(278 days)
The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)
The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The DEKA Smartperio device consists of: An AC/DC power supply unit CPU controller LASER source Cooling system User interface with LCD touch screen Beam delivery system Laser activation is controlled by footswitch.
The provided document is a 510(k) summary for the DEKA SmartPerio laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available, noting where information is absent.
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria typically seen in performance studies for new medical devices, nor does it report specific device performance metrics in detail beyond a comparison of technical specifications with a predicate device.
Instead, the document's primary "acceptance criteria" appear to be meeting electrical safety and electromagnetic compliance standards, as well as demonstrating substantial equivalence to a legally marketed predicate device.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (Summary from comparison) |
|---|---|
| Substantial Equivalence: | |
| - Indications for use | DEKA SmartPerio's indications are a subset of the predicate device's indications. |
| - Technological Characteristics (Laser Wavelength, Energy per Pulse, Pulses per Second, Pulse duration, Average Power, Aiming Beam wavelength, Aiming beam power, Delivery system, Power Requirements, Weight, Dimensions) | Most are identical or similar, with differences noted as not affecting safety and effectiveness. |
| Safety Standards Compliance: | |
| - AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, cl:2009/(R)2012 and a2:2010/(R)2012 (Medical Electrical Equipment) | Compliant |
| - IEC 60601-1-2 Ed. 4 (Electromagnetic disturbance) | Compliant |
| - IEC60601-2-22 Ed 3.1 (Laser equipment safety) | Compliant |
| - IEC 60825-1 Ed. 3.0 (Safety of laser products) | Compliant |
| Biocompatibility: | Subject device relies on biocompatibility of already FDA-cleared accessories. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" only refers to compliance with electrical and laser safety standards. This implies there was no "test set" of patient data in the sense of a clinical trial or performance study. The data provenance and sample size for such a test set are therefore not applicable or not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical test set or ground truth adjudication using experts is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set or ground truth adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The DEKA SmartPerio is a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The DEKA SmartPerio is a physical medical device (laser surgical instrument), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical performance study requiring a "ground truth" (e.g., for diagnostic accuracy) was performed or reported.
8. The sample size for the training set
Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm.
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August 23, 2021
El.En. Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, FI 50041 Italy
Re: K203396
Trade/Device Name: Deka Smartperio 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: NVK, GEX Dated: August 2, 2021 Received: August 6, 2021
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. 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 located 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.
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
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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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). 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-device-advice-comprehensive-regulatoryassistance/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,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K203396
Device Name DEKA SMARTPERIO
| Indications for Use (Describe) | The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.) |
|---|---|
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) Summary
DEKA SMARTPERIO
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 2, 2021
Device Trade Name:
DEKA SMARTPERIO
Common Name:
Nd:YAG Pulsed Laser
Classification Name:
Laser surgical instrument for use in general and plastic surgery and in dermatology
Product Code :
GEX
Classification Number: 21 CFR 878.4810
Equivalent Device:
Millennium Dental Technologies, Inc : PerioLase Dental Laser (K030290) (Primary predicate)
Device Description:
The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip.
The DEKA Smartperio device consist s of:
- An AC/DC power supply unit
- CPU controller
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K203396
- LASER source
- . Cooling system
- . User interface with LCD touch screen
- . Beam delivery system
Laser activation is controlled by footswitch.
Electrical specifications are:
115V ~ single phase, 50/60 Hz, Absorbed electric power1840 VA (max)
Indications for Use:
The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system.
The device is intended to be used in dentistry.
The following are the oropharyngeal indications for use:
Abscess Incision and Drainage
Apthous Ulcers Treatment
Biopsies Excision and Incision
Crown lengthening
Hemostatic assistance
Fibroma Removal
Frenectomy
Frenotomy
Gingival Incision and Excision
Gingivectomy
Gingivoplasty
Operculectomy
Oral Papillectomy
Tissue retraction for Impression
Vestibuloplasty.
Selective ablation of enamel (first degree) caries
Exposure of unerupted / partially erupted teeth
Implant recovery
Lesion (tumor) removal
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Leukoplakia
Pulpotomy
Pulpotomy as adjunct to root canal therapy
Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility.
Laser assisted new attachment procedure (cementum-mediated periodontal ligament newattachment to the root surface in the absence of long junctional epithelium.)
Comparison with the predicate device:
DEKA SMARTPERIO is substantially equivalent to the Millennium Dental Technologies, Inc PerioLase Dental Laser System (K030290):
| Proposed 510(k) Device | Primary Predicate Device | Comparison | |
|---|---|---|---|
| DeviceTradeName | DEKA SMARTPERIOK203396 | Millennium Dental Technologies,Inc : PerioLase Dental LaserK030290 | |
| Indications for use | Intraoral procedures: soft tissuedental, general, oral maxillofacial,and cosmetic surgery.Intended for ablating, incising,excising, vaporization andcoagulation of soft tissues using acontact fiber-optic delivery system.The device is intended to be used indentistry.The following are the oropharyngealindications for use:Abscess Incision and DrainageApthous Ulcers TreatmentBiopsies Excision and IncisionCrown lengthening | Intraoral soft tissue dental, general,oral maxillo-facial and cosmeticsurgery.Intended for ablating, incising,excising, vaporization andcoagulation of soft tissues using acontact fiber optic delivery system.The device will be used in thefollowing areas: general andcosmetic dentistry, otolaryngology,arthroscopy, gastroenterology,general surgery, dermatology &plastic surgery, neurosurgery,gynecology, urology, ophthalmologyand pulmonary surgery.The following are the oropharyngealindications for use:Abscess Incision and DrainageApthous Ulcers TreatmentBiopsies Excision and IncisionCrown lengthening | Indications for use ofproposed device are a subset of indications for useof the predicate device.Proposed device is notintended forotolaryngology,arthroscopy,gastroenterology, generalsurgery, dermatology &plastic surgery,neurosurgery,gynecology,urology,ophthalmology andpulmonary surgery. |
| Hemostatic assistance | Hemostatic assistance | ||
| Fibroma Removal | Fibroma Removal | ||
| Frenectomy | Frenectomy | ||
| Frenotomy | Frenotomy | ||
| Gingival Incision and Excision | Gingival Incision and Excision | ||
| Gingivectomy | Gingivectomy | ||
| Gingivoplasty | Gingivoplasty | ||
| Operculectomy | Operculectomy | ||
| Oral Papillectomy | Oral Papillectomy | ||
| Tissue retraction for Impression | Tissue retraction for Impression | ||
| Vestibuloplasty. | Vestibuloplasty. | ||
| Selective ablation of enamel (firstdegree) caries | Selective ablation of enamel (firstdegree) caries | ||
| Exposure of unerupted / partiallyerupted teeth | Exposure of unerupted / partiallyerupted teeth | ||
| Implant recovery | Implant recovery | ||
| Lesion (tumor) removal | Lesion (tumor) removal | ||
| Leukoplakia | Leukoplakia | ||
| Pulpotomy | Pulpotomy | ||
| Pulpotomy as adjunct to root canaltherapy | Pulpotomy as adjunct to root canaltherapy | ||
| Removal of filling material such asgutta percha or resin as adjuncttreatment during root canalretreatment Sulcular debridement(removal of diseased or inflamed softtissue in the periodontal pocket) toimprove clinical indices includinggingival index, gingival bleedingindex, probe depth, attachment leveland tooth mobility tooth mobility. | Removal of filling material such asgutta percha or resin as adjuncttreatment during root canalretreatment Sulcular debridement(removal of diseased or inflamed softtissue in the periodontal pocket) toimprove clinical indices includinggingival index, gingival bleedingindex, probe depth, attachment leveland tooth mobility tooth mobility. | ||
| Laser assisted new attachmentprocedure (cementum-mediatedperiodontal ligament new-attachment to the root surface in theabsence of long junctionalepithelium.) | Laser assisted new attachmentprocedure (cementum-mediatedperiodontal ligament new-attachment to the root surface in theabsence of long junctionalepithelium.) |
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| Product code | GEX | GEX | Identical |
|---|---|---|---|
| Laser Wavelength | 1064 nm | 1064 nm | Identical |
| Energy per Pulse | 20-300 mJ | 20-300 mJ | Identical |
| Pulses per Second | 10-100 Hz | 10-100 Hz | Identical |
| Pulse duration | 100-650 µs | 100-650 µs | Identical |
| Average Power | 0.2-6W | 0.2-6W | Identical |
| AimingBeamwavelength | 635 nm | 635 nm | Identical |
| Power of Aimingbeam | 3 mW | 5mW | Similar, difference inaiming beam power doesnot affect safety andeffectiveness. |
| Delivery system | optical fiber (cleared with K124003,K200234) guided to the target tissuewith the aid of handpiece and tip(cleared with K952006) | optical fiber guided to the targettissue with the aid of handpiece andtip | Similar delivery systemaccessories. Subjectdevice uses already FDAcleared accessories, whilefor predicate device theyare included in the deviceFDA clearance. Thisdifference does not affectsafety and effectiveness. |
| PowerRequirements | 115Vac, 50/60 Hz, 16Amps | 110-120 VAC, 50/60 Hz, 8 Amps,Single phase; 200 - 240 VAC, 50 Hz, 4Amps | Both devices had powerrequirements consistentwith US standards.Difference in power inputcurrent does not affectsafety and effectiveness. |
| Weight | 38 Kg | 45 lbs. [20.4 Kgs]/38 lbs. [17.2 Kgs] | Difference in weight doesnot affect safety andeffectiveness. |
| Dimensions | 68x23x65cm | 11" (width) x 19" (depth) x 25"(height) | Difference in dimensionsdoes not affect safetyand effectiveness. |
| Biocompatibility | Yes- the only parts that can get incontact with patient have alreadybeen cleared by FDA (K124003,K200234, K952006) | YES (predicate device cleared byFDA) | Subject device relies onbiocompatibility ofaccessories alreadycleared by FDA; no dataavailable from predicatedevice |
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Clinical Performance Data:
None
Non-Clinical Performance Data:
The DEKA SMARTPERIO has been tested and found in compliance with following standards:
. AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, cl:2009/(R)2012 and a2:2010/(R)2012 – Medical Electrical Equipment – Part 1: general requirements for basic safety and essential performance.
. IEC 60601-1-2 Ed. 4 - Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbance – Requirements and tests.
. IEC60601-2-22 Ed 3.1 Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment.
. IEC 60825-1 Ed. 3.0 – Safety of laser products – Part 1 : Equipment classification, and requirements.
Conclusion:
Based on the comparison of indications for use and the technological characteristics, and on the outcome of non-clinical performance data provided , we can conclude that the DEKA SMARTPERIO is as safe, as effective, and performs as well as the legally marketed predicate device.
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.