BIA / VITALITY ANALYZER

K130856 · Ipgdx, LLC · MNW · Nov 25, 2013 · Cardiovascular

Device Facts

• Record ID: K130856
• Device Name: BIA / VITALITY ANALYZER
• Applicant: Ipgdx, LLC
• Product Code: MNW · Cardiovascular
• Decision Date: Nov 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended 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.

Device Story

Vitality Analyzer™/BIA Analyzer™ is an impedance plethysmograph used to estimate body composition. Device measures electrical impedance of body; uses bioelectrical impedance analysis (BIA) principles to calculate Fat Free Mass, Fat Mass, Total Body Water, and Extra-Cellular Water. Intended for over-the-counter use by healthy individuals aged 18-87. Output provides body composition metrics to user for health monitoring. Device operates via electrical sensing; data processing converts impedance measurements into body composition estimates.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impedance plethysmograph; utilizes bioelectrical impedance analysis (BIA) to measure body electrical impedance. Device estimates body composition parameters (Fat Free Mass, Fat Mass, Total Body Water, Extra-Cellular Water).

Indications for Use

Indicated for generally healthy subjects aged 18-87 years for estimation of body composition parameters including Fat Free Mass, Fat Mass, Total Body Water, and Extra-Cellular Water.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

{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 [phone] or [phone] 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