(28 days)
Not Found
No
The provided text describes a CO2 laser system and its components, with no mention of AI or ML technologies.
Yes
The device is used for medical treatments like incision, excision, ablation, and vaporization of body soft tissue, which are therapeutic interventions.
No
Explanation: The device description and intended use indicate that this is a surgical laser system used for tissue modification (incision, excision, ablation, vaporization), not for diagnosing conditions.
No
The device description clearly outlines a physical laser system with a CO2 laser source, articulated arm, and scanning unit, indicating it is a hardware-based medical device, not software-only.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states that this device is a laser system used for surgical procedures like incision, excision, ablation, and vaporization of body soft tissue. This is a therapeutic device that acts directly on the patient's body, not a diagnostic device that analyzes samples.
- Intended Use: The intended use describes surgical applications in various medical specialties. It does not mention any diagnostic testing or analysis of biological samples.
Therefore, this device falls under the category of a surgical or therapeutic medical device, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
The DEKA Smartxide Family of laser system are medical devices equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 30W/50W/60W. 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 Family laser is equipped with a Scanning Unit 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
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 actual maximum laser output for each model (30W, 50W, 60W). The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide Punto and Smartxide Touch.
- Verification of electric safety and EMC compliance for the 60W model as worst case electric configuration. The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide Touch.
- Verification of new covers design specifications for Smartxide Punto.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in blue, followed by "U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" in a smaller font size below.
February 21, 2018
El.En Electronic Engineering S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 It
Re: K180193
Trade/Device Name: DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) 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: January 22, 2018 Received: January 24, 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 (QS) regulation (21 CFR Part 820);
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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/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 -23 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) K180193
Device Name
DEKA Smartxide family (Smartxide Touch, Smartxide Punto)
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 family of Laser Systems - 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:
January 22, 2018
Device Trade Name:
Deka Smartxide family (Smartxide Touch, Smartxide Punto)
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 Smartxide Touch (K172362)
Device Description:
The DEKA Smartxide Family of laser system are medical devices equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 30W/50W/60W. 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 Family laser is equipped with a Scanning Unit that allows to perform skin resurfacing treatments.
4
The modifications to the devices are
-
- different maximum available output power: 60W, 30W and 50W and
-
- different external system and scanner covers for DEKA SmartXide Punto models.
The intended use of the modified devices, as described in the labeling, has not changed as a result of the modifications.
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.
Substantial equivalence discussion:
The DEKA Smartxide family of laser systems is substantially equivalent to the DEKA Smartxide Touch (K172362).
| Device Trade
Name | DEKA SMARTXIDE
FAMILY OF LASER
SYSTEMS | PREDICATE DEVICE
DEKA SMARTXIDE TOUCH
(K172362) |
|-------------------------------|-----------------------------------------------------|-------------------------------------------------------|
| Laser Type | CO2 | CO2 |
| Wavelength | 10.6μm | 10.6μm |
| Max Power | 30W, 50W (Smartxide Punto)
60W (Smartxide Touch) | 40W |
| Handpieces Spot
Sizes | 0.2 mm, 0.4 mm | 0.2 mm, 0.4 mm |
| Pulse Duration | 0.02 to 70 ms | 0.02 to 70 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 family of laser systems 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 following verification and validation activities have been performed on the modified devices:
- Verification of actual maximum laser output for each model (30W, 50W, 60W). The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide Punto and Smartxide Touch.
5
- Verification of electric safety and EMC compliance for the 60W model as worst case electric configuration. The test methods, acceptance criteria and test results are documented in the Design History File of Smartxide Touch.
- Verification of new covers design specifications for Smartxide Punto. -
Conclusion:
We can conclude that the DEKA Smartxide family of laser systems is substantially equivalent to the predicate device.
Additional Information:
None