The MH01 laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

It is indicated in medical specialties including, but not limited to:

Urology
Gastroenterology
Arthroscopy
Neurosurgery
Pulmonary
Gynecology
ENT
Dermatology
Plastic Surgery
General Surgery

Device Description

This Special 510(k) of the modified device MH01 is submitted due to Device Modifications of the already cleared device Litho DK30 (K141403Q): MH01 differs from Litho DK30 (K141403Q) about: - housing of components: tower frame instead of desktop - graphic user interface The modified device MH01 has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications. The modified and unmodified devices have the same components, the same laser source emission specifications and the same controlling principles. Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um.

AI/ML Overview

This document is an FDA 510(k) premarket notification for a medical device called MH01. It describes modifications made to an already cleared device, the Litho DK30, and asserts that the MH01 is substantially equivalent to the predicate device.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" are compliance with relevant safety and performance standards for medical electrical equipment and laser products. The reported device performance is its successful passing of these tests.

Acceptance Criteria (Standards)	Reported Device Performance
IEC 60601-1:2005, Mod - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance	"The modified device MH01 passed all the required testing and is in compliance with all applicable sections."
IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.	"The modified device MH01 passed all the required testing and is in compliance with all applicable sections."
IEC 60601-2-22 Third Edition 2007-05, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment	"The modified device MH01 passed all the required testing and is in compliance with all applicable sections."
IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements	"The modified device MH01 passed all the required testing and is in compliance with all applicable sections."
21 CFR 1040.10 and 1040.11 (Performance Standards for Light-Emitting Devices)	"This device complies with 21 CFR 1040.10 and 1040.11."

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

Sample Size: The document does not specify a "test set" in terms of subject or patient data. The testing described is engineering and electrical safety testing of the device itself. Therefore, the "sample size" is effectively one (1) device (the modified MH01) that underwent the tests.
Data Provenance: Not applicable in the context of patient data. The testing was performed on the device by Quanta System SPA in Italy, as indicated by the applicant's address. The testing seems to be prospective (performed on the newly modified device).

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

Not applicable. The ground truth for this type of testing (electrical safety, EMC, laser safety) is established by adherence to the published standards (IEC, FDA CFR) themselves. The "experts" would be the engineers and technicians performing the tests and comparing the results against the limits and criteria defined in these standards. Their qualifications would be in electrical engineering, safety testing, and laser physics, but specific details are not provided in this regulatory document.

4. Adjudication method for the test set:

Not applicable. This is not a study involving human reader interpretation or clinical endpoints. The "adjudication" is a direct comparison of measured device parameters against the limits set by the referenced international 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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a modification to a laser surgical instrument, which does not involve AI or human interpretation in the way typical MRMC studies for diagnostic AI would.

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

No, a standalone algorithm performance study was not done. This device is a physical laser system, not an algorithm.

7. The type of ground truth used:

The ground truth used for this submission is compliance with recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, and 21 CFR 1040.10/1040.11). These standards define the acceptable performance, safety limits, and testing methodologies for medical electrical and laser equipment.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

Summary

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

Quanta System SPA Mr. Francesco Dell'Antonio Compliance Manager Via IV Novembre, 116 21058 Solbiate Olana (Va) Italy

September 3, 2015

Re: K15220 Trade/Device Name: MH01 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: July 23, 2015 Received: August 7, 2015

Dear Mr. Dell'Antonio:

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

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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 (OS) 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/ResourcesforYou/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.

For

Sincerely yours,

Joshua C. Nipper -S

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)

K15220

Device Name MH01

Indications for Use (Describe)

It is indicated in medical specialties including, but not limited to:

· Urology
· Gastroenterology
Arthroscopy
Neurosurgery
Pulmonary
Gynecology
· ENT
· Dermatology
· Plastic Surgery
· General Surgery

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5. Special 510(K) SUMMARY - Device Modifications

Introduction:

This document contains the 510(k) Summary for the device MH01. The basis of this submission is Modifications to Device already cleared. The content of this summary is based on the requirements of 21 CFR 807.92(c).

Applicant /ManufacturerName and Address:	Quanta System SPAVia IV Novembre, 116Solbiate Olona (VA)Italy, 21058
510(k) Contact Person:	Francesco Dell'AntonioCompliance ManagerQuanta System SPA
	Email: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	July 23th, 2015
Device Name:	MH01
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Basis for Submission:	Device modifications
Legally Marketed Device	Litho DK30 (K141403) – Quanta System SPA

The modified device MH01 is claimed to be derived from the legally marketed (unmodified) device Litho DK30 (K141403) because MH01 is the tower version of the already cleared device Litho DK30 (K141403) with modified graphic user interface.

Performance Standards:

This device complies with 21 CFR 1040.10 and 1040.11.

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General Device Description:

graphic user interface
The modified device MH01 has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications.

The modified and unmodified devices have the same components, the same laser source emission specifications and the same controlling principles.

Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um.

There are not incremental changes from the original clearance K141403Q to be taken into account other than the differences between modified and unmodified devices.

Description of the modifications:

The modified device MH01 shares the same architecture and the same laser source of the unmodified device Litho DK30: both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 µm, with no change in the fundamental scientific technology of the device.

The modified device MH01 has the same intended use of the unmodified device. Moreover the intended use of the modified device, as described in its labelling, has not changed as a result of the modifications.

The following modifications have been implemented on the cleared device Litho DK30 (K141403) in order to get the tower version named MH01:

A new mechanical structure housing the internal components, and related covers have been developed
। The GUI (Graphic User Interface) has been reviewed

Based on the nature of the changes implemented, the device underwent and successfully passed EMC, electrical safety and performance testing according to IEC 60601-1 and its collateral standards.

Picture 7-1 shows the external appearance of the modified device and the unmodified device.

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Image /page/6/Picture/1 description: The image contains two medical devices. The device on the left is a black and silver box with a screen that displays various settings and parameters. The device on the right is a white machine with a screen on top and a large pink "R" logo on the side. Both devices appear to be used for medical treatments or procedures.

Picture 5-1 – device Litho DK30 (on the left) and MH01 (on the right)

Intended Use/Indications for Use

The modified device MH01 has the same intended use of the unmodified device, as follows:

lt is indicated in medical specialties including, but not limited to:

Urology
Gastroenterology
Arthroscopy
Neurosurgery
Pulmonary
Gynecology
ENT
Dermatology
. Plastic Surgery
General Surgery

Moreover the intended use of the modified device, as described in its labelling, has not changed as a result of the modifications.

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Substantial Equivalence:

The modified and unmodified devices have the same components, the same laser sources with the same emission specifications and the same controlling principles.

The modified device MH01 has the same intended use of the unmodified device.

Thus the modified device MH01 is substantially equivalent to the previously leqally marketed device Litho DK30 (K141403).

Performace testing

The modified device MH01 was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:

-IEC 60601-1:2005, Mod - Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
-IEC 60601-2-22 Third Edition 2007-05, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
-IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements

The modified device MH01 passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.

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.