The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use: General Surgery, Dermatology, Plastic Surgery and Podiatry - Debridement of wounds.

Device Description

The EPIC 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC 10 laser is comprised of a base console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The Epic 10 delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Biolase Epic 10 laser surgical instrument, seeking to expand its Indications for Use to include "Debridement of wounds."

Here's an analysis of the acceptance criteria and study information, based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission process for a device that is substantially equivalent to a predicate device generally focuses on demonstrating that the new device is as safe and effective as the predicate. In this specific case, the submission is about expanding the Indications for Use for an already cleared device (Epic 10, cleared under K130465). Therefore, the "acceptance criteria" here are to demonstrate substantial equivalence to predicate devices that already have the "Debridement of wounds" indication.

Acceptance Criteria (Demonstrated Substantial Equivalence for "Debridement of wounds")	Reported Device Performance (Epic 10)
Technological Characteristics: Comparable to predicate devices with the desired indication.	The Epic 10 shares similar descriptive information, laser classification, operating voltage, laser medium (InGaAsP vs. Diode Laser/GaAlAs), wavelength range (940 +/- 10nm vs. 980nm +/- 10%), current frequency, output power range (10W vs. up to 120W in predicates), power mode, pulse repetition rate, pulse duration, aiming beam, and materials with the predicate devices.
Intended Use: Consistent with predicate devices for the expanded indication.	The Epic 10's expanded indication for "Debridement of wounds" is explicitly listed among the indications for use of all three predicate devices.
Safety and Effectiveness: No new questions of safety or effectiveness are raised.	The document states that non-clinical and clinical testing were not performed on this device because the purpose was to expand indications based on already cleared predicate devices. The conclusion is that the clinical performance for the expanded indication is "deemed to be substantially equivalent" to the predicates.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not applicable. The submission explicitly states, "Clinical testing was not conducted on this device." Instead, substantial equivalence is claimed based on a comparison to predicate devices that already have the "Debridement of wounds" indication.
Data Provenance: Not applicable, as no new clinical or non-clinical studies were performed for this specific 510(k) submission. The data provenance implicitly refers to the prior FDA clearances of the predicate devices (K100558, K072779, K060114), which would have involved their own testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. No new test set (clinical or otherwise) was generated for this expanded indication submission. The "ground truth" for the predicate devices' indications would have been established during their original clearance processes.

4. Adjudication Method for the Test Set

Not applicable, as no new test set was used.

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 interpretive tool. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a surgical instrument operated by a human, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable for this specific submission as no new testing was performed. The basis for clearance relies on the established "ground truth" and safety/effectiveness demonstrations of the predicate devices for the "Debridement of wounds" indication. For a surgical device, ground truth in design would typically involve engineering specifications, biocompatibility, electrical safety, and performance characteristics (e.g., power output, beam quality), validated against regulatory standards and possibly preclinical models. Clinical ground truth for efficacy would come from clinical trials or established medical practice.

8. The Sample Size for the Training Set

Not applicable. The device is a surgical laser, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria for this specific 510(k):

The "study" in this context is a comparison to legally marketed predicate devices that already carry the expanded indication. Biolase demonstrated that its Epic 10 device is "substantially equivalent" to these predicates for the indication "Debridement of wounds" by showing that:

Predicate Devices: QUANTA Diode Laser Family (K100558), Ceralas D980 Diode Laser (K072779), and Vectra Laser System and Accessories (K060114) all include "Debridement of wounds" in their Indications for Use.
Technological Characteristics: The Epic 10 shares similar fundamental technological characteristics (laser type, power delivery, general operating principles) with these predicate devices. The document includes a table comparing these characteristics, highlighting that while there might be differences in specific parameters (e.g., maximum power output), these are not considered to raise new questions of safety or effectiveness regarding the expanded indication when compared to the range and functionality of the predicate devices.
Lack of New Testing: The submission explicitly states that "Non-clinical testing was not performed on this device since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearance... The indication included in this 510(k) has already been cleared by the FDA for equivalent medical devices..." and "Clinical testing was not conducted on this device."

Therefore, the "proof" is the argument of substantial equivalence based on the established safety and effectiveness of the identified predicate devices for the specified expanded indication.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the seal in a circular fashion. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2014

Biolase Incorporated Ms. Colleen Boswell Vice President, Regulatory Affairs/Quality Assurance 4 Cromwell Irvine, California 92618

Re: K140120 Trade/Device Name: Epic 10 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: GEX Dated: September 15, 2014 Received: September 16, 2014

Dear Ms. Boswell:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S 2014.10.10 13:24:59 -04'00' Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K140120

Indications for Use

510(k) Number (if known):

Device Name: Epic 10

Indications for Use:

General Surgery, Dermatology, Plastic Surgery and Podiatry

Debridement of wounds .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Biolase - Epic 10 - 510(k) Submission

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510(k) Summary

Submitter:

Biolase, Inc. 4 Cromwell Irvine, California 92618 (949) 226-8470 - Phone (949) 273-6688 - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: October 2014

Trade Name Epic 10 ●
Common Name - Diode Laser
Classification Name - Laser surgical instrument for use in general and plastic surgery and in dermatology, per 21 CFR 878.4810
. Product Code - GEX

Devices for Which Substantial Equivalence is Claimed:

QUANTA Diode Laser Family, Quanta System, S.p.A., K100558
Ceralas D980 Diode Laser (Models D15, D25), Biolitec, Inc., K072779
Vectra Laser System and Accessories, Xintec Corporation, dba, Convergent Laser Technologies, . · K060114

Device Description

Statement of Intended Use

The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation, and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use:

..............................................................................................................................................................................

General Surgery, Dermatology, Plastic Surgery and Podiatry

Debridement of wounds

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Summary of Technological Characteristics

DescriptiveInformation	Epic 10(K140120)	QUANTA Diode Laser Family(K100558)	Ceralas Diode 980nm LaserSystem (Models D15, D25)(K072779)	Vectra Laser System andAccessories(K060114)
Company	Biolase, Inc.	Quanta System S.p.A.	Biolitec, Inc.	Xintec Corporation, dba,Convergent Laser Technologies
Indications for Use	The Epic 10 is intended foruse as a laser surgicalinstrument requiring theincision, excision,vaporization, ablation andhemostasis, or coagulationof soft tissue. It isindicated for the followingexpanded Indications forUse:	General Surgery, Dermatology,Plastic Surgery and PodiatryExcision, ablation, vaporizationand photocoagulation of skinlesions, hemostasis, incision,excision, vaporization, ablationand debulking of soft tissue,abdominal, rectal, skin, fat ormuscle tissue anddermabrasion. Examplesinclude:	General Surgery, Dermatology,Plastic Surgery and PodiatryExcision, ablation, vaporizationand photocoagulation of skinlesions, hemostasis, incision,excision, vaporization, ablationand debulking of soft tissue,abdominal, rectal, skin, fat ormuscle tissue anddermabrasion. Examplesinclude:	General Surgery, Dermatology,Plastic Surgery and PodiatryExcision, ablation, vaporizationand photocoagulation of skinlesions, hemostasis, incision,excision, vaporization, ablationand debulking of soft tissue,abdominal, rectal, skin, fat ormuscle tissue anddermabrasion. Examplesinclude:
	General Surgery,Dermatology, PlasticSurgery and PodiatryDebridement ofwounds	Matrixectomy Excision of neuromas Excision of periungual andsubungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitusulcers Hepatobiliary tumors Mastectomy	Matrixectomy Excision of neuromas Excision of periungual andsubungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitusulcers Hepatobiliary tumors Mastectomy	Matrixectomy Excision of neuromas Excision of periungual andsubungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitusulcers Hepatobiliary tumors Mastectomy
DescriptiveInformation	Epic 10(K140120)	QUANTA Diode Laser Family(K100558)	Ceralas Diode 980nm LaserSystem (Models D15, D25)(K072779)	Vectra Laser System andAccessories(K060114)
		• Dermabrasion	• Dermabrasion	• Dermabrasion
		• Vaporization and hemostasisof capillary hemangioma	• Vaporization and hemostasisof capillary hemangioma	• Vaporization and hemostasisof capillary hemangioma
		• Excision, vaporization andhemostasis of abdominaltumors	• Excision, vaporization andhemostasis of abdominaltumors	• Excision, vaporization andhemostasis of abdominaltumors
		• Excisions, vaporization andhemostasis of rectalpathology	• Excisions, vaporization andhemostasis of rectalpathology	• Excisions, vaporization andhemostasis of rectalpathology
		• Pilonidal cystectomy	• Pilonidal cystectomy	• Pilonidal cystectomy
		• Herniorapphy	• Herniorapphy	• Herniorapphy
		• Adhesiolysis	• Adhesiolysis	• Adhesiolysis
		• Parathyroidectomy	• Parathyroidectomy	• Parathyroidectomy
		• Laparoscopiccholecystectomy	• Laparoscopiccholecystectomy	• Laparoscopiccholecystectomy
		• Thyroidectomy	• Thyroidectomy	• Thyroidectomy
		• Resection of organs	• Resection of organs	• Resection of organs
		• Debridement of wounds	• Debridement of wounds	• Debridement of wounds
		• Photocoagulation ofteleangectasis of the legs andface	• Photocoagulation ofteleangectasis of the legs andface	• Photocoagulation ofteleangectasis of the legsand face
		• Photocoagulation of vascularlesions of the face andextremities	• Photocoagulation of vascularlesions of the face andextremities	• Photocoagulation ofvascular lesions of the faceand extremities
		• Endovascular coagulation ofthe greater saphenous vein ofthe thigh in patients withsuperficial vein reflux		• Endovascular coagulation ofthe greater saphenous veinof the thigh in patients withsuperficial vein reflux
		• Treatment of reticular veins		• Treatment of reticular veins
Descriptive Information	Epic 10(K140120)	QUANTA Diode Laser Family(K100558)and branch varicosities	Ceralas Diode 980nm Laser System (Models D15, D25)(K072779)	Vectra Laser System and Accessories(K060114)and branch varicosities
Laser Classification	IV (4)	IV (4)	IV (4)	IV (4)
Operating Voltage	100 - $240V-1.5A$	100 - 240V	100 - 220V	100 - 220 VAC
Laser Medium	InGaAs	Diode Laser	GaAlAs	Diode Laser
Wavelength	$940 \pm 10nm$	980nm	980nm	$980nm \pm 10% (882-1078 nm)$
Current Frequency	50 - 60 Hz	50 - 60 Hz	50 - 60 Hz	50 - 60 Hz
Max Output Power	10 W	30W	15W (D15), 25W (D25)	10/20/30W; 60W; 80W; 100W; 120W
Power Mode	Continuous, Pulse Modulation	Continuous, Pulse Modulation	Continuous, Pulse Modulation	Continuous, Pulse Modulation
Pulse Repetition Rate	Up to 20 KHz	1 - 200 Hz	Not Listed by Manufacturer	Not Listed by Manufacturer
Pulse Duration	0.01 ms - 20 ms	3 - 2500 ms	0.01 - 99.9 sec	Not Listed by Manufacturer
Aiming Beam	Laser Diode, max 1mW,625 - 670nm, Class 3B	Laser Diode, max 3mW, 635,Class 3R	Laser Diode, max 4mW, 635	Laser Diode, Green, 532
Materials	Medical grade plastics, steel,stainless steel, aluminum, brass, andelectronic parts andcomponents	Medical grade plastics, steel,stainless steel, aluminum, brass,and electronic parts andcomponents	Medical grade plastics, steel,stainless steel, aluminum, brassand electronic parts andcomponents	Medical grade plastics, steel,stainless steel, aluminum, brass,and electronic parts andcomponents

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Biolase - Epic 10 - 510(k) Submissior

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Biolase - Epic 10 - 510(k) Submission

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Biolase - Epic 10 - 510(k) Submission

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Non-Clinical Test Data

Non-clinical testing was not performed on this device since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearance under 510(k) No. K130465. The indication included in this 510(k) has already been cleared by the FDA for equivalent medical devices manufactured by Quanta System, S.p.A., Biolitec Inc. and Xintec Corporation, dba, Convergent Laser Technologies.

Clinical Test Data

Clinical testing was not conducted on this device.

Conclusion

Based upon the comparison of the Epic 10 with the predicate devices previously cleared by the FDA, the clinical performance of the Epic 10 for the Indication for Use described above is deemed to be substantially equivalent to the legally-marketed predicate devices, the QUANTA Diode Laser Family, the Ceralas Diode 980nm Diode Laser (Models D15, D25) and the Vectra Laser System and Accessories.

Biolase - Epic 10 - 510(k) Submission

Section 5 Page 6 of 6

Regulation Number and Section

§ 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.