PTG-05

K240347 · Zimmer Medizinsysteme GmbH · NGX · Jul 21, 2024 · Physical Medicine

Device Facts

• Record ID: K240347
• Device Name: PTG-05
• Applicant: Zimmer Medizinsysteme GmbH
• Product Code: NGX · Physical Medicine
• Decision Date: Jul 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. Strengthening, toning, and firming of buttocks & thighs. Strengthening, toning, and firming of arms.

Device Story

PTG-05 is a non-invasive, powered muscle stimulator used in clinical settings to increase musculature in abdominals, buttocks, thighs, and arms. The device delivers biphasic, middle-frequency electrical currents via up to 8 channels to stimulate muscle tissue. Users are guided by an interface to select treatment areas and protocols; electrodes are placed according to on-screen illustrations. The system features 5 pre-set protocols based on patient training levels, with animations indicating work/relax phases. An 'Expert mode' allows independent channel intensity adjustment, while 'Link-mode' enables patient-controlled intensity via remote. The device includes safety features like automatic overload/no-load trips and a warning system for current density exceeding 2mA/cm². By inducing muscle contractions, the device aims to strengthen and tone targeted muscle groups, providing a non-surgical option for body contouring and muscle conditioning.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 60601-1-6, IEC 62366-1), and waveform tracing/measurement. Risk management was performed per ISO 14971.

Technological Characteristics

Powered muscle stimulator; 100-240VAC input. PC-ABS plastic housing. 8 output channels using symmetrical biphasic rectangular/square waveforms. 12" LCD interface. Connectivity includes remote control for patient-operated intensity. Electrical isolation via medical-grade PSU (2xMOPP) and transformers. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and ISO 14971. Sterilization: single-use electrodes (K140340).

Indications for Use

Indicated for individuals seeking improvement of abdominal tone, strengthening of abdominal muscles, development of a firmer abdomen, and strengthening, toning, and firming of buttocks, thighs, and arms.

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

• truSculpt Flex (K212866)

Reference Devices

• NuEra Tight RF Family

Submission Summary (Full Text)

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July 21, 2024

Zimmer MedizinSysteme GmbH Scott Blood Principal Regulatory Consultant QARA Consulting LLC 151 Gleasondale Road Stow, MA 01775 USA

Re: K240347

Trade/Device Name: PTG-05 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: June 20, 2024 Received: June 24, 2024

Dear Scott Blood:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Heather L. Dean -S

Heather Dean, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

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## Indications for Use

Submission Number (if known)

K240347

Device Name

PTG-05

Indications for Use (Describe)

· Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.

- · Strengthening, toning, and firming of buttocks & thighs.
- · Strengthening, toning, and firming of arms.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary PTG-05 K240347

## 1. Basic Information-Submitter:

| 510(k) Owner: | Zimmer MedizinSysteme GmbH<br>Junkersstrasse 9<br>89231 Neu-Ulm<br>Germany<br>Establishment Registration: 8010720 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Ms. Ute Killet<br>Manager Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>E-Mail: [e-mail] |
| Official Contact: | Mr. Scott Blood<br>Principal Regulatory Consultant<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | February 22, 2024 |

#### 2. Device Name:

Trade Name: Classification Name: Regulation Number: Product Code: Classification:

PTG-05 Stimulator, Muscle, Powered, For Muscle Conditioning 21 CFR 890.5850 NGX Class II

- 3. Predicate Device: truSculpt Flex - K212866 Company Name:
# Johari Digital Healthcare Limited

#### 4. Device Description:

The PTG-05 is a non-invasive therapeutic device. The device produces an electrical current that interacts with the tissues of the human body. The PTG-05 is intended to increase the musculature of the abdominals, buttocks, arms and thighs. The device is intended to be used with single-use electrodes from Zimmer MedizinSysteme GmbH (K140340) or equivalent. The output of biphasic and middle frequency currents for muscle stimulation

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Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is in grayscale.

with maximum 8 channels at a time allows to treat several treatment areas simultaneously.

For an efficient treatment the user is guided via user interface throughout the whole treatment. First, the user can select the treatment area with the device illustrating where to place the electrodes. The modules are automatically matched to the specific treatment area while highlighted in the color of the matching trunk cable of the module.

In the therapy screen, the user can select one of the 5 pre-set treatment protocols for each treatment region based on the training level of the patient.

During the treatment, an animation of the electrodes is shown in the screen that outlines if the protocol is in a "work-phase" which means a contraction phase or if the protocol is in a "relax-phase" which refers to a muscle relax phase.

#### Expert mode

In addition, all 4 modules can be split into 8 channels using "Expert mode" for a precise adjustment of the individual channels. This is ideal to set different intensities for the inner musculature than for the outer musculature of a specific treatment area, for example.

#### Link-mode

All of the modules can be linked together which enables the use of the remote control where the patient by itself can set the intensity and stop the therapy at any time.

#### 5. Indications for Use Statement:

The PTG-05 is intended for:

- Improvement of abdominal tone, for strengthening of the abdominal muscles, for ● development of firmer abdomen.
- Strengthening, toning and firming of buttocks & thighs.
- o Strengthening, toning and firming of arms

The Indications for Use statement of PTG-05 is similar to that of the predicate device NuEra Tight RF Family.

#### 6. Technological Characteristics:

There are only a few technological differences between the subject device and the predicate device. Those differences are discussed below and do not affect or raise any new types of safety or performance questions.

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| TECHNOLOGICAL<br>CHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | Equivalence<br>Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power<br>Source | Zimmer<br>MedizinSysteme GmbH<br>PTG-05<br>This Submission<br>100-240VAC, 50/60Hz,<br>max. 100VA | Johari Digital Healthcare<br>Limited<br>truSculpt flex<br>K212866<br>100-240AC, 50/60Hz,<br>75VA | Similar |
| Method of Line Current<br>Isolation | a) AC Power supply is<br>converted to DC Power<br>supply thorough a<br>medical grade PSU,<br>which has isolation of<br>2XMOPP<br>(IEC 60601-1)<br><br>(b) Isolation thru<br>transformer between<br>device and patient | a) AC Power supply is<br>converted to DC Power<br>supply thorough a<br>medical grade PSU,<br>which has isolation of<br>2XMOPP (IEC60601-1)<br><br>(b) Isolation thru<br>transformer between<br>device and patient | Identical |
| Patient Leakage Current<br>Normal condition | Normal condition = less<br>than 100μA | Normal condition = less<br>than 100μA | Identical |
| Patient Leakage Current<br>Single Fault condition | Single fault condition =<br>less than 300 μA | Single fault condition =<br>less than 300 μA | Identical |
| Components | Main unit,<br><br>8 reusable trunk cables<br>16 reusable electrode<br>cables<br><br>2 packages of single-<br>use Zimmer electrodes<br>(K140340)<br><br>1 Power Cord | Main unit,<br><br>8 Stainless steel<br>reusable electrodes pairs<br>(16 electrodes)<br><br>4 electrode lead wires<br><br>1 AC Power Cord<br><br>4 Hydrogel pads<br><br>2 reusable silicone belts<br>(cummerbunds) | Similar<br><br>The components are sufficient for the<br>device operation, so there are no<br>questions of safety or effectiveness.<br><br>The predicate device supports 4<br>output channels which allow the<br>connection of 16 electrodes to the<br>devices whereby 2 electrodes are<br>always run in parallel. The subject<br>device has 8 output channels suitable<br>to also attach 16 electrodes. This<br>configuration offers an even safer<br>usage of the device while the<br>application form remains the same<br>and the treatment is as effective as<br>the predicate device. |
| Display | 12" LCD | 12" LCD | Identical |
| Number of Output Modes | 5<br><br>Level 1, Level 2, Level 3,<br>Level 4, Level Intense | 3<br><br>Prep, Tone, Sculpt | Similar<br><br>The output modes of the subject device<br>are precisely matched to the body<br>regions. The predicate device does not<br>have this feature. The output modes of<br>the predicate device are identical for all<br>body regions. Therefore, the subject<br>device is safer due to the adjustment to<br>the body region. |
| TECHNOLOGICAL<br>CHARACTERISTICS | SUBJECT DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>PTG-05<br>This Submission | PREDICATE DEVICE<br>Johari Digital Healthcare<br>Limited<br>truSculpt flex<br>K212866 | Equivalence<br>Discussion |
| Output<br>Channels | 8 | 4 | modes while the subject device offers 5<br>output modes thereby output mode 1<br>Similar |
| | | | The number of outputs is being<br>increased from 4 to 8 to provide<br>enhanced customization and flexibility<br>to the user.<br>The predicate device supports 4 output<br>channels which allow the connection of<br>16 electrodes to the devices whereby 2<br>electrodes are always run in parallel.<br>The subject device has 8 output<br>channels suitable to attach 16<br>electrodes. This configuration offers<br>even safer usage of the device while<br>the application form remains the same<br>and the treatment is as effective as the<br>predicate device. |
| Synchronous or<br>Alternating? | Synchronous | Synchronous | Identical |
| Method of Channel Isolation | Output 1 to 8 are<br>completely isolated by<br>transformers. Only power<br>supply and ground are<br>common. | Transformer | Identical |
| Regulated Current<br>Or<br>Regulated Voltage | Regulated current | Tran conductance | Different |
| | | | The subject device controls the output<br>current by a common current regulation<br>method this ensures safety of the<br>device and is tested during IEC 60601-<br>2-10 testing. |
| Software/Firmware/<br>Microprocessors controls? | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes | Yes | Identical |
| Automatic No-Load Trip? | Yes | No | Different |
| | | | Device studied for electrical safety in its<br>intended environment per IEC 60601-1<br>and determined to be electrical safe. |
| Automatic Shut off? | Yes (In case of therapy<br>time running out or in<br>case of an error) | Yes | Identical |
| Patient Override Control? | Yes (If override control<br>means that the patient<br>can stop the treatment | Yes | Identical |
| TECHNOLOGICAL<br>CHARACTERISTICS | SUBJECT DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>PTG-05<br>This Submission | PREDICATE DEVICE<br>Johari Digital Healthcare<br>Limited<br>truSculpt flex<br>K212866 | Equivalence<br>Discussion |
| | He can do so by pressing<br>pause on the remote) | | |
| On/Off Status on Display | Yes | Yes | Identical |
| Low Battery on Display | N/A | N/A | Identical |
| Voltage/Current Level on<br>Display | Yes | Yes | Identical |
| Timer Range (minutes) | Up to max. 30 minutes<br>per protocol | 45 Minutes - for Classic<br>Mode<br>15 Minutes - for Flex+<br>mode | Similar<br>Treatment time is in the range of the<br>predicate device and is a user-settable<br>parameter. |
| Compliance With Voluntary<br>Standards? | Yes<br>IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-10 &<br>ISO 14971 | Yes<br>IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-10 &<br>ISO 14971 | Identical |
| Compliance With 21 CFR<br>898? | Yes, the electrode cable<br>can never be plugged in<br>the AC socket, not even<br>accidentally as the cable<br>has an isolation on both<br>sides. | Yes, the electrode cable<br>can never be plugged in<br>the AC socket, not even<br>accidentally | Identical |
| Weight | 45kg<br>(inlcuding max. work<br>load) | 32.66 Kgs | Different<br>The weight relates to the technical<br>setup and therefore differs but does not<br>influence safety. |
| Dimension (L x W x H) | 117cm x 80cm x 80cm<br>31"(L) x 31"(W) x 46" (H) | 14"(L) x 17.5"(W) x<br>40"(H) | Different<br>The dimensions of the predicate device<br>are verified and validated during safety<br>and usability testing. Both tests show<br>that the dimensions are adequate and<br>guarantee a safe and effective usage of<br>the device. |
| Housing Material and<br>construction | PC-ABS Plastic Body | ABS Plastic Body | Similar<br>Changing the material of the subject<br>device to PC-ABS does not effect<br>safety as mechanical properties of the 2<br>materials are equal and material<br>behavior for the subject device is also<br>tested while IEC60601-1 test. |
| Operating Temperature | 50°F to 104°<br>(+10°C to + 40°C)<br>10% to 90% rel. humidity,<br>620-1060 hPa | Temperature: +15°C to<br>+35°C<br>Relative Humidity: 30%<br>to 75% (non-condensing)<br>Barometric pressure: | Different<br>No influence on safety and<br>effectiveness |
| TECHNOLOGICAL<br>CHARACTERISTICS | SUBJECT DEVICE<br>Zimmer<br>MedizinSysteme GmbH<br>PTG-05<br>This Submission | PREDICATE DEVICE<br>Johari Digital Healthcare<br>Limited<br>truSculpt flex<br>K212866 | Equivalence<br>Discussion |
| | | 700hPA to 1060hPa | |
| Transport and storage<br>environment | -4°F to 158°F<br>(-20°C to + 70°C)<br>10% to 90% rel. humidity,<br>620–1060 hPa | Temperature: +5°C to<br>45°C<br>Relative Humidity: 10%<br>to 85% (non-condensing) | Different<br>No influence on safety and<br>effectiveness |

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Image /page/7/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in a bold, sans-serif font, with a line above the "z". Below the word "zimmer" is the word "MedizinSysteme" in a smaller, lighter font. The logo is in grayscale.

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Image /page/8/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray color and the background is white.

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Image /page/9/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray color.

# Output Specification Comparison by Mode

| # | Parameters | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>PTG-05<br>This Submission | PREDICATE DEVICE<br>Johari Digital Healthcare<br>Limited<br>truSculpt flex<br>K212866 |
|----|-------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | Mode Name | Level 1<br>Level 2 | Prep |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step Wave<br>Square Wave<br>(Biphasic rectangular symmetric) | Step Sine Wave |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω<br>320 Vpp @ 2kΩ<br>360 Vpp @ 10kΩ<br>100Vpp @ 500Ω<br>320Vpp @2kΩ<br>360Vpp @10kΩ | 100Vpp @ 500Ω (±10%)<br>125Vpp @ 2KΩ (±10%)<br>133Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current1 | 200mA @ 500 Ohm<br>160mA @ 2k Ohm<br>36 mA @ 10kOhm<br>200mA @500 Ohm<br>160mA @2k Ohm<br>36mA @ 10k Ohm | 200mA @ 500 Ohm<br>62.5mA @ 2K Ohm<br>13.5mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs<br>200 µs, 300µs | 125µS (± 10%) @ 500Ω |
| 6. | Frequency | Pulse Frequency:<br>2500Hz@ 500 Ω = (1/125)<br>8000Hz@ 500 Ω = (1/ 400)<br>Modulation:<br>20-24 Hz@ 500 Ω | Channel 1:<br>4000Hz (± 10%) @ 500 Ω<br>Channel 2:<br>4001 - 4100Hz (± 10%) @<br>500 Ω<br>Resultant: 1 - 100Hz |

¹ Device has a warning system that alerts the user when the maximum current density exceeds 2mA/cm².

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Image /page/10/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray color.

| | | SUBJECT DEVICE | PREDICATE DEVICE |
|-----|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| # | Parameters | Zimmer MedizinSysteme GmbH<br>PTG-05 | Johari Digital Healthcare<br>Limited |
| | | This Submission | truSculpt flex<br>K212866 |
| 7. | For Interferential modes only<br>- Beat frequency<br>- | N/A | 1 - 100Hz |
| 8. | For multiphasic Waveform<br>- Symmetrical Phases?<br>- Phase duration<br>- | No multiphasic wave form.<br>Either biphasic or modulated sine<br>wave. | Yes<br>125µS |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic in<br>nature the net charge would be<br>Zero) | 0µC @ 500Ω (Being<br>Biphasic in nature the net<br>charge would be Zero) |
| 10. | Maximum Phase Charge | 12.5 µC (125µs pulse)<br>40 µC (400µs pulse)<br>20µC @500 Ω Load (200 µs)<br>30µC @500 Ω Load (300 µs) | 12.5 µC |
| 11. | Maximum Current Density | 4.06 mA/ cm²<br>*measured with 56mm round electrodes<br>4.06 mA/ cm²<br>*measured with 56mm round electrodes | 2.88 mA/cm²<br>*measured with 59 x 59mm square<br>electrodes |
| 12. | Maximum Power Density | 0.203 W/cm²<br>*measured with 56mm round electrodes<br>0.203 W/cm²<br>*measured with 56mm round electrodes | 0.144 W/cm²<br>*measured with 59 x 59mm square<br>electrodes |
| 13. | Burst Mode<br>- Pulses Per Burst<br>- Burst Per second<br>- Bust Duration<br>- Duty Cycle<br>- | N/A | N/A |
| 14. | ON Time | N/A | N/A |
| 15. | OFF Time | N/A | N/A |
| 16. | Additional Features | N/A | Sweep Frequency 1-<br>100Hz |

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Image /page/11/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray letters. Below it, in smaller, lighter gray letters, are the words "MedizinSysteme."

| # | Parameters | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>PTG-05 | PREDICATE DEVICE<br>Johari Digital Healthcare Limited<br>truSculpt flex |
|-----|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | | This Submission | K212866 |
| | Mode Name | Level 3<br>Level 4 | Tone |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step Wave<br>Square Wave<br>(Biphasic rectangular<br>symmetric) | Square Wave |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω<br>320 Vpp @ 2kΩ<br>360 Vpp @ 10kΩ<br>100Vpp @ 500Ω<br>320Vpp @2kΩ<br>360Vpp @10kΩ | 70Vpp @ 500Ω (±10%)<br>125Vpp @ 2KΩ (±10%)<br>150Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current² | 200mA @ 500 Ohm<br>160mA @ 2k Ohm<br>36 mA @ 10kOhm<br>200mA @500 Ohm<br>160mA @2k Ohm<br>36mA @ 10k Ohm | 140mA @ 500 Ohm<br>62.5mA @ 2K Ohm<br>15mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs<br>200 µs, 300µs | 350µS (± 10%) @ 500Ω |
| 6. | Frequency | Pulse Frequency:<br>2500Hz@ 500 Ω<br>8000Hz@ 500 Ω<br>Modulation: 28-45 Hz@ 500 Ω | 99 Hz (± 10%) @ 500Ω |
| 7. | For Interferential modes only<br>Beat frequency | N/A | N/A |
| 8. | For multiphasic Waveform<br>Symmetrical Phases?<br>Phase duration | No multiphasic wave form.<br>Either biphasic or modulated<br>sine wave. | Yes, Symmetrical Biphasic<br>350 µS |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic in<br>nature the net charge would be<br>Zero) | 0μC @ 500Ω (Being Biphasic in<br>nature the net charge would be<br>Zero) |
| 10. | Maximum Phase Charge | 12.5 µC (125µs pulse)<br>40 µC (400µs pulse)<br>20µC @500 Ω Load (200 µs)<br>30μC @500 Ω Load (300 µs) | 24.50 µC @ 500Ω Load |
| 11. | Maximum Current Density | 4.06 mA/ cm²<br>* measured with 56mm round electrodes<br>4.06 mA/ cm²<br>* measured with 56mm round electrodes | 2.02 mA/cm²<br>*measured with 59 x 59mm square electrodes |
| # | Parameters | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>PTG-05<br>This Submission | PREDICATE DEVICE<br>Johari Digital Healthcare Limited<br>truSculpt flex<br>K212866 |
| 12. | Maximum Power Density | 0.203 W/cm²<br>*measured with 56mm round electrodes<br>0.203 W/cm²<br>*measured with 56mm round electrodes | 0.070 W/cm²<br>*measured with 59 x 59mm square electrodes |
| 13. | Burst Mode<br>- Pulses Per Burst<br>- Burst Per second<br>- Bust Duration<br>- Duty Cycle | N/A | N/A |
| 14. | ON Time | N/A | 6 seconds |
| 15. | OFF Time | N/A | 4 seconds |
| 16. | Additional Features | N/A | N/A |
| # | Parameters | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>PTG-05<br>This Submission | PREDICATE DEVICE<br>Johari Digital Healthcare Limited<br>truSculpt flex<br>K212866 |
| | Mode Name | Level 5 | Sculpt |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step Wave | Modulated Sine Wave |
| | | Square Wave<br>(Biphasic rectangular<br>symmetric) | |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω<br>320 Vpp @ 2kΩ<br>360 Vpp @ 10kΩ<br>100Vpp @ 500Ω<br>320Vpp @2kΩ<br>360Vpp @10kΩ | 100Vpp @ 500Ω (±10%)<br>125Vpp @ 2KΩ (±10%)<br>135Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current3 | 200mA @ 500 Ohm<br>160mA @ 2k Ohm<br>36 mA @ 10kOhm<br>200mA @500 Ohm<br>160mA @2k Ohm<br>36mA @ 10k Ohm | 200mA @ 500 Ohm<br>62.5mA @ 2K Ohm<br>13.5mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs | 125µS (± 10%) @ 500Ω |
| | | 200 µs, 300µs | |
| 6. | Frequency | Pulse Frequency:<br>2500Hz@ 500 Ω<br>8000Hz@ 500 Ω<br>Modulation: 35-65 Hz@ 500 Ω | 4000Hz (± 10%) @ 500 Ω<br>Resultant: 1 – 100Hz |
| 7. | For Interferential modes only<br>- Beat frequency | N/A | N/A |
| 8. | For multiphasic Waveform<br>- Symmetrical Phases?<br>- Phase duration | No multiphasic wave form.<br>Either biphasic or modulated<br>sine wave. | Yes, Symmetrical Biphasic<br>125µS (± 10%) |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic in<br>nature the net charge would be<br>Zero) | 0µC @ 500Ω (Being Biphasic in<br>nature the net charge would be<br>Zero) |
| 10. | Maximum Phase Charge | 12.5 µC (125µs pulse)<br>40 µC (400µs pulse)<br>20µC @500 Ω Load (200 µs)<br>30µC @500 Ω Load (300 µs) | 12.5 µC |
| 11. | Maximum Current Density | 4.06 mA/ cm²<br>* measured with 56mm round electrodes<br>4.06 mA/ cm²<br>* measured with 56mm round electrodes | 2.88 mA/cm²<br>*measured with 59 x 59mm square electrodes |
| # | Parameters | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>PTG-05<br>This Submission | PREDICATE DEVICE<br>Johari Digital Healthcare Limited<br>truSculpt flex<br>K212866 |
| 12. | Maximum Power Density | 0.203 W/cm²<br>*measured with 56mm round electrodes<br>0.203 W/cm²<br>*measured with 56mm round electrodes | 0.144 W/cm²<br>*measured with 59 x 59mm square electrodes |
| 13. | Burst Mode<br>- Pulses Per Burst<br>- Burst Per second<br>- Bust Duration<br>- Duty Cycle | N/A | N/A |
| 14. | ON Time | N/A | N/A |
| 15. | OFF Time | N/A | N/A |
| 16. | Additional Features | N/A | Sweep Frequency 1-100Hz |

² Device has a warning system that alerts the user when the maximum current density exceeds 2mA/cm².

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Image /page/12/Picture/0 description: The image contains the logo for Zimmer MedizinSysteme. The word "zimmer" is in a bold, sans-serif font, with a horizontal line above the letters. Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is in grayscale.

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Image /page/13/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is in grayscale.

³ Device has a warning system that alerts the user when the maximum current density exceeds 2mA/cm².

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Image /page/14/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray color.

#### 7. Performance data

The technological characteristics of the PTG-05 device has been verified based on assessments of electrical safety, performance testing, biocompatibility and usability.

The following testing has been conducted with satisfactory results:

- Usability & Risk Management: Usability and Risk Management assessments were ● done using worst-case assumptions to verify user interface, safety features and satisfactory performance.
- Electrostimulation waveform measurement ●
- . Waveform tracing

The following consensus standards were used in the development of this device:

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Image /page/15/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "r". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is in gray color and set against a white background.

| Standards | Standards<br>Organization | Standards Title |
|-----------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1 Edition 3.2<br>2020-08<br>CONSOLIDATED<br>VERSION | IEC | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| 60601-1-2 Edition 4.1<br>2020-09 | IEC | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Electromagnetic disturbances - Requirements and tests |
| 60601-1-6 Edition 3.1<br>2013-10 | IEC | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |
| 62304 Edition 1.1 2015-<br>06 | IEC | Medical devices software -software life cycle processes |
| 62366-1 Edition 1.1<br>2020-06<br>CONSOLIDATED<br>VERSION | IEC | Medical devices - Part 1: Application of usability engineering to<br>medical devices |
| 14971 Third Edition<br>2019-12 | ISO | Medical devices - Application of risk management to medical<br>devices |

All required performance tests were conducted and show substantial equivalence with the predicate device.

## 8. Conclusion:

Zimmer MedizinSysteme GmbH has demonstrated that the PTG-05 device is substantially equivalent to the predicate device.