(23 days)
The SMARTXIDE PRO is a medical device indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties 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.
SmartXide PRO is a 10.6um carbon dioxide laser (CO2 laser), which is highly absorbed by water. Since tissue is comprised mostly of water, this invisible wavelength is highly effective in the surgical treatment of soft tissues. Moreover, SmartXide PRO device can be equipped with a scanning unit, called HiScan DOT, which can be connected to the arm to provide high performance in specific fields. The scanning unit is intended for fractionated skin resurfacing or traditional skin resurfacing. The modifications to the device consist of a restyling of the device (chassis, cover plastic, dimensions, weight, plastic cover, CPU and GUI), a restyling of HiScan DOT unit. The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.
The provided text is a 510(k) summary for the SmartXide PRO device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a rigorous clinical study with novel performance metrics.
Therefore, the document does not contain the detailed information typically found in a clinical study report that directly addresses acceptance criteria and device performance in the way you've outlined. Specifically:
- There is no table of acceptance criteria and reported device performance. The "Performance Data" section only mentions electrical safety, EMC, and software validation, which are technical standards tests, not clinical performance metrics against specific acceptance criteria for efficacy or diagnostic accuracy.
- No sample size for a test set, data provenance, or details on ground truth establishment are provided because a clinical performance study (e.g., an MRMC study or standalone algorithm performance study) was not conducted or required for this type of submission (a Special 510(k) for device modifications where the intended use has not changed).
- Information on experts, adjudication methods, MRMC studies, or standalone performance is absent for the same reason.
- No training set size or ground truth establishment for a training set is mentioned, as this is related to AI/ML model development, which is not described nor a primary focus of this device's submission.
The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device based on identical (or nearly identical) indications for use and technological characteristics. The "Substantial equivalence discussion" table (part of section {5}) is the primary "proof" for this submission, showing feature-by-feature comparison to the predicate device.
Given the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study design as they relate to a clinical performance study. The document focuses on regulatory compliance through substantial equivalence, not on establishing a new performance claim for the device against pre-defined clinical acceptance criteria.
If the request implies that I should infer what such a study would look like for a hypothetical AI/ML device where the provided text is a template, that is outside the scope of merely extracting information from the given document.
In summary, the provided document does not contain the information required to answer your prompt because it is a 510(k) summary demonstrating substantial equivalence, not a report of a clinical performance study against specific acceptance criteria.
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March 20, 2024
El.En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50141 Italy
Re: K240537
Trade/Device Name: Smartxide Pro 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: February 21, 2024 Received: February 26, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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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 (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tanisha L. Hithe -Tanisha L. s 2024.03.20 Hithe -S 13:13:42 -04'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240537
Device Name SMARTXIDE PRO
Indications for Use (Describe)
The SMARTXIDE PRO is a medical device indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties 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
SmartXide PRO - Special 510(k)
K240537
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:
March 18, 2024
Device Trade Name: SMARTXIDE PRO
Manufacturer:
DEKA M.E.L.A. srl Via Baldanzese, 17 50041 Calenzano (FI), Italy
Common Name:
Laser for Surgery and Dermatology
Regulation Number:
21 CFR 878.4810
Regulation Name:
Laser surgical instrument for use in General and Plastic surgery and in Dermatology
Regulation Class:
Class II
Product Code: GEX
Predicate Devices:
Smart CO2 (SmartXide, Smart US20D) Lasers with DOT scanner (K072159).
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Device Description:
SmartXide PRO is a 10.6um carbon dioxide laser (CO2 laser), which is highly absorbed by water. Since tissue is comprised mostly of water, this invisible wavelength is highly effective in the surgical treatment of soft tissues.
Moreover, SmartXide PRO device can be equipped with a scanning unit, called HiScan DOT, which can be connected to the arm to provide high performance in specific fields.
The scanning unit is intended for fractionated skin resurfacing or traditional skin resurfacing.
The modifications to the device consist of a restyling of the device (chassis, cover plastic, dimensions, weight, plastic cover, CPU and GUI), a restyling of HiScan DOT unit.
The intended use of the modified device, as described in the labelling has not changed as a result of the modifications. Labelling itself has been updated also to include general improvements that have been implemented since predicate device clearance and considered as minor changes.
Intended Use:
The SmartXide PRO is a medical device indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties 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 SmartXide PRO device is substantially equivalent to the Smart CO2 (SmartXide, Smart US20D) lasers with DOT scanner (K072159)
| Device Trade Name | Proposed DeviceSMARTXIDE PRO | Predicate DeviceSmart CO2 (SmartXide,Smart US20D) Lasers withDOT scanner (K072159) | Comment |
|---|---|---|---|
| Indications for Use | The SmartXide PRO is amedical device indicated forincision, excision, ablation,vaporization and coagulationof body soft tissues includingintraoral tissues, in medicalspecialities includingaesthetic (dermatology andplastic surgery),otolaryngology (ENT),gynaecology, neurosurgery,dental and oral surgery andgenitourinary surgery. | The Smart CO2 (SmartXideand Smart US20D) Laserswith DOT scanner areindicated for incision,excision, ablation,vaporization and coagulationof body soft tissues includingintraoral tissues, in medicalspecialties includingaesthetic (dermatology andplastic surgery),otolaryngology (ENT),gynaecology, neurosurgery,dental and oral surgery andgenitourinary surgery. | Identical |
| Device Trade Name | Proposed Device | Predicate Device | Comment |
| SMARTXIDE PRO | Smart CO2 (SmartXide,Smart US20D) Lasers withDOT scanner (K072159) | ||
| The use with the scanningunit is indicated for ablativeskin resurfacing. | The use with this scanningunit is indicated for ablativeskin resurfacing. | ||
| Laser Type | CO2 | CO2 | Identical |
| Wavelength(μm) | 10.6 | 10.6 | Identical |
| Power(Watt) | 30 W | 30 W (SmartXlde)25 W (Smart US20D) | Identical |
| Aiming beam | 635 nm, 1mW | 635-670 nm, 3 mW | Almost identicalThe difference doesnot affect safety andeffectiveness of thedevice |
| Handpiece Spot Sizes(millimiter diameter) | 0.2 - 0.4 mm | 0.2 - 0.4 mm | Identical |
| Pulse Width(milliseconds) | 1 - 80 ms | 0.2 - 80 ms | SubsetThe difference doesnot affect safety andeffectiveness of thedevice |
| Device Trade Name | Proposed DeviceSMARTXIDE PRO | Predicate DeviceSmart CO2 (SmartXide,Smart US20D) Lasers withDOT scanner (K072159) | Comment |
| Pulse Rate(Pulse/Second) | 5 - 100 Hz | 5 - 100 Hz | Identical |
| Scanning area | Variable based on thepattern selected | Variable based on thepattern selected | Identical |
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Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the SmartXide DOT device, according to the following standards:
- AAMI/ANSI ES60601-1 Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance.
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- IEC 60601-2-22 Medical electrical equipment Pat 2-22: Particular requirements for basic ● and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
- IEC 60825-1 Safety of laser products Part 4: Equipment classification and requirements. ●
Software Validation and Verification Testing
Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submission for Device Software Functions".
Conclusion:
Based on the comparison of indication for use and the technological characteristics, we can conclude that SmartXide PRO device is safe, as effective, and performs as well as the legally marketed predicate device (K072159).
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.