(88 days)
No
The summary describes a device that measures tissue dielectric constant and calculates ratios. There is no mention of AI or ML algorithms being used for analysis or interpretation.
No
The device is used to assess tissue water differences to aid in forming a clinical judgment of unilateral lymphedema, not to provide therapy.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The device is not intended to make a diagnosis or predict arm lymphedema."
No
The device description explicitly states it is a "bioelectrical analyzer" with a "hand-held main unit" and an "integrated open-ended coaxial probe" that produces and measures electromagnetic waves. This indicates a hardware component is essential to the device's function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The device description clearly states that the probe is placed onto the skin and measures properties of the skin and upper subcutis directly. It does not analyze blood, urine, tissue samples, or other specimens removed from the body.
- The intended use is a local assessment of tissue water differences. While this information aids in clinical judgment, it's a direct measurement of a physical property of the tissue in situ, not an analysis of a biological sample.
The device is a bioelectrical analyzer that measures tissue dielectric constant, which is a physical property related to water content. This is distinct from the analysis of biological or chemical markers in a sample, which is the hallmark of an IVD.
N/A
Intended Use / Indications for Use
MoistureMeterD Compact and LymphScanner is a device utilizing inter-am ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected ann tissues to aid in forming a clinical judgment of unilateral lymphedema in adult women. The device is not intended to make a dagnosis or predict arm lymphedema.
Product codes
OBH
Device Description
The MoistureMeterD Compact (MMDC) and the LymphScanner are identical differently labelled bioelectrical analyzers to measure localized tissue fluid content. High-frequency electromagnetic waves produced in the hand-held main unit are guided into integrated open-ended coaxial probe. When the probe is placed onto the skin, skin and upper subcutis is exposed to electromagnetic field. In skin and upper subcutis electromagnetic fields are interacting with tissue water molecules by rotation causing absorption of electromagnetic energy in tissue. The devices measure the amplitude and phase shift of the reflected electromagnetic wave and calculate tissue dielectric constant (TDC). Tissue dielectric constant (TDC) is an index of localized tissue water content. The measured TDC value can be converted into Percentage Water Content (PWC) value.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm tissues
Indicated Patient Age Range
adult women
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
Substantial equivalence of the devices is based on clinical studies in healthy female volunteers, women waiting for surgery of breast cancer, women operated for breast cancer, women at risk for lymphedema or a diagnosis of lymphedema. From absolute measurement values of at risk or affected arm and contralateral non-affected arm the inter-arm TDC or PWC ratios are calculated by dividing the respective measurement values. The inter-arm ratio supports local assessment of tissue water differences between at risk or affected and contralateral non-affected arm.
Substantial equivalence between the MoistureMeterD Compact or LymphScanner and predicate MoistureMeterD provided with M25 probe was confirmed by determining the inter-arm TDC or PWC ratio in women with both instruments. Inter-arm TDC ratios were not statistically different with respect to device (MoistureMeterD Compact vs MMD provided with M25). Since the LymphScanner uses the same identical technology as the MoistureMeterD Compact, the same clinical performance data also concern the LymphScanner.
Clinical studies also confirmed that the inter-arm TDC or PWC ratio is a robust indicator to describe tissue water differences between at risk or affected and contralateral nonaffected arm tissues since the inter-arm TDC or PWC ratio directly indicates percentage difference of tissue fluid contents of at risk or affected arm compared with contralateral non-affected arm.
Clinical results summarized that the MoistureMeterD Compact is safe to use in women without any adverse effects and meet the objective of substantial equivalency assessed using the robust inter-arm TDC or PWC ratios.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
May 27, 2022
Delfin Technologies Ltd % Patrick Danciu President F Care Systems USA (dba: Delfin USA LLC) 11098 Biscayne Blvd, Suite 301 Miami, Florida 33161
Re: K220557
Trade/Device Name: MoistureMeterD Compact, LymphScanner Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: January 17, 2022 Received: February 28, 2022
Dear Patrick Danciu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gema Gonzalez Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220557
Device Name
MoistureMeterD Compact and LymphScanner
Indications for Use (Describe)
MoistureMeterD Compact and LymphScanner is a device utilizing inter-am ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected ann tissues to aid in forming a clinical judgment of unilateral lymphedema in adult women. The device is not intended to make a dagnosis or predict arm lymphedema.
Enter description of indications for
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Delfin Technologies. The logo features a blue abstract shape resembling a dolphin leaping out of the water. To the right of the graphic is the company name, "Delfin," in a bold, blue font. Below "Delfin" is the word "Technologies" in a smaller, lighter font.
K220557 Page 1 of 3
1(3)
Section 5 - 510(k) Summary
510(k) submitter's name:
Delfin Technologies Ltd FIN - 70210 Kuopio, Finland Tel: +358 50 911 1199 Fax: +358 17 222 2343 Contact: Jouni Nuutinen, CEO Email: jouni.nuutinen@delfintech.com
Submission Correspondent:
DELFIN-USA LLC 11098 Biscayne Blvd, Suite 301 Miami FL 33161, USA Tel: 786 288 0740, Cell 305 987 1822 Contact Name: Patrick Danciu, President Email: pdanciu@delfin-usa.com
Date Prepared: 27 May 2022
Device Identification:
| Trade Name: | MoistureMeterD Compact and LymphScanner |
|---|---|
| Common name: | Moisturemeter |
| Classification Name: | Impedance Plethysmograph |
| Regulation Number: | 21 CFR 870.2770 |
| Product Code: | OBH |
| Panel: | Cardiovascular |
| Device Class: | Class II |
Predicate device:
| Company: | Delfin Technologies Ltd |
|---|---|
| Trade Name: | MoistureMeterD |
| 510(k) Number: | K143310 |
| Classification name: | Impedance Plethysmograph |
| Regulation number: | 21 CFR 870.2770 |
| Product code: | OBH |
| Classification panel: | Cardiovascular |
| Device class: | Class II |
4
Image /page/4/Picture/0 description: The image contains the logo for Delfin Technologies. The logo features a stylized blue wave-like shape on the left, followed by the company name "Delfin" in a larger, bolder blue font. Below "Delfin" is the word "Technologies" in a smaller, thinner black font. Below the logo is the text "General Description:" in a larger, bold font.
2(3)
The MoistureMeterD Compact (MMDC) and the LymphScanner are identical differently labelled bioelectrical analyzers to measure localized tissue fluid content. High-frequency electromagnetic waves produced in the hand-held main unit are guided into integrated open-ended coaxial probe. When the probe is placed onto the skin, skin and upper subcutis is exposed to electromagnetic field. In skin and upper subcutis electromagnetic fields are interacting with tissue water molecules by rotation causing absorption of electromagnetic energy in tissue. The devices measure the amplitude and phase shift of the reflected electromagnetic wave and calculate tissue dielectric constant (TDC). Tissue dielectric constant (TDC) is an index of localized tissue water content. The measured TDC value can be converted into Percentage Water Content (PWC) value.
Indications for Use - MoistureMeterD Compact and LymphScanner:
MoistureMeterD Compact and LymphScanner is a device utilizing inter-aim ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected aim tissues to aid in forming a clinical judgment of unilateral lymphedema in adult women. The device is not intended to make a diagnosis or predict arm lymphedema.
Technologv:
The MoistureMeterD Compact and LymphScanner have the same technological characteristics as the predicate device MoistureMeterD, the essential difference being in the outlook of devices and probe construction. The MoistureMeterD Compact and LymphScanner are handheld battery-powered bioelectrical analyzers that contain a high-frequency electromagnetic wave generator and open-ended coaxial probe integrated into main unit. In the predicate bioelectrical analyzer MoistureMeterD applying the identical technological characteristics the probe is connected to main unit by coaxial cable.
Dimensions of the probe in the MoistureMeterD Compact and LymphScanner are identical to the M25 probe in the MoistureMeterD. Discussion related to substantial equivalence is thus focussed to compare performance characteristics between MoistureMeterD Compact or LymphScanner with the MoistureMeterD provided with M25 probe.
When the probes of the MoistureMeterD Compact, LymphScanner or the predicate device MoistureMeterD is placed onto the skin, the devices are guiding the electromagnetic waves into skin. After absorption of electromagnetic energy by tissue
5
Image /page/5/Picture/0 description: The image shows the logo for Delfin Technologies. The logo consists of a blue graphic on the left and the company name on the right. The graphic is a stylized wave or curve in shades of blue. The company name is written in a sans-serif font, with "Delfin" in a larger, bolder font and "Technologies" in a smaller font below it.
3(3)
water molecules the amplitude and phase shift of the reflected wave are respectively measured by all devices. From this information the devices calculate tissue dielectric constant (TDC) in MoistureMeterD and from TDC converted value, Percentage Water Content (PWC) for the MoistureMeterD Compact and LymphScanner. Both TDC and PWC are directly proportional to localized tissue water content.
Substantial Equivalence:
The MoistureMeterD Compact and LymphScanner have the same indications for use statements with the predicate device MoistureMeterD provided with M25 probe. Substantial equivalence of the devices is based on clinical studies in healthy female volunteers, women waiting for surgery of breast cancer, women operated for breast cancer, women at risk for lymphedema or a diagnosis of lymphedema. From absolute measurement values of at risk or affected arm and contralateral non-affected arm the inter-arm TDC or PWC ratios are calculated by dividing the respective measurement values. The inter-arm ratio supports local assessment of tissue water differences between at risk or affected and contralateral non-affected arm.
Substantial equivalence between the MoistureMeterD Compact or LymphScanner and predicate MoistureMeterD provided with M25 probe was confirmed by determining the inter-arm TDC or PWC ratio in women with both instruments. Inter-arm TDC ratios were not statistically different with respect to device (MoistureMeterD Compact vs MMD provided with M25). Since the LymphScanner uses the same identical technology as the MoistureMeterD Compact, the same clinical performance data also concern the LymphScanner.
Clinical studies also confirmed that the inter-arm TDC or PWC ratio is a robust indicator to describe tissue water differences between at risk or affected and contralateral nonaffected arm tissues since the inter-arm TDC or PWC ratio directly indicates percentage difference of tissue fluid contents of at risk or affected arm compared with contralateral non-affected arm.
Clinical results summarized that the MoistureMeterD Compact is safe to use in women without any adverse effects and meet the objective of substantial equivalency assessed using the robust inter-arm TDC or PWC ratios. Slight technological differences between the MoistureMeterD Compact or LymphScanner and predicate device MoistureMeterD do not raise any new issues on safety or effectiveness as discussed further within this submission.
Conclusion:
The MoistureMeterD Compact and LymphScanner described in this 510(k) notification are safe, equally effective and substantially equivalent to the predicate device MoistureMeterD provided with M25 probe.