(115 days)
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 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.
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.
The provided 510(k) summary for the "BC body composition software" does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for a diagnostic device.
Instead, the submission focuses on substantial equivalence to predicate devices based on its indications for use and general functional equivalence. There are no detailed acceptance criteria or a dedicated study with performance metrics in the provided text.
Here's a breakdown of the requested information based on the available text:
Acceptance Criteria and Device Performance
The document does not explicitly state acceptance criteria in the form of numerical thresholds for accuracy, sensitivity, specificity, or other performance metrics. The acceptance is based on the device's functional equivalence to predicate devices and its ability to calculate and track the listed body composition parameters.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Calculation and Historical Tracking of: Actual Impedance | YES |
| Calculation and Historical Tracking of: Actual Phase Angle (PA) | YES |
| Calculation and Historical Tracking of: Estimated Body Fat (FAT) | YES |
| Calculation and Historical Tracking of: Estimated Fat Free Mass (FFM) | YES |
| Calculation and Historical Tracking of: Estimated Total Body Water (TBW) | YES |
| Calculation and Historical Tracking of: Estimated Intra-Cellular Water (ICW) | YES |
| Calculation and Historical Tracking of: Estimated Extra-Cellular Water (ECW) | YES |
| Calculation and Historical Tracking of: Estimated Basal Metabolic Rate (BMR) | YES |
| Calculation and Historical Tracking of: Estimated Daily Energy Expenditure (DEE) | YES |
| Calculation and Historical Tracking of: Actual Body Mass Index (BMI) | YES |
| Use of prediction equations developed as a result of clinical studies (with references) | YES (The user selects from several sets of equations, each assembled from one or more studies) |
| Non-diagnostic nature; does not express opinions with regard to any specific disease or medical condition | YES |
| Substantial equivalence to predicate devices (RJL Systems BIA-103, Impedimed DF-50, BodyStat QuadScan 4000) based on listed indications and functionalities | YES |
Study Details (Based on available information)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not describe a specific "test set" or a separate clinical study with a defined sample size for the BC software itself. It mentions that the "prediction equations developed as the result of clinical studies" are used. However, it does not provide details on these underlying studies' sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no specific test set described for the BC software itself where experts established ground truth. The "prediction equations" are referred to as being from "clinical studies," but no details about these studies or expert involvement are provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a software accessory for body composition analysis; it does not involve human readers interpreting medical images or data that would typically be part of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a "software accessory" that takes input from Bio-Impedance Analyzers and user-entered data (name, age, height, weight, gender, activity level, frame size). It then applies prediction equations. While the calculations are algorithm-only, the setup inherently has a "human-in-the-loop" for data entry and selection of equations. There is no standalone performance study described for the software's accuracy against a ground truth. Its performance is tied to the validity of the selected prediction equations, which are from other "clinical studies" not detailed here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document states the BC application "relies on prediction equations developed as the result of clinical studies." For these underlying studies that generated the prediction equations, the "ground truth" for body composition parameters would typically be established using methods like:
- DEXA (Dual-energy X-ray absorptiometry): A gold standard for body composition.
- Hydrostatic weighing: Another common validation method.
- Isotope dilution (for TBW): For accurate total body water measurements.
- Anthropometric measurements combined with other techniques: Depending on the specific parameter.
However, the document for the BC software does not specify the ground truth used in the original clinical studies that developed the prediction equations.
8. The sample size for the training set:
Not applicable for the BC software itself. The BC software utilizes pre-existing prediction equations. The sample sizes for the training sets of those underlying prediction equations are not provided in this 510(k) summary.
9. How the ground truth for the training set was established:
Not applicable for the BC software itself. As above, the ground truth establishment for the training sets of the underlying prediction equations is not detailed in this document.
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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
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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.
| CompanyDevice Name | RJL SystemsBC | RJL SystemsBIA-103 | Predicate DevicesImpedimedDF-50 | BodyStatQuadScan 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 EnergyExpenditure | 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.
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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.
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dina and 9 m
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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
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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
Page 1 of 1
§ 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.