(82 days)
No
The summary describes a laser system with different delivery methods and wavelengths. There is no mention of any computational processing, image analysis, or adaptive algorithms that would suggest the use of AI or ML. The device parameters are selected manually, and the modification is purely mechanical (addition of a waveguide).
Yes
The device is indicated for incision, ablation, vaporization, and coagulation of body soft tissues across various medical specialties, which are all therapeutic actions.
No
The device description clearly states its purpose is for "incision, ablation, vaporization, and coagulation of body soft tissues" using laser technology, which are therapeutic and surgical functions, not diagnostic ones.
No
The device description clearly outlines a physical laser system with hardware components like laser sources, articulated arms, waveguides, and handpieces. While it mentions software verification and validation, the core device is a hardware-based medical laser system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The DEKA SmartXide2 Trio CO2 laser is a surgical laser system used for direct interaction with body soft tissues (incision, ablation, vaporization, coagulation). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes surgical procedures on various body tissues, not the analysis of biological specimens.
Therefore, the DEKA SmartXide2 Trio CO2 laser falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 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.
4
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
DEKA SmartXide2 Trio | Predicate Device
K113504
DEKA SmartXide2
Laser System and delivery
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 |
5
| Feature | Proposed 510(k) Device
DEKA SmartXide2 Trio | Predicate Device
K113504
DEKA SmartXide2
Laser System and delivery
accessories |
|-----------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 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 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 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