(431 days)
Not Found
No
The summary describes a laser system with different wavelengths and delivery methods. It mentions controlled velocity and defined patterns for beam movement, but this is described as a function of scanning units, not AI/ML. There is no mention of AI, ML, deep learning, or any related terms in the document.
Yes
The device is indicated for various medical procedures such as incision, ablation, vaporization, and coagulation of body soft tissues across many medical specialties, which are therapeutic interventions.
No
This device is a surgical laser system used for incision, ablation, vaporization, and coagulation of tissues, not for diagnosing conditions.
No
The device description clearly outlines a physical laser system with hardware components such as a CO2 laser source, diode laser sources, articulated arm, optical fibers, handpieces, footswitch, and control panel. It is not solely software.
Based on the provided information, the DEKA SmartXide2 CO2 and diode laser system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for "incision, ablation, vaporization and coagulation of body soft tissues" in various medical specialties. This describes a surgical or therapeutic intervention performed directly on the patient's body.
- Device Description: The device description details a laser system that delivers energy to tissue for cutting, vaporizing, and coagulating. This is consistent with a surgical tool.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided information does not mention the analysis of any such specimens.
Therefore, the DEKA SmartXide2 is a surgical laser system, not an IVD.
N/A
Intended Use / 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.
Product codes
GEX
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.
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)
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
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
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.
1
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:
2
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
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human well-being.
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.
4
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
5
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) | |
|---|---|
| -------------------------------------------------------- | -- |
Neil R Oaden 2013.01.31 1/5:44:15 -05'00'
(Division Sign-Off) Division of Surgical Devices 510(k) Number K113504