(141 days)
The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.
The Hygeia-5 Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not life-supporting or life-sustaining devices. The device operates on the same pressure swing adsorption (PSA) principle as other oxygen concentrators. They use the same type of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. Most concentrators use two sieve beds, alternating between the beds using one bed to generate the oxygen while the other is flushed for regeneration. The Hygeia-5 differs in as much as it has 5 smaller beds instead of two large beds and uses a rotating valve to distribute the air to the sieve beds and control the cycle of the adsorption and regeneration. This concept/design is similar to the Sequal device. As with other concentrators, it has an Oxygen reservoir to collect the oxygen before distribution to the patient. The Oxygen concentrator is also equipped with electronic alarms to monitor for power failure and over or under pressure of the pneumatic system.
The provided text describes a 510(k) premarket notification for the Hygeia-5 Oxygen Concentrator, which is a medical device. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the way a clinical trial or algorithm performance study would.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabulated format. Instead, it relies on a statement of meeting specifications and substantial equivalence to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: Provide supplemental oxygen. | Meets the indication to "provide supplemental oxygen for adults requiring supplemental oxygen." |
| Technological Characteristics Equivalence: Operate on PSA principle, use molecular sieve material, have oxygen reservoir, and electronic alarms. | "The technological characteristics are the same as the predicate devices.""Operates on the same pressure swing adsorption (PSA) principle.""Uses the same type of molecular sieve material.""Has 5 smaller beds instead of two large beds and uses a rotating valve... similar to the Sequal device.""Equipped with electronic alarms to monitor for power failure and over or under pressure." |
| Safety and Effectiveness Equivalence: Comparable performance to legally marketed predicate devices. | "Verification testing has confirmed the product meets its specifications.""Substantially equivalent to products currently legally marketed in the USA." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any sample size for a test set in the context of an AI/algorithm performance study. The "verification testing" mentioned is likely internal engineering validation, not a clinical trial with a specific patient test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The submission is for a physical medical device (oxygen concentrator), not an AI/algorithm requiring expert-annotated ground truth.
4. Adjudication Method for the Test Set
Not applicable for the reasons mentioned above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was done, as this is not an AI/algorithm. The comparison is against predicate devices based on technological characteristics and functional equivalence, not human reader performance.
6. Standalone Performance Study
The document states, "Verification testing has confirmed the product meets its specifications." This refers to the standalone performance of the physical device against its design specifications, not an "algorithm only without human-in-the-loop performance" in the context of AI.
7. Type of Ground Truth Used
For a physical device like an oxygen concentrator, the "ground truth" would be established by:
- Engineering specifications and standards (e.g., oxygen concentration levels, flow rates, alarm functionality).
- Performance data demonstrating adherence to these specifications.
- Comparison to the established performance of predicate devices.
The document implies that the device's performance was measured against its internal specifications and deemed equivalent to predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not an AI/algorithm, so there is no training set in that context.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons mentioned above.
In summary, the provided text is a 510(k) summary for a physical medical device (oxygen concentrator). The "acceptance criteria" revolve around established safety and effectiveness standards for such devices and demonstrating substantial equivalence to already-marketed predicate devices. It does not contain information related to AI/algorithm performance, clinical study design, or ground truth establishment in the manner described by the detailed questions.
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SUMMARY OF SAFETY AND EFFECTIVENESS
"510(k) SUMMARY" Prepared by: YC Lee Date Prepared: April 14, 2007
| 9.1 | Manufacturer: | KEDL International LimitedUnit C, Lot 1718-DD221,Tan Cheung, Sai Kung,New Territories, Hong Kong |
|---|---|---|
| 9.2 | Submitted By: | Contact - P/L BiomedicalLee Leichter7690 Cameron CircleFort Myers, FL 33912Tel -- 239-768-1118Fax - 815-550-0162 |
| 9.3 | Trade/Proprietary Name: | Hygeia-5 Oxygen Concentrator |
| 9.4 | Common/Usual Name: | Oxygen Concentrator |
| 9.5 | Classification Name: | Portable Oxygen GeneratorPanel: 73Procode: CAW |
ે છે. ક Comparison to Currently Marketed Devices
The Hygeia-5 Oxygen concentrators are substantially equivalent to the Devilbiss 5 Liter Oxygen concentrators (K991722) and Sequal Integra Model 6323 concentrators (K942082).
9.7 Device Description
The Hygeia-5 Oxygen Concentrators are prescription devices designed to provide an inexpensive supply of supplemental oxygen in a home or institution without a continuous source of purified oxygen. They are not life-supporting or life-sustaining devices. The device operates on the same pressure swing adsorption (PSA) principle as other oxygen concentrators. They use the same type of molecular sieve material that binds with the water and nitrogen in filtered room air to leave a gas that is approximately 93% oxygen when delivered to the patient. Most concentrators use two sieve beds, alternating between the beds using one bed to generate the oxygen while the other is flushed for regeneration. The Hygeia-5 differs in as much as it has 5 smaller beds instead of two large beds and uses a rotating valve to distribute the air to the sieve beds and control the cycle of the adsorption and regeneration. This concept/design is similar to the Sequal device. As with other concentrators, it has an Oxygen reservoir to collect the oxygen before
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distribution to the patient. The Oxygen concentrator is also equipped with electronic alarms to monitor for power failure and over or under pressure of the pneumatic system.
Indication/Intended Use 0.8
The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.
ರಿ. ಶಿ Technological Characteristics
The technological characteristics are the same as the predicate devices.
9.10 Performance Data
Verification testing has confirmed the product meets its specifications.
9.11 Conclusion
KEDL International concludes based on the information presented that the Hygeia-5 Concentrators are substantially equivalent to products currently legally marketed in the USA.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A." in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 2008
KEDL International Limited C/O Mr. Lee Leichter P/L Biomedical 7690 Cameron Circle Fort Myers, FL 33912
Re: K081267
Trade/Device Name: Hygeia-5 Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Codc: CAW Dated: September 22, 2008 Received: September 22, 2008
Dear Mr. Leichter:
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. Leichter
Please be adviscd 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Thamuels Yermor
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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INDICATIONS FOR USE STATEMENT
510(k) File Number:
Device Name:
Indications For Use:
Hygeia-5 Oxygen Concentrator
The Hygeia-5 Oxygen concentrators are indicated to provide supplemental oxygen for adults requiring supplemental oxygen and are intended to be used in the home or institutional environment. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Prescription Use V
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D) Subpart C)
(21 CFR 801
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Eyaluation (ODE) That
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: _______________________________________________________________________________________________________________________________________________________________
§ 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).