(88 days)
The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
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 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
The provided text describes a medical laser system, the ECHOLASER X4, and its substantial equivalence to a predicate device for the purpose of FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in terms of clinical or algorithmic efficacy.
The document focuses on regulatory compliance and comparison with a predicate device (DORNIER MEDILAS D 1064 laser system) based on technical specifications and intended use.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical or algorithmic performance, which is not detailed here.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be fully provided. The document lists technical specifications of the device and compares them to a predicate device. It doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device, or a specific outcome measure for a therapeutic device) or detailed "reported device performance" against such criteria. The performance shown is primarily technical parameters.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (ECHOLASER X4) | Predicate Device Performance (DORNIER MEDILAS D 1064) |
|---|---|---|
| Indications for Use: Cutting, vaporization, ablation, coagulation of soft tissue (endoscopic, open surgery), treatment/removal of vascular lesions (tumors) | Same | Same |
| Laser Type: DIODE | DIODE | DIODE |
| Wavelength: 1064 nm ± 10% | 1064 nm ± 10% | 1064 nm ± 10% |
| Output Mode: Multimode | Multimode | Multimode |
| Maximum Delivered Power: Comparable | 28W | 30W |
| Stability of Output Power Level: ±20% | ±20% | ±20% |
| Beam Diameter: 0.3 mm | 0.3 mm | 0.3 mm |
| Mode of Operation: Continuous wave | Continuous wave | Continuous wave |
| Aiming Beam Laser Type: Diode | Diode | Diode |
| Aiming Beam Wavelength: Comparable | 630-670 nm | 632 nm |
| Aiming Beam Maximum Delivered Output Power: Comparable | < 3 mW | < 1 mW |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not mentioned. The document explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" only refers to conformance with electrical and laser safety standards. There was no clinical test set or data provenance mentioned for performance evaluation.
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):
- Not applicable / Not mentioned. No clinical test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not mentioned. 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:
- Not applicable. This document describes a laser surgical instrument, not an AI-assisted diagnostic or therapeutic device that would involve human readers. No MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not mentioned. No clinical ground truth was established as no clinical performance study was conducted or reported here.
8. The sample size for the training set:
- Not applicable / Not mentioned. No training set for an algorithm is relevant to this device description.
9. How the ground truth for the training set was established:
- Not applicable / Not mentioned. No training set or ground truth establishment is relevant to this device description.
In summary, the provided FDA document for the ECHOLASER X4 focuses solely on demonstrating substantial equivalence to a predicate device based on technical specifications and intended use, and conformance to electrical and laser safety standards. It does not contain information about clinical performance studies, test sets, ground truth, or expert involvement, as these were not required for this type of 510(k) submission based on the presented information.
{0}------------------------------------------------
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.
September 4, 2018
El.En Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 It
Re: K181510
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: June 5, 2018 Received: June 8, 2018
Dear Paolo Peruzzi:
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/cfpmr/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.
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
{1}------------------------------------------------
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name ECHOLASER X4
Indications for Use (Describe)
The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
| 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
"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 ECHOLASER X4
Submitter:
El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI), Italy
Contact:
Paolo Peruzzi Regulatory Affairs Manager & Official Correspondent Phone: +39.055.8826807 E-mail: p.peruzzi@elen.it
Date Summary Prepared:
June 5, 2018
Device Trade Name:
ECHOLASER X4
Common Name:
Medical Laser system
Classification Name:
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX)
Classification Number:
21 CFR 878.4810
Equivalent Devices:
DORNIER MEDILAS D 1064 laser system (K080959).
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 1 to 4 optical fibres. The operator can use 1 to 4 fibres simultaneously, one independent from the other in both activation and power adjustment. Laser activation is controlled by footswitch.
Intended Use:
The ECHOLASER X4 laser system is intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes , hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
Substantial equivalence discussion:
The ECHOLASER X4 is substantially equivalent to the DORNIER MEDILAS D 1064 laser system (K080959).
{4}------------------------------------------------
| Device Trade Name | Proposed 510(k) Device | Predicate Device |
|---|---|---|
| ECHOLASER | K080959DORNIER MEDILAS D 1064 | |
| Indications for Use | The ECHOLASER X4 laser system is intendedfor use in cutting, vaporization, ablation andcoagulation of soft tissue in conjunction withendoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes,cystoscopes and colonoscopies), inincision/excision, vaporization, ablation andcoagulation of soft tissue in contact and non-contact open surgery (with or without ahandpiece), and in the treatment and/orremoval of vascular lesions (tumors). | The DORNIER MEDILAS D 1064 LaserModel is intended for use in cutting,vaporization, ablation and coagulation of softtissue in conjunction with endoscopicequipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes,cystoscopes and colonoscopies), inincision/excision, vaporization, ablation andcoagulation of soft tissue in contact and non-contact open surgery (with or without ahandpiece), and in the treatment and/orremoval of vascular lesions (tumors). |
| Laser Type | DIODE | DIODE |
| Wavelength (μm) | 1064 nm ± 10% | 1064 nm ± 10% |
| Output mode | Multimode | Multimode |
| Maximum delivered Power | 28W | 30W |
| Stability of the output powerlevel | ±20% | ±20% |
| Beam diameter | 0.3 mm | 0.3 mm |
| Mode of operation | Continuous wave | Continuous wave |
| Aiming BeamLaser TypeWavelengthMaximumDelivered OutputPower | Diode630-670 nm< 3 mW | Diode632 nm<1 mW |
The ECHOLASER X4 has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances.
Clinical Performance Data:
None
Non-Clinical Performance Data:
The ECHOLASER X4 was tested for standards conformance with the following standards:
AAMI/ANSI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1- Safety of laser products – Part 1: Equipment classification and requirements.
Conclusion:
We can conclude that the ECHOLASER X4 laser system is substantially equivalent to the predicate device .
Additional Information:
None
§ 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.