(626 days)
Not Found
Not Found
No
The description focuses on measuring electrical capacitance and displaying a calculated value (SEM Value and SEM Delta). There is no mention of AI, ML, image processing, or training/test sets related to algorithmic learning. The performance study compares the device's output to clinical judgment, not an AI/ML model's output.
No.
The device is intended to be used as an adjunct to standard of care for assessing the risk of pressure ulcers, not for treating them.
Yes
Explanation: The device is described as a tool to assess changes in electrical capacitance of tissue to detect early indicators of pressure ulcers, providing a "SEM Value" and "SEM Delta" that are used "as an adjunct to the standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers." This function clearly aligns with the definition of a diagnostic device, as it aims to identify a condition (increased risk of pressure ulcers).
No
The device description explicitly states it is a hand-held, portable device consisting of a single electrode sensor, an integrated pressure sensor, and hardware, in addition to software. It also includes an inductive charging mat and power supply. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the SEM Scanner (Model 200) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- SEM Scanner Function: The SEM Scanner directly interacts with the patient's tissue (heels and sacrum) to measure electrical capacitance. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to assess tissue in situ as an adjunct to standard of care for pressure ulcer risk, not to diagnose a condition based on laboratory analysis of a specimen.
Therefore, the SEM Scanner falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SEM Scanner (Model 200) is intended to be used by healthcare professionals as an adjunct to standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.
Product codes
QEF
Device Description
The SEM Scanner (Model 200) is a hand-held, portable device that consists of a single electrode sensor, an integrated pressure sensor, and hardware and software to run a user interface device screen that displays the device status, battery status, SEM Value, and SEM Delta ("SEM Δ"). The SEM Scanner (Model 200) is pre-calibrated. The SEM Scanner (Model 200) is provided with an inductive charging mat and power supply for recharging the device unit.
The SEM Scanner (Model 200) assesses changes in electrical capacitance of tissue and expresses the result in a SEM Value of 0.3 to 3.9. SEM is a unitless number (not an International System of Unit). The SEM Scanner (Model 200) displays a △ (delta) value after taking a minimum of three (3) SEM Values readings. A minimum of four readings were taken to obtain a result during the supporting clinical studies. The reported SEM A is used as an adjunct to the standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heels and sacrum
Indicated Patient Age Range
Greater or equal to 55 years of age
Intended User / Care Setting
healthcare professionals
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
A total of 12 study sites. nine US centers and three UK centers, participated in this prospective. multi-site, longitudinal, blinded study. In total, 77.8% of the enrolled subjects were from US centers and 22.2% were from UK centers. This study enrolled a total of 189 subjects, who had provided their written informed consent or by verbal/ written consent of the subjects' legally authorized representative, from April through November 2016.
The study was carried out by a clinical study team at each participating site comprised of a Principal Investigator, Study Coordinator, and individuals acting in study roles of "Generalists" and "Specialists." Daily assessments were limited to up to two assessors within each assessment team. Comprising one team, the "Specialist" was assigned to nursing staff who were the facility's experts on wound care to continue "standard of care" evaluations. The "gold standard" in this case is the clinical judgment of the wound/tissue viability experts.
Comprising a second team, the "Generalist" included individuals who did not provide pressure ulcer care to the enrolled subjects and consisted of a wider range of healthcare providers: wound experts, ward nurses, nursing assistants, or medical assistants.
Blinding between assessment teams, the Specialists, was employed. The Study Coordinator acted as the "gate-keeper" to help maintain blinding. In addition to blinding between Specialists and Generalists, the study was also blinded to staff at BBI during enrollments by an independent consultant to BBI (PhD Epidemiologist) managing the Medrio database, an electronic data capture system. The purpose of this study was to compare the SEM Scanner to the current Standard of Care, Visual Skin Assessment (VSA), in identifying patients with tissue at increased risk of developing pressure ulcers at the heels or sacrum.
Enrolled subjects were expected to be evaluated once daily throughout the observation period for a minimum of 6 days to maximum of 21 days upon enrollment or until earlier exit from the study. The minimum of 6 days was selected to optimize the probability of observing an early pressure ulcer should one develop. The maximum of 21 days was selected to set expectations for the study sites on the upper bound for length of participation. The total number of evaluation days include the day of enrollment (day 0).
Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:
- Specialist Risk Assessments .
- Specialist Skin Assessment (including pressure ulcer diagnosis) .
- . Generalists SEM Scanner Readings
- . Prevention/Intervention Questionnaire
Summary of Performance Studies
Type: Prospective, multi-site, longitudinal, blinded study.
Sample Size: 189 subjects. 182 subjects with 437 anatomical locations were used for ITT analysis.
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
Primary Endpoint:
Positive Detection is defined as observations of two or more SEM Δ >0.5 from three consecutive series of SEM Scanner readings prior to pressure ulcer diagnosis by clinical judgment of the Specialist. A sensitivity of at least 0.70 is defined for positive detection success as a measure of the primary effectiveness performance.
Negative Detection is defined as observations of two or more SEM Δ
§ 876.2100 Pressure ulcer management tool.
(a)
Identification. A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user's decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 876.9.
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DE NOVO CLASSIFICATION REQUEST FOR SEM SCANNER (MODEL 200)
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Pressure ulcer management tool. A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user's decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.
NEW REGULATION NUMBER: 21 CFR 876.2100
CLASSIFICATION: Class I (Exempt from premarket notification review, subject to limitations in 21 CFR 876.9)
PRODUCT CODE: QEF
BACKGROUND
DEVICE NAME: SEM Scanner (Model 200)
SUBMISSION NUMBER: DEN170021
DATE DE NOVO RECEIVED: April 3, 2017
SPONSOR INFORMATION:
Bruin Biometrics, LLC 10960 Wilshire Blvd., # 950 Los Angeles, CA 90024
INDICATIONS FOR USE
The SEM Scanner (Model 200) is intended to be used by healthcare professionals as an adjunct to standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.
LIMITATIONS
The sale, distribution, and use of the SEM Scanner (Model 200) are restricted to prescription use in accordance with 21 CFR 801.109.
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WARNING: The standard of care should be followed for reducing the risk of developing pressure ulcers. Readings from the SEM Scanner 200 can be used to support increased intervention, but should never be to the basis for decreasing intervention.
WARNING: This device is not intended to be used for detecting or diagnosis of pressure ulcers.
WARNING: To prevent the spread of infection, the SEM Scanner 200 should be properly cleaned and disinfected according to the instructions provided in this Instructions for Use after it is used on a patient.
WARNING: Should the device come in contact with non-sterile surfaces (for example, if it falls on the floor) it should be cleaned and disinfected before obtaining another patient reading.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
RATIONALE FOR EXEMPTION
Section 510(1) of the FD&C Act (21 U.S.C. 360(1)) provides that a class I device is not subject to the premarket notification requirements under section 510(k) of the FD&C Act unless the device is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury. FDA has determined that the device does meet these criteria and, therefore, premarket notification is not required for the device.
General controls provide reasonable assurance of safety and effectiveness, if device manufacturers comply with such requirements, which includes current good manufacturing practice requirements (21 CFR part 820), including design controls (820.30) due to the inclusion of software, and general labeling (21 CFR part 801). Examples exceeding the limitations of exemption could include indications for diagnostic purposes, clinical decision making, carly detection of pressure ulcers, measurement of sub-epidermal moisture, supporting a user's decision to decrease intervention, or the device operates using a different fundamental scientific technology.
DEVICE DESCRIPTION
The SEM Scanner (Model 200) is a hand-held, portable device that consists of a single electrode sensor, an integrated pressure sensor, and hardware and software to run a user interface device screen that displays the device status, battery status, SEM Value, and SEM Delta ("SEM Δ"). The SEM Scanner (Model 200) is pre-calibrated. The SEM Scanner (Model 200) is provided with an inductive charging mat and power supply for recharging the device unit.
The SEM Scanner (Model 200) assesses changes in electrical capacitance of tissue and expresses the result in a SEM Value of 0.3 to 3.9. SEM is a unitless number (not an International System
2
of Unit). The SEM Scanner (Model 200) displays a △ (delta) value after taking a minimum of three (3) SEM Values readings. A minimum of four readings were taken to obtain a result during the supporting clinical studies. The reported SEM A is used as an adjunct to the standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.
Image /page/2/Picture/1 description: The image shows two medical devices on a white background. The device on the left is a gray and white handheld device with a screen that reads "bruin BIOMETRICS SEM". An arrow points to the action button on the top of the device, which turns the device on and off and resets readings. The device on the right is a white device with a red button in the center.
- Figure 2. SEM Scanner (Model 200) Top View Figure 2. The electrode on the bottom showing Display and Action Button of the SEM Scanner (Model 200)
Image /page/2/Picture/3 description: The image shows a gray and cream-colored device on a white background. The device has a smooth, rounded shape with a gray top and a cream-colored bottom. There are small, raised dots on the side of the cream-colored part. The device appears to be resting on a small, circular base.
Figure 3. SEM Scanner (Model 200) Side View
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Image /page/3/Figure/0 description: The image shows a Bruin Biometrics device with a screen displaying various information. The screen shows the SEM value as 0.0, a delta symbol, and a status indicator that reads "Ready". There is also a battery gauge and a pressure indicator with yellow and green bars, indicating pressure levels.
Figure 4. SEM Scanner (Model 200) Display (V3.60)
| Item | Function |
|---|---|
| Action Button | Clears SEM readings and turns the Scanner unit ON/OFF. |
| Battery Gauge | Battery icon indicating current battery state of charge |
| △ (Delta) | Calculated difference between the minimum and maximum SEM |
| Values in the set of readings taken | |
| SEM | Display of SEM Value for the last completed reading |
| Pressure Indicator | Bars indicating the applied pressure while taking a SEM reading. The |
| color changes from yellow to green to yellow as applied pressure | |
| increases. Green bars indicate the correct pressure is applied to take the | |
| SEM reading and the SEM Value will show on the screen. | |
| Status Indicator | Number of acquired readings, status indicator, or error messages |
| Table 1. Legend for Figure 4 |
A SEM Value of zero (0.0) shown on the display screen represents when the device is not measuring or when SEM readings are cleared out from the screen.
Product Specifications
| Product Feature | Specification |
|---|---|
| Capacitance Range | (b) (4) |
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| Product Feature | Specification |
|---|---|
| Method of Taking a Reading | Reading is triggered when pressure is applied to the electrodes |
| Battery Source | Operates on a rechargeable lithium ion polymer batter Continuous operation for at least 3 hours Charges using inductively coupled energy transfer in a fully enclosed charging system Includes a temperature detection component that will stop the battery from charging if the battery temperature threshold is exceeded |
| Device Unit Enclosure (“Packaging System”) | Integrated housing enclosure for the electrical components No external connectors No exposed electrically live element IPX1 water ingress protection |
| Electrode System Package Support | Includes an elastomer support for the electrode |
| Environmental Requirements | Device operates over the range of 15 to 35°C at 5 to 90% humidity (non-condensing) |
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The skin-contacting materials, such as the elastomer membrane, rubber, and polyimide materials, were tested to be biocompatible for the intended use of the device. Testing was conducted following FDA's guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"," issued June 16, 2016. Testing included:
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for In . Vitro cytotoxicity
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for . irritation and delayed-type hypersensitivity
The device did not cause an irritating, sensitizing or cytotoxic effect upon the skin.
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SHELF LIFE/REPROCESSING
Cleaning and Disinfection Testing
The device is nonsterile. Cleaning and disinfection testing was conducted following FDA's guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," issued March 17, 2015.
Wear Testing - Repeat Exposure to Cleaning and Disinfection Agents
Wear testing was conducted to assess wear-induced failure of the device components and potential degradation of the seal material or functional performance due to exposure to cleaning agents used during cleaning and disinfection.
ELECTROMAGNETIC CAPABILITY & ELECTROMAGNETIC SAFETY
Electromagnetic Compatibility (EMC) and Electrical Safety verification testing were conducted to confirm the EMC and electrical safety of the device. Testing was conducted in accordance with:
- IEC 60601-1 (3rd edition). Medical Electrical Equipment General Requirements . for safety and essential performance
- EN 60601-1-2:2001/A1:2006, Medical electrical equipment. General . requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
| Test Description | Test Parameter |
|---|---|
| Electrostatic discharge | ±6 contact discharge |
| ± kV air discharge | |
| Radiated, Radiofrequency, | |
| Electromagnetic Field Immunity | Radiated Immunity, 3 V/m, 80 – 2500 MHz, |
| 80% AM at 1 kHz | |
| Electrical Fast Transient/Burst | AC power ports, ±2 kV |
| Surge Immunity | AC power ports, ±1 and ±2 kV |
| Immunity to Conducted Disturbances, | |
| Induced by Radiofrequency Fields | AC power ports, 0.15-80 MHz, 3 Vrms, 80% |
| AM at 1 kHz | |
| Power Frequency Magnetic Field | |
| Immunity | 3 Arms/m |
| Voltage Dips and Short Interruption | |
| Immunity | AC power lines |
| Reduction 30%, 25 periods | |
| Reduction 60%, 5 periods | |
| Reduction 100%, 0.5 periods | |
| Reduction 100%(b) (4) periods |
- · EN 60529-1:1992, Degrees of protection provided by enclosures (IP Code)
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| Test Description | Test Parameter |
|---|---|
| Radiated Emissions - CISPR 11 | Class A |
| Conducted Emissions (AC Mains) - | |
| CISPR 11 | Class A |
Electrical safety testing per EN 60529-1 was also conducted to verify the degree of protection provided by the enclosure against access of persons to hazardous parts, water, and solid foreign objects.
MAGNETIC RESONANCE (MR) COMPATIBILITY
The SEM Scanner (Model 200) has not been tested for MR Compatibility and should not be used in an MRI suite.
SOFTWARE
The agency considers the software to be a minor level of concern (LOC) because inadvertent software errors (e.g., failures or latent design flaws) are unlikely to cause any injury to the patient or operator.
All of the elements of software information as outlined in FDA's guidance documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005) were provided.
Overall, the software documentation included in the De Novo request is in sufficient. detail to provide reasonable assurance that the software will operate in a manner described in the specifications.
SUMMARY OF CLINICAL INFORMATION
A total of 12 study sites. nine US centers and three UK centers, participated in this prospective. multi-site, longitudinal, blinded study. In total, 77.8% of the enrolled subjects were from US centers and 22.2% were from UK centers. This study enrolled a total of 189 subjects, who had provided their written informed consent or by verbal/ written consent of the subjects' legally authorized representative, from April through November 2016.
The study was carried out by a clinical study team at each participating site comprised of a Principal Investigator, Study Coordinator, and individuals acting in study roles of "Generalists" and "Specialists." Daily assessments were limited to up to two assessors within each assessment team. Comprising one team, the "Specialist" was assigned to nursing staff who were the facility's experts on wound care to continue "standard of care" evaluations. The "gold standard" in this case is the clinical judgment of the wound/tissue viability experts.
7
Comprising a second team, the "Generalist" included individuals who did not provide pressure ulcer care to the enrolled subjects and consisted of a wider range of healthcare providers: wound experts, ward nurses, nursing assistants, or medical assistants.
Blinding between assessment teams, the Specialists, was employed. The Study Coordinator acted as the "gate-keeper" to help maintain blinding. In addition to blinding between Specialists and Generalists, the study was also blinded to staff at BBI during enrollments by an independent consultant to BBI (PhD Epidemiologist) managing the Medrio database, an electronic data capture system. The purpose of this study was to compare the SEM Scanner to the current Standard of Care, Visual Skin Assessment (VSA), in identifying patients with tissue at increased risk of developing pressure ulcers at the heels or sacrum.
Enrolled subjects were expected to be evaluated once daily throughout the observation period for a minimum of 6 days to maximum of 21 days upon enrollment or until earlier exit from the study. The minimum of 6 days was selected to optimize the probability of observing an early pressure ulcer should one develop. The maximum of 21 days was selected to set expectations for the study sites on the upper bound for length of participation. The total number of evaluation days include the day of enrollment (day 0).
Daily assessments were performed at the sacrum and both heels unless the anatomical location(s) were not assessable. Daily assessments included:
- Specialist Risk Assessments .
- Specialist Skin Assessment (including pressure ulcer diagnosis) .
- . Generalists SEM Scanner Readings
- . Prevention/Intervention Questionnaire
Primary Endpoint:
Positive Detection is defined as observations of two or more SEM Δ >0.5 from three consecutive series of SEM Scanner readings prior to pressure ulcer diagnosis by clinical judgment of the Specialist. A sensitivity of at least 0.70 is defined for positive detection success as a measure of the primary effectiveness performance.
Negative Detection is defined as observations of two or more SEM Δ 10; or Norton 0.5 | 42 | 87.4% | 77.8%, 96.7% | 124 | 33.0% | 27.6%, 38.7% |
Sensitivity and specificity analysis was performed following an analysis rule of 2 of 3 consecutive observations of a SEM Δ of 0.6 or above ("SEM positive") or SEM Δ of 0.5 or less ("SEM negative") from a five-day window from study exit or when a pressure ulcer is identified by visual skin assessment. This analysis rule was defined before study analysis was performed.
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The study was successful in meeting the sensitivity endpoint of at least 70% for positive detection success. ITT study results demonstrated a sensitivity of 195% CI: (6) (4% -(b) (4) %) for detecting pressure ulcers between the SEM Scanner and clinical judgment per visual skin assessment.
The ITT study results showed a specificity of (97% (95% CI (4) (4) % - (6) (4) %) in this study. This did not meet the specificity endpoint of at least 55% for negative detection success.
Safety Endpoint Results
Of the 189 patients enrolled in this study, there were zero (0%) reports of adverse events related to use of the SEM Scanner device units, which meets the safety endpoint of the study. In total, adverse events from five subjects were reported in this study. Four of the five events were categorized as unrelated, and the remaining one event was because of underlying disease.
Interpretation of the △ Symbol:
-
A A A △ > 0.6 (0.6 and above) at an anatomical site may suggest increased risk for pressure ulcers ("positive")
The A value should be considered in conjunction with other measures of standard of care and clinical judgment.
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
Labeling meets the requirements for prescription use in accordance with 21 CFR § 801.109. Labeling for the device includes the following:
- Instructions on how to operate the device with explanations of user-interface features.
- Instructions to clean and disinfect the device between each patient.
- . A contraindication that the device is not to be used on open wounds, in order to reduce the potential for cross-contamination between patients.
- . A statement indicating that the device is not intended to be used as a standalone device. but rather as an adjunct to clinical judgment. Any decision to intervene or not should be based solely on the experience and expertise of the clinician.
- Information on electrical safety and electromagnetic compatibility.
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RISKS TO HEALTH
The risks associated with the pressure ulcer management tool are adverse tissue reaction, transmission of infection between patients, electromagnetic interference with patient monitoring equipment, and electrical shock. The severity and incidence of these risks to health are relatively low due to the very limited patient contact with the device. As such, general controls are sufficient to mitigate these risks and reasonably assure safety and effectiveness. General controls include but are not limited to good manufacturing practice requirements (21 CFR part 820), including design controls (820.30) due to the inclusion of software, and general labeling (21 CFR part 801).
BENEFIT-RISK DETERMINATION
The SEM Scanner Model 200 is a hand-held, portable device that consists of a single electrode sensor, an integrated pressure sensor, and hardware and software to run a user interface device screen. The risks to health associated with SEM Scanner Model 200 include adverse tissue reaction, transmission of infection between patients, electromagnetic interference with patient monitoring equipment, and electrical shock, none of which occurred in the clinical trial. These risks are considered low and can be mitigated with general controls.
The performance characteristics of this device reveals a sensitivity of 87% and a specificity of 33% in a population at risk for pressure ulcers. These outcomes demonstrate a clinical benefit as an adjunct to standard of care to help identify patients at increased risk for pressure ulcer where further interventions can be beneficial. As stated in the warnings in the labeling, readings from the device should never be used to support reduced intervention compared to standard of care
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The SEM Scanner (Model 200) is intended to be used by healthcare professionals as an adiunct to standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.
The probable benefits outweigh the probable risks for the SEM Scanner (Model 200). The device provides benefits and the risks can be mitigated by the use of general controls.
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CONCLUSION
The De Novo request for the SEM Scanner (Model 200) is granted and the device is classified as follows:
Product Code: QEF Device Type: Pressure ulcer management tool Class: I (Exempt from premarket notification review, subject to limitations in 21 CFR 876.9) Regulation Number: 21 CFR 876.2100