SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300

K073227 · Aiia Communication, Inc. · MNW · Mar 20, 2008 · Cardiovascular

Device Facts

• Record ID: K073227
• Device Name: SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
• Applicant: Aiia Communication, Inc.
• Product Code: MNW · Cardiovascular
• Decision Date: Mar 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

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

Device Story

SLIMMANAGER (Models N40, SM-300) is a body composition analyzer using Bioelectrical Impedance Analysis (BIA). Device sends weak electric current through body; detects impedance response based on water content in muscle/cellular fluids versus fat/bone tissues. Transforms impedance data into estimates of lean tissue, fat, and water mass. N40 features integrated Linux system with touch monitor; SM-300 interfaces with external PC. Used by individuals for self-monitoring; measurements saved locally or transmitted via Internet to personal web page for progress tracking without expert intervention. Output provides users with body composition metrics to monitor health changes over time.

Clinical Evidence

Bench and clinical testing performed. Results indicate device is as safe and effective as predicate devices. No specific clinical trial metrics (e.g., sensitivity, specificity) provided in summary.

Technological Characteristics

BIA technology; 8-electrode tactile configuration. N40: Linux-based with touch monitor. SM-300: PC-interfaced. Power: AC100-120/200-240V. Connectivity: Internet transmission for web-based data storage. Measuring scope: 1-200kg (N40), 1-150kg (SM-300).

Indications for Use

Indicated for measurement of body composition parameters in healthy subjects. Parameters include ECW, ICW, TBW, ECW/TBW, body fat, body lean, dry lean, metabolic rates, segmental lean mass, and (for N40) skeletal muscle mass, weight, BMI, and impedance values.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Biospace InBody 230 (K062603)
• AIIA communication Inc. SLIMMANAGER(SM-X, SM-E) (K051589)

Submission Summary (Full Text)

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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 : [phone] Fax : [phone] Homepage : http://www.aiia.co.kr March 10, 2007 Contact: Ho Lee, R&D Manager

- 1. 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
- 3. 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
- 4. 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.
- 5. 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.

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- 6. Substantial Equivalence Chart, SLIMMANAGER, Body composition analyzer (Models: N40, SM-300).

| Company | Biospace | AIIA communication<br>Inc. | AIIA communication<br>Inc. | AIIA<br>communication Inc. | AIIA<br>communication Inc. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Model | InBody 230 | SLIMMANAGER(SM-X,<br>SM-E) | SLIMMANAGER(N40) | SLIMMANAGER(SM-<br>300) | |
| 510(k)<br>no. | K062603 | K051589 | New | New | |
| Method | Bioelectrical<br>Impedance<br>Analysis | Bioelectrical Impedance<br>Analysis | Bioelectrical<br>Impedance Analysis | Bioelectrical<br>Impedance Analysis | |
| Electrode | 8 electrodes | 8 electrodes | 8 electrodes | 8 electrodes | |
| Type | tactile | tactile | tactile | tactile | |
| Intended<br>Use | Estimated :<br>ECW, ICW, TBW<br>ECW/TBW<br>Body Fat<br>Body Lean +Dry Lean<br>Metabolic Rates<br>Segmental Lean Mass<br>Skeletal Muscle Mass<br>Actual :<br>Weight<br>BMI<br>Impedance Values | Estimated :<br>ECW, ICW, TBW<br>ECW/TBW<br>Body Fat<br>Body Lean +Dry Lean<br>Metabolic Rates<br>Segmental Lean Mass<br>Actual :<br>Weight<br>BMI<br>Impedance Values | Estimated :<br>ECW, ICW, TBW<br>ECW/TBW<br>Body Fat<br>Body Lean +Dry Lean<br>Metabolic Rates<br>Segmental Lean Mass<br>Skeletal Muscle Mass<br>Actual :<br>Weight<br>BMI<br>Impedance Values | Estimated :<br>ECW, ICW, TBW<br>ECW/TBW<br>Body Fat<br>Body Lean +Dry Lean<br>Metabolic Rates<br>Segmental Lean Mass<br>Actual :<br>Weight<br>BMI<br>Impedance Values | |
| Frequency | 20, 100KHz | 5, 50, 250, 500KHz | 500Hz, 50, 500KHz | 50KHz | |
| Measuring<br>scope | 10 ~ 250 kg | 1 ~ 250 kg | 1 ~ 200 kg | 1 ~ 150 kg | |
| Position | Upright | Upright | Upright | Upright | |
| Display | 240x320 STN LCD | 1024x768<br>Color TFT<br>Touch<br>Screen LCD | 640x480 Color TFT<br>Touch Screen LCD | PC interface | |
| Power | AC100~120/200~240V | AC100~120/200~240V | AC100~120/200~240V | AC100~120/200~240V | |

## 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.

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## 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.

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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 [phone] or [phone] 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

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## 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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