(72 days)
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
The GENTLEray 980 Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system.
The KaVo GENTLEray 980 Diode Dental Laser System's acceptance criteria and the study proving it meets these criteria are outlined through a comparison to predicate devices, focusing on technical specifications and intended use rather than direct performance metrics like sensitivity or specificity. This is a 510(k) submission, which primarily establishes substantial equivalence.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are the specifications of the predicate devices. The "reported device performance" is the specifications of the proposed device, demonstrating equivalence. There are no explicit quantitative performance metrics like sensitivity, specificity, or AUC provided in this document as it's a laser device for surgical procedures, not a diagnostic tool.
| Feature | Predicate Device (e.g., Biolitec Smilepro 980) | Proposed Device (KaVo GENTLEray 980) | Acceptance (Equivalence) |
|---|---|---|---|
| Technical Specifications | |||
| Wavelength | 980 nm | 980 nm | Met |
| Output Power | 15W | 12W | Similar (within range) |
| Power Range | 1-15W | 0.4 - 12W | Similar (within range) |
| Increments | 1W | 0.2 - 1W | Similar (within range) |
| Operating Modes | Pulsed or Continuous | Pulsed or Continuous | Met |
| Pulse Duration ON | 0.01 to 99.9 Sec. | 25μs to 99.9 Sec. | Similar (within range) |
| Pulse Duration OFF | 0.01 to 99.9 Sec. | 25μs to 99.9 Sec. | Similar (within range) |
| Frequency | 100 Hz | 20,000 Hz | Different, but considered acceptable for equivalence |
| Aiming beam | 635 nm, 4mW; Red | 635 nm, <1mW; Red | Similar (within safety limits) |
| Cooling | Air Cooled | Air Cooled | Met |
| Weight | 15 lbs. (9kg) | 9 lbs. (4.5kg) | Similar |
| Dimensions | 14" x 9" x 7" | 10.5" x 7" x 6" | Similar |
| Power Requirements | 110/220 V | 100 - 240 V | Similar |
| Sterilization Methods | Steam Autoclave | Steam Autoclave | Met |
| Irrigant Supply | Peristaltic Pump | Peristaltic Pump | Met |
| Intended Use | |||
| Surgical Procedures | Same list of procedures | Same list of procedures | Met |
Note: The table above primarily lists the Biolitec Smilepro 980 as a predicate for comparison, but the document also references ADT Diolase 980 D and Elexxion Claros. The Elexxion Claros had a different wavelength (810 nm) and significantly different output power, which makes the KaVo GENTLEray 980 more directly comparable to the other 980 nm predicate devices for wavelength.
2. Sample size used for the test set and the data provenance
The document indicates that "bench and user testing data" were analyzed. However, no specific sample sizes for test sets (e.g., number of procedures, number of patients) or the data provenance (e.g., country of origin, retrospective/prospective) are detailed in this summary. The comparison focuses on technical specifications to establish substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For device submissions based on substantial equivalence to existing technology, clinical efficacy is often inferred from the predicate device and the new device's adherence to relevant performance standards, rather than through a new clinical trial with expert-established ground truth.
4. Adjudication method for the test set
No adjudication method is mentioned as there is no specific clinical "test set" and outcome assessment detailed in this summary for the purpose of establishing efficacy or accuracy against a ground truth.
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. This device is a laser surgical instrument, not an AI-assisted diagnostic or interpretative 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. This device is a surgical instrument that operates with human-in-the-loop (a dentist or surgeon). There is no "algorithm-only" performance for such a device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
No explicit "ground truth" of the type typically used for diagnostic or AI algorithm validation is mentioned. The basis for clearance is demonstrating that the device is "as safe and effective as the predicate device" through comparison of:
- Technical specifications: (e.g., wavelength, power, operating modes)
- Performance standards compliance: The device complies with 21 CFR §1010 and 21 CFR §1040.
- Validation testing: "electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions."
- Intended use: The intended use is identical to the predicate devices.
The "ground truth" for this type of submission is essentially the established safety and efficacy of the legally marketed predicate devices, combined with testing showing the proposed device meets manufacturing and performance standards relevant to its technical operation.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device, and thus does not involve a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML device, and thus does not involve a training set or its associated ground truth establishment.
Summary of the Study Proving Acceptance Criteria:
The study proving the KaVo GENTLEray 980 Diode Dental Laser System meets its "acceptance criteria" (defined as substantial equivalence to predicate devices) is a comparison study based on technical specifications, intended use, and compliance with performance standards.
The manufacturer, KaVo Dental Corporation, conducted:
- Bench testing: This would involve laboratory testing of the device's technical specifications (wavelength, power output, pulse characteristics, safety features, etc.) against design requirements and comparison to predicate device specifications.
- User testing: While not explicitly detailed, this would likely involve verification that the device functions as intended in a simulated or actual use environment, confirming operability and safety.
- Compliance testing: The device was tested to ensure compliance with the appropriate sections of 21 CFR §1010 and 21 CFR §1040 (performance standards for laser products).
- Validation testing of hardware and software functions: This ensures the device's components and control systems operate correctly and safely.
- Electromagnetic compatibility (EMC) testing.
- Electrical safety testing.
The conclusion drawn by KaVo, and subsequently accepted by the FDA, is that the GENTLEray 980 Diode Laser System is "as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device." This means the device met the "acceptance criteria" by demonstrating equivalence to devices already cleared for market.
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KO 72262
Image /page/0/Picture/1 description: The image contains two logos, one on the left and one on the right. The logo on the left is a stylized design, while the logo on the right contains the words "GENDEX" on the top line and "DEXIS" on the bottom line. The text in the logos is in a simple, sans-serif font.
| Applicant: | KaVo Dental Corporation | OCT 26 2007 |
|---|---|---|
| Address: | 340 East Main StreetLake Zurich, IL 60047USA | |
| Phone Number:Fax Number: | 847-550-6800847-550-6825 | |
| Contact Person: | Mari Lambert | |
| Summary Prepared: | October 4, 2007 | |
| Name of Device: | KaVO GENTLEray 980 | |
| Trade Name: | GENTLEray 980 | |
| Common Name: | GENTLEray | |
| Classification Name: | Laser surgical instrument for use in general and plastic surgeryand in dermatology | |
| CFR Number: | 21 CFR §878.4810 | |
| Product Code: | GEX | |
| Product Description: | The GENTLEray 980 Diode Dental Laser System is a portableinstrument intended for ablating, incising, excising, andcoagulating intraoral soft tissue (including the marginal andinterdental gingiva) using a contact fiber optic delivery system. | |
| Intended Use: | Intra- and extra-oral surgery including incision, excision,hemostasis, coagulation and vaporization of soft tissue.The GENTLEray 980 Diode Dental Laser System is intended foruse in the following procedures: Frenectomy, Frenotomy,Biopsy, Operculectomy, Implant Recovery, Gingivectomy,Gingivoplasty, Gingival Troughing, Crown Lengthening,Hemostasis of Donor Site, Removal of Granulation Tissue,Laser-assisted Flap Surgery, Debridement of Deseased EpithelialLining, Incisions and Draining of Abscesses, Tissue Retractionfor Impressions, Papillectomy, Vestibuloplasty, Excision ofLesions, Leukoplakia, Exposure of Unerupted/Partially EruptedTeeth, Removal of Hyperplastic Tissues, Treatment of AphthousUlcers, Sulcular Debridement, Pulpotomy, Pulpotomy as anAdjunct to Root Canal Therapy, and Light Activation of | |
| PerformanceStandards: | The GENTLEray 980 Diode Dental Laser System complies withthe appropriate sections of 21 CFR §1010 and 21 CFR §1040. | |
| SubstantialEquivalence: | The GENTLEray 980 Diode Dental Laser System has the sameintended use and the same or substantially equivalent technicalspecifications and mechanism of action as compared with thenamed predicated devices. The KaVo GENTLEray 980 DiodeLaser is substantially equivalent to the Ceramoptec Ceralas D15(K983058, K991891) sold latterly under the BioLitec brandname SmilePro™ 980, the ADT Diolase 980 D Laser System(K023547) and the Elexxion Claros (K063152). Performancetesting to validate the safety and effectiveness of theGENTLEray 980 Diode Dental Laser System includes electricalsafety, electromagnetic compatibility, and validation testing ofboth hardware and software functions. The comparison ofspecifications are as follows: |
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KO72262
| Specifications | Proposed Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Wavelength | KaVo GENTLEray 980 | Biolitec Smilepro 980 | ADT Diolase 980 D | Elexxion Claros |
| 980 nm | 980 nm | 980 nm | 810 nm | |
| Output Power | 12W | 15W | 15 W | 30 W |
| Power Range | .4 - 12W | 1-15W | .2 - 15 W | 0.01W - 30 W |
| Increments | .2 - 1W | 1W | .2 - 1W | 0.01W - 1 W |
| Operating Modes | Pulsed or Continuous | Pulsed or Continuous | Pulsed or Continuous | Pulsed or Continuous |
| Pulse Duration ON | 25μs to 99.9 Sec. | 0.01 to 99.9 Sec. | 0.01 to 99.9 Sec | 25μs to 99.9 Sec. |
| Pulse Duration OFF | 25μs to 99.9 Sec. | 0.01 to 99.9 Sec. | 0.01 to 99.9 Sec | 25μs to 99.9 Sec. |
| Frequency | 20.000 Hz | 100 Hz | 100 Hz | 20.000 Hz |
| Aiming beam | 635 nm, <1mW; Red | 635 nm, 4mW; Red | 635 nm, 4mW; Red | 635 nm, 4mW; Red |
| Cooling | Air Cooled | Air Cooled | Air Cooled | Air Cooled |
| Weight | 9 lbs. (4.5kg) | 15 lbs. (9kg) | 11 lbs. (5kg) | 48 lbs. (22kg) |
| Dimensions | 10.5" x 7" x 6" | 14" x 9" x 7" | 14" x 9" x 3" | 33" x 18" x 20" |
| PowerRequirements | 100 - 240 V | 110/220 V | 110/220 V | 110/220 V |
| SterilizationMethods | Steam Autoclave | Steam Autoclave | Steam Autoclave | Steam Autoclave |
| Irrigant Supply | Peristaltic Pump | Peristaltic Pump | Peristaltic Pump | None |
| Indications for Use | Intra- and extra-oralsurgery including incision,excision, hemostasis,coagulation andvaporization of soft tissue.The device is intended foruse in the followingprocedures: Frenectomy,Frenotomy, Biopsy,Operculectomy, ImplantRecovery, Gingivectomy,Gingivoplasty, GingivalTroughing, CrownLengthening, Hemostasisof Donor Site, Removal of | Intra- and extra-oralsurgery including incision,excision, hemostasis,coagulation andvaporization of soft tissue.The device is intended foruse in the followingprocedures: Frenectomy,Frenotomy, Biopsy,Operculectomy, ImplantRecovery, Gingivectomy,Gingivoplasty, GingivalTroughing, CrownLengthening, Hemostasisof Donor Site, Removal of | Intra- and extra-oralsurgery including incision,excision, hemostasis,coagulation andvaporization of soft tissue.The device is intended foruse in the followingprocedures: Frenectomy,Frenotomy, Biopsy,Operculectomy, ImplantRecovery, Gingivectomy,Gingivoplasty, GingivalTroughing, CrownLengthening, Hemostasisof Donor Site, Removal of | Dental Soft TissueIndications IncludingPulpal Tissues*Incision, excision,vaporization, ablation andcoagulation of oral softtissues, including:Excisional and incisionalbiopsies, Exposure ofunerupted teeth, Fibromaremoval, Frenectomy,Frenotomy, Gingivaltroughing for crownimpressions,Gingivectomy |
| Laser-assisted FlapSurgery, Debridement ofDeseased EpithelialLining, Incisions andDraining of Abscesses,Tissue Retraction forImpressions,Papillectomy,Vestibuloplasty, Excisionof Lesions, Leukoplakia,Exposure ofUnerupted/PartiallyErupted Teeth, Removalof Hyperplastic Tissues,Treatment of AphthousUlcers, SulcularDebridement, Pulpotomy,Pulpotomy as an Adjunctto Root Canal Therapy,and Light Activation ofBleaching Materials. | Laser-assisted FlapSurgery, Debridement ofDeseased EpithelialLining, Incisions andDraining of Abscesses,Tissue Retraction forImpressions,Papillectomy,Vestibuloplasty, Excisionof Lesions, Leukoplakia,Exposure ofUnerupted/PartiallyErupted Teeth, Removalof Hyperplastic Tissues,Treatment of AphthousUlcers, SulcularDebridement, Pulpotomy,Pulpotomy as an Adjunctto Root Canal Therapy,and Light Activation ofBleaching Materials. | Laser-assisted FlapSurgery, Debridement ofDeseased EpithelialLining, Incisions andDraining of Abscesses,Tissue Retraction forImpressions,Papillectomy,Vestibuloplasty, Excisionof Lesions, Leukoplakia,Exposure ofUnerupted/PartiallyErupted Teeth, Removalof Hyperplastic Tissues,Treatment of AphthousUlcers, SulcularDebridement, Pulpotomy,Pulpotomy as an Adjunctto Root Canal Therapy,and Light Activation ofBleaching Materials. | incision and excision,Hemostasis andcoagulation, Implantrecovery, Incision anddrainage of abscesses,Leukoplakia,Operculectomy, Oralpapillectomies,Pulpotomy, Pulpotomy asan adjunct to root canaltherapy, Reduction ofgingival hypertrophy, Softtissue crown lengthening,Treatment of cankersores, herpetic andaphthous ulcers of theoral mucosa, andVestibuloplasty.*For use on adult andpediatric patientsLaser PeriodontalProceduresLaser soft tissuecurettage, Laser removalof diseased, infected,inflamed and necrosedsoft tissue within theperiodontal pocket,Removal of highlyinflamed edematoustissue affected by bacteriapenetration of the pocketlining and junctionalepithelium, Sulculardebridement (removal ofdiseased or inflamed softtissue in the periodontalpocket to improve clinicalindices including gingivalindex, gingival bleedingindex, probe depth,attachment loss and toothmobility)Tooth WhiteningLaser assistedwhitening/bleaching ofteeth, Light activation forbleaching materials forteeth. | |
:
:
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02262
Conclusion:
After analyzing both bench and user testing data, it is the conclusion of Kavo that the GENTLEray 980 Diode Laser System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
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Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kavo America % Intertek Testing Services Mr. Daniel W. Lehtonen 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
OCT 2 6 2007
Re: K072262 Trade/Device Name: GENTLEray 980 Diode Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and and in dermatology Regulatory Class: II Product Code: GEX Dated: October 10, 2007 Received: October 11, 2007
Dear Mr. Lehtonen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Daniel W. Lehtonen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/suport/index.html
Sincerely yours,
Mark A. Milkeron
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K022262
Device Name: GENTLEray 980 Diode Laser System
Indications for Use:
Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue.
The GENTLEray 980 Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flan Singgry, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arlene A. Millerson
(Division of General, Restorative, and Neurological Dev
KO 72262
510(k) Number
§ 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.