(305 days)
The EMG CTX01-XXX Series Oxygen Concentrator is designed to provide 1 to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding an oxygen concentrator (EMG CTX01-XXX Series Oxygen Concentrator). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the request.
The request asks for specific details about a study proving the device meets acceptance criteria, including:
- Table of acceptance criteria and reported device performance: This information is not present.
- Sample size, test set, and data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance study: Not mentioned.
- Type of ground truth: Not mentioned.
- Training set sample size: Not mentioned.
- Ground truth for training set: Not mentioned.
The document primarily focuses on regulatory approval based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria that might be found in a clinical trial report or a more technical submission for a novel device or AI/ML-based device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document is a regulatory clearance letter, not a technical performance report.
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OCT 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EMG Technologies Company Limited C/O Mr. Leonard Frier Official Correspondent MET Laboratories, Incorporated 914 West Patapsco Avenue Baltimore, MD 21230
Re: K043520
Trade/Device Name: EMG CTX01-XXX Series Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Concentrator Regulatory Class: II Product Code: CAW Dated: September 6, 2005 Received: September 15, 2005
Dear Mr. Frier:
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. Frier
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 vours.
Susan Runon
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
510K number: K043520
Device Name: EMG CTX01-XXX Series Oxygen Concentrator
Indications For Use: The EMG CTX01-XXX Series Oxygen Concentrator is designed to provide 1 to 5 liters per minute oxygen for the patient who has been prescribed oxygen therapy by a physician. This device is used in home type environments, nursing homes, patient care facilities, etc.
(Part 21 CFR 801 Subpart D) Prescription Use XXXX_ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cun Suim
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
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).