(172 days)
No
The provided text does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on the laser technology and its operation.
Yes
The device is used to "necrotize or coagulate soft tissue," which is a direct therapeutic action to address medical conditions.
No
The device description indicates that the ECHOLASER X4 is a laser system used for necrotizing or coagulating soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode" and transmits the beam via optical fibers, indicating it is a hardware device.
Based on the provided information, the ECHOLASER X4 laser system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "necrotize or coagulate soft tissue through interstitial irradiation." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that delivers energy via optical fibers for tissue treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The ECHOLASER X4 is used inside the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064 nm.
Product codes
GEX
Device Description
The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via optical fibers. The operator can use 1 to 4 (or 1 to 2 in case of two channels model) fibers simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, cardiovascular thoracic surgery (excluding the heart and the pericardial sac), dermatology, ear-nose-throat, gastroenterology, general surgery, gynecology, head and neck, orthopedics, pulmonology, radiology, urology.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests were performed:
i) Biocompatibility assessment per ISO 10993.
No additional non-clinical testing is needed since the subject device is identical to the primary predicate.
No additional clinical testing is needed since the subject device is identical to the primary predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of 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.
May 3, 2022
Elesta Spa % Maurizio Pantaleoni RA/QA Consultant Maurizio Pantaleoni Via Borgo Santa Cristina 12 Imola, Bologna 40026 Italy
Re: K213594
Trade/Device Name: Echolaser X4 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: April 4, 2022 Received: April 6, 2022
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-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 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 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.
Purva Pandya, D.Eng. 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) K213594
Device Name ECHOLASER X4
Indications for Use (Describe)
The ECHOLASER X4 laser system is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064 nm.
Type of Use (Select one or both, as applicable)
| ☑ Remediation Use (Part 21 CFR 601.21 and P) | ☐ Same-Time Studies (21 CFR 601.21 and s) |
|---|---|
| ---------------------------------------------- | ------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
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: October 22, 2021
Name & Classification 2.
Common Name/Trade Name/Device Name: ECHOLASER X4
Classification names Powered laser surgical instrument (GEX)
Laser surgical instrument for use in general and plastic surgery and Regulation Name in dermatology (21 CFR§878.4810).
Product Code GEX
CLASS: II
3. Predicate Devices
| Predicate | Applicant | Device name | 510(k) Number |
|---|---|---|---|
| Primary | EL.EN. ELECTRONIC | ||
| ENGINEERING SPA | ECHOLASER X4 | K181510 | |
| Reference | Medtronic Navigation Inc. | Visualase Thermal Therapy System | K181859 |
4
The device modification is related to the ECHOLASER X4, already cleared by the Agency with K181510.
Requested change is related to a language revision of the Intended use of ECHOLASER X4, in order to reflect the description of applications of a predicate device which was unavailable at the of the previous submission K181510. A reference predicate (K181859) is provided in support of the change in the intended use language.
No other changes have been made to the existing ECHOLASER X4 cleared by the Agency under K181510.
The technical features, the design, the performance and safety of the ECHOLASER X4 device are not affected by this device modification since they are precisely the same .
4. Device description
The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in CW mode. The laser beam is transmitted via optical fibers . The operator can use 1 to 4 (or 1 to 2 in case of two channels model) fibers simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
5. Indications for Use
The ECHOLASER X4 laser system is indicated for use 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, at a wavelength of 1064nm.
Explanation of Differences: The above indications for use language is different than the indications for use language present in the primary predicate K181510. However, the intended use of the subject and predicate devices is identical (i.e., thermal destruction of the soft tissue of interest). Moreover, the modified language is comparable to the language present in the indications for use of the reference predicate and does not raise different questions of safety and effectiveness.
6. Summary of Technological Similarities/Differences
The device modification is related to the language revision of the Intended use of ECHOLASER X4. No other relevant changes have been made to the existing ECHOLASER X4 cleared by the Agency under K181510.
| Subject Device | Primary Predicate Device | Comments | |
|---|---|---|---|
| Product Name | ECHOLASER X4 | ECHOLASER X4 | NA |
| 510(K) No. | K213594 | K181510 | NA |
| Applicant | Elesta SpA | El.En. SpA | NA |
| Classification | 21 CFR§878.4810, Laser | ||
| Surgical Instrument for | 21 CFR§878.4810, Laser | ||
| Surgical Instrument for Use in | Identical | ||
| Subject Device | Primary Predicate Device | Comments | |
| Use in General and Plastic | |||
| Surgery and in | |||
| Dermatology | General and Plastic Surgery | ||
| and in Dermatology | |||
| Product Code | GEX | GEX | Identical |
| Indications for | The ECHOLASER X4 laser | The ECHOLASER X4 laser | Comparable, do not raise |
| Use | system is indicated for use | system is intended for use in | different questions of safety |
| to necrotize or coagulate | cutting, vaporization, ablation | and effectiveness since the | |
| tissue | |||
| through | |||
| soft | and coagulation of soft tissue | intended use are the same. | |
| interstitial irradiation | |||
| in | in conjunction with | ||
| medicine and surgery in | endoscopic equipment | ||
| cardiovascular | |||
| thoracic | (including laparoscopes , | ||
| surgery (excluding | |||
| the | hysteroscopes, | ||
| heart and the vessels in the | bronchoscopes, gastroscopes, | ||
| pericardial | |||
| sac), | cystoscopes and | ||
| ear-nose- | |||
| dermatology, | colonoscopies), in | ||
| throat | |||
| surgery, | incision/excision, | ||
| gastroenterology, general | vaporization, ablation and | ||
| surgery, gynecology, head | coagulation of soft tissue in | ||
| and neck surgery, plastic | contact and non-contact | ||
| orthopedics, | |||
| surgery, | open surgery (with or without | ||
| pulmonology, radiology, | a handpiece), and in the | ||
| and | |||
| urology, | |||
| at | |||
| a | treatment and/or removal of | ||
| wavelength of 1064nm. | vascular lesions (tumors). | ||
| Laser Type | DIODE | DIODE | Identical |
| Wavelength (μm) | 1064 nm ± 10% | 1064 nm ± 10% | Identical |
| Output mode | Multimode | Multimode | Identical |
| Maximum | 28W (up to 7 W for each | 28W (up to 7 W for each laser | Identical |
| delivered Power | laser fiber) | fiber) | |
| Stability of the | ±20% | +20% | Identical |
| output power | |||
| level | |||
| Mode of | Continuous wave | Continuous wave | Identical |
| operation | |||
| Output power | 0.5W | 0.5W | Identical |
| increments | |||
| Cooling | TEC | TEC | Identical |
| Emission | Controlled by footswitch | Controlled by footswitch | Identical |
| Aiming Beam | Diode | Diode | Identical |
| Laser Type | |||
| ● | 630-670 nm | 630-670 nm | |
| Wavelength | |||
| ● |