(77 days)
Not Found
No
The 510(k) summary describes a mechanical system for filling oxygen cylinders and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is described as an "Oxygen Cycling System" intended for "supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use" and states it provides "93% (± 3%) oxygen." Supplying oxygen to patients indicates a therapeutic purpose. Furthermore, its predicate devices are also oxygen delivery systems, reinforcing its therapeutic nature.
No
The "Intended Use / Indications for Use" states that the device is for "supplying pressurized oxygen to fill oxygen cylinders," indicating a therapeutic rather than diagnostic function.
No
The device description clearly indicates it is an "Oxygen Cylinder Filling System," which is a hardware device used to fill oxygen cylinders. There is no mention of software as the primary or sole component.
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 pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: It's described as an "Oxygen Cylinder Filling System," which aligns with its therapeutic purpose.
- Lack of Diagnostic Elements: 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.
- No Image Processing, AI/ML, or Imaging Modality: These are often associated with diagnostic devices that analyze images or data for diagnostic purposes. Their absence further supports that this is not an IVD.
In summary, the Model 535D Oxygen Cycling System is a medical device used for providing oxygen, which is a treatment/support function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Model 535D Oxygen Cyling System is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. The device is intended to provide 93% (± 3%) oxygen. This device can be used in homes, nursing homes, patient care facilities, etc.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
Not Found
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
homes, nursing homes, patient care facilities, etc.
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
§ 868.5440 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
Kos3240
Section 5.0 510(k) Summary
Administrative Information and Device Identification
| Name and address of the manufacturer and
sponsor of the 510(k) submission: | Sunrise Medical
100 Devilbiss Drive
Somerset, PA 15501 |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the manufacturer
of the new device: | 2515872 |
| Official contact person for all correspondence: | Joseph E. Olsavsky
Director - Regulatory Affairs
Sunrise Medical
100 DeVilbiss Drive
Somerset, PA 15501
Phone: 814-443-7690
Fax: 814-443-7597
Email: joe.olsavsky@sunmed.com |
| Date Prepared: | November 17, 2005 |
| Device Name: | Oxygen Cylinder Filling System |
| Proprietary name of new device: | DeVilbiss Oxygen Cylinder Filling
System |
| Common or usual name of the device: | Oxygen Cylinder Filling System |
| DeVilbiss Model Number | Model 535 Series |
| Classification of the predicate device: | Class II |
| Classification of new device: | Class II |
| Classification Panel: | Anesthesiology |
| Panel Code: | CAW |
| CFR Regulation Number: | 21 CFR 868.5440 |
| Predicate Device Name(s) and 510(k)
number(s): | CHAD Therapeutics Total O2
Delivery System (K013472)
CHAD Therapeutics Total O2
Delivery System (K971889) |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2006
3 2006
Sunrise Medical Mr. Joseph E. Olsavsky Director Regulatory Affairs Respiratory Products Division 100 DeVilbiss Drive Somerset, Pennsylvania 15501-2125
Re: K053240
Trade/Device Name: DeVilbiss Oxygen Cylinder Filling Systems Regulation Number: 868.5440 Regulation Name: Portable oxygen Generator Regulatory Class: II Product Code: CAW Dated: November 17, 2005 Received: November 18, 2005
Dear Mr. Olsavsky:
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.
2
Page 2 -- Mr. Olsavsky
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,
Chiu Lin, Ph.D.
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
3
K053240 DeVilbiss Oxygen Filling System Additional Information Request
Indications for Use
510(k) Number: (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: _____________ DeVilbiss Model 535D Oxygen Cylinder Filling System
Indications For Use:
The Model 535D Oxygen Cyling System is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. The device is intended to provide 93% (± 3%) oxygen. This device can be used in homes, nursing homes, patient care facilities, etc.
Prescription Use X (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)
Qum Sylom
(Division Sign-Off)
Division of Ano thoriningy, General Hospital. Infection Control, Dental Devices
510(k) Number:
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