MX-7000 CO2 laser system is indicated for use in non-fractionated mode is Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and in Podiatry.

When used in fractionated mode, the MX-7000 CO2 system is indicated for use ablative skin re-surfacing, Wrinkle, Fine line, Rhylides, Furrow in Dermatology, Plastic surgery, and in General surgery.

Device Description

MX-7000 Laser system utilize a Co2 module to generate a laser beam with wave length of 10.600 nm and used fractional or non fractional mode for different indication. The Doctor can optimize the effect for different applications by controlling the power of laser pulse and using different hand pieces.

The system are supplied with two hand pieces ( Scanned or/and Dynamic),depend the device configuration

This system consist of

Optic main Bench assembly, Articulated Arm LCD control panel, Laser Cooling system Hand pieces set, Foot Pedal switch.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (MX-7000 MICROXEL CO2 Laser system). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data to establish performance against acceptance criteria in the manner described in the request. Thus, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment, including MRMC studies or standalone algorithm performance, is not available in this document.

However, I can extract information related to the device's intended use and the regulatory conclusion, which are implicitly related to its "meeting acceptance criteria" in the context of a 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

Information Not Available in the Document:

A table of acceptance criteria and the reported device performance: This document does not establish specific quantitative performance metrics or acceptance criteria for a clinical study comparing the device's output to a predefined standard or clinical endpoint. The "performance" is implicitly tied to its substantial equivalence to predicate devices, which are already deemed safe and effective for their intended uses.
Sample sizes used for the test set and the data provenance: No test sets or associated sample sizes are mentioned for performance evaluation in a clinical study context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical study with ground truth establishment is not detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a CO2 laser system, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Information Related to "Acceptance Criteria" (in the context of a 510(k)):

In the context of a 510(k) submission the "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, main function, technology, principal operation, and performance. The "study" that proves this is the 510(k) submission itself, where the applicant provides comparative information and justifications.

Here's the closest approximation of the requested table and relevant details based on the provided text:

1. Table of Acceptance Criteria (as implied by 510(k) substantial equivalence) and Reported Device Performance

"Acceptance Criteria" Category (Implied by 510(k))	Predicate Device Performance / Characteristics (Implicit Baseline)	MX-7000 MICROXEL Reported Performance / Characteristics
Intended Use	Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in non-fractionated mode, and ablative skin re-surfacing, Wrinkle, Fine line, Rhylides, Furrow in fractionated mode. (as per legally marketed predicate devices). Used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and Podiatry.	Non-fractionated mode: Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. Used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and in Podiatry. Fractionated mode: Ablative skin re-surfacing, Wrinkle, Fine lines, Rhylides, Furrow. Used in Dermatology, Plastic surgery, and General surgery.
Technology	CO2 module generating a laser beam with a wavelength of 10,600 nm.	CO2 module to generate a laser beam with a wavelength of 10,600 nm.
Principal Operation	Utilizes fractional or non-fractional mode; Doctor can optimize effect by controlling power of laser pulse and using different hand pieces.	Utilizes fractional or non-fractional mode for different indications; Doctor can optimize the effect for different applications by controlling the power of laser pulse and using different hand pieces. Two hand pieces (Scanned or/and Dynamic) supplied.
Safety Standards Compliance	Compliance with relevant industry and medical device safety standards (e.g., IEC standards).	Manufactured in accordance with: - IEC 60601 Medical Electrical equipment part 1. General requirement for safety amend 2 1995 - IEC60601-1-2 Electro magnetic compatibility test ED 2001 EMC test - IEC60601-1-22-22: 1996 Particular requirement for the safety and Diagnostic of Therapeutic laser Equipment.
Conclusion of Equivalence	Predicate devices are considered safe and effective for their stated indications.	"The D.S.E, MX-7000 Co2 system, in this submission, is substantially equivalent to several already cleared predicate device in respect to Intended use, Main function, Technology, Principal operation and performance. So, it does not raise any additional concerns regarding safety and effectiveness." (Bio-Med USA) FDA's conclusion: "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

2. Sample sized used for the test set and the data provenance:

Not applicable for a typical clinical test set in this 510(k) submission. The "test" is a comparison to predicate devices based on design and technical specifications, not a clinical trial with a defined patient sample size.
Data provenance: The submission originates from Bio-Med USA Inc. (U.S.) and the manufacturer is Dae Shin Enterprise (Seoul, Korea). The data provided in the 510(k) is a compilation of device specifications and comparisons to predicate devices, not patient data from a specific country of origin. This is a retrospective submission to the FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set requiring expert ground truth is described. The "experts" involved are the regulatory reviewers at the FDA who assess the substantial equivalence claim, and the engineers/scientists at Dae Shin Enterprise who designed and tested the device to meet its specifications and relevant standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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 surgical laser, not an imaging or diagnostic AI-assisted device subject to MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices based on a demonstration that the new device is functionally and technologically equivalent and therefore "as safe and effective" as the predicates.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established:

Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a clinical study report with detailed performance metrics and acceptance criteria in the typical sense of a diagnostic or interventional efficacy trial.

Summary

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K1118,31 bygewtf@

DEC 1 9 2011

Summary of safety and effectiveness

In accordance with Section 513 (1) of the SMDA as defined in 21CFR part 807.3 this summary is submitted to obtain Pre-Market 510 (K) notification.

1. Submitter / Contact person.

Mr. Young Chi. President Bio-Med USA Inc. ( Reg Nr. 2246683) 111 Ellison Street, Paterson, NJ 07505. U.S.A. Tel: 1 973 278 5222 Fax: 201 934 6030 e mail : biomedusa(@msn.com

2. Manufacturer

Dae Shin Enterprise. 401/2, 170-5 Gruo-dong, Guro-gu, Seoul, Korea Tel: 2 2025 1151 Fax : 2 2025 1154 Contact: K. Kim President

3. Name of Device

Trade name	MX-7000 MICROXEL
Classification name	Powered, Laser surgical instrument with Micro-beam/Fractional output
Common name	CO2 Laser system
Regulation	880.4810
Class	II
Product Code	ONG
Subsequent product code	GEX

4. Legally marketed Predicate Device

K100610	eCO2 Plus Laser	Lutronic
K100590	Edge CO2 Laser,	JM Systems

5. Device Description

The system are supplied with two hand pieces ( Scanned or/and Dynamic),depend the device configuration

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This system consist of

K111831 Page @ of @

Optic main Bench assembly, Articulated Arm LCD control panel, Laser Cooling system Hand pieces set, Foot Pedal switch.

Manufactured in accordance with both mandatory and voluntary standard

IEC 60601 Medical Electrical equipment part 1. General requirement for safety amend 2 1995 IEC60601-1-2 Electro magnetic compatibility test ED 2001 EMC test IEC60601-1-22-22: 1996 Particular requirement for the safety and Diagnostic of Therapeutic laser Equipment

6. Intended use

When used in fractionated mode, the MX-7000 CO2 system is indicated for use ablative skin re-surfacing, Wrinkle, Fine line, Rhylides, Furrow in Dermatology, Plastic surgery, and in General surgery.

7. Conclusion.

The D.S.E, MX-7000 Co2 system, in this submission, is substantially equivalent to several already cleared predicate device in respect to Intended use, Main function, Technology, Principal operation and performance.

So, it does not raise any additional concerns regarding safety and effectiveness.

Bio-Med USA will update and include in this summary any other information deemed seasonally necessary by the FDA

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

DEC 1 9 2011

Bio-Med USA, Inc. % Mr. Young Chi President 111 Ellison Street Paterson, New Jersey 07505

Re: K111831

Trade/Device Name: MX-7000, Microxel 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: ONG, GEX Dated: September 02, 2011 Received: December 13, 2011

Dear Mr. Chi:

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.

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Page 2 - Mr. Young Chi

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for use statement

510 (K) number : K111831

Device name : MX-7000, MICROXEL

Indication for use : MX-7000 CO2 laser system is intended for use in non-fractionated mode for Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General Surgery, Gynecology, Neurosurgery, and in Podiatry.

When used in fractionated mode, the MX-7000 CO2 system is intended to be used for ablative skin re-surfacing, Wrinkle, Fine lines, Ryhides, Furrow in Dermatology, in Plastic surgery, and in General surgery.

Prescription use or/and Over the Counter use XX (Part 21 CFR 801 Sub part D ) (Part 21CFR 801 Sub part C)

Please do not write below line-continued an another pages if needed

Concurrence of CDRH, office of Device Evaluation ( ODE )

Nel R.P. Quiles for man

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111831

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.