DEKA SMARTXIDE AND DELIVERY ACCESSORIES

K113504 · El.En Electronic Engineering Spa · GEX · Feb 1, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K113504
• Device Name: DEKA SMARTXIDE AND DELIVERY ACCESSORIES
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

DEKA SmartXide2 is a multi-source surgical laser system featuring an 80W CO2 laser (10600nm) and an optional 50W diode laser (940nm or 980nm). CO2 laser energy is delivered via an articulated arm with seven mirrors and a micromanipulator; diode laser energy is delivered via optical fibers and handpieces. System includes internal air pump for optics protection. Operated by physicians in clinical/surgical settings via front panel controls and footswitch. Scanning units move the beam in defined patterns to optimize ablation and limit lateral thermal damage. Output enables precise tissue incision, excision, vaporization, and coagulation. Benefits include faster surgical procedures and reduced collateral tissue damage.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and histological evaluations performed on three different animal tissues to assess ablation depth and lateral thermal damage, supported by literature data.

Technological Characteristics

System includes 80W CO2 laser (10600nm) and 50W diode laser (940nm/980nm). CO2 delivery via articulated arm with seven mirrors; diode delivery via optical fibers. Dimensions: 210cm x 59cm x 56cm; Weight: 95kg. Power: 100-120Vac or 220-230Vac. Includes internal air pump for optics. Features scanning units for controlled beam movement.

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues across various surgical specialties including dermatology, plastic surgery, ENT, gynaecology, urology, neurosurgery, orthopaedics, general/thoracic surgery, gastroenterology, and dental/oral surgery. Applicable to both open and endoscopic procedures.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: [phone] E-mail: [e-mail] · ·

January 30, 2013

DEKA SmartXide2 laser system and delivery accessories

t

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.

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.

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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 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.

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 [phone]. 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 [phone] or [phone] 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:

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.

V Prescriptive Use (Part 21 CFR 801 Subpart D)

OR

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