(259 days)
No
The summary describes a laser system with standard components and functionality, and there is no mention of AI or ML terms, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used for medical procedures like incision, excision, and ablation of body tissues across various medical specialties, which are therapeutic actions.
No
The device is described as a laser for incision, excision, ablation, vaporization, and coagulation of body soft tissues, which are all therapeutic procedures, not diagnostic ones. Its "Intended Use" clearly lists surgical applications.
No
The device description clearly outlines a physical laser system with hardware components (articulated arm, delivery accessory, footswitch) and significant weight and dimensions, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser used for surgical procedures on body soft tissues. It directly interacts with the patient's body for incision, excision, ablation, vaporization, and coagulation.
- Intended Use: The intended use is for various surgical specialties, all of which involve direct treatment of the patient.
The device's function and intended use are entirely focused on surgical intervention on living tissue, not on analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The SmartXide² laser is indicated for incision, excision, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Product codes
GEX
Device Description
DEKA SmartXide² is a laser with a wavelength of 10600 nm having a maximal power of 60 Watts. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end.
Laser activation is by footswitch. Overall weight of the laser is 95 Kg, and the size is 210 x 59 x 56 cm (H x W x D).
Electrical requirement is 100-120 Vac 15A, 50-60 Hz, single phase
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
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)
Animal study on sheep's skin was conducted to show the comparative effects of Smartxide laser and Affinity lasers on thermal lesion depth and width as well as ablation depth and width.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DEKA SmartXide² Laser System (K113504), Cynosure CO2 Laser (K081424)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
Electronic Engineering S.p.A. Mr. Paolo Peruzzi Regulatory Affairs Manager 50041 Calenzano (FI) Italy
Re: K133895 Trade/Device Name: DEKA SmartXide2 Laser System 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 4, 2014 Received: August 6, 2014
Dear Mr. 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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- 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) K133895
Device Name DEKA Smartxide2
Indications for Use (Describe)
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Neil R Ogden -S 2014.09.04 14:57:31 -04'00
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510(K) Summary
| Submitter: | El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI), Italy |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paolo Peruzzi
Regulatory Affairs Manager
Phone: +39-055-882-6807
Email: p.peruzzi@elen.it |
| Date Summary Prepared: | December 18, 2013 |
| Device Trade Name: | DEKA SmartXide² Laser System |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, Surgical, Powered, Laser
79-GEX
21 CFR 878.4810 |
| Equivalent Device:
Affirm | DEKA SmartXide² Laser System (K113504) and Cynosure
CO2 Laser (K081424) |
| Device Description: | DEKA SmartXide² is a laser with a wavelength of 10600 nm having a maximal power of 60 Watts. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end.
Laser activation is by footswitch. Overall weight of the laser is 95 Kg, and the size is 210 x 59 x 56 cm (H x W x D).
Electrical requirement is 100-120 Vac 15A, 50-60 Hz, single phase |
| Intended Use: | The SmartXide² laser is indicated for incision, excision, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing. |
| | Comparison: The SmartXide² laser has the same indications for use, the same principle of operation, the same wavelength and the same pulse energy range as the predicate devices. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
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| Animal Study Data : | Animal study on sheep's skin was conducted to show the
comparative effects of Smartxide laser and Affinity lasers on
thermal lesion depth and width as well as ablation depth and
width. |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion:
intended | The SmartXide 2 laser is a safe and effective device for the |