Deka Smartxide2 Trio

K181867 · El.En Electronic Engineering Spa · GEX · Oct 2, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181867
• Device Name: Deka Smartxide2 Trio
• Applicant: El.En Electronic Engineering Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 2, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Medical laser system comprising 80W CO2 laser (10600nm) and optional 50W diode laser (940nm or 980nm). CO2 laser energy delivered via articulated arm or flexible silica capillary hollow waveguide; diode laser energy delivered via optical fibers. System operated by physician in clinical settings; parameters selected via front panel; activation via footswitch. Device provides surgical cutting, ablation, and coagulation of soft tissues. Modification adds hollow waveguide delivery for CO2 laser to improve access in specific surgical procedures. Benefits include enhanced surgical precision and versatility in soft tissue management.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical verification and validation activities, including verification of CO2 laser output using the waveguide and software validation.

Technological Characteristics

System includes 80W RF-excited CO2 laser and 50W semiconductor diode laser. Delivery via articulated arm (seven-mirror assembly) or flexible silica capillary hollow waveguide. Dimensions: 240cm x 59cm x 56cm; Weight: 100kg. Electrical: 100-120Vac or 220-230Vac. Includes integrated surgical scanning system (HiScan Surg., Endoscan).

Indications for Use

Indicated for incision, excision, ablation, vaporization, and coagulation of soft tissues across various medical specialties including dermatology, plastic surgery, podiatry, ENT, gynecology, neurosurgery, orthopedics, general/thoracic surgery, 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

• DEKA SmartXide2 (K113504)

Reference Devices

• Waveguides by Laser Engineering (K112166)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
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| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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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: [phone] E-mail: [e-mail]

### 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 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.

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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.

## 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) Device<br>DEKA SmartXide2 Trio | Predicate Device<br>K113504<br>DEKA SmartXide2<br>Laser System and delivery<br>accessories |
|-----------------|------------------------------------------------|--------------------------------------------------------------------------------------------|
| 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) Device<br>DEKA SmartXide2 Trio | Predicate Device<br>K113504<br>DEKA SmartXide2<br>Laser System and delivery<br>accessories |
|-----------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Spot size | 0.125 mm - 1.5 mm (articulated arm)<br>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 scanning<br>system | Integrated<br>(HiScan Surg., Endoscan) | Integrated<br>(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<br>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 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