(157 days)
Not Found
No
The description details a device that uses pre-set or operator-controlled parameters for physical and energy-based treatments. While it uses a microprocessor, there is no mention of AI or ML algorithms for decision-making, data analysis, or adaptive learning.
Yes
The intended use explicitly states the device is for the "relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite," which are therapeutic applications.
No
The device description and intended use indicate that the T-SHAPE 2 provides therapeutic effects (e.g., relief of muscle aches, reduction of cellulite) through physical manipulation and energy application, rather than diagnosing conditions. It does not perform any diagnostic functions or provide diagnostic information.
No
The device description clearly outlines a physical console unit, handpieces, light sources, RF electrodes, and motorized components, indicating it is a hardware-based medical device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the relief of muscle aches and pains, muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. These are all physical treatments applied externally to the body.
- Device Description: The description details a device that uses heat (infrared and RF), mechanical manipulation (massage, vacuum, rollers, spheres), and light energy applied to the tissue. This is consistent with a physical therapy or aesthetic device, not a diagnostic device that analyzes samples from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies described focus on skin tolerance, effect, and cosmetic properties of the treatment, which aligns with the stated intended use and not with diagnostic accuracy.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
Product codes (comma separated list FDA assigned to the subject device)
NUV, PBX
Device Description
T-SHAPE 2 treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an targeted manner.
T-SHAPE 2 is also equipped with:
- Two light sources type inside some handpieces (see below) with the following wavelengths: 650 and l 980 nm.
- -Electrodes for bipolar RF energy (500 kHz/ 1 MHz / 1,5 MHz).
Through the display, the light sources and RF energy can be fully deactivated or activated.
The light sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
For the RF energy the user can select frequency between 2 MHz, 1 MHz, 500 kHz and intensity between the 10 levels available.
T-SHAPE 2 comprises a main console unit and several handpieces.
A microprocessor-based system controller is used to monitor and direct all the system function and the graphic user interface.
The main console can be connected to the following handpieces (two different hand piece can be connected at the same time):
- -Large multipole handpiece with 6 diode laser and 6 RF plates;
- -Medium multipole handpiece with 4 diode laser and 4 RF plates;
- -Small multipole handpiece 4 RF plates and 1 red LED;
- -Thermal imaging camera;
- -Roll handpiece with 4 diode laser and 2 motorized roller with RF;
- -Mesosphere handpiece with 45 motorized rotating spheres.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance data:
The following performance data are provided in support of the substantial equivalence determination:
Biocompatibility testing
Materials in contact with patient skin, for a duration less than 24 hours, were evaluated according to the "biocompatibility flow chart for the selection of toxicity tests for 510(k)s", attachment C of "Criteria of Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)".
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the T-SHAPE 2 device.
The system complies with the IEC 60601-1, IEC 60825-1 standards for safety and the IEC 60601-1-2 and IEC TR 60601-4-2 standards for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Performance Bench Testing
T-SHAPE 2 has been evaluated to verify the skin tolerance, effect and cosmetic properties of a professional treatment through evaluations and instrumental analysis performed by professionals under medical supervision and consumer self-assessments.
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.
K122579 – VelaShape – Syneron Medical, Limited, K191528 – Venus Legacy Pro – Venus Concept Ltd., K211272 – ICOONE Laser Med – I-Tech Industries SRL
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 22, 2023
B&M S.R.L. Marketing Nel Benessere % Chiara Violini Consultant Endo Engineering Srl Via Del Consorzio, 41 Falconara Marittima, Ancona 60015 Italy
Re: K231092
Trade/Device Name: T-shape 2 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: NUV, PBX Dated: August 22, 2023 Received: August 23, 2023
Dear Chiara Violini:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Hithe -S Tanisha L. 2023.09.22 Hithe -S 20:49:01 -04'00'
Tanisha Hithe, MS, MHS Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K231092
Device Name T-SHAPE 2
Indications for Use (Describe)
The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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lite.
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the text "BALDAN" in large, bold, sans-serif font, with a horizontal line directly underneath it. Below the line, the word "GROUP" is printed in a smaller, sans-serif font, with each letter aligned directly under the corresponding letter of "BALDAN". The text is black against a white background.
510(k) Summary
Introduction:
This document contains the 510(k) Summary for the T-SHAPE 2 device. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant/ | B&M S.R.L. |
|---|---|
| Manufacturer | MARKETING NEL BENESSERE |
| Name and Address: | Via Leonardo Bruni, 25 |
| 20158 Milano (MI) | |
| Italy | |
| 510(k) Contact Person: | Chiara Violini |
| Consultant | |
| Email: c.violini@endoengineering.it | |
| Phone: +39-071-9156048 | |
| Fax: +39-071-0971883 | |
| Date Prepared: | 30/01/2023 |
| Device Name: | T-SHAPE 2 |
| Common or Usual Name: | Multifunction platform with LLLT, RF, vacuum and massager. |
| Classification: | Class II |
| Classification Name: | Massager, Vacuum, Light Induced Heating (NUV) |
| Massager, Vacuum, Radio Frequency Induced Heat (PBX) | |
| Regulation number: | 21 CFR 878.4810 (NUV) |
| 21 CFR 878.4400 (PBX) | |
| Classification product code: | NUV, PBX |
| Predicate Devices: | K122579 – VelaShape – Syneron Medical, Limited |
| K191528 – Venus Legacy Pro – Venus Concept Ltd. | |
| K211272 – ICOONE Laser Med – I-Tech Industries SRL |
4
Image /page/4/Picture/0 description: The image shows the text "BALDAN" in a bold, sans-serif font, with a horizontal line underneath. Below the line, the word "GROUP" is printed in a smaller, sans-serif font, with each letter centered under the corresponding letter of "BALDAN". The overall design is simple and clean, likely representing a company or organization name.
Description of the device:
T-SHAPE 2 treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an targeted manner.
T-SHAPE 2 is also equipped with:
- Two light sources type inside some handpieces (see below) with the following wavelengths: 650 and l 980 nm.
- -Electrodes for bipolar RF energy (500 kHz/ 1 MHz / 1,5 MHz).
Through the display, the light sources and RF energy can be fully deactivated or activated.
The light sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
For the RF energy the user can select frequency between 2 MHz, 1 MHz, 500 kHz and intensity between the 10 levels available.
T-SHAPE 2 comprises a main console unit and several handpieces.
A microprocessor-based system controller is used to monitor and direct all the system function and the graphic user interface.
The main console can be connected to the following handpieces (two different hand piece can be connected at the same time):
- -Large multipole handpiece with 6 diode laser and 6 RF plates;
- -Medium multipole handpiece with 4 diode laser and 4 RF plates;
- -Small multipole handpiece 4 RF plates and 1 red LED;
- -Thermal imaging camera;
- -Roll handpiece with 4 diode laser and 2 motorized roller with RF;
- -Mesosphere handpiece with 45 motorized rotating spheres.
Indication for Use:
The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
5
Image /page/5/Picture/0 description: The image shows the logo for Baldan Group. The word "BALDAN" is in large, bold, sans-serif font, with a horizontal line underneath. Below the line, the word "GROUP" is written in a smaller, sans-serif font, with each letter centered under the corresponding letter of "BALDAN".
Comparison of Technological Characteristics:
T-SHAPE 2 has the same technological characteristics (massager, vacuum, RF energy, light source, control mechanisms) and specifications as its predicate devices.
6
| BALDAN
GROUP | T-SHAPE 2 | B&M S.R.L.
MARKETING NEL BENESSE
Via Leonardo Bruni, 25 |
|-----------------|-----------|---------------------------------------------------------------|
| | | 20158 Milano (MI)
Phone: (+39) 02 393 583 |
| | | Email: info@baldangroup. |
| Specifications | Predicate Device
(Primary) | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to
Predicate |
|---------------------------|-------------------------------|---------------------------------------------------------------------------------------|--------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------|
| Device Name
(K number) | VelaShape
K122579 | Venus Legacy Pro
K191528 with 4D
Body (LB2) and 4D
Face (LF2)
applicators | ICOONE Laser Med
K211272 | T-SHAPE 2 | / |
| Submitter | Syneron Medical,
Limited | Venus Concept Ltd. | I-Tech Industries SRL | B&M S.R.L.
MARKETING NEL
BENESSERE | / |
| Product Code | NUV | GEX, PBX | NUV, ISA | NUV, PBX | Not considered ISA
and GEX because
they are already
considered in NUV
and PBX |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4400 | 21 CFR 878.4810 | 21 CFR 878.4810 | / |
| Regulatory Class | II | II | II | II | / |
| Product Picture | Image: Velashape device | Image: Venus Legacy Pro device | Image: ICOONE Laser Med device | Image: T-Shape 2 device | / |
7
| B | A | L | D | N |
|---|---|---|---|---|
| G | R | O | U | P |
T-SHAPE 2
Via Leonardo Bruni, 25 20158 Milano (MI) Phone: (+39) 02 393 5831
Email: info@baldangroup.it
| Specifications | Predicate Device
(Primary) | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to
Predicate |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Device Name
(K number) | VelaShape
K122579 | Venus Legacy Pro
K191528 with 4D
Body (LB2) and 4D
Face (LF2)
applicators | ICOONE Laser Med
K211272 | T-SHAPE 2 | / |
| Mains | 110 VAC; 4A; 50 Hz;
Single Phase
230 VAC; 2.5A; 50 Hz;
Single Phase | 100-120 VAC / 60Hz
220-240 VAC / 50Hz | 240/110 Vac | 100-120 VAC / 60Hz
220-240 VAC / 50Hz | Equivalent to
Predicate Devices |
| Weight | 20 kg. / 44.1 lbs | 40 kg | 191,80 lb (87 kg) | 95 kg | Equivalent to
Predicate Devices |
| Dimensions | 38 x 49 x 132 cm /
15 x 19 x 51.8 inch | 40X40X100 cm
(DxWxH) | 37,40x80,71x19,68
inch (95x205x50 cm) | 57 x 86 x 1.70 cm | Equivalent to
Predicate Devices |
| Biocompatibility | Unknown | Materials are
biocompatible | Biological Evaluation
Of Medical Devices -
Part 10: Tests For
Irritation And Skin
Sensitization /
Biological Evaluation
Of Medical Device -
Part 5: Test for
cytotoxicity - According
to ISO10993-10:2010,
10993-5:2009 and
10993-12:2012 | Biological evaluation
for cytotoxicity,
irritation, and skin
Sensitization | Equivalent to
Predicate Devices |
| Specifications | Predicate Device | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to |
| | (Primary) | | | | Predicate |
| Device Name
(K number) | VelaShape
K122579 | Venus Legacy Pro
K191528 with 4D
Body (LB2) and 4D
Face (LF2)
applicators | ICOONE Laser Med
K211272 | T-SHAPE 2 | / |
| Indications for use | The VelaShape is
indicated for the relief
of minor muscle aches
and pain, relief of
muscle spasm,
temporary
improvement of local
blood circulation,
temporary reduction in
the appearance of
cellulite, and for
temporary reduction
of thighs
circumferences. | When used with the
4D Body (LB2) and 4D
Face (LF2) applicators,
the Venus Legacy Pro
device is intended for
the delivery of non-
thermal RF combined
with Massage and
magnetic field pulses
for the treatment of
the following medical
conditions:
• Relief of minor
muscles aches and
pain, relief of muscle
spasm
• Temporary
improvement of local
blood circulation
• Temporary reduction
in the appearance of
cellulite | ICOONE Laser med
(also referred to as
ICOONE Medical laser)
is indicated for the
relief of minor muscle
aches and pain, relief
of muscle spasms,
temporary
improvement of local
blood circulation, and
temporary reduction in
the appearance of
cellulite. | The T-SHAPE 2 and its
hand pieces are
indicated for the relief
of minor muscle aches
and pain, relief of
muscle spasms,
temporary
improvement of local
blood circulation, and
temporary reduction in
the appearance of
cellulite. | Equivalent to
Predicate Devices |
| System component | Light, RF, Massage,
Suction, Rollers | RF, Massage, Suction,
Rollers | Light, Massage,
Suction, Rollers | Light, RF, Massage,
Suction, Rollers | Equivalent to
primary predicate
device |
| Massage | | | | | |
8
B A L D A N
GROUP
T-SHAPE 2
Via Leonardo Bruni, 25 20158 Milano (MI) Phone: (+39) 02 393 5831
Email: info@baldangroup.it
9
| BALDAN
GROUP | T-SHAPE 2 | B&M S.R.L.
MARKETING NEL BENESSERE
Via Leonardo Bruni, 25
20158 Milano (MI)
Phone: (+39) 02 393 5831
Email: info@baldangroup.it |
| ----------------- | ----------- | ------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| Specifications | Predicate Device
(Primary) | Predicate Device | Predicate Device | Device object of 510(k) | Comparison to
Predicate |
|-----------------------------------|-------------------------------|---------------------------------------------------------------------------------------|--------------------------------|------------------------------------------------------------|----------------------------------------------|
| Device Name
(K number) | VelaShape
K122579 | Venus Legacy Pro
K191528 with 4D
Body (LB2) and 4D
Face (LF2)
applicators | ICOONE Laser Med
K211272 | T-SHAPE 2 | / |
| Mechanical
Massage | Yes | Yes | Yes | Yes | Equivalent to
Predicate Devices |
| Light | | | | | |
| Infrared
wavelengths | 850 nm | Not present | 650nm (LED)/ 915 nm
(LASER) | 650/980 nm | See Substantial
Equivalence
discussion |
| Maximum
power/power
density | 3.3 W | / | 1 W (915 nm)
2.69 W/m² | 2 W/m² | / |
| Suction/vacuum | | | | | |
| Mode | Pulsed | Unknown | Fractioned | Pulsed | Equivalent to
predicate devices |
| Maximum Pressure | - 390 mbar | - 400 mbar | Unknown | - 400 mbar | Equivalent to
predicate devices |
| Radio Frequency | | | | | |
| Frequency | 1 MHz | 1 MHz | Not present | Selectable between
2 MHz
1,5 MHz
1 MHz
500 kHz | See Substantial
Equivalence
discussion |
| Peak RF POWER | 150 W | 150 W | / | 150 W | Equivalent to
predicate devices |
| Mode | Bi-polar | Bi-polar | / | Bi-polar | Equivalent to
predicate devices |
10
Image /page/10/Picture/0 description: The image shows the logo for Baldan Group. The word "BALDAN" is written in large, bold, serif font, with a horizontal line running underneath it. Below the line, the word "GROUP" is written in a smaller, sans-serif font. The letters are evenly spaced and the overall design is simple and professional.
Performance data:
The following performance data are provided in support of the substantial equivalence determination:
Biocompatibility testing
Materials in contact with patient skin, for a duration less than 24 hours, were evaluated according to the "biocompatibility flow chart for the selection of toxicity tests for 510(k)s", attachment C of "Criteria of Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)".
Safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the T-SHAPE 2 device.
The system complies with the IEC 60601-1, IEC 60825-1 standards for safety and the IEC 60601-1-2 and IEC TR 60601-4-2 standards for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Performance Bench Testing
T-SHAPE 2 has been evaluated to verify the skin tolerance, effect and cosmetic properties of a professional treatment through evaluations and instrumental analysis performed by professionals under medical supervision and consumer self-assessments.
Comparison of Intended Use:
T-SHAPE 2 device's Intended Use is the same Intended Use of its predicate device.
Substantial Equivalence:
T-SHAPE 2 device is as safe and effective as its predicate devices.
T-SHAPE 2 device has the same intended use and same technological characteristics and specification as its predicate devices, moreover, T-SHAPE 2 has been tested in accordance to consensus standard to demonstrate safety and Performance.
The choice of four frequencies allows you to act more precisely on different layers of the tissue, contrary to a single fixed frequency.
The safety of the treatment is due to the characteristics of the latest generation equipment, which allow you to constantly monitor the parameters set during the session. The system has two safety levels: the first is preset on the skin resistance values with gradual emission of current pulses, the skin resistance have been considered variable between 50 and 500 Ohm and the voltage and power values of the settable 10 level has been calculated considering this range of skin resistance; the second is the intensity by the operator who monitors moment by moment the progress of the treatment and the endogenous heat triggered. Each frequency level respects this operating mode to avoid excessive heating.
11
Image /page/11/Picture/0 description: The image shows the text "BALDAN" in large, bold letters, with a horizontal line running underneath it. Below the line, the word "GROUP" is written in smaller letters, aligned with the letters above. The text appears to be a logo or heading, possibly for a company or organization named Baldan Group.
Thus, T-SHAPE 2 device is substantially equivalent to its predicate devices.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, than the legally marketed predicate devices.