The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Device Description

The subject device is derived from the legally marketed (unmodified) device Litho 60 (K172025). This Special 510(k) is submitted due to Device Modifications of the already cleared device Litho 60 (K172025) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power and frequency.

AI/ML Overview

This document describes the FDA clearance (K180922) for the Quanta System SPA's Holmium laser systems (Empower H100, Cyber Ho 100, Litho 100). However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance related to diagnostic accuracy, or human reader performance with or without AI assistance.

The submission is specifically a Special 510(k) for "Device modifications" to an already cleared device (Litho 60, K172025). This type of submission generally relies on demonstrating that the modified device remains substantially equivalent to the predicate device, primarily through engineering, performance, safety, and software testing, rather than new clinical efficacy studies.

Therefore, I cannot provide an answer that includes:

A table of acceptance criteria and reported device performance related to clinical outcomes.
Sample sizes for test sets where clinical performance (e.g., diagnostic accuracy) would be evaluated.
Number of experts for ground truth establishment.
Adjudication methods.
MRMC studies or effect sizes of human reader improvement with AI.
Standalone algorithm performance.
Type of ground truth used for clinical performance.
Training set sample size or ground truth establishment for a training set (as this is not an AI/ML device where such details would be relevant to the submission type).

Based on the provided text, the acceptance criteria and study proving the device meets them are focused on engineering performance, safety, and software validation.

Here's what can be extracted from the document regarding acceptance criteria and performance testing for these modifications:

1. Acceptance Criteria and Reported Device Performance (as per a Special 510(k) for device modifications):

Acceptance Criteria Category	Details (as per device modifications)	Reported Performance
Electrical Safety	Compliance with IEC 60601-1:2012, ed 3.1; IEC 60601-2-22: 2012-10 ed 3.1.	"The subject device passed all the required testing and applicable sections of the above-mentioned performance standards."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 Edition 4: 2014.	"The subject device passed all the required testing and applicable sections of the above-mentioned performance standards."
Laser Safety	Compliance with IEC 60825-1 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements.	"The subject device passed all the required testing and applicable sections of the above-mentioned performance standards."
General Performance	Not explicitly detailed but implied by "performance testing" to ensure the broadening of laser emission parameters (power and frequency) works as intended.	"The subject device passed all the required testing and applicable sections of the above-mentioned performance standards."
Software Verification and Validation	Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."	"Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..."
Intended Use/Indications for Use Preservation	The modified device must maintain the same intended use as the unmodified predicate device.	"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."
Fundamental Scientific Technology Preservation	The device must continue to be based on Holmium laser sources.	"The subject and unmodified devices have intended use and the same fundamental scientific technology, based on Holmium laser sources."

2. Sample Size and Data Provenance:
This document indicates that the tests conducted were primarily engineering/bench testing and software verification/validation. These types of tests do not typically use "patient data" or "test sets" in the context of clinical performance evaluation. The data provenance would be laboratory results from the manufacturer.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable for this type of submission. Ground truth for engineering tests is based on established scientific principles, physical measurements, and standard compliance.

4. Adjudication Method for Test Set:
Not applicable. These are objective engineering and software tests, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document does not mention any clinical studies, MRMC studies, or AI assistance for human readers. This is a laser surgical instrument, and the modifications are related to its hardware, software, and emission parameters, not an AI diagnostic component.

6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device (laser), not a standalone algorithm.

7. Type of Ground Truth Used:
For the various tests conducted (electrical safety, EMC, laser safety, software), the "ground truth" is adherence to recognized consensus standards (e.g., IEC 60601 series, IEC 60825-1) and internal design specifications, verified through objective measurements and checks.

8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning model development.

9. How the Ground Truth for the Training Set Was Established:
Not applicable.

In summary, the provided FDA clearance letter and summary for K180922 focuses on demonstrating substantial equivalence through non-clinical testing for hardware and software modifications to an existing device, rather than new clinical efficacy studies or performance evaluation of an AI-driven system.

Summary

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May 8, 2018

quanta system spa Francesco Dell'antonio Vice President Regulatory Affairs and QA via Acquedotto 109 Samarate (Va), 21017 It

Re: K180922

Trade/Device Name: Empower H100, Cyber Ho 100, Litho 100 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: March 29, 2018 Received: April 9, 2018

Dear Francesco 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, 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 Part 807); labeling (21 CFR Part 801); medical device 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer R. Stevenson -S3

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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Indications for Use

510(k) Number (if known) K180922

Device Name

Multicavity Holmium laser

Indications for Use (Describe)

Urology

Open and endoscopic surgery (incision, excision, resection, ablation,

vaporization, coagulation and haemostasis) including:

· Urethral Strictures
· Bladder Neck Incisions (BNI)
· Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors,
· Ablation of Benign Prostatic Hypertrophy (BPH),
· Transurethral incision of the prostate (TUIP)
· Holmium Laser Resection of the Prostrate (HoLRP)
· Holmium Laser Enucleation of the Prostate (HoLEP)
· Holmium laser Ablation of the Prostate (HoLAP)
· Condylomas
· Lesions of external genitalia

Lithotripsy and Percutaneous Urinary Lithotripsy

· Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate,

monohydrate and calcium oxalate
· dehydrate stones.
· Endoscopic fragmentation of kidney calculi
· Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.

Gastroenterology

Open and endoscopic Gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including:

· Appendectomy
Polyps
Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
· Gastric ulcers

FORM FDA 3881 (1/14)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Duodenal ulcers
Non Bleeding Ulcers
Pancreatitas
· Haemorrhoids
· Cholecystectomy
· Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
· Telangiectasias
· Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
· Gastritis
· Esophagitis
Esophageal ulcers
· Varices
· Colitis
Mallory-Weiss tear
Gastric Erosions

Arthroscopy

Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:

· Ligament and tendon Release
Contouring and sculpting of articular surfaces
· Capsulectomy in the Knee
Chondreplasty in the Knee
· Debridement of inflamed synovial tissue
Chondromalacia Ablation
Chondromalacia and tears
Plica Removal
· Meniscectomy
Loose Body Debridement
· Lateral retinecular release

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

· Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-SI lumbar discs, including Foraninoplasty Percutaneous Cervical Disc Decompression/Discectomy

Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology

Open and laparoscopic gynaecological surgery (incision, excision, ablation, vaporization, coagulation and haemostasis) of soft tissue

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:

Endonasal/sinus Surgery
Partial turbinectomy
Polypectomy

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· Dacryocystorhinostomy
Frontal Sinusotomy
Ethmoidectomy
Maxillary antrostomy
· Functional endoscopic sinus surgery

General Surgery

Open, laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) including:

Appendectomy
· Skin incision
· Excision of external and internal lesions
· Complete of partial resection of internal organs, tumors and lesions
Biopsy

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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5. 510(K) SUMMARY

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:	March 29th 2018
Brand Names:	Empower H100, Litho 100, Cyber Ho100
Common name:	Multicavity Holmium laser
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 60 (K172025) – Quanta System SPALumenis Pulse 120h (K140388) – Lumenis LTD

The subject device is derived from the legally marketed (unmodified) device Litho 60 (K172025).

Performance Standards:

There are no mandatory performance standards for this device.

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Description of the modifications:

This Special 510(k) is submitted due to Device Modifications of the already cleared device Litho 60 (K172025) due to hardware and software change, together with a broadening of the range of some laser emission parameters such as power and frequency.

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 subject device has the same intended use of the unmodified device, as follows:

Error! Reference source not found.

Performace testing

The subject device underwent performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances:

-IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-IEC 60601-1-2 Edition 4: 2014, 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: 2012-10 ed 3.1, 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. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements

The subject device passed all the required testing and complicable sections of the abovementioned performance standards.

Software verification and validation

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Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Comparison with predicate device:

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

Summary

The subject device is substantially equivalent to its identified 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.