(77 days)
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.
Oxygen Cylinder Filling System
This document is a 510(k) summary for the DeVilbiss Oxygen Cylinder Filling System (K053240). It focuses on administrative information and the FDA's clearance letter, rather than detailed performance studies or acceptance criteria.
Therefore, the requested information for acceptance criteria and study details cannot be fully extracted from the provided text. The document is primarily focused on the regulatory clearance process.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
Cannot be fully extracted.
The document states the device's indication to "provide 93% (± 3%) oxygen." This implies an acceptance criterion for oxygen purity but does not provide a table of performance results or other acceptance criteria (e.g., filling speed, pressure limits, safety features).
2. Sample size used for the test set and the data provenance
Cannot be extracted. The document does not describe any specific test sets, sample sizes, or data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an Oxygen Cylinder Filling System, not an AI or diagnostic device that would require expert-established ground truth for a test set in the traditional sense of medical imaging or clinical diagnosis. The performance would be assessed against technical specifications (e.g., oxygen purity, pressure, filling time).
4. Adjudication method for the test set
Not applicable. See point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device for filling oxygen cylinders, not an algorithm. Its performance would inherently be "standalone" in terms of its function as a machine.
7. The type of ground truth used
Cannot be extracted as described in the prompt's examples. For this type of device, "ground truth" would relate to its manufacturing specifications and performance against those specifications (e.g., a calibrated oxygen analyzer to verify purity, pressure gauges, timers). The document does not detail this.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of available information:
- Indications For Use: The device is intended for use in supplying pressurized oxygen to fill oxygen cylinders for patients' ambulatory use. It is intended to provide 93% (± 3%) oxygen.
- Predicate Devices: CHAD Therapeutics Total O2 Delivery System (K013472 & K971889). The substantial equivalence determination likely relied on comparisons to the performance and safety profiles of these predicates, rather than extensive new clinical studies detailed in this summary.
To obtain the detailed acceptance criteria and study data for this device, one would typically need to consult the full 510(k) submission, which often includes more extensive testing reports (e.g., engineering test reports, biocompatibility, electrical safety, performance testing against specifications). The provided summary is a high-level regulatory document.
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Kos3240
Section 5.0 510(k) Summary
Administrative Information and Device Identification
| Name and address of the manufacturer andsponsor of the 510(k) submission: | Sunrise Medical100 Devilbiss DriveSomerset, PA 15501 |
|---|---|
| FDA registration number of the manufacturerof the new device: | 2515872 |
| Official contact person for all correspondence: | Joseph E. OlsavskyDirector - Regulatory AffairsSunrise Medical100 DeVilbiss DriveSomerset, PA 15501Phone: 814-443-7690Fax: 814-443-7597Email: joe.olsavsky@sunmed.com |
| Date Prepared: | November 17, 2005 |
| Device Name: | Oxygen Cylinder Filling System |
| Proprietary name of new device: | DeVilbiss Oxygen Cylinder FillingSystem |
| 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 O2Delivery System (K013472)CHAD Therapeutics Total O2Delivery System (K971889) |
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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.
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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
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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:
Page of of ___________________________________________________________________________________________________________________________________________________________________
§ 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).