(278 days)
No
The summary describes a laser device for soft tissue procedures and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes
The device is described as a laser for various soft tissue dental, general, oral maxillofacial, and cosmetic surgeries, and its intended use section lists numerous procedures aimed at treating conditions and restoring health, which aligns with the definition of a therapeutic device. The reference to therapeutic laser equipment in the standards further supports this.
No
The device description and intended use outline various surgical procedures (ablating, incising, excising, vaporization, coagulation) and treatments (e.g., frenectomy, gingivectomy, pulpotomy). While it is used for treatment, it does not explicitly state any diagnostic functions such as identifying disease, or measuring physiological parameters for diagnosis. One mention of "diagnostic laser equipment" is in reference to a safety standard (IEC 60601-2-22 Ed 3.1) which covers general requirements, not necessarily indicating the device's specific diagnostic capability.
No
The device description explicitly details hardware components such as a laser source, cooling system, power supply, CPU controller, user interface with LCD touch screen, beam delivery system, and footswitch. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the DEKA SmartPerio system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for performing various intraoral surgical procedures on soft tissues. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a laser device that delivers energy through a fiber optic cable to the target tissue. This is a therapeutic device, not one used for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. The DEKA SmartPerio is a surgical laser used for treatment.
N/A
Intended Use / 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 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.)
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 DEKA Smartperio device consist s 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.
Electrical specifications are:
115V ~ single phase, 50/60 Hz, Absorbed electric power1840 VA (max)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral, oropharyngeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentistry
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: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). On the left, there 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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
5
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
6
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 | |
|---|---|---|---|
| Device | |||
| Trade | |||
| Name | DEKA SMARTPERIO | ||
| K203396 | Millennium Dental Technologies, | ||
| Inc : PerioLase Dental Laser | |||
| K030290 | |||
| Indications for use | Intraoral procedures: soft tissue | ||
| dental, general, oral maxillofacial, | |||
| and cosmetic surgery. |
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 | Intraoral soft tissue dental, general,
oral maxillo-facial and cosmetic
surgery.
Intended for ablating, incising,
excising, vaporization and
coagulation of soft tissues using a
contact fiber optic delivery system.
The device will be used in the
following areas: general and
cosmetic dentistry, otolaryngology,
arthroscopy, gastroenterology,
general surgery, dermatology &
plastic surgery, neurosurgery,
gynecology, urology, ophthalmology
and pulmonary surgery.
The following are the oropharyngeal
indications for use:
Abscess Incision and Drainage
Apthous Ulcers Treatment
Biopsies Excision and Incision
Crown lengthening | Indications for use of
proposed device are a sub
set of indications for use
of the predicate device.
Proposed device is not
intended for
otolaryngology,
arthroscopy,
gastroenterology, general
surgery, dermatology &
plastic surgery,
neurosurgery,
gynecology,
urology,
ophthalmology and
pulmonary 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 (first
degree) caries | Selective ablation of enamel (first
degree) caries | | |
| Exposure of unerupted / partially
erupted teeth | Exposure of unerupted / partially
erupted teeth | | |
| Implant recovery | Implant recovery | | |
| Lesion (tumor) removal | Lesion (tumor) removal | | |
| Leukoplakia | Leukoplakia | | |
| Pulpotomy | Pulpotomy | | |
| Pulpotomy as adjunct to root canal
therapy | 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. | 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.) | Laser assisted new attachment
procedure (cementum-mediated
periodontal ligament new-
attachment to the root surface in the
absence of long junctional
epithelium.) | | |
7
8
| 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 |
| Aiming | |||
| Beam | |||
| wavelength | 635 nm | 635 nm | Identical |
| Power of Aiming | |||
| beam | 3 mW | 5mW | Similar, difference in |
| aiming beam power does | |||
| not affect safety and | |||
| effectiveness. | |||
| Delivery system | optical fiber (cleared with K124003, | ||
| K200234) guided to the target tissue | |||
| with the aid of handpiece and tip | |||
| (cleared with K952006) | optical fiber guided to the target | ||
| tissue with the aid of handpiece and | |||
| tip | Similar delivery system | ||
| accessories. Subject | |||
| device uses already FDA | |||
| cleared accessories, while | |||
| for predicate device they | |||
| are included in the device | |||
| FDA clearance. This | |||
| difference does not affect | |||
| safety and effectiveness. | |||
| Power | |||
| Requirements | 115Vac, 50/60 Hz, 16Amps | 110-120 VAC, 50/60 Hz, 8 Amps, | |
| Single phase; 200 - 240 VAC, 50 Hz, 4 | |||
| Amps | Both devices had power | ||
| requirements consistent | |||
| with US standards. | |||
| Difference in power input | |||
| current does not affect | |||
| safety and effectiveness. | |||
| Weight | 38 Kg | 45 lbs. [20.4 Kgs]/38 lbs. [17.2 Kgs] | Difference in weight does |
| not affect safety and | |||
| effectiveness. | |||
| Dimensions | 68x23x65cm | 11" (width) x 19" (depth) x 25" | |
| (height) | Difference in dimensions | ||
| does not affect safety | |||
| and effectiveness. | |||
| Biocompatibility | Yes- the only parts that can get in | ||
| contact with patient have already | |||
| been cleared by FDA (K124003, | |||
| K200234, K952006) | YES (predicate device cleared by | ||
| FDA) | Subject device relies on | ||
| biocompatibility of | |||
| accessories already | |||
| cleared by FDA; no data | |||
| available from predicate | |||
| device |
9
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.