(126 days)
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
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.
The provided text is a 510(k) Summary for a medical device called "SLIMMANAGER, Body composition analyzer (Models: N40, SM-300)". It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance data in a format typically found in clinical trials.
Therefore, the requested information elements related to specific acceptance criteria, test set details (sample size, data provenance, expert involvement, adjudication), multi-reader multi-case studies, standalone performance, and training set details are not explicitly available within the provided text.
The document states that "The results of bench and clinical testing indicates that the new device is as safe and effective as the predicate devices." and later, "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."
This indicates that a study was conducted, and its results led to the conclusion of substantial equivalence. However, the specific acceptance criteria, method, and results of that study are not detailed in this summary.
Here's a breakdown of what can be inferred or is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided. The document states that "bench and clinical testing indicates that the new device is as safe and effective as the predicate devices," implying an comparison was made, but the specific metrics, thresholds, or performance values are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly provided. The document mentions "clinical testing data" but does not specify the sample size, data provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not explicitly provided. For a body composition analyzer using Bioelectrical Impedance Analysis (BIA), ground truth would typically be established against a gold standard method (e.g., DEXA or underwater weighing), not by expert consensus interpreting images. The document does not describe how ground truth was established, nor does it mention any expert involvement for this purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not explicitly provided. As expert consensus is not the stated method for ground truth, an adjudication method isn't relevant in the typical sense.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a standalone body composition analyzer, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The device itself is what is being evaluated for its "safe and effective" performance in comparison to predicate devices, indicating a standalone evaluation of its measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but implied to be a comparison to predicate devices. The document states "as safe and effective as the predicate devices." In BIA studies, "ground truth" for body composition parameters is typically established using established gold-standard methods (e.g., DEXA, underwater weighing, or multi-compartment models). The 510(k) summary doesn't specify which "ground truth" was used in their clinical testing. It primarily focuses on equivalence to other BIA devices.
8. The sample size for the training set
- Not applicable/Not explicitly provided. While the device uses Bioelectrical Impedance Analysis (BIA), which can involve algorithms, the summary doesn't describe a machine-learning-based "training set" in the context of AI. BIA devices typically use established physiological models and equations.
9. How the ground truth for the training set was established
- Not applicable/Not explicitly provided. See point 8.
Summary of available information regarding the study:
- Device: SLIMMANAGER, Body composition analyzer (Models N40, SM-300)
- Purpose of Study (as described): To demonstrate that the new device is as safe and effective as the predicate devices (Biospace InBody 230 K062603; AIIA communication Inc. SLIMMANAGER (SM-X, SM-E) K051589).
- Methodology: Bench and clinical testing was performed.
- Conclusion: The device is substantially equivalent to the predicate devices.
- Measured Parameters (Indications for Use): 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.
To fully answer your questions, one would need to refer to the detailed clinical study report that was submitted as part of the 510(k) application, which is not included in this summary.
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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.
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-
- Substantial Equivalence Chart, SLIMMANAGER, Body composition analyzer (Models: N40, SM-300).
| Company | Biospace | AIIA communicationInc. | AIIA communicationInc. | AIIAcommunication Inc. | AIIAcommunication Inc. |
|---|---|---|---|---|---|
| Model | InBody 230 | SLIMMANAGER(SM-X,SM-E) | SLIMMANAGER(N40) | SLIMMANAGER(SM-300) | |
| 510(k)no. | K062603 | K051589 | New | New | |
| Method | BioelectricalImpedanceAnalysis | Bioelectrical ImpedanceAnalysis | BioelectricalImpedance Analysis | BioelectricalImpedance Analysis | |
| Electrode | 8 electrodes | 8 electrodes | 8 electrodes | 8 electrodes | |
| Type | tactile | tactile | tactile | tactile | |
| IntendedUse | Estimated :ECW, ICW, TBWECW/TBWBody FatBody Lean +Dry LeanMetabolic RatesSegmental Lean MassSkeletal Muscle MassActual :WeightBMIImpedance Values | Estimated :ECW, ICW, TBWECW/TBWBody FatBody Lean +Dry LeanMetabolic RatesSegmental Lean MassActual :WeightBMIImpedance Values | Estimated :ECW, ICW, TBWECW/TBWBody FatBody Lean +Dry LeanMetabolic RatesSegmental Lean MassSkeletal Muscle MassActual :WeightBMIImpedance Values | Estimated :ECW, ICW, TBWECW/TBWBody FatBody Lean +Dry LeanMetabolic RatesSegmental Lean MassActual :WeightBMIImpedance Values | |
| Frequency | 20, 100KHz | 5, 50, 250, 500KHz | 500Hz, 50, 500KHz | 50KHz | |
| Measuringscope | 10 ~ 250 kg | 1 ~ 250 kg | 1 ~ 200 kg | 1 ~ 150 kg | |
| Position | Upright | Upright | Upright | Upright | |
| Display | 240x320 STN LCD | 1024x768Color TFTTouchScreen LCD | 640x480 Color TFTTouch Screen LCD | PC interface | |
| Power | AC100 | AC100 | AC100 | AC100 |
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 (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
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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
Page 1 of 1
§ 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.