SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514

K122388 · Seca GmbH & Co. KG · MNW · May 2, 2013 · Cardiovascular

Device Facts

• Record ID: K122388
• Device Name: SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
• Applicant: Seca GmbH & Co. KG
• Product Code: MNW · Cardiovascular
• Decision Date: May 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The seca mBCA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages. In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (FFM), Fat Mass (FM), Fat Mass Indices (FMI and FMMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis (BIVA), Energy stored in body (Ebody) and Phase Angle (Φ). The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca analytics 115 for data management, calculations and display of information.

Device Story

Scale and impedance plethysmograph; measures body weight and height; performs multi-frequency segmental bioelectrical impedance analysis (BIA) (right arm, trunk, right leg, left leg, right/left body sides). Inputs: weight, height, bioelectrical impedance (resistance, reactance). Outputs: BMI, REE, TEE, and body composition metrics (TBW, ICW, ECW, LST, FFM, FM, FMI, FMMI, SMM, BIVA, Ebody, Phase Angle). Used in clinical settings; operated by healthcare professionals or patients. Optional seca analytics 115 PC software provides data management, calculations, and display. Output assists clinicians in monitoring growth, weight changes, and body composition status.

Clinical Evidence

Bench and clinical testing performed. Impedance and weight measurements compared to InBody 720. TBW compared to deuterium oxide dilution; ECW compared to sodium bromide dilution; LST compared to GE Lunar iDXA. FFM estimated via four-compartment model incorporating DXA, BOD POD, and deuterium oxide dilution. No specific sensitivity/specificity metrics provided.

Technological Characteristics

Multi-frequency segmental bioelectrical impedance analyzer. Measures resistance, reactance, and phase angle. Integrates weight scale and height recording. Optional connectivity to PC software (seca analytics 115).

Indications for Use

Indicated for individuals of all ages to monitor growth and weight changes via BMI, REE, and TEE. For healthy individuals aged 18+, indicated for estimation of body composition parameters including TBW, ICW, ECW, LST, FFM, FM, FMI, FMMI, SMM, BIVA, Ebody, and Phase Angle.

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 720 (K052646)

Reference Devices

• GE Lunar iDXA Bone Densitometer (K052581)
• BOD POD Sonamet Body Composition Analyzer (K060848)

Submission Summary (Full Text)

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| seca medical Body Composition Analyzer 514 | 510(k) Summary - section 05 |
|--------------------------------------------|-----------------------------|
| 510(k) Premarket Notification - K122388 | page 1 of 2 |

2 2013 MAY

#### Submitter Information 1

Owner: Address:

Internet:

Contact:

E-mail:

seca gmbh & co. kg. Hammer Steindamm 9 - 25 22089 Hamburg Germany www.seca.com

Djavaneh Blalaie - Quality Management [phone] - 259 [phone] - 3259 [e-mail]

Date prepared:

Telephone Number: FAX Number:

April 22, 2013

# 2 Device Name

Common Device Name: Trade names:

Device Class: Classification Code: Regulation number:

Body Composition Analyzer seca medical Body Composition Analyzer 514, seca mBCA 514, seca mBCA, seca 514 Class II MNW - Analyzer, Body Composition 21 CFR 870.2770

#### Predicate Device 0

### BioSpace InBody 720

Common Device Name: Trade names: Device Class: Classification Code: Regulation number: 510(k) number:

Body fat meter Biospace Body Composition Analyzer, Model Inbody 720 Class II MNW - Analyzer, Body Composition 21 CFR 870.2770 K052646

#### Device Description র্ব

The seca mBCA 514 is a scale and impedance plethysmograph body composition analyzer for estimation of the body composition of individuals based on the Bioelectrical Impedance Analysis (BIA). The device measures bioelectrical impedance values by means of multi frequency,

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| seca medical Body Composition Analyzer 514 | 510(k) Summary - section 05 |
|--------------------------------------------|-----------------------------|
| 510(k) Premarket Notification - K122388 | page 2 of 2 |

segmental measurements (right arm, trunk, right leg, left leg, right body side and left body side).

# 5 Intended Use

The seca mBCA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages.

In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (FFM), Fat Mass (FM), Fat Mass Indices (FMI and FMMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis (BIVA), Energy stored in body (Ebody) and Phase Angle (Φ).

The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca analytics 115 for data management, calculations and display of information.

# 6 Safety and Effectiveness Comparison

The results of bench and clinical testing demonstrate that the seca mBCA 514 is as safe and effective as the predicate device. Impedance raw data measurements (Impedance. Resistance, Reactance, and Phase Angle) and measurements of Weight were compared against measurements made by the Biospace InBody 720 (K052646). Estimation of Total Body Water (TBW) was compared against the deuterium oxide dilution method. Estimation of Extra Cellular Water (ECW) was compared against the sodium bromide dilution method. Estimation of Lean Soft Tissue (LST) was compared against measurements obtained from the GE Lunar iDXA Bone Densitometer (K052581). Fat-Free Mass (FFM) was estimated by applying the four compartment model, which incorporates measurements from the GE Lunar iDXA Bone Densitometer (K052581), the BOD POD Sonamet Body Composition Analyzer (K060848), and the deuterium oxide dilution method.

# 7 Conclusion

The differences with the predicate devices and methods are sufficiently minor to establish substantial equivalence, and do not impact the safety or the effectiveness of the device when used as labeled.

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2013

seca gmbh & co. kg % Mr. Seth A. Mailhot Special Counsel Sheppard Mullin Richter & Hampton LLP 13001 Street, NW. 11th Floor East WASHINGTON DC 20005-3314

Re: K122388

Trade/Device Name: seca mBCA 514 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: April 24, 2013 Received: April 25, 2013

Dear Mr. Mailhot:

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.

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Page 2 - Mr. Seth A. Mailhot

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); medical device reporting (reporting of medical 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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

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### Indications for Use

## 510(k) Number (if known): K122388

Device Name: seca mBCA 514

### Intended Use:

The seca mBCA 514 measures body Weight and records body Height for calculation of Body Mass Index (BMI), Resting Energy Expenditure (REE) and Total Energy Expenditure (TEE) to monitor growth process and weight changes in individuals of all ages.

In healthy individuals aged 18 years and older the device also measures body impedance (Reactance Xc and Resistance R) for estimation of body composition. Estimation of body composition includes Total Body Water (TBW), Intra Cellular Water (ICW), Extra Cellular Water (ECW), Lean Soft Tissue (LST), Fat-Free Mass (FFM), Fat Mass (FM), Fat Mass Indices (FMI and FMMI), Skeletal Muscle Mass (SMM), Bioelectrical Impedance Vector Analysis (BIVA), Energy stored in body (Ebody) and Phase Angle (Φ).

The seca mBCA 514 can be used in conjunction with the optional PC software accessory seca analytics 115 for data management, calculations and display of information.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Herbert - S

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122388 510(k) Number