(21 days)
Not Found
No
The description focuses on the laser technology, articulated arm, and scanning units for controlled energy delivery. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a laser system used for various medical procedures such as incision, excision, ablation, vaporization, and coagulation of body soft tissue, which are all therapeutic actions.
No
The device is described as a surgical laser used for incision, excision, ablation, vaporization, and coagulation of body soft tissue. These are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines significant hardware components including a CO2 laser, articulated arm, and scanning units, and provides physical specifications (weight, size, electrical requirements). While software verification and validation are mentioned, the core of the device is hardware-based.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a CO2 laser used for surgical procedures like incision, excision, ablation, vaporization, and coagulation of body soft tissue. It directly interacts with the patient's body.
- Intended Use: The intended use describes surgical procedures performed on the patient, not laboratory testing of samples.
- Device Description: The description focuses on the physical components of the laser system and its delivery mechanism, not on reagents, test strips, or analytical processes typical of IVDs.
Therefore, this device is a surgical laser, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GEX
Device Description
The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. 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 device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing.
The overall weight is approximately 62 kg and the sizes are 42 x 122 x 54cm (W x H x D) with folded articulated arm.
Electrical requirements: 100-230V ~ 50/60Hz, 1200VA (max).
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
Clinical Performance Data: None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the SMARTXIDE TETRA PRO device, according to the following standards:
- ANSI AAMI 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 - 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.
Software Validation and Verification Testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions".
Key Metrics
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.
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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 square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
March 12, 2024
El.En. S.p.A. Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50141 Italy
Re: K240497
Trade/Device Name: Smartxide Tetra 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 20, 2024 Received: February 20, 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 (OS) 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 medical devices and radiation-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 -S Tanisha L. Hithe -S 2024.03.12 09:07:47 -04'00'
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
Submission Number (if known)
Device Name
SMARTXIDE TETRA PRO
Indications for Use (Describe)
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.
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 TETRA PRO- Special 510(k)
510(k) Submission Number: K240497
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:
February 20th, 2024
Device Trade Name: SMARTXIDE TETRA PRO
Common Name: Medical Laser
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument for use in General and Plastic and in Dermatology
Laser Surgical Instrument for use in General and Plastic and in Derma
Regulatory Class: Class II
Product Code: GEX
Predicate Device:
DEKA Smartxide family (Smartxide Touch, Smartxide Punto) (K180193)
Device Description:
The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum power. 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
5
along its axis regardless of the arm orientation. The device may be used in combination with scanning units in order to achieve greater predictability and reproducibility. The use with the scanning units is indicated for layer-by-layer char-free ablation, enhancing the safety of the treatment with more uniform, accurate and controllable impact such as ablative skin resurfacing.
The overall weight is approximately 62 kg and the sizes are 42 x 122 x 54cm (W x H x D) with folded articulated arm.
Electrical requirements: 100-230V ~ 50/60Hz, 1200VA (max).
Indications for 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.
6
Comparison with The Predicate Device:
| Device Trade Name | Subject Device
SMARTXIDE TETRA PRO | Predicate Device
K180193
DEKA Smartxide family (Smartxide Touch,
Smartxide Punto) | Comment |
|----------------------------|---------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------|
| Laser Type | CO2 | CO2 | Identical |
| Wavelength | 10.6μm | 10.6μm | Identical |
| Max Power | 40W | 30W, 50W (Smartxide Punto)
60W (Smartxide Touch) | In the range of
predicate device |
| Handpieces Spot Sizes | 0.2 mm, 0.4 mm | 0.2 mm, 0.4 mm | Identical |
| Pulse Duration | 0.02 to 70 ms | 0.02 to 70 ms | Identical |
| Pulse Rep Rate | 5 to 100 Hz | 5 to 100 Hz | Identical |
| Scanner Spot size | 350μm | 350μm | Identical |
| Scanner Focal length (EFL) | 100 mm | 100 mm | Identical |
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Clinical Performance Data:
None
Non-Clinical Performance Data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the SMARTXIDE TETRA PRO device, according to the following standards:
. ANSI AAMI ES60601-1Medical 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 - 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.
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 Submissions for Device Software Functions".
Conclusion:
On the basis of the comparison with the predicate device and on the non-clinical performance data, we can conclude that SMARTXIDE TETRA PRO is deemed to be substantially equivalent to the predicate device for the proposed indications for use.
Additional Information:
None