(167 days)
The revised DeVilbiss 5 Liter Oxygen Concentrator is designed to provide supplemental low flow oxygen therapy for patients suffering from COPD, cardiovascular disease, and lung disorders. The oxygen concentrator is used in home type environments: homes, patient care facilities, etc.
The DeVilbiss 5 Liter Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.
The revised DeVilbiss 5 Liter Oxygen Concentrator is a 1-5 lpm, pressure swing adsorption, oxygen concentrator based on molecular sieve technology. Room air is drawn into the concentrator via a piston style compressor. The air then passes through a series of filters that remove dust, bacteria, and other particulates. A pneumatic valve directs air into one of the two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen flows through, thereby producing an enriched oxygen product for the patient. Simultaneously in the other bed, nitrogen is desorbed as the pressure decreases and is exhausted into the atmosphere. A momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an enhanced nitrogen purge. The cycle continues, providing a continuous flow of oxygen at a purity of 93% +/-3% to the patient. The concentrator is available with or without an oxygen monitoring device.
The provided text describes a 510(k) submission for a medical device, the DeVilbiss 5 Liter Oxygen Concentrator. However, it does not contain information about a study with acceptance criteria in the typical sense of a clinical or performance study with a test set, ground truth established by experts, or sample sizes for training and testing.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States. This pathway primarily relies on comparing the technological characteristics and performance of the new device to a device that is already legally on the market.
Here's an analysis based on your requested categories, highlighting where the information is available and where it's not applicable in this context:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Oxygen purity of 90% or greater at 1-5 lpm of oxygen output | Meets a purity of 93% +/- 3% (stated in Device Description) and meets the requirement (stated in Performance Data) |
| Safety and effectiveness equivalent to the predicate device | "no effect on safety and effectiveness" (stated in Performance Data and other sections) |
| Non-hazardous and non-toxic materials (molecular sieve) | Both UOP 5A-MG and Oxysiv-5 are non-hazardous and non-toxic (stated in Technological Characteristics) |
| Functionality of alarms appropriate for safety and effectiveness | Modified software and reduction in alarms "do not present new issues of concentrator safety or effectiveness" (stated in Technological Characteristics) |
Notes on Acceptance Criteria: The "acceptance criteria" here are largely implicit, derived from industry standards and the comparison to the predicate device. The primary performance metric mentioned is oxygen purity.
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This document does not describe a clinical or performance study with a test set of human/animal subjects or a dataset in the way an AI/ML study would. The performance data is stated as "Based on tests performed," implying internal engineering or bench testing, not a formal clinical trial with a defined test set.
- Data Provenance: Not applicable in the context of clinical data. The "tests performed" would likely be internal V&V (Verification and Validation) carried out by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in the sense of expert consensus on clinical cases, is not part of this 510(k) submission for an oxygen concentrator. The "ground truth" for this device's performance is objective measurement of oxygen purity.
4. Adjudication method for the test set
- Not applicable. There is no test set in the clinical/AI sense that would require adjudication.
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-powered device, nor is it a diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a standalone medical device (oxygen concentrator), but not in the context of an "algorithm only" performance study. Its performance (oxygen purity) is inherent to the device's function, not an algorithm's output.
7. The type of ground truth used
- Ground Truth: Objective measurements of oxygen purity (e.g., using an oxygen analyzer) and verification of other mechanical/electrical specifications (e.g., pressure relief valve function, alarm functionality). This is not an expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
Summary:
The provided document describes a 510(k) submission for an oxygen concentrator, which demonstrates substantial equivalence to "legally marketed predicate devices." The "study" referenced is not a typical clinical trial or AI performance study. Instead, it involves bench testing and engineering verification to confirm that the revised device meets established performance specifications (primarily oxygen purity) and that any changes (e.g., to the valve, cycling mechanism, or alarms) do not negatively impact safety and effectiveness compared to the predicate device. The "acceptance criteria" are therefore derived from the established performance of similar devices and general regulatory requirements for medical device safety and efficacy.
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6.0 510(k) Summary
Submitter's Name: Greg Clites
Address: Sunrise Medical HHG Inc Respiratory Products Division 100 DeVilbiss Drive P.O. Box 635 Somerset, PA 15501-0635
Phone #: 814-443-7441
Fax #: 814-443-7571
Contact Person: Greg Clites
Date Summary Prepared: May 14, 1999
Name of Device: DeVilbiss 5 Liter Oxygen Concentrator
Common Name: Oxygen Concentrator
Classification Name: Portable Oxygen Generator
Legally Marketed Device to which Equivalence is Claimed: DeVilbiss 5 Liter Oxygen Concentrator*
Manufacturer: Sunrise Medical HHG Inc Respiratory Products Division 100 DeVilbiss Drive P.O. Box 635 Somerset, PA 15501-0635
Predicate Device 510(k) Number: K953815
- The original FDA 510(k) submittal name for the predicate device was the "5 LPM Oxygen Concentrator".
Device Description:
The revised DeVilbiss 5 Liter Oxygen Concentrator is a 1-5 lpm, pressure swing adsorption, oxygen concentrator based on molecular sieve technology. Room air is drawn into the concentrator via a piston style compressor. The air then passes through a series of filters that remove dust, bacteria, and other particulates. A pneumatic valve directs air into one of the two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen flows through, thereby producing an enriched oxygen product for the patient. Simultaneously in the other bed, nitrogen is desorbed as the pressure decreases and is exhausted into the atmosphere. A momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an enhanced nitrogen purge. The cycle continues, providing a continuous flow of oxygen at a purity of 93% +/-3% to the patient. The concentrator is available with or without an oxygen monitoring device.
Intended Use of the Device:
The revised DeVilbiss 5 Liter Oxygen Concentrator is designed to provide supplemental low flow oxygen therapy for patients suffering from COPD, cardiovascular disease, and lung disorders. The oxygen concentrator is used in home type environments: homes, patient care facilities, etc.
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Technological Characteristics:
The key technological characteristic differences between the revised DeVilbiss 5 Liter Oxygen Concentrator and the predicate DeVilbiss 5 Liter Oxygen Concentrator are summarized below:
The operating principle of the single pneumatic valve revised DeVilbiss 5 Liter Oxygen Concentrator is the same as the dual pneumatic valve predicate DeVilbiss 5 Liter Oxygen Concentrator, with the revised concentrator operates with a timed cycle and the predicate concentrator cycles based on the monitoring of system pressure. Operating principle:
Room air is drawn into the pressure swing adsorption molecular sieve technology oxygen concentrator by a compressor. Exiting the compressor, the air enters a four-way directional valve and is directed into one of two cylinders containing molecular sieve material. Nitrogen is adsorbed in the bed being pressurized, while oxygen flows through, thereby producing an enriched oxygen product for the patient. The other bed is simultaneously being depressurized, cleansing the bed of nitrogen. The process is alternated between the two beds assuring the patient a continuous supply of oxygen. The additional predicate concentrator valve serves to enhance the nitrogen purge with the UOP 5A-MG molecular sieve material to meet the required performance specification. The revised concentrator accomplishes this enhanced nitrogen purge of UOP Oxysiv-5 molecular sieve material via a momentary intermediate valve position, enabling the revised concentrator to meet the required performance specification. Both UOP 5A-MG and Oxysiv-5 are non-hazardous and non-toxic.
The predicate DeVilbiss 5 Liter Oxygen Concentrator cycles based on a fixed pressure setting detected in the oxygen accumulator tank. When a pc board mounted pressure transducer detects the set pressure in the accumulator tank, the microprocessor shifts the pneumatic valving. The revised concentrator cycles based on a fixed cycle time. The microprocessor shifts the pneumatic valving according to this fixed time.
While the method of shifting the valve to cycle the system is different, the operating principle of the pressure swing adsorption concentrator is the same for both the revised DeVilbiss 5 Liter Oxygen Concentrator and the predicate device. The oxygen purity requirement to the patient is satisfied for both products, hence there is no effect on safety and effectiveness.
The revised and predicate concentrator electronics have been designed with the same microprocessor. Since the functionality of the electronics has been modified for the revised concentrator with implementation of the timed cycle and an accompanying decrease in alarms, the processor is different. With the exception of the No Power and the Low Pressure alarms, the alarm features (High Pressure, Long Cycle, and No Flow) have been removed from the revised concentrator. New software documentation will be generated accordingly. A high pressure indication is most directly tied to the safety of the patient. This will mechanically be maintained via the use of a pressure relief valve on the revised concentrator. The Long and Short Cycle alarms are not necessary on the revised concentrator since it is controlled by a fixed cycle time The High Pressure, Long Cycle, and Short Cycle alarms shut the predicate concentrator down in the event that one of these conditions was detected by the software, in an effort to protect the concentrator from deterioration, but are not directly tied to the oxygen performance. Hence, the modified software and accompanying reduction in the patient alert alarms from the revised DeVilbiss 5 Liter Oxygen Concentrator do not present new issues of concentrator safety or effectiveness.
Performance Data:
The key performance descriptor for the oxygen concentrator devices is the oxygen purity performance at 1-5 lpm of oxygen output. The theoretical maximum oxygen purity which is capable from a molecular sieve concentrator is 95.5%, and the commonly accepted minimum level in the concentrator market is 90%. Based on tests performed, both the revised DeVilbiss 5 Liter Oxygen Concentrator and the predicate concentrator meet this requirement.
Conclusion: The oxygen purity levels for the revised and predicate concentrators are equivalent, hence there is no effect on safety and effectiveness.
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NOV -3 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Greq Clites Sunrise Medical HHG Inc. Respiratory Products Division 100 DeVilbiss Drive P.O. Box 635 Somerset, PA 15501-0635
Re: K991722 DeVilbiss 5 Liter Oxygen Concentrator Regulatory Class: II (two) Product Code: 73 CAW Dated: August 31, 1999 Received: September 1, 1999
Dear Mr. Clites:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Greg Clites
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
feccions. Hwacteristanse for,
Ceila M. Witten, Ph.D., M.D.
Acting Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): __ K991722
Device Name: DeVilbiss 5 Liter Oxygen Concentrator
Indications For Use:
The DeVilbiss 5 Liter Oxygen Concentrator is intended for use as an oxygen concentrator to provide supplemental low flow oxygen therapy in the home, nursing homes, patient care facilities, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
JoAu Westerman
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K971722
Prescription Use x (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).