(54 days)
Not Found
No
The description focuses on the physical process of oxygen concentration (molecular sieve, pressure swing adsorption) and does not mention any computational or algorithmic features indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is intended to provide supplemental oxygen to persons requiring oxygen therapy, which is a therapeutic purpose.
No
The device provides supplemental oxygen therapy and does not assess or diagnose any medical condition.
No
The device description clearly states it is a physical medical device that produces concentrated oxygen from room air using molecular sieve and a pressure swing adsorption process, and delivers it via a nasal cannula. This involves hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide supplemental oxygen to persons requiring oxygen therapy." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description explains how it concentrates oxygen from room air and delivers it to the patient. This process is related to providing a medical treatment, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This oxygen concentrator does not fit that description.
N/A
Intended Use / Indications for Use
The Respironics L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining.
The Respironics L4 Oxygen Concentrator is intended for use in the home or hospital/institutional environment.
Product codes
CAW
Device Description
The Respironics L4 Oxygen Concentrator is a smaller and lighter medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. Like its predicate the Respironics L4 Oxygen Concentrator uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 5 LPM and is offered with an optional Oxygen Percentage Indicator.
Like its predicate, the Respironics L4 Oxygen Concentrator delivers oxygen to the patient via a nasal cannula.
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
home or hospital/institutional environment
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)
Design verification tests were performed on the Respironics L4 Oxygen Concentrator 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
. . . .
Respironics L4 Oxygen Concentrator
TAB 3 510(K) SU ETY & EFFECTIVENE 【 S
| Official Contact | Zita A. Yurko
Manager, Regulatory Affairs
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------|
| | 724-387-4120
724-387-4206 (fax)
Email: Zita.Yurko@Respironics.com |
| Classification Reference | 21 CFR 868.5440 |
| Product Code | CAW - Generator, Oxygen, Portable |
| Common/Usual Name | Oxygen Concentrator |
| Proprietary Name | Respironics L4 Oxygen Concentrator |
| Predicate Device(s) | Respironics "Twister" Oxygen Concentrator (K972614) |
| 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.
- Same operating principle. ם
- 0 Same technology.
- D Same manufacturing process.
Design verification tests were performed on the Respironics L4 Oxygen Concentrator 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.
Intended Use
The Respironics L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining.
The Respironics L4 Oxygen Concentrator is intended for use in the home or hospital/institutional environment.
Device Description
The Respironics L4 Oxygen Concentrator is a smaller and lighter medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. Like its predicate the Respironics L4 Oxygen Concentrator uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 5 LPM and is offered with an optional Oxygen Percentage Indicator.
Like its predicate, the Respironics L4 Oxygen Concentrator delivers oxygen to the patient via a nasal cannula.
2
Image /page/2/Picture/1 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 representing its body and wings. The eagle is enclosed in a circle with the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics, Incorporated Ms. Zita A. Yurko Manager, Regulatory Affairs Sleep & Home Respiratory Group 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668
UN 2 8 2006
Re: K061261
Trade/Device Name: L4 Oxygen Concentrator Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 7, 2006 Received: June 9. 2006
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 (five the indications for use stated in the enclosure) to legally marketed predicate devires 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 offecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 10.0898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
3
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); 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,
Oive
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
4
Indications for Use
510(k) Number (if known): K061261
Device Name: L4 Oxygen Concentrator
Indications For Use: The L4 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life supporting or life sustaining
For use in the home or hospital/institutional environment.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
i
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in of Anesthesiology, General Hospital,
Lon Contiol, Dental Devices
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