HEBE (NP0000763)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 12, 2025 Novasonix Technology S.L % Shilpa Gampa Senior Manager Freyr Inc 150 College Rd W #102 Princeton, New Jersey 08540 Re: K241733 Trade/Device Name: Hebe (np0000763) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: PBX Dated: March 13, 2025 Received: March 13, 2025 Dear Shilpa Gampa: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 16, 2025. Specifically, FDA is updating this SE Letter to correct a typo in the device name as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Long Chen, Ph.D., OHT4: Office of Surgical and Infection Control Devices, 301-796-6389, long.chen@fda.hhs.gov. Sincerely, James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.05.12 14:04:32 -04'00" 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 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} FDA U.S. FOOD & DRUG ADMINISTRATION April 16, 2025 Novasonix Technology S.L % Shilpa Gampa Senior Manager Freyr Inc 150 College Rd W #102 Princeton, New Jersey 08540 Re: K241733 Trade/Device Name: Hebe (np0000763); Hera (np0000706) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX, GEX Dated: March 13, 2025 Received: March 13, 2025 Dear Shilpa Gampa: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {2} K241733 - Shilpa Gampa Page 2 (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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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). {3} K241733 - Shilpa Gampa Page 3 Sincerely, James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.04.16 07:26:47 -04'00' 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 {4} FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. | | --- | --- | | 510(k) Number (if known) K241733 | | | Device Name HEBE | | | Indications for Use (Describe) HEBE is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation | | | 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. | | | This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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." | | {5} 510(k) Number K241733 # 510 (k) Summary Contact Details 510(k) Number K241733 510(k) Type Traditional Applicant Information NOVASONIX TECHNOLOGY S.L c/ Pla de Ramasar 52, Pol. Ind, Carrer Pla del Ramassar Granollers, Barcelona, 08402, Spain Contact Mr. Carlos Navarro +34 931 356 541 cnavarro@novasonix.es Data Prepared 13-March-2025 Device Name(s) HEBE Common Name Massager, Vacuum, Radio Frequency Induced Heat Regulatory Class Class II (21CFR 878.4400) Product Code PBX Regulation Names Electrosurgical cutting and coagulation device and accessories Predicate and Reference Devices | 510(k) Ref | Pro Code/Reg No | Trade Name | Applicant | | --- | --- | --- | --- | | Primary Predicate Device | | | | | K210867 | PBX - Massager, Vacuum, Radio Frequency Induced Heat | NuEra Tight RF Family | Bios s.r.l. | | Reference Device | | | | | K161458 | PBX -Massager, Vacuum, Radio Frequency Induced Heat | Deep Care | Indiba USA Inc. | # Device Description HEBE is a device indicated for radiofrequency (RF) treatments at $448\mathrm{kHz}$ . This frequency is associated with pain reduction and improved functionality in patients with musculoskeletal disorders. This wavelength promotes ion mobilization between the intracellular and extracellular matrix and restores cell membrane permeability. The energy generated at $448\mathrm{kHz}$ improves cell membrane permeability, enhancing intracellular and extracellular exchange and tissue regeneration. Furthermore, high-intensity radiofrequency treatment at $448\mathrm{kHz}$ can induce significant hyperthermia, which can lead to a considerable increase in cell metabolism and accelerated recovery. These hyperthermal adaptations to radiofrequency treatment are based on vasodilation, causing a targeted local increase of blood perfusion and decreases in muscle tension and spasm, increased oxygen and nutrient supply, and healing acceleration. {6} 2 510(k) Number K241733 RF treatment can be applied through either capacitive or resistive electrodes that pass radiofrequency to the human body. HEBE has 3 different technologies: - Monopolar Capacitive Radiofrequency - Monopolar Resistive Radiofrequency - Bipolar Resistive Radiofrequency Indications of Use HEBE is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation. {7} 510(k) Number K241733 # Predicate Device Comparison | SrNo | Feature | Subject Device | Predicate Device | Reference Device | Similarity | | --- | --- | --- | --- | --- | --- | | 1 | Device Name | HEBE | NuEra Tight RF Family | Deep Care | N/A | | 2 | Device Manufacturer | Novasonix Technology S.L. | Bios s.r.l. | Indiba USA Inc. | N/A | | 3 | 510(K) Number | | K210867 | K161458 | N/A | | 4 | Product Code | PBX - Massager, Vacuum, Radio Frequency Induced Heat | PBX - Massager, Vacuum, Radio Frequency Induced Heat | PBX -Massager, Vacuum, Radio Frequency Induced Heat | Same | | 5 | Regulation | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 | Same | {8} 510(k) Number K241733 | 6 | Indications for Use | HEBE medical device is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation. | The NuEra Tight RF Family 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 local circulation; * To provide, with a massage device, a temporary reduction in the appearance of cellulite. | The Indiba Diathermia Radiofrequency Devices are intended to provide topical heating for the purpose of elevating tissues temperature for treatment of selected medical conditions such as relief of pain, muscle spasms, increase in local Circulation. The Massage device provided is intended to provide a temporary reduction in the appearance of cellulite. | Same | | --- | --- | --- | --- | --- | --- | 4 {9} 510(k) Number K241733 | 7 | Principle of action | Radio frequency waves penetrate in exposed tissue and produce heat, increasing the temperature on a certain part of the body for therapeutic purposes. | Electromagnetic waves penetrate in exposed tissue and produce heat, increasing the temperature on a certain part of the body for therapeutic purposes. | The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. The temperature on the skin is measured using a separate IR (Infra-red) thermometer and there is an integrated massage device that can be used to massage the skin during cellulite treatment. | Same | | --- | --- | --- | --- | --- | --- | | 8 | Clinical use | Prescription Use | Prescription Use | Prescription Use | Same | | 9 | Electrical Protection | Class I Type BF | Class I type BF | Class I type BF | Same | | 10 | User Interface | Touch Screen | Touch Screen | Touch Screen | Same | | 11 | Firmware Controlled | Yes | Yes | Yes | Same | | 12 | Type of energy | Radiofrequency waves | Radiofrequency waves | Radiofrequency waves | Same | | 13 | Temperature Control | Yes with external IR thermometer | Yes | Yes with external IR thermometer | Same | | 14 | Applicator Types | Reusable Electrodes: Monopolar Capacitive (Coating material: Polyamide) Monopolar Resistive (Material: Stainless steel) | Reusable Electrodes: Monopolar Capacitive Bipolar Resistive Small handpiece tip provided sterile and disposable | Reusable Electrodes: Monopolar Capacitive (Coating material: Polyamide) Monopolar Resistive (Material: Stainless steel) | Same with K161458. With the exception that the predicate device has no | 5 {10} 510(k) Number K241733 | | | Bipolar Resistive (Material: Stainless steel) The electrodes are inserted into a handle/handpiece Electrodes dimensions and Power density: Capacitive: Size in diameter (Power density) There are four sizes 20 mm (63.69 W/cm²), 40mm (15.89 W/cm²), 60mm (28.26 W/cm²) and 80-mm (4.37 W/cm²), and 5.5 mm thickness. Resistive: Size in diameter (Power density) There are three sizes. 40mm (9.93 W/cm²), 60mm (4.42 W/cm²) 80mm (2.48 W/cm²) and 5.5 mm thickness. Bipolar: Size in diameter (Power density) There are two sizes. 30mm (48.82 W/cm²), 70mm (6.9 W/cm²), and 5.5 mm thickness). | The electrodes are inserted into a handle/handpiece. Electrodes Dimensions for Monopolar Capacitive: ø20 mm, ø30 mm, ø40 mm, ø60 mm, ø70 mm, ø80 mm, ø100 mm, ø40 mm | The electrodes are inserted into a handle/handpiece. Electrode dimensions Capacitive: Flat circular shape and sized at 30-, 40-, 55- and 65-mm diameter. Resistive: Flat circular shape and sized at 35-, 50- and 65-mm diameter. | bipolar applicator Same with K210867 with the exception of the small area handpiece tip provided EtO sterile for single use and does not use Monopolar resistive type of applicator. Applicator area for Bipolar electrode not reported. Power density not reported for K210867 & K161458 | | --- | --- | --- | --- | --- | --- | 6 {11} 510(k) Number K241733 | 15 | Use of Return Plate | Yes, except in treatments with bipolar electrode. Characteristics: Flexible Size: 20x14 cm; Area covered 280 cm² (small) Size 28x20 cm; Area covered 560 cm² (large). Material: Stainless Steel | Yes, except in treatments with bipolar electrode. Characteristics: Disposable return plates | Yes Characteristics: Flexible Size: 20x26 cm Area covered 520 cm² Material: Stainless Steel | Same except that area covered information is not available for K210867 | | --- | --- | --- | --- | --- | --- | | 16 | Use of conductive cream | Yes, to provide thermal transfer assistance. | Yes, to provide thermal transfer assistance. | Yes, to provide thermal transfer assistance. | Same | | 17 | Other Accessories | Handles, IR thermometer, power cable, trolley | Handles, IR thermometer, power cable, trolley | Handles, IR thermometer, power cable, trolley | Same | | 18 | Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 | Same | | 19 | Type of body contact | Superficial contact on healthy skin | Superficial contact on healthy skin | Superficial contact on healthy skin | Same | | 20 | Sterilization | No | Only the small area handpiece tip provided EtO sterile for single use. | No | Same | 7 {12} 510(k) Number K241733 | 21 | Electrode reprocessing | Yes, after electrode cleaning | Yes, except for the small area handpiece tip provided EtO sterile for single use. | Yes, after electrode cleaning | Same | | --- | --- | --- | --- | --- | --- | | 22 | Shelf life | 50000 Hours in continuous operation | Information not available | Information not available | N/A | | Performance specifications | | | | | | | 23 | Treatment temperature range | +43 °C – +45 °C | +40 °C – +42 °C | +10 °C – +40 °C | Please refer to the foot notes a at the end of the table | | 24 | Frequency | 448 KHz | 470 kHz; 1 MHz; 2 MHz; 4 MHz; 6 MHz | 400 kHz - 449 kHz | Same | | 25 | Output RF Power | Max 200 W | Max 250 W | Max 200 W | Same | | 26 | Voltage | 100-240 V | 100 - 240 V | 100 - 240 V | Same | | Safety Features | | | | | | 8 {13} 510(k) Number K241733 | 27 | Temperature and Power | The device contains current sensor in the electronics that generates the RF signal. By controlling the current, the treatment temperature is controlled. If the measured current is out of the acceptance range the device stops and issues a warning through the GUI. -Internal over-temperature protection by means of a fan that is activated and regulates its power according to the measurement of an internal temperature sensor in the device. Controlling the current intensity generated by the electronics generating the RF also controls the output power. | Information not available | -Output protected against accidental short circuit between neutral plate and active electrode. -Output over-voltage limitation -Output over-power limitation -Contact detection with patient skin -Internal over-temperature protection | Same with Indiba internal over-temperature protection. | | --- | --- | --- | --- | --- | --- | a The 510(k) Summary of the reference device K161458 stated in its performance testing “The validation confirmed that after a minimum of 5 minutes the Indiba Diathermia Radiofrequency Device can raise, and maintain, the skin temperature to the range of 40-45 °C under capacitive and resistive applications.” ## Performance Date and Bench Test The Verification and validation were performed on the device using the established methods by using the predicate device. The test was conducted in accordance with the following standards. {14} 10 510(k) Number K241733 - IEC 60601-1; Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance; - IEC 60601-1-2; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests; - IEC 60601-1-6; Medical Electrical Equipment – Part 1-6: General Requirements For Basic Safety And Essential Performance – Collateral Standard: Usability; - IEC 60601-2-2: 2009 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 - IEC 62304; Medical Device – Software Life Cycle Processes The Biocompatibility of the device was conducted in accordance with the following standards. - ISO 10993-1-2018: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - ISO 10993-5-2009: Biological evaluation of medical devices - Part 5 Test for invitro cytotoxicity - ISO 10993-10-2010: Biological evaluation of medical devices - Part 10 Test for irritation and Skin Sensitization Conclusion The HEBE has the same intended use and similar indications for use, technological characteristics and principles of operation as its predicate device & Reference device. The performance testing the non-clinical testing is performed and its similar to the Predicate device. HEBE devices are safe and effective and are substantially equivalent to the predicate devices in terms of performance.