Laser Thermal Therapy Kit

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May 22, 2023 Elesta SPA % Maurizio Pantaleoni RA/OA Consultant Maurizio Pantaleoni Via Borgo Santa Cristina 12 Imola, Bologna 40026 Italy Re: K230460 Trade/Device Name: Laser Thermal Therapy Kit Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: February 17, 2023 Received: February 21, 2023 Dear Maurizio Pantaleoni: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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. 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Sincerely. # Jianting Wang -S Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230460 Device Name LASER THERMAL THERAPY KIT #### Indications for Use (Describe) The LASER THERMAL THERAPY KIT used to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the perical sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------| | <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> 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." {3}------------------------------------------------ # 510(k) SUMMARY ## K230460 The 510(k) Summary of the LASER THERMAL THERAPY KIT is provided on the next page. This 510(k) Summary is being submitted as required by 21 CFR 807.92. {4}------------------------------------------------ #### 1. General Information Applicant: ELESTA SpA Via Baldanzese, 17 Calenzano (FI) Italy 50041, Italy Tel. +39 055 8826807 Fax +39 055 7766698 Establishment Registration Number: 3015077548 Contact for the application: Maurizio Pantaleoni Via Borgo Santa Cristina 12 Imola (BO) 40026, Italy Tel. +39 3484435155 Email: maurizio.pantaleoni@gmail.com Summary Preparation Date: February, 17 2023 - 2. Name & Classification #### Device Name: LASER THERMAL THERAPY KIT Classification names Accessory to powered surqical laser instrument (GEX) Accessory to powered surgical laser instrument (21 CFR§878.4810). Requlation Name Product Code GEX CLASS: II #### 3. Device description The LASER THERMAL THERAPY KIT is used to transfer laser energy from the laser unit to the tissue site for the treatment. The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA (272μm core quartz fiber with distal end outer diameter 420um and NA 0.2) and an introducer needle (21G). The device is sterile and single use. - 4. Indications for Use The LASER THERMAL THERAPY KIT used to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, orthopedics, pulmonology, radiology, and urology (e.g. Benign Prostatic Hyperplasia), at a wavelength of 1064nm. {5}------------------------------------------------ #### 5. Predicate devices LASER THERMAL THERAPY KIT is substantially equivalent to the following device legally marketed in the U.S. market: | Applicant | Device name | 510(k) Number | |-----------------|---------------------------|---------------| | BioTex Inc., US | Visualase Laser fiber LDF | K053087 | Complete substantial equivalence information is provided in the Section XII of this submission. - 6. Reference Device The LASER THERMAL THERAPY KIT consist of a Fiber Optic for PLA and an Introducer needle. For what concern the contact materials relevant for biocompatibility, the Fiber Optic for PLA is equivalent to the following device legally marketed in the U.S. Furthermore the Echolaser X4 reference device was also cleared to be use used orthopaedics, as the subject device. | Applicant | Device name | 510(k) Number | |-------------|------------------------|---------------| | Oberon GmbH | Oberon Surgical Fibers | K140470 | | Elesta Spa | ECHOLASER X4 | K213594 | - 7. Comparison of technological characteristics with the predicate devices | | Subject Device | Primary predicate device | |-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Name | LASER THERMAL THERAPY KIT | Visualase Laser fiber LDF | | Manufacturer | Elesta SpA, Italy | BioTex Inc., US | | Indication for Use | The LASER THERMAL THERAPY KIT is<br>used to direct laser energy to soft<br>tissue, to necrotize and coagulate soft<br>tissue through interstitial irradiation<br>or thermal therapy in<br>medicine and surgery, in<br>cardiovascular thoracic surgery<br>(excluding the heart and the vessels<br>in the pericardial sac),<br>dermatology, ear-nose-throat surgery,<br>gastroenterology, general surgery,<br>gynecology, head and neck surgery,<br>plastic surgery, orthopaedics,<br>pulmonology, radiology, and urology<br>at a wavelength of 1064nm. | The LDF is indicated for use to necrotize<br>or coagulate soft tissue through interstitial<br>irradiation or thermal therapy in medicine<br>and surgery in cardiovascular<br>thoracic surgery (excluding the heart and the<br>vessels in the pericardial sac),<br>dermatology, ear-nose-throat surgery,<br>gastroenterology, general surgery,<br>gynecology, head and neck surgery,<br>neurosurgery, plastic surgery, pulmonology,<br>radiology, and urology, for<br>wavelengths 800nm through 1064nm. | | Device Regulatory<br>Classification | Accessory to powered surgical laser<br>instrument | Accessory to powered surgical laser<br>instrument | {6}------------------------------------------------ | | FDA 878.4810 | FDA 878.4810 | |----------------------|-----------------------------------------------------------|-----------------------------------------------------------| | Product code | GEX | GEX | | Device Class | Accessory to powered surgical laser instrument<br>Class 2 | Accessory to powered surgical laser instrument<br>Class 2 | | 510 (k) number | To be obtained | K053087 | | Fiber core diameter | 272 μm | 400 μm (200 – 1000) | | Numerical Aperture | 0.22 | 0.37 | | Proximal connector | SMA 905 | SMA 905 | | Wavelength | 1064 nm | 532-1064nm | | Laser Operation mode | Continuous Wave | Continuous Wave | | Lesion shape | Elliptical shape | Ellipsoidal / Round | | Max Power | 7 W | 8 W for 400μm | ## 8. Non Clinical Performance test Engineering studies has been executed on the device in order to assess and check the correct presence of the expected performances and its safety. These studies (eq effectiveness and efficiency of the laser light transmission of the fiber, including power loss, mechanical and optical functionalities test etc...) demonstrates that the device is effective in quiding and transmitting the laser light, emitted by the laser system, in order to efficiently emit it outside the fiber tip, in the target region of interest, without relevant power losses. Takinq into account also the verified effectiveness of the fiber to be coupled to the 21G introducer needles showing a specific protrusion distance with a fixed tolerance, these fibers result able to accurately reach the target tissue thanks to the needle quidance and to allow a safe emission of the laser light without causing no indirect and undesired thermal damages to the patient. Other tests has been furthermore performed, for the subject device, to validate ETHYLENE OXIDE sterilization in compliance with ISO 11135 requirements and shelf life, in compliance with the recognized standards ASTM F1980-16 and ASTM F1929-15. Finally data available allow also to confirm biocompatibility of the device in compliance with ISO10993-1 standard. Therefore, considering all the verifications performed, Elesta Laser Thermal Therapy Kit medical device, composed by Fiber Optic for PLA and Introducer Needle, shows and confirms all the expected performances required. ## 9. Conclusions In light of evidences summarized above and based on classification, intended use and technological characteristics, the subject device is substantially equivalent to the identified predicate devices.