(167 days)
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.
- Strengthening, toning and firming of arms
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 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.
The provided text is a 510(k) summary for the PTG-05 device. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a clinical study proving device performance against such criteria. The "Performance data" section only mentions that testing for electrical safety, performance testing, biocompatibility, and usability were conducted satisfactorily, along with specific waveform measurements and adherence to consensus standards. It explicitly states: "All required performance tests were conducted and show substantial equivalence with the predicate device." This indicates technical performance testing, not clinical performance against acceptance criteria for the indicated uses (strengthening, toning, firming of muscles).
Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them in the way requested. The document focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and adherence to safety and performance standards, rather than presenting a clinical study with acceptance criteria for the stated indications.
If this were a document providing clinical study results, the requested information would typically be found in sections describing clinical trials, performance goals, statistical analysis, and outcomes related to the stated indications for use (muscle tone improvement, strengthening, toning, firming).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray letters. Below that, the words "MedizinSysteme" are in a smaller, lighter gray font.
510(k) Summary PTG-05 K240347
1. Basic Information-Submitter:
| 510(k) Owner: | Zimmer MedizinSysteme GmbHJunkersstrasse 989231 Neu-UlmGermanyEstablishment Registration: 8010720 |
|---|---|
| Ms. Ute KilletManager Regulatory AffairsPhone: +49-7319761-216Fax: +49-731-9761-118E-Mail: u.killet@zimmer.de | |
| Official Contact: | Mr. Scott BloodPrincipal Regulatory ConsultantPhone: 978.729.5978Fax: +49-731-9761-118E-mail: scottqara@gmail.com |
| 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
-
- 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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Image /page/6/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 line above the "z" and "r". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, lighter font. The logo is in grayscale.
| TECHNOLOGICALCHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | EquivalenceDiscussion |
|---|---|---|---|
| PowerSource | ZimmerMedizinSysteme GmbHPTG-05This Submission100-240VAC, 50/60Hz,max. 100VA | Johari Digital HealthcareLimitedtruSculpt flexK212866100-240AC, 50/60Hz,75VA | Similar |
| Method of Line CurrentIsolation | a) AC Power supply isconverted to DC Powersupply thorough amedical grade PSU,which has isolation of2XMOPP(IEC 60601-1)(b) Isolation thrutransformer betweendevice and patient | a) AC Power supply isconverted to DC Powersupply thorough amedical grade PSU,which has isolation of2XMOPP (IEC60601-1)(b) Isolation thrutransformer betweendevice and patient | Identical |
| Patient Leakage CurrentNormal condition | Normal condition = lessthan 100μA | Normal condition = lessthan 100μA | Identical |
| Patient Leakage CurrentSingle Fault condition | Single fault condition =less than 300 μA | Single fault condition =less than 300 μA | Identical |
| Components | Main unit,8 reusable trunk cables16 reusable electrodecables2 packages of single-use Zimmer electrodes(K140340)1 Power Cord | Main unit,8 Stainless steelreusable electrodes pairs(16 electrodes)4 electrode lead wires1 AC Power Cord4 Hydrogel pads2 reusable silicone belts(cummerbunds) | SimilarThe components are sufficient for thedevice operation, so there are noquestions of safety or effectiveness.The predicate device supports 4output channels which allow theconnection of 16 electrodes to thedevices whereby 2 electrodes arealways run in parallel. The subjectdevice has 8 output channels suitableto also attach 16 electrodes. Thisconfiguration offers an even saferusage of the device while theapplication form remains the sameand the treatment is as effective asthe predicate device. |
| Display | 12" LCD | 12" LCD | Identical |
| Number of Output Modes | 5Level 1, Level 2, Level 3,Level 4, Level Intense | 3Prep, Tone, Sculpt | SimilarThe output modes of the subject deviceare precisely matched to the bodyregions. The predicate device does nothave this feature. The output modes ofthe predicate device are identical for allbody regions. Therefore, the subjectdevice is safer due to the adjustment tothe body region. |
| TECHNOLOGICALCHARACTERISTICS | SUBJECT DEVICEZimmerMedizinSysteme GmbHPTG-05This Submission | PREDICATE DEVICEJohari Digital HealthcareLimitedtruSculpt flexK212866 | EquivalenceDiscussion |
| OutputChannels | 8 | 4 | modes while the subject device offers 5output modes thereby output mode 1Similar |
| The number of outputs is beingincreased from 4 to 8 to provideenhanced customization and flexibilityto the user.The predicate device supports 4 outputchannels which allow the connection of16 electrodes to the devices whereby 2electrodes are always run in parallel.The subject device has 8 outputchannels suitable to attach 16electrodes. This configuration offerseven safer usage of the device whilethe application form remains the sameand the treatment is as effective as thepredicate device. | |||
| Synchronous orAlternating? | Synchronous | Synchronous | Identical |
| Method of Channel Isolation | Output 1 to 8 arecompletely isolated bytransformers. Only powersupply and ground arecommon. | Transformer | Identical |
| Regulated CurrentOrRegulated Voltage | Regulated current | Tran conductance | Different |
| The subject device controls the outputcurrent by a common current regulationmethod this ensures safety of thedevice and is tested during IEC 60601-2-10 testing. | |||
| Software/Firmware/Microprocessors controls? | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes | Yes | Identical |
| Automatic No-Load Trip? | Yes | No | Different |
| Device studied for electrical safety in itsintended environment per IEC 60601-1and determined to be electrical safe. | |||
| Automatic Shut off? | Yes (In case of therapytime running out or incase of an error) | Yes | Identical |
| Patient Override Control? | Yes (If override controlmeans that the patientcan stop the treatment | Yes | Identical |
| TECHNOLOGICALCHARACTERISTICS | SUBJECT DEVICEZimmerMedizinSysteme GmbHPTG-05This Submission | PREDICATE DEVICEJohari Digital HealthcareLimitedtruSculpt flexK212866 | EquivalenceDiscussion |
| He can do so by pressingpause on the remote) | |||
| On/Off Status on Display | Yes | Yes | Identical |
| Low Battery on Display | N/A | N/A | Identical |
| Voltage/Current Level onDisplay | Yes | Yes | Identical |
| Timer Range (minutes) | Up to max. 30 minutesper protocol | 45 Minutes - for ClassicMode15 Minutes - for Flex+mode | SimilarTreatment time is in the range of thepredicate device and is a user-settableparameter. |
| Compliance With VoluntaryStandards? | YesIEC 60601-1,IEC 60601-1-2,IEC 60601-2-10 &ISO 14971 | YesIEC 60601-1,IEC 60601-1-2,IEC 60601-2-10 &ISO 14971 | Identical |
| Compliance With 21 CFR898? | Yes, the electrode cablecan never be plugged inthe AC socket, not evenaccidentally as the cablehas an isolation on bothsides. | Yes, the electrode cablecan never be plugged inthe AC socket, not evenaccidentally | Identical |
| Weight | 45kg(inlcuding max. workload) | 32.66 Kgs | DifferentThe weight relates to the technicalsetup and therefore differs but does notinfluence safety. |
| Dimension (L x W x H) | 117cm x 80cm x 80cm31"(L) x 31"(W) x 46" (H) | 14"(L) x 17.5"(W) x40"(H) | DifferentThe dimensions of the predicate deviceare verified and validated during safetyand usability testing. Both tests showthat the dimensions are adequate andguarantee a safe and effective usage ofthe device. |
| Housing Material andconstruction | PC-ABS Plastic Body | ABS Plastic Body | SimilarChanging the material of the subjectdevice to PC-ABS does not effectsafety as mechanical properties of the 2materials are equal and materialbehavior for the subject device is alsotested while IEC60601-1 test. |
| Operating Temperature | 50°F to 104°(+10°C to + 40°C)10% to 90% rel. humidity,620-1060 hPa | Temperature: +15°C to+35°CRelative Humidity: 30%to 75% (non-condensing)Barometric pressure: | DifferentNo influence on safety andeffectiveness |
| TECHNOLOGICALCHARACTERISTICS | SUBJECT DEVICEZimmerMedizinSysteme GmbHPTG-05This Submission | PREDICATE DEVICEJohari Digital HealthcareLimitedtruSculpt flexK212866 | EquivalenceDiscussion |
| 700hPA to 1060hPa | |||
| Transport and storageenvironment | -4°F to 158°F(-20°C to + 70°C)10% to 90% rel. humidity,620–1060 hPa | Temperature: +5°C to45°CRelative Humidity: 10%to 85% (non-condensing) | DifferentNo influence on safety andeffectiveness |
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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 DEVICEZimmer MedizinSysteme GmbHPTG-05This Submission | PREDICATE DEVICEJohari Digital HealthcareLimitedtruSculpt flexK212866 |
|---|---|---|---|
| Mode Name | Level 1Level 2 | Prep | |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step WaveSquare Wave(Biphasic rectangular symmetric) | Step Sine Wave |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω320 Vpp @ 2kΩ360 Vpp @ 10kΩ100Vpp @ 500Ω320Vpp @2kΩ360Vpp @10kΩ | 100Vpp @ 500Ω (±10%)125Vpp @ 2KΩ (±10%)133Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current1 | 200mA @ 500 Ohm160mA @ 2k Ohm36 mA @ 10kOhm200mA @500 Ohm160mA @2k Ohm36mA @ 10k Ohm | 200mA @ 500 Ohm62.5mA @ 2K Ohm13.5mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs200 µs, 300µs | 125µS (± 10%) @ 500Ω |
| 6. | Frequency | Pulse Frequency:2500Hz@ 500 Ω = (1/125)8000Hz@ 500 Ω = (1/ 400)Modulation:20-24 Hz@ 500 Ω | Channel 1:4000Hz (± 10%) @ 500 ΩChannel 2:4001 - 4100Hz (± 10%) @500 ΩResultant: 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 GmbHPTG-05 | Johari Digital HealthcareLimited |
| This Submission | truSculpt flexK212866 | ||
| 7. | For Interferential modes only- Beat frequency- | N/A | 1 - 100Hz |
| 8. | For multiphasic Waveform- Symmetrical Phases?- Phase duration- | No multiphasic wave form.Either biphasic or modulated sinewave. | Yes125µS |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic innature the net charge would beZero) | 0µC @ 500Ω (BeingBiphasic in nature the netcharge would be Zero) |
| 10. | Maximum Phase Charge | 12.5 µC (125µs pulse)40 µC (400µs pulse)20µC @500 Ω Load (200 µs)30µC @500 Ω Load (300 µs) | 12.5 µC |
| 11. | Maximum Current Density | 4.06 mA/ cm²*measured with 56mm round electrodes4.06 mA/ cm²*measured with 56mm round electrodes | 2.88 mA/cm²*measured with 59 x 59mm squareelectrodes |
| 12. | Maximum Power Density | 0.203 W/cm²*measured with 56mm round electrodes0.203 W/cm²*measured with 56mm round electrodes | 0.144 W/cm²*measured with 59 x 59mm squareelectrodes |
| 13. | Burst Mode- Pulses Per Burst- Burst Per second- Bust Duration- 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 |
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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 DEVICEZimmer MedizinSysteme GmbHPTG-05 | PREDICATE DEVICEJohari Digital Healthcare LimitedtruSculpt flex |
|---|---|---|---|
| This Submission | K212866 | ||
| Mode Name | Level 3Level 4 | Tone | |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step WaveSquare Wave(Biphasic rectangularsymmetric) | Square Wave |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω320 Vpp @ 2kΩ360 Vpp @ 10kΩ100Vpp @ 500Ω320Vpp @2kΩ360Vpp @10kΩ | 70Vpp @ 500Ω (±10%)125Vpp @ 2KΩ (±10%)150Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current² | 200mA @ 500 Ohm160mA @ 2k Ohm36 mA @ 10kOhm200mA @500 Ohm160mA @2k Ohm36mA @ 10k Ohm | 140mA @ 500 Ohm62.5mA @ 2K Ohm15mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs200 µs, 300µs | 350µS (± 10%) @ 500Ω |
| 6. | Frequency | Pulse Frequency:2500Hz@ 500 Ω8000Hz@ 500 ΩModulation: 28-45 Hz@ 500 Ω | 99 Hz (± 10%) @ 500Ω |
| 7. | For Interferential modes onlyBeat frequency | N/A | N/A |
| 8. | For multiphasic WaveformSymmetrical Phases?Phase duration | No multiphasic wave form.Either biphasic or modulatedsine wave. | Yes, Symmetrical Biphasic350 µS |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic innature the net charge would beZero) | 0μC @ 500Ω (Being Biphasic innature the net charge would beZero) |
| 10. | Maximum Phase Charge | 12.5 µC (125µs pulse)40 µC (400µs pulse)20µC @500 Ω Load (200 µs)30μC @500 Ω Load (300 µs) | 24.50 µC @ 500Ω Load |
| 11. | Maximum Current Density | 4.06 mA/ cm²* measured with 56mm round electrodes4.06 mA/ cm²* measured with 56mm round electrodes | 2.02 mA/cm²*measured with 59 x 59mm square electrodes |
| # | Parameters | SUBJECT DEVICEZimmer MedizinSysteme GmbHPTG-05This Submission | PREDICATE DEVICEJohari Digital Healthcare LimitedtruSculpt flexK212866 |
| 12. | Maximum Power Density | 0.203 W/cm²*measured with 56mm round electrodes0.203 W/cm²*measured with 56mm round electrodes | 0.070 W/cm²*measured with 59 x 59mm square electrodes |
| 13. | Burst Mode- Pulses Per Burst- Burst Per second- Bust Duration- 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 DEVICEZimmer MedizinSysteme GmbHPTG-05This Submission | PREDICATE DEVICEJohari Digital Healthcare LimitedtruSculpt flexK212866 |
| Mode Name | Level 5 | Sculpt | |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step Wave | Modulated Sine Wave |
| Square Wave(Biphasic rectangularsymmetric) | |||
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω320 Vpp @ 2kΩ360 Vpp @ 10kΩ100Vpp @ 500Ω320Vpp @2kΩ360Vpp @10kΩ | 100Vpp @ 500Ω (±10%)125Vpp @ 2KΩ (±10%)135Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current3 | 200mA @ 500 Ohm160mA @ 2k Ohm36 mA @ 10kOhm200mA @500 Ohm160mA @2k Ohm36mA @ 10k Ohm | 200mA @ 500 Ohm62.5mA @ 2K Ohm13.5mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs | 125µS (± 10%) @ 500Ω |
| 200 µs, 300µs | |||
| 6. | Frequency | Pulse Frequency:2500Hz@ 500 Ω8000Hz@ 500 ΩModulation: 35-65 Hz@ 500 Ω | 4000Hz (± 10%) @ 500 ΩResultant: 1 – 100Hz |
| 7. | For Interferential modes only- Beat frequency | N/A | N/A |
| 8. | For multiphasic Waveform- Symmetrical Phases?- Phase duration | No multiphasic wave form.Either biphasic or modulatedsine wave. | Yes, Symmetrical Biphasic125µS (± 10%) |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic innature the net charge would beZero) | 0µC @ 500Ω (Being Biphasic innature the net charge would beZero) |
| 10. | Maximum Phase Charge | 12.5 µC (125µs pulse)40 µC (400µs pulse)20µC @500 Ω Load (200 µs)30µC @500 Ω Load (300 µs) | 12.5 µC |
| 11. | Maximum Current Density | 4.06 mA/ cm²* measured with 56mm round electrodes4.06 mA/ cm²* measured with 56mm round electrodes | 2.88 mA/cm²*measured with 59 x 59mm square electrodes |
| # | Parameters | SUBJECT DEVICEZimmer MedizinSysteme GmbHPTG-05This Submission | PREDICATE DEVICEJohari Digital Healthcare LimitedtruSculpt flexK212866 |
| 12. | Maximum Power Density | 0.203 W/cm²*measured with 56mm round electrodes0.203 W/cm²*measured with 56mm round electrodes | 0.144 W/cm²*measured with 59 x 59mm square electrodes |
| 13. | Burst Mode- Pulses Per Burst- Burst Per second- Bust Duration- 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/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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| Standards | StandardsOrganization | Standards Title |
|---|---|---|
| 60601-1 Edition 3.22020-08CONSOLIDATEDVERSION | IEC | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance |
| 60601-1-2 Edition 4.12020-09 | IEC | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests |
| 60601-1-6 Edition 3.12013-10 | IEC | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability |
| 62304 Edition 1.1 2015-06 | IEC | Medical devices software -software life cycle processes |
| 62366-1 Edition 1.12020-06CONSOLIDATEDVERSION | IEC | Medical devices - Part 1: Application of usability engineering tomedical devices |
| 14971 Third Edition2019-12 | ISO | Medical devices - Application of risk management to medicaldevices |
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.
§ 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).