(462 days)
No
The summary describes a therapeutic heating device and massage device with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The 'Device Description' explicitly states that FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are "active and therapeutic medical devices." Additionally, their 'Intended Use' describes them as treating "selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation," which are therapeutic purposes.
No
The device description and intended use state that it provides topical heating for treatment and temporary reduction in the appearance of cellulite, not for diagnosing conditions.
No
The device description explicitly states that FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are "active and therapeutic medical devices that perform their function by releasing energy to the human body," indicating a hardware component responsible for energy delivery. The performance studies also include electrical and tissue testing, further suggesting a physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for "topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions" and "temporary reduction in the appearance of cellulite." These are therapeutic applications performed directly on the patient's body.
- Device Description: The description states they are "active and therapeutic medical devices that perform their function by releasing energy to the human body." This further reinforces their therapeutic nature.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition based on in vitro testing.
IVD devices are used 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
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a temporary reduction in the appearance of cellulite.
Product codes
PBX
Device Description
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are active and therapeutic medical devices that perform their function by releasing energy to the human body.
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
Performance Testing:
- Electrical: Compliance with EN 60601-1 (Pass), Compliance with EN 60601-1-2 (Pass)
- Tissue Testing: Compare thermal spread of devices (Equivalent)
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. A comparative thermal test was performed on human skin in order to experimentally verify the transfer of energy to the biological tissue of both devices. This verification was carried out by measuring the trend of the temperature increase in the biological tissue over time, at different energy levels.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 26, 2024
Golden Star Srl Tiziana Borrelli Product Manager Via Enrico Pallini 9 Roma, 00149 Italy
Re: K232966
Trade/Device Name: Fisiowarm 7.0 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: September 18, 2024 Received: November 27, 2024
Dear Tiziana Borrelli:
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.
1
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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/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,
Francisco Delgado -S 12:01:43 2024.12.26
Image /page/2/Picture/4 description: The image contains some text on the left side, including '00'05- and 2024.12.26. The text 'elgado -S' is also visible. On the right side, there is a faded watermark of the letters 'FDA'.
for Long Chen, Ph.D. 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
3
Indications for Use
Submission Number (if known)
Device Name
FISIOWARM 7.0 (FISIOWARM 7.0)
Indications for Use (Describe)
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a 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)
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4
SECTION 5 510 (k) SUMMARY
5
510(k) Notification
510 (k) SUMMARY
SUBMITTER INFORMATION
| A. Company Name: | ||
|---|---|---|
| -- | ------------------ | -- |
- B. Company Address:
- C. Company Phone: Company e-mail:
D. Contact person:
GOLDEN STAR S.r.l.
Via Enrico Pallini 9 00149 Roma (RM) - Italy
+39 06 5897627 amministrazione@goldenstar.it
Stefano Giordano CEO Golden Star S.r.l.
E. Date Summary Prepared: 18th September 2023
DEVICE IDENTIFICATION
| A. Device Name: | FISIOWARM 7.0 300 & FISIOWARM 7.0
400 |
|-----------------------|---------------------------------------------------------|
| B. Common Name: | Electrosurgical, Cutting & Coagulation &
Accessories |
| C. Classification: | Class II |
| D. Product Code: | PBX |
| E. Regulation Number: | 878.4400 |
| E. Submission Type: | 510k (Original Submission) |
LEGALLY MARKETED PREDICATE DEVICE
| Primary predicate device | 510 (k) Holder | 510 (k) No. | Date cleared |
|---|---|---|---|
| Winback Back 3SE | WINBACK USA Corp | K162828 | September 18th, 2017 |
6
DEVICE DESCRIPTION
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are active and therapeutic medical devices that perform their function by releasing energy to the human body.
Performance Testing
The following performance testing was conducted to prove compliance with performance requirements and support substantial equivalence:
| Test | Objective | Result |
|---|---|---|
| Electrical | Compliance with EN 60601-1 | Pass |
| Compliance with EN 60601-1-2 | Pass | |
| Tissue Testing | Compare thermal spread of | |
| devices | Equivalent |
INDICATIONS FOR USE STATEMENT
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a temporary reduction in the appearance of cellulite.
SUBSTANTIAL EQUIVALENCE
All information provided with the present submission supports the substantial equivalence for FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 with the predicate device and its accessories that have identical characteristics and intended use and similar indication statement. In addition all clinical data and all performance tests that have been performed in accordance with the Standards for the Software Evaluation and for the Electrical and Electromagnetic Safety test, demonstrate FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 safety and effectiveness for its intended use.
The following matrix illustrates the equivalencies of FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400, as well as the substantial equivalent predicate device.
PREDICATE DEVICES COMPARISON CHART Table 1
7
| | GOLDENSTAR S.r.l.
FISIOWARM 7.0 300
FISIOWARM 7.0 400
New Device | WINBACK USA Corp Winback
Back 3SE
Predicate device |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| "K" NUMBERS | K232966 | K162828 |
| Proprietary name | FISIOWARM 7.0 300
FISIOWARM 7.0 400 | Winback Back 3SE |
| CFR Section | 878.4400 | 878.4400 |
| Pro-code | PBX | PBX |
| Intended /
Indications for
use | FISIOWARM® 7.0 300 and
FISIOWARM® 7.0 400 are
intended to provide topical
heating for the purpose of
elevating tissue temperature for
the treatment of selected medical
conditions such as relief of pain,
muscle spasms, and increase in
local circulation. The massage
devices are intended to provide a
temporary reduction in the
appearance of cellulite. | The Winback Back 3SE is intended to
provide topical heating for the purpose
of elevating tissue temperature for the
treatment of selected medical
conditions such as relief of pain,
muscle spasms, and increase in local
circulation. The Winback Back 3SE
massage devices are intended to
provide a temporary reduction in
the appearance of cellulite. |
| Mode of
operation | Radiofrequency energy | Radiofrequency energy |
| Output | Unipolar/Bipolar/Multifunction* | Unipolar/Multipolar |
| Power Supply | 100-240VAC
50/60Hz | 110-250 VAC
50/60 Hz |
| Frequency | 300kHz – 1 MHz | 300kHz – 1 MHz |
| Max RF Power | 300W - 400W** | 300W |
| Configuration | Console with accessories | Cart mounted console with
accessories |
| Electrical Safety
Standards | Complies with IEC60601-1,
IEC60601-1-2, IEC60601-2-2 | Complies with IEC60601-1,
IEC60601-1-2, IEC60601-2-2 |
| Handpieces | Resistive, capacitive | Resistive, capacitive |
| Electrodes | Resistive, capacitive, neutral,
dermato-functional, static
automatic, neutral dynamic | Resistive, capacitive, neutral,
dermato-functional, static
automatic, neutral dynamic |
- Bipolar and Multifunction Outputs are the Multipolar Output splitted in two separated connectors.
** The Fisiowarm 400 can handle 30% more power for very demanding and intensive usage.
8
TECHNICAL CHARACTERISTICS
A comparison of the technological characteristics of FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 and the predicate device has been performed. The results of this comparison demonstrate that the technologic characteristics and the operating principle of FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are the same or very similar to those of the claimed predicate device. Where any differences arise from the analysis of the predicate device characteristics and those of the device subject of this submission, the clinical data evaluated from scientific publications give scientific evidence of the safety and the effectiveness of FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400. The system was evaluated and found compliant with IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, and ISO 10993-1 for biocompatibility of the handpieces and electrodes. Verification and validation data show that the device meets all product specifications.
PERFORMANCE DATA
Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. A comparative thermal test was performed on human skin in order to experimentally verify the transfer of energy to the biological tissue of both devices. This verification was carried out by measuring the trend of the temperature increase in the biological tissue over time, at different energy levels.
Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.
CLINICAL DATA
The devices have been designed and validated in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or other people, provided that any risk which may be associated with its use constitute acceptable risks when weighed against the benefits to the patient and is compatible with a high level of protection of health and safety.
CONCLUSION
Based on the foregoing, FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510(k) submission. Safety and effectiveness were reasonably assured, justifying 510 (k) clearance.