(90 days)
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.
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.
The provided text describes a 510(k) summary for the "LASER THERMAL THERAPY KIT" by Elesta SpA. This document outlines the device's technical characteristics and claims substantial equivalence to existing predicate devices. However, it does not contain details about specific acceptance criteria and a study proving the device meets those criteria in terms of clinical performance or diagnostic accuracy.
The non-clinical performance tests mentioned focus on engineering aspects like laser light transmission, power loss, mechanical and optical functionalities, sterilization, shelf-life, and biocompatibility. These are essential for device safety and basic functionality but do not relate to clinical effectiveness or user performance against predefined clinical criteria.
Therefore, I cannot provide the requested information regarding clinical acceptance criteria and a study demonstrating the device meets them from the given text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not define clinical acceptance criteria for the device's performance in terms of treatment outcomes or diagnostic accuracy. The "reported device performance" referred to in the text relates to engineering tests (e.g., effectiveness and efficiency of laser light transmission, power loss, mechanical/optical functionalities, sterilization, shelf-life, biocompatibility).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No clinical test set or data provenance is mentioned in the document. The tests described are engineering and laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No clinical test set, ground truth, or expert involvement is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No clinical test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This device is a laser thermal therapy kit, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study is not applicable to its stated function, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is a hardware component (fiber optic and introducer needle) for delivering laser energy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. No clinical ground truth is discussed. The "ground truth" for the non-clinical tests would be the established engineering specifications and standards (e.g., power output measurements, ISO standards for sterilization).
8. The sample size for the training set:
- Cannot be provided. No training set for an algorithm is mentioned as this is a medical device hardware component.
9. How the ground truth for the training set was established:
- Cannot be provided. As above, no training set for an algorithm is mentioned.
In summary, the provided document focuses on substantiating equivalence to predicate devices based on design, intended use, technological characteristics, and non-clinical engineering and bench testing. It does not include information about clinical performance studies or specific acceptance criteria for treatment efficacy or diagnostic accuracy.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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. 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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.
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) | |
|---|---|
| ☑ 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."
{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
-
- 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.
-
- 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.
- Indications for Use
{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.
-
- 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.
- Reference Device
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 |
-
- 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 isused to direct laser energy to softtissue, to necrotize and coagulate softtissue through interstitial irradiationor thermal therapy inmedicine and surgery, incardiovascular thoracic surgery(excluding the heart and the vesselsin the pericardial sac),dermatology, ear-nose-throat surgery,gastroenterology, general surgery,gynecology, head and neck surgery,plastic surgery, orthopaedics,pulmonology, radiology, and urologyat a wavelength of 1064nm. | The LDF is indicated for use to necrotizeor coagulate soft tissue through interstitialirradiation or thermal therapy in medicineand surgery in cardiovascularthoracic surgery (excluding the heart and thevessels in the pericardial sac),dermatology, ear-nose-throat surgery,gastroenterology, general surgery,gynecology, head and neck surgery,neurosurgery, plastic surgery, pulmonology,radiology, and urology, forwavelengths 800nm through 1064nm. |
| Device RegulatoryClassification | Accessory to powered surgical laserinstrument | Accessory to powered surgical laserinstrument |
{6}------------------------------------------------
| FDA 878.4810 | FDA 878.4810 | |
|---|---|---|
| Product code | GEX | GEX |
| Device Class | Accessory to powered surgical laser instrumentClass 2 | Accessory to powered surgical laser instrumentClass 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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.