The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractionated mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry.

The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractionated mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

Device Description

The BIOXEL CO2 Surgical Laser System is used in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.

This equipment consists of main body, Articulated Arm, hand-piece, protective goggles, foot switch and power cable. In a main body, there are a monitor displaying all information needed by an operator at a glance and a touch LCD screen, which facilitates operation of this equipment at user's convenience. The laser output is initiated with the foot switch.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the BIOXEL Fractional CO2 Surgical Laser System. This document outlines the device's characteristics, indications for use, and a comparison to predicate devices, but it does not contain the detailed information typically found in a scientific study that proves the device meets specific acceptance criteria.

Instead, the document focuses on regulatory compliance and demonstrating substantial equivalence to previously marketed devices. Therefore, I cannot construct the requested table and answer the study-specific questions as the necessary information is not present in the provided text.

Here's what I can extract and what is missing:

Information Present:

Device Name: BIOXEL Fractional CO2 Surgical Laser System
Indications for Use:
- Non-fractionated mode: Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues in Dermatology, Plastic and General Surgery, Neurosurgery, and Podiatry.
- Fractionated mode: Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.
Predicate Devices: K111831 MX-7000 MICROXEL and K180036 SMAXEL.
Summary of Performance Testing (General):
- Software: Verification and validation testing confirm appropriateness for release.
- Electrical Safety and Electromagnetic Compatibility: Tested per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
- Biocompatibility: Established per ISO 10993-5.
Conclusion: The device was found substantially equivalent to predicate devices.

Information NOT Present (which would be required to answer your questions):

Specific Acceptance Criteria: The document mentions general performance (e.g., "performs as intended") and compliance with recognized consensus standards (electrical, EMC, biocompatibility). However, it does not list measurable acceptance criteria (e.g., "power output must be within +/- 5% of target," "ablation depth will be X mm +/- Y mm in Z tissue after N pulses," "complication rate not to exceed X%").
Reported Device Performance against specific criteria: Without specific criteria, there are no reported performance values to compare against them.
Details of the "Study" (if it can be called that in this context): The document refers to "testing" (software verification, electrical safety, biocompatibility) but not to a clinical or comparative performance study in the way typically discussed for AI/diagnostic devices.
Sample Size (test set, training set): Not mentioned for any type of performance data.
Data Provenance (country, retrospective/prospective): Not mentioned.
Number of experts and their qualifications: Not applicable, as there's no mention of expert-derived ground truth or human reader studies.
Adjudication method: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported.
Standalone (algorithm only) performance: Not applicable, as this is a physical laser device, not an AI algorithm.
Type of ground truth used: Not applicable, as there's no diagnostic or predictive algorithm being evaluated in a clinical context.
How ground truth for training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device, not a research paper detailing the performance of a diagnostic algorithm against specific clinical acceptance criteria. It affirms compliance with general safety and performance standards for market authorization but does not delve into the kind of detailed performance metrics you've requested.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

BraunSolutions % Mr. Alexander Henderson Official Correspondent 970 South Dawson Way Unit 14 Aurora, Colorado 80012-3827

Re: K173359

Trade/Device Name: BIOXEL Fractional CO2 Surgical Laser System 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, ONG Dated: June 1, 2018 Received: June 5, 2018

Dear Mr. Henderson:

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 Actinclude 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 device

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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.

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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: 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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Indications for Use

510(k) Number (if known) K173359

Device Name BIOXEL CO2 Surgical Laser System

Indications for Use (Describe)

The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractionated mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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RM. 1412, SJ TECHNO VILLE, 278, BEOTKKOT-RO, GEUMCHEON-GU, SEOUL, KOREA

TEL : 82-2-3281-9091 FAX : 82-2-3281-8011 E-MAIL : amimed@amimed.co.kr

EXECUTIVE SUMMARY

1. Name of Device

Trade/Device Name: BIOXEL Fractional CO2 Surgical Laser System Regulation Number: 21CFR 878.4810 Regulation Name: Powered Laser Surgical Instrument Regulation Description: Laser Surgical instrument for use in general and plastic surgery and dermatology. Device Class: II Product Code: GEX

2. Predicate Devices

K111831 MX-7000 MICROXEL, Dae Shin Enterprises K180036 SMAXEL, IDS, Ltd.

3. Prior Submissions Statement

There were no prior submissions for the BIOXEL Fractional CO2 Surgical Laser System.

4. Device Description

The BIOXEL CO2 Surgical Laser System is used in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.

5. Indications for Use

The BIOXEL CO2 Surgical Laser System is indicated for use, in the non-fractional mode, for Incision, Excision, Ablation, Vaporization, and Coagulation of Human Body Soft Tissues. The system is intended for use in Dermatology, Plastic and General Surgery, Neurosurgery and Podiatry.

The BIOXEL CO2 Surgical Laser System is indicated for use, in the fractional mode, for Ablative Skin Resurfacing, Wrinkle, Fine line, Rhylides, and Furrows in Dermatology.

6. Comparison Chart to Predicate Devices

Characteristics	BIOXEL (AMI, Inc.)Subject Device	SMAXEL (IDS, Ltd.)K180036	MICROXEL (Dae Shin)K111831
Laser Wavelength	10,600nm	10,600nm	10,600nm
Laser Type	CO2	CO2	CO2
Maximum Power	40W	40W	40W
Laser TransferMethod	Articulated Arm with handpiece	Articulated Arm withhand piece	Articulated Arm withhand piece
Dimensions(mm)	440 x 480 x 1,830	420 x 410 x 920	420 x 410 x 1,120
Weight	50 kgs	50 kgs	45 kgs
Energy	1-30 mJ	5-30 mJ	4-30 mJ

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RM. 1412, SJ TECHNO VILLE, 278, BEOTKKOT-RO, GEUMCHEON-GU, SEOUL, KOREA

TEL : 82-2-3281-9091 FAX : 82-2-3281-8011 E-MAIL : amimed@amimed.co.kr

Density	1-23 Level	1-23 Level	1-23 Level
Scan Size	20 x 20 mm	20 x 20 mm	5 x 15 mm
Scan Shape	Square, Hexagonal,Triangular, Circular	Square, Hexagonal,Triangular, Circular	Square, Circle
Mode	Fractional ModeGeneral (CW, Normal Pulse,Super Pulse, Ultra Pulse)	General, Fractional, Non-Factional, Low PowerFractional	Fractional ModeNormal Mode(CW, SuperDream Pulse, UltraDream Pulse)
Off Time	0.2 ~ 2.5 sec, Single	0.5 ~ 2.5 sec, Single	0.5 ~ 1.5 sec, Single

8. Summary of Performance Testing

The BIOXEL performs as intended based on performance data provided in the submission.

Software: Verification and validation testing of the software confirm that the software version is appropriate for release.

Electrical Safety and Electromagnetic Compatibility: The BIOXEL has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22 and IEC 60825-1).

Biocompatibility: Biocompatibility of the patient contacting components of the device has been established per ISO 10993-5.

9. Conclusion

The BIOXEL CO2 Surgical Laser System was found to be substantially equivalent to the predicate devices.

The BIOXEL CO2 Surgical Laser System shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.

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.