(126 days)
No
The description mentions "Established algorithms are used to analyze data and calculate extracellular fluid impedance levels," but does not mention AI, ML, or any related terms. The performance studies focus on electrical safety, software V&V, biocompatibility, and comparative/functional performance, without any mention of AI/ML model training or testing.
Yes.
The device is intended for the noninvasive monitoring of patients with fluid management problems suffering from heart failure, which implies use in a therapeutic context (managing a medical condition).
Yes
The device's intended use is for "noninvasive monitoring of patients with fluid management problems suffering from heart failure," and it helps clinicians in "monitoring and management of patients with fluid management problems," which falls under the scope of diagnostic or monitoring devices.
No
The device description explicitly states the system consists of hardware components (hand and footplate with electrodes, Android tablet) in addition to the software (SOZOapp, SOZOhub).
Based on the provided information, the SOZO Fluid Status Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SOZO device measures electrical impedance by applying a small electrical current through the patient's body (hands and feet). It does not analyze blood, urine, tissue, or any other biological specimen.
- The device description clearly states it measures electrical energy across the body. This is a physical measurement, not a chemical or biological analysis of a specimen.
- The intended use is for noninvasive monitoring of fluid status. This is achieved through bioimpedance analysis, which is a physical measurement technique.
Therefore, the SOZO Fluid Status Monitor falls under the category of a non-invasive medical device that uses bioimpedance analysis for monitoring fluid status.
N/A
Intended Use / Indications for Use
The SOZO Fluid Status Monitor 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.
Product codes (comma separated list FDA assigned to the subject device)
DSB
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 ("SOZOhub") contained within the hospital/facility network.
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 measures small quantities of electrical energy (2004A RMS) across 256 frequencies, spaced logarithmically from 3kHz to 1000kHz. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right sides of the body, and present the impedance levels for the clinician to review. These scores facilitate the clinician's nonitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
under the direction of a physician, hospital/facility network
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)
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.
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.
Comparative performance: a test fixture was used to create multiple fixed impedance loads representing different 'humans'. Using this test fixture, a SOZO™ system was compared against a IMED-Z system to verify correlation in outputs. The SOZO system showed a very strong correlation (r > 0.99) compared to the cleared ZOE system.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ImpediMed Limited's IMED-Z (K142503)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
NMT, Inc's ZOE Fluid Status Monitor (K133301), ImpediMed Limited's SOZO™ (K172122), ImpediMed Limited's SFB7 (K052319)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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December 22, 2017
ImpediMed Limited % Reuben Lawson Senior Director, Regulatory Affairs and Clinical ImpediMed Inc. 5900 Pasteur Court. Unit 125 Carlsbad, CA 92008
Re: K172507 Trade/Device Name: SOZO™ Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: DSB Dated: November 21, 2017 Received: November 22, 2017
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. 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 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.
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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for 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
510(k) Number (if known) K172507
Device Name SOZOTM
Indications for Use (Describe)
The SOZO Fluid Status Monitor 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
ImpediMed's SOZO™ system
Submitter:
| ImpediMed Limited
Unit 1
50 Parker Court
Pinkenba Qld 4008
| Australia | |
|---|---|
| Phone: 760 585 2104 | |
| Facsimile: 760 804 9245 | |
| Contact Person: Reuben Lawson | |
| Date Prepared: August 17, 2017 | |
| Name of Device: | SOZO™ |
| Common or Usual Name: | Body Fluid Analyzer |
| Regulation Number: | 21 CFR§820.2770 |
| Regulation Name: | Impedance Plethysmograph |
| Regulatory Class: | II |
| Product Code: | DSB |
| Predicate Device: | ImpediMed Limited's IMED-Z (K142503) |
| Reference Devices: | NMT, Inc's ZOE Fluid Status Monitor (K133301) |
| ImpediMed Limited's SOZO™ (K172122) | |
| ImpediMed Limited's SFB7 (K052319) |
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 ("SOZOhub") contained within the hospital/facility network.
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 measures small quantities of electrical energy (2004A RMS) across 256 frequencies, spaced logarithmically from 3kHz to 1000kHz. Established algorithms are used to analyze data and calculate extracellular fluid impedance levels for left and right sides of the body, and present the impedance levels for the
4
clinician to review. These scores facilitate the clinician's nonitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.
Intended Use/Indications for Use
The SOZO Fluid Status Monitor 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.
Summary of Technological Characteristics
Bioimpedance 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'sense' channels are used ● to measure each side of the body;
- . 'Drive' channels deliver very low levels of current (200uA RMS);
- . 'Sense' channels measure current (I), voltage (V) and phase angle (Ph), and calculates three bioimpedance parameters: impedance (Z), resistance (R) and reactance (Xc) to calculate the impedance values and estimate extracellular fluid
Minor technological differences exist between the subject and predicate devices:
- . SOZO™ utilizes a revamped external housing using stainless steel electrodes fortaking bioimpedance measurements;
- SOZO™ utilizes more frequencies (256 frequencies logarithmically spaced from 3kHzto . 1000kHz);
- . SOZO™ is wall powered rather than battery powered;
- . Data is stored in and accessed from a local database (SOZOhub) utilizing separatesoftware installed on a network connected PC.
- . SOZO™ is controlled through an Android app on a supplied tablet, which is paired to the SOZO™ hardware over Bluetooth connection, and connects with the local database over Wi-Fi.
Purpose of 510(k)
The purpose of this 510(k) is to clear the design changes presented in the SOZO™ system and indications for use presented in the SOZObeat measurement module.
These changes are intended to provide a faster, more streamlined customer experience with a more aesthetically pleasing design.
Performance Data
The SOZO™ system has gone through appropriate testing per design controls to confirm the new design's functionality and performance.
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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.
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.
Comparative performance: a test fixture was used to create multiple fixed impedance loads representing different 'humans'. Using this test fixture, a SOZO™ system was compared against a IMED-Z system to verify correlation in outputs. The SOZO system showed a very strong correlation (r > 0.99) compared to the cleared ZOE system.
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.
Conclusions
The SOZO™ system has the same intended uses /indications, and similar technological characteristics, and principles of operation as its predicate device. In addition, the technological differences between the SOZO™ system and its predicate device raise no new or different issues of safety or effectiveness. Design controls demonstrate that the SOZO™ system is as safe and effective as the cleared device version. Thus, the SOZO™ system is substantially equivalent.