The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, excision, ablation, or photocaogulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.

Device Description

The Aurora MD-30 CO2 Laser is a Carbon Dioxide (CO2) surgical laser system that can deliver up to 30 watts of laser power in the 11.2-micron range in the infrared. The laser can be used in a variety of surgical specialties. The power can be selectively delivered either through an articulated arm or through infrared fibers using an integrated electromechanically controlled optical switch that directs the beam either vertically into the articulated arm or at an angle into the fiber. The laser can operate in either continuous wave, pulsed or super pulse modes. It can deliver laser power down to 1/2 a watt and can operate down to millisecond pulse widths. The system also has a visible aiming beam to indicate where the CO2 laser beam will be delivered.

The laser system has a 12inch highly visible color touchscreen to control the laser. It consists of a small self-contained floor standing, easily moveable console which contains the laser and all associated electronics and delivery systems.

The Aurora MD-30 CO2 Laser has an integrated dual switch adapter that is operated by an electrical linear motor and controlled by the console. The switch allows the user to redirect the laser beam from the articulated arm to the fiber as desired.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Aurora MD-30 CO2 Laser). It describes the device, its intended use, and compares its technological characteristics to predicate devices. Crucially, it states that "Clinical testing was not required to establish substantial equivalence" and therefore, the document does not contain any information about a study that proves the device meets acceptance criteria related to accuracy or performance in a clinical setting.

The "Non-Clinical Testing Summary" table lists tests against various IEC standards (e.g., IEC 60601-1 for basic safety and essential performance, IEC 60601-2-22 for laser equipment, IEC 60601-1-2 for electromagnetic compatibility). These are engineering and safety tests, not clinical performance tests.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical performance, as the document explicitly states such a study was "NA - Clinical testing was not required to establish substantial equivalence."

To answer your request, if this were an AI/ML device or a device where clinical performance was required for substantial equivalence, the document would contain sections detailing:

A table of acceptance criteria and the reported device performance: This would list target metrics (e.g., sensitivity, specificity, accuracy, concordance with experts) and the achieved values from a clinical study.
Sample size used for the test set and the data provenance: Details on how many cases were in the test set, where the data came from (e.g., specific hospitals, a registry), and if it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information on how many clinicians reviewed the cases, and their credentials.
Adjudication method: How disagreements amongst experts were resolved (e.g., primary reads, consensus review, super-reviewer).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Description of the study design, and effect sizes (e.g., improvement in reader performance with AI assistance).
If a standalone performance (algorithm only) was done: The performance metrics (sensitivity, specificity, AUROC, etc.) of the algorithm on its own.
The type of ground truth used: Whether it was expert consensus, pathology reports, follow-up data, etc.
The sample size for the training set: The number of cases used to train the AI model.
How the ground truth for the training set was established: Similar to the test set, but for the data used to teach the model.

Since the provided document pertains to a surgical laser system where substantial equivalence was demonstrated through comparison to predicate devices and engineering/safety non-clinical testing, it does not include the type of clinical performance data you are asking for.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, bold blue font.

September 22, 2022

Laser Engineering, Inc. Laurie Dobbs Quality Assurance 475 Metroplex Drive Suite 401 Nashville, Tennessee 37211

Re: K211605

Trade/Device Name: Dual Switch 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: May 20, 2021 Received: May 25, 2021

Dear Laurie Dobbs:

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.

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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 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 (QS) 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.

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211605

Device Name Aurora MD-30 CO2 Laser

Indications for Use (Describe)

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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Laser Engineering 510k

510(k) Summary

In accordance with 21 CFR 807.92 the 510(k) Summary for the Laser Engineering Aurora MD-30 CO2 Laser is provided below.

Submitter:	Laser Engineering475 Metroplex Drive, Suite 401Nashville, TN 37211Tel: (615) 739-5418
Contact Person:	Laurie DobbsManagement RepresentativeEmail: 1.dobbs@americansurg.com
Date Prepared:	8-22-2022
Device Proprietary Name:	Aurora MD-30 CO2 Laser
Device Common Name:	Aurora MD-30 CO2 Laser
Classification Name:	Powered Laser Surgical Instrument
Classification Regulation:	21 CFR 878.4810
Product Code:	GEX
Predicate Device Name(s):	MD CO2 Surgical Laser SystemDual Switch
Predicate Manufacturer:	Laser Engineering
Predicate 510k(s):	K905676, K951812

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Device Description:

Indications for Use:

The intended use for the Aurora MD-30 CO2 Laser is for the vaporization, excision, ablation, or photocoagulation of soft tissue in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.

Technological Characteristics Compared to Predicate Device

Product	UltrapulseLaser	MD CO2Laser & DualSwitch	Aurora MD-30 CO2 laser
510(K)Number	K951812	K905676	K211605
Manufacturer	Coherent/Lumenis	LaserEngineering,Inc	LaserEngineering,Inc
Laser Type	CO2 GasLaser	CO2 GasLaser	CO2 GasLaser	Same
OperatingWavelengths	11.1Microns	10.6 Microns	11.2 Microns	Similar
OutputPower	0.5 to 45Watts	0.5 to 30Watts	0.5 to 30Watts	Similar
Laser BeamMode	TEM00	TEM00	TEM00	Same

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OperatingModes	Continuousor Pulsed	Continuousor Pulsed	Continuousor Pulsed	Same
Pulse Widths	0.01 to 1.0Sec	0.05 to 1.0Sec	0.05 to 1.0Sec	Same/Similar
Controlmethod	ComputerandTouchscreen	ComputerandTouchscreen	ComputerandTouchscreen	Same
Aiming BeamPower	5 Milliwatts	5 Milliwatts	5 Milliwatts	Same
Laser PowerDeliverySystem	Articulatedarm	Articulatedarm orHollowWaveguide	Articulatedarm orHollowWaveguide	Same/Similar
BeamSwitchingMethod	n/a	ManualSwitch	Electro-mechanicalLinear Motor	Different
OutputIndicator	LEDs	LEDs	LEDs	Same

The proposed device's output parameters are either the same or similar as output parameters from the predicate devices. The proposed device uses an electro-mechanical motor rather than a manual switch to divert the output beam. This modification does not raise new types of questions regarding the safety and efficacy of the device, and the proposed device's beam diverter has been tested to demonstrate that it can be used safely and effectively for the proposed indications for use.

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Non-Clinical Testing Summary

Test Standard	Test Description	Test Report	Test Results
IEC 60601-1:2005Ed.3+A1;C1:2014	Medical Electrical Equipment - Part 1:General Requirements For BasicSafety And Essential Performance	104954641BOX-002	PASS
IEC 60601-1-6:2010Ed.3+A1	Medical Electrical Equipment - Part 1-6: General Requirements For BasicSafety And Essential Performance -Collateral Standard: Usability	104954641BOX-003	PASS
IEC 60601-2-22:2019 Ed.4	Medical Electrical Equipment - Part 2-22: Particular Requirements for BasicSafety and Essential Performance ofSurgical, Cosmetic, Therapeutic andDiagnostic Laser Equipment	104954641BOX-004	PASS
IEC 60601-1-2:2014Ed.4	Medical Electrical Equipment - Part 1-2: General Requirements For Safety -Collateral Standard: ElectromagneticCompatibility - Requirements AndTests	104954641BOX-017	PASS

Clinical Testing:

NA - Clinical testing was not required to establish substantial equivalence

Conclusions:

The proposed device utilizes technological characteristics that are the same or are similar to the predicate devices. The proposed device's technological characteristics do not raise new types of questions regarding safety and effectiveness, and performance testing conducted supports that the device can be used safety and effectively for the proposed indications for use above. Based on the comparison and analysis of data within this 510(k) submission, the proposed device is considered to be Substantially Equivalent (SE) 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.