(62 days)
Root Canal Hard Tissue Indications (for use on adult and pediatric patients)
- Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment
EdgePro is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr: YSGG)solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. EdgePro utilizes advanced laser and water atomization technologies to cut, shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
This 510(k) summary for the Biolase EdgePro laser system does not include a detailed study proving the device meets specific acceptance criteria for its intended clinical use. Instead, it relies on substantial equivalence to a predicate device (Waterlase Express) and non-clinical performance data.
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific success rates for root canal preparation or disinfection) nor does it report specific clinical performance metrics for the EdgePro. The "performance" described is largely comparative to the predicate device in terms of technical characteristics and safety standards.
However, based on the "Comparison of EdgePro to Waterlase Express" table (Table 1) and the performance data section, we can infer some qualitative "acceptance criteria" through equivalence:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Meets ISO 10993-1 via predicate device; materials are the same. |
| Electrical Safety | Meets IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60. |
| EMC | Meets IEC 60601-1-2. |
| Software Functionality | Performs according to specifications and intended functions; V&V conducted per FDA guidance. |
| Bench Performance (Technical Characteristics) | Performs "as well as" the predicate device (Waterlase Express) across parameters like wavelength, output mode, fluence per spot, and repetition rate. Deviations in max power output, max pulse energy, spot size, and pulse duration are deemed sufficient for effective root canal indications or for convenience only, thus maintaining substantial equivalence. |
| Clinical Effectiveness | Assumed to be equivalent to the predicate device because the indications for use are a subset and performance characteristics are considered equivalent. No new clinical data presented. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set: Not applicable. No clinical testing was performed for the EdgePro subject device. The device relies on equivalence to the predicate.
- Bench Testing: The document states "Testing was conducted to evaluate performance between the subject device and predicate device." However, it does not provide any details on the sample size (e.g., how many devices were tested, how many times each parameter was measured) or data provenance for this bench testing.
- Biocompatibility (for Predicate Device): Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set with human subject data requiring expert ground truth establishment was conducted for the EdgePro in this submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test data was collected from human subjects for the EdgePro subject device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not performed for the subject device since the indications for use are a subset of the predicate device and the performance characteristics are equivalent."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is not an AI/algorithm-only device. It is a laser surgical instrument. The software verification and validation would be considered a form of standalone performance assessment, but it's for the device's operational software, not an AI algorithm performing a diagnostic or prognostic task.
7. The Type of Ground Truth Used
- Biocompatibility: The ground truth would be accepted biological safety standards (e.g., ISO 10993-1) as demonstrated by laboratory tests for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity.
- Electrical Safety & EMC: Ground truth is defined by compliance with recognized international standards (IEC 60601 series).
- Software Verification & Validation: Ground truth is the device's functional specifications and FDA guidance for software in medical devices.
- Bench Testing: Ground truth is defined by the technical specifications of the device and comparative performance to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a medical laser, not a machine learning model, so there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
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December 22, 2021
Biolase Inc. Ed Balcos Manager, Regulatory Affairs 27042 Towne Centre Drive, Suite 270 Foothill Ranch, California 92610
Re: K213428
Trade/Device Name: EdgePro 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: November 4, 2021 Received: November 22, 2021
Dear Ed Balcos:
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213428
Device Name EdgePro
Indications for Use (Describe)
Root Canal Hard Tissue Indications (for use on adult and pediatric patients)
- Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment
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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510(k) SUMMARY - K213428
I. SUBMITTER
Biolase. Inc 27042 Towne Centre Drive, Suite 270 Foothill Ranch, CA 92610 USA Tel: (949) 226-8119 Fax: (949) 273-6677 Contact Person: Ed Balcos Email: ebalcos@biolase.com Date Prepared: October 18, 2021
II. DEVICE
| Name of Device: | EdgePro |
|---|---|
| Common Name: | Er,Cr:YSGG Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) |
| Device Class: | II |
| Product Code: | NVK, GEX |
PREDICATE DEVICE III.
Waterlase Express, Biolase, Inc., K161669 (Primary Predicate)
- DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION EdgePro IV. is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr: YSGG)solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. EdgePro utilizes advanced laser and water atomization technologies to cut, shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
Biolase. Inc. EdgePro - Special 510(k) Submission
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V. INDICATIONS FOR USE
The EdgePro indications for use are as follows:
Root Canal Hard Tissue Indications (for use on adult and pediatric patients)
- Root canal preparation including enlargement .
- Root canal debridement and cleaning ●
Root Canal Disinfection (for use on adult and pediatric patients)
- Laser root canal disinfection after endodontic treatment ●
Biolase, Inc. EdgePro – Special 510(k) Submission
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The EdgePro subject device and the Waterlase Express predicate device are based on the same technological principlesincluding:
- Solid-state Er, Cr;YSGG laser at 2780nm wavelength ●
- Laser is running at a free-running mode without any additional light modulation features
- Output radiation is pulsed and can be controlled in multiple ways: energy per ● pulse,pulse duration and pulse repetitionrate
- System contains air/water supply that allows controlled delivery of very precisewater particles to the treatment site
- System is PEMS, programmable embedded medical system
Detailed Description of Changes Made
EdgePro is based on the previously cleared Waterlase Express device (K161669), but limited to previously cleared indications for use;
Root Canal Hard Tissue Indications ।
- Root canal preparation including enlargement and .
- Root canal debridement and cleaning
- -Root Canal Disinfection
- Laser root canal disinfection after endodontic treatment .
EdgePro has changes made to the cosmetic exterior housing and integrated interface/control panel configured to be focused on the limited root canal indications as previously stated.
Summary of technological characteristics between the subject and predicate device is presented in Table 1, below.
Biolase. Inc. EdgePro - Special 510(k) Submission
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Table 1: Comparison of EdgePro to Waterlase Express
| Subject Device(K213428) | Predicate Device(K161669) | Comparison | |
|---|---|---|---|
| Device Name | EdgePro | Waterlase Express | |
| Product Code | GEX | GEX | No Change |
| Application | Dental | Dental | No Change |
| Laser Medium | Er, Cr: YSGG | Er, Cr: YSGG | No Change |
| Laser Classification | IV(4) | IV(4) | No Change |
| Wavelength | 2780 nm | 2780 nm | No Change |
| Max Power Output | Up to 2 W | Up to 4 W | Max power of 2W is sufficient foreffective root canal indicationsTherefore, substantially equivalent. |
| Output Mode | Pulsed | Pulsed | No Change |
| Max Pulse Energy | 100mJ | 200 mJ | Lower max pulse energy, is sufficientfor effective root canal indicationsTherefore, substantially equivalent. |
| Fluence per Spot | 10—170 J/cm2 | 10—170 J/cm2 | No Change |
| Repetition Rate(Frequency) | 5-50 Hz | 5-50 Hz | No Change |
| Spot Size | 200 – 500 μm | 200 – 1,200 μm | Convenience only; therefore, substantially equivalent. |
| Pulse Duration(Width) | 60 μs | 60 μs, 700 μs | Eliminated Soft Mode, Hard model is sufficient for effective root canal indicationsTherefore, substantially equivalent. |
| Aiming Beam | Diode laser, max 3 mW, 625-670 nm | Diode laser, max 3 mW, 625-670 nm | No Change |
| Operating Voltage | 100 / 230 VAC | 100 / 230 VAC | No Change |
| User Interface /Control Panel | Integrated Display | Tablet PC | Convenience only; therefore, substantially equivalent. |
| Footswitch | Wireless / Wired | Wireless / Wired | No Change |
| Labeling | IFU | IFU | Limited to Root Canal Indications; therefore, substantially equivalent. |
| Materials | Medical grade plastic, stainless steel, aluminum, brass, and electronic parts and components | Medical grade plastic, stainless steel, aluminum, brass, and electronic parts and components | No Change |
| Subject Device | Predicate Device | Comparison | |
| General Hard Tissue Indications (for use in adult andpediatric patients)• Class I, II, III, IV and V cavity preparation• Caries removal• Hard tissue surface roughening or etching• Enameloplasty, excavation of pits and fissures forplacement of sealants | Limited to Root CanalIndications; therefore,substantially equivalent. | ||
| Indications forUse | Root Canal Hard TissueIndications• Root canal preparation includingenlargement• Root canal debridement andcleaning | Root Canal Hard Tissue Indications• Root canal preparation including enlargement• Root canal debridement and cleaningRoot Canal Disinfection• Laser root canal disinfection after endodontic treatment | |
| Root Canal Disinfection• Laser root canal disinfection afterendodontic treatment | Endodontic Surgery (Root Amputation) Indications• Flap preparation – incision of soft tissue to prepare a flapand expose the bone• Cutting bone to prepare a window access to the apex(apices) of the root(s)• Apicoectomy – amputation of the root end• Root end preparation for retrofill amalgam or composite• Removal of pathological tissues (i.e., cysts, neoplasm orabscess) and hyperplastic tissues (i.e., granulation tissue)from around the apex |
Biolase, Inc. EdgePro – Special 510(k) Submission
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| NOTE: Any tissue growth (i.e., cyst, neoplasm or otherlesions) must be submitted to a qualified laboratory forhistopathological evaluation. |
|---|
| Bone Surgical Indications |
| • Cutting, shaving, contouring and resection of oral osseoustissues (bone) |
| • Osteotomy |
| Soft Tissue Indications including Pulpal Tissues (for useon adult and pediatric patient) |
| Incision, excision, vaporization, ablation and coagulation oforal soft tissues including: |
| • Excisional and incisional biopsies |
| • Exposure of unerupted teeth |
| • Fibroma removal |
| • Flap preparation – incision of soft tissue to prepare a flapand expose the bone |
| • Flap preparation – incision of soft tissue to prepare a flapand expose unerupted teeth (hard and soft tissueimpactions) |
| • Frenectomy and frenotomy |
| • Gingival troughing for crown impressions |
| • Gingivectomy |
| • Gingivoplasty |
| • Gingival incision and excision |
| • Hemostasis |
| • Implant recovery |
| • Incision and drainage of abscesses |
| • Laser soft tissue curettage of the post-extraction toothsockets and the periapical area during apical surgery |
| • Leukoplakia |
| • Operculectomy |
| • Oral papillectomies |
| • Pulpotomy |
| • Pulp extirpation |
| • Pulpotomy as an adjunct to root canal therapy |
| • Root canal debridement and cleaning |
| • Reduction of gingival hypertrophy |
| • Soft tissue crown lengthening |
| • Treatment of canker sores, herpetic and aphthous ulcers ofthe oral mucosa |
| • Vestibuloplasty |
| • Removal of pathological tissues (i.e., cysts, neoplasm orabscess) and hyperplastic tissues (i.e., granulation tissue)from around the apex |
| NOTE: Any tissue growth (i.e., cyst, neoplasm or otherlesions) must besubmitted to a qualified laboratory for histopathologicalevaluation |
| Laser Periodontal Procedures |
| • Full thickness flap |
| • Partial thickness flap |
| • Split thickness flap |
| • Laser soft tissue curettage |
| • Laser removal of diseased, infected, inflamed andnecrosed soft tissue within the periodontal pocket |
| • Removal of highly inflamed edematous tissue affected bybacteria penetration of the pocket lining junctionalepithelium |
| • Removal of granulation tissue from bony defects |
| • Sulcular debridement (removal of diseased, infected,inflamed or necrosed soft tissue in the periodontal pocket |
Image /page/9/Figure/2 description: The image shows the text "Biolase, Inc." on the first line and "EdgePro – Special 510(k) Submission" on the second line. The text is in a simple, sans-serif font and is aligned to the left. The image appears to be a title or heading for a document or presentation related to Biolase, Inc. and their EdgePro product's 510(k) submission.
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Image /page/10/Figure/2 description: The image shows the text "Biolase, Inc." on the first line and "EdgePro – Special 510(k) Submission" on the second line. The text is in a simple, sans-serif font and is aligned to the left. The image appears to be a title or heading for a document or presentation related to Biolase, Inc. and their EdgePro product's 510(k) submission.
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| to improve clinical indices including gingival index,gingival bleeding index, probe depth, attachment loss andtooth mobility)• Osteoplasty and osseous recontouring (removal of bone tocorrect osseous defects and create physiologic osseouscontours)• Ostectomy (resection of bone to restore bony architecture,resection of bone for grafting, etc.)• Osseous crown lengthening• Removal of subgingival calculi in periodontal pocketswithperiodontitis by closed or open curettage• Waterlase Er,Cr:YSGG assisted new attachment procedure(cementum-mediated periodontal ligament new-attachment to the root surface in the absence of longjunctional epithelium. | |||
|---|---|---|---|
| Other changesto labeling ordesign sincethe mostrecentlycleared 510(k) | No Change | No Change | No Change |
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VII. PERFORMANCE DATA
The following performance data were provided in support of substantial equivalence determination:
Biocompatibility Testing
Biocompatibility was not performed for the subject device since the materials as same from the predicate device and theperformance characteristics are equivalent.
Biocompatibility performed for the predicate device evaluation was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process, as recognized by the FDA.The battery of testing included cytotoxicity, sensitization, intracutaneous reactivity and systemic toxicity. The results demonstrate biocompatibility of the device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Safety testing of EdgePro was conducted according to recognized standards: IEC 60601-1-2 standard for EMC and IEC60601-1, IEC 60601-2-22, IEC 60825-1 and IEC 80601-2-60 for safety. The device meets applicable requirements related to the above-referenced standards.
Software Verification and Validation
Software verification and validation testing was performed and documentation was provided as recommended by FDA'sGuidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices and "Guidance for the Content of Premarket Submission for Management of Cybersecurity in Medical Devices". The results demonstrate that EdgePro performs according to specifications and functions intended.
Bench Testing
Testing was conducted to evaluate performance between the subject device and predicate device. The results demonstrate thatEdgePro performs as well as the predicate device, Waterlase Express.
Biolase, Inc. EdgePro - Special 510(k) Submission
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Clinical Testing
Clinical testing was not performed for the subject device since the indications for use are a subset of the predicate device andthe performance characteristics are equivalent.
VIII. CONCLUSION
EdgePro is substantially equivalent to its legally marketed predicate device, Waterlase Express, in technical characteristics, operating principle and mechanismof action. It has the same indications for use and equivalent performance. Therefore, it can be concluded that EdgePro is as safe and effective as the predicate device.
Biolase, Inc. EdgePro – Special 510(k) Submission
§ 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.