OHMNISCAN NG

K073334 · Christine Valmy, Inc. · MNW · Aug 22, 2008 · Cardiovascular

Device Facts

• Record ID: K073334
• Device Name: OHMNISCAN NG
• Applicant: Christine Valmy, Inc.
• Product Code: MNW · Cardiovascular
• Decision Date: Aug 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The main intended uses of Ohmniscan NG is to deduce: - . Impedance(Z in ohms) - Total body water(TBW in L and in %) . - . Lean Mass(LM in KG) - . Fat Mass(FM in KG and %) - . Basal Metabolism(Kcal) - Daily energy needs(Kcal) . - . B.M.I.(Basal Mass Index).

Device Story

Ohmniscan NG is a portable bioimpedance analyzer for body composition assessment. Device applies low-intensity 50 KHz alternating current via four-polar method to measure body resistance/impedance. Inputs include user demographic data (age, sex, height, weight, activity level). Device calculates body composition metrics (TBW, lean mass, fat mass, basal metabolism, daily energy needs, BMI). Used in clinical or wellness settings for initial assessment and treatment monitoring; allows tracking of fat loss. Stores up to 100 customer records with multiple measurements for comparison. Includes pen, connection wires, electrodes, and integrated printer for result tickets. Provides objective data to healthcare providers or users to motivate and monitor health/fitness progress.

Clinical Evidence

No clinical data provided; substantial equivalence is based on identical technological characteristics and intended use to the predicate device.

Technological Characteristics

Portable bioimpedance analyzer; four-polar measurement method; 50 KHz alternating current; includes electrodes, connection wires, and integrated printer. Device stores up to 100 customer records.

Indications for Use

Indicated for healthy adults (18-65) with no known disease or condition to estimate impedance, total body water, lean mass, fat mass, basal metabolism, daily energy needs, and BMI.

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

• Bodystat Ltd. (K002835)

Submission Summary (Full Text)

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# 510K Summary

Date: 11/14/2007

#### Multiwell

AUG 22 2008

Zi du grand pont 13640 La Roque D'Antheron France Tel :[phone] Fax:[phone]

Contact Person: Mr. Philippe Dijol

## Sec 5.1 – Summary Information

| Submission Correspondent: | Christine Valmy Inc. |
|---------------------------|-----------------------------------------------|
| Address: | 285 Changebridge Road<br>Pine Brook, NJ 07058 |
| Phone: | 973-575-1050 |
| Fax: | 973-227-5646 |
| Contact: | Mr. Peter de Haydu |
| Submission Sponsor: | Multiwell machines |
| Date Prepared: | 11/14/2007 |
| Trade Name: | Ohmniscan NG |
| Common Name: | Analyzer, Body Composition |
| Classification: | Class II |
| Panel: | Cardiovascular |
| Regulation #: | 870.2770 |
| Product Code: | MNW |

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# K073334 PAGE 2 OF 3

# Sec 5.2- Device Description:

Ohmniscan NG is a high performance portable bioimpedance measuring device that enables evaluation of daily energy needs, fat mass (in % of total weight and in kg), lean mass (in kg) hydric condition (in % of total weight and in kg), body mass index, using a painless micro current technique.

It is used for the initial assessment and for treatment monitoring. Regular check allows fat loss to be monitored and the results are used as a highly motivational tool.

Ohmniscan NG releases a very low intensity alternating current at a 50 KHz frequency, by applying the four polar methods to measure the body resistance. This measurement determines the client's impedance.

Ohmniscan NG enables the creation of 100 customer cards with upto 8 measurements of the customer, their records, the interpretations, and the comparison between 2 measurements of the same client. It enables the creation of a customer file with surname, first name, sex, race, age, height, weight, activity, date of measurement, interpretation, and comparisons. Its fast measuring function allows calculations to be made in a minimum amount of time and they can be interpreted later. The unit comes complete with pen, connection wires and electrodes. The device is delivered with printer for ticket results.

## Sec 5.3-Intended Use

The main intended uses of Ohmniscan NG is to deduce:

- . Impedance(Z in ohms)
- Total body water(TBW in L and in %) .
- . Lean Mass(LM in KG)
- . Fat Mass(FM in KG and %)
- . Basal Metabolism(Kcal)
- Daily energy needs(Kcal) .
- . B.M.I.(Basal Mass Index).

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# +073334 3 OF 3

#### Sec 5.4- Predicate Devices

The predicate device referenced in this submission is:

Bodystat Ltd. Po Box 50. Douglas Isle Of Man British Isles, BR IM99 1 DQ Bodystat K 002835

## Sec 5.5- Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

Besides the point that Ohmniscan NG comes with the printer for ticket results, there are no differences between the Multiwell Machine, Ohmniscan NG and the predicate device specifications, and therefore no new issues are raised regarding safety and effectiveness. There are no differences in the technological characteristics or in the intended use of these devices.

The Ohmniscan NG device is identical to the predicate device, and therefore we have determined this device to be substantially equivalent to the referenced predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the department's services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### AUG 22 2008

Mr. Peter de Haydu President Christine Valmy, Inc. 285 Change Bridge Road PINE BROOK NJ 07058

K073334 Rc:

> Trade/Device Name: Ohmniscan NG Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: II Product Code: MNW Dated: August 19, 2008 Received: August 20, 2008

Dear Mr. Haydu:

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.

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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K073334

#### Ohmniscan NG

#### Indication for use:

Ohmnsiscan NG is a non prescription device and is used on healthy subjects with no known disease or condition, and is identified as used for generally healthy adults (18-65). It is used to estimate the following:

- Impedance(Z in ohms) .
- Total body water (TBW in L and in %) .
- Lean Mass(LM in KG) .
- Fat Mass (FM in KG and %) .
- Basal Metabolism(Kcal) .
- Daily energy needs(Kcal) ●
- B.M.I. (Body Mass Index). .

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use _X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

ivision of Reproductive. Abdominal and Radiological Devic

Radiological Devices
510(k) Number K013334

Indication for Use

Ohmniscan NG