(66 days)
No
The description focuses on bioimpedance spectroscopy measurements and standard electrical and software testing, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is described as a bioimpedance spectroscopy device that supports the measurement of extracellular volume differences between the limbs and presents data as an aid to clinical assessment of lymphedema, not for treating the condition.
Yes.
The device measures extracellular volume differences and displays them as an L-Dex ratio to aid in the clinical assessment of lymphedema, which is a diagnostic purpose.
No
The device description explicitly states that the system consists of hardware components (hand and footplate with electrodes, Android tablet, load cells) in addition to the software ("SOZOapp"). Performance studies also include testing of hardware aspects like electrical safety, biocompatibility, and weight scale verification.
Based on the provided information, the SOZO Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is performed outside of the body.
- SOZO Pro Function: The SOZO Pro measures bioimpedance directly on the patient's body by applying small electrical currents and measuring the response. This is an in vivo measurement, meaning it's done within the living body.
- Intended Use: The intended use describes the device as a bioimpedance spectroscopy device for use on adult human patients to measure extracellular volume differences between limbs. This is a direct measurement on the patient, not a test of a specimen taken from the patient.
Therefore, the SOZO Pro falls under the category of a medical device that performs measurements directly on the patient, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SOZO Pro has the following uses:
For adult human patients at risk of lymphedema:
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.
The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or imadiated.
Product codes
OBH
Device Description
The SOZO Pro system consists of a connected hand and footplate with built-in stainless-steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware, and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloud- hosted database. Patient weight is measured with load cells located in the SOZO Pro foot unit or can be hand entered.
Bioimpedance measurements require the patient's weight to be measured by a scale embedded in the base of the system or for the weight of the patient to be entered manually. Following the collection of the patient weight, the patient contacts the SOZO Pro with their bare hands and feet on stainless steel electrodes. The impedance measurement takes about 30 seconds, during which the SOZO Pro® system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limbs
Indicated Patient Age Range
adult human patients
Intended User / Care Setting
clinician. Prescription Use
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)
The SOZO Pro system has gone through appropriate testing per design controls to confirm functionality and performance of the indications.
Electrical safety/EMC: testing was performed according to the requirements set forth in IEC 60601 (subparts -1, -1-2, and -1-6). It was determined that the SOZO Pro device meets electrical safety and EMC requirements, and CB certificate was granted for the system.
Software V&V: the SOZO Pro same level of concern software documentation as the predicate device was created and testing performed in accordance with ISO 62304. The software was verified and validated to meet acceptance criteria and perform as intended.
Biocompatibility: testing was performed by an accredited third party according to the requirements set forth in ISO 10993 for a low risk, limited contact device. It was determined that the patient contact areas of SOZO Pro system passed biocompatibility testing with no failures reported as they are unchanged from the reference device.
Functional performance: performance testing was undertaken using fixed loads and comparing modified SOZO Pro to predicate SOZO measurements to demonstrate that outputs remained consistently accurate and precise.
Weight Scale Verification: Scale verification testing for SOZO Pro was performed in accordance with the NIST Handbook 44 (2022 Edition) and EU Directive 2014/31/EU for non-automatic weighing instruments. Scale verification testing experienced no failures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
May 4, 2023
ImpediMed Limited % Richard Hines Senior Manager of Regulatory Affairs 5900 Pasteur Court, Ste. 125 Carlsbad, California 92008
Re: K230530/S001 Trade/Device Name: SOZO Pro Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: OBH Dated: April 7, 2023 Received: April 7, 2023
Dear Richard Hines:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 -S
Gema Gonzalez, MS 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
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Indications for Use
510(k) Number (if known) K230530
Device Name SOZO Pro
Indications for Use (Describe) The SOZO Pro has the following uses:
For adult human patients at risk of lymphedema:
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical as sessment of lym phedema.
The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged or imadiated.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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impedimed®
510(k) SUMMARY
ImpediMed SOZO Pro
Submitter
| ImpediMed Limited
Unit 1
50 Parker Court
Pinkenba, Qld 4008
| Australia | |
|---|---|
| Phone: | 760 585 2104 |
| Facsimile: | 760 804 9425 |
| Contact Person: | Richard Hines |
| Contact Email: | rhines@impedimed.com |
| Date Prepared: | April 5, 2023 |
| Name of Device: | SOZO Pro® |
| Common or Usual Name | Body Fluid Analyzer |
| Regulation Number | 21 CFR §870.2770 |
| Regulation Name | Impedance Plethysmograph |
| Regulatory Class | II |
| Product Code: | OBH (Monitor, Extracellular Fluid, Lymphedema, Extremity) |
| Predicate Device: | SOZO® (K180126) |
| Reference Device: | SOZO® (K193410) |
Purpose of the Special 510(k) Notice
The purpose of the 510(k) is to clear the SOZO Pro device which is a modification of the predicate K180126 SOZO device to include a weight scale to allow for patient weights to be measured directly with the device, along with updates to the stand hardware and electrodes. Software updates were included to integrate the scale and weight measurement capabilities.
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Indications for Use
The SOZO Pro has the following uses:
For adult human patients at risk of lymphedema:
A bioimpedance spectroscopy device for use on adult human patients, utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular volume differences between the limbs and is presented to the clinician on an L-Dex scale as an aid to their clinical assessment of lymphedema.
The use of the device to obtain an L-Dex score is only indicated for patients who will have or who have had lymph nodes, from the axillary and/or pelvic regions, either removed, damaged, or irradiated.
Device Description
The SOZO Pro system consists of a connected hand and footplate with built-in stainless-steel electrodes, paired with an Android tablet over Bluetooth connection. An app ("SOZOapp"), supplied with the tablet, controls the functionality of the hardware, and supplies the bioimpedance measurement data to a database ("MySOZO") managed on an external cloud- hosted database. Patient weight is measured with load cells located in the SOZO Pro foot unit or can be hand entered.
Bioimpedance measurements require the patient's weight to be measured by a scale embedded in the base of the system or for the weight of the patient to be entered manually. Following the collection of the patient weight, the patient contacts the SOZO Pro with their bare hands and feet on stainless steel electrodes. The impedance measurement takes about 30 seconds, during which the SOZO Pro® system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced from 3kHz to 1000kHz and measures the resulting voltage levels.
Technological Characteristics
Bioimpedance spectroscopy is the technological principle for both the subject and predicate devices. The subject and predicate devices are based on the following same fundamental technological elements:
ം Use of electrodes to take measurements; two channels are used to measure each side of the body.
o Delivery of very low levels of current (200µA RMS) across 256 frequencies logarithmically spaced from 3kHz to 1000kHz.
o Measure current (I), voltage (V) and phase angle (Ph) and calculates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc) to estimate extracellular fluid, intracellular fluid, and total body water.
o Data is stored in and accessed from a cloud-based database (MySOZO) using a web browser interface. SOZO Pro is controlled through an Android app ("SOZOapp") on a supplied tablet, which is paired to the SOZO Pro hardware over Bluetooth connection and connects with the MySOZO database over Wi-Fi.
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K230530 Page 3 of 3
Performance Data
The SOZO Pro system has gone through appropriate testing per design controls to confirm functionality and performance of the indications.
Electrical safety/EMC: testing was performed according to the requirements set forth in IEC 60601 (subparts -1, -1-2, and -1-6). It was determined that the SOZO Pro device meets electrical safety and EMC requirements, and CB certificate was granted for the system.
Software V&V: the SOZO Pro same level of concern software documentation as the predicate device was created and testing performed in accordance with ISO 62304. The software was verified and validated to meet acceptance criteria and perform as intended.
Biocompatibility: testing was performed by an accredited third party according to the requirements set forth in ISO 10993 for a low risk, limited contact device. It was determined that the patient contact areas of SOZO Pro system passed biocompatibility testing with no failures reported as they are unchanged from the reference device.
Functional performance: performance testing was undertaken using fixed loads and comparing modified SOZO Pro to predicate SOZO measurements to demonstrate that outputs remained consistently accurate and precise.
Weight Scale Verification: Scale verification testing for SOZO Pro was performed in accordance with the NIST Handbook 44 (2022 Edition) and EU Directive 2014/31/EU for non-automatic weighing instruments. Scale verification testing experienced no failures.
Substantial Equivalence
The modified SOZO Pro has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate device. The differences in the SOZO Pro device's technological characteristics to the predicate SOZO device do not raise any new questions of safety or effectiveness:
Conclusions
Testing discussed above demonstrates that the modified SOZO Pro device is as safe and effective and performs as well as or better than the predicate device.