The DEKA SmartXide2 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 940nm diode laser is indicated for incision, excision, vaporization ablation 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.

The DEKA SmartXide2 980nm diode laser is indicated for 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.

Device Description

The DEKA SmartXide" system 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 connected to its distal end.

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.

An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations.

The DEKA SmartXide2 CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator.

The scanning units move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation.

The CO2 laser focalized on very little spots by the micromanipulator and moved by scanning systems is useful to fasten the surgical procedures and limit the thermal damage to the tissues surrounding the ablation.

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

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 system.

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 95 kg, and the size is 210 cm x 59 cm x 56 cm (H x W x D).

Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

AI/ML Overview

Analysis of Acceptance Criteria and Device Performance for DEKA SmartXide2 Laser System

Based on the provided 510(k) summary (K113504), the DEKA SmartXide2 laser system is a medical laser system intended for various surgical applications. The submission's primary focus is demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria established by the manufacturer and validated through a standalone study.

1. Table of Acceptance Criteria and Reported Device Performance

As the submission is for substantial equivalence, formal quantitative acceptance criteria are not explicitly stated in the document in the way they would be for a novel device proving its safety and efficacy de novo. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device performs "as well as, or better than" the predicate devices. The performance is assessed through non-clinical bench testing and historical literature data.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance	Evidence Type
Safety: Device operates without undue risk to patient or user.	Demonstrated through bench test data and literature review showing that the DEKA SmartXide2 behaves "as well as, or better than" predicate devices.	Non-clinical bench tests (histological evaluations), literature data.
Effectiveness: Device achieves its intended purpose for the claimed indications.	Demonstrated through bench test data and literature review showing that the DEKA SmartXide2 behaves "as well as, or better than" predicate devices. Specifically, histological evaluations assessed ablation depth and lateral thermal damage.	Non-clinical bench tests (histological evaluations), literature data.
Technological Characteristics: Principle of operation and key features are comparable to predicate devices.	Stated that the device "shares same indication for use, same principle of operation and essentially same technological characteristics and performances" as its predicate devices.	Comparison tables of features against predicate devices (not provided in excerpt), device description.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in the context of a clinical trial. The testing involved "histological evaluations... on three different animal tissues." The number of samples or specimens within those animal tissues is not specified.
Data Provenance: The data is non-clinical bench test data conducted on "three different animal tissues." It is retrospective in the sense that existing scientific literature was used to support claims. The country of origin for the animal tissue studies is not specified, but the submitter is based in Italy.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for the non-clinical histological evaluations in the manner it would be done for diagnostic imaging or a comparative clinical study. The histological evaluations likely involved standard laboratory protocols and analyses by trained histologists or pathologists, but no specific number or qualifications of "experts" for ground truth establishment are provided.

4. Adjudication Method for the Test Set

Given the nature of the non-clinical bench testing (histological evaluations and literature review), there was no mention of an adjudication method like 2+1 or 3+1 typically used in clinical studies with human readers. The results of the histological assessments would be based on scientific measurement and interpretation protocols within a laboratory setting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Performance Data: None." The evaluation was based on non-clinical bench testing and literature review to demonstrate substantial equivalence, not a direct comparison of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the DEKA SmartXide2 laser system. This device is a surgical laser system controlled by a human operator, not an AI algorithm. There is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" was derived from histological evaluations of ablated animal tissues, measuring parameters like ablation depth and lateral thermal damage. This is a direct physical measurement/assessment rather than expert consensus, pathology report (though pathology methods are used), or outcomes data in humans.

8. The Sample Size for the Training Set

Not applicable. The DEKA SmartXide2 is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As a physical medical device, there is no "training set" for which ground truth needs to be established.

Summary

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510(k) Summary

KII3504

FEB 0 1 2013

Submitter:

Contact:

Date Summary Prepared:

Device Trade Name:

Common Name:

Classification Name:

Equivalent Devices:

Device Description:

El.En. S.p.A. via Baldanzese, 17 50041 Calenzano (FI), Italy

Paolo Peruzzi Regulatory Affairs Manager Phone: +39.055.8826807 E-mail: standards@elen.it · ·

January 30, 2013

DEKA SmartXide2 laser system and delivery accessories

CO2 and Diode Laser System

Instrument, surgical, powered, laser 79-GEX, 21 CFR 878.4810

Lumenis UltraPulse Surgitouch (K030147) Quanta System Polysurge Diode Laser family (K083613) Biolitec 100W Ceralas Diode 980 nm model D100 (K050824)

The DEKA SmartXide" system 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 connected to its distal end.

An air flow is provided by an internal pump in order to avoid dust and particles deposition on the optics during laser operations.

The DEKA SmartXide2 CO2 laser can be used with DEKA CO2 scanning units and the DEKA EasySpot Hybrid micromanipulator.

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The scanning units move the beam on the tissue with controlled velocity and defined patterns to optimize the laser ablation.

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

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 system.

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 95 kg, and the size is 210 cm x 59 cm x 56 cm (H x W x D).

Electrical requirement is 100-120Vac 50/60Hz, 220-230Vac 50Hz, 16A.

The DEKA SmartXide2 CO2 laser is indicated for 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.

The DEKA SmartXide2 940nm diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization, ablation and coagulation of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, gynaecology, urology, general surgery, ENT, gastroenterology and dental procedures.

The DEKA SmartXide 980nm diode laser is indicated for 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.

Indications for Use:

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accessories is substantially equivalent to its predicate devices. It shares same indication for use, same principle of operation and essentially same technological characteristics and performances. Nonclinical Performance Data:

Comparison:

Bench test data and literature data have been provided in order to demonstrate that DEKA SmartXide2, despite some differences in emission parameters, behaves as well as, or better than, the predicate devices.

The DEKA SmartXide2 laser system with its delivery :

Several histological evaluations have been performed on three different animal tissues, in terms of ablation depth and lateral thermal damage; moreover literature data have been provided to support the DEKA SmartXide2 safety and effectiveness for the claimed indications for use.

None

The tables of comparative features and the provided non clinical performance data show that the DEKA SmartXidelaser system with its delivery accessories is as safe and effective and performs as well as or better than the predicate devices, for the indications for use mentioned above.

Additional Information:

Clinical Performance Data:

Conclusion:

None

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Food and Drug Administration. 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ELEN. Electronic Engineering SPA % Mr. Paolo Peruzzi Regulatory Affairs Manager and Offical Correspondent 17 Via Baldanzese Calenzano, Italy 50041

February 1, 2013

Re: K113504

Trade/Device Name: DEKA SmartXide2 laser system and delivery accessories Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology

Regulatory Class: II

Product Code: GEX Dated: January 08, 2013

Received: January 14, 2013

Dear Mr. 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Paolo Peruzzi

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

FOR Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

510(K) Number (if known): K113504

Device Name: DEKA SmartXide laser system and delivery accessories

Indications for Use:

V Prescriptive Use (Part 21 CFR 801 Subpart D)

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Neil R Oaden 2013.01.31 1/5:44:15 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number K113504

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.