(115 days)
No
The device description explicitly states that it uses "prediction equations developed as the result of clinical studies" and allows the user to select from "several different sets of equations." There is no mention of AI or ML algorithms being used for these calculations or predictions.
No.
The device is a software accessory that calculates and tracks body composition parameters, and it explicitly states that it is "non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition." Therefore, it is not a therapeutic device.
No
The "Device Description" section explicitly states, "The BC application is non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition."
Yes
The device is described as a "software accessory" and its function is to perform calculations and historical tracking based on data entered by the user. While it requires data from separate hardware (Bio-Impedance Analyzers) and a personal computer, the device itself is the software application performing the calculations and data management.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Calculation and Historical Tracking" of various body composition parameters. While these parameters can be relevant to health, the software itself is performing calculations based on data obtained from a separate device (the Bio-Impedance Analyzer). It is not performing a test on a biological sample in vitro (outside the body).
- Device Description: The description explicitly states that the "BC application is non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition." This is a key characteristic that differentiates it from an IVD, which is used to diagnose or aid in the diagnosis of diseases or conditions.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or being used for diagnostic purposes.
The software acts as an accessory to a Bio-Impedance Analyzer, which measures electrical properties of the body. The software then uses these measurements and other user-provided data to calculate estimated body composition parameters. This is a different function than an IVD.
N/A
Intended Use / Indications for Use
BC is a software accessory for RJL Systems Quantum-X, Quantum Desktop, and Quantum-III. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-III analyzers, the computer must have an available serial port.
Indications:
Calculation and Historical Tracking of:
- Actual Impedance .
- Actual Phase Angle (PA) .
- . Estimated Body Fat (FAT)
- . Estimated Fat Free Mass (FFM)
- . Estimated Total Body Water (TBW)
- . Estimated Intra-Cellular Water (ICW)
- . Estimated Extra-Cellular Water (ECW)
- Estimated Basal Metabolic Rate (BMR) .
- Estimated Daily Energy Expenditure (DEE) .
- . Actual Body Mass Index (BMI)
Product codes (comma separated list FDA assigned to the subject device)
MNW
Device Description
The BC application is intended to be used as a software accessory to RJL Systems' existing line of Bio-Impedance Analyzers ( K830292 and K862383 ). The user obtains values for the Resistance and Reactance of an individual, and enters these numbers, along with the individual's name, age, height, weight, gender, activity level, frame size, and optionally, subject ID and desired target weight. These values are stored in a database to enable historical tracking, and are then used in a series of prediction equations to estimate the parameters listed above.
For estimating body composition parameters, the BC application relies on prediction equations developed as the result of clinical studies. The user is provided the opportunity to select from several different sets of equations, each assembled from one or more studies. References are provided for every set of equations, except for those contained in the original RJL BIA-103 device software.
The BC application is non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition.
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
BC is intended only for use on normally healthy adults and adolescents age 9-94.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary
RJL Systems, Inc. 33939 Harper Avenue Clinton Township, Michigan 58035, USA Phone : 586-790-0200 Fax : 586-790-0205 Homepage : http://www.rjlsystems.com
- Identification of the Device: Proprietary - Trade Name: BC body composition software Common Name: Body Composition Analyzer Classification Number: 21 CFR 870.2770 Classification Name: Impedance Plethysmograph Product Code: MNW
3) Indications for use
BC is a software accessory for RJL Systems Quantum-X, Quantum Desktop, and Quantum-III. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-III analyzers, the computer must have an available serial port.
Indications:
Calculation and Historical Tracking of:
- Actual Impedance .
- Actual Phase Angle (PA) .
- . Estimated Body Fat (FAT)
- . Estimated Fat Free Mass (FFM)
- . Estimated Total Body Water (TBW)
- . Estimated Intra-Cellular Water (ICW)
- . Estimated Extra-Cellular Water (ECW)
- Estimated Basal Metabolic Rate (BMR) .
- Estimated Daily Energy Expenditure (DEE) .
- . Actual Body Mass Index (BMI)
AUG - 2 2007
1
Device Description 4)
The BC application is intended to be used as a software accessory to RJL Systems' existing line of Bio-Impedance Analyzers ( K830292 and K862383 ). The user obtains values for the Resistance and Reactance of an individual, and enters these numbers, along with the individual's name, age, height, weight, gender, activity level, frame size, and optionally, subject ID and desired target weight. These values are stored in a database to enable historical tracking, and are then used in a series of prediction equations to estimate the parameters listed above.
For estimating body composition parameters, the BC application relies on prediction equations developed as the result of clinical studies. The user is provided the opportunity to select from several different sets of equations, each assembled from one or more studies. References are provided for every set of equations, except for those contained in the original RJL BIA-103 device software.
The BC application is non-diagnostic in nature and does not express any opinions with regard to any specific disease or medical condition.
| Company
Device Name | RJL Systems
BC | RJL Systems
BIA-103 | Predicate Devices
Impedimed
DF-50 | BodyStat
QuadScan 4000 |
|-----------------------------|-------------------|------------------------|-----------------------------------------|---------------------------|
| 510(k) number | | K862383 | K050395 | K002835 |
| OTC | YES | YES | YES | YES |
| Indication | | | | |
| Impedance | YES | | YES | YES |
| Phase Angle | YES | | YES | |
| Body Fat | YES | YES | YES | YES |
| Fat Free Mass | YES | YES | YES | YES |
| Total Body Water | YES | YES | YES | YES |
| Intra-Cellular Water | YES | | YES | YES |
| Extra-Cellular Water | YES | | YES | YES |
| Body Mass Index | YES | | YES | YES |
| Basal Metabolic Rate | YES | YES | YES | YES * |
| Daily Energy
Expenditure | YES | | | YES * |
5) Substantial Equivalence Chart
( * ) The Indications for Use statement for the BodyStat QuadScan 4000 simply states "Metabolic Rates". However, the QuadScan 4000 reports "Basal Metabolism" and "Activity Metabolism". Activity Metabolism is an accepted synonym for "Daily Energy Expenditure".
The product comparison chart establishes that the BC software application does not raise any new questions concerning safety and effectiveness and is equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is written in a simple, sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
- 2 2007
Mr. Barry Callahan IT Director RJL Systems 33939 Harper Avenue CLINTON TOWNSHIP MI 48035
K070999 Re:
Trade/Device Name: BC (Body Composition Software) Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: July 17, 2007 Received: July 18, 2007
Dear Mr. Callahan:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The text around the perimeter of the seal is difficult to read due to the image quality.
dina and 9 m
3
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 allthe 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours.
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K070999
Device Name: BC ( Body Composition Software )
BC is a software accessory for RJL Systems Quantum-X, Quantum-X, Quantum Desktop, and Quantum-III. It requires a separate personal computer running the Windows Operating System. To automatically retrieve data from the Quantum Desktop and Quantum-III analyzers, the computer must have an available serial port.
Indications for Use:
Calculation and Historical Tracking of:
- Actual Impedance .
- Actual Phase Angle (PA) .
- Estimated Body Fat (FAT) .
- Estimated Fat Free Mass (FFM) .
- . Estimated Total Body Water (TBW)
- Estimated Intra-Cellular Water (ICW) ●
- Estimated Extra-Cellular Water (ECW) ●
- Estimated Basal Metabolic Rate (BMR) .
- Estimated Daily Energy Expenditure (DEE) .
- Actual Body Mass Index (BMI) .
BC is intended only for use on normally healthy adults and adolescents age 9-94.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert Remmer
vision of Reproductive, Abdominal and Radiological Devic 510(k) Number
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