(112 days)
No
The summary describes a laser device with increased power and focuses on its intended use and safety testing, with no mention of AI or ML.
Yes
The device is intended to perform surgical procedures such as incision, excision, and coagulation of soft tissues, as well as therapeutic treatments for conditions like abscesses, ulcers, and periodontitis, which directly aim to treat or alleviate a medical condition.
No
The device is described as a laser system for ablating, incising, excising, vaporization and coagulation of soft tissues, as well as for various surgical procedures. It is not mentioned anywhere that the device is used to diagnose diseases or conditions.
No
The device description explicitly states it is a Nd:YAG laser device that delivers laser through an optical fiber, handpiece, and tip, indicating it is a hardware-based medical device.
Based on the provided information, the DEKA SmartPerio system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- The DEKA SmartPerio system is a laser device intended for performing surgical procedures directly on soft tissues within the mouth. It is used for actions like ablating, incising, excising, vaporization, and coagulation.
The intended use and device description clearly indicate that this is a surgical tool used for direct intervention on the patient's body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, 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. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)
Product codes
NVK, GEX
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 modification to the device consists in the increasing of the average output power from 6W to 10W. The intended use of the modified device, as described in the labelling, has not changed as a result of the modifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral soft tissue (oropharyngeal)
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
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the modified DEKA SMARTPERIO 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.
Additional tests were conducted on the modified DEKA SMARTPERIO, according to the following standards: 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.
Conclusion: Based on the comparison of indications for use and the technological characteristics, we can conclude that the modified DEKA SMARTPERIO is as safe, as effective, and performs as well as the unmodified legally marketed predicate device (K203396).
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name in a sans-serif font. The logo is simple and professional, conveying the agency's authority and mission.
March 11, 2022
El.En Electronic Engineering Spa Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano. Florida 50041
Re: K213658
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: February 7, 2022 Received: February 10, 2022
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name DEKA SMARTPERIO
Indications for Use (Describe)
surgery. The DEKA SmartPerio is intended for ablating, incising, 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. 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 system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic
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.
3
K213658
510(K) Summary
DEKA SMARTPERIO – Special 510(k)
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:
January 3, 2022
Device Trade Name:
DEKA SMARTPERIO
Common Name:
Laser, dental, soft tissue
Classification Name:
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology
Product Code:
NVK, GEX
Regulatory Class:
Class II
Classification Number:
21 CFR 878.4810
4
Predicate Device:
DEKA SMARTPERIO (K203396)
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 modification to the device consists in the increasing of the average output power from 6W to 10W.
The intended use of the modified device, as described in the labelling, has not changed as a result of the modifications.
Indications for Use:
The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, gral 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
5
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 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.)
Substantial equivalence discussion:
The modified DEKA SMARTPERIO is substantially equivalent to the DEKA SMARTPERIO device, cleared by FDA with K203396:
| Proposed 510(k) Device | Predicate Device | Comparison | |
|---|---|---|---|
| DEKA SMARTPERIO | DEKA SMARTPERIO | ||
| Device Trade Name | K203396 | ||
| Indications for use | The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, | The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, | Identical |
6
| vaporization and coagulation of soft | vaporization and coagulation of soft |
|---|---|
| tissues using a contact fiber-optic | tissues using a contact fiber-optic |
| delivery system. | delivery system. |
| The device is intended to be used in | The device is intended to be used in |
| dentistry. | dentistry. |
| The following are the oropharyngeal | The following are the oropharyngeal |
| indications for use: | indications for use: |
| Abscess Incision and Drainage | Abscess Incision and Drainage |
| Apthous Ulcers Treatment | Apthous Ulcers Treatment |
| Biopsies Excision and Incision | Biopsies Excision and Incision |
| Crown lengthening | Crown lengthening |
| 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 (first | Selective ablation of enamel (first |
| degree) caries | degree) caries |
| Exposure of unerupted / partially | Exposure of unerupted / partially |
| erupted teeth | erupted teeth |
| Implant recovery | Implant recovery |
| Lesion (tumor) removal | Lesion (tumor) removal |
| Leukoplakia | Leukoplakia |
| Pulpotomy | Pulpotomy |
| Pulpotomy as adjunct to root canal | Pulpotomy as adjunct to root canal |
| therapy | therapy |
7
| | 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.) | 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.) | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Product code | NVK, 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 | 0.2-10W | 0.2-6W | The
modification
does not
adversely
affect safety
and
effectiveness |
| Aiming Beam
wavelength | 635 nm | 635 nm | Identical |
| Power of Aiming
beam | 5 mW | 5mW | Identical |
Performance data:
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the modified DEKA SMARTPERIO device, according to the following standards:
- ANSI AAMI ES60601-1Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
8
- . 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.
Additional non-clinical testing conducted
Additional tests were conducted on the modified DEKA SMARTPERIO, according to the following standards:
- 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.
Conclusion:
Based on the comparison of indications for use and the technological characteristics, we can conclude that the modified DEKA SMARTPERIO is as safe, as effective, and performs as well as the unmodified legally marketed predicate device (K203396).