(208 days)
Pollogen STOP U Model UXV
No
The description mentions a programmable logic controller (PLC) and software for operational and safety functions, but there is no mention of AI, ML, or related concepts like training/test sets, image processing, or performance metrics typically associated with AI/ML devices.
Yes
The device is intended for the non-invasive treatment of mild to moderate facial wrinkles, which constitutes a therapeutic purpose.
No
The device description states its purpose is for "non-invasive treatment of mild to moderate facial wrinkles" and it "heats the tissue to improve the appearance of wrinkles," indicating therapeutic rather than diagnostic intent.
No
The device description explicitly states it is a hand-held device consisting of hardware components such as a user interface, PLC (microcontroller embedded in PCBA), RF power module, power supply, and RF electrodes. It generates RF energy through these hardware components.
Based on the provided information, the CurrentBody Skin RF (ST030) device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the non-invasive treatment of facial wrinkles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device generates radiofrequency energy to heat tissue and improve the appearance of wrinkles. This is a physical treatment method, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. The CurrentBody Skin RF device operates externally on the skin for a cosmetic/therapeutic effect.
N/A
Intended Use / Indications for Use
The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.
Product codes
PAY
Device Description
The CurrentBody Skin RF device is an OTC, home-use hand-held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:
- . User Interface
- Programmable logic controller (PLC, microcontroller) embedded in PCBA .
- RF power module ●
- . Power Supply
- RF electrodes .
The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
Technical specifications:
- Maximal power output: 5±1 Watt. ●
- . Frequency: 1±0.05 MHz
- Maximal temperature allowed: 40.5 ± 0.5ºC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial wrinkles
Indicated Patient Age Range
adults
Intended User / Care Setting
Intended Operator: Lay Person
Intended Operating Environment: Home Use Device
over-the-counter home-use device
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 following performance data (bench tests) were provided in support of the performance, safety and efficacy of the CurrentBody Skin RF device as well as the substantial equivalence determination.
Safety Bench Tests and Verification & Validation (V&V) Summary
- . Over-heating safety. The two redundant thermistors embedded in the device constantly measure the skin temperature and constantly alter the power emitted to maintain the temperature constant within the target treatment temperature range (maximal temperature of 40.5 ± 0.5ºC). Power accuracy. The device was validated on a 200 Ω load, which is appropriate as the reference of the average load of the user. The measured total power was within the error margin, indicating that the device met the acceptance criteria.
- Parameter validation. The device was tested for its varied parameters, ● including radio frequency, pulse cycle, wave form and pulse duration. All results were within the acceptance criteria.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the CurrentBody Skin RF device. The device complies with:
- IEC 60601-1:2005/EN 60601-1:2006, General safety standard: safety . requirements for medical electrical systems.
- IEC 60601-1-2:2014/EN 60601-1-2:2015, Medical electrical equipment . Part 1-2 - General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-1-11:2015, Medical electrical equipment Part 1-11 -. Requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 60601-2-2: 2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern because inadvertent software errors could result in skin burns to the user.
Human Factors Validation Testing
A Self-Selection and Human Factors validation study was performed to demonstrate that users can safely and effectively self-select, prepare and perform treatment with the CurrentBody Skin RF device.
Thermal Effects on porcine belly skin
In order to provide further evidence for the equivalence of the spatio-temporal heating profile of the subject and predicate devices, a bench experiment was conducted in porcine belly skin samples instrumented with multiple calibrated temperature probes. Measurements showed comparable (near identical) spatiotemporal tissue heating between the subject and predicate devices.
Thus, the CurrentBody Skin RF device can be regarded as thermally equivalent to the approved Pollogen STOP U Model UXV device and no risks are raised regarding the safety and efficacy of the device.
No animal testing was performed with the subject device.
No clinical testing was performed with the subject device, as it is substantially equivalent to the predicate device, and thus requires no additional clinical data to prove its safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4420 Electrosurgical device for over-the-counter aesthetic use.
(a)
Identification. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance data must demonstrate that the device meets all design specifications and performance requirements. The following performance characteristics must be tested: Over-heating, power accuracy radiofrequency, pulse cycle, waveform, pulse duration, and device characterization parameters.
(2) Label comprehension and self-selection performance evaluation must demonstrate that the intended over-the-counter users can understand the package labeling and correctly choose the device for the indicated aesthetic use.
(3) Usability performance evaluation must demonstrate that the over-the-counter user can correctly use the device, based solely on reading the directions for use, to treat the indicated aesthetic use.
(4) Clinical performance evaluation must demonstrate that the device performs as intended under anticipated conditions of use to achieve the intended aesthetic results.
(5) The patient-contacting components of the device must be demonstrated to be biocompatible.
(6) Instructions for cleaning the device must be validated.
(7) Performance data must be provided to demonstrate the electromagnetic compatibility and electrical safety, including the mechanical integrity, of the device.
(8) Software verification, validation, and hazard analysis must be performed.
(9) Labeling must include:
(i) Warnings, precautions, and contraindications to ensure the safe use of the device for the over-the-counter users.
(ii) A statement that the safety and effectiveness of the device's use for uses other than the indicated aesthetic use are not known.
(iii) A summary of the clinical information used to establish effectiveness for each indicated aesthetic usage and observed adverse events.
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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 6, 2024
EL Global Trade Ltd. Sivan Fishman RA/QA Manager 6th Ha-Gavish St. Netanya, 4250706 Israel
Re: K232424
Trade/Device Name: CurrentBody Skin RF Regulation Number: 21 CFR 878.4420 Regulation Name: Electrosurgical Device For Over-The-Counter Aesthetic Use Regulatory Class: Class II Product Code: PAY Dated: February 5, 2024 Received: February 6, 2024
Dear Sivan Fishman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (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 website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/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, Digitally signed by Mark Mark Trumbore -S Date: 2024.03.06 15:31:16
-05'00' Trumbore -S Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233705
Device Name CurrentBody Skin RF (ST030)
Indications for Use (Describe)
The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
1. DATE PREPARED: March 3RD, 2024
510(K) OWNER NAME 2.
EL Global Trade Ltd. 6th Ha-Gavish St., Netanya 4250706, Israel. Phone: +972-9-7889069, Fax: +972-9-7734831.
Contact person name: Sivan Fishman, RA/QA Manager Phone: +972-54-5223677, Fax: +972-9-7734831 E mail: sivanf(@sensica.com
3. DEVICE NAME
Common/Usual Name: OTC device for skin tightening based on RF
Proprietary/Trade Name: CurrentBody Skin RF
Model Name: ST030
Classification: EL Global Trade Ltd.'s CurrentBody Skin RF device has been classified as Class II device under the following classification names:
| Classification Name | Product
Code | Regulation
Number | Panel |
|-----------------------------------------------------------------------|-----------------|----------------------|--------------------------------|
| Electrosurgical device
for over-the-counter
(OTC) aesthetic use | PAY | 878.4420 | General and Plastic
Surgery |
4. PREDICATE DEVICES
EL Global Trade Ltd.'s CurrentBody Skin RF device is substantially equivalent to the following Predicate Device:
Pollogen Stop U Model UXV device,
cleared under 510(k) number K220322 on May 4th, 2023.
ട്. DEVICE DESCRIPTION
4
The CurrentBody Skin RF device is an OTC, home-use hand-held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:
- . User Interface
- Programmable logic controller (PLC, microcontroller) embedded in PCBA .
- RF power module ●
- . Power Supply
- RF electrodes .
The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
Technical specifications:
- Maximal power output: 5±1 Watt. ●
- . Frequency: 1±0.05 MHz
- Maximal temperature allowed: 40.5 ± 0.5ºC.
INTENDED USE/ INDICATIONS FOR USE 6.
5
The CurrentBody Skin RF device is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.
7. NON-CLINICAL (BENCH) PERFORMANCE DATA
The following performance data (bench tests) were provided in support of the performance, safety and efficacy of the CurrentBody Skin RF device as well as the substantial equivalence determination.
Safety Bench Tests and Verification & Validation (V&V) Summary
- . Over-heating safety. The two redundant thermistors embedded in the device constantly measure the skin temperature and constantly alter the power emitted to maintain the temperature constant within the target treatment temperature range (maximal temperature of 40.5 ± 0.5ºC). Power accuracy. The device was validated on a 200 Ω load, which is appropriate as the reference of the average load of the user. The measured total power was within the error margin, indicating that the device met the acceptance criteria.
- Parameter validation. The device was tested for its varied parameters, ● including radio frequency, pulse cycle, wave form and pulse duration. All results were within the acceptance criteria.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the CurrentBody Skin RF device. The device complies with:
- IEC 60601-1:2005/EN 60601-1:2006, General safety standard: safety . requirements for medical electrical systems.
6
- IEC 60601-1-2:2014/EN 60601-1-2:2015, Medical electrical equipment . Part 1-2 - General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-1-11:2015, Medical electrical equipment Part 1-11 -. Requirements for the medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . IEC 60601-2-2: 2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern because inadvertent software errors could result in skin burns to the user.
Human Factors Validation Testing
A Self-Selection and Human Factors validation study was performed to demonstrate that users can safely and effectively self-select, prepare and perform treatment with the CurrentBody Skin RF device.
Thermal Effects on porcine belly skin
In order to provide further evidence for the equivalence of the spatio-temporal heating profile of the subject and predicate devices, a bench experiment was conducted in porcine belly skin samples instrumented with multiple calibrated
7
temperature probes. Measurements showed comparable (near identical) spatiotemporal tissue heating between the subject and predicate devices.
Thus, the CurrentBody Skin RF device can be regarded as thermally equivalent to the approved Pollogen STOP U Model UXV device and no risks are raised regarding the safety and efficacy of the device.
8. PERFORMANCE TESTING - ANIMAL
No animal testing was performed with the subject device.
9. CLEANING, STERILIZATION, SHELF LIFE AND BIOCOMPATIBILITY
The CurrentBody Skin RF device is a non-sterile, reusable device, intended for a single user. The device cleaning instructions are based on the cleaning instructions of the predicate device due to the fact that both devices are made from the same materials and used similarly.
The shelf-life expectancy of the device is 5 years, similarly to the predicate device.
The biocompatibility evaluation for the CurrentBody Skin RF device was conducted in accordance with the FDA guidance "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.'" September 8, 2023, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
10. CLINICAL PERFORMANCE DATA
No clinical testing was performed with the subject device, as it is substantially equivalent to the predicate device, and thus requires no additional clinical data to prove its safety and efficacy.
8
11. SUBSTANTIAL EQUIVALENCE
The indications for use and technological characteristics of the CurrentBody Skin RF device are substantially equivalent to the indications for use and technological characteristics of the predicate device, as can be seen in the technology comparison table below.
The design and components of both devices (i.e., power supply, RF generator and controller) are similar. The performance specifications of the CurrentBody Skin RF (i.e., RF frequency and electrical power) are substantially equivalent to those of the predicate device. The safety features and compliance with safety standards of both are similar. The body contact materials are similar. The minor differences in the technological characteristics do not raise new safety or effectiveness concerns and are demonstrated to be substantially equivalent through relevant performance tests. Furthermore, the CurrentBody Skin RF device has qualified with varied performance tests, including software validation testing, electrical and mechanical safety testing according to IEC 60601-1, electromagnetic compatibility testing according to IEC 60601-1-2, compatibility as medical electrical equipment for home healthcare environment according to 60601-1-11, and high frequency of surgical equipment according to IEC 60601-2-2. The performance tests demonstrated that the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.
9
| Feature | EL Global
CurrentBody Skin RF
[K232424]
New Device | Pollogen
STOP U Model UXV
[K220322]
Predicate Device |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | El Global Trade Ltd. | Pollogen Ltd. |
| Device Class | Class II | Class II |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery |
| Product code | PAY | PAY |
| Regulation number | 21 CFR 878.4420 | 21 CFR 878.4420 |
| Device type | Over-The-Counter Radiofrequency
Coagulation Device For Wrinkle
Reduction | Over-The-Counter Radiofrequency
Coagulation Device For Wrinkle
Reduction |
| Regulation description | Electrosurgical device for over-the-
counter aesthetic use | Electrosurgical device for over-the-
counter aesthetic use |
| Intended use | The CurrentBody Skin RF is an over-
the-counter home use device intended
for non-invasive treatment of mild to
moderate facial wrinkles for adult
users who have Fitzpatrick Skin
Types I-IV. | The Stop U Model UXV Skin RF is
an over-the-counter home use device
intended for non-invasive treatment of
mild to moderate facial wrinkles for
adult users who have Fitzpatrick Skin
Types I-IV. |
| Deep Tissue Heating
Electromagnetic
Energy | RF | RF |
| Mode of Operation | RF Bipolar Energy | RF Bipolar Energy |
| Mechanism of
Operation | The device is a home-use hand-held
device generating pulses of RF energy
that is emitted into the skin. RF
energy heats the tissue to improve the
appearance of wrinkles and rhytides.
It is a non-invasive and non-ablative
device. | The device is a home-use hand-held
device generating pulses of RF energy
that is emitted into the skin. RF
energy heats the tissue to improve the
appearance of wrinkles and rhytides.
It is a non-invasive and non-ablative
device. |
| RF Carrier Frequency | 1 MHz RF (Bi-polar) | 1 MHz RF (Bi-polar) |
| Operating RF Power
(200 Ohms) | $5W \pm 1$ | $5.7W \pm 10%$ |
| Waveform | Sinusoid | Sinusoid |
| Number of electrodes | 4 round electrodes (2 pairs of Bi-polar
electrodes). | 4 round electrodes (2 pairs of Bi-polar
electrodes). |
| Electrode Diameter | 6mm | 6mm |
| Intended population | Adult healthy men and women
(Fitzpatrick skin type I-IV) who desire
to reduce facial wrinkles. | Adult healthy men and women
(Fitzpatrick skin type I-IV) who desire
to reduce facial wrinkles. |
| Feature | EL Global
CurrentBody Skin RF
[K232424]
New Device | Pollogen
STOP U Model UXV
[K220322]
Predicate Device |
| Intended Operating
Environment | Home Use Device | Home Use Device |
| Intended Operator | Lay Person | Lay Person |
| Dimensions, (LXHXW)
[mm³] | 145 X 45 X 42 | 134 X 51 X 32 |
| Weight [gr] | 96 | 85 |
| Applicator Effective
Area | 1 cm² | 1 cm² |
| Total Power Density
(fluence) | $5 W/cm^2 \pm 1$ | $5.7 W/cm^2 \pm 10%$ |
| Distance Between
Electrodes | 1 cm | 1 cm |
| Penetration Depth | ~0.5 cm | ~0.5 cm |
| Body contact materials | ABS plastic shell.
Chrome coated electrodes. | ABS plastic shell.
Chrome coated electrodes. |
| Heating Levels | 1 energy level
(5 ± 1 W) | 1 energy level
(5.7W ± 10%). |
| RF Energy Emission
Indicator | Yes (Temperature sensors) | Yes (Temperature sensor) |
| Electrical requirements | 100-240 V,
50-60 Hz
9 V, 1.5 A | 100-240 V
50-60 Hz
8 V, 1.5 A |
| Biocompatibility | All parts that are in contact with
patient comply with the requirements
of ISO 10993-1. | All parts that are in contact with
patient comply with the requirements
of ISO 10993-1. |
| Software | Verified and validated, according to
the FDA guidance. | Verified and validated, according to
the FDA guidance. |
| Testing | Electrical safety & EMC, usability
study | Electrical safety & EMC, usability
study |
10
12. CONCLUSIONS
Based on the performance testing and comparison to predicate devices, the CurrentBody Skin RF device is substantially equivalent to the previously cleared Pollogen Stop U Model UXV predicate device.