(267 days)
Not Found
No
The document describes a laser surgical instrument and its components, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The document explicitly states "therapeutic device" and describes its intended use as a medical instrument for surgical procedures on soft tissue, indicating a therapeutic purpose.
No
The device description clearly states its intended use is as a "laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue," which are all therapeutic actions, not diagnostic ones.
No
The device description clearly outlines hardware components such as a laser diode, fiber optic cable, handpiece, base console, and wireless footswitch.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue." This describes a device used on the body for surgical procedures, not a device used on samples taken from the body for diagnostic purposes.
- Device Description: The description details a laser system that emits energy via a fiber optic cable to a handpiece for direct application to tissue. This is consistent with a surgical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the Epic 10 is a surgical laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, wounds
Indicated Patient Age Range
Not Found
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)
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 testing was not conducted on this device.
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.
0
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
1
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
2
Indications for Use
510(k) Number (if known):
Device Name: Epic 10
Indications for 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 .
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
Section 4 Page 2 of 2
3
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
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.
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
4
Summary of Technological Characteristics
.
1
:
| Descriptive
Information | Epic 10
(K140120) | QUANTA Diode Laser Family
(K100558) | Ceralas Diode 980nm Laser
System (Models D15, D25)
(K072779) | Vectra Laser System and
Accessories
(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 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
Excision, ablation, vaporization
and photocoagulation of skin
lesions, hemostasis, incision,
excision, vaporization, ablation
and debulking of soft tissue,
abdominal, rectal, skin, fat or
muscle tissue and
dermabrasion. Examples
include: | General Surgery, Dermatology,
Plastic Surgery and Podiatry
Excision, ablation, vaporization
and photocoagulation of skin
lesions, hemostasis, incision,
excision, vaporization, ablation
and debulking of soft tissue,
abdominal, rectal, skin, fat or
muscle tissue and
dermabrasion. Examples
include: | General Surgery, Dermatology,
Plastic Surgery and Podiatry
Excision, ablation, vaporization
and photocoagulation of skin
lesions, hemostasis, incision,
excision, vaporization, ablation
and debulking of soft tissue,
abdominal, rectal, skin, fat or
muscle tissue and
dermabrasion. Examples
include: |
| | General Surgery,
Dermatology, Plastic
Surgery and Podiatry
Debridement of
wounds | Matrixectomy Excision of neuromas Excision of periungual and
subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus
ulcers Hepatobiliary tumors Mastectomy | Matrixectomy Excision of neuromas Excision of periungual and
subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus
ulcers Hepatobiliary tumors Mastectomy | Matrixectomy Excision of neuromas Excision of periungual and
subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus
ulcers Hepatobiliary tumors Mastectomy |
| Descriptive
Information | Epic 10
(K140120) | QUANTA Diode Laser Family
(K100558) | Ceralas Diode 980nm Laser
System (Models D15, D25)
(K072779) | Vectra Laser System and
Accessories
(K060114) |
| | | • Dermabrasion | • Dermabrasion | • Dermabrasion |
| | | • Vaporization and hemostasis
of capillary hemangioma | • Vaporization and hemostasis
of capillary hemangioma | • Vaporization and hemostasis
of capillary hemangioma |
| | | • Excision, vaporization and
hemostasis of abdominal
tumors | • Excision, vaporization and
hemostasis of abdominal
tumors | • Excision, vaporization and
hemostasis of abdominal
tumors |
| | | • Excisions, vaporization and
hemostasis of rectal
pathology | • Excisions, vaporization and
hemostasis of rectal
pathology | • Excisions, vaporization and
hemostasis of rectal
pathology |
| | | • Pilonidal cystectomy | • Pilonidal cystectomy | • Pilonidal cystectomy |
| | | • Herniorapphy | • Herniorapphy | • Herniorapphy |
| | | • Adhesiolysis | • Adhesiolysis | • Adhesiolysis |
| | | • Parathyroidectomy | • Parathyroidectomy | • Parathyroidectomy |
| | | • Laparoscopic
cholecystectomy | • Laparoscopic
cholecystectomy | • Laparoscopic
cholecystectomy |
| | | • Thyroidectomy | • Thyroidectomy | • Thyroidectomy |
| | | • Resection of organs | • Resection of organs | • Resection of organs |
| | | • Debridement of wounds | • Debridement of wounds | • Debridement of wounds |
| | | • Photocoagulation of
teleangectasis of the legs and
face | • Photocoagulation of
teleangectasis of the legs and
face | • Photocoagulation of
teleangectasis of the legs
and face |
| | | • Photocoagulation of vascular
lesions of the face and
extremities | • Photocoagulation of vascular
lesions of the face and
extremities | • Photocoagulation of
vascular lesions of the face
and extremities |
| | | • Endovascular coagulation of
the greater saphenous vein of
the thigh in patients with
superficial vein reflux | | • Endovascular coagulation of
the greater saphenous vein
of the thigh in patients with
superficial 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, and
electronic parts and
components | Medical grade plastics, steel,
stainless steel, aluminum, brass,
and electronic parts and
components | Medical grade plastics, steel,
stainless steel, aluminum, brass
and electronic parts and
components | Medical grade plastics, steel,
stainless steel, aluminum, brass,
and electronic parts and
components |
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Biolase - Epic 10 - 510(k) Submissior
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Biolase - Epic 10 - 510(k) Submission
Section 5 Page 4 of 6
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Biolase - Epic 10 - 510(k) Submission
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Section 5 Page 5 of 6
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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