(105 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies. The device is described as a laser with interchangeable handpieces activated by a footswitch, which is a standard description for a non-AI/ML laser device.
Yes
The device is used for incision, excision, ablation, vaporization, and coagulation of body soft tissues for surgical and aesthetic applications, as well as for various periodontal applications, all of which fall under therapeutic uses.
No
The device is a surgical laser intended for incision, excision, ablation, vaporization, and coagulation of body soft tissues. It is used for therapeutic and aesthetic applications, not for diagnosing medical conditions.
No
The device description clearly states it is a 10,600 nm CO2 laser device with a maximum power of 40W, delivering output through interchangeable handpieces activated by a footswitch. This describes a physical hardware device, 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 (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The SmartXide UltraSpeed laser is a surgical device that directly interacts with body tissues in vivo (within the body) for procedures like incision, excision, ablation, and coagulation. It is used for surgical and aesthetic applications.
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's body.
- Device Description: The description details a laser device used for delivering energy to tissue, not for analyzing samples.
Therefore, the SmartXide UltraSpeed laser falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SmartXide UltraSpeed laser is incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and aesthetic applications.
Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:
- · Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
- · Biopsies
- Frenectomy, Frenum release
- Gingivoplasty
- Papillectomy
- · Vestibuloplasty
- · Hyperplasia
- Operculectomy
- · Drainage (abscess)
- · Flap surgerv
- · Fibroma (nonmalignant tumor, mucosa, tongue)
- Epulis
- · Aphthous ulcers
- · Removal of soft tissue, cysts, and tumors
- · Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).
Product codes
GEX
Device Description
DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
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
medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology
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)
Clinical Performance Data: None
Non-Clinical Performance Data: Non clinical Performance Tests according to the following standards have been performed:
- ISO 10993-1 Fourth edition 2009-10-15 biological evaluation of medical devices - part 1: evaluation and testing within a risk management process
- IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment part 1-2: general . requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- IEC 60601-2-22 Edition 3.1 2012-10, 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 Edition 2.0 2007-03, safety of laser products part 1: equipment classification, ● and requirements.
Tests results demonstrated compliance to related standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
November 17, 2017
ELEN Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, 50041 Italy
Re: K172363
Trade/Device Name: Deka Smartxide Ultraspeed 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):
1
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 -$3
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Device Name
SmartXide UltraSpeed
Indications for Use (Describe)
The SmartXide UltraSpeed laser is incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and aesthetic applications.
Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:
- · Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
- · Biopsies
- Frenectomy, Frenum release
- Gingivoplasty
- Papillectomy
- · Vestibuloplasty
- · Hyperplasia
- Operculectomy
- · Drainage (abscess)
- · Flap surgerv
- · Fibroma (nonmalignant tumor, mucosa, tongue)
- Epulis
- · Aphthous ulcers
- · Removal of soft tissue, cysts, and tumors
· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
DEKA SmartXide UltraSpeed
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 02, 2017
Device Trade Name:
DEKA SmartXide UltraSpeed
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:
DEKA Smart US 20D/UltraSpeed and Smart Clinic laser (K081181).
Device Description:
DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
Intended Use:
SmartXide UltraSpeed laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications. Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:
· Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
· Biopsies
- Frenectomy, Frenum release
4
K172363 Page 2 of 3
- Gingivoplasty
- Papillectomy
- Vestibuloplasty
- · Hyperplasia
- · Operculectomy
- · Drainage (abscess)
- · Flap surgery
- · Fibroma (nonmalignant tumor, mucosa, tongue)
- Epulis
- · Aphthous ulcers
- · Removal of soft tissue, cysts, and tumors
- · Laser assisted new attachment procedure (cementum-mediated periodontal ligament newattachment to the root surface in the absence of long junctional epithelium).
Substantial equivalence discussion:
The DEKA SmartXide UltraSpeed is substantially equivalent to the Smart US 20D/UltraSpeed and Smart Clinic laser (K081181).
| Device Trade Name | DEKA SmartXide UltraSpeed | Predicate Device
K081181
Smart US 20D/UltraSpeed
and Smart Clinic lasers |
|----------------------|------------------------------------------|-----------------------------------------------------------------------------------|
| Laser Type | CO2 | CO2 |
| Wavelength (nm) | 10600 | 10600 |
| Power (Watts) | 40 | Smart US20D/Ultraspeed: 25
Smart Clinic: 50 |
| Spot Sizes
(mm) | 0.2; 0.4 | 0.2; 0.4 |
| Exposure | Continuous, single and repeated
pulse | Continuous, single and
repeated pulse |
| Pulse width (ms) | 0.02-70 | 0.2-80 |
| Repetition rate (Hz) | 5-100 | 5-100 |
| Aiming beam | Diode laser, 4.0 mW | Diode laser, 1.0 mW |
The DEKA SmartXide UltraSpeed 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:
5
K172363 Page 3 of 3
Non clinical Performance Tests according to the following standards have been performed:
- ISO 10993-1 Fourth edition 2009-10-15 biological evaluation of medical devices - part 1: evaluation and testing within a risk management process
- IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment part 1-2: general . requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
- IEC 60601-2-22 Edition 3.1 2012-10, 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 Edition 2.0 2007-03, safety of laser products part 1: equipment classification, ● and requirements.
Tests results demonstrated compliance to related standards.
Conclusion:
Base on substantially equivalence discussion and on non Clinical Performance data, we can conclude that the DEKA SmartXide UltraSpeed laser system is substantially equivalent to the predicate device .
Additional Information:
None