(62 days)
Not Found
No
The device description focuses on laser and water atomization technology, and there are no mentions of AI, ML, or related concepts in the provided text.
Yes.
The device is used for root canal preparation, debridement, cleaning, and disinfection, all of which are therapeutic interventions.
No.
The device description and intended use clearly state that EdgePro is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr: YSGG) solid-state laser used for root canal preparation (enlargement, debridement, cleaning) and disinfection, as well as cutting, shaving, contouring, roughening, etching, resecting oral hard tissues, and performing oral soft tissue removal, incision, excision, ablation and coagulation. These are all therapeutic or interventional actions, not diagnostic ones.
No
The device description clearly outlines a physical laser system with hardware components including a console, laser head, power supply, cooling system, fiber cable, handpiece, and footswitch. While it includes a tablet PC as a control panel and mentions software verification and validation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the EdgePro clearly indicates it is a laser system used for surgical procedures within the root canal. It physically interacts with and modifies hard and soft tissues.
- Intended Use: The intended uses listed are "Root Canal Hard Tissue Indications" and "Root Canal Disinfection," both of which are direct treatments performed on the patient's body, not tests performed on samples outside the body.
Therefore, the EdgePro is a therapeutic device used for dental procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
NVK, GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal, oral hard tissues, oral soft tissue
Indicated Patient Age Range
adult and pediatric patients
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility Testing: Not performed for the subject device. Predicate device evaluation was conducted in accordance with ISO 10993-1. Results demonstrate biocompatibility.
Electrical Safety and Electromagnetic Compatibility (EMC): Safety testing of EdgePro was conducted according to IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22, IEC 60825-1 and IEC 80601-2-60. The device meets applicable requirements.
Software Verification and Validation: Performed as recommended by FDA's Guidance 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". Results demonstrate that EdgePro performs according to specifications and functions intended.
Bench Testing: Conducted to evaluate performance between the subject device and predicate device. Results demonstrate that EdgePro performs as well as the predicate device, Waterlase Express.
Clinical Testing: Not performed for the subject device since the indications for use are a subset of the predicate device and the performance characteristics are equivalent.
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
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
2
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
5
Image /page/5/Picture/0 description: The image shows the word "BIOLASE" in a bold, sans-serif font. The word is in a dark blue color. The background is white, which makes the word stand out.
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
6
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 for
effective root canal indications
Therefore, substantially equivalent. |
| Output Mode | Pulsed | Pulsed | No Change |
| Max Pulse Energy | 100mJ | 200 mJ | Lower max pulse energy, is sufficient
for effective root canal indications
Therefore, 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 indications
Therefore, 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 and
pediatric patients)
• Class I, II, III, IV and V cavity preparation
• Caries removal
• Hard tissue surface roughening or etching
• Enameloplasty, excavation of pits and fissures for
placement of sealants | Limited to Root Canal
Indications; therefore,
substantially equivalent. |
| Indications for
Use | Root Canal Hard Tissue
Indications
• Root canal preparation including
enlargement
• Root canal debridement and
cleaning | Root Canal Hard Tissue Indications
• Root canal preparation including enlargement
• Root canal debridement and cleaning
Root Canal Disinfection
• Laser root canal disinfection after endodontic treatment | |
| | Root Canal Disinfection
• Laser root canal disinfection after
endodontic treatment | Endodontic Surgery (Root Amputation) Indications
• Flap preparation – incision of soft tissue to prepare a flap
and 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 or
abscess) and hyperplastic tissues (i.e., granulation tissue)
from around the apex | |
Biolase, Inc. EdgePro – Special 510(k) Submission
7
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| NOTE: Any tissue growth (i.e., cyst, neoplasm or other
lesions) must be submitted to a qualified laboratory for
| histopathological evaluation. |
|---|
| Bone Surgical Indications |
| • Cutting, shaving, contouring and resection of oral osseous |
| tissues (bone) |
| • Osteotomy |
| Soft Tissue Indications including Pulpal Tissues (for use |
| on adult and pediatric patient) |
| Incision, excision, vaporization, ablation and coagulation of |
| oral soft tissues including: |
| • Excisional and incisional biopsies |
| • Exposure of unerupted teeth |
| • Fibroma removal |
| • Flap preparation – incision of soft tissue to prepare a flap |
| and expose the bone |
| • Flap preparation – incision of soft tissue to prepare a flap |
| and expose unerupted teeth (hard and soft tissue |
| impactions) |
| • 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 tooth |
| sockets 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 of |
| the oral mucosa |
| • Vestibuloplasty |
| • Removal of pathological tissues (i.e., cysts, neoplasm or |
| abscess) and hyperplastic tissues (i.e., granulation tissue) |
| from around the apex |
| NOTE: Any tissue growth (i.e., cyst, neoplasm or other |
| lesions) must be |
| submitted to a qualified laboratory for histopathological |
| evaluation |
| Laser Periodontal Procedures |
| • Full thickness flap |
| • Partial thickness flap |
| • Split thickness flap |
| • Laser soft tissue curettage |
| • Laser removal of diseased, infected, inflamed and |
| necrosed soft tissue within the periodontal pocket |
| • Removal of highly inflamed edematous tissue affected by |
| bacteria penetration of the pocket lining junctional |
| epithelium |
| • 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 and
tooth mobility)
• Osteoplasty and osseous recontouring (removal of bone to
correct osseous defects and create physiologic osseous
contours)
• Ostectomy (resection of bone to restore bony architecture,
resection of bone for grafting, etc.)
• Osseous crown lengthening
• Removal of subgingival calculi in periodontal pockets
with
periodontitis 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 long
junctional epithelium. | |
|-------------------------------------------------------------------------------------------|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Other changes
to labeling or
design since
the most
recently
cleared 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
13
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