(105 days)
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.
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.
This document is an FDA 510(k) premarket notification for the DEKA SMARTXIDE TOUCH laser system. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets said criteria related to clinical performance.
Here's a breakdown of why the requested information cannot be fully provided from this document:
- Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" (page 4). This means no clinical study was presented to demonstrate the device's effectiveness in a clinical setting against specific acceptance criteria.
- Substantial Equivalence: The FDA's 510(k) pathway often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies for every device. For devices like lasers that perform well-understood physical actions (ablation, vaporization), non-clinical testing for safety and electrical performance is often sufficient if the device operates similarly to existing ones.
Therefore, most of your specific questions cannot be answered based on the provided text. I will provide what can be gleamed from the document related to "acceptance criteria" through non-clinical testing.
Acceptance Criteria and Study for DEKA SMARTXIDE TOUCH
Based on the provided FDA 510(k) summary, the device's acceptance criteria are primarily related to non-clinical performance data and conformance to established international standards for medical electrical equipment and laser safety. There is no clinical performance data or associated acceptance criteria presented in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Data | Conformance to IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) | The DEKA SMARTXIDE TOUCH was tested for standards conformance with IEC 60601-1. (Implies compliance was achieved to meet this criterion for substantial equivalence). |
| Conformance to IEC 60601-1-2 (Medical electrical equipment - Collateral standard: Electromagnetic compatibility - Requirements and tests) | The DEKA SMARTXIDE TOUCH was tested for standards conformance with IEC 60601-1-2. (Implies compliance was achieved). | |
| Conformance to IEC 60601-2-22 (Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment) | The DEKA SMARTXIDE TOUCH was tested for standards conformance with IEC 60601-2-22. (Implies compliance was achieved). | |
| Conformance to IEC 60825-1 (Safety of laser products - Equipment classification and requirements) | The DEKA SMARTXIDE TOUCH was tested for standards conformance with IEC 60825-1. (Implies compliance was achieved). | |
| (Implied) Performance Equivalence to Predicate Device (Non-Clinical) | Operates with similar technical specifications and function for its intended use as the AFFIRM CO2 and AFFIRM CO2 HP laser systems (K081424). | The table on page 4 demonstrates comparable technical specifications: - Laser Type: CO2 (matches predicate) - Wavelength: 10.6μm (matches predicate) - Max Power: 40W (within range of predicate: 25W, 60W HP) - Handpieces Spot Sizes: 0.2 mm, 0.4 mm (matches predicate) - Pulse Duration: 0.02 to 70 ms (comparable to predicate: 0.2 to 80 ms) - Pulse Rep Rate: 5 to 100 Hz (matches predicate) - Scanner Spot size: 350μm (matches predicate) - Scanner Focal length (EFL): 100mm (matches predicate) The document states: "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." |
Note: The "reported device performance" for the standards conformance is an interpretation that the device met these standards, as non-conformance would likely prevent 510(k) clearance.
2. Sample size used for the test set and the data provenance
- Test set sample size: Not applicable for a clinical test set as no clinical performance data was provided. For non-clinical (engineering/safety) testing, the "sample size" typically refers to the device itself and its components, which are tested against relevant standards. The provenance for these tests would be internal laboratory testing by the manufacturer or accredited testing bodies.
- Data provenance: Not explicitly stated beyond "The DEKA SMARTXIDE TOUCH was tested for standards conformance...". This likely refers to in-house testing by the manufacturer or third-party labs contracted by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable as no clinical study with a "ground truth" established by human experts was conducted or referenced in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable as no clinical study requiring adjudication was conducted or referenced.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a laser surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for clinical performance. For non-clinical testing, the "ground truth" would be the specifications and requirements of the international standards (e.g., specific electrical safety limits, laser output parameters).
8. The sample size for the training set
- Not applicable as no clinical training set was used.
9. How the ground truth for the training set was established
- Not applicable as no clinical training set was used.
In summary, the provided document focuses on demonstrating substantial equivalence to an existing lawfully marketed device through comparison of technical specifications and conformance to recognized safety and electrical standards. It explicitly states there is no clinical performance data. Therefore, the questions related to clinical trials, expert ground truth, and AI performance are not addressed by this FDA submission.
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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):
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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/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.
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Substantial equivalence discussion:
The DEKA SMARTXIDE TOUCH is substantially equivalent to the AFFIRM CO2 and AFFIRM CO2 HP laser systems (K081424).
| Device TradeName | DEKA SMARTXIDETOUCH | Predicate DeviceAFFIRM CO2 andAFFIRM CO2 HPK081424 |
|---|---|---|
| Laser Type | CO2 | CO2 |
| Wavelength | 10.6μm | 10.6μm |
| Max Power | 40W | 25W60W (HP) |
| HandpiecesSpot 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 Spotsize | 350μm | 350μm |
| Scanner Focallength (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
§ 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.