(126 days)
Not Found
No
The description focuses on Bioelectrical Impedance Analysis (BIA) technology and data transmission/storage, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is described as a body composition analyzer for measurement in healthy subjects, providing analytical information rather than therapeutic intervention.
No
The device is a body composition analyzer that measures physical parameters like body fat, lean mass, and water content. It is not indicated for diagnosing diseases or medical conditions.
No
The device description explicitly states that SLIMMANAGER uses Bioelectrical Impedance Analysis technology and sends an electric current through the body, indicating the presence of hardware components for measurement. It also mentions specific models (N-40 and SM-300) with hardware descriptions (Linux system with touch monitor, interfaced with customer's PC).
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 SLIMMANAGER uses Bioelectrical Impedance Analysis (BIA) to measure body composition parameters like body fat, lean mass, and water content. This is done by sending a weak electric current through the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is for "Measurement in healthy subjects of: Estimated : ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass; Actual: Weight, BMI, Impedance Values". This is a measurement of physical characteristics, not a diagnostic test on a biological sample.
Therefore, the SLIMMANAGER falls under the category of a non-IVD medical device used for body composition analysis.
N/A
Intended Use / Indications for Use
For Measurement in healthy subjects of: Estimated : ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass; Actual: Weight, BMI, Impedance Values
Product codes (comma separated list FDA assigned to the subject device)
MNW
Device Description
SLIMMANAGER is a body composition analyzer and uses Bioelectrical Impedance Analysis technology to determine body composition parameters. Using a principle that an electric current has a low impedance when it flows in muscle or cellular fluids containing lots of water while it has a high impedance such as in fat and bone tissues slowing and stopping an applied current, BIA sends an extremely weak electric current through the body and detects the relative response after it flows our body's various substances, and then it can determines lean tissue, fat, water mass. All measurements made by SLIMMANAGER can be recorded & saved in the website real-time by the Internet transmission as well in the device, and in his own page people could check their changing progress even a minute change without an expert's advice at anywhere, at anytime. N-40 is designed by Linux system with touch monitor, while SM-300 should be interfaced with customer's PC.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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MAR 2 0 2008
510(k) Summary K073227 AIIA Communication Inc. Geumwon building, #714-1, Bokjung-dong, Sujung-gu, Sungnam-si, Gyunggi-do. Korea Tel : +82-31-751-3697 Fax : +82-31-751-2648 Homepage : http://www.aiia.co.kr March 10, 2007 Contact: Ho Lee, R&D Manager
-
- Identification of the Device: Proprietary-Trade Name: SLIMMANAGER, Body composition analyzer (Models: N40, SM-300). Classification Names: 74 MNW ANALYZER, BODY COMPOSITION Common/Usual Name: Body composition analyzer
- Equivalent legally marketed devices Biospace InBody 230 K062603; AIIA communication ni Inc. SLIMMANAGER(SM-X, SM-E) K051589
-
- Indications for Use (intended use) (Models SM-300 and N40) For Measurement in healthy subjects of: Estimated : ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass; Actual: Weight, BMI, Impedance Values
-
- Description of the Device: SLIMMANAGER is a body composition analyzer and uses Bioelectrical Impedance Analysis technology to determine body composition parameters. Using a principle that an electric current has a low impedance when it flows in muscle or cellular fluids containing lots of water while it has a high impedance such as in fat and bone tissues slowing and stopping an applied current, BIA sends an extremely weak electric current through the body and detects the relative response after it flows our body's various substances, and then it can determines lean tissue, fat, water mass. All measurements made by SLIMMANAGER can be recorded & saved in the website real-time by the Internet transmission as well in the device, and in his own page people could check their changing progress even a minute change without an expert's advice at anywhere, at anytime. N-40 is designed by Linux system with touch monitor, while SM-300 should be interfaced with customer's PC.
-
- 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
Image /page/1/Picture/0 description: The image shows the text "K073227 PAGE 2 OF 2". The text appears to be handwritten. The numbers are slightly distorted, but still legible.
-
- Substantial Equivalence Chart, SLIMMANAGER, Body composition analyzer (Models: N40, SM-300).
| Company | Biospace | AIIA communication
Inc. | AIIA communication
Inc. | AIIA
communication Inc. | AIIA
communication Inc. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Model | InBody 230 | SLIMMANAGER(SM-X,
SM-E) | SLIMMANAGER(N40) | SLIMMANAGER(SM-
300) | |
| 510(k)
no. | K062603 | K051589 | New | New | |
| Method | Bioelectrical
Impedance
Analysis | Bioelectrical Impedance
Analysis | Bioelectrical
Impedance Analysis | Bioelectrical
Impedance Analysis | |
| Electrode | 8 electrodes | 8 electrodes | 8 electrodes | 8 electrodes | |
| Type | tactile | tactile | tactile | tactile | |
| Intended
Use | Estimated :
ECW, ICW, TBW
ECW/TBW
Body Fat
Body Lean +Dry Lean
Metabolic Rates
Segmental Lean Mass
Skeletal Muscle Mass
Actual :
Weight
BMI
Impedance Values | Estimated :
ECW, ICW, TBW
ECW/TBW
Body Fat
Body Lean +Dry Lean
Metabolic Rates
Segmental Lean Mass
Actual :
Weight
BMI
Impedance Values | Estimated :
ECW, ICW, TBW
ECW/TBW
Body Fat
Body Lean +Dry Lean
Metabolic Rates
Segmental Lean Mass
Skeletal Muscle Mass
Actual :
Weight
BMI
Impedance Values | Estimated :
ECW, ICW, TBW
ECW/TBW
Body Fat
Body Lean +Dry Lean
Metabolic Rates
Segmental Lean Mass
Actual :
Weight
BMI
Impedance Values | |
| Frequency | 20, 100KHz | 5, 50, 250, 500KHz | 500Hz, 50, 500KHz | 50KHz | |
| Measuring
scope | 10 ~ 250 kg | 1 ~ 250 kg | 1 ~ 200 kg | 1 ~ 150 kg | |
| Position | Upright | Upright | Upright | Upright | |
| Display | 240x320 STN LCD | 1024x768
Color TFT
Touch
Screen LCD | 640x480 Color TFT
Touch Screen LCD | PC interface | |
| Power | AC100120/200240V | AC100120/200240V | AC100120/200240V | AC100120/200240V | |
7. Conclusion
After analyzing both bench and clinical testing data, it is the conclusion of AIIA Communication Inc.that the SLIMMANAGER, Body composition analyzer (Models: N40, SM-300). 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAR 2 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AIIA Communication Inc. c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 DEERFIELD IL 60015
K073227 Re:
Trade/Device Name: SLIMMANAGER, Body composition analyzer (Models N40, SM-300) Regulation Number: 21 CFR §870.2770. Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: March 10, 2008 Received: March 13, 2008
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. Iisting 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 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.
3
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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073227
Device Name: SLIMMANAGER, Body composition analyzer (Models N40, SM-300)
Indications For Use: For Measurement in healthy subjects of:
Estimated : ECW, ICW, TBW, ECW/TBW, Body Fat, Body Lean +Dry Lean Metabolic Rates, Segmental Lean Mass. Model N40 adds: Skeletal Muscle Mass Actual : Weight, BMI, 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)
Divided Sine Corp.
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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