(268 days)
K 002835
K 002835
No
The summary describes a bioimpedance device that uses a micro current technique to measure body composition. It mentions calculations and data storage but does not include any terms or descriptions indicative of AI or ML technology being used for analysis or interpretation.
No
The device is used for estimation, assessment and monitoring of body composition parameters, and results are used as a motivational tool, but it does not claim to treat, prevent, or mitigate any disease or condition.
No
The device is described as a "non prescription device" used on "healthy subjects with no known disease or condition" to "estimate" various body composition parameters. It is explicitly stated that it is used for "initial assessment and for treatment monitoring," but the context of "treatment" is further qualified by the phrase "fat loss to be monitored" and "highly motivational tool," which implies wellness or fitness tracking rather than medical diagnosis of a disease or condition. Diagnostic devices are typically used to identify or characterize diseases or medical conditions.
No
The device description explicitly states it is a "high performance portable bioimpedance measuring device" that "releases a very low intensity alternating current" and "comes complete with pen, connection wires and electrodes." This indicates it includes hardware components for measurement, not just software.
Based on the provided information, the Ohmniscan NG is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Ohmniscan NG measures electrical impedance directly on the body using electrodes. It does not analyze biological samples.
- The intended use and device description clearly state that it measures body composition parameters (impedance, body water, lean mass, fat mass, metabolism, BMI) using bioimpedance. This is a physical measurement technique applied externally to the body.
Therefore, the Ohmniscan NG falls under the category of a non-invasive medical device used for body composition analysis, not an IVD.
N/A
Intended Use / Indications 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). .
Product codes
MNW
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.
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
18-65
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 002835
Reference Device(s)
Not Found
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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510K Summary
Date: 11/14/2007
Multiwell
AUG 22 2008
Zi du grand pont 13640 La Roque D'Antheron France Tel :04.42.28.48.20 Fax:04.42.28.50.81
Contact Person: Mr. Philippe Dijol
Sec 5.1 – Summary Information
| Submission Correspondent: | Christine Valmy Inc. |
|---|---|
| Address: | 285 Changebridge Road |
| 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 |
1
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).
2
+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.
3
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.
4
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/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
5
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