(258 days)
Not Found
No
The description details a calculation based on fixed variables (electrical impedance, height, weight, age, gender) using internal software, without mentioning any adaptive or learning algorithms characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is intended for measurement and estimation of body composition, not for treating or alleviating a medical condition.
No
This device is designed to measure body weight and estimate body composition (body fat, water, muscle, bone mass) using bioelectrical impedance analysis, which is a measurement function rather than a diagnostic one. While it provides data related to body health, it does not diagnose diseases or conditions.
No
The device description clearly states it is a "scale device" with "two electrodes" that the patient steps on, indicating it includes hardware components for measurement. While it uses internal software for calculation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Shine Overseas Marketing Limited Weight & Body Fat Monitoring Scale measures body composition (weight, fat, water, muscle, bone) by passing a small electrical current through the body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to measure body composition in generally healthy adults, not to diagnose or monitor diseases based on analysis of bodily fluids or tissues.
Therefore, this device falls under the category of a general wellness device or a medical device that measures physiological parameters directly from the body, but not an IVD.
N/A
Intended Use / Indications for Use
The Shine Overseas Marketing Limited Weight & Body Fat Monitoring Scale, Model BS0105 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass and bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults (from ages 18-80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
Product codes
MNW
Device Description
The patient steps on the scale device, where two electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Shine Overseas Marketing Limited Weight and Body Fat Scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance. height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
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 ages 18 to 80
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)
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
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
APR - 9 2012
17149
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 3, 2011
- Company and Correspondent making the submission:
Name – Shine Overseas Marketing Limited
Address – Unit 1, 14/F., Yue Xiu Building, 160-174 Lockhart Road, Wanchai, Hong Kong, China
Telephone – +86-755-8618 2000
Fax - +86-755-8618 2500
Contact - Jacky Lee
Email - charliemack@irc-us.com
- Device :
Trade/proprietary name: Shine Overseas Marketing Limited; Weight and Body Fat
Scale, SHINE BS0105
| Common Name | : Analyzer, Body Fat |
|---|---|
| ------------- | ---------------------- |
Classification Name : Impedance plethysmograph
- Predicate Devices :
Tanita BC-533, (K040778)
4. Classifications Names & Citations :
21CFR 870.2770, MNW, Body Fat Analyzer, Class 2
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5. Description :
5.1 General
The patient steps on the scale device, where two electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Shine Overseas Marketing Limited Weight and Body Fat Scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance. height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
5.2 Direction
As discussed in the General description, the Shine Overseas Marketing Limited Weight and Body Fat Scale is relatively simple to use. The user inputs the variable data of age, height, and gender. The user steps onto the scale and the devices measures the user weight and body impedance (via the Bioelectric lmpedance through the two electrodes on the scale). The scale displays the user's body fat composition. Upon the user's selection, the device can also display the user's weight.
- Indication for use :
The Shine Overseas Marketing Limited Weight & Body Fat Monitoring Scale, Model BS0105 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass and bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults (from ages 18 to 80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy.
2
-
- Comparison with predicate device :
Shine Overseas Marketing Limited believes that the Shine Overseas Marketing Limited Weight and Body Fat Scale is substantially equivalent to the Tanita BC-533 (K040778).
- Comparison with predicate device :
8. Safety and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification TH Leaguer. Inc. concludes that The Shine Overseas Marketing Limited Weight and Body Fat Scale is safe and effective and substantially equivalent to predicate devices as described herein.
END
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SHINE OVERSEAS MARKETING LIMITED % Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way ECHO OR 97826
APR - 9 2012
Re: K112149
Trade/Device Name: Weight & Body Fat Monitoring Scale, Model BS0105 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: March 26, 2012 Received: April 4, 2012
Dear Mr. Mack:
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. 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toure of a now a a determination that your device complies with other requirements of the Act that I D. I has intestant as and regulations administered by other Federal agencies. You must of any Federal statutes and sognements, including, but not limited to: registration and listing . eonlipy will and the 110 b ag (21 CFR Part 801); medical device reporting (reporting of medical
4
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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Ticho
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
5
Indications for Use
510(k) Number (if known):
Device Name: Weight & Body Fat Monitoring Scale, Model BS0105
Indications for Use:
The Shine Overseas Marketing Limited Weight & Body Fat Monitoring Scale, Model BS0105 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass and bones mass using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults (from ages 18-80) who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level
of hydration such as pregnancy.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K112149 |
| Page | of |
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