(268 days)
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). .
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.
The provided text is a 510(k) summary for the Ohmniscan NG device, which is a bioimpedance measuring device intended for body composition analysis. The core of this submission is to demonstrate substantial equivalence to a predicate device, not to present a de novo study with detailed acceptance criteria and performance data for the Ohmniscan NG itself.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. The document primarily focuses on comparing the new device to the predicate device to assert substantial equivalence.
Here's an breakdown based on the provided text, indicating where information is present and where it is not:
Acceptance Criteria and Device Performance Study
The K073334 510(k) summary does not describe specific acceptance criteria or an independent study conducted to prove the Ohmniscan NG device meets those criteria with performance metrics like sensitivity, specificity, or accuracy. Instead, the submission's goal is to establish "substantial equivalence" to a legally marketed predicate device (Bodystat K002835).
The manufacturer asserts that "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."
This means the "acceptance criteria" here are met by demonstrating the new device is functionally and technologically identical to the predicate device, excluding a minor accessory (the printer).
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria or reported device performance metrics (e.g., accuracy, precision) for the Ohmniscan NG is provided in this 510(k) summary. The "performance" is implicitly tied to being substantially equivalent to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative metrics. The primary criterion is "substantial equivalence" to the predicate device. | The device's performance is implied to be equivalent to the predicate device, Bodystat K002835, due to "no differences in the technological characteristics or in the intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical study or a test set of data used to evaluate the Ohmniscan NG device's performance independently. The claims are based on similarity to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The Ohmniscan NG is a standalone bioimpedance analyzer, not an AI-assisted diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone bioimpedance measuring device. However, a standalone performance study with specific metrics (e.g., accuracy against a gold standard) is not described in this 510(k) summary. The submission relies on the device's functional equivalence to its predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth reference is mentioned as part of a performance study for the Ohmniscan NG in this document.
8. The sample size for the training set
Not applicable. This device does not appear to involve machine learning models that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for machine learning.
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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 RoadPine 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 (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
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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
§ 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.