(269 days)
No
The summary describes a device that uses Bioelectrical Impedance Analysis (BIA) and standard calculations to estimate body composition. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance studies compare the device's measurements and estimations to predicate and reference devices using established methods, not AI/ML-based approaches.
No
The device measures and estimates various body composition parameters. It is intended for monitoring growth and weight changes, and estimating body composition, not for treating or preventing any disease or condition.
No.
The device measures body weight, height, BMI, REE, TEE, and estimates body composition parameters (e.g., TBW, FFM, FM). These measurements describe physiological states and body components but are not used to diagnose a specific disease or condition.
No
The device description explicitly states it is a "scale and impedance plethysmograph body composition analyzer" and measures bioelectrical impedance values, indicating it is a hardware device with integrated software. The optional PC software accessory is for data management, not the primary medical device function.
Based on the provided information, the seca mBCA 514 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- seca mBCA 514 Function: The seca mBCA 514 measures physical characteristics of the body directly (weight, height, impedance) and uses these measurements to estimate body composition. It does not analyze specimens taken from the body.
The device is a body composition analyzer that uses bioelectrical impedance analysis (BIA), which is a non-invasive method applied to the body itself, not to a sample taken from the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MNW
Device Description
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, segmental measurements (right arm, trunk, right leg, left leg, right body side and left body side).
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
"individuals of all ages" for weight, height, BMI, REE, TEE monitoring.
"healthy individuals aged 18 years and older" for body composition estimation.
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 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.
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.
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.
0
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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 +49 40 20 00 00 - 259 +40 40 20 00 00 - 3259 djavaneh.blalaie@seca.com
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,
1
| 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.
2
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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.
3
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 (800) 638-2041 or (301) 796-7100 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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Herbert - S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K122388 510(k) Number