(45 days)
Not Found
No
The description focuses on standard oxygen concentration technology (Pressure Swing Adsorption) and breath detection, with no mention of AI or ML terms or functionalities.
Yes
The device is intended to provide supplemental oxygen, which directly addresses a physiological need (oxygen deficiency) and is used for therapeutic purposes in various environments.
No
The device is an oxygen concentrator that delivers supplemental oxygen, it does not diagnose any condition.
No
The device description clearly outlines hardware components such as a power supply, battery, chambers, valves, and a sieve bed assembly, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Delphi Portable Oxygen Concentrator provides supplemental oxygen directly to a patient through a nasal cannula. It works by concentrating oxygen from the air.
- Intended Use: The intended use is to provide supplemental oxygen for breathing, not to analyze biological samples.
The description clearly indicates that this is a therapeutic device that delivers a substance (oxygen) to the patient, rather than a diagnostic device that analyzes samples from the patient.
N/A
Intended Use / Indications for Use
The Delphi Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institution, or travel environments. The POC is a prescription only device and not intended for life-supporting or lifesustaining. The users of the Deiphi Portable Oxygen Concentrator are adults requiring oxygen therapy to treat conditions such as COPD. The POC is designed to enable its users to be more mobile in their daily activities both indoors and outdoors.
Product codes
CAW
Device Description
The Delphi Portable Oxygen Concentrator is lightweight and can deliver ≥ 87% oxygen to a patient through a standard single-lumen nasal cannula. The device detects a patient breath and operates by delivering a bolus of oxygen during the inhalation period. The device can be set to deliver flowrates between 1-5 LPM with increments of 0.5 LPM to a patient. The device can be operated when powered by the 100-240VAC AC/DC power supply provided with the unit and designed to operate with a DC automotive adaptor. In addition, the device contains a rechargeable battery allowing it to be carried by a patient while traveling. The Delphi Portable Oxygen Concentrator (POC) uses Pressure Swing Adsorption technology to deliver concentrated oxygen. A series of chambers and valves allows pressurized air to enter the sieve bed assembly, effectively separating nitrogen from the air. When one chamber is receiving pressurized air, the other is purging nitrogen back into the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in a chamber to be delivered to a patient when the device detects a patient breath.
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
adults
Intended User / Care Setting
Home, institution, or travel environments
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image shows the word "DELPHI" in a bold, sans-serif font. The letters are black and appear to have a slightly rough or textured edge, giving them a distinct look. The word is presented in a straightforward, horizontal arrangement.
Medical Systems 5725 Delphi Drive Troy, MI 48098-2815 USA
510(k) Summary (As required by section 807.92(c)) Section V
| Submitter: | Delphi Medical Systems
5725 Delphi Drive
Troy MI 48098 | JAN - 3 2008 |
|---------------------------------|------------------------------------------------------------------------|--------------|
| Contact: | Gilbert Roque Jr., Sr. Regulatory Affairs Engineer | |
| Telephone: | (248) 813-2373 | |
| Fax: | (248) 813-5008 | |
| Date Prepared: | July 2007 | |
| DEVICE NAME AND CLASSIFICATIONS | | |
| Type of Submission: | Traditional 510(k) | |
| Proprietary Name: | Delphi Portable Oxygen Concentrator
Model RS-00400 | |
| Common Name: | Portable Oxygen Concentrator | |
| Classification Name: | Portable Oxygen Generator | |
| Product Code: | CAW | |
| Medical Specialty / Panel: | Anesthesiology | |
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 868.5440 | |
| Predicate Device: | Airsep Corporation, LifeStyle Oxygen
Concentrator, 510(k) # K020324 | |
Intended Use:
The Delphi Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institution, or travel environments.
Device Description:
The Delphi Portable Oxygen Concentrator is lightweight and can deliver ≥ 87% oxygen to a patient through a standard single-lumen nasal cannula. The device detects a patient breath and operates by delivering a bolus of oxygen during the inhalation period.
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Image /page/1/Picture/0 description: The image shows the word "DELPHI" in a bold, sans-serif font. The letters are black and have a slightly rough or textured appearance, as if they were created with a brush or marker. The word is centered and takes up most of the frame, making it the primary focus of the image. The background is plain and white.
Medical Systems 5725 Delphi Drive Troy, MI 48098-2815 USA
The device can be set to deliver flowrates between 1-5 LPM with increments of 0.5 LPM to a patient. The device can be operated when powered by the 100-240VAC AC/DC power supply provided with the unit and designed to operate with a DC automotive adaptor. In addition, the device contains a rechargeable battery allowing it to be carried by a patient while traveling.
Indications for Use:
The POC is a prescription only device and not intended for life-supporting or lifesustaining. The users of the Deiphi Portable Oxygen Concentrator are adults requiring oxygen therapy to treat conditions such as COPD. The POC is designed to enable its users to be more mobile in their daily activities both indoors and outdoors
Technological Characteristics:
The Delphi Portable Oxygen Concentrator (POC) uses Pressure Swing Adsorption technology to deliver concentrated oxygen. A series of chambers and valves allows pressurized air to enter the sieve bed assembly, effectively separating nitrogen from the air. When one chamber is receiving pressurized air, the other is purging nitrogen back into the air. The cycle is repeated continuously. The concentrated oxygen created at each cycle is stored in a chamber to be delivered to a patient when the device detects a patient breath.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
JAN - 3 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Delphi Medical Systems C/O Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709
Re: K073242
Trade/Device Name: Portable Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: December 17, 2007 Received: December 19, 2007
Dear Mr. Rongero:
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. Rongero
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.
George Y. Michael Duns
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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Medical Systems 5725 Delphi Drive Troy, MI 48098-2815 USA
Section IV: Indications for Use Statement
Applicant: Delphi Medical Systems
510(k) Number:
Portable Oxygen Concentrator Device Name:
Indications for Use:
The Portable Oxygen Concentrator is intended to provide supplemental oxygen in a home, institutional, or travel environment.
Prescription Use Only: _ X __
Over-the-Counter Use: ________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
and the comments of the comments of
Concurrence of CDRH, Office of Device Evaluation (ODE)
of Anesthesia Devices, General Hospital, and
Infection Control Devices
K073242Portable Oxygen Concentrator