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.

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.

AI/ML Overview

This document is a 510(k) summary for the Stella BIO device, which is a neuromuscular electronic stimulator, non-implantable incontinence device, and biofeedback device. The purpose of this summary is to demonstrate that the Stella BIO device is substantially equivalent to a legally marketed predicate device, the Stiwell med4 (K080950).

Key Acceptance Criteria and Device Performance:

The document primarily focuses on demonstrating substantial equivalence by comparing the Stella BIO to its predicate device across various "designations" (Powered Muscle Stimulator, Functional Electrical Stimulation, Transcutaneous Electrical Nerve Stimulation, Incontinence Programs, Biofeedback). Instead of defining explicit acceptance criteria with numerical targets as one might for a diagnostic AI, the acceptance criteria here are implicitly met by demonstrating that any differences between the new device and the predicate device, or adherence to relevant voluntary standards (IEC, ANSI/AAMI, FDA guidance), do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" table below is constructed by extracting the key comparative metrics and the conclusions drawn regarding their impact on safety and effectiveness.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Feature/Characteristic	Acceptance Criteria (Implicit)	Reported Stella BIO Performance	Conclusion of Impact on SE (Safety/Effectiveness)
General Characteristics
Power Source	Must not influence essential performance or basic safety, and still align with substantial equivalence to predicate.	Battery Pack Li-Ion 7,4 V (Predicate: 11,1 V). Compliant with IEC 62133, IEC 60601-1. Battery operated, so no line current isolation needed.	Does not influence essential performance or basic safety, nor impact substantial equivalence.
Number of Output Modes	Must comply with IEC 60601-1 and IEC 60601-2-10 requirements.	4 (EMS, TENS, Biofeedback, Incontinence) (Predicate: 1).	Does not impact essential performance, basic safety, or substantial equivalence.
Compliance with Voluntary Standards	Must comply with recognized FDA standards and not raise new safety/effectiveness questions.	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, IEC 62304, IEC 62366, IEC 62133, ANSI/AAMI NS4 (Predicate: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). Additional standard ANSI/AAMI NS4.	Does not impact essential performance, basic safety, or substantial equivalence.
Weight & Dimensions	Compliance with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-11 requirements.	Weight: 112 g (Predicate: 440 g). Dimensions: 91.5 x 68.4 x 24 mm (Predicate: 175 x 95 x 30 mm).	Differences do not raise any safety or effectiveness issues.
Powered Muscle Stimulator (PMS)
Treatment Time Range	Compliance with IEC 60601-1 and IEC 60601-2-10.	1 - 60 min (Predicate: 2 - 120 min).	Does not impact essential performance, basic safety, or substantial equivalence.
Number of Output Channels	Compliance with IEC 60601-1 and IEC 60601-2-10.	Up to 8 (Predicate: 4).	Does not impact essential performance, basic safety, or substantial equivalence.
Waveform Shape	Electrical stimulation for all waveforms must be safe and compliant with IEC 60601-2-10.	Rectangular, triangular, trapezoidal, sinusoidal (Predicate: Rectangular). New shapes are safer due to lower maximal phase charge, current density.	Does not impact essential performance, basic safety, or substantial equivalence.
Max Output Voltage/Current	Compliance with IEC 60601-2-10.	Varied (e.g., Max Output Voltage (2kΩ): 60 V vs 115 V for predicate; Max Output Current (2kΩ): 30 mA vs 50 mA for predicate). All tested and compliant.	Does not impact essential performance, basic safety, or substantial equivalence.
Max Current/Power Density	Lower or compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s and IEC 60601-2-10. Max Power density < 0.25 W/cm² to reduce thermal burns.	Max Current Density (500Ω): 0.22 mA/cm² (Predicate: 12.5 mA/cm²). Max Power Density (500Ω): 0.63 mW/cm² (Predicate: 7.9 mW/cm²). Lower, and compliant with FDA guidance (0.22 < 0.25 W/cm²).	Does not impact essential performance, basic safety, or substantial equivalence.
On/Off Time	Compliance with FDA Guidance Document for Powered Muscle Stimulator 510(k)s.	On Time: 1-10 s (Predicate: 1-20 s). Off Time: 1-60 s (Predicate: 1-50 s).	Will not raise any safety or effectiveness issue.
EMG Specifications (Applicable to PMS, FES, Incontinence, Biofeedback)
EMG Sensitivity/Sample Rate/Range	Improved performance over predicate, without impacting SE.	Sensitivity: 0.5 µV (Predicate: 1 µV). Sample Rate: Up to 4 kHz (Predicate: 3 kHz). Range: ± 6000 µV (Predicate: 1-2000 µV).	Considered an improvement; does not impact SE.
EMG Bandwidth/Signal Processing	Not impacting essential performance, basic safety or substantial equivalence due to different filtering methods/algorithms (both standard).	Bandwidth: 0 - 2 kHz pre-filtering/20 - 100 Hz post (Predicate: 70-480 Hz). Signal Processing: RMS (New) vs. AVR (Predicate).	Does not impact essential performance, basic safety, or substantial equivalence.
Synchronous/Alternating Triggering	Synchronous acquisition is an improvement over alternating; not impacting SE.	Synchronous (Predicate: Alternating). Allows sample-to-sample comparison.	Considered an improvement; does not impact SE.
Incontinence Programs
Pulse Width/Frequency	Within range of standard EMS pulse modulation and compliant with FDA Guidance and IEC 60601-2-10.	Pulse Width: 150-250 µs (Predicate: 300-500 µs). Frequency: 0-50 Hz (Predicate: 5-60 Hz).	Does not raise new safety or effectiveness questions.
Max Phase Charge/Current Density/Power Density	Compliant with FDA Guidance and IEC 60601-2-10. Max Power density < 0.25 W/cm² to reduce thermal burns.	Max Phase Charge: 25 µC (Predicate: 50 µC). Max Current Density (500Ω): 0.65 mA/cm² (Predicate: 4.7 mA/cm²). Max Power Density (500Ω): 0.40 mW/cm² (Predicate: 0.42-105 mW/cm²). Lower, and compliant with FDA guidance (<0.25W/cm²).	Does not raise new safety or effectiveness questions.
Biofeedback
Time Range	Compliance with IEC 60601-1 and IEC 60601-2-10.	5-20 min (Default 10 min) (Predicate: 5-30 min).	Does not impact essential performance, basic safety, or substantial equivalence.

2. Sample Size and Data Provenance:

This document is a 510(k) summary for a physical medical device (neuromuscular stimulator) and associated software, not a diagnostic AI/ML model that would typically involve a "test set" of clinical data to establish diagnostic performance. Therefore, the concepts of "sample size used for the test set" and "data provenance" (country, retrospective/prospective) in the context of clinical performance are not directly applicable in the way they would be for an AI/ML diagnostic.

The "testing" mentioned in this document refers to:

Bench Testing / Electrical Safety / EMC Testing: These are engineering and performance verification tests performed in a lab setting to ensure the device meets specified electrical, safety, and electromagnetic compatibility standards (e.g., IEC 60601 series). No specific "sample size" is mentioned for these tests, as they are typically conducted on a limited number of devices to demonstrate design compliance.
Software Verification and Validation (V&V): This ensures the software functions as intended and mitigates risks. Again, this is a technical V&V process, not a clinical data-driven "test set."
Usability Testing: This assesses the user interface and safety of use.
Biocompatibility Testing: For materials in contact with the body.

The document does not describe a clinical study with patients or a "test set" of clinical data adjudicated by experts to prove diagnostic accuracy or clinical effectiveness for the device's indications for use. The substantial equivalence is argued based on technological characteristics and compliance with recognized standards, assuming that the predicate device's clinical performance and safety profile are well-established.

3. Number of Experts used for Ground Truth and Qualifications:

Not applicable, as this is solely based on substantial equivalence to a predicate device and compliance with engineering standards, rather than a clinical study requiring expert adjudication of ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document does not describe any clinical studies involving human readers or the measurement of human reader improvement with or without AI assistance. This device is not an AI diagnostic tool in the typical sense that would necessitate such a study.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No standalone clinical performance study was done. The document focuses on the technical performance of the device's stimulation and biofeedback functions, its safety, and its electromagnetic compatibility through bench testing and compliance with recognized standards. This is not a software-only diagnostic AI that would generally have a "standalone performance" measurement against clinical ground truth.

7. The Type of Ground Truth Used:

For the purpose of this 510(k) submission, the "ground truth" is that the predicate device (Stiwell med4) is already legally marketed and presumed safe and effective for its intended uses. The "proof" is the demonstration through engineering tests and comparison of technical specifications that the new device (Stella BIO) is "substantially equivalent" to this established predicate, meaning its differences do not raise new questions of safety or effectiveness. There is no clinical "ground truth" derived from patient outcomes or expert consensus on a test set mentioned.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that undergoes "training" on a dataset. The software within the device is validated against its functional requirements and safety specifications, rather than being "trained" on data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for an AI/ML model for this device.

Summary

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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

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:

· 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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.Romualda Traugutta 6h44-100 Gliwice, Poland
Contact Person:	Dr. Michal MikulskiChief 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 ProductCode	Common Name	Regulation Description	RegulationNumber
IPF	Stimulator, Muscle, Powered	Powered muscle stimulator	890.5850
GZJ	Stimulator, Nerve,Transcutaneous, For Pain Relief	Transcutaneous electrical nervestimulator for pain relief.	882.5890
HCC	Device, Biofeedback	Biofeedback device.	882.5050
GZI	Stimulator, Neuromuscular,External Functional	External functional neuromuscularstimulator.	882.5810
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Nonimplanted electricalcontinence 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)number	Predicatedevice	Manufacturer	RegulationNumber	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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Product GmbHKaiserstrasse 391070 ViennaAustria	HCC, GZI, KPI
------------------------------------------------------------	---------------

Applicable FDA Product Codes, Common Name, Regulation Description and Regulation Number for the Predicate Device:

FDA ProductCode	Common Name	Regulation Description	RegulationNumber
IPF	Stimulator, Muscle, Powered	Powered muscle stimulator	890.5850
GZJ	Stimulator, Nerve,Transcutaneous, For Pain Relief	Transcutaneous electrical nervestimulator for pain relief.	882.5890
HCC	Device, Biofeedback	Biofeedback device.	882.5050
GZI	Stimulator, Neuromuscular,External Functional	External functional neuromuscularstimulator.	882.5810
KPI	Stimulator, Electrical, Non-Implantable, For Incontinence	Nonimplanted electricalcontinence device.	876.5320

Device Description:

Stella BIO is a single presentation device (one hardware) with a single software for Prescription and Home Use by prescription from a medical professional.

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)

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 /Specification	New Device	Predicate	Difference
510(k) Number	K210002	K080950	N/A
Manufacturer	EGZOTech	Otto Bock	N/A
Device Name,Model	Stella BIO	STIWELL med4	N/A
Prescription orOTC	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 UseStatement	For Prescription and HomeUse by prescription from amedical professional:	For Prescription:
	The Stella BIO is aneuromuscular electronicstimulator indicated for useunder medical supervision foradjunctive therapy in thetreatment of medical diseasesand conditions	The STIWELL med4 is aneuromuscular electronicstimulator indicated for useunder medical supervision foradjunctive therapy in thetreatment of medical diseasesand conditions.
	As a powered musclestimulator, Stella BIO isindicated for the followingconditions:- Relaxation of musclespasms,- Prevention or retardation ofdisuse atrophy,- Increasing local bloodcirculation,- Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis,- Maintaining or increasingrange of motion.- Muscle re-education,	As a powered musclestimulator the STIWELL med4is indicated for the followingconditions:- Relaxation of muscle spasms,- Prevention or retardation ofdisuse atrophy,- Increasing local bloodcirculation,- Muscle re-education,- Immediate post-surgicalstimulation of calf muscles toprevent venous thrombosis,- Maintaining or increasingrange of motion.
	As a transcutaneous electricalnerve stimulator for pain relief,Stella BIO is indicated for thefollowing conditions:- Symptomatic relief andmanagement of chronic (long-term), intractable pain,- Adjunctive treatment in themanagement of post-surgicalpain and post traumatic acute	As a transcutaneous electricalnerve stimulator for pain reliefthe STIWELL med4 isindicated for the followingconditions:- Symptomatic relief andmanagement of chronic (long-term), intractable pain,- Adjunctive treatment in themanagement of post-surgical

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pain.	pain and post traumatic acutepain.
As a biofeedback device StellaBIO is indicated for:- Biofeedback, relaxation andmuscle re- educationpurposes.	As a biofeedback device theSTIWELL med4 is indicated for:- Biofeedback, relaxation andmuscle re- education purposes.
As an external functionalneuromuscular stimulatorStella BIO is indicated for thefollowing conditions:- Helps to relearn voluntarymotor functions of theextremities.	As an external functionalneuromuscular stimulator theSTIWELL med4 is indicated forthe following conditions:- Helps to relearn voluntarymotor functions of theextremities.
As a non-implanted electricalcontinence device, Stella BIOis indicated for the followingconditions:- Acute and ongoing treatmentof stress, urge or mixed urinaryincontinence and where thefollowing results may improveurinary control: inhibition of thedetrusor muscles throughreflexive mechanisms andstrengthening of pelvic floormuscles.- Incontinence treatment forassessing EMG activity of thepelvic floor and accessorymuscles such as abdominaland the gluteus muscles.	As a non-implanted electricalcontinence device theSTIWELL med4 is indicated forthe following conditions:- Acute and ongoing treatmentof stress, urge or mixed urinaryincontinence and where thefollowing results may improveurinary control: inhibition of thedetrusor muscles throughreflexive mechanisms andstrengthening of pelvic floormuscles.- Incontinence treatment forassessing EMG activity of thepelvic floor and accessorymuscles such as abdominaland the gluteus muscles.
Patient population: Stella BIOPrescription and Home Use byprescription from a medicalprofessional can be used onadults aged 22 yrs and older.Environments of Use: Clinics,hospital and homeenvironments.
Platform: Stella BIO is abattery-powered, wirelessdevice, accessible throughsoftware.

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Environment ofUse	Clinics, hospital and homeenvironments	Clinics, hospital and homeenvironments	Same
Patient population	Adults 22 yrs and older	Adults	Same
Power Source	Battery Pack Li-Ion 7,4 V	Battery Pack Li-lon11,1 V	DifferentNote 1
Method of LineCurrent Isolation	N/A (Battery)	Medical Class II Power Adapter- Mascot (12,6VDC-15,1W)	DifferentNote 1
Patient LeakageCurrent(normal condition,μΑ )	N/ABattery Operated Device(<100µA patient leakage)	N/ABattery Operated Device(<100µA patient leakage)	Same
Patient LeakageCurrent(single faultcondition)	N/ABattery Operated Device(<100µA patient leakage)	N/ABattery Operated Device(<100µA patient leakage)	Same
Number of OutputModes	4(EMS, TENS, Biofeedback,Incontinence)	1	DifferentNote 2
Software/Firmware/Microprocessorcontrol	YES	YES	Same
AutomaticOverload Trip	YES	YES	Same
Automatic No-LoadTrip	YES	YES	Same
Automatic Shut Off	YES (10 min)	YES (10 min)	Same
Patient OverrideControl	YES (Button)	YES (Stop Button)	Same
Indicator Display:On/Off Status	YES	YES	Same
Indicator Display:Low Battery	YES	YES	Same
Indicator Display:Voltage/CurrentLevel	YES	YES	Same
Compliance withVoluntaryStandards	IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11IEC 62304IEC 62366IEC 62133ANSI/AAMI NS4	IEC 60601-1IEC 60601-1-2IEC 60601-2-10	DifferentNote 3
Compliance with 21CFR 898	YES	YES	Same
Weight	112 g	440 g	SENote 4
Dimension(WxHxL) in [mm]	91.5 x 68.4 x 24 mm	175 x 95 x 30 mm	SENote 4
Housing materialand Construction	Plastic(Injection Molded ABS)	Plastic(Injection Molded ABS)	Same

{10}------------------------------------------------

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.

{11}------------------------------------------------

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/Specifications	New Device	Predicate	Differences:
510(k) Number	K210002	K0809050	N/A
Manufacturer	EGZOTech	Otto Bock	N/A
Device Name,Model	Stella BIO	STIWELL med4	N/A
Treatment TimeRange [min]	1 - 60 min	2 - 120 min	DifferentNote1PMS
Number of OutputChannels	Up to 8	4	DifferentNote2PMS
	EMG Specifications
Number of EMGChannels	Up to 8	Up to 4	DifferentNote EMG
EMG sensitivity	0.5 μV	1 μV	DifferentNote EMG
EMG detection(bipolar/monopolar)	Bipolar	Bipolar	Same
EMG SamplingRate	Up to 4 kHz	3 kHz	DifferentNote EMG
EMG range (µV)	± 6 000 μV	1 - 2000 μV	DifferentNote EMG
EMG bandwidth	0 - 2 kHz pre-filtering20 - 100 Hz post	70-480 Hz	DifferentNote EMG
EMG signalprocessing (e.g.RMS)	RMS (Root Mean Square)	AVR (Average Retched Value)	DifferentNote EMG
Synchronous orAlternating	Synchronous	Alternating	DifferentNote EMG
Method ofChannel Isolation	Multiplexer	Transformer, Inductive couplers	DifferentNote EMG
Regulated Currentor RegulatedVoltage	Regulated Current	Regulated Current	Same
Output Specifications
Waveform	Biphasic symmetrical	Biphasic symmetrical	Same
Shape	Rectangular,triangular,trapezoidal, sinusoidal	Rectangular	DifferentNote3PMS
Maximum OutputVoltage (500Ω)	50 V	50 V	DifferentNote4PMS
Maximum OutputVoltage (2kΩ)	60 V	115 V	DifferentNote4PMS
Maximum OutputVoltage (10kΩ)	N/A	N/A	DifferentNote4PMS
Maximum OutputCurrent (500Ω)	100 mA	100 mA	DifferentNote4PMS
Maximum OutputCurrent (2kΩ)	30 mA	50 mA	DifferentNote4PMS
Maximum OutputCurrent (10kΩ)	N/A	N/A	DifferentNote4PMS
Pulse Width(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: BeatFrequency (Hz)
For multiphasicwaveforms only:Symmetricalphases?	N/A	N/A	Same
For multiphasicwaveforms only:Phase Duration(including units)	N/A	N/A	Same
Net Charge [µCper pulse] (500Ω)	0 µCSame positive and negativeimpulse	0 µCSame positive and negativeimpulse	Same
Maximum PhaseCharge [µC](500Ω)	40 µC	40 µC	Same
Maximum CurrentDensity [mA/cm2](500Ω)	0.22 mA/cm2	12,5 mA/cm2	DifferentNote 5PMS
Maximum PowerDensity [W/cm2](500Ω)	0.63 mW/cm2	7,9m W/cm2	DifferentNote 5PMS
On Time[seconds]	1 - 10 s	1 - 20 s	DifferentNote 6 PMS
Off Time[seconds]	1 - 60 s	1 - 50 s	DifferentNote 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

{13}------------------------------------------------

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.

{14}------------------------------------------------

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/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 EMGChannels	Up to 8	Up to 4	DifferentNote EMG
EMG sensitivity	0.5 μV	1 μV	DifferentNote EMG
EMG detection(bipolar/monopolar)	Bipolar	Bipolar	Same
EMG Sampling Rate	Up to 4 kHz	3 kHz	DifferentNote EMG
EMG range (μV)	$\pm$ 6 000 μV	1 - 2000 μV	DifferentNote EMG
EMG bandwidth	0 - 2 kHz pre-filtering20 - 100 Hz post	70-480 Hz	DifferentNote EMG
EMG signal processing(e.g. RMS)	RMS (Root Mean Square)	AVR (AverageValue)	Retched DifferentNote EMG
Synchronous orAlternating	Synchronous	Alternating	DifferentNote EMG
Method of ChannelIsolation	Multiplexer	Transformer,couplers	Inductive DifferentNote EMG
Output Specifications
Waveform	Biphasic symmetrical	Biphasic symmetrical	Same
Shape	Rectangular	Rectangular	Same
Maximum OutputVoltage (500Ω)	50 V	50 V	Same
Maximum OutputVoltage (2kΩ)	60 V	115 V	DifferentNote 1 FES
Maximum OutputVoltage (10kΩ)	N/A	N/A	Same
Maximum OutputCurrent (500Ω)	100 mA	100 mA	Same
Maximum OutputCurrent (2kΩ	30 mA	58 mA	DifferentNote 1 FES
Maximum OutputCurrent (10kΩ)	N/A	N/A	Same
Pulse Width (specialtyunits)	50 μs - 400 μs	50 μs - 400 μs	Same
Frequency (Hz)	1 - 140 HzDefault: 35 Hz	1 - 140 HzDefault: 35 Hz	Same
Net Charge [μC perpulse] (500Ω)	0μCSame positive and negativeimpulse	0μCSame positive and negativeimpulse	Same
Maximum PhaseCharge [µC] (500Ω)	40 µC	40 µC	Same
Maximum CurrentDensity [mA/cm2](500Ω)	0.22 mA/cm2	12,5 mA/cm2	DifferentNote 2 FES
Maximum PowerDensity [W/cm2](500Ω)	0.63 mW/cm2	7,9 mW/cm2	DifferentNote 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"

"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"

"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.

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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"

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/Specifications	New Device	Predicate Device	Differences:
510(k) Number	K210002	K0809050	-
Manufacturer	EGZOTech	Otto Bock	-
Device Name,Model	Stella BIO	STIWELL med4	-
Treatment TimeRange [minutes]	10 - 120 min	10 - 120 min	Same
Output Specification
Waveform	Biphasic symmetrical	Biphasic symmetrical	Same
Shape	Rectangular	Rectangular	Same
Maximum OutputVoltage (500Ω)	50 V	50 V	Same
Maximum OutputVoltage ( $2kΩ$ )	60 V	115 V	DifferentNote1
			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: Burstsper second	2	2	Same
Burst Mode: Burstduration (seconds)	100 ms	100 ms	Same
Burst Mode: DutyCycle	20 %	20 %	Same
On Time [seconds]	Continuous or Burst	Continuous or Burst	Same
Off Time [seconds]	N/A	N/A	Same

{19}------------------------------------------------

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.

{20}------------------------------------------------

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
Device Name,Model	Stella BIO	STIWELL med4	N/A
Treatment TimeRange [minutes]	0 - 60 min	2 - 25 min	DifferentNote 1 KPI

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Image /page/21/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 entire logo is in black and white.

EMG Specifications
Number of EMGChannels	Up to 8	Up to 4	DifferentNote EMG
EMG sensitivity	0.5 μV	1 μV	DifferentNote EMG
EMG detection(bipolar/monopolar)	Bipolar	Bipolar	Same
EMG SamplingRate	Up to 4 kHz	3 kHz	DifferentNote EMG
EMG range (μV)	± 6 000 μV	1 - 2000 μV	DifferentNote EMG
EMG bandwidth	0 - 2 kHz pre-filtering20 - 100 Hz post	70-480 Hz	DifferentNote EMG
EMG signalprocessing(e.g.RMS)	RMS (Root Mean Square)	AVR (Average Retched Value)	DifferentNote EMG
Synchronous orAlternating	Synchronous	Alternating	DifferentNote EMG
Method ofChannel Isolation	Multiplexer	Transformer, Inductive couplers	DifferentNote EMG
Output Specifications
Waveform	Biphasic symmetrical	Biphasic symmetrical	Same
Shape	Rectangular	Rectangular	Same
Maximum OutputVoltage (500Ω)	50V	50V	Same
Maximum OutputVoltage (2 kΩ)	60V	115V	DifferentNote 2 KPI
Maximum OutputVoltage (10 kΩ)	N/A	N/A	Same
Maximum OutputCurrent (500Ω)	100mA	100mA	Same
Maximum OutputCurrent (2 kΩ)	30mA	58mA	DifferentNote 2 KPI
Maximum OutputCurrent (10kΩ)	N/A	N/A	Same
Pulse Width(specialty units)	150 µs - 250 µsprogram dependent	300 - 500 µsprogram dependent	DifferentNote 3 KPI
Frequency (Hz)	0 - 50 Hzprogram dependent	5 - 60 Hzprogram dependent	DifferentNote 3 KPI
Net Charge [µCper pulse] (500Ω)	0µCSame positive and negativeimpulse	0µCSame positive and negativeimpulse	Same
Maximum PhaseCharge [µC](500Ω)	25 µC	50 µC	DifferentNote 4 KPI
Maximum CurrentDensity [mA/cm2](500Ω)	0.65 mA/cm2Surface = 1.93 cm2For the smallest electrode surfacearea	4.7mA/cm2Surface = 21.2cm2	DifferentNote 4 KPI
Maximum PowerDensity [W/cm2](500Ω)	0.40 mW/cm2At maximum frequency of 50Hzpulse width 250µS and current of100mA.Smallest Electrode area (PR - 06A): 1.93 cm2	0.42 - 105 mW/cm2Surface = 21,2 cm2	DifferentNote 4 KPI
On Time[seconds]	1 - 6 s	9 - 13 s	DifferentNote 5 KPI
Off Time[seconds]	0 - 12 s	3 - 9 s	DifferentNote 5 KPI

{22}------------------------------------------------

Image /page/22/Picture/0 description: The image contains the logo for EGZO Tech. The logo consists of a stylized, geometric shape resembling a three-leaf clover or a triangular arrangement of curved lines, positioned to the left of the text "EGZO Tech". The text is in a bold, sans-serif font, with "EGZO" appearing larger than "Tech".

Substantial Equivalence discussion and Differences Analysis - Output Specifications for Incontinence Programs - Comparison with Predicate Device

Note 1 KPI: "Treatment Time range"

The incontinence programs of the new device have a pre-set time range between 15 - 20 min (program dependent), similar to predicate. The new device has one additional "Custom Program" where time range can be adjusted by a medical professional in the range of 1-60 min. Although the "Treatment Time range" in the new device is slightly different from the time range in predicate device K080950 it complies with IEC 60601-1 and IEC 60601-2-10 requirements and doesn't impact essential performance, basic safety or substantial equivalence.

{23}------------------------------------------------

Image /page/23/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"

"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"

"EMG Signal processing"

"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 does not impact essential performance, basic safety or substantial equivalence.

Note 2 KPI: "Maximum Output Voltage", "Maximum Output Current".

Note 3 KPI: "Pulse width modulation" and "Frequency"

The new device has slightly different pulse widths (150 us - 250 µs in the new device) vs 300 µs - 500 us in the predicate device K080950. Although the "pulse width" is different from the predicate device, it is within the range of the standard EMS pulse modulation that is compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s, so the differences of function specification will not raise any safety or effectiveness issue.

{24}------------------------------------------------

Image /page/24/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 converging at a central point. To the right of the symbol is the text "EGZO Tech" in a bold, sans-serif font. The word "EGZO" is in a larger font size than "Tech".

The frequency for the new device is 0 - 50 Hz and is similar to the predicate K0809050 (5-60 Hz). This difference does not raise new types of safety or effectiveness questions because all devices are using standard EMS stimulation frequencies that are compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s. Maximum pulse frequency of the new device was tested and is compliant with IEC 60601-2-10.

Note 4 KPI: "Maximum Phase charge", "Maximum Current Density", "Maximum Power Density" The "Maximum phase charge of the new device is 25 µC for the new device and is different from the predicate K080950 (50 µC). This difference does not raise new types of safety or effectiveness questions because all devices are compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s and were tested and are compliant with IEC 60601-2-10.

The "Maximum Current Density" and "Maximum Power Density" are different 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 smallest surface electrode used in the new device is lower than in the predicate (0.40 mW/cm2 in the new device vs. 105 mW/cm2 in the predicate K080950). Moreover, the Maximum Power Density for the smallest electrode used in the 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 and Maximum Power Density 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 5 KPI: "On/Off time"

Although the "on/off" time is slightly different for both devices it is compliant with FDA Guidance Document for Powered Muscle Stimulator 510(k)s and the difference between on and off time ranges doesn't impact essential performance, basic safety or substantial equivalence.

Biofeedback
Characteristics/Specifications	New Device	Predicate Device	Differences
510(k) Number	K210002	K080950	N/A
Manufacturer	EGZOTech	Otto Bock	N/A
Device Name,Model	Stella BIO	STIWELL med4	N/A
Time Range[minutes]	5- 20 minDefault 10 min	5 - 30 min	DifferentNoteHCC
EMG Specifications
Number of EMGChannels	Up to 8	Up to 4	DifferentNote EMG
EMG sensitivity	0.5 µV	1 µV	DifferentNote EMG
EMG detection(bipolar/monopolar	Bipolar	Bipolar	Same
EMG SamplingRate	Up to 4 kHz	3 kHz	DifferentNote EMG
EMG range (µV)	± 6 000 µV	1 - 2000 μV	DifferentNote EMG
EMG bandwidth	0 - 2 kHz pre-filtering20 - 100 Hz post	70-480 Hz	DifferentNote EMG
EMG signalprocessing(e.g.RMS)	RMS (Root Mean Square)	AVR (Average Retched Value)	DifferentNote EMG
Synchronous orAlternating	Synchronous	Alternating	DifferentNote EMG
Method of ChannelIsolation	Multiplexer	Transformer, Inductive couplers	DifferentNote EMG
Output Specification for Biofeedback
Waveform	Not applicable	Not applicable	Same
Shape	Not applicable	Not applicable	Same
Maximum OutputVoltage (500Ω)	Not applicable	Not applicable	Same
Maximum OutputVoltage(2kΩ)	Not applicable	Not applicable	Same
Maximum OutputVoltage (10kΩ)	Not applicable	Not applicable	Same
Maximum OutputCurrent (500Ω)	Not applicable	Not applicable	Same
Maximum OutputCurrent (2kΩ)	Not applicable	Not applicable	Same
Maximum OutputCurrent (10kΩ)	Not applicable	Not applicable	Same
Pulse Width(specialty units)	Not applicable	Not applicable	Same
Frequency (Hz)	Not applicable	Not applicable	Same
Net Charge [µCper pulse] (500Ω)	Not applicable	Not applicable	Same
Maximum PhaseCharge [µC](500Ω)	Not applicable	Not applicable	Same
Surface area oftheelectrodes	Not applicable	Not applicable	Same
Maximum CurrentDensity [mA/cm2](500Ω)	Not applicable	Not applicable	Same
Maximum PowerDensity [W/cm2](500Ω)	Not applicable	Not applicable	Same
On Time [seconds]	Not applicable	Not applicable	Same
Off Time [seconds]	Not applicable	Not applicable	Same
Additional features	Not applicable	Not applicable	Same

Biofeedback Designation Comparison of Proposed New Device and Predicate Device

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Image /page/25/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized graphic on the left and the text "EGZO Tech" on the right. The graphic is a circular design with three curved lines intersecting in the center. The text is in a bold, sans-serif 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/26/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, abstract symbol on the left and the text "EGZO Tech" on the right. The symbol is composed of three curved shapes that appear to be intertwined, forming a triangular shape with a small circle in the center. The text "EGZO Tech" is written in a bold, sans-serif font.

Substantial Equivalence discussion and Differences Analysis - Output Specifications for EMG Biofeedback - Comparison with Predicate Device

Note 1 HCC: "Treatment Time range"

Although the "Time range" in the new device is different from the time range in predicate device K080950, it complies with IEC 60601-1 and IEC 60601-2-10 requirements and doesn't impact essential performance, basic safety or substantial equivalence.

Note EMG:

"EMG Specifications"

"EMG sensitivity", "EMG sampling rate" and "EMG range"

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Image /page/27/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 circular shape. The text "EGZO Tech" is written in a bold, sans-serif font.

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"

"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"

Conclusion: Stiwell med4 was chosen as predicate to the subject device due to the intended use, indications, performance, as well as the function and device testing specification that had been performed. Minor variations between the subject and the predicate device were found and listed within the above discussion. Considerable amount of testing, including electrical safety, electronic compatibility, software validation and verification and usability testing were performed to support the claims of appropriately chosen predicate device.

In accordance with 21 CFR Part 807 and based on the data provided through Substantial Equivalence Discussion it is stated that Stella BIO Device is substantially equivalent as the predicate device Stiwell med4 Powered Muscle Stimulator.

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Stella BIO device in the intended environment of use is supported by testing that was conducted in accordance with the FDA June 1999 Draft "Guidance Document for Powered Muscle Stimulator 510(k)s", CDRH, which outlines Technological Characteristics, Electrode Lead Wires and Patient cables performance standards and Electromagnetic Compatibility (EMC) requirements.

The following testing was conducted to prove safety and effectiveness as well as substantial equivalence to the predicate device:

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Image /page/28/Picture/0 description: The image shows the logo for EGZO Tech. The logo consists of a stylized, geometric shape resembling a triangle with curved edges and a small circle at the center, positioned to the left of the text "EGZO Tech". The text is in a simple, sans-serif font, with "EGZO" in a bolder typeface than "Tech".

Electrical safety and electromagnetic compatibility (EMC)

IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic disturbances - Requirements and tests.
IEC 60601-2-10 -Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
IEC 60601-1-11 -Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
-IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications.
ANSI/AAMI NS4 Transcutaneous Electrical Nerve Stimulators -

Wi-Fi and Bluetooth testing

The device contains a wireless module with FCC ID: 2AC7Z-ESP WROOM 32 that has been tested and complies with:

FCC CFR47 Part 15C(2017) Radio Frequency Devices -

Software

-	IEC 62304	Medical device software — Software life cycle processes.
Usability
-	IEC 62366	Applying Human Factors and Usability Engineering to Medical Device.
Risk analysis
-	ISO 14971	Medical devices - Application of risk management to medical devices.
Biocompatibility
-	ISO 10993-1	Biological Evaluation of Medical Devices - Part 1: “Evaluationand Testing Within a Risk Management Process”. As dictatedby the application and duration of contact with the intact skin,the device testing included the Cytotoxicity, Sensitization and

Irritation.

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Quality

ISO 13485 Quality management System -

Additional standards

- IEC 62353	Medical electrical equipment - Recurrent test and test after repair ofmedical electrical equipment
- EN 1041	Information supplied by the manufacturer of medical devices
- ISO 15223-1	Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied - Part 1: General requirements
- 93/42/EEC Annex II	Medical Devices Directive, CE Marking for Europe.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards. It was our conclusion that Stella BIO tested met all relevant requirements of the aforementioned tests.

Software information:

Software verification and validation testing were conducted and supported by documentation according to the FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The details of the software license for Prescription and Home Use by prescription from a medical professional software license were clearly demonstrated in the software documentation and the risks related to the software products were mitigated. The software for this device was considered as a "Moderate" level of concern. The proposed subject device is in compliance with IEC 62304 test standard requirements

Conclusions:

Stella BIO is a single device (one hardware) with a single software license for Prescription and Home Use by prescription from a medical professional. The intended use of the Stella BIO device is equivalent with those of the referenced Predicate device for prescription and home use by prescription from a medical professional K080950. The basic technological characteristics are mostly the same for both software licenses of subject and predicate devices with small differences which doesn't raise any safety or effectiveness issues. Comparing the hardware and the software of the subject device it is equivalent to the above mentioned predicate device.

The Stella BlO device complies with the requirement of IEC 60601-2-10, IEC60601-1-2, IEC 60601-1-11 and ANSI/AAMI NS4. The bench testing and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Stella BIO device is substantially equivalent to the predicate device K080950.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).