QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator

K150413 · Cymedica Orthopedics, Inc. · IPF · Apr 2, 2015 · Physical Medicine

Device Facts

• Record ID: K150413
• Device Name: QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
• Applicant: Cymedica Orthopedics, Inc.
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). Indications for Use: As an NMES device, indications are for the following conditions: - Relaxation of muscle spasms - Retardation or prevention of disuse atrophy - Increasing local blood circulation - Re-educating muscles - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a TENS device, indications are for the following conditions: - Symptomatic relief and management of chronic intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain

Device Story

Multifunctional electrotherapy device; provides NMES and TENS. Inputs: user-selected treatment programs via touchscreen/tactile buttons. Operation: closed-loop feedback system monitors voltage/current to deliver electrical pulses to motor points (NMES) or nerve pathways (TENS). Output: electrical stimulation via conductive garment/electrodes. Used in healthcare facilities or home environments; operated by clinicians or patients. Healthcare providers prescribe programs; patients adjust intensity for comfort. Benefits: muscle re-education, atrophy prevention, pain management. System includes user interface, battery-powered pods, conductive garments, electrodes, and gel.

Clinical Evidence

Bench testing only. No clinical data. Safety and effectiveness demonstrated via electrical safety (IEC 60601-1, 60601-2-10), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), and usability (IEC 62366) testing. Software validated per FDA guidance. Performance parameters compared against predicates to confirm equivalence.

Technological Characteristics

Power-regulated electrotherapy device. NMES: pulsed monophasic; TENS: symmetric biphasic. Powered by 3.7V Li-ion battery. Components: user interface, conductive garment, electrodes, electrode gel. Connectivity: standalone. Sterilization: not specified. Software: embedded, manages treatment programs and feedback loop. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-10, ISO 10993, ISO 14971.

Indications for Use

Indicated for patients requiring muscle stimulation or pain management. NMES indications: muscle spasm relaxation, disuse atrophy prevention, blood circulation improvement, muscle re-education, post-surgical calf stimulation for venous thrombosis prevention, and range of motion maintenance. TENS indications: chronic intractable pain relief and post-surgical/post-trauma acute pain management.

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

• Kneehab XP (K110350)
• MediStim XP (AvivaStim XP) (K082011)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 24, 2015

CyMedica Orthopedics, Inc c/o David Yungvirt Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, NY 1011

Re: K150413

Trade/Device Name: QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: March 3, 2015 Received: March 4, 2015

Dear Mr. Yungvirt:

This letter corrects our substantially equivalent letter of September 15, 2015.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part Part 801). please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure

Enclosure

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## Indications for Use

510(k) Number (if known) K150413

#### Device Name

QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS)

#### Indications for Use (Describe)

The QB1 Powered Muscle Stimulator System (NMES) &Transcutaneous Electrical Nerve Stimulator System (TENS); QB-1000 is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).

Indications for Use:

As an NMES device, indications are for the following conditions:

- Relaxation of muscle spasms
- Retardation or prevention of disuse atrophy
- Increasing local blood circulation
- Re-educating muscles
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion

As a TENS device, indications are for the following conditions:

- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CEP 801 Subnart D) | Over-The-Counter Use (21 CER 801 Subpart C) |

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# 510(k) Summary

# CyMedica Orthopedics, Inc.

QB1 NMES and TENS Systems

### 1- SUBMITTER

| Manufacturer Name: | CyMedica Orthopedics, Inc.<br>19120 N. Pima Rd. Suite 135<br>Scottsdale, AZ 85255<br>Telephone [phone]<br>FAX [phone] |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Kereshmeh Shahriari<br>19120 N. Pima Rd. Suite 135<br>Scottsdale, AZ 85255<br>[e-mail]<br>Telephone [phone]<br>FAX [phone] |
| 510(k) Summary Preparation<br>Date | February 13th, 2015 |
| 510(k) Number | K150413 |
| 2- DEVICE | |
| Trade/Proprietary Name: | QB1 Powered Muscle Stimulator System (NMES) &<br>Transcutaneous Electrical Nerve Stimulator System<br>(TENS); QB-1000 |
| Common Name: | Muscle stimulator |
| Classification Names: | Powered muscle stimulator (21 CFR 890.5850) |
| Product Code: | NMES device; IPF<br>TENS device: GZJ |
| Device Class: | 2 |

These devices are reviewed by the Division of Neurological and Physical Medicine Devices.

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## 3- PREDICATE DEVICE

| Name & 510(k) Number: | Kneehab XP, K110350 |
|-----------------------|-------------------------------------|
| | MediStim XP (AvivaStim XP), K082011 |
| | |

Manufacturer:

Bio-Medical Research, Ltd.

# 4- DEVICE DESCRIPTION

The CyMedica Orthopedics QB1 System is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that allows for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). The principles of electrotherapy emulate the process observed during a voluntary muscle contraction. The QB1 system delivers stimulation based on the principles of NMES and TENS. NMES pulses stimulate motor points of target muscles, causing a muscle contraction. This can help re-educate and strengthen muscles following an injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.

The OB1 NMES and TENS systems are prescription devices in the USA and are intended to be used following the directions of a healthcare provider. The device may be used in a healthcare facility setting or by a patient or lay operator in a home environment.

In NMES mode, the QB1 system provides two therapeutic treatment programs: Post-Operative and Strength. Its simplified programming makes the device convenient for home use; after placing the electrodes and selecting the program as prescribed by a healthcare professional, the patient only needs to increase the intensity to a comfortable level to begin therapy. The OB1 NMES Post-Operative and Strength programs utilize an electrical stimulus that, when properly applied, activates specific muscles or muscle groups to help treat disuse muscle atrophy and to reeducate muscles. This is achieved via a closed loop feedback system that minimizes energy delivery to the targeted treatment areas.

In NMES mode, the OB1 system consists of a Conductive garment with an incorporated NMES pod, User Interface device with a battery charger, NMES electrodes, and electrode gel.

The QB1 device also offers a TENS program for pain management. The QB1 TENS system consists of a TENS pod. User Interface device with a battery charger. TENS electrodes, and electrode gel.

The QB1 User Interface is programmed with an embedded software to manage the treatment programs and communicate with the User Interface touchscreen, NMES conductive garment, and TENS pod. The User Interface allows the user to select a treatment from the available treatment programs stored in the memory component of the NMES conductive garment and TENS pod. The User Interface utilizes a touchscreen and tactile buttons for user control. The User Interface device is powered by an internal rechargeable 3.7 V Lithium Ion battery that, when fully charged, can deliver at least three-20 minute treatments before requiring a recharge. The QB1

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USB charger can fully recharge the battery in approximately five hours.

The QB1 system accessories include:

- . OB1 electrodes for NMES application
- OB1 electrodes for TENS application
- QB1 electrode gel ●

# 5- INDICATIONS FOR USE

The QB1 System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).

The intended use of QB1 NMES device, including any indications for use, is limited to use in rehabilitation, including providing adjunctive therapy in rehabilitation for medical purposes.

Indications for Use:

As an NMES device, indications are for the following conditions.

- 1) Relaxation of muscle spasms
- 2) Retardation or prevention of disuse atrophy
- 3) Increasing local blood circulation
- 4) Re-educating muscles
- 5) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- 6) Maintaining or increasing range of motion

Programs NMES Post-Op and NMES Strength provide the above indications.

| Treatment | Pulse | Duration | Frequency | Pulse | Duty | Work | Relaxation | Contraction | Rest | Indications |
|-----------|------------|----------|-----------|-------|-------|-------|------------|-------------|-------|----------------|
| Program | shape | | | width | cycle | cycle | time | time | time | numbers |
| NMES | Monophasic | 20 min | 50 pps | 5 ms | 25% | 13 s | 10 s | 3 s | 3.4 s | 1, 2, 3, 4, 5, |
| Post-Op | | | | | | | | 2 cycles | | 6 |
| NMES | Monophasic | 20 min | 50 pps | 5 ms | 25% | 12 s | 10 s | 1 s | 1.4 s | 1, 2, 3, 4, 5, |
| Strength | | | | | | | | 5 cycles | | 6 |

The QB1 TENS device is intended for pain relief.

As a TENS device, indications are for the following conditions:

- 7) Symptomatic relief and management of chronic intractable pain
- 8) Adjunctive treatment for post-surgical and post-trauma acute pain

Program TENS pain management provides the above indications.

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| Treatment<br>Program | Pulse<br>shape | Duration | Frequency | Pulse<br>width | Duty<br>cycle | Work<br>cycle | Interphase<br>interval<br>time | Indications<br>numbers |
|-------------------------|--------------------------|----------|-----------|----------------|---------------|---------------|--------------------------------|------------------------|
| TENS Pain<br>Management | Biphasic,<br>symmetrical | 20 min | 100 pps | 1 ms | 20% | Continuous | 4 ms | 7, 8 |

## 6- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

CyMedica Orthopedics, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, the QB1 System is substantially equivalent in indications and design principles to predicate devices, which have been determined by FDA to be substantially equivalent to preamendment devices: Bio-Medical Research, Ltd, Kneehab XP device, K110350 and MediStim XP (AvivaStim XP), K082011. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

The intended use, design, materials and functional characteristics of the QB1 System and the predicate devices are substantially the same. The subject device and predicate devices are for prescription use, portable, hand-held, and home healthcare environment devices. The power in QB1 device Kneehab XP device is derived from a rechargeable battery that is pre-installed in the unit. There are two channels of stimulation in all three devices. In all three devices the user needs to select the desired treatment program and adjust the intensity. All three devices employ a ramp-up, work, and rest phases.

The following table summarizes the technological characteristics of the subject device and predicate devices:

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| Parameter | QB1 NMES<br>POST-OP | QB1 NMES<br>STRENGTH | QB1 TENS | Kneehab XP-<br>NMES | Kneehab XP-<br>NMES | Kneehab XP-<br>TENS | MediStim<br>XP-NMES | MediStim<br>XP-TENS |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|------------------------------------------|------------------------------------------|----------------------------------------|----------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| 510(k) Number | K150413 | K150413 | K150413 | K110350 | K110350 | K110350 | K082011 | K082011 |
| Mode or Program Name | POST-OP | STRENGTH | TENS | Program 1 | Program 5 | Program 7 | Program 1 | Program 9 |
| Waveform (e.g., pulsed<br>monophasic, biphasic) | Pulsed<br>Monophasic | Pulsed<br>Monophasic | Symmetric<br>Biphasic | Pulsed, Symmetrical,<br>Biphasic | Pulsed, Symmetrical,<br>Biphasic | Pulsed, Symmetrical,<br>Biphasic | Pulsed, Symmetrical,<br>Biphasic | Pulsed, Symmetrical,<br>Biphasic |
| Shape (e.g., rectangular,<br>spike, rectified<br>sinusoidal) | Complex | Complex | Complex | Square | Square | Square | Square | Square |
| Maximum Output<br>Voltage (volts, rms)<br>(+/- %) | 3.4 @500Ω<br>6.1 @ 2 kΩ<br>8.5 @10 kΩ | 3.4 @500Ω<br>6.1 @ 2 kΩ<br>8.5 @10 kΩ | 0.18 @500Ω<br>0.19 @ 2 kΩ<br>0.20 @10 kΩ | 25.5 @500Ω<br>46.8 @ 2 kΩ<br>34.0 @10 kΩ | 25.8 @500Ω<br>50.3 @ 2kΩ<br>34.2 @10kΩ | 40 @500Ω<br>61.7 @ 2kΩ<br>25.7 @10k Ω | 33.5 @500Ω<br>Error message for high load<br>Error message for high load | 20.9 @500Ω<br>Error message for high load<br>Error message for high load |
| Maximum Output<br>Current (mA, rms) (+/-<br>%) | 6.8 @500Ω<br>3.0 @ 2 kΩ<br>0.9 @10 kΩ | 6.8 @500Ω<br>3.0 @ 2 kΩ<br>0.9 @10 kΩ | 0.36 @500Ω<br>0.10 @ 2 kΩ<br>0.02 @10 kΩ | 51.0 @500Ω<br>23.4 @ 2k Ω<br>3.4 @10kΩ | 51.6 @500Ω<br>25.2 @ 2k Ω<br>3.4 @10kΩ | 80.0 @500Ω<br>30.8 @ 2k Ω<br>2.6 @10kΩ | 67 @500Ω<br>Error message for high load<br>Error message for high load | 41.8 @500Ω<br>Error message for high load<br>Error message for high load |
| Duration of primary<br>(depolarizing) phase<br>(µsec) | 5000 | 5000 | N/A<br>(Continuous) | 300 | 300 | N/A<br>(Continuous) | 400 | 150 |
| Pulse Duration (µsec) | 5000 | 5000 | 1000 | 640 | 640 | 300 | 800 | 300 |
| Frequency (Hz) [or Rate<br>(pps)] | 50 | 50 | 100 | 50 | 50 | 99 | 50 | 99 |
| For interferential modes<br>only: Beat Frequency<br>(Hz) | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| For<br>multiphasic<br>waveforms<br>only: | | | | | | | | |
| Symmetrical phases? | N/A | N/A | N/A | Yes | Yes | Yes | Yes | Yes |
| Phase duration | N/A | N/A | 1 ms | 300 µs | 300 µs | 0.3 ms | 400 µs | 150 µs |
| Net Charge<br>(microcoulombs (µC) per<br>pulse) (If zero, state method<br>of achieving zero net<br>charge.) | 0 @500Ω<br>(Symmetric<br>Biphasic) | 0 @500Ω<br>(Symmetric<br>Biphasic) | 0 @500Ω<br>(Symmetric<br>Biphasic) | 0 @500Ω<br>(Symmetric<br>Biphasic) | 0 @500Ω<br>(Symmetric<br>Biphasic) | 0 @500Ω<br>(Symmetric<br>Biphasic) | 126 @500Ω | 126 @500Ω |
| Maximum Phase<br>Charge, (µC) | 25.2 µC<br>@500Ω | 25.2 µC<br>@500Ω | 19.8 µC<br>@500Ω | 23.4 µC<br>@500Ω | 0.14 µC<br>@500Ω | 43.0 @500Ω | 126 @500Ω | 126 @500Ω |
| Maximum Current<br>Density (mA/cm², r.m.s.) | 0.61 @500Ω | 0.62 @500Ω | 0.964 @500Ω | 2.63 @500Ω | 1.64 @500Ω | 0.014 @500Ω | 0.27 @500Ω | 0.27 @500Ω |
| Maximum Average<br>Current (average<br>absolute value), mA | 51.0 @500Ω | 51.6 @500Ω | 80.0 @500Ω | 67 @500Ω | 41.8@500Ω | 0.36 @500Ω | 6.8 @500Ω | 6.8 @500Ω |
| Maximum Average<br>Power Density, (W/cm²),<br>(using smallest electrode<br>conductive surface area) | 0.016 @500Ω | 0.016 @500Ω | 0.039 @500Ω | 0.088 @500Ω | 0.034 @500Ω | 2.6 E-6<br>@500Ω | 0.001 @500Ω | 0.001<br>@500Ω |
| (a) Pulses per<br>burst | 250 | 250 | N/A<br>(Continuous<br>Pulse) | | N/A<br>(Continuous<br>Pulse) | N/A<br>(Continuous<br>Pulse) | 50 | 150 |
| Burst<br>Mode | 0.10 | 0.10 | 5 | | 5 | 5 | 0.23 | 0.087 |
| (c) Burst duration<br>(seconds) | 0.50 | 0.5 | Continuous | | Continuous | Continuous | 1 | 3 |
| (d) Duty Cycle:<br>Line (b) x<br>Line (c) | 600 | 600 | 900 | | 900 | N/A | 0.23 | 0.26 |
| ON Time (seconds) | Continuous | Continuous | Continuous | | Continuous | N/A | 276 | 312 |
| OFF Time (seconds) | N/A | N/A | N/A | | N/A | N/A | 924 | 888 |
| Additional Features<br>(specify if applicable) | N/A | N/A | N/A | | N/A | N/A | N/A | N/A |

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#### QB1 system differs from the Kneehab XP and MediStim XP devices in the following areas:

#### Difference Area

- 1 Output Regulation: QB1 system is a power regulated stimulator while Kneehab XP and MediStim XP are current regulated stimulators
- 2 Number of Electrodes: QB1 system uses three electrodes for NMES application while Kneehab XP uses 4 electrodes for NMES application.
- 3 Electrode Sizes: QB1 electrode sizes are 25.86, 51.61, and 51.61 cm2 while the Kneehab XP electrode sizes are 194, 74, 83, and 66 cm2. Three MediStim XP electrode sizes are 20.25 cm², 25 cm², 49 cm² .
#### Equivalence Discussion

Various voltage, current, and power regulated stimulators exist which indicate the control methodology used. The QB1 power controlled stimulator monitors both voltage and current. As shown in Section 18, the system has been fully tested per IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-10, IEC 62366 and meets all standard requirements and FDA guidance requirements. It adequately controls the stimulator outputs to the allowable ranges and within the tolerance limits provided in the standards and guidance, evidenced in IEC 60601-2-10. The QB1 output power levels are lower than Kneehab XP and MediStim XP as evidenced in Tables 2-4 of OB1 Design Verification & Validation, QB-0030-034, Section 018 of this submission. Accordingly, the QB1 power regulated stimulator poses no new safety risks and is substantially equivalent to the predicate.

Various electrical stimulation systems use two or more than two electrodes to deliver the stimulation energy. The choice of three electrodes versus the four electrodes is purely to target the thigh muscle regions desired. The main safety concern with number of electrodes is to have sufficient surface area and appropriate power output levels to prevent potential skin burns. As tested in OB1 Design Verification & Validation, QB-0030-034, Section 018 of this submission and evidenced in Tables 2-4, the maximum current densities of OB1 are lower than Kneehab XP. Accordingly, the difference in electrodes in the QB1 system poses no new safety risks and is substantially equivalent to the predicate.

Various electrical stimulation systems use different sizes of electrodes to deliver the stimulation energy. The choice of the QB1 electrodes is to have sufficient area for stimulation but to be sufficiently small to target the thigh muscle regions desired. The main safety concern with number of electrodes is to have sufficient surface area and appropriate power output levels to prevent potential skin burns. As tested in QB1 Design

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Verification & Validation, OB-0030-034, Section 018 of this submission and evidenced in Tables 2-4, the maximum current densities of QB1 are lower than Kneehab XP and MediStim XP despite the smaller electrode sizes. Accordingly, the difference in electrode sizes in the QB1 system poses no new safety risks and is substantially equivalent to the predicate.

- 4 Waveform and Shape: QB1 NMES treatment waveform is a pulsed. monophasic and complex shape. QB1 TENS treatment waveforms is pulsed, symmetrical, biphasic, and complex shape. Kneehab XP and MediStim XP are pulsed. symmetrical, biphasic and rectangular shape with interphase interval.
Various electrical stimulation systems use various waveforms and shapes to deliver the stimulation energy. The design philosophy of the OB1 waveforms was to produce sufficient muscle contractions while maintaining comfort for the user. The QB1 waveforms are generally lower in amplitude and wider in pulse width to minimize the power required for muscle activation and maximize the comfort. The main safety concern with the waveform and shape is that the power output does not produce skin burns or other user health risks. As tested in OB1 Design Verification & Validation, QB-0030-034, Section 018 of this submission and evidenced in Tables 2-4, the OB1 waveforms are at lower voltage and current and therefore power levels than the Kneehab XP and MediStim XP. Accordingly, the difference in waveforms in the QB1 system poses no new safety risks and is substantially equivalent to the predicate.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.

### 7- PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence.

To demonstrate the safety, the QB1 system was tested for electrical safety, electromagnetic compatibility, usability, biocompatibility, and risk management requirements.

To demonstrate the safety, the QB1 System was tested per the following standards:

- o IEC 60601-1, Medical electrical equipment- General requirements for basic safety and essential performance
- IEC 60601-1-2, Medical electrical equipment- Part 1-2: General requirements for basic 0 safety and essential performance- Collateral standard: Electromagnetic compatibility requirements

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- IEC 60601-2-10, Medical electrical equipment- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulator
- 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
- o IEC 60601-1-6. Medical electrical equipment- Part 1-6: General requirements for basic safety and essential performance- Collateral standard: Usability including IEC 62366: Application of usability engineering to medical devices
- IEC 62366: 2007, Medical devices -- Application of usability engineering to medical ● devices
- ISO 10993-1: 2009, Biological evaluation of medical devices- Part 1: Evaluation and 0 testing within a risk management process
- ISO 10993-5: 2009, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- 0 ISO 10993-10: 2010, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- ISO 14971: 2007, Application of risk management to medical devices

In addition, to demonstrate the QB1 system effectiveness and performance substantial equivalency of the subject device, QB1 NMES and TENS system and the predicate devices Kneehab XP (K110350) and MediStim XP (K082011) were tested according to the following FDA guidance documents:

- o FDA Final Guidance Document for Powered Muscle Stimulator 510(k). June 9, 1999
- FDA Draft Guidance Document, Class II special controls guidance document: 0 Transcutaneous electrical nerve stimulator for pain relief. April 5, 2010

# Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the QB1 system, consisting of the User Interface, battery charger, conductive garment, and electrodes. The system compiles with the IEC 60601-1, IEC 60601-2-10, and 60601-11 standards for safety and the IEC 60601-1-2 standard for EMC.

# Software Verification & Validation Testing

The device's software has been validated in accordance with the requirements set forth in the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical

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Devices (May 11, 2005). The software validation tests demonstrated that the software version meets its design requirements.

# Human Factors and Usability

The human factors and usability study was conducted to validate the usability of the QB1 system in the home environment. The results of the study support the instructions for successfully using the device as intended. The results of human factors and usability study substantiates the acceptability of the risks identified during the risk assessment activities. The QB1 system complies with the IEC 60601-1-6: 2010 for usability and IEC 62366: Application of usability engineering to medical devices.

# 8- CONCLUSION

Based on the performance testing and the supporting documentation, it can be concluded that the OB1 NMES and TENS system is safe, effective, and substantially equivalent to the predicate devices. The QB1 device output pulse parameters provide a safe and effective treatment for the NMES and TENS applications.

Based on the acceptable bench test results, QB1 compliance with the applicable standards, and low current and voltage values, the OB1 device is considered safe and as effective as the predicate devices, Kneehab XP (K110350) and MediStim XP (K082011) for its intended uses and indications for use. The QB1 NMES and TENS pulse parameters and waveform are selected and designed so they would provide a safe and effective treatment for the indications for use.