(159 days)
The ElectroFluidGraph™is used to estimate the subject's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water; in "generally healthy" subjects of 21 to 87 years old.
Not Found
The provided FDA 510(k) document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
This document is a letter from the FDA granting substantial equivalence for the ElectroFluidGraph™ device, meaning it's deemed equivalent to a predicate device already on the market without requiring new clinical trials to prove safety and efficacy. The letter primarily focuses on regulatory compliance, outlining the requirements for marketing the device.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance: This information is not present in the document.
- Sample size used for the test set and data provenance: No test set or data provenance is detailed.
- Number of experts used to establish ground truth and their qualifications: No ground truth establishment is described.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study or effect size: No human reader study is discussed.
- Standalone performance study: No standalone algorithm performance is described.
- Type of ground truth used: Not applicable as no ground truth is discussed.
- Sample size for the training set: No training set is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document states the device "is used to estimate the subject's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water; in 'generally healthy' subjects of 21 to 87 years old." However, it does not provide any performance metrics (e.g., accuracy, precision, correlation with a gold standard) to demonstrate how well it performs these estimations.
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Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Akern USA, LLC c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 5401 S. Cottonwood Court GREENWOOD VILLAGE CO 80121
OCT 1 4 2009
Re: K091369
Trade/Device Name: ElectroFluidGraph" Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 13, 2009 Received: August 14, 2009
Dear Mr. Walls:
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 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.
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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K091369
Device Name: ElectroFluidGraph™
Indications for Use: The ElectroFluidGraph™is used to estimate the subject's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water; in "generally healthy" subjects of 21 to 87 years old.
Prescription Use (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)
Tomh Wh
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
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§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.