(116 days)
No
The description focuses on bioelectrical impedance analysis (BIA) and does not mention AI or ML.
No
The device is used for measurement of body composition parameters and does not involve any therapeutic intervention or treatment.
No
The device is described as a body composition analyzer that measures various body parameters (e.g., body fat, water) in healthy subjects. It does not mention diagnosing, treating, or preventing any disease or condition.
No
The device description explicitly states "InBody 3.0 is an impedance plethysmograph body composition analyzer" and describes its function based on "bioelectrical impedance analysis (BIA)," which involves applying electrical currents and analyzing the response. This indicates the device includes hardware components for generating and measuring electrical signals, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Measurement Of: Estimated... Actual..." body composition parameters in healthy subjects. This involves measuring physical characteristics of the body directly, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description clearly states it's an "impedance plethysmograph body composition analyzer" that uses "bioelectrical impedance analysis (BIA)". This is a non-invasive method applied to the body's surface.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures physical properties of the body itself.
N/A
Intended Use / Indications for Use
For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, Body Mass Index (BMI),and Impedance Values
Product codes
74 MNW
Device Description
InBody 3.0 is an impedance plethysmograph body composition analyzer. The device determines 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.
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
Not Found
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)
The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K042528
PAGE 1 OF 2
JAN 1 1 2005
EXHIBIT 2 510(k) Summary
Biospace Corporation Limited 363 Yangjae-dong, Seocho-gu, Seoul 137-898, Korea Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http:// www.biospace.co.kr November 8, 2004 Contact: Kichul Cha, CEO
-
- Identification of the Device: Proprietary-Trade Name: InBody AP1 BODY COMPOSITION ANALYZER Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter
-
- Indications for Use (intended use) For use only in healthy subjects for Measurement Of: Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW to TBW ratio, Body Fat, Body Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Actual : Weight, Body Mass Index (BMI),and Impedance Values
- Description of the Device: InBody 3.0 is an impedance plethysmograph body 4. composition analyzer. The device determines 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.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices.
1
| | BodyStat
QuadScan 4000 | RJL Systems
BIA-101A | Biospace Body
Composition
Analyzer Model
InBody AP1 | Biospace Body
Composition
Analyzer Model
InBody 3.0 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
number | K002835 | K830292 | K023478 | |
| Intended
Use | Body composition
analyzer | Body composition
analyzer | Body composition
analyzer | Body composition
analyzer |
| Indications
for Use
(Healthy
subjects) | Measurement Of:
Estimated :
Extra-Cellular Water,
Intra-Cellular Water,
Total Body Water,
Body Fat,
Body Lean + Dry
Lean,
Metabolic Rates,
Actual :
Waist/Hip Ratio,
Body Mass Index
(BMI),
and Impedance
Values:
5, 50, 100, 200kHz | Measurement Of:
Resistance and
Reactance Value:
50kHz | Measurement Of:
Estimated :
Extra-Cellular Water,
Intra-Cellular Water,
Total Body Water,
Body Fat,
Body Lean + Dry
Lean,
Metabolic Rates,
Actual :
Weight,
Body Mass Index
(BMI),
and Impedance
Values:
5, 50, 250kHz | Measurement Of:
Estimated :
Extra-Cellular
Water(ECW),
Intra-Cellular
Water(ICW),
Total Body Water
(TBW),
ECW to /TBW ratio
Body Fat,
Body Lean + Dry
Lean,
Metabolic Rates,
Segmental Lean
Mass
Actual :
Weight,
Body Mass Index
(BMI),
and Impedance
Values:
5, 50, 250, 500kHz |
| Analysis
Method | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance | Bioelectrical
Impedance |
| Operating
parameters | Frequency :
5, 50, 100, 200kHz | Frequency :
50kHz | Frequency :
5, 50, 250kHz | Frequency :
5, 50, 250, 500kHz |
| Electrode
Type | adhesive | adhesive | tactile | tactile |
| Number /
Placement
of Electrodes | 4 electrodes
placed on
hands and feet | 4 electrodes
placed on
hands and feet | 8 electrodes
placed on thumbs,
palms, heels, and
fore-feet | 8 electrodes
placed on thumbs,
palms, heels, and
fore-feet |
| Impedance
Measuring | Whole Body
( Right Arm to Right | Whole Body
( Right Arm to Right | Right Arm, Left Arm,
Trunk,
Right Leg, Left Leg | Right Arm, Left Arm,
Trunk,
Right Leg, Left Leg |
6. Substantial Equivalence Chart, InBody AP1 BODY COMPOSITION ANALYZER
7. Conclusion
Leg )
Supine
Site
Patient
Position
- After analyzing both belief and clinical teams and effective as the producate
InBody 3.0 BODY COMPOSITION ANALYZER as safe and effective as the predicate Ifibody 3.0 BODT COMI OUTFORTITIVE - BEAT - Substantially equivalent to the predicate devices.
Leg )
Supine
Upright
Upright
2
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2005
Biospace Corporation Limited c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K042528
Trade/Device Name: InBody 3.0 Body Composition Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 8, 2004 Received: November 9, 2004
Dear Mr. Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of pror to ria) 2011-07-12, 11:25 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 r ou may, dictere, manner are a e act include requirements for annual registration, listing of general oonline provisioning practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 acc 10) ... Existing major regulations affecting your device can be it may of subjoct to adamestic segulations, 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 i Tease be advised that I Drivision that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must of any I ederal statures and rougherents, including, but not limited to: registration and listing Comply with and No. 3 requirently Part 801); good manufacturing practice requirements as set (21 CFR Part 801), acceming (21 CFR Part 820); and if applicable, the electronic form in the quality by tickle (QB) -13
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter whil anow you to obgin maining of substantial equivalence of your device to a legally premarked notheation: "The PDF maning station 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 If you desire specific acvice for your as not 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 Also, prease note the regulation on your responsibilities under the Act from the 007.97). I Ou may obtain other gational and Consumer Assistance at its toll-free number (800) DIVISION of Shian Manufacturers, Internet address http://www.fda.gov/cdrb/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
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
K042528 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:_Biospace InBody 3.0
Indications For Use:
For use only in healthy subjects for Measurement Of: For use only in nealthy Subjects for modelier Water (ICW),Total Body Water
Estimated : Extra-Cellular Water (ECW), Intra-Cellular Water (ICW),Total Botas Estimated : Extra-Ochaldi Water (Eot. P) , Lean + Dry Lean, Metabolic Rates, Segmental Lean Mass Segmental Eoun Mass Index (BMI),and Impedance Values
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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)
David R. Syrom
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042528
Page 1 of 1