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 devices belonging to Multicavity Holmium laser family are laser devices based on a Holmium laser source. The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "Litho 150, Cyber Ho 150" (Multicavity Holmium laser). It describes device modifications and asserts substantial equivalence to a predicate device (Litho 100/60, K192600).

However, this document does not contain the detailed information necessary to complete the requested table and answer questions 2-9.

Here's why and what information is missing:

Acceptance Criteria and Reported Performance: The document states that the device "underwent and successfully passed electrical safety, EMC and performance testing" according to specific standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and "Software Verification and Validation Testing". However, it does not provide specific numerical acceptance criteria (e.g., "power output must be within +/- 5%") or the actual numerical performance results of these tests (e.g., "power output was 150W +/- 2W"). It only confirms successful passing of these tests.
Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These questions are typically relevant for studies evaluating the clinical effectiveness or diagnostic accuracy of a device, especially those involving AI/ML models, image analysis, or outcomes assessment. This 510(k) is for a surgical laser, and the "performance testing" mentioned refers to engineering and safety standards, not a clinical study to establish diagnostic or treatment efficacy performance metrics in terms of sensitivity, specificity, accuracy, or similar measures against a clinical ground truth.

Therefore, I cannot populate the table or answer questions 2-9 based on the provided text.

However, I can extract the available information regarding the device's technical specifications and the standards it met:

1. Table of Acceptance Criteria and Reported Device Performance

Device Parameter/Test Type	Acceptance Criteria (Stated)	Reported Device Performance (Stated)
Technical Specifications
Wavelength	Not explicitly stated as a criterion, but predicate device (Litho 100) has 2100nm. Subject device has same.	2100nm (Subject device, unchanged from predicate)
Max Energy	Not explicitly stated as a criterion, but predicate device (Litho 100) has 5J. Subject device has same.	5J (Subject device, unchanged from predicate). Reference device (MultiPulse HoPlus) has up to 6.0 J.
Max Power	Not explicitly stated as a criterion. Predicate device (Litho 100) has 100W/105W. Subject device is modified to higher power.	152W (Subject device, increased from predicate). Reference device (MultiPulse HoPlus) has 140 W.
Max Frequency	Not explicitly stated as a criterion. Predicate device (Litho 100) has 80Hz. Subject device is modified to higher frequency.	100Hz (Subject device, increased from predicate). Reference device (MultiPulse HoPlus) has from 5 to 100 Hz.
Pulse Duration	Not explicitly stated as a criterion. Predicate device has up to 1100 µs. Subject device has same.	Up to 1100 µs (Subject device, unchanged from predicate). Reference device (MultiPulse HoPlus) has up to 1700 µs.
Performance Testing (Compliance)
Electrical Safety	Compliance with IEC 60601-1:2012, ed 3.1 and IEC 60601-2-22: 2012-10 ed 3.1.	"Successfully passed electrical safety... testing" according to specified standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 Edition 4: 2014.	"Successfully passed... EMC... testing" according to specified standard.
Laser Safety	Compliance with IEC 60825-1 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements.	"Successfully passed electrical safety... testing" according to specified standard. (Implied, as laser safety is part of this type.)
Performance Testing (General)	Not explicitly defined beyond compliance with specified IEC standards for general performance in the context of electrical/laser medical equipment.	"Successfully passed... performance testing."
Software Verification & Validation	As recommended by 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..."

Regarding the other questions (2-9):

The document provides no information on these points because the submission is a "Special 510(k)" for device modifications based on hardware changes (increased power and frequency) to an already cleared device (K192600). The basis for this type of submission relies on demonstrating that the modified device remains substantially equivalent to the predicate through engineering and safety testing, not typically through new clinical studies involving human subjects or extensive ground truth establishment in the manner described by these questions. Such detailed clinical study methodology would be expected for novel devices or significant changes impacting clinical performance but is not provided for this specific submission type.

Summary

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June 30, 2020

Image /page/0/Picture/1 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Quanta System Spa Francesco Dell'antonio Vice President Regulatory Affairs and QA Via Acquedotto 109 Samarate (Va), 21017 Italy

Re: K201455

Trade/Device Name: Litho 150, Cyber Ho 150 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 25, 2020 Received: June 1, 2020

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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,

Colin Kejing Chen Acting Assistant Director 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) K201455

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)

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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 Foraminoplasty 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, resection, ablation, vaporization 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)

2 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:	May 25th 2020
Brand Names:	Litho 150, Cyber Ho 150
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
Predicate Device	Litho 100/60 (K192600) – Quanta System SPA
Reference Device	MultiPulse HoPlus (K161257), Asclepion Laser TechnologiesGmbh

The subject device is derived from the legally marketed (predicate) deviced Litho 100 (K192600).

Performance Standards:

There are no mandatory performance standards for this device.

Description of the device:

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The devices belonging to Multicavity Holmium laser family are laser devices based on a Holmium laser source.

The main parts (subsystems) of the device are the Holmium laser source, the power electronics, the optical delivery system, the control electronics and the cooling system. A specific software controls the device functions and allows the user selections. Laser emission is triggered by a footswitch.

Description of the modifications:

The device has the same technological characteristics as the predicate device and only differ for maximum power and maximum frequency.

This Special 510(k) is submitted due to Device Modifications of the already cleared device Litho 100 (K192600) due to hardware changes to support 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 and performance testing.

	Subject device	K192600
Laser Source	Unchanged	-
Laser cavity	Unchanged	-
Technical	Wavelength 2100nm	Wavelength 2100nm
specifications	Max energy 5J	Max energy 5J
	Max power 152W	Max power 100W
	Max frequency 100Hz	Max frequency 80Hz
Software	Same with minor improvement	-
Hardware	4 laser cavities	3 laser cavities
External appearance	Unchanged	-
Graphic user	Unchanged	-
interface
Virtual basket mode	present	present

Summary of the technological characteristics

	Subject device	predicate device	additional referencedevice
510(k)		K192600	K161257
model name	Litho 150, Cyber Ho 150	Litho 100, Cyber Ho 100	MultiPulse HoPlus
manufacturer	Quanta System SpA	Quanta System SpA	Asclepion Laser
			Technologies Gmbh
Laser Source	Pulsed Holmium laser (CHT:YAG)	Pulsed Holmium laser(CHT:YAG)	Pulsed Holmium laser(CHT:YAG)
Wavelength(nm)	2.1 µm	2.1 µm	2.1 um

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Emission	pulsed	pulsed	pulsed
Pulse duration	up to 1100 µs	up to 1100 µs	up to 1700 µs
Energy perpulse	up to 5.0 Joule	up to 5.0 Joule	up to 6.0 J
Frequency	up to 100 Hz	up to 80 Hz	from 5 to 100 Hz
Max averagepower	152W	105 W	140 W
Pulsemodulationmode	Virtual basket mode	Virtual basket mode	N/A

Deliverysystem	Optical fibers	Optical fibers	Optical fibers
Aiming beam	Green diode laser < 5 mW	Green diode laser < 5 mW	Green diode laser < 5 mW

Indications for Use

The Multicavity Holmium laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic incision, excision, 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.

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 urethral, 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.

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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
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

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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, 0 including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy

Gynaecology

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

ENT

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

Endonasal/sinus Surgery
Partial turbinectomy
Polypectomy
Dacryocystorhinostomy
Frontal Sinusotomy
Ethmoidectomy
Maxillary antrostomy
o Functional endoscopic sinus surgery

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, 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

Accessories

This device is intended to be used together with delivery optical fiber that separately received a FDA clearance for an intended use compatible with the one of this device.

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Performance testing

The subject device was subject to testing according to 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 following testing were performed on the modified device:

-Software Verification and Validation Testing: 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 the same 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.