(23 days)
Not Found
No
The summary describes a CO2 laser device and its modifications, focusing on hardware and software updates for control and user interface. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is indicated for incision, ablation, vaporization, and coagulation of body soft tissues, which are therapeutic actions. It is used in various medical and surgical specialties for treatment purposes, including ablative skin resurfacing.
No
Explanation: The device is described as a surgical laser used for incision, ablation, vaporization, and coagulation of soft tissues, and for skin resurfacing. Its function is to treat tissues, not to diagnose conditions.
No
The device description clearly states it is a 10.6um carbon dioxide laser (CO2 laser), which is a hardware device. The modifications mentioned are also related to the physical components of the device and its scanning unit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "carbon dioxide laser (CO2 laser)" used for "surgical treatment of soft tissues". This further reinforces its use in surgical procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used to directly treat tissues within the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues including intraoral 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)
Electrical safety and electromagnetic compatibility (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 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".
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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).
2
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
3
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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4
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).
5
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 Device
SMARTXIDE PRO | Predicate Device
Smart CO2 (SmartXide,
Smart US20D) Lasers with
DOT scanner (K072159) | Comment |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Indications for Use | The SmartXide PRO is a
medical device indicated for
incision, excision, ablation,
vaporization and coagulation
of body soft tissues including
intraoral tissues, in medical
specialities including
aesthetic (dermatology and
plastic surgery),
otolaryngology (ENT),
gynaecology, neurosurgery,
dental and oral surgery and
genitourinary surgery. | The Smart CO2 (SmartXide
and Smart US20D) Lasers
with DOT scanner are
indicated for incision,
excision, 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. | Identical |
| Device Trade Name | Proposed Device | Predicate Device | Comment |
| | SMARTXIDE PRO | Smart CO2 (SmartXide,
Smart US20D) Lasers with
DOT scanner (K072159) | |
| | The use with the scanning
unit is indicated for ablative
skin resurfacing. | The use with this scanning
unit is indicated for ablative
skin 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 identical
The difference does
not affect safety and
effectiveness of the
device |
| 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 | Subset
The difference does
not affect safety and
effectiveness of the
device |
| Device Trade Name | Proposed Device
SMARTXIDE PRO | Predicate Device
Smart CO2 (SmartXide,
Smart US20D) Lasers with
DOT scanner (K072159) | Comment |
| Pulse Rate
(Pulse/Second) | 5 - 100 Hz | 5 - 100 Hz | Identical |
| Scanning area | Variable based on the
pattern selected | Variable based on the
pattern selected | Identical |
6
7
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.