(105 days)
Not Found
No
The document describes a CO2 laser system with an articulated arm and scanning unit, focusing on mechanical and optical delivery of laser energy. There is no mention of AI, ML, image processing, or data-driven algorithms for treatment planning or execution.
Yes
The device is used for incision, excision, ablation, and vaporization of body soft tissue, which are therapeutic interventions.
No
Explanation: The device is a CO2 laser system used for various surgical procedures such as incision, excision, ablation, and vaporization of soft tissue. Its described functions are all therapeutic or surgical, not diagnostic.
No
The device description clearly states it is a medical device equipped with a laser source, articulated arm, and scanning unit, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The DEKA SMARTXIDE TOUCH is a laser device used for surgical procedures (incision, excision, ablation, vaporization) directly on body soft tissue. This is an in vivo (within the body) procedure.
- Intended Use: The intended use clearly describes surgical applications on living tissue, not the analysis of specimens.
- Device Description: The description details a laser source, articulated arm, and scanning unit for delivering energy to the body, not for processing or analyzing biological samples.
Therefore, the function and intended use of the DEKA SMARTXIDE TOUCH align with a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Incision, excision, ablation, vaporization of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Product codes
GEX
Device Description
The DEKA SMARTXIDE TOUCH is a medical device equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 40W. The laser energy is delivered to the treatment area via 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. The DEKA SMARTXIDE TOUCH laser is equipped with a Scanning Unit, HiScan DOT+, that allows to perform skin resurfacing treatments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissue including intraoral tissue, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
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 DEKA SMARTXIDE TOUCH was tested for standards conformance with the following standards: IEC 60601-1- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. IEC 60601-1-2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests. IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60825-1- Safety of laser products - Part 1: Equipment classification and requirements.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 17, 2017
ELEN Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 Italy
Re: K172362
Trade/Device Name: Deka Smartxide Touch 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 22, 2017 Received: August 24, 2017
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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) 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@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Jennifer R. Stevenson -53
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name DEKA SMARTXIDE TOUCH
Indications for Use (Describe)
Incision, excision, ablation, vaporization of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
| 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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510(K) Summary
DEKA SMARTXIDE TOUCH
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:
August 2, 2017
Device Trade Name: DEKA SMARTXIDE TOUCH
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:
AFFIRM CO2 and AFFIRM CO2 HP laser system (K081424).
Device Description:
The DEKA SMARTXIDE TOUCH is a medical device equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 40W. The laser energy is delivered to the treatment area via 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. The DEKA SMARTXIDE TOUCH laser is equipped with a Scanning Unit, HiScan DOT+, that allows to perform skin resurfacing treatments.
Intended Use:
Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
4
Substantial equivalence discussion:
The DEKA SMARTXIDE TOUCH is substantially equivalent to the AFFIRM CO2 and AFFIRM CO2 HP laser systems (K081424).
| Device Trade
Name | DEKA SMARTXIDE
TOUCH | Predicate Device
AFFIRM CO2 and
AFFIRM CO2 HP
K081424 |
|-------------------------------|-------------------------|----------------------------------------------------------------|
| Laser Type | CO2 | CO2 |
| Wavelength | 10.6μm | 10.6μm |
| Max Power | 40W | 25W
60W (HP) |
| Handpieces
Spot Sizes | 0.2 mm, 0.4 mm | 0.2 mm, 0.4 mm |
| Pulse Duration | 0.02 to 70 ms | 0.2 to 80 ms |
| Pulse Rep Rate | 5 to 100 Hz | 5 to 100 Hz |
| Scanner Spot
size | 350μm | 350μm |
| Scanner Focal
length (EFL) | 100mm | 100mm |
The DEKA SMARTXIDE TOUCH has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances.
Clinical Performance Data:
None
Non-Clinical Performance Data:
The DEKA SMARTXIDE TOUCH was tested for standards conformance with the following standards:
IEC 60601-1- Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility - Requirements and tests.
IEC 60601-2-22 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
IEC 60825-1- Safety of laser products - Part 1: Equipment classification and requirements.
Conclusion:
We can conclude that the DEKA SMARTXIDE TOUCH laser system is substantially equivalent to the predicate device .
Additional Information:
None