RFG-01

{0}------------------------------------------------ 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:<br>- provide topical heating for the purpose of elevating tissue temperature for the treatment of<br>selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local<br>circulation.<br>- provide, with a massage device, a temporary reduction in the appearance of cellulite. | | | | Type of Use (Select one or both, as applicable) | <table><tr><td><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</td><td><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ 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<br>Junkersstrasse 9<br>89231 Neu-Ulm<br>Germany<br>Establishment Registration: 8010720 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------| | | Ms. Ute Killet<br>Manager Regulatory Affairs<br>Phone: +49-7319761-216<br>Fax: +49-731-9761-118<br>E-Mail: u.killet@zimmer.de | | Official Contact: | Mr. Scott Blood<br>Principal Consultant<br>Phone: 978.729.5978<br>Fax: +49-731-9761-118<br>E-mail: scottqara@gmail.com | | Date Summary Prepared: | January 19, 2024 | 2. 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. {5}------------------------------------------------ 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<br>and<br>Regulation | General & Plastic Surgery<br>21 CFR 878.4400<br>PBX - Massager, Vacuum,<br>Radio Frequency Induced<br>Heat | General & Plastic<br>Surgery<br>21 CFR 878.4400<br>PBX - Massager,<br>Vacuum, Radio<br>Frequency Induced<br>Heat | General & Plastic Surgery<br>21 CFR 878.4400<br>GEI - Electrosurgical,<br>Cutting & Coagulation &<br>Accessories<br>PBX - Massager, Vacuum,<br>Radio Frequency Induced<br>Heat | | Indications for<br>Use | The RFG-01 is intended<br>for:<br>- to provide topical heating<br>for the purpose of<br>elevating tissue<br>temperature for the<br>treatment of selected<br>medical conditions such as<br>temporary relief of pain,<br>muscle spasms, and<br>increase in local<br>circulation.<br>- to provide, with a<br>massage device, a<br>temporary reduction in the<br>appearance of cellulite. | The NuEra Tight FR<br>Family is intended for:<br>- to provide topical<br>heating for the purpose<br>of elevating tissue<br>temperature for the<br>treatment of selected<br>medical conditions such<br>as temporary relief of<br>pain, muscle spasms,<br>and increase in local<br>circulation.<br>- to provide, with a<br>massage device, a<br>temporary reduction in the<br>appearance of<br>cellulite. | When used with the<br>Octipolar (LB1) or<br>Diamondpolar (LF1)<br>applicators, the Venus<br>Legacy Pro device is<br>intended for use in<br>dermatologic and general<br>surgical procedures for<br>females for the non-<br>invasive treatment of<br>moderate to severe facial<br>wrinkles and rhytides in<br>Fitzpatrick skin types I-IV.<br><br>When used with the 4D<br>Body (LB2) or 4D Face<br>(LF2) applicators, the<br>Venus Legacy Pro device<br>is intended for the delivery<br>of non-thermal RF<br>combined with Massage<br>and magnetic field pulses<br>for the treatment of the<br>following medical<br>conditions:<br>• Relief of minor muscles<br>aches and pain, relief of<br>muscle spasm<br>• Temporary improvement<br>of local blood circulation<br>• Temporary reduction in<br>the appearance of cellulite | | Technological<br>Characteristics | SUBJECT DEVICE | PREDICATE DEVICE | REFERENCE DEVICE | | | Zimmer MedizinSysteme<br>GmbH<br>RFG-01<br>This Submission | Bios s.r.l. | Venus Concept USA Inc. | | Principle of<br>action | Electromagnetic waves<br>penetrate in exposed tissue<br>and produce heat,<br>increasing the temperature<br>on a certain part of the body<br>for therapeutic purposes. | Electromagnetic waves<br>penetrate in exposed tissue<br>and produce heat,<br>increasing the temperature<br>on a certain part of the body<br>for therapeutic purposes. | Electromagnetic waves<br>penetrate in exposed tissue<br>and produce heat, increasing<br>the temperature on a certain<br>part of the body for<br>therapeutic purposes. | | Clinical Use | Prescription Use | Prescription Use | Prescription Use | | Electrical<br>Protection | Class I Type BF | Class I Type BF | unknown | | User Interface | Touch Screen | Touch Screen | unknown | | Firmware<br>controlled | Yes | Yes | Yes | | Type of Energy | Radiofrequency waves and<br>Vacuum | Radiofrequency waves | RF Energy<br>2. Pulsed Magnetic Field<br>(PMF)<br>3. Vacuum | | Temperature<br>Control | Yes | Yes | Yes | | Frequency | 1 MHz, 2 MHz, 4 MHz | 470 kHz; 1 MHz; 2 MHz; 4 MHz;<br>6 MHz | 1 MHz | | Output RF<br>Power | Small handpiece: Max 30W<br>Medium handpiece: Max<br>46W<br>Large handpiece: Max 88W | Max 250W | Maximal RF output power for<br>each applicator -<br>Octipolar (LB1),<br>Diamondpolar (LF1), 4D<br>Body (LB2) and 4D Face<br>(LF2): up to 150W | | Power<br>Requirements | 110 - 240V ~ 50/60Hz | 100 – 240 V | 100-120 VAC / 60Hz<br>220-240 VAC / 50Hz | | Vacuum<br>pressure<br>handpieces | Small handpiece<br>Unavailable<br><br>Medium handpiece<br>Continuous and Pulse1-3:<br>0~300mmHg<br><br>Large handpiece<br>Continuous and Pulse1:<br>0~270mmHg<br>Pule 2 and Pulse 3:<br>0~300mmHg | unavailable | -400mbar | | Materials | Materials are biocompatible | Materials are biocompatible | Materials are biocompatible | The Indications for Use statement of RFG-01 is identical to the predicate device NuEra Tight RF Family. #### 6. Technological Characteristics: {7}------------------------------------------------ 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. {8}------------------------------------------------ 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: {9}------------------------------------------------ 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<br>and the reference device Venus Legacy Pro Device | | | |----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Technological<br>Characteristics | Difference in Characteristics | Discussion on why this difference<br>does not affect the overall safety and<br>effectiveness of the subject device<br>when compared to the predicate<br>device and the reference device | | Type of Energy | Subject: Radiofrequency waves<br>and Vacuum<br>Predicate: Radiofrequency waves<br>Reference:<br>1. RF Energy<br>2. Pulsed Magnetic Field (PMF)<br>3. Vacuum | The medium and large handpieces of<br>the subject device can be used with or<br>without vacuum as well as the reference<br>device. A treatment with vacuum allows<br>an even deeper application with heat. | | Frequency | Subject: 1 MHz, 2 MHz, 4 MHz<br>Predicate: 470 kHz; 1 MHz; 2 MHz;<br>4 MHz; 6 MHz<br>Reference: 1 MHz | For the radiofrequency function, the only<br>difference is that the predicate device<br>(K200359) works at additional<br>frequencies of 470kHz and 6MHz, the<br>reference device (K191528) works only<br>at a single frequency of 1MHz. The<br>subject device works at multiple<br>frequencies as the predicate device and<br>includes the single frequency of the<br>reference device. | | Output RF Power | Subject:<br>Small handpiece: Max 30.0W<br>Medium handpiece: Max 46W<br>Large handpiece: Max 88W<br>Predicate: 250W maximum<br>Reference: 150W maximum | Even with less power, the effectiveness<br>of treatment is guaranteed. The safety<br>of the application is even increased due<br>to less power. Since the required<br>temperature is reached even with<br>reduced power and the risk of burns due<br>to excessive temperatures is minimized. | | Power Requirements | Subject: 110 - 220V, ~50/60Hz<br>Predicate: 100 - 240V<br>Reference:<br>100-120 VAC / 60Hz<br>220-240 VAC / 50Hz | No impact. The energy source is<br>sufficient to operate the device under<br>normal operating conditions. | | Characteristic difference between subject device RFG-1, predicate device NuEra Tight RF Family<br>and the reference device Venus Legacy Pro Device | | | | Technological<br>Characteristics | Difference in Characteristics | Discussion on why this difference<br>does not affect the overall safety and<br>effectiveness of the subject device<br>when compared to the predicate<br>device and the reference device | | Vacuum pressure<br>handpieces | Subject:<br>Medium handpiece<br>Continuous and Pulse1-3:<br>0~300mmHg<br><br>Large handpiece<br>Continuous and Pulse1:<br>0~270mmHg<br>Pulse 2 and Pulse 3:<br>0~300mmHg<br><br>Predicate: unavailable<br>Reference: -400mbar | The maximum vacuum pressure of the<br>subject device and the reference device<br>is the same (400mbar = 300mmHg) | {10}------------------------------------------------ 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<br>Organization | Standards Title | |-----------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 60601-1 Edition 3.2<br>2020-08<br>CONSOLIDATED<br>VERSION | IEC | Medical electrical equipment – Part 1: General requirements for<br>basic safety and essential performance | | 60601-1-2 Edition 4.1<br>2020-09 | IEC | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance – Collateral standard:<br>Electromagnetic disturbances – Requirements and tests | | 60601-1-6 Edition 3.1<br>2013-10 | IEC | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability | | 60601-2-2 Edition 6.0<br>2017-03 | IEC | Medical electrical equipment - Part 2-2: Particular requirements<br>for the basic safety and essential performance of high frequency<br>surgical equipment and high frequency surgical accessories | | 62304 Edition 1.1 2015-<br>06 | IEC | Medical devices software –software life cycle processes | | 62366-1 Edition 1.1<br>2020-06<br>CONSOLIDATED<br>VERSION | IEC | Medical devices - Part 1: Application of usability engineering to<br>medical devices | | 10993-1 Fifth Edition<br>2018-08 | ISO | Biological evaluation of medical devices – Part 1: Evaluation and<br>testing within a risk management process | | 10993-5 Third Edition<br>2009-06-01 | ISO | Biological evaluation of medical devices – Part 5: Tests for in vitro<br>cytotoxicity | | 10993-10 Third Edition<br>2010-08-01 | ISO | Biological evaluation of medical devices – Part 10: Tests for<br>irritation and skin sensitization | | 10993-18 Second Edition<br>2020-01 | ISO | Biological evaluation of medical devices – Part 18: Chemical<br>characterization of medical device materials within a risk<br>management process | | 10993-23 Frist Edition<br>2021-01 | ISO | Biological evaluation of medical devises - Part 23: Tests for<br>irritation | | 14971 Third Edition<br>2019-12 | ISO | Medical devices – Application of risk management to medical<br>devices | {12}------------------------------------------------ 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<br>Zimmer MedizinSysteme<br>GmbH<br>RFG-01<br>This Submission | PREDICATE DEVICE<br>Bios s.r.l.<br>NuEra Tight RF Family<br>K200359 | REFERENCE DEVICE<br>Venus Concept USA Inc.<br>Venus Legacy Pro<br>Device<br>K191528 | |------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------| | ANSI/AAMI<br>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.