(249 days)
No
The description focuses on bioelectrical impedance analysis (BIA) and its underlying principles, with no mention of AI or ML algorithms being used for data processing or analysis. The performance studies are comparison tests between different models, not evaluations of AI/ML performance.
No.
The device is used for measurement and analysis of body composition parameters, which are diagnostic in nature, not therapeutic.
Yes
Explanation: The device is used for the "Measurement of" various body composition parameters and provides "Body composition analysis results" to "health care professionals in their management of the relative balance and levels of fat and lean tissue." While it doesn't explicitly state diagnosing diseases, the ability to measure and manage body composition for healthcare professionals indicates a diagnostic purpose related to assessing a patient’s physiological state.
No
The device description explicitly states "These devices are impedance plethysmograph body composition analyzers" and describes the use of "applied electrical current" and "electrical signals" to perform bioelectrical impedance analysis (BIA). This indicates the device includes hardware components for applying and measuring electrical signals, making it more than just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The device description clearly states that it uses bioelectrical impedance analysis (BIA) by applying electrical currents to the body (specifically arms and legs) to measure body composition parameters. It does not analyze samples like blood, urine, or tissue outside of the body.
- The intended use focuses on measuring body composition parameters directly from a living subject. The list of measurements includes things like skeletal muscle mass, body fat, body water, and metabolic rates, all of which are assessed in vivo.
- The device description details a method of direct measurement on the body. BIA involves applying electrodes to the skin and measuring the body's response to electrical signals.
While the device provides information that can be valuable to healthcare professionals in managing patient health, the method of obtaining this information does not involve the in vitro examination of specimens.
N/A
Intended Use / Indications for Use
For use only in healthy subjects for Measurement of:
Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control
Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for In8ody720], Reactance Values [only for InBody720], Phase Angle [only for InBody720]
Product codes
MNW
Device Description
These devices are impedance plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue
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
From age 3 ~ age 99
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)
Clinical Performance Test for InBody120:
- Study Type: Comparison performance test
- Sample Size: 39 examinees
- Data Source: Comparison between InBody120 and InBody720 (FDA premarket notification obtained)
- Key Results: The test was conducted from August 19th, 2012 to August 23rd, 2012.
Clinical Performance Test for InBody370:
- Study Type: Comparison performance test
- Sample Size: 88 examinees
- Data Source: Comparison between InBody370 and InBody720 (FDA premarket notification obtained)
- Key Results: The test was conducted from September 3rd, 2012 to September 5th, 2012.
Clinical Performance Test for InBody520:
- Study Type: Comparison performance test
- Sample Size: 75 examinees
- Data Source: Comparison between InBody520 and InBody J30 (FDA premarket notification obtained)
- Key Results: The test was conducted from July 2nd, 2010 to July 4th, 2010.
Clinical Performance Test for InBody 720:
- Study Type: Comparison performance test
- Sample Size: 62 examinees
- Data Source: Comparison between InBody J30 and InBody720 (FDA premarket notification obtained)
- Key Results: The test was conducted from July 2nd, 2010 to July 4th, 2010.
Conclusion:
The new models (InBody120, InBody370, InBody520, InBody720) have very similar technological characteristics to the predicate devices and performed comparably. They use the same scientific principles for measurements. Therefore, the new models are substantially equivalent to the predicates cleared in 2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
NOV 2 5 2013
K130777 Page 1 of 4
510(k) Summary K130777 Biospace Corporation Limited Donghyun Building, 518-10 Dogok 2 - Dong Gangnam-Gu. Seoul. KOREA 135-854 Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http://www.inbody.com DATE PREPARED: February 15, 2013 Contact: Kichul Cha, CEO
- Identification of the Devices:
Proprietary-Trade Names:
- Biospace Body Composition Analyzer, Model InBody 120 .
- . Biospace Body Composition Analyzer, Model InBody 370
- � Biospace Body Composition Analyzer, Model InBody 720
- . Biospace Body Composition Analyzer, Model InBody 520
Classification Names: ANALYZER, BODY COMPO5ITION Common/Usual Name: Body fat meter Regulation Description: Impedance plethysmograph. Classification Panel: Cardiovascular Product Code: MNW Regulation Number: 870. 2770 Classification: =
- Equivalent legally marketed devices: (Predicate device Information) 2. Biospace Body Composition Analyzer Model InBody 170, InBody J30 InBody S10, K110689 The Segmental Body Water indication was cleared in K123228, InBody 770, InBody510, InBody$10, InBody H20.
-
- Indications for Use:
For use only in healthy subjects for Measurement of:
Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control
Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for In8ody720], Reactance Values [only for InBody720], Phase Angle [only for InBody720]
Page 20 of 2539
1
Description: These devices are impedance plethysmograph body composition analyzers. These 4. devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. I Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue
ഗ് Safety and Effectiveness, comparison to predicate device. The results of bench, safety, and software testing indicates that the new devices are as safe and effective as the predicate device.
| Devices | | InBody
170 | InBody
I30 | InBody
510 | InBody
120 | InBody
370 | InBody
720 | InBody
520 |
|---------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| 510(k)
number | | K110689 | K110689 | K110689 | New | New | New | New |
| Manufacturer | | Biospace | Biospace | Biospace | Biospace | Biospace | Biospace | Biospace |
| Measurement
of Estimated : | Extra-
Cellular
Water
(ECW) | V | V | V | V | V | V | V |
| | Intra-
Cellular
Water
(ICW) | V | V | V | V | V | V | V |
| | Total Body
Water
(TBW) | V | V | V | V | V | V | V |
| | Skeletal
Muscle
Mass | V | V | V | V | V | V | V |
| | Body Fat
Mass | V | V | V | V | V | V | V |
| | Lean Body
Mass | V | V | V | V | V | V | V |
| | Dry Lean
Mass | V | V | V | V | V | V | V |
| | Basal
Metabolic
Rates | V | V | V | V | V | V | V |
| | Segmental
Lean Mass | V | V | V | V | V | V | V |
| | ECW/TBW | V | V | V | V | V | V | V |
| | Segmental
Body Fat | V | V | V | V | V | V | V |
| Devices | | InBody
170 | InBody
130 | InBody
510 | InBody
120 | InBody
370 | InBody
720 | InBody
520 |
| | mass | | | | | | | |
| | %
Segmental
Body Fat | V | V | V | | | | |
| | Energy
expend-
iture of
activity | V | V | V | | | | |
| | Visceral
Fat Area | V | V | V | | | | |
| | Segmental
Body
Water | (Cleared in
K123228) | (Cleared in
K123228) | (Cleared in
K123228) | V | V | V | V |
| Measure-
ment of
Actual : | Weight | V | V | | V | V | V | V |
| | Height | | V | | V | V | V | V |
| | Body Mass
Index
(BMI) | V | V | V | V | V | V | V |
| | Impedance
Values | 20, 100kHz | 5, 50,
250kHz | 1, 5, 50,
250, 500,
1,000kHz | 20, 100kHz | 5, 50,
250kHz | 1, 5, 50,
250, 500,
1,000kHz | 5,
50, 500
kHz |
| | Reactance
Values | | | 5, 50,
250kHz | | | 5, 50,
250kHz | |
| | Phase
Angle | | | 5, 50,
250kHz | | | 5,50,250k
Hz | |
| Measurement
method | | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance |
| Electrode
type | | 4 electric poles
8 points Touch
type electrode
measure-
ment | 4 electric
poles 8
points Touch
type
electrode
measure-
ment | 4 electric
poles 8
points Touch
type
electrode
measure-
ment | 4 electric poles
8 points Touch
type electrode
measurement | 4 electric
poles 8
points Touch
type
electrode
measure-
ment | 4 electric
poles 8
points Touch
type
electrode
measure-
ment | 4 electric
poles 8
points Touch
type
electrode
measure-
ment |
| Power Source | | Input
power: AC
100-
120/200-
240V, 50/60
Hz, 1.2A
Output
power:
DC12V, 3.4A | Input
power: AC
100-
120/200-
240V,
50/60Hz,
1.2A
Output
power:
DC12V,
3.4A | Input
power: AC
100-
120/200-
240V,
50/60Hz,
1.2A
Output
power:
DC12V,
3.4A | Input
power: AC
100-
120/200-
240V, 50/60
Hz, 1.2A
Output
power:
DC12V, 3.4A | Input
power: AC
100-
120/200-
240V,
50/60Hz,
1.2A
Output
power:
DC12V,
3.4A | 100-
240V~,
50/60Hz
No
adapter | Input
power: AC
100-
120/200-
240V,
50/60Hz,
1.2A
Output
power:
DC12V,
3.5A |
| Equipment weight | | 14.3kg | 29kg | 2kg | 5.7kg | 20 kg | 45kg | 26kg |
| Equipment size | | 396(W)
x
608(L)
x | 360(W)
x
640(L)
x | 202(W)
x
322(L)
x
| 393(W)
x
516(L)
x | 460(W)
x
677(L)
x | 520(W)
x
870(L)
x | 522 (W) x
843(L)
x |
| Devices | InBody
170 | InBody
J30 | InBody
S10 | InBody
120 | InBody
370 | InBody
720 | InBody
520 | |
| | mm | mm | | | mm | mm | mm | |
| Measurement
time | 30 seconds | 30
seconds | 110
seconds | Weight
measure-
ment 357
seconds,
Impedance
measure-
ment 5
seconds. | 45
seconds | Less than
1 minute
for
medical
mode(Less
than 2
minutes
for
research
purpose
mode) | 50
seconds | |
| Measurement
age | From age 3
~ age 99 | From age
3 ~ age 99 | From age 3
~ age 99 | From age 3
~ age 99 | From age
3 ~ age 99 | From age 3
~ age 99 | From age
3 ~ age 99 | |
| Measurement weight | 10 ~ 250kg | 10 ~ 250kg | 10 ~ 250kg | 5 ~ 250kg | 10 ~ 250kg | 10 ~ 250kg | 10 ~ 250kg | |
ર. Comparison table
Page 21 of 2539
2
Page 22 of 2539
3
Discussion of Non-Clinical Testing; Electromagnetic and Safety Testing was conducted to IEC 7. Software validation was conducted. Literature was compiled and 60601-1 and IEC 60601-1-2. reviewed.
8. Discussion of Clinical Testing:
In order to verify InBody120's clinical performance, we conducted comparison performance test between InBody120 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from August 19rd, 2012 to August 23th, 2012 with a group of 39 examinees. In order to verify InBody370's clinical performance, we conducted comparison performance test between InBody370 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from September 3rd, 2012 to September 5th, 2012 with a group of 88 examinees. In order to verify InBody520's clinical performance, we conducted comparison performance test between InBody520 and InBody J30 that obtained FDA premarket notification under FDA law. The test was conducted from July 2nd, 2010 to July 4th, 2010 with a group of 75 examinees. In order to verify InBody 720's clinical performance, we conducted comparison performance test between InBody J30 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from July 2nd, 2010 to July 4th, 2010 with a group of 62 examinees
As compared to our predicate devices (our own brand) these new models have 9. Conclusion: very similar technological characteristics and performed comparably to our predicates. The same scientific principles are used to produce the measurements. We therefore conclude that our new models are substantially equivalent to our predicates cleared in 2011.
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 stylized human figure with three arms or extensions reaching upwards. The figure is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2013
Biospace Corporation Limited % Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Ct Naples, FL 34114
K130777 Re:
Trade/Device Name: Biospace Body Composition Analyzer, Model InBody120 Biospace Body Composition Analyzer, Model InBody 370 Biospace Body Composition Analyzer, Model InBody 720 Biospace Body Composition Analyzer, Model InBody 520 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: October 28, 2013 Received: October 30, 2013
Dear Daniel Kamm,
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. Ilisting 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.
5
Page 2 - Daniel Kamm, P.E.
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 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/ucm1115809.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/ReportaProblem/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/Industry/default.htm.
Sincerely yours,
Herbert P.Lerner -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
6
Indications for Use
510(k) Number (if known): K130777
Device Names:
-
- Biospace Body Composition Analyzer, Model InBody120
-
Biospace Body Composition Analyzer, Model InBody370
-
Biospace Body Composition Analyzer, Model InBody720
-
Biospace Body Composition Analyzer, Model InBody520
Indications for use:
For use only in healthy subjects for Measurement of:
Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental · Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control
Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody720], Reactance Values [only for InBody720], Phase Angle fonly for InBody720]
| Prescription Use | AND/OR | Over-The-Counter Use | X |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Herbert P 2013.11.25 15:0