(366 days)
Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
The Delfin MoistureMeterD is a high-frequency bioelectrical analyzer used to detect tissue fluid. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance and. moreover the tissue dielectric constant (TDC). The tissue dielectric constant (TDC) supports the measurement of local tissue fluid.
I apologize, but the provided text does not contain the specific details about acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, or adjudication methods for the Delfin MoistureMeterD. The document is an FDA 510(k) clearance letter and summary, which confirms the device's substantial equivalence to a predicate device but does not include the detailed study results that would typically contain such information.
To answer your request thoroughly, I would need a different document, such as a clinical study report, a scientific publication, or a more detailed section of the 510(k) submission that discusses the performance testing.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2015
Delfin Technologies, Ltd. % Theodore Sullivan Counsel Buchanan Ingersoll & Rooney, PC 1700 K Street NW Suite 300 Washington DC 20006
Re: K143310 Trade/Device Name: MoistureMeterD Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: October 16, 2015 Received: October 19, 2015
Dear Theodore Sullivan,
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.
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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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.
Benjamin R. Fisher -S
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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Indications for Use Statement
510(k) Number (if known): K143310
Device Name: MoistureMeterD
Indications For Use:
Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
Prescription Use x x AND/OR
Over-The-Counter Use -------------------------------------
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
Submitters Name and Address: Delfin Technologies Ltd Microkatu 1 P.O Box 1199 FI-70211 Kuopio FINLAND
Contact Name: Jouni Nuutinen Date Prepared: 4/18/2012
Device Identification: Trade Name: MoistureMeterD Classification Name: Impedance Plethysmograph Regulation Number: 21 CFR 870.2770 Product Code: OBH Panel: Cardiovascular Device Class: Class II
Predicate device: Company: ImpediMed Limited Trade Name: L-Dex U400 BIS Extra Cellular Fluid Analysis 510(k) Number: K080825 Classification name: Impedance Plethysmograph Regulation number: 870.2770 Product code: OBH Classification panel: Cardiovascular Device class: Class II
General Description:
The Delfin MoistureMeterD is a high-frequency bioelectrical analyzer used to detect tissue fluid. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance and. moreover the tissue dielectric constant (TDC). The tissue dielectric constant (TDC) supports the measurement of local tissue fluid.
Intended Use / Indications for Use:
Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
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Technology:
MoistureMeterD is a bioelectrical analyzer that contains two-electrode systems. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance, and moreover the tissue dielectric constant (TDC). The TDC supports the measurement of local tissue fluid. The device operates at a single frequency at 265 +/-20 MHz. At high radiofrequency both extra and intra cellular fluid volume is reached. The MoistureMeterD is battery operated device.
Substantial Equivalence:
MoistureMeterD product has the same intended use as a previous device and similar indications. MoistureMeterD provides information on tissue fluid volume and are used by or under supervision of physicians or other professionals to assist in forming a clinical judgement. The slight technological differences do not raise any new issues on safety or effectiveness as discussed further within this submission.
Conclusion:
For all of the foregoing reasons. Delfin Technology Ltd believes that the MoistureMeterD described in this 510(k) notification is substantially equivalent to the predicate device and may be safely marketed in the United States.
§ 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.