It 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 thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Device Description

DEKA SmartXide² is a laser with a wavelength of 10600 nm having a maximal power of 60 Watts. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end.

Laser activation is by footswitch. Overall weight of the laser is 95 Kg, and the size is 210 x 59 x 56 cm (H x W x D).

Electrical requirement is 100-120 Vac 15A, 50-60 Hz, single phase

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the DEKA SmartXide2 Laser System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new type of device. Therefore, the information needed to answer the prompt thoroughly is not present in this document.

Here's an assessment based on the available information:

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

This information is not explicitly provided. The 510(k) summary aims to demonstrate substantial equivalence to a predicate device, DEKA SmartXide² Laser System (K113504) and Cynosure CO2 Laser (K081424), rather than meeting specific performance acceptance criteria for a novel device. The comparison focuses on:

Indications for Use: The SmartXide² laser has the same indications for use as the predicate devices.
Principle of Operation: Same as predicate devices.
Wavelength: Same as predicate devices (10600 nm).
Pulse Energy Range: Same as predicate devices.

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

Sample Size for Test Set: Not applicable in the context of human clinical trials for performance acceptance criteria. The document mentions an animal study.
Data Provenance: The animal study was conducted on "sheep's skin," but details about the country of origin, retrospective or prospective nature are not provided.

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. The document does not describe the use of human experts in establishing ground truth for performance evaluation in the way a diagnostic AI device might.

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

This information is not provided and is not applicable to the type of safety and performance study described (animal study for thermal lesion assessment).

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a laser surgical instrument, not a diagnostic AI device requiring human reader interpretation.

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

Standalone Study: Not directly applicable. The device itself (the laser system) is essentially "standalone" in its operation once activated by a human user via footswitch. It's a therapeutic device, not an algorithm providing diagnostic output.

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

For the animal study:

Ground Truth Type: The study aimed to show "comparative effects of Smartxide laser and Affinity lasers on thermal lesion depth and width as well as ablation depth and width." This implies direct measurement of physical parameters on the tissue. The specific method for establishing this "ground truth" (e.g., histological analysis, direct measurement with calipers) is not detailed.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document does not describe a machine learning or AI algorithm that would require a training set.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no training set mentioned for this device.

Summary of Device and Study (as per document):

The DEKA SmartXide2 Laser System is a surgical laser. The 510(k) submission seeks to demonstrate substantial equivalence to existing predicate devices (DEKA SmartXide² Laser System K113504 and Cynosure CO2 Laser K081424).

The provided document indicates:

Nonclinical Performance Data: None mentioned beyond the animal study.
Clinical Performance Data: None mentioned.
Animal Study Data: An animal study on sheep's skin was conducted. This study's purpose was to demonstrate "comparative effects of Smartxide laser and Affinity lasers on thermal lesion depth and width as well as ablation depth and width." The results presumably showed comparable effects to establish equivalence, but the specific numerical results or acceptance criteria for these measurements are not detailed in this summary.

Conclusion stated: "The SmartXide 2 laser is a safe and effective device for the intended [use]." This general conclusion is based on the demonstration of substantial equivalence rather than meeting pre-defined acceptance criteria for a novel device performance.

Summary

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

September 5, 2014

Electronic Engineering S.p.A. Mr. Paolo Peruzzi Regulatory Affairs Manager 50041 Calenzano (FI) Italy

Re: K133895 Trade/Device Name: DEKA SmartXide2 Laser System 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: August 4, 2014 Received: August 6, 2014

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. 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 requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -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) K133895

Device Name DEKA Smartxide2

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.09.04 14:57:31 -04'00

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510(K) Summary

Submitter:	El.En. S.p.A.Via Baldanzese, 1750041 Calenzano (FI), Italy
Contact:	Paolo PeruzziRegulatory Affairs ManagerPhone: +39-055-882-6807Email: p.peruzzi@elen.it
Date Summary Prepared:	December 18, 2013
Device Trade Name:	DEKA SmartXide² Laser System
Common Name:	Medical Laser System
Classification Name:	Instrument, Surgical, Powered, Laser79-GEX21 CFR 878.4810
Equivalent Device:Affirm	DEKA SmartXide² Laser System (K113504) and CynosureCO2 Laser (K081424)
Device Description:	DEKA SmartXide² is a laser with a wavelength of 10600 nm having a maximal power of 60 Watts. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end.Laser activation is by footswitch. Overall weight of the laser is 95 Kg, and the size is 210 x 59 x 56 cm (H x W x D).Electrical requirement is 100-120 Vac 15A, 50-60 Hz, single phase
Intended Use:	The SmartXide² laser is indicated for incision, excision, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
	Comparison: The SmartXide² laser has the same indications for use, the same principle of operation, the same wavelength and the same pulse energy range as the predicate devices.
Nonclinical Performance Data:	none
Clinical Performance Data:	none

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Animal Study Data :	Animal study on sheep's skin was conducted to show thecomparative effects of Smartxide laser and Affinity lasers onthermal lesion depth and width as well as ablation depth andwidth.
Conclusion:intended	The SmartXide 2 laser is a safe and effective device for the

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.