(209 days)
Not Found
No
The description focuses on bioelectrical impedance analysis (BIA) and does not mention AI or ML.
No
The device measures body composition parameters but does not describe any therapeutic function or intervention.
No
The device measures various body composition parameters like body fat and water content, which are indicators of overall health, but it does not diagnose medical conditions or diseases.
No
The device description explicitly states it is an "impedance plethysmograph body composition analyzer" and relies on "bioelectrical impedance analysis (BIA)" which involves applying an electrical current 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The InBody AP1 is a body composition analyzer that uses bioelectrical impedance analysis (BIA). This method involves applying electrical currents to the body and measuring the impedance, which is then used to estimate body composition parameters. This is a non-invasive method performed on the body, not on samples taken from the body.
- Intended Use: The intended use is for measuring body composition parameters like water, fat, and lean mass, as well as metabolic rates and BMI. These are measurements of the body itself, not diagnostic tests performed on samples.
Therefore, the InBody AP1 falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For 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
Product codes
74 MNW
Device Description
InBody AP1 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
Whole Body (Right Arm to Right Leg), Right Arm, Left Arm, Trunk, Right Leg, Left Leg
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)
K002835, K830292, K930599, K011652
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
EXHIBIT 2 510(k) Summary of Safety and Effectiveness
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
October 2, 2002 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 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.
-
- Description of the Device: InBody AP1 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.
-
- 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 | Biospace Body Composition
Analyzer Model InBody AP1 |
|-------------------------------------|------------------------------------------|--------------------------------------------------------|
| 510(k) number | K002835 | |
| Intended Use | Body composition analyzer | Body composition analyzer |
| Indications for Use | Measurement Of: | Measurement Of: |
| | Estimated : | Estimated : |
| | Extra-Cellular Water, | Extra-Cellular Water, |
| | Intra-Cellular Water, | Intra-Cellular Water, |
| | Total Body Water, | Total Body Water, |
| | Body Fat, | Body Fat, |
| | Body Lean + Dry Lean, | Body Lean + Dry Lean, |
| | Metabolic Rates, | Metabolic Rates, |
| | Actual : | Actual : |
| | Waist/Hip Ratio, | Weight, |
| | Body Mass Index (BMI), | Body Mass Index (BMI), |
| | and Impedance Values | and Impedance Values |
| Analysis Method | Bioelectrical Impedance | Bioelectrical Impedance |
| Operating parameters | Frequency : | Frequency : |
| | 5, 50, 100, 200kHz | 5, 50, 250kHz |
| Electrode Type | adhesive | tactile |
| Number /
Placement of Electrodes | 4 electrodes | 8 electrodes |
| | placed on | placed on thumbs, palms, heels, |
| | hands and feet | and fore-feet |
| Impedance Measuring Site | Whole Body
( Right Arm to Right Leg ) | Right Arm, Left Arm, Trunk,
Right Leg, Left Leg |
| | | |
| Patient Position | Supine | Upright |
6. Substantial Equivalence Chart, InBody AP1 BODY COMPOSITION ANALYZER
7. Conclusion
After analyzing both bench and clinical testing data, it is the conclusion of Biospace that the InBody AP1 BODY COMPOSITION ANALYZER as safe and effective as the predicate devices, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices.
2
Image /page/2/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 three overlapping birds in flight, with flowing lines suggesting movement or energy. The entire logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2003
Biospace Corporation Limited c/o Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
Re: K023478
Trade/Device Name: Biospace InBody, Model AP1, Body Composition Analyzer Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: February 11, 2003 Received: February 12, 2003
Dear Mr. 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, 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 (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.
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); 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.
3
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
j) Indications for Use
K023478 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Device Name: InBody AP1 BODY COMPOSITION ANALYZER
Indications for Use: For 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
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ OR Over the Counter Use_ (Per 21 CFR 801.109)
Nancy C Hogdon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .