(298 days)
The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure.
This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
The SOZO 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 cloudhosted database.
Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO™ system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced logarithmically from 3kHz to 1000kHz and measures the resulting voltage levels.
The provided text describes the SOZO Body Fluid Analyzer and its clearance via a 510(k) premarket notification. The document focuses on showing substantial equivalence to a predicate device rather than presenting a detailed study proving device performance against specific acceptance criteria for heart failure monitoring. However, it does mention that "The SOZO system has gone through appropriate testing per design controls to confirm functionality and performance of the indications." and "The software was verified and validated to meet acceptance criteria and perform as intended."
Based on the provided text, a direct, comprehensive study with specific acceptance criteria and detailed performance metrics for the device's clinical indication (monitoring heart failure patients with fluid management problems) is not explicitly detailed. The document primarily focuses on demonstrating substantial equivalence through:
- Software V&V: "The software was verified and validated to meet acceptance criteria and perform as intended." - This refers to internal software development and testing, not a clinical performance study.
- Electrical safety/EMC: Tested per IEC 60601.
- Biocompatibility: Tested per ISO 10993.
- Functional performance: Tested design reliability by repeatedly placing weights.
Given the scope of the provided text, I cannot provide detailed acceptance criteria directly linked to clinical performance for heart failure monitoring, nor a study proving those criteria are met for the full clinical indication. The document states "Performance data demonstrates that the modified SOZO is as safe and effective as its predicate," but does not elaborate on what specific performance data was collected for heart failure monitoring.
Therefore, the following information is based on the limited details provided in the text regarding "acceptance criteria" and "performance," largely inferring from the context of a 510(k) submission focused on demonstrating substantial equivalence to a predicate device, rather than a de novo clinical validation for the heart failure indication against quantitative performance targets.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred/Stated) | Reported Device Performance (as per document) |
|---|---|---|
| Software Validation | Software meets requirements and functions as intended. | "The software was verified and validated to meet acceptance criteria and perform as intended." |
| Electrical Safety/EMC | Compliance with relevant electrical safety and electromagnetic compatibility standards. | "Meets electrical safety and EMC requirements, and CB certificate was granted." (per IEC 60601) |
| Biocompatibility | Device materials are biocompatible for limited contact. | "Passed biocompatibility testing with no failures reported." (per ISO 10993) |
| Functional Reliability | Device remains functional throughout its intended life under physical stress. | "Expected to remain functional throughout its intended life." |
| Equivalence to Predicate | "As safe and effective" as the predicate device. | "Performance data demonstrates that the modified SOZO is as safe and effective as its predicate." |
| Cole Plot Grading Feature (New Feature) | Helps users assess the quality of the overall measurement. | Modification added; implies it functions as intended to assist in quality assessment. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical performance data for heart failure monitoring. The performance data mentioned (software V&V, electrical safety, biocompatibility, functional performance) appear to be part of engineering design verification and validation processes. No clinical test set size or data provenance (e.g., country of origin, retrospective/prospective) for clinical effectiveness in heart failure monitoring is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as a clinical test set with externally established ground truth for heart failure monitoring is not described in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 SOZO Body Fluid Analyzer is described as a non-invasive monitoring device for fluid management, not an AI-assisted diagnostic imaging tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a "Body Fluid Analyzer" that provides data "under the direction of a physician" and "in conjunction with other clinical data." This indicates it's a device intended for clinical use with human interpretation, not a standalone AI algorithm for diagnosis. The phrase "algorithm only" performance would not be directly applicable in the way it is for an AI-driven image analysis tool, for example.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the engineering and software validation, the 'ground truth' would be the design requirements and specifications themselves. For clinical performance related to its indication (monitoring fluid management in heart failure), the text does not specify how clinical ground truth was established, as it primarily relies on substantial equivalence to a predicate device rather than a new clinical trial.
8. The sample size for the training set
Not applicable. The document does not describe a machine learning model that would require a "training set" in the context of its primary claim, but rather a bioimpedance-based measurement device.
9. How the ground truth for the training set was established
Not applicable.
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October 2, 2020
ImpediMed Limited, Inc. Reuben Lawson Senior Director, Regulatory Affairs and Clinical 5900 Pasteur Court, Unit 125 Carlsbad, CA 92008
Re: K193410
Trade/Device Name: SOZO Body Fluid Analyzer Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: DSB Dated: September 1, 2020 Received: September 4, 2020
Dear Reuben Lawson:
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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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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); 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.
Carolyn Y. Neuland, Ph.D. 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 Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: 06/30/2020 |
| See PRA Statement on last page |
| 510(k) Number (if known) | K193410 |
|---|---|
| -------------------------- | --------- |
Device Name SOZO® Body Fluid Analyzer
Indications for Use (Describe)
The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure.
This device is intended for use, under the direction of a physician, for the nonitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (7/17)
Page 1 of 1 FDA
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Page 1 of 3
510(k) SUMMARY
ImpediMed's modified SOZO
Submitter:
| ImpediMed LimitedUnit 150 Parker CourtPinkenba, Qld 4008Australia | |
|---|---|
| Phone: | 760 585 2014 |
| Facsimile: | 760 804 9245 |
| Contact Person: | Reuben Lawson |
| Date Prepared: | 2 October 2020 |
| Name of Device: | SOZO® Body Fluid Analyzer |
| Common or Usual Name: | Body Fluid Analyzer |
| Regulation Number: | 21 CFR§870.2770 |
| Regulation Name: | Impedance Plethysmograph |
| Regulatory Class: | II |
| Product Code: | DSB |
| Predicate Device: | ImpediMed Limited's SOZO (K172507) |
Purpose of the Traditional 510(k) Notice
The purpose of the 510(k) is to clear modifications including updates to software architecture and user functionality to improve the ease of use of the system.
Indications for Use
The SOZO Body Fluid Analyzer is intended for adult patients living with heart failure.
This device is intended for use, under the direction of a physician, for the noninvasive monitoring of patients with fluid management problems suffering from heart failure. Data from the device should be considered in conjunction with other clinical data.
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Device Description
The SOZO 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 cloudhosted database.
Measurements require the patient to make contact with bare hands and feet on stainless steel electrodes. The measurement takes about 30 seconds, during which the SOZO™ system applies small levels of electrical energy (200µA RMS) to the body across 256 frequencies spaced logarithmically 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 'drive' and two 'sense' channels are O used to measure each side of the body
- 'Drive' channels deliver very low levels of current (200µa RMS) across 256 O frequencies logarithmically spaced from 3kHz to 1000kHz;
- 'Sense' channels measure current (I), voltage (V) and phase angle (Ph), and O calculates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc) to estimate extracellular fluid, intracellular fluid and total body water.
- Data is stored in and accessed from a cloud-based database (MySOZO) using a web o browser interface. SOZO is controlled through an Android app ("SOZOapp") on a supplied tablet, which is paired to the SOZO hardware over Bluetooth connection, and connects with the MySOZO database over Wi-Fi.
Performance Data
The SOZO 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 device meets electrical safety and EMC requirements, and CB certificate was granted for the system.
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Software V&V: the 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 SOZO system passed biocompatibility testing with no failures reported.
Functional performance: multiple SOZO systems were tested for design reliability by repeatedly placing weights on the components that encounter the most physical stress. Testing showed that the system is expected to remain functional throughout its intended life.
Substantial Equivalence
The modified SOZO has the same intended use and similar indications, principles of operation, and technological characteristics as its predicate device. The following differences in the modified SOZO device's technological characteristics do not raise any new questions of safety or effectiveness:
- Modification to SOZOapp adding a Cole plot grading feature to help users assess the quality of the overall measurement.
- Changes to plastic materials of construction used in hand- and footplates.
Performance data demonstrates that the modified SOZO is as safe and effective as its predicate. Thus, the modified SOZO is substantially equivalent to its predicate devices.
Conclusions
Testing discussed above demonstrates that the modified SOZO device is as safe and effective, and performs as well as or better than the predicate device.
§ 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.