressurized oxygen to fill oxygen cylinders for patient's ambulatory use.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schalter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091028