Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components, energy delivery mechanism (radio frequency), and basic control parameters (temperature, vacuum). There is no mention of algorithms that learn or adapt based on data, image processing for analysis, or any terms related to AI/ML.

Therapeutic

Yes
The device is described as intended to elevate tissue temperature for the treatment of various medical conditions, including temporary relief of pain and muscle spasms, and to increase local circulation. It also temporarily reduces the appearance of cellulite with a massage device. These are therapeutic applications.

Diagnostic

No

The device is intended for therapeutic purposes (topical heating for pain relief, muscle spasms, circulation, and cellulite reduction), not for diagnostic purposes of identifying or confirming a disease or condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a console, display, handpieces, electrodes, and an RF generator, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the RFG-01 is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states the device is for topical heating to treat medical conditions and reduce the appearance of cellulite. This involves direct interaction with the patient's body for therapeutic purposes.
Device Description: The description details a device that applies radio frequency energy to the patient's tissues through electrodes in contact with the skin. This is an external, non-invasive treatment.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. The RFG-01's function is to deliver energy to the body for therapeutic effects.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The RFG-01 is intended to:

provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
provide, with a massage device, a temporary reduction in the appearance of cellulite.

Product codes

PBX

Device Description

The RFG-01 is a mobile standalone equipment with four wheels and consists of a console (main unit), a color display with touch operation and three handpieces (small, medium, and large).

The device develops localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. The purpose of the treatment based on the radiofrequency system is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The devices use RF electrodes of the resistive (or bipolar) types. Resistive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts. The use of different sizes allows efficient and effective treatment of various parts of the body. Two of the three handpieces can be used with or without vacuum, allowing an even deeper application of heat. The handpieces are to be used with a small amount of contact lotion, the purpose of which is to assist in heat transfer. The LEDs on every handpiece indicate the coupling and the correct temperature range during the treatment. The color touchscreen displays all treatment-related parameters.

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

Prescription Use

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

The technological characteristics of the RFG-01 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.
RF Power Accuracy ●
Vacuum Pressure Accuracy
Thermal Effect on Skin testing ●

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

60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
60601-1-2 Edition 4.1 2020-09
60601-1-6 Edition 3.1 2013-10
60601-2-2 Edition 6.0 2017-03
62304 Edition 1.1 2015-06
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION
10993-1 Fifth Edition 2018-08
10993-5 Third Edition 2009-06-01
10993-10 Third Edition 2010-08-01
10993-18 Second Edition 2020-01
10993-23 Frist Edition 2021-01
14971 Third Edition 2019-12

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

Key Metrics

Not Found

Predicate Device(s)

K200359

Reference Device(s)

K191528

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 15, 2024

Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant QARA Consulting 151 Gleasondale Road Stow, Massachusetts 01775

Re: K240178

Trade/Device Name: RFG-01 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: January 19, 2024 Received: January 23, 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 (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/cdrb/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 820.70) 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,

Long H. Chen -S Digitally signed by Long H. Chen -S
Date: 2024.07.15 11:02:03 -04'00'

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

2

Center for Devices and Radiological Health

3

Indications for Use

Submission Number (if known)	K240178
Device Name	RFG-01
Indications for Use (Describe)	The RFG-01 is intended to:

provide topical heating for the purpose of elevating tissue temperature for the treatment of
selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local
circulation.
provide, with a massage device, 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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 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.

510(k) Summary RFG-01 K240178

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 Consultant
Phone: 978.729.5978
Fax: +49-731-9761-118
E-mail: scottqara@gmail.com |
| Date Summary Prepared: | January 19, 2024 |

Device Name:

Trade Name:	RFG-01
Common Name:	Electrosurgical cutting and coagulation accessories

Classification Name: Regulation Number: Product Code: Classification:

3. Predicate Device: Company Name:

Reference Device: Company Name:

n device and Massager, Vacuum, Radio Frequency Induced Heat 21 CFR 878.4400 PBX Class II

NuEra Tight RF Family - K200359 Bios s.r.l.

Venus Legacy Pro Device – K191528 Venus Concept USA Inc.

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Image /page/5/Picture/0 description: The image shows the text "K240178" at the top, followed by the logo for Zimmer MedizinSysteme. The Zimmer logo is in a sans-serif font, with the word "zimmer" in a larger, bolder font than the words "MedizinSysteme" below it. The logo and text are in grayscale.

4. Device Description:

The RFG-01 is a mobile standalone equipment with four wheels and consists of a console (main unit), a color display with touch operation and three handpieces (small, medium, and large).

The device develops localized heat to warm the subcutaneous tissue by means of radio frequency energy, delivered through electrodes in contact with the patient. The purpose of the treatment based on the radiofrequency system is to raise the temperature inside the tissues up to maximum of 45°C. Therefore, depending on the treatment and intended use, different parts of the body can be treated. The devices use RF electrodes of the resistive (or bipolar) types. Resistive RF electrodes have different sizes and plug into an RF handpiece that provides connection to the RF generator (through the electrode connectors). Handpieces of different shapes are available to facilitate use by the operator on different body parts. The use of different sizes allows efficient and effective treatment of various parts of the body. Two of the three handpieces can be used with or without vacuum, allowing an even deeper application of heat. The handpieces are to be used with a small amount of contact lotion, the purpose of which is to assist in heat transfer. The LEDs on every handpiece indicate the coupling and the correct temperature range during the treatment. The color touchscreen displays all treatment-related parameters.

5. Indications for Use Statement:

The RFG-01 is intended for:

· to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
· to provide, with a massage device, a temporary reduction in the appearance of cellulite.

6

Image /page/6/Picture/0 description: The image shows the text "K240178" at the top. Below that is the logo for Zimmer MedizinSysteme. The logo is in gray and features the word "zimmer" in a stylized font, with a line above the "z" and "i". Below "zimmer" is the text "MedizinSysteme" in a smaller font.

	SUBJECT DEVICE	PREDICATE DEVICE	REFERENCE DEVICE
	Zimmer MedizinSysteme	Bios s.r.l.	Venus Concept USA Inc.
ATTRIBUTE	GmbH
	RFG-01	NuEra Tight RF Family	Venus Legacy Pro Device
	This Submission	K200359	K191528
Product Code
and
Regulation	General & Plastic Surgery
21 CFR 878.4400
PBX - Massager, Vacuum,
Radio Frequency Induced
Heat	General & Plastic
Surgery
21 CFR 878.4400
PBX - Massager,
Vacuum, Radio
Frequency Induced
Heat	General & Plastic Surgery
21 CFR 878.4400
GEI - Electrosurgical,
Cutting & Coagulation &
Accessories
PBX - Massager, Vacuum,
Radio Frequency Induced
Heat
Indications for
Use	The RFG-01 is intended
for:

to provide topical heating
for the purpose of
elevating tissue
temperature for the
treatment of selected
medical conditions such as
temporary relief of pain,
muscle spasms, and
increase in local
circulation.
to provide, with a
massage device, a
temporary reduction in the
appearance of cellulite. | The NuEra Tight FR
Family is intended for:
to provide topical
heating for the purpose
of elevating tissue
temperature for the
treatment of selected
medical conditions such
as temporary relief of
pain, muscle spasms,
and increase in local
circulation.
to provide, with a
massage device, a
temporary reduction in the
appearance of
cellulite. | When used with the
Octipolar (LB1) or
Diamondpolar (LF1)
applicators, the Venus
Legacy Pro device is
intended for use in
dermatologic and general
surgical procedures for
females for the non-
invasive treatment of
moderate to severe facial
wrinkles and rhytides in
Fitzpatrick skin types I-IV.

Medium handpiece
Continuous and Pulse1-3:
0~300mmHg

The Indications for Use statement of RFG-01 is identical to the predicate device NuEra Tight RF Family.

6. Technological Characteristics:

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Image /page/7/Picture/0 description: The image contains the text "K240178" at the top, which appears to be a product or document identifier. Below this, there is a logo that reads "zimmer" in a stylized font. Underneath "zimmer", the text "MedizinSysteme" is present, indicating that the logo is for a medical systems company named Zimmer.

There are only a few technological differences between the subject device, the predicate and reference 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/8/Picture/0 description: The image shows the text "K240178" at the top, followed by the logo for Zimmer MedizinSysteme. The Zimmer logo is in gray and features a stylized "Z" with horizontal lines above the text "MedizinSysteme" in a smaller font. The logo is simple and professional.

The Zimmer MedizinSysteme GmbH subject device RFG-01 has the same technological characteristics as the predicate and the reference device except of the following:

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Image /page/9/Picture/0 description: The image shows the text "K240178" at the top, followed by the word "Zimmer" in a stylized font. Below "Zimmer" is the text "MedizinSysteme" in a smaller font. The text appears to be a logo or identifier for a medical systems company.

| Characteristic difference between subject device RFG-1, predicate device NuEra Tight RF Family

and the reference device Venus Legacy Pro Device
Technological
Characteristics	Difference in Characteristics	Discussion on why this difference
does not affect the overall safety and
effectiveness of the subject device
when compared to the predicate
device and the reference device
Type of Energy	Subject: Radiofrequency waves
and Vacuum
Predicate: Radiofrequency waves
Reference:

RF Energy
Pulsed Magnetic Field (PMF)
Vacuum | The medium and large handpieces of
the subject device can be used with or
without vacuum as well as the reference
device. A treatment with vacuum allows
an even deeper application with heat. |
| Frequency | Subject: 1 MHz, 2 MHz, 4 MHz
Predicate: 470 kHz; 1 MHz; 2 MHz;
4 MHz; 6 MHz
Reference: 1 MHz | For the radiofrequency function, the only
difference is that the predicate device
(K200359) works at additional
frequencies of 470kHz and 6MHz, the
reference device (K191528) works only
at a single frequency of 1MHz. The
subject device works at multiple
frequencies as the predicate device and
includes the single frequency of the
reference device. |
| Output RF Power | Subject:
Small handpiece: Max 30.0W
Medium handpiece: Max 46W
Large handpiece: Max 88W
Predicate: 250W maximum
Reference: 150W maximum | Even with less power, the effectiveness
of treatment is guaranteed. The safety
of the application is even increased due
to less power. Since the required
temperature is reached even with
reduced power and the risk of burns due
to excessive temperatures is minimized. |
| Power Requirements | Subject: 110 - 220V, 50/60Hz
Predicate: 100 - 240V
Reference:
100-120 VAC / 60Hz
220-240 VAC / 50Hz | No impact. The energy source is
sufficient to operate the device under
normal operating conditions. |
| Characteristic difference between subject device RFG-1, predicate device NuEra Tight RF Family
and the reference device Venus Legacy Pro Device | | |
| Technological
Characteristics | Difference in Characteristics | Discussion on why this difference
does not affect the overall safety and
effectiveness of the subject device
when compared to the predicate
device and the reference device |
| Vacuum pressure
handpieces | Subject:
Medium handpiece
Continuous and Pulse1-3:
0300mmHg

Large handpiece
Continuous and Pulse1:
0270mmHg
Pulse 2 and Pulse 3:
0300mmHg

Predicate: unavailable
Reference: -400mbar | The maximum vacuum pressure of the
subject device and the reference device
is the same (400mbar = 300mmHg) |

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Image /page/10/Picture/0 description: The image contains the text "K240178" at the top, followed by the logo for Zimmer MedizinSysteme. The Zimmer logo is in a sans-serif font and is in bold. Below the Zimmer logo, the text "MedizinSysteme" is written in a smaller font size.

7. Performance data

The technological characteristics of the RFG-01 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.
RF Power Accuracy ●
Vacuum Pressure Accuracy
Thermal Effect on Skin testing ●

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

11

K240178

Zimmer MedizinSysteme

| 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 |
| 60601-2-2 Edition 6.0
2017-03 | IEC | Medical electrical equipment - Part 2-2: Particular requirements
for the basic safety and essential performance of high frequency
surgical equipment and high frequency surgical accessories |
| 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 |
| 10993-1 Fifth Edition
2018-08 | ISO | Biological evaluation of medical devices – Part 1: Evaluation and
testing within a risk management process |
| 10993-5 Third Edition
2009-06-01 | ISO | Biological evaluation of medical devices – Part 5: Tests for in vitro
cytotoxicity |
| 10993-10 Third Edition
2010-08-01 | ISO | Biological evaluation of medical devices – Part 10: Tests for
irritation and skin sensitization |
| 10993-18 Second Edition
2020-01 | ISO | Biological evaluation of medical devices – Part 18: Chemical
characterization of medical device materials within a risk
management process |
| 10993-23 Frist Edition
2021-01 | ISO | Biological evaluation of medical devises - Part 23: Tests for
irritation |
| 14971 Third Edition
2019-12 | ISO | Medical devices – Application of risk management to medical
devices |

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Image /page/12/Picture/0 description: The image contains the text "K240178" at the top, which appears to be a reference or identification number. Below this, there is a logo that includes the word "zimmer" in a stylized font. Underneath "zimmer", the words "MedizinSysteme" are written in a smaller font size, indicating that the logo is for a medical systems company.

The following table shows a comparison of the performance testing in comparison to the predicate device and the reference device:

| Standards | SUBJECT DEVICE
Zimmer MedizinSysteme
GmbH
RFG-01
This Submission | PREDICATE DEVICE
Bios s.r.l.
NuEra Tight RF Family
K200359 | REFERENCE DEVICE
Venus Concept USA Inc.
Venus Legacy Pro
Device
K191528 |
|------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| ANSI/AAMI
ES60601-1 | X | X | X |
| IEC 60601-1-2 | X | X | X |
| IEC 60601-1-6 | X | X | X |
| IEC 60601-2-2 | X | X | X |
| IEC 62304 | X | X | X |
| IEC 62366-1 | X | unknown | unknown |
| ISO 14971 | X | unknown | unknown |
| ISO 10993-1 | X | X | unknown |
| ISO 10993-5 | X | X | unknown |
| ISO 10933-10 | X | X | unknown |
| ISO 10933-18 | X | unknown | unknown |
| ISO 10933-23 | X | unknown | unknown |

According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate device and the reference device.

8. Conclusion:

Zimmer MedizinSysteme GmbH has demonstrated that the RFG-01 device is substantially equivalent to the predicate device.