The DEKA SmartXide2 Trio CO2 laser is indicated for incision, ablation, vaporization, and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The DEKA Smartxide2 Trio 940nm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures.

The DEKA SmartXide2 Trio 980mm diode laser is incision, excision, vaporization ablation and coagulation of soft tissues (open and endoscopic surgery) in medical specialties including plastic surgery, dermatology, ear, nose and throat and oral surgery (otolaryngology), gynaecology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

Device Description

The DEKA SmartXide2 Trio is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.

The CO2 laser radiation has a wavelength of 10600nm and is delivered to the treatment area through an articulated arm and a delivery accessory (handpiece/scanner/micromanipulator) connected to its distal end, or through a hollow waveguide.

The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation.

The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating which is highly reflective at the intended wavelength of use.

The waveguides used with DEKA Smartxided Trio are manufactured by Laser Engineering and have been cleared by FDA with K112166.

The diode laser source can be provided in two alternative wavelengths: 940nm and 980mm.

The diode laser radiation is delivered to the treatment area through optical fibers, which are guided to the target tissue with the aid of handpieces. The spot size is effectively the diameter of the fiber being connected to the system.

Emission parameters are selected on the front panel while laser emission is activated by a footswitch. The on-off switch and emergency switch are also located on the front panel of the svstem.

A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.

Overall weight of the device is 100 kg, and the size is 240 cm x 59 cm x 56 cm (H x W x D). Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

The modification to the device is the addition of a hollow waveguide delivery system as an alternative to the articulated arm for the CO2 laser beam . It allows easier delivery of laser energy to the targeted tissue in some surgical procedures.

The intended use of the modified devices, as described in the labelling, has not changed as a result of the modification.

AI/ML Overview

The provided document is a 510(k) summary for the DEKA Smartxide2 Trio, a medical laser system. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to provide a detailed study proving the device meets specific acceptance criteria in the format requested.

Therefore, the information required for a comprehensive answer regarding acceptance criteria and a detailed study proving the device meets these criteria is largely not present in this type of FDA submission.

Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is missing:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria linked to reported device performance metrics in the way one might expect from a detailed clinical or performance study. Instead, it focuses on demonstrating equivalence in features and specifications between the proposed device and the predicate device.

The Feature table on pages 4 and 5 implicitly shows the "performance" by comparing the specifications of the new device to the predicate. The "acceptance criteria" for this submission appear to be that the new device's specifications (including the new delivery system) are within an acceptable range or identical to the predicate, and that the "Intended Use" and "Principle of operation" remain the same.

Feature Type	Acceptance Criteria (Implied from Predicate)	Reported Device Performance (DEKA SmartXide2 Trio)
CO2 Laser
Laser type	CO2 laser - sealed off - RF excited	CO2 laser - sealed off - RF excited
Wavelength	10.6 µm	10.6 µm
Delivery system	Articulated arm	Articulated arm, Waveguide
Output power	0.1 W to 80 W	0.1 W to 80 W
Spot size	0.125 mm - 1.5 mm (articulated arm)	0.125 mm - 1.5 mm (articulated arm), 0.3 -0.5 mm (waveguide)
Pulse length	0.04ms to 0.9s	0.04ms to 0.9s
Pulse Rate	5 to 800 Hz	5 to 800 Hz
Aiming beam	635 nm, 5mW max	635 nm, 5mW max
Surgical scanning system	Integrated (HiScan Surg., Endoscan)	Integrated (HiScan Surg., Endoscan)
Diode Laser
Laser type	Semiconductor Diode Laser	Semiconductor Diode Laser
Wavelength (nm)	940, 980 nm	940, 980 nm
Output power	0.5W - 50W	0.5W - 50W
Spot size (mm)	0.2, 0.3, 0.6 mm	0.2, 0.3, 0.6 mm
Laser Operating Modes	CW, pulsed	CW, pulsed
Pulsed mode Ton	5ms to 2s	5ms to 2s
Delivery system	Optical Fiber	Optical Fiber
Aiming beam	630-670mm, 3mW max	630-670mm, 3mW max

The key change is the addition of a hollow waveguide delivery system for the CO2 laser. The "acceptance criteria" for this modification would be that its performance (e.g., CO2 laser output characteristics when using the waveguide) is safe and effective for the stated indications, and equivalent to the existing articulated arm delivery or the predicate device's capabilities.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document explicitly states "Clinical Performance Data: None" and describes "Non-Clinical Performance Data" as verification and validation activities. These are typically in-house engineering and bench tests, not studies with patient samples.

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)

This information is not provided. As "Clinical Performance Data: None" and the data being non-clinical verification/validation, there would be no ground truth established by medical experts in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Not applicable given the type of data presented.

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

This information is not provided. This device is a surgical laser system, not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not provided. As mentioned, this is not an AI algorithm. The performance evaluation focuses on the physical device's specifications.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the "Non-Clinical Performance Data," the "ground truth" would be established by engineering specifications, technical standards, and internal test procedures. For example, a laser power meter would provide the "ground truth" for laser output power, or precise measurement tools for spot size. This is not derived from medical expert consensus or patient outcomes.

8. The sample size for the training set

This information is not provided. The device is a physical laser system, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

This information is not provided. Not applicable as there is no training set.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The document broadly refers to "Non-Clinical Performance Data" as the study proving the device meets acceptance criteria. These activities included:

Verification of CO2 laser output using the waveguide: This would involve testing the power, wavelength, beam stability, and other characteristics of the CO2 laser when delivered through the new waveguide. The acceptance criteria would be that these outputs meet predefined engineering specifications and are comparable to or within the established range of the predicate device's articulated arm delivery.
Verification and validation of modified software: This ensures that any software changes related to the new waveguide or other aspects of the device operate correctly, safely, and as intended. Acceptance criteria would be based on software requirements and testing protocols.

The document explicitly states that "The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide2 Trio," but these specific details are not included in this 510(k) summary. The overarching "proof" is that these non-clinical tests confirmed the modified device (including the new waveguide) performs equivalently and safely to the predicate device, allowing it to maintain the same indications for use.

Summary

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October 2, 2018

El.En Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 It

Re: K181867

Trade/Device Name: Deka Smartxide2 Trio 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: July 10, 2018 Received: July 12, 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/ofdocs/ofpmn.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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 the reporting 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 mediation-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 -S

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

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Indications for Use

510(k) Number (if known) K181867

Device Name DEKA SMARTXIDE2 TRIO

Indications for Use (Describe)

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)

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510(K) Summary

DEKA Smartxide2 Trio - Special 510(k)

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:

July 10, 2018

Device Trade Name:

Deka Smartxide2 Trio

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:

DEKA Smartxide2 (K113504)

Device Description:

The DEKA SmartXide2 Trio is a medical laser system equipped with a 80W CO2 laser source and an (optional) 980nm or 940nm 50W diode laser source.

The waveguide consists of a flexible silica capillary whose inside wall has been coated with a durable coating which is highly reflective at the intended wavelength of use.

The waveguides used with DEKA Smartxided Trio are manufactured by Laser Engineering and have been cleared by FDA with K112166.

The diode laser source can be provided in two alternative wavelengths: 940nm and 980mm.

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Emission parameters are selected on the front panel while laser emission is activated by a footswitch. The on-off switch and emergency switch are also located on the front panel of the svstem.

A warning light is located on the top cover, close to the control panel. Light ON state indicates that the system is enabled and ready.

Overall weight of the device is 100 kg, and the size is 240 cm x 59 cm x 56 cm (H x W x D). Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

The intended use of the modified devices, as described in the labelling, has not changed as a result of the modification.

Intended Use:

CO2 laser

Incision, excision, ablation, vaporization, and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

940nm diode laser

Incision, excision, vaporization and coagulation of soft tissues (open surgery), cutting. vaporization, ablation and coagulation of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures.

980nm diode laser

Incision, excision, vaporization ablation and coagulation of soft tissues (open and endoscopic surgery) in medical specialties including plastic surgery, dermatology, ear, nose and throat and oral surgery (otolaryngology), gynaecology, urology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

Substantial equivalence discussion:

The DEKA Smartxide Trio is substantially equivalent to the DEKA Smartxide (K113504).

Feature	Proposed 510(k) DeviceDEKA SmartXide2 Trio	Predicate DeviceK113504DEKA SmartXide2Laser System and deliveryaccessories
CO2 laser
Laser type	CO2 laser - sealed off - RF excited	CO2 laser - sealed off - RF excited
Wavelength	10.6 µm	10.6 µm
Delivery system	Articulated arm, Waveguide	Articulated arm
Output power	0.1 W to 80 W	0.1 W to 80 W

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Feature	Proposed 510(k) DeviceDEKA SmartXide2 Trio	Predicate DeviceK113504DEKA SmartXide2Laser System and deliveryaccessories
Spot size	0.125 mm - 1.5 mm (articulated arm)0.3 -0.5 mm (waveguide)	0.125 mm - 1.5 mm (articulated arm)
Pulse length	0.04ms to 0.9s	0.04ms to 0.9s
Pulse Rate	5 to 800 Hz	5 to 800 Hz
Aiming beam	635 nm, 5mW max	635 nm, 5mW max
Surgical scanningsystem	Integrated(HiScan Surg., Endoscan)	Integrated(HiScan Surg., Endoscan)
Diode laser
Laser type	Semiconductor Diode Laser	Semiconductor Diode Laser
Wavelength (nm)	940, 980 nm	940, 980 nm
Output power	0.5W - 50W	0.5W - 50W
Spot size (mm)	0.2, 0.3, 0.6 mm	0.2, 0.3, 0.6 mm
Laser OperatingModes	CW, pulsed	CW, pulsed
Pulsed mode Ton	5ms to 2s	5ms to 2s
Delivery system	Optical Fiber	Optical Fiber
Aiming beam	630-670mm, 3mW max	630-670mm, 3mW max

The DEKA Smartxide Trio has the same indications for use as the abovementioned predicate device, with same principle of operation and same performances.

Clinical Performance Data:

None

Non-Clinical Performance Data:

The following verification and validation activities have been performed on the modified devices:

Verification of CO2 laser output using the waveguide. The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide2 Trio.
Verification and validation of modified software. The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide2 Trio.

Conclusion:

We can conclude that the DEKA Smartxide Trio Laser system is substantially equivalent to the predicate device.

Additional Information:

None

Regulation Number and Section

§ 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.