STELLA BIO
Device Facts
| Record ID | K210002 |
|---|---|
| Device Name | STELLA BIO |
| Applicant | Egzotech Sp. Z O. O. |
| Product Code | IPF · Physical Medicine |
| Decision Date | Oct 1, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
For Prescription and Home Use by prescription from a medical professional: The Stella BIO is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions. As a powered muscle stimulator, Stella BIO is indicated for the following conditions: - Relaxation of muscle spasms, - Prevention or retardation of disuse atrophy, - Increasing local blood circulation, - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, - Maintaining or increasing range of motion, - Muscle re-education. As a transcutaneous electrical nerve stimulator for pain relief, Stella BIO is indicated for the following conditions: - Symptomatic relief and management of chronic (long-term), intractable pain, - Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain. As a biofeedback device, Stella BIO is indicated for: - Biofeedback, relaxation, and muscle re- education. As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions: - Helps to relearn voluntary motor functions of the extremities. As a non-implanted electrical continence device, Stella BIO is indicated for the following conditions: • Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles. • Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles.
Device Story
Stella BIO is a battery-powered, wireless neuromuscular stimulator; used in clinics, hospitals, or home environments by patients under medical prescription. Device inputs include EMG signals from pelvic floor/accessory muscles; device processes these via internal software to provide electrical stimulation (EMS, TENS, FES, biofeedback). Output is delivered via electrodes to the patient. Healthcare providers use software to adjust, monitor, and progress therapy; patients follow prescribed programs. Device benefits include muscle re-education, pain management, and improved urinary control. System includes mobile software (PC/tablet/smartphone) for therapy management and statistics retrieval.
Clinical Evidence
Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11), EMC (IEC 60601-1-2), battery safety (IEC 62133-2), software validation (IEC 62304), usability (IEC 62366), risk management (ISO 14971), and biocompatibility (ISO 10993-1).
Technological Characteristics
Battery-powered (Li-Ion 7.4V), wireless device. Housing: injection-molded ABS plastic. Waveforms: biphasic symmetrical (rectangular, triangular, trapezoidal). Connectivity: Bluetooth/Wi-Fi (FCC ID: 2AC7Z-ESP WROOM 32). Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62133, ANSI/AAMI NS4.
Indications for Use
Indicated for adults aged 22+ for muscle spasm relaxation, disuse atrophy prevention, blood circulation, post-surgical calf stimulation, range of motion maintenance, muscle re-education, chronic/post-surgical/post-traumatic pain relief, biofeedback, motor function relearning, and urinary incontinence treatment (stress, urge, mixed).
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Predicate Devices
- Stiwell med4 (K080950)
Related Devices
- K202648 — Biofeedback Nerve and Muscle Stimulator · Shenzhen Konmed Technology Co., Ltd. · Dec 8, 2020
- K080950 — STIWELL MED4 · Otto Bock, Austria GmbH · Apr 2, 2009
- K053434 — MYOTRAC INFINITI ELECTRICAL STIMULATOR · Thought Technology , Ltd. · Mar 15, 2006
- K213043 — Levator Elite (Model LE9011) · Shenzhen Dongdixin Technology Co., Ltd. · Feb 25, 2022
- K201290 — Medline DeNovo 4Pro Electrical Stimulation Device · Medline Industries, Inc. · Sep 21, 2020
Submission Summary (Full Text)
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October 1, 2021
EGZOTech Sp. z o. o. % Vaibhav Rajal Official Correspondent for EGZOTech Sp. z o.o. mdi Consultants. Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K210002
Trade/Device Name: Stella Bio Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF. GZJ. HCC. GZI. KPI Dated: September 3, 2021 Received: September 3, 2021
Dear Vaibhav Rajal:
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
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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 medical devices and radiation-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,
Patrick Antkowiak, PhD Assistant Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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) K210002
Device Name STELLA BIO
Indications for Use (Describe)
For Prescription and Home Use by prescription from a medical professional:
The Stella BIO is a neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions
As a powered muscle stimulator, Stella BIO is indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation,
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- · Maintaining or increasing range of motion,
- · Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief. Stella BIO is indicated for the following conditions:
- · Symptomatic relief and management of chronic (long-term), intractable pain,
- · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
As a biofeedback device, Stella BIO is indicated for:
· Biofeedback, relaxation and muscle re-education.
As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions: · Helps to relearn voluntary motor functions of the extremities.
As a non-implanted electrical continence device, Stella BIO is indicated for the following conditions:
· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
· Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles.
Patient population: Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older.
Environments of Use: Clinics, hospital and home environments.
Platform: Stella BIO is a battery-powered, wireless device, accessible through software.
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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Image /page/4/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, triangular shape on the left, and the text "EGZO Tech" on the right. The triangular shape is made up of three curved lines that intersect in the center. The text is in a bold, sans-serif font, with "EGZO" in a larger font size than "Tech".
# 510(k) SUMMARY
The assigned 510(k) number is: K210002
# Submitter's Identification:
| Submitter's Name and Address: | EGZOTech Sp. Z.o.o.<br>Romualda Traugutta 6h<br>44-100 Gliwice, Poland |
|-------------------------------|------------------------------------------------------------------------|
| Contact Person: | Dr. Michal Mikulski<br>Chief Executive Officer |
| Telephone: | +48 32 750 49 45 |
| Email: | fda@egzotech.com |
| Date: | October 1, 2021 |
#### Name of the Device:
Stella BIO Trade Name:
FDA Product Codes, Common Name, Regulation Description and Regulation Number:
| FDA Product<br>Code | Common Name | Regulation Description | Regulation<br>Number |
|---------------------|---------------------------------------------------------------|----------------------------------------------------------------|----------------------|
| IPF | Stimulator, Muscle, Powered | Powered muscle stimulator | 890.5850 |
| GZJ | Stimulator, Nerve,<br>Transcutaneous, For Pain Relief | Transcutaneous electrical nerve<br>stimulator for pain relief. | 882.5890 |
| HCC | Device, Biofeedback | Biofeedback device. | 882.5050 |
| GZI | Stimulator, Neuromuscular,<br>External Functional | External functional neuromuscular<br>stimulator. | 882.5810 |
| KPI | Stimulator, Electrical, Non-<br>Implantable, For Incontinence | Nonimplanted electrical<br>continence device. | 876.5320 |
### Information for the 510(k) Cleared Device (Predicate Device):
## Predicate Device for Prescription and Home Use by prescription from a medical professional:
| 510(k)<br>number | Predicate<br>device | Manufacturer | Regulation<br>Number | Product Code | Clearance Date |
|------------------|---------------------|----------------------|----------------------|--------------|----------------|
| K080950 | Stiwell med4 | Otto Bock Healthcare | 890.5850 | IPF, GZJ, | 2009-04-02 |
EGZOTech Sp. z o.o., ul. Romualda Traugutta 6H, 44-100 Gliwice, Poland Telephone: 0048 32 750 49 45 ; e-mail: office@egzotech.com ; https://egzotech.com; REF: 001 510(k) Summary 4 dated 2021-05-07 09:35
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Image /page/5/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, triangular shape on the left, and the text "EGZO Tech" on the right. The triangular shape is made up of three curved lines that intersect in the center, forming a sort of pinwheel design. The text is in a bold, sans-serif font.
| Product GmbH<br>Kaiserstrasse 39<br>1070 Vienna<br>Austria | HCC, GZI, KPI |
|------------------------------------------------------------|---------------|
|------------------------------------------------------------|---------------|
# Applicable FDA Product Codes, Common Name, Regulation Description and Regulation Number for the Predicate Device:
| FDA Product<br>Code | Common Name | Regulation Description | Regulation<br>Number |
|---------------------|---------------------------------------------------------------|----------------------------------------------------------------|----------------------|
| IPF | Stimulator, Muscle, Powered | Powered muscle stimulator | 890.5850 |
| GZJ | Stimulator, Nerve,<br>Transcutaneous, For Pain Relief | Transcutaneous electrical nerve<br>stimulator for pain relief. | 882.5890 |
| HCC | Device, Biofeedback | Biofeedback device. | 882.5050 |
| GZI | Stimulator, Neuromuscular,<br>External Functional | External functional neuromuscular<br>stimulator. | 882.5810 |
| KPI | Stimulator, Electrical, Non-<br>Implantable, For Incontinence | Nonimplanted electrical<br>continence device. | 876.5320 |
# Device Description:
The Stella BIO is a neuromuscular electronic stimulator, non-implantable incontinence device and biofeedback device, designed for stationary use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient.
Stella BIO is a single presentation device (one hardware) with a single software for Prescription and Home Use by prescription from a medical professional.
For the Prescription and Home Use by prescription from a medical professional Software License, the medical professional has the ability to adjust, monitor and progress the therapy. This License comes with two User Manuals:
- User Manual for the medical professionals (including instructions on how to adjust parameters ● of the programs and prescribe exercises for patients)
- User Manual for the patient (including instruction on how to use programs prescribed and adjusted by the medical professional)
The Stella BIO is a battery-powered, wireless device, accessible through software on a mobile device (PC, tablet or smartphone). Statistics reqarding the completed treatment can be retrieved from the PC.
In order to gain a proper understanding of Stella BIO, it is important to read the manual before beginning to use the Stella BIO.
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Image /page/6/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized symbol on the left and the text "EGZO Tech" on the right. The symbol is a geometric shape with three curved lines intersecting at a central point. The text is in a bold, sans-serif font, with "EGZO" in a darker shade than "Tech".
### Indications for Use
#### For Prescription and Home Use by prescription from a medical professional:
The Stella BIO is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator, Stella BIO is indicated for the following conditions:
- · Relaxation of muscle spasms,
- · Prevention or retardation of disuse atrophy,
- · Increasing local blood circulation.
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis,
- Maintaining or increasing range of motion,
- Muscle re-education.
As a transcutaneous electrical nerve stimulator for pain relief, Stella BIO is indicated for the following conditions:
- Symptomatic relief and management of chronic (long-term), intractable pain,
- · Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain.
As a biofeedback device, Stella BIO is indicated for:
- · Biofeedback, relaxation, and muscle re- education.
As an external functional neuromuscular stimulator, Stella BIO is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities.
As a non-implanted electrical continence device, Stella BIO is indicated for the following conditions: • Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: inhibition of the detrusor muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
· Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as abdominal and the gluteus muscles.
Patient population: Stella BIO Prescription and Home Use by prescription from a medical professional can be used on adults aged 22 yrs and older.
Environments of Use: Clinics, hospital and home environments.
Platform: Stella BIO is a battery-powered, wireless device, accessible through software.
### Comparison to the 510(k) Cleared Devices (Predicate Devices)
| Basic Device Characteristics | | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Characteristics /<br>Specification | New Device | Predicate | Difference |
| 510(k) Number | K210002 | K080950 | N/A |
| Manufacturer | EGZOTech | Otto Bock | N/A |
| Device Name,<br>Model | Stella BIO | STIWELL med4 | N/A |
| Prescription or<br>OTC | Prescription and Home Use | Prescription | Same |
| Product codes | IPF, GZJ, HCC, GZI, KPI | IPF, GZJ, HCC, GZI, KPI | Same |
| Classification | Class II | Class II | Same |
| Indications For Use<br>Statement | For Prescription and Home<br>Use by prescription from a<br>medical professional: | For Prescription: | |
| | The Stella BIO is a<br>neuromuscular electronic<br>stimulator indicated for use<br>under medical supervision for<br>adjunctive therapy in the<br>treatment of medical diseases<br>and conditions | The STIWELL med4 is a<br>neuromuscular electronic<br>stimulator indicated for use<br>under medical supervision for<br>adjunctive therapy in the<br>treatment of medical diseases<br>and conditions. | |
| | As a powered muscle<br>stimulator, Stella BIO is<br>indicated for the following<br>conditions:<br>- Relaxation of muscle<br>spasms,<br>- Prevention or retardation of<br>disuse atrophy,<br>- Increasing local blood<br>circulation,<br>- Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis,<br>- Maintaining or increasing<br>range of motion.<br>- Muscle re-education, | As a powered muscle<br>stimulator the STIWELL med4<br>is indicated for the following<br>conditions:<br>- Relaxation of muscle spasms,<br>- Prevention or retardation of<br>disuse atrophy,<br>- Increasing local blood<br>circulation,<br>- Muscle re-education,<br>- Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis,<br>- Maintaining or increasing<br>range of motion. | |
| | As a transcutaneous electrical<br>nerve stimulator for pain relief,<br>Stella BIO is indicated for the<br>following conditions:<br>- Symptomatic relief and<br>management of chronic (long-<br>term), intractable pain,<br>- Adjunctive treatment in the<br>management of post-surgical<br>pain and post traumatic acute | As a transcutaneous electrical<br>nerve stimulator for pain relief<br>the STIWELL med4 is<br>indicated for the following<br>conditions:<br>- Symptomatic relief and<br>management of chronic (long-<br>term), intractable pain,<br>- Adjunctive treatment in the<br>management of post-surgical | |
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Image /page/7/Picture/0 description: The image shows the logo for EGZOTech. The logo consists of a stylized symbol on the left and the text "EGZOTech" on the right. The symbol is a geometric shape with three curved lines intersecting at a central point. The text is in a bold, sans-serif font.
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Image /page/8/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized symbol on the left and the text "EGZO Tech" on the right. The symbol is a geometric shape with three curved lines intersecting at a central point. The text is in a bold, sans-serif font.
| pain. | pain and post traumatic acute<br>pain. |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| As a biofeedback device Stella<br>BIO is indicated for:<br>- Biofeedback, relaxation and<br>muscle re- education<br>purposes. | As a biofeedback device the<br>STIWELL med4 is indicated for:<br>- Biofeedback, relaxation and<br>muscle re- education purposes. |
| As an external functional<br>neuromuscular stimulator<br>Stella BIO is indicated for the<br>following conditions:<br>- Helps to relearn voluntary<br>motor functions of the<br>extremities. | As an external functional<br>neuromuscular stimulator the<br>STIWELL med4 is indicated for<br>the following conditions:<br>- Helps to relearn voluntary<br>motor functions of the<br>extremities. |
| As a non-implanted electrical<br>continence device, Stella BIO<br>is indicated for the following<br>conditions:<br>- Acute and ongoing treatment<br>of stress, urge or mixed urinary<br>incontinence and where the<br>following results may improve<br>urinary control: inhibition of the<br>detrusor muscles through<br>reflexive mechanisms and<br>strengthening of pelvic floor<br>muscles.<br>- Incontinence treatment for<br>assessing EMG activity of the<br>pelvic floor and accessory<br>muscles such as abdominal<br>and the gluteus muscles. | As a non-implanted electrical<br>continence device the<br>STIWELL med4 is indicated for<br>the following conditions:<br>- Acute and ongoing treatment<br>of stress, urge or mixed urinary<br>incontinence and where the<br>following results may improve<br>urinary control: inhibition of the<br>detrusor muscles through<br>reflexive mechanisms and<br>strengthening of pelvic floor<br>muscles.<br>- Incontinence treatment for<br>assessing EMG activity of the<br>pelvic floor and accessory<br>muscles such as abdominal<br>and the gluteus muscles. |
| Patient population: Stella BIO<br>Prescription and Home Use by<br>prescription from a medical<br>professional can be used on<br>adults aged 22 yrs and older.<br>Environments of Use: Clinics,<br>hospital and home<br>environments. | |
| Platform: Stella BIO is a<br>battery-powered, wireless<br>device, accessible through<br>software. | |
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Image /page/9/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, abstract symbol on the left, resembling three interconnected shapes forming a triangular design. To the right of the symbol is the text "EGZO Tech", with "EGZO" in a bold, sans-serif font and "Tech" in a lighter weight font.
| Environment of<br>Use | Clinics, hospital and home<br>environments | Clinics, hospital and home<br>environments | Same |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|---------------------|
| Patient population | Adults 22 yrs and older | Adults | Same |
| Power Source | Battery Pack Li-Ion 7,4 V | Battery Pack Li-lon<br>11,1 V | Different<br>Note 1 |
| Method of Line<br>Current Isolation | N/A (Battery) | Medical Class II Power Adapter<br>- Mascot (12,6VDC-15,1W) | Different<br>Note 1 |
| Patient Leakage<br>Current<br>(normal condition,<br>μΑ ) | N/A<br>Battery Operated Device<br>(<100µA patient leakage) | N/A<br>Battery Operated Device<br>(<100µA patient leakage) | Same |
| Patient Leakage<br>Current<br>(single fault<br>condition) | N/A<br>Battery Operated Device<br>(<100µA patient leakage) | N/A<br>Battery Operated Device<br>(<100µA patient leakage) | Same |
| Number of Output<br>Modes | 4<br>(EMS, TENS, Biofeedback,<br>Incontinence) | 1 | Different<br>Note 2 |
| Software/<br>Firmware/<br>Microprocessor<br>control | YES | YES | Same |
| Automatic<br>Overload Trip | YES | YES | Same |
| Automatic No-Load<br>Trip | YES | YES | Same |
| Automatic Shut Off | YES (10 min) | YES (10 min) | Same |
| Patient Override<br>Control | YES (Button) | YES (Stop Button) | Same |
| Indicator Display:<br>On/Off Status | YES | YES | Same |
| Indicator Display:<br>Low Battery | YES | YES | Same |
| Indicator Display:<br>Voltage/Current<br>Level | YES | YES | Same |
| Compliance with<br>Voluntary<br>Standards | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11<br>IEC 62304<br>IEC 62366<br>IEC 62133<br>ANSI/AAMI NS4 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | Different<br>Note 3 |
| Compliance with 21<br>CFR 898 | YES | YES | Same |
| Weight | 112 g | 440 g | SE<br>Note 4 |
| Dimension<br>(WxHxL) in [mm] | 91.5 x 68.4 x 24 mm | 175 x 95 x 30 mm | SE<br>Note 4 |
| Housing material<br>and Construction | Plastic<br>(Injection Molded ABS) | Plastic<br>(Injection Molded ABS) | Same |
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Image /page/10/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized symbol on the left and the text "EGZO Tech" on the right. The symbol is a geometric shape with three curved lines intersecting at a central point. The text "EGZO Tech" is in a sans-serif font, with "EGZO" in a bold font and "Tech" in a regular font.
Substantial Equivalence discussion and Differences analysis for Basic Device Characteristics -Comparison with the predicate Device:
#### ● Note 1 : "Power Source" and "Method of Line Current isolation"
The predicate device as well as the subject device are battery powered. Although the battery provided by the new device is different from the battery of the predicate device, it is compliant with IEC 62133 standard. Moreover, the new device is IEC 60601-1 compliant and has been tested for electrical safety with a positive result. Because the new device is battery powered it doesn't require methods of line current isolation and patient leakage current is not applicable. Therefore differences in power source doesn't influence essential performance or basic safety, as well as doesn't impact substantial equivalence to the predicate device.
#### . Note 2: "Number of Output Modes"
Although the "Number of Output Modes" is different from the predicate device they all comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence.
#### . Note 3: "Voluntary Standards"
The new device complies with the same voluntary standards as the predicate device as well as additional standard ANSI/AAMI NS4. All voluntary standards are recognized FDA standards and this change difference doesn't impact essential performance, basic safety or substantial equivalence.
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Image /page/11/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, geometric shape on the left and the text "EGZO Tech" on the right. The geometric shape is composed of three curved lines that intersect to form a triangular shape with a circular element in the center. The text "EGZO Tech" is written in a bold, sans-serif font.
#### Note 4: Weight" and "Dimensions" .
Although "Weight" and "Dimensions" of subject device are different from the predicate device, they all comply with IEC 60601-1, IEC 60601-2-10 and IEC 60601-1-11 requirements, thus the differences of the function specifications does not raise any safety or effectiveness issue.
# Powered Muscle Stimulator Designation Comparison of Proposed New Device and Predicate Device
| Powered Muscle Stimulator | | | | |
|---------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------|-------------------------------|--|
| Characteristics/<br>Specifications | New Device | Predicate | Difference<br>s: | |
| 510(k) Number | K210002 | K0809050 | N/A | |
| Manufacturer | EGZOTech | Otto Bock | N/A | |
| Device Name,<br>Model | Stella BIO | STIWELL med4 | N/A | |
| Treatment Time<br>Range [min] | 1 - 60 min | 2 - 120 min | Different<br>Note<br>1<br>PMS | |
| Number of Output<br>Channels | Up to 8 | 4 | Different<br>Note<br>2<br>PMS | |
| | EMG Specifications | | | |
| Number of EMG<br>Channels | Up to 8 | Up to 4 | Different<br>Note EMG | |
| EMG sensitivity | 0.5 μV | 1 μV | Different<br>Note EMG | |
| EMG detection<br>(bipolar/monopola<br>r) | Bipolar | Bipolar | Same | |
| EMG Sampling<br>Rate | Up to 4 kHz | 3 kHz | Different<br>Note EMG | |
| EMG range (µV) | ± 6 000 μV | 1 - 2000 μV | Different<br>Note EMG | |
| EMG bandwidth | 0 - 2 kHz pre-filtering<br>20 - 100 Hz post | 70-480 Hz | Different<br>Note EMG | |
| EMG signal<br>processing (e.g.<br>RMS) | RMS (Root Mean Square) | AVR (Average Retched Value) | Different<br>Note EMG | |
| Synchronous or<br>Alternating | Synchronous | Alternating | Different<br>Note EMG | |
| Method of<br>Channel Isolation | Multiplexer | Transformer, Inductive couplers | Different<br>Note EMG | |
| Regulated Current<br>or Regulated<br>Voltage | Regulated Current | Regulated Current | Same | |
| Output Specifications | | | | |
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same | |
| Shape | Rectangular,<br>triangular,<br>trapezoidal, sinusoidal | Rectangular | Different<br>Note<br>3<br>PMS | |
| Maximum Output<br>Voltage (500Ω) | 50 V | 50 V | Different<br>Note<br>4<br>PMS | |
| Maximum Output<br>Voltage (2kΩ) | 60 V | 115 V | Different<br>Note<br>4<br>PMS | |
| Maximum Output<br>Voltage (10kΩ) | N/A | N/A | Different<br>Note<br>4<br>PMS | |
| Maximum Output<br>Current (500Ω) | 100 mA | 100 mA | Different<br>Note<br>4<br>PMS | |
| Maximum Output<br>Current (2kΩ) | 30 mA | 50 mA | Different<br>Note<br>4<br>PMS | |
| Maximum Output<br>Current (10kΩ) | N/A | N/A | Different<br>Note<br>4<br>PMS | |
| Pulse Width<br>(specialty units) | 50 µs - 400 µs | 50 µs - 400 µs | Same | |
| Frequency (Hz) | 1 Hz - 140 Hz | 1 - 140 Hz | Same | |
| For interferential | N/A | N/A | Same | |
| modes only: Beat<br>Frequency (Hz) | | | | |
| For multiphasic<br>waveforms only:<br>Symmetrical<br>phases? | N/A | N/A | Same | |
| For multiphasic<br>waveforms only:<br>Phase Duration<br>(including units) | N/A | N/A | Same | |
| Net Charge [µC<br>per pulse] (500Ω) | 0 µC<br>Same positive and negative<br>impulse | 0 µC<br>Same positive and negative<br>impulse | Same | |
| Maximum Phase<br>Charge [µC]<br>(500Ω) | 40 µC | 40 µC | Same | |
| Maximum Current<br>Density [mA/cm2]<br>(500Ω) | 0.22 mA/cm2 | 12,5 mA/cm2 | Different<br>Note 5<br>PMS | |
| Maximum Power<br>Density [W/cm2]<br>(500Ω) | 0.63 mW/cm2 | 7,9m W/cm2 | Different<br>Note 5<br>PMS | |
| On Time<br>[seconds] | 1 - 10 s | 1 - 20 s | Different<br>Note 6 PMS | |
| Off Time<br>[seconds] | 1 - 60 s | 1 - 50 s | Different<br>Note 6 PMS | |
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Image /page/12/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, abstract symbol on the left, resembling three curved shapes intertwined around a central point. To the right of the symbol is the text "EGZO Tech" in a bold, sans-serif font. The logo is simple and modern in design.
EGZOTech Sp. z o.o., ul. Romualda Traugutta 6H, 44-100 Gliwice, Poland
Telephone: 0048 32 750 49 45 ; e-mail: office@egzotech.com ; https://egzotech.com; REF: 001_510(k) Summary_4 dated 2021-05-07 09:35
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Image /page/13/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, geometric shape on the left, resembling a three-leaf clover or a stylized letter 'V' repeated three times around a central point. To the right of the shape is the text "EGZO Tech" in a simple, sans-serif font, with "EGZO" in a bolder typeface than "Tech".
# Substantial Equivalence discussion and Differences Analysis - Output Specifications for Powered Muscle Stimulator - Comparison with Predicate Device
### Note 1 PMS: "Treatment Time range"
Although the "Treatment Time range" in the new device is different from the time range in predicate device, it complies with IEC 60601-1 and IEC 60601-2-10 requirements and doesn't impact essential performance, basic safety or substantial equivalence.
### Note 2 PMS: "Number of Output Channels"
Although the "Number of Output Channels" are different from the predicate device they all comply with IEC 60601-1 and IEC 60601-2-10 requirements and the difference doesn't impact essential performance, basic safety or substantial equivalence.
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Image /page/14/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, triangular shape on the left, resembling three interconnected loops. To the right of the shape is the text "EGZO Tech", with "EGZO" in a bold, sans-serif font and "Tech" in a lighter, sans-serif font. The logo is simple and modern, with a clean design.
# Note EMG:
# "EMG Specifications"
The new device as well as the predicate device provide similar EMG- triggered EMS programs that enable the new device to bridge muscle stimulation with patient-initiated muscle contractions to achieve the same unchanged indications for use under 21 CFR 890,5850.
# "EMG sensitivity", "EMG sampling rate" and "EMG range"
The new device has an improved EMG sensitivity and sample rate compared to the predicate K080950. This can be considered an improvement and difference doesn't impact essential performance, basic safety or substantial equivalence. The difference in EMG range between the new device and predicate K080950 results from the difference in analog-to-digital converters and voltage references used for both devices. As the new device has a higher maximal EMG range, it can be considered an improvement and difference does not impact essential performance, basic safety or substantial equivalence.
# "EMG bandwidth"
The difference in EMG bandwidth results in the difference in filtering methods for both devices - digital for the new device and analog for the predicate K080950. The difference doesn't impact essential performance, basic safety or substantial equivalence.
# "EMG Signal processing"
Additionally, the new device has a different signal processing algorithm - RMS (Root Mean Square) in comparison to AVR (Average Retched Value) for the predicate K080950. Both methods yield comparable results and are industrial standards. Therefore, difference doesn't impact essential performance, basic safety or substantial equivalence.
# "Alternating or Synchronous"
The new device has a Synchronous EMG acquisition triggering. That is an improvement over Alternating EMG acquisition in predicate device K080950, as the EMG samples can be acquired and compared sample-to-sample, which in Alternating sampling is not possible. This can be considered an improvement and difference doesn't impact essential performance, basic safety or substantial equivalence.
# Note 3 PMS: "Shape of the waveforms"
Predicate device provide only biphasic rectangular waveforms. The new device provides additional waveforms shapes (triangular, trapezoidal) in addition to rectangular waveforms. Electrical stimulation for triangular, trapezoidal waveforms are safer than rectangular waveforms due to lower maximal phase charge, current density. Additionally, electrical stimulation for all waveforms were tested and are compliant with the requirements in IEC 60601-2-10. The difference in waveforms doesn't impact essential performance, basic safety or substantial equivalence.
# Note 4 PMS: "Maximum Output Voltage" and "Maximum Output Current"
Although the "Maximum Output Voltage" and "Maximum Output Current" of the new device are different than in the predicate device, they were all tested and are compliant with IEC 60601-2-10. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence.
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Image /page/15/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, geometric shape on the left and the text "EGZO Tech" on the right. The geometric shape is a triangular design with curved lines and a small circle in the center. The text is in a bold, sans-serif font.
# Note 5 PMS: "Maximum Current Density" and "Maximum Power Density"
The "Maximum Current Density" and "Maximum Power Density" of the new device is lower than in the predicate device K080950 and doesn't impact essential performance, basic safety or substantial equivalence. The Maximum Power density for the new device is 0.63 mW/cm2 in the predicate K080950. This is especially related to the electrodes used in both devices which are different. The Maximum Power density for the new device is less than 0.25 Watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns and The Maximum Current Density for all waveforms of the new device is compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s, thus the difference doesn't impact essential performance, basic safety or substantial equivalence.
### Note 6 PMS: "On/Off time"
Although "on and off time" are slightly different, the new device is compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s and the difference will not raise any safety or effectiveness issue. The subject device and the predicate device have the technical specifications that are within a range of other FDA cleared powered muscle stimulators.
| Functional Electrical Stimulation (FES) | | | |
|-----------------------------------------------|------------------------------------------------|------------------------------------------------|---------------------------------|
| Characteristics/<br>Specifications | New Device | Predicate Device | Differences |
| 510(k) Number | K210002 | K0809050 | N/A |
| Manufacturer | EGZOTech | Otto Bock | N/A |
| Device Name, Model | Stella BIO | STIWELL med4 | N/A |
| Time Range [minutes] | 15 - 60 min | 15 - 60 min | Same |
| EMG Specifications | | | |
| Number of EMG<br>Channels | Up to 8 | Up to 4 | Different<br>Note EMG |
| EMG sensitivity | 0.5 μV | 1 μV | Different<br>Note EMG |
| EMG detection<br>(bipolar/monopolar) | Bipolar | Bipolar | Same |
| EMG Sampling Rate | Up to 4 kHz | 3 kHz | Different<br>Note EMG |
| EMG range (μV) | $\pm$ 6 000 μV | 1 - 2000 μV | Different<br>Note EMG |
| EMG bandwidth | 0 - 2 kHz pre-filtering<br>20 - 100 Hz post | 70-480 Hz | Different<br>Note EMG |
| EMG signal processing<br>(e.g. RMS) | RMS (Root Mean Square) | AVR (Average<br>Value) | Retched Different<br>Note EMG |
| Synchronous or<br>Alternating | Synchronous | Alternating | Different<br>Note EMG |
| Method of Channel<br>Isolation | Multiplexer | Transformer,<br>couplers | Inductive Different<br>Note EMG |
| Output Specifications | | | |
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum Output<br>Voltage (500Ω) | 50 V | 50 V | Same |
| Maximum Output<br>Voltage (2kΩ) | 60 V | 115 V | Different<br>Note 1 FES |
| Maximum Output<br>Voltage (10kΩ) | N/A | N/A | Same |
| Maximum Output<br>Current (500Ω) | 100 mA | 100 mA | Same |
| Maximum Output<br>Current (2kΩ | 30 mA | 58 mA | Different<br>Note 1 FES |
| Maximum Output<br>Current (10kΩ) | N/A | N/A | Same |
| Pulse Width (specialty<br>units) | 50 μs - 400 μs | 50 μs - 400 μs | Same |
| Frequency (Hz) | 1 - 140 Hz<br>Default: 35 Hz | 1 - 140 Hz<br>Default: 35 Hz | Same |
| Net Charge [μC per<br>pulse] (500Ω) | 0μC<br>Same positive and negative<br>impulse | 0μC<br>Same positive and negative<br>impulse | Same |
| Maximum Phase<br>Charge [µC] (500Ω) | 40 µC | 40 µC | Same |
| Maximum Current<br>Density [mA/cm2]<br>(500Ω) | 0.22 mA/cm2 | 12,5 mA/cm2 | Different<br>Note 2 FES |
| Maximum Power<br>Density [W/cm2]<br>(500Ω) | 0.63 mW/cm2 | 7,9 mW/cm2 | Different<br>Note 2 FES |
| On Time [seconds] | 1 - 20 s | 1 - 20 s | Same |
| Off Time [seconds] | 1 - 30 s or Trigger controlled (min. 1 - 30 s) | 1 - 30 s or Trigger controlled (min. 1 - 30 s) | Same |
# Functional Electrical Stimulation Designation Comparison of Proposed New Device and Predicate Device
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Image /page/16/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, abstract symbol on the left, resembling a three-leaf clover or a stylized letter 'V' with a circle in the center. To the right of the symbol is the text "EGZO Tech", with "EGZO" in bold and "Tech" in a regular font.
EGZOTech Sp. z o.o., ul. Romualda Traugutta 6H, 44-100 Gliwice, Poland
Telephone: 0048 32 750 49 45 ; e-mail: office@egzotech.com ; https://egzotech.com;
REF: 001_510(k) Summary_4 dated 2021-05-07 09:35
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Image /page/17/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized symbol on the left and the text "EGZO Tech" on the right. The symbol is a geometric shape with three curved lines intersecting at a central point. The text "EGZO Tech" is written in a bold, sans-serif font.
# Substantial Equivalence discussion and Differences Analysis - Output Specifications for Functional Electrical Stimulation - Comparison with Predicate Device
### Note EMG:
## "EMG Specifications"
The new device as well as the predicate device provide similar EMG- triggered EMS programs that enable the new device to bridge muscle stimulation with patient-initiated muscle contractions to achieve the same unchanged indications for use under 21 CFR 890.5850.
### "EMG sensitivity", "EMG sampling rate" and "EMG range"
The new device has an improved EMG sensitivity and sample rate compared to the predicate K080950. This can be considered an improvement and difference doesn't impact essential performance, basic safety or substantial equivalence. The difference in EMG range between the new device and predicate K080950 results from the difference in analog-to-digital converters and voltage references used for both devices. As the new device has a higher maximal EMG range, it can be considered an improvement and difference doesn't impact essential performance, basic safety or substantial equivalence.
### "EMG bandwidth"
The difference in EMG bandwidth results in the difference in filtering methods for both devices - digital for the new device and analog for the predicate K080950. The difference doesn't impact essential performance, basic safety or substantial equivalence.
### "EMG Signal processing"
Additionally, the new device has a different signal processing algorithm - RMS (Root Mean Square) in comparison to AVR (Average Retched Value) for the predicate K080950. Both methods yield comparable results and are industrial standards. Therefore difference doesn't impact essential performance, basic safety or substantial equivalence.
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, geometric shape on the left and the text "EGZO Tech" on the right. The geometric shape is a triangular design with curved lines and a small circle in the center. The text is in a bold, sans-serif font.
"Alternating or Synchronous"
The new device has a Synchronous EMG acquisition triggering. That is an improvement over Alternating EMG acquisition in predicate device K080950, as the EMG samples can be acquired and compared sample-to-sample, which in Alternating sampling is not possible. This can be considered an improvement and difference doesn't impact essential performance, basic safety or substantial equivalence,
# Note 1 FES: "Maximum Output Voltage", "Maximum Output Current".
Although the "Maximum Output Voltage" and "Maximum Output Current" at 2kΩ of the new device are different than in the predicate device, they are all compliant and tested with IEC 60601-2-10. Therefore the difference doesn't impact essential performance, basic safety or substantial equivalence.
# Note 2 FES: "Maximum Current Density" and "Maximum Power Density"
Although the "Maximum Current Density" and "Maximum Power Density" of subject device are different from the predicate device, which is related to the electrode surface that is different for both devices, they all comply with the FDA guidance requirement for Powered Muscle Stimulator 510 (k)s, so the differences of function specification will not raise any safety or effectiveness issue.
# Transcutaneous Electrical Nerve Stimulation Comparison of Proposed New Device and Predicate Device
| Transcutaneous Electrical Nerve Stimulation (TENS) | | | |
|------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|------------------------|
| Characteristics/<br>Specifications | New Device | Predicate Device | Differences: |
| 510(k) Number | K210002 | K0809050 | - |
| Manufacturer | EGZOTech | Otto Bock | - |
| Device Name,<br>Model | Stella BIO | STIWELL med4 | - |
| Treatment Time<br>Range [minutes] | 10 - 120 min | 10 - 120 min | Same |
| Output Specification | | | |
| Waveform | Biphasic symmetrical | Biphasic symmetrical | Same |
| Shape | Rectangular | Rectangular | Same |
| Maximum Output<br>Voltage (500Ω) | 50 V | 50 V | Same |
| Maximum Output<br>Voltage ( $2kΩ$ ) | 60 V | 115 V | Different<br>Note<br>1 |
| | | | TENS |
| Maximum Output Voltage (10kΩ) | N/A | N/A | Same |
| Maximum Output Current (500Ω) | 100 mA | 100 mA | Same |
| Maximum Output Current (2kΩ) | 30 mA | 58 mA | Different Note 1 TENS |
| Maximum Output Current (10kΩ) | N/A | N/A | Same |
| Pulse Width (specialty units) | 150 µs - 200 µs | 150 µs - 200 µs | Same |
| Frequency (Hz) | 2 Hz - 100 Hz | 2 Hz -100 Hz | Same |
| For interferential modes only: Beat Frequency (Hz) | N/A | N/A | Same |
| For multiphasic waveforms only: Symmetrical phases | N/A | N/A | Same |
| For multiphasic waveforms only: Phase Duration (including units) | N/A | N/A | Same |
| Net Charge [µC per pulse] (500Ω) | 0 µC Same positive and negative impulse | 0 µC Same positive and negative impulse | Same |
| Maximum Phase Charge [µC] (500Ω) | 20 µC | 20 µC | Same |
| Maximum Current Density [mA/cm2] (500Ω) | 0.15 mA/cm2 | 12.5 mA/cm2 | Different Note 2 TENS |
| Maximum Power Density [W/cm2] (500Ω) | 0.28 mW/cm2 | 1.0 mW/cm2 | Different Note 2 TENS |
| Burst Mode: Pulse per burst | 8 | 8 | Same |
| Burst Mode: Bursts<br>per second | 2 | 2 | Same |
| Burst Mode: Burst<br>duration (seconds) | 100 ms | 100 ms | Same |
| Burst Mode: Duty<br>Cycle | 20 % | 20 % | Same |
| On Time [seconds] | Continuous or Burst | Continuous or Burst | Same |
| Off Time [seconds] | N/A | N/A | Same |
EGZOTech Sp. z o.o., ul. Romualda Traugutta 6H, 44-100 Gliwice, Poland Telephone: 0048 32 750 49 45 ; e-mail: office@egzotech.com ; https://egzotech.com; REF: 001 510(k) Summary 4 dated 2021-05-07 09:35
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Image /page/19/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, abstract symbol on the left, resembling three curved shapes intertwined around a central point. To the right of the symbol is the text "EGZO Tech" in a bold, sans-serif font. The logo is simple and modern in design.
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Image /page/20/Picture/0 description: The image shows the logo for EGZOTech. The logo consists of a stylized symbol on the left and the text "EGZOTech" on the right. The symbol is a geometric shape with three curved lines converging at a central point. The text is in a bold, sans-serif font, with "EGZO" in a darker shade than "Tech".
#### Substantial Equivalence discussion and Differences Analysis - Output Specifications for TENS -Comparison Predicate Device with
Note 1 TENS: "Maximum Output Voltage" , "Maximum Output Current".
Although the "Maximum Output Voltage" and "Maximum Output Current" at 2kΩ of the new device are different from in the predicate device, they are all compliant and tested with IEC 60601-2-10. Therefore, the difference doesn't impact essential performance, basic safety or substantial equivalence.
### Note 2 TENS: "Maximum Current Density" and "Maximum Power density"
The Maximum Current Density and Maximum Power Density of the new device is lower than in the predicate device. This is especially related to the electrodes used in the predicate device, which are different. The Maximum Power density for the new device is less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns. The Maximum Current Density is compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s and the difference doesn't impact essential performance, basic safety or substantial equivalence.
### Incontinence Programs Designation Comparison of Proposed New Device and Predicate Device
| Incontinence Programs | | | |
|-----------------------------------|------------|------------------|-------------------------|
| | New Device | Predicate Device | Differences |
| 510(k) Number | K210002 | K080950 | N/A |
| Manufacturer | EGZOTech | Otto Bock | N/A…
