IMPEDIMED - BODY COMPOSITION ANALYSIS

{0}------------------------------------------------ K050395 PAGE 1 OF 4 ImpediMed JUL 1 3 2005 # ImpediMed Limited Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia ABN 65 089 705 144 Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496 Email: enquires@impedimed.com # 510 (k) Summary ImpediMed Imp DF50 Body Composition Analysis #### APPLICANT INFORMATION Company Name and address: Contact Name and numbers: ImpediMed Limited 4B/2404, Logan Road Eight Mile Plains Brisbane, QLD - 4113_ > Mr Neville Bertwistle General Manager Phone: (+61) 7 3423 1777 Fax: (+61) 7 3423 1496 E-mail: nbertwistle@impedimed.com Date of summary prepared: Dec 24, 2004 #### DEVICE IDENTIFICATION Trade/Proprietary name: Classification name: Regulation number/CFR section: Product code: Classification panel: Device class: Imp DF50 Body Composition Analysis Impedance Plethysmograph 21 CFR 870.2770 DSB MN W Cardiovascular Class II Letterhead Summary.doc Page 1 of 4 000019 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "K050395 PAGE 2 OF 4" in the upper left corner. The right side of the image contains a logo for "ImpediMed". The logo is black and white and has a stylized design. # ImpediMed Limited Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia ABN 65 089 705 144 Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496 Email: enquires@impedimed.com 1. | Company: | RJL Systems, Inc | |--------------|------------------------------------------| | Device name: | BIOELECTRICAL IMPEDANCE ANALYZER<br>#101 | 510 (K) number: Product code: K 830292 DSB - 2 . | Company | BODYSTAT LTD | |-----------------|------------------------------------------------------| | Device name: | BODYSTAT 1500MDD BODY COMPOSITION<br>MONITORING UNIT | | 510 (K) number: | K 994242 | | Product code: | MNW | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "K050395 PAGE 3 OF 4" at the top. Below the text is the logo for "ImpediMed" in a stylized font. The logo is surrounded by a circular design that looks like brush strokes. ABN 65 089 705 144 ImpediMed Limited Garden City Office Park Eight Mile Plains QLD 4113 Building 4B PO Box 4612 Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496 Email: enquires@impedimed.com # Australia ## INTENDED USE / INDICATIONS FOR USE IN ENDED USE / INDIOATIONS / Office / Sturements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water (TBW), intracellular water (ICW), and extracellular water (ECW). #### DEVICE DESCRIPTION DEVICE DESCRIP HON The Imp DF50 is a single frequency bioelectrical impedance analyser. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition: fat-free mass (FFM) and fat mass (FM), and fluid distribution: total body water, intracellular water, and extracellular water. ## TECHNOLOGICAL CHARECTERISTICS The ImpediMed Imp DF50 Body Composition Analyzer is a battery powered, accurate, handheld, single frequency, bioelectrical impedance analysis instrument operating in tetra-polar mode. The device accurately measures current, voltage and phase angle, and calculates impedance, resistance and reactance. Bioelectrical impedance analysis measures the impedance or opposition to the flow of an electric current through the body fluids contained mainly in the lean and fat tissue. Impedance is low in lean tissue, where intracellular fluid and electrolytes are primarily contained, but high in fat tissue. Impedance is thus related to total body water volume. In practice, a small constant current, typically 200 uA± 10uA peak-to-peak at a fixed frequency of 50 kHz± 100Hz is passed between two current electrodes spanning the body. The voltage {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for ImpediMed. The logo is in black and white and features the company name in a stylized font. Above the logo, there is some handwritten text that reads '2050395' and 'AGE 4 OF 4'. The logo is surrounded by a series of curved lines that resemble sound waves. ABN 65 089 705 144 # ImpediMed Limited Telephone: +61 (0)7 3423 1777 Facsimile: +61 (0)7 3423 1496 Building 4B Garden City Office Park PO Box 4612 Eight Mile Plains QLD 4113 Australia Email: enquires@impedimed.com drop measured between a second pair of voltage-sensing electrodes provides a measure of impedance. The performance of the device may be checked with the aid of a calibration circuit (supplied as an accessory) for quality assurance or servicing purposes. Prediction equations from peer reviewed journal articles, generated by correlating impedance measures against an independent estimate of Total Body Water (TBW), may be used to convert measured impedance to a corresponding estimate of TBW. Lean body mass is then calculated from this estimate using an assumed hydration for lean tissue. Fat mass is subsequently calculated as the difference between body weight and lean body mass. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, with three wavy lines representing the staff and a simplified head at the top. JUL 1 3 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Neville Bertwistle VP Operations ImpediMed Limited Building 4B, Garden City Office Park P.O. Box 4612 Eight Mile Plains QLD 4113 AUSTRALIA Re: K050395 K030575 Trade/Device Name: Imp DF50 and Body Composition Analysis software Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: June 24, 2005 Received: June 24, 2005 Dear Mr. Bertwistle: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained institution workstad in interests a referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to regary manated provice Amendments or to commerce prior to May 28, 1970, the chacultions of the Federal Food. Drug, 1994, Drug, devices that have been reclassified in accessed to the device, subject to the general controls and Cosment Act (Act). Tou may, metere, maille to determine that the medical devices you provisions of the Act. However, you are responsible to determine that the a provisions of the Act. Trowever, you are respensioner with equivalent under the results reast use as components in the Kir have enner beth active act), or were legally on the market prior to r were notification process (Section 510(k) of the act), or were legally of t premarket fromicallon process (Section 3 ro(s) of the Medical Device Amendments. Please not: If your May 28, 1970, the enacinent une of the Medical Britished) and further process (e.g., sterilize) purchase your device components in bulk (i.e., unfinished) and further The spe purchase your device components in ounk (f.o., annualing these components in your like in a f days of you must submit a new 516(x) before mouthing ans for annual registration, listing of devices, controls provisions of the Fet meridate rigated ing and prohibitions against misbranding and : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), and If your device is classificu (\$cc above) into entine regulations affecting your device can be it may be subject to additional controls. Existing major regulations affective if may be subject to additional controls. Extroing might on 898. In addition, FDA may found in the Code of Peacharting your device in the Federal Register. {5}------------------------------------------------ Page 2 -- Mr. Neville Bertwistle Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA \$ Issualice of a substance orgains with other requirements of the Act that FDA has made a determination that your devices with of earning - You mus that FDA has made a delerimiation that your acceded by other federal agencies. "You must or any Federal statutes and regulations and including, but not limited to: registration (21 CFR Part comply with all the Act's requirements, including, and manufacturing pra comply with all the Act s requirements, mending (21 CFR Part 801); good manufacturing practice 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); and if 807); listing (21 CFR Fall 807); laboling (21 CFR (QS) regulation (21 CFR Part 820); and if requirements as set lorth in the quality Systems (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) 1978 (the subserver and allers of a line of a legsinglemes of your device to a This letter will allow you to begin matical equivalence of your device of your device to a legally premarket notification. The FDA finding of substance and this permits vour premarket notification. The PDA Indusg of Jacks, for your device and thus, permits your device on the Jabeli marketed proceed to the market. If you desire specific advice for your device on the labeling device to proceed to the market. If you desire specific advice for your device n device to proceed to the market. Tryou desire speces as (240) 276-011 15. Also, please note the regulation, please contact the Office of Complaner as (are in 10 CFR Part 807.97). regulation entitled, "Misbranding by reference to premarket notifical under the Ast from th regulation entitled, "Misolanding of responsibilities under the Act from the Act from the You may obtain other general information on your respearer Assistance at its toll free number Division of Smanr (301) 443-6597, or at its Internet address (000) 050 = 6da.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C Swogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### Indications for Use # 510(k) Number (if known): K050395 Device Name: Imp DF50 and Body Composition Analysis software #### Indications For Use: A body composition analyzer and a software package that will estimate display and store the following body composition parameters: Fat-free Mass (FFM), Fat Mass (FM), Total Body Water (TBW), Intra cellular Water (ICVV), I Fut noo Mass (ECW), Body Mass Index (BMI) and Basal Metabolic Rate (BMR). Extra octualiar vialer (2 x 77), voltage and phase angle (Phi), and from these values calculates The device moductions our only ready which are used to estimate the above body resistance (1), roustanto (1), roustanto (1), also display the user's height, weight, age, % oompoolion parameter of measurement, Practitioner's name and Device serial number. This device is intended for use on healthy children (9 - 16 years old), general and obese adult rubjects, only for body composition assessment in the home or clinical environment. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _YES_ (21 CFR 801 Subpart C) (Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Division Sign-Off | |-------------------| |-------------------| Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K050395 | |---------------|---------| |---------------|---------| Page 1 of ____________________________________________________________________________________________________________________________________________________________________ STARTS 000003