(167 days)
Not Found
No
The description details a standard electrical muscle stimulation device with pre-set protocols and user-adjustable settings. There is no mention of AI or ML in the device description, intended use, or performance studies. The device operates based on pre-defined electrical current patterns, not adaptive algorithms.
Yes
The device description states "The PTG-05 is a non-invasive therapeutic device." and its intended uses are for strengthening and firming muscles, which are therapeutic actions.
No.
The device's stated intended use is for strengthening, toning, and firming muscles, which are therapeutic rather than diagnostic activities. It does not mention detecting, monitoring, or diagnosing any medical conditions.
No
The device description explicitly states it is a "non-invasive therapeutic device" that "produces an electrical current" and is intended to be used with "single-use electrodes". This indicates the device includes hardware components for electrical stimulation, not just software.
Based on the provided information, the PTG-05 device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen," and similar purposes for buttocks, thighs, and arms. These are therapeutic, not diagnostic, applications.
- Device Description: The description details a non-invasive therapeutic device that produces electrical current for muscle stimulation. This aligns with a physical therapy or aesthetic device, not a device used to diagnose conditions based on in vitro samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers of disease, or providing diagnostic information.
- Performance Studies: The performance studies focus on electrical safety, performance testing, biocompatibility, and usability, which are typical for therapeutic devices, not IVDs. Key metrics like sensitivity, specificity, PPV, and NPV (common for diagnostic devices) are explicitly stated as "Not Applicable."
In summary, the PTG-05 is a therapeutic electrical muscle stimulation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
NGX
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, buttocks, thighs, arms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
All required performance tests were conducted and show substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
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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510(k) Summary PTG-05 K240347
1. Basic Information-Submitter:
| 510(k) Owner: | Zimmer MedizinSysteme GmbH
Junkersstrasse 9
89231 Neu-Ulm
Germany
Establishment Registration: 8010720 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Ms. Ute Killet
Manager Regulatory Affairs
Phone: +49-7319761-216
Fax: +49-731-9761-118
E-Mail: u.killet@zimmer.de |
| Official Contact: | Mr. Scott Blood
Principal Regulatory Consultant
Phone: 978.729.5978
Fax: +49-731-9761-118
E-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
5
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.
| TECHNOLOGICAL
CHARACTERISTICS | SUBJECT DEVICE | PREDICATE DEVICE | Equivalence
Discussion |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power
Source | Zimmer
MedizinSysteme GmbH
PTG-05
This Submission
100-240VAC, 50/60Hz,
max. 100VA | Johari Digital Healthcare
Limited
truSculpt flex
K212866
100-240AC, 50/60Hz,
75VA | Similar |
| Method of Line Current
Isolation | a) AC Power supply is
converted to DC Power
supply thorough a
medical grade PSU,
which has isolation of
2XMOPP
(IEC 60601-1)
(b) Isolation thru
transformer between
device and patient | a) AC Power supply is
converted to DC Power
supply thorough a
medical grade PSU,
which has isolation of
2XMOPP (IEC60601-1)
(b) Isolation thru
transformer between
device and patient | Identical |
| Patient Leakage Current
Normal condition | Normal condition = less
than 100μA | Normal condition = less
than 100μA | Identical |
| Patient Leakage Current
Single Fault condition | Single fault condition =
less than 300 μA | Single fault condition =
less than 300 μA | Identical |
| Components | Main unit,
8 reusable trunk cables
16 reusable electrode
cables
2 packages of single-
use Zimmer electrodes
(K140340)
1 Power Cord | Main unit,
8 Stainless steel
reusable electrodes pairs
(16 electrodes)
4 electrode lead wires
1 AC Power Cord
4 Hydrogel pads
2 reusable silicone belts
(cummerbunds) | Similar
The components are sufficient for the
device operation, so there are no
questions of safety or effectiveness.
The predicate device supports 4
output channels which allow the
connection of 16 electrodes to the
devices whereby 2 electrodes are
always run in parallel. The subject
device has 8 output channels suitable
to also attach 16 electrodes. This
configuration offers an even safer
usage of the device while the
application form remains the same
and the treatment is as effective as
the predicate device. |
| Display | 12" LCD | 12" LCD | Identical |
| Number of Output Modes | 5
Level 1, Level 2, Level 3,
Level 4, Level Intense | 3
Prep, Tone, Sculpt | Similar
The output modes of the subject device
are precisely matched to the body
regions. The predicate device does not
have this feature. The output modes of
the predicate device are identical for all
body regions. Therefore, the subject
device is safer due to the adjustment to
the body region. |
| TECHNOLOGICAL
CHARACTERISTICS | SUBJECT DEVICE
Zimmer
MedizinSysteme GmbH
PTG-05
This Submission | PREDICATE DEVICE
Johari Digital Healthcare
Limited
truSculpt flex
K212866 | Equivalence
Discussion |
| Output
Channels | 8 | 4 | modes while the subject device offers 5
output modes thereby output mode 1
Similar |
| | | | The number of outputs is being
increased from 4 to 8 to provide
enhanced customization and flexibility
to the user.
The predicate device supports 4 output
channels which allow the connection of
16 electrodes to the devices whereby 2
electrodes are always run in parallel.
The subject device has 8 output
channels suitable to attach 16
electrodes. This configuration offers
even safer usage of the device while
the application form remains the same
and the treatment is as effective as the
predicate device. |
| Synchronous or
Alternating? | Synchronous | Synchronous | Identical |
| Method of Channel Isolation | Output 1 to 8 are
completely isolated by
transformers. Only power
supply and ground are
common. | Transformer | Identical |
| Regulated Current
Or
Regulated Voltage | Regulated current | Tran conductance | Different |
| | | | The subject device controls the output
current by a common current regulation
method this ensures safety of the
device 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 its
intended environment per IEC 60601-1
and determined to be electrical safe. |
| Automatic Shut off? | Yes (In case of therapy
time running out or in
case of an error) | Yes | Identical |
| Patient Override Control? | Yes (If override control
means that the patient
can stop the treatment | Yes | Identical |
| TECHNOLOGICAL
CHARACTERISTICS | SUBJECT DEVICE
Zimmer
MedizinSysteme GmbH
PTG-05
This Submission | PREDICATE DEVICE
Johari Digital Healthcare
Limited
truSculpt flex
K212866 | Equivalence
Discussion |
| | He can do so by pressing
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
Display | Yes | Yes | Identical |
| Timer Range (minutes) | Up to max. 30 minutes
per protocol | 45 Minutes - for Classic
Mode
15 Minutes - for Flex+
mode | Similar
Treatment time is in the range of the
predicate device and is a user-settable
parameter. |
| Compliance With Voluntary
Standards? | Yes
IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10 &
ISO 14971 | Yes
IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10 &
ISO 14971 | Identical |
| Compliance With 21 CFR
898? | Yes, the electrode cable
can never be plugged in
the AC socket, not even
accidentally as the cable
has an isolation on both
sides. | Yes, the electrode cable
can never be plugged in
the AC socket, not even
accidentally | Identical |
| Weight | 45kg
(inlcuding max. work
load) | 32.66 Kgs | Different
The weight relates to the technical
setup and therefore differs but does not
influence safety. |
| Dimension (L x W x H) | 117cm x 80cm x 80cm
31"(L) x 31"(W) x 46" (H) | 14"(L) x 17.5"(W) x
40"(H) | Different
The dimensions of the predicate device
are verified and validated during safety
and usability testing. Both tests show
that the dimensions are adequate and
guarantee a safe and effective usage of
the device. |
| Housing Material and
construction | PC-ABS Plastic Body | ABS Plastic Body | Similar
Changing the material of the subject
device to PC-ABS does not effect
safety as mechanical properties of the 2
materials are equal and material
behavior for the subject device is also
tested 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°C
Relative Humidity: 30%
to 75% (non-condensing)
Barometric pressure: | Different
No influence on safety and
effectiveness |
| TECHNOLOGICAL
CHARACTERISTICS | SUBJECT DEVICE
Zimmer
MedizinSysteme GmbH
PTG-05
This Submission | PREDICATE DEVICE
Johari Digital Healthcare
Limited
truSculpt flex
K212866 | Equivalence
Discussion |
| | | 700hPA to 1060hPa | |
| Transport and storage
environment | -4°F to 158°F
(-20°C to + 70°C)
10% to 90% rel. humidity,
620–1060 hPa | Temperature: +5°C to
45°C
Relative Humidity: 10%
to 85% (non-condensing) | Different
No influence on safety and
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.
8
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.
9
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
Zimmer MedizinSysteme GmbH
PTG-05
This Submission | PREDICATE DEVICE
Johari Digital Healthcare
Limited
truSculpt flex
K212866 |
|----|-------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| | Mode Name | Level 1
Level 2 | Prep |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step Wave
Square Wave
(Biphasic rectangular symmetric) | Step Sine Wave |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω
320 Vpp @ 2kΩ
360 Vpp @ 10kΩ
100Vpp @ 500Ω
320Vpp @2kΩ
360Vpp @10kΩ | 100Vpp @ 500Ω (±10%)
125Vpp @ 2KΩ (±10%)
133Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current1 | 200mA @ 500 Ohm
160mA @ 2k Ohm
36 mA @ 10kOhm
200mA @500 Ohm
160mA @2k Ohm
36mA @ 10k Ohm | 200mA @ 500 Ohm
62.5mA @ 2K Ohm
13.5mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs
200 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 Ω
Channel 2:
4001 - 4100Hz (± 10%) @
500 Ω
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 | |
| PTG-05 | Johari Digital Healthcare | ||
| Limited | |||
| This Submission | truSculpt flex | ||
| K212866 | |||
| 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 sine
wave. | Yes
125µS |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic in
nature the net charge would be
Zero) | 0µC @ 500Ω (Being
Biphasic in nature the net
charge 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 electrodes
4.06 mA/ cm²
*measured with 56mm round electrodes | 2.88 mA/cm²
*measured with 59 x 59mm square
electrodes |
| 12. | Maximum Power Density | 0.203 W/cm²
*measured with 56mm round electrodes
0.203 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 |
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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
Zimmer MedizinSysteme GmbH
PTG-05 | PREDICATE DEVICE
Johari Digital Healthcare Limited
truSculpt flex |
|-----|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | | This Submission | K212866 |
| | Mode Name | Level 3
Level 4 | Tone |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step Wave
Square Wave
(Biphasic rectangular
symmetric) | Square Wave |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω
320 Vpp @ 2kΩ
360 Vpp @ 10kΩ
100Vpp @ 500Ω
320Vpp @2kΩ
360Vpp @10kΩ | 70Vpp @ 500Ω (±10%)
125Vpp @ 2KΩ (±10%)
150Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current² | 200mA @ 500 Ohm
160mA @ 2k Ohm
36 mA @ 10kOhm
200mA @500 Ohm
160mA @2k Ohm
36mA @ 10k Ohm | 140mA @ 500 Ohm
62.5mA @ 2K Ohm
15mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs
200 µs, 300µs | 350µS (± 10%) @ 500Ω |
| 6. | Frequency | Pulse Frequency:
2500Hz@ 500 Ω
8000Hz@ 500 Ω
Modulation: 28-45 Hz@ 500 Ω | 99 Hz (± 10%) @ 500Ω |
| 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 modulated
sine wave. | Yes, Symmetrical Biphasic
350 µS |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic in
nature the net charge would be
Zero) | 0μC @ 500Ω (Being Biphasic in
nature the net charge 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) | 24.50 µC @ 500Ω Load |
| 11. | Maximum Current Density | 4.06 mA/ cm²
- measured with 56mm round electrodes
4.06 mA/ cm² - measured with 56mm round electrodes | 2.02 mA/cm²
*measured with 59 x 59mm square electrodes |
| # | Parameters | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
PTG-05
This Submission | PREDICATE DEVICE
Johari Digital Healthcare Limited
truSculpt flex
K212866 |
| 12. | Maximum Power Density | 0.203 W/cm²
*measured with 56mm round electrodes
0.203 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 DEVICE
Zimmer MedizinSysteme GmbH
PTG-05
This Submission | PREDICATE DEVICE
Johari Digital Healthcare Limited
truSculpt flex
K212866 |
| | Mode Name | Level 5 | Sculpt |
| 1. | Waveform | Symmetrical Biphasic | Symmetrical Biphasic |
| 2. | Shape | Rectangular Step Wave | Modulated Sine Wave |
| | | Square Wave
(Biphasic rectangular
symmetric) | |
| 3. | Maximum Output Voltage | 100 Vpp @ 500Ω
320 Vpp @ 2kΩ
360 Vpp @ 10kΩ
100Vpp @ 500Ω
320Vpp @2kΩ
360Vpp @10kΩ | 100Vpp @ 500Ω (±10%)
125Vpp @ 2KΩ (±10%)
135Vpp @ 10KΩ (±10%) |
| 4. | Maximum Output Current3 | 200mA @ 500 Ohm
160mA @ 2k Ohm
36 mA @ 10kOhm
200mA @500 Ohm
160mA @2k Ohm
36mA @ 10k Ohm | 200mA @ 500 Ohm
62.5mA @ 2K Ohm
13.5mA @ 10K Ohm |
| 5. | Pulse Width | 125µs, 400µs | 125µS (± 10%) @ 500Ω |
| | | 200 µs, 300µs | |
| 6. | Frequency | Pulse Frequency:
2500Hz@ 500 Ω
8000Hz@ 500 Ω
Modulation: 35-65 Hz@ 500 Ω | 4000Hz (± 10%) @ 500 Ω
Resultant: 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 modulated
sine wave. | Yes, Symmetrical Biphasic
125µS (± 10%) |
| 9. | Net charge | 0μC @ 500Ω (Being Biphasic in
nature the net charge would be
Zero) | 0µC @ 500Ω (Being Biphasic in
nature the net charge 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 electrodes
4.06 mA/ cm² - measured with 56mm round electrodes | 2.88 mA/cm²
*measured with 59 x 59mm square electrodes |
| # | Parameters | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
PTG-05
This Submission | PREDICATE DEVICE
Johari Digital Healthcare Limited
truSculpt flex
K212866 |
| 12. | Maximum Power Density | 0.203 W/cm²
*measured with 56mm round electrodes
0.203 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.
12
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.
13
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.
14
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:
15
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
Organization | Standards Title |
|-----------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1 Edition 3.2
2020-08
CONSOLIDATED
VERSION | IEC | Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance |
| 60601-1-2 Edition 4.1
2020-09 | IEC | Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral standard:
Electromagnetic disturbances - Requirements and tests |
| 60601-1-6 Edition 3.1
2013-10 | IEC | Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability |
| 62304 Edition 1.1 2015-
06 | IEC | Medical devices software -software life cycle processes |
| 62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION | IEC | Medical devices - Part 1: Application of usability engineering to
medical devices |
| 14971 Third Edition
2019-12 | ISO | Medical devices - Application of risk management to medical
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.