The Cyber Ho 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 haemostasis 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
0 ENT
Dermatology 0
Plastic Surgery ●
General Surgery .

Device Description

This Special 510(k) of the modified device Cyber Ho is submitted due to Device Modifications of the already cleared device Litho (K163009) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power, energy and frequency.

AI/ML Overview

The provided text is a 510(k) Summary for the Cyber Ho laser system, detailing modifications made to an already cleared device, Litho (K163009). The document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. It does not contain information about acceptance criteria for a diagnostic algorithm, a study proving device meeting acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.

Instead, the document details physical device modifications, regulatory compliance, and performance testing related to electrical safety, electromagnetic compatibility, and laser equipment standards.

Here's an analysis of what is present and what is missing based on your request:

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

Not provided. The document does not include quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics typically associated with a diagnostic or AI algorithm. It only states that the device "successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards" and "passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. This information is relevant to studies involving patient data or images, which are not described here. The study here focuses on device engineering performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. This information is relevant to clinical studies where expert consensus is used to establish ground truth for a diagnostic algorithm. The document describes engineering and safety testing.

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

Not applicable/Not provided. This is relevant for clinical studies involving expert readers, which is not the type of study described.

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 provided/Not applicable. This document describes a laser surgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant to this submission.

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

Not applicable/Not provided. The device is a surgical laser system, not an algorithm, so "standalone algorithm performance" is not relevant in this context.

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

Not applicable/Not provided. The "ground truth" in this context refers to compliance with established engineering and safety standards (e.g., electrical safety limits, EMC emission limits).

8. The sample size for the training set:

Not applicable/Not provided. This pertains to machine learning algorithms, which are not the subject of this 510(k) submission.

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

Not applicable/Not provided. As above, this relates to machine learning.

Summary of what the document does provide regarding device performance and compliance:

The document describes the Cyber Ho laser system, which is a modification of a previously cleared device, Litho (K163009). The modifications include hardware and software changes, and a broadening of laser emission parameters (power, energy, frequency).

Performance Standards and Compliance (as described):

No mandatory performance standards specific to this device type were identified, but the device underwent and passed testing according to the following recognized consensus standards:
- IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- 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
- EN 60601-1-6:2010 + A1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
- IEC 60601-2-22:2007+ A1:2012 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 Ed. 2.0 (2007) Safety of laser products - Part 1: Equipment classification and requirements
Reported Device Performance (Qualitative):
- "The device underwent and successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards."
- "The modified device Cyber Ho passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

In essence, the study described in this 510(k) summary is an engineering and regulatory compliance study demonstrating that the modified device continues to meet established safety and performance requirements for medical electrical equipment and laser products, rather than a clinical study evaluating diagnostic accuracy or AI performance.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

March 3, 2017

Quanta System Spa Francesco Dell'Antonio Vice President Regulatory Affairs and QA Via Acquedotto 109 Samarate (va), 21017 IT

Re: K170331

Trade/Device Name: Cyber Ho 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: February 1, 2017 Received: February 2, 2017

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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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" (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 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.

Sincerely,

Jennifer R. Stevenson -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
-------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------

510(k) Number (if known)	K170331
Device Name	Cyber Ho
Indications for Use (Describe)	The Cyber Ho laser system, including a fiber optic delivery system, is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, 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:	UrologyGastroenterologyArthroscopyNeurosurgeryPulmonaryGynecologyENTDermatologyPlastic SurgeryGeneral 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)

FORM FDA 3881 (1/14)	Page 1 of 2	PSC Publishing Services (301) 443-6740 EF
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5. Special 510(K) SUMMARY - Device Modifications

Introduction:

This document contains the 510(k) Summary for the device Cyber Ho. The basis of this submission is Modifications to a 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 Acquedotto, 109Samarate (VA)Italy, 21017
510(k) Contact Person:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPA
	Email: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	February 1st 2017
Device Name:	Cyber Ho
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Basis for Submission:	Device modifications
Legally Marketed Device	Litho (K163009) - Quanta System SPALumenis Pulse 120h (K140388) - Lumenis LTD

Performance Standards:

There are no mandatory performance standards for this device.

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Description of the modifications:

The modified device 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.

Based on the nature of the changes implemented, the device underwent and successfully passed electrical safety, EMC, performance testing and software verifications and validation according to the relevant standards.

Intended Use/Indications for Use

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

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

. Urology
Gastroenterology
Arthroscopy .
. Neurosurgery
Pulmonary .
. Gynecology
0 ENT
Dermatology 0
Plastic Surgery ●
General Surgery .

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Substantial Equivalence:

The modified and unmodified devices have the same intended use and the same fundamental scientific technology, based on Holmium laser sources.

The modified device Cyber Ho has a broader range of emission parameters compared to the unmodified device Litho, therefore another predicate device, Lumenis Pulse 120h (K140388), has been considered in order to demonstrate the safety and effectiveness of the parameters combinations not included in the unmodified device.

Thus the modified device Cyber Ho is substantially equivalent to its identified predicate devices.

Performace testing

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

IEC 60601-1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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

EN 60601-1-6:2010 + A1:2013 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability

IEC 60601-2-22:2007+ A1:2012 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 Ed. 2.0 (2007) Safety of laser products - Part 1: Equipment classification and requirements

The modified device Cyber Ho 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.