(242 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technology in medical devices. The device description and performance study sections are also marked as "Not Found," further limiting the ability to identify such technologies.
No
The device estimates body composition parameters and is not described as treating or preventing any medical condition or disease.
No
The device is intended to estimate body composition parameters, not to diagnose a medical condition.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. Without this information, it's impossible to definitively classify the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device Intended Use: The BIA/Vitality Analyzer™ is intended to estimate body composition parameters (Fat Free Mass, Fat Mass, Total Body Water, Extra-Cellular Water) in "generally healthy" subjects. This is a measurement of physical characteristics of the body itself, not an analysis of a sample taken from the body.
- Lack of Sample Analysis: There is no mention of analyzing any biological samples (blood, urine, etc.) in the intended use or device description.
Therefore, the BIA/Vitality Analyzer™ falls outside the scope of an In Vitro Diagnostic device. It appears to be a device that directly interacts with the body to take measurements, likely using bioelectrical impedance analysis (BIA) as suggested by the name.
N/A
Intended Use / Indications for Use
The BIA/Vitality Analyzer™ is indicated for "generally healthy" subjects of 18 to 87 years old. The BlA/Vitality Analyzer™ is intended to estimate a person's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water.
Product codes
MNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 to 87 years old
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the eagle in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2013
IPGDx, LLC % Kevin Walls. RAC Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127
Re: KI 30856
Trade/Device Name: Vitality Analyzer™/BIA Analyzer™ Regulation Number: 21 CFR& 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 29, 2013 Received: August 30, 2013
Dear Kevin 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. JThe general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
Page 2 - Kevin Walls, RAC
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 device-related adverse events) (21 CFR 803); 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.
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/ReportalProblem/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/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Herbert P. Verner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K130856
Device Name: Vitality Analyzer™/BIA Analyzer™
Indications for Use: The BIA/Vitality Analyzer™ is indicated for "generally healthy" subjects of 18 to 87 years old. The BlA/Vitality Analyzer™ is intended to estimate a person's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water.
Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR
(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)
Herbert P. Lerner 2013.11.25 115:54
Page 1 of 1