PRECISION ONE LIFECARE; DETECTO; DETECTO

K130952 · Precision One Lifecare, Ltd. · MNW · Sep 26, 2013 · Cardiovascular

Device Facts

• Record ID: K130952
• Device Name: PRECISION ONE LIFECARE; DETECTO; DETECTO
• Applicant: Precision One Lifecare, Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Body fat percentage	Multiple regression algorithms	—	—	—	—	Comparative performance study: 70 participants (50 adults and 20 children)	—
Total body water percentage	Multiple regression algorithms	—	—	—	—	Comparative performance study: 70 participants (50 adults and 20 children)	—
Bone mass percentage	Multiple regression algorithms	—	—	—	—	Comparative performance study: 70 participants (50 adults and 20 children)	—
Muscle mass percentage	Multiple regression algorithms	—	—	—	—	Comparative performance study: 70 participants (50 adults and 20 children)	—

Indications for Use

The Precision One Lifecare and Detecto body fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only. Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults). Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old. Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only. The scales are not intended for diagnosis.

Device Story

Body fat scales utilize foot-to-foot bioelectrical impedance analysis (BIA) to estimate body composition. Device inputs include user-entered personal data (age, height, gender, weight) and electrical impedance measurements (current, voltage, phase angle) captured via stainless steel electrodes on the platform. A 90μA current is passed through the user's feet. An internal MCU processes these inputs using published regression algorithms to calculate body fat, water, muscle, and bone percentages, plus daily calorie recommendations. Used in home settings by consumers; output displayed on integrated LCD. Provides fitness assessment and tracking for up to 12 users. Benefits include non-invasive monitoring of body composition trends for health management.

Clinical Evidence

Bench testing only. Comparative performance study conducted with 70 participants (50 adults, 20 children) measuring parameters on both subject and predicate devices to validate algorithm outputs. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Single-frequency (50kHz) BIA analyzer. Materials: glass or stainless steel platform with 2 or 4 stainless steel electrodes. Power: 3V DC (AAA or Li CR2032 batteries). Connectivity: standalone. Software: multiple regression algorithms for body composition prediction. Dimensions/form factor: digital scale with LCD display.

Indications for Use

Indicated for healthy individuals aged 7-17 (body fat only) and 18-80 (body fat, water, muscle, bone, calorie intake) for body composition estimation. Children <7 and adults >80 restricted to weight measurement only. Not for diagnostic use.

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

• Tanita Model: SC331 - Body Composition Analyzer (K090479)

Submission Summary (Full Text)

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#### Section 5. . 510(k) Summary (21 CFR 807.92)

Date prepared: August 22, 2013

Submitter:

Precision One Lifecare Limited Flat 906, 9/F., Technology Plaza, 29-35 Sha Tsui Road Ysuen Wan, N.T., Hong Kong Contact Person: Jenny Chan Ph: 852 – 2735 5798 Fax: [phone] Email: [e-mail] Proprietary name: Precision One Lifecare and Detecto Body Fat scales Common name: Body fat scale Classified name: Body composition analyzer CFR 870.2770 Product code: MNW

Intended use:

The Precision One Lifecare and Detecto body fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only.

Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults).

Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old.

Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only.

The scales are not intended for diagnosis.

The specific model names and numbers for these scales are: Precision One Lifecare model numbers - 7853, 7840, 7841, 7850, 7851, and 7856. Detecto model numbers - D221, D222, D223, D212, D207, D201, D202, D203, D204, and D205

SEP 26 2013

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#### Substantial equivalence:

The Precision One Lifecare and Detecto Body Fat scales are substantially equivalent to: Tanita Model: SC331 - Body Composition Analyzer (K090479)

#### Models:

Precision One Lifecare

- Removable Remote Glass LCD Digital Body Fat/Body Composition: 7 in 1 Analysis, . Model 7853 (EF932)
- Glass LCD Digital Body Composition: 3 in 1 Analysis, Model 7840, 7841 (EF9621) .
- . LCD Digital Body Fat/Body Composition: 5 in 1 Analysis, Model 7850 (EF151)
- Glass LCD Digital Body Fat/Body Composition: 7 in 1 Analysis, Model 7851 (EF941) .
- Stainless Steel LCD Digital Body Fat/Body Composition: 5 in 1 Analysis, Model 7856 . (EF432)

Detecto

- . Glass LCD Digital Body Composition: 6 in 1 Analysis, Models D221 (EF971), D222 (EF972), D223 (EF973)
- Glass LCD Digital Body Composition: 6 in 1 Analysis, Model D212 (EF962) .
- . Wide Body Glass LCD Digital Body Fat/Body Composition: 7 in 1 Analysis, Model D207 (EF934)
- LCD Digital Body Fat/Body Composition: 7 in 1 Analysis, Model D201 (EF921/H) .
- Heavy Duty Glass LCD Digital Body Fat/Body Composition: 7 in 1 Analysis, Model . D202 (EF541)
- . Glass LCD Digital Body Fat/Body Composition: 5 in 1 Analysis, Model D203 (EF906)
- . Stainless Steel Body Composition: 5 in 1 Analysis, Model D204 (EF432)
- Wide Body Glass LCD Digital Body Fat/Body Composition: 7 in 1 Analysis, Model . D205 (EF922)

#### Device description

The following device description pertains to all models.

- The Body Fat scales use BIA (Bio Impedance Analysis) technology which passes an . electrical current through the body to estimate body fat percent, muscle percent, body water percent, and bone percent. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.
- . The devices are single frequency electrical bio-impedance analyzer. All models measure current, voltage and phase angle, calculate impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition of: body fat percent, body water percent, muscle mass percent, bone mass percent, daily calories intake recommendation, and provides a fitness assessment. All models have a bi-polar set of contact electrodes which are attached to stainless steel pads on the platform of the analyzer.

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- The scales can store the personal data of up to 12 users. As well as being an analyzer, . these devices can be used as a conventional scale. The models have one operating mode: Algorithm Mode.
- . Algorithm Mode; Displays estimates of body fat percent and body water percent. The devices compute these values using accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children.
- The devices consist of a main unit having a glass or stainless steel platform for the . user to step on. On the platform, 2 stainless steel electrodes are mounted which are connected to the electronics circuitry with the analyzing MCU. When the user steps on the electrodes (1 for each foot) a small current of about 90μA will pass through the user body through the 2 feet to complete the close circuitry in order for the analyzer to measure and capture the electrical data change in terms of Bio electrical impedance, resistance, reactance, taking into account other parameters as to personal data of Age, Height, Gender, and Weight.

Summary of technological characteristics compared to predicate devices The Body Fat scales and Tanita Model SC331 (K090479) are intended for use to measure weight, bioelectrical impedance, and estimate body composition (fat, muscle, bone and water) by BIA in a healthy individual.

The technology underlying BIA estimation for the Body Fat scales and Tanita Model SC-331 (K090479) is the same. Design considerations - software design, with LCD visual display, use of multiple regression algorithms to predict body composition based upon body weight, bioelectrical impedance measurements, energy source consideration, multi-polar surface electrodes, electrical current in 5 - to 50 kilohertz range at levels of 90 microamperes to 250 microamperes - are the same.

Comparison of these intended and technological characteristics demonstrate that Body Fat scales are substantially equivalent to the predicate device.

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| | Subject Device: | Predicate Device: |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Body Fat scales | Tanita Body Composition |
| Feature | | Analyser Model: SC-331 |
| 510(k) Number | | K090479 |
| Sponsor | Precision One Lifecare., Ltd. | Tanita Corporation |
| Weighing Technology | Strained Gauge Load Cell | Stained Gauge Load Cell |
| Weight Capacity | 150 kg / 330 lb<br>180 kg / 400 lb<br>200 kg / 440 lb | 270 kg / 600 lb |
| Device Description | Utilizes a "foot-to-foot"<br>bioelectrical impedance<br>analysis (BIA) technology to<br>determine internal body<br>composition. | Utilizes a "foot-to-foot"<br>bioelectrical impedance (BIA)<br>technology to determine<br>internal body composition. |
| Analysis Method | BIA<br>(Bioelectrical Impedance<br>Analysis) | BIA<br>(Bioelectrical Impedance<br>Analysis) |
| BMI Measurement | NA | Yes |
| Input Item: | | |
| Age Range | 7 - 99 years (1 yr increment | 5- 99 years (1 year Increment) |
| Gender | Male & Female | Male & Female |
| Height Range | 100-250 cm / 3.03 ft-7 ft<br>11.5" | 90 - 249.9 cm / 3 ft - 7 ft<br>11.5" |
| Operating Frequency Range | 50KHz | 50KHz |
| Power Source | 2*AAA (3 Volt DC)<br>1 or 2 Li CR2032 batteries (3<br>Volt DC) | AC - DC adaptor of<br>Input 100-240Vac 50/60 hz,<br>1.5 A converted to 7Volt DC<br>output to the device |
| Measuring current (A) | 90μA | 90μA |
| Contact Electrodes | Bi-polar | Tetra-polar |
| Measuring Impedance Range | 150 – 1200 Ω | 150 – 1200 Ω |
| Operating Keys | 3 or 4 keys<br>1 key: Setting & real time<br>clock<br>1 key: Alarm on/setting,<br>upward increase scrolling.<br>1 key: Weight Mode,<br>downward decrease scrolling<br>1 key: Memory recall<br>comparison mode. Start<br>mode for measuring Body<br>Composition. | 1 key for printer<br>1 key for clothing weight.<br>1 key for mode selection<br>between Body Composition &<br>Weight Only.<br>1 key for selection of lb or kg<br>1 key for setting date/time to<br>printer.<br>4 keys for setting Body Type:<br>Standard, Athlete, Male,<br>Female.<br>11 keys for numeric input<br>1 key for clear / cancel<br>Total 21 keys |
| Measuring/Weighing<br>Platform | Glass | Plastic |
| Number of Electrodes | 2 or 4 | 4 |

The following table provides a comparison of features to the predicate.

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#### Testing

The Body Fat Scales were tested by an independent laboratory for compliance to the requirements of IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). Test results showed compliance.

The performance of Body Fat Scales was compared to the performance of the predicate device through testing conducted by the sponsor. This testing consisted of 70 participants (50 adults and 20 children) standing on both the predicate scale and a Body Fat scale to obtain measureable parameters which are also used for algorithm calculations. This testing showed the two scales provide substantially equivalent results.

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 26, 2013

Precision One Lifecare, Ltd. % Steven Chernoff Vice President Drug & Device Development Co., Inc. P.O. Box 3515 Redmond. WA 98073

Re: K130952

Trade/Device Name: Precision One Lifecare and Detecto Body Fat scales Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 22, 2013 Received: August 26, 2013

Dear Steven Chernoff,

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 10 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.

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.

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Page 2 - Steven Chernoff

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/ucm 1 5809.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/Medicall.ovices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincercly yours.

## Herbert P. Lerner -S

Acting 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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#### Section 4 - Indications for Use Statement

#### Indications for Use

510(k) Number (if known):

Device Name: Precision One Lifecare and Detecto Body Fat scales

#### Indications for Use

The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BLA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only.

Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults). Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old.

Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only. The scales are not intended for diagnosis.

The specific model names and numbers for these scales are: Precision One Lifecare model numbers - 7853, 7840, 7841, 7850, 7851, and 7856. Detecto model numbers - D221, D222, D223, D212, D207, D201, D202, D203, D204, and D205

| Prescription Use |
|-----------------------------|
| (Part 21 CFR 801 Subpart D) |

Over-The-Counter Use AND/OR ਮ (Part 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)

# Herbert P. Lerner -S