HS-890A 980mm Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization , incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as vascular lesions and dental procedure.

Device Description

The Diode Laser Therapy Device is a desktop device which utilizes a semiconductor diode with invisible infrared radiation as a laser source (980nm). The laser power is delivered to the treatment via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system and laser system.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "980nm Diode Laser Therapy Device." This document details the device's characteristics, its intended use, and its comparison to a predicate device for the purpose of demonstrating substantial equivalence. It is important to note that the document does not describe acceptance criteria and a study proving a device meets those criteria in the context of an AI/machine learning-based device. Instead, it outlines the regulatory approval process for a traditional medical laser device.

Therefore, many of the requested items (e.g., sample size for test set, expert qualifications for ground truth, MRMC study, training set information) are not applicable to the content of this document.

However, I can extract the information that is available:

1. A table of acceptance criteria and the reported device performance:

The document does not present acceptance criteria in a table format with reported device performance in the way one would for an AI/ML device evaluating statistical metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly the adherence to established performance standards for medical laser devices, and the reported device performance is its successful compliance with these standards.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with Electrical Safety standard IEC 60601-1	Device complies with IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012
Compliance with Electromagnetic Compatibility standard IEC 60601-1-2	Device complies with IEC 60601-1-2:2014
Compliance with Laser Safety standard IEC 60825-1	Device complies with IEC 60825-1:2014
Compliance with Particular Requirements for Laser Equipment standard IEC 60601-2-22	Device complies with IEC 60601-2-22:2007(third edition) +A1:2012
Device functions as intended within its specifications (e.g., wavelength, power output, pulse width, operation mode, delivery system, aiming beam, laser class, operation interface, power supply, dimensions, weight, safety classification, software)	Device specifications (e.g., 980nm±10nm wavelength, 1-30W output power, 5~400ms pulse width, etc.) are listed and compared to the predicate device, implying performance within these stated parameters. The "Non-Clinical Testing" section states that tests were performed to "verify that the proposed device met all design specification" and "The test result demonstrated that the proposed device complies with the following standards."
Substantial Equivalence to Predicate Device (K151890)	Concluded: "Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device."

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

This information is not applicable. The device is a physical laser therapy device, not an AI/ML algorithm that processes data. Testing involved engineering and safety compliance rather than data analysis.

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

This information is not applicable. Ground truth, in the context of this device, would refer to the physical and electrical safety standards outlined, which are established by recognized regulatory and standardization bodies.

4. Adjudication method for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical review of imaging or complex diagnoses for AI/ML performance evaluation. The testing here is for compliance with technical standards.

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:

This information is not applicable. This is not an AI-assisted device, and no human reader studies are mentioned.

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

This information is not applicable. The device is a standalone physical laser system, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's acceptance is its compliance with established international and national standards for medical electrical equipment and laser safety. These include:

IEC 60601-1 (General requirements for basic safety and essential performance)
IEC 60601-1-2 (Electromagnetic disturbances)
IEC 60825-1 (Safety of Laser products - Equipment classification and requirements)
IEC 60601-2-22 (Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment)

The document explicitly states that "The test result demonstrated that the proposed device complies with the following standards."

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary

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August 16, 2019

Shanghai Apolo Medical Technology Co., Ltd. % Claire Zhang Manager Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705 , Building 1, West Guangzhong Road 555, Jingan District, Shanghai, 200071 China

Re: K191349

Trade/Device Name: 980nm Diode Laser Therapy Device 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 17, 2019 Received: May 20, 2019

Dear Claire Zhang:

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.

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

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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 (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,

Neil R. P. Ogden, M.S. Acting Team Assistant Director Light Based Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191349

Device Name Diode Laser Therapy Device

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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Section 3-510(k) summary

I Submitter

Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231,China

Establishment Registration Number: 3007120647

Contact person: Felix Li Position: Regulatory Affairs Phone: +86-138 4919 0618 Fax: +86-21-34622840 E-mail: liqiang@apolo.com.cn

II Proposed Device

Trade Name of Device:	980nm Diode Laser Therapy Device
Common name:	Powered Laser Surgical Instrument
Regulation Number:	21 CFR 878.4810
Regulatory Class:	Class II
Product code:	GEX
Review Panel:	General & Plastic Surgery

III Predicate Devices

510(k) Number:	K151890
Trade name:	Medical Diode Laser Systems
Common name:	Powered Laser Surgical Instrument
Classification:	Class II
Product Code:	GEX
Manufacturer	Wuhan Gigaa Optronics Technology Company., Ltd.

IV Device description

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The proposed device includes power supply system, delivery system, control system, cooling system and laser system.

V Indication for use

The Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as: vascular lesions and dental procedure.

Item	Proposed device	Predicate device(K151890)
Product name	Diode Laser Therapy Device	Medical Diode Laser System
Product Code	GEX	GEX
Regulation No.	21 CFR 878.4810	21 CFR 878.4810
Class	Class II	Class II
Model	HS-890A	VELAS II-30B
Indication for use	The Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization, incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as: vascular lesions and dental procedure.	The “VELAS II-30A/30B” are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including Vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology

		Endovascular coagulation, OralSurgery and Dental Procedures,Lase assisted lipolysis.
Laser Type	GaA1As Diode Laser	GaA1As Diode Laser
Components	Laser system, Color touchscreen, Fiber, Footswitch	Laser system, Color touch screen,Fiber, Footswitch.
Wavelength	980nm±10nm	VELAS II-30B: 980nm±10nm
Outputpower	1-30W	1-30W
Pulse width	5~400ms	10ms~2.5s
Operationmode	CW, single pulse, repeatpulse	CW, single pulse, repeat pulse
LightDeliverysystem	Fiber core diameter: 300µm,NA=0.22With SMA905 connector	Fiber core diameter: 400µm, 600µmNA≥0.22With SMA905 connector
Aimingbeam	650nm, ≤2mW , adjustable	Diode laser of 635/532nm powermax.<5mW, adjustable.
Laser class	4	4
Operationinterface	Color LCD touch screen	Color LCD touch screen
Powersupply	100-240VAC, 50/60Hz	100-240VAC, 50/60Hz,
Dimension	280mm[W]× 270mm[L]×370mm[H]	400mm[W]×385mm[L]×200mm[H]
Weight	8kg	12.9kg
Safetyclassification	Class I	Class I
Software	Yes	Yes

VI Comparison of technological characteristics with the predicate devices

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VII Non-Clinical Testing

A battery of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:

Electrical safety and electromagnetic compatibility

IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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IEC 60601-1-2:2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and requirements

IEC 60601-2-22:2007(third edition) +A1:2012 for use in conjunction with IEC 60601-1:2005 (third edition) +A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for the safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

VIII Clinical Testing

It is not applicable.

IX Conclusion

Base on the performance testing and validation studies that the subject device is substantially equivalent to the predicate device.

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.