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 text describes a 510(k) premarket notification for a medical device (Quanta System Spa's Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60) which involves a modification to existing cleared devices. The modification is the addition of a new emission mode called "Virtual Basket" based on pulse modulation.

Critically, this document does not contain acceptance criteria or study data that proves the device meets specific performance metrics.

The submission is a Special 510(k) for device modifications, which means it evaluates whether the modified device remains substantially equivalent to its predicate devices, rather than establishing new performance benchmarks through de novo studies. Due to this, the level of detailed performance study data, acceptance criteria, and clinical trial information typically associated with complex AI/ML device submissions is not present.

Here's what can be extracted, and what information is explicitly not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical acceptance criteria for a new clinical performance claim. The primary "acceptance" is substantial equivalence to the predicate device, implying no adverse change in safety or effectiveness with the software modification.	Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original device was performed. Software Verification and Validation Testing was conducted according to FDA guidance for software in medical devices.

Explanation: The document states, "Based on the nature of the changes implemented, the device underwent and successfully passed software verifications and validation according to the relevant standards." This implies the "acceptance criteria" were successful completion of these tests. However, no specific numerical or qualitative performance criteria are listed for the "Virtual Basket" mode.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not applicable in the context of a clinical test set with patients/data. The testing involved bench testing (presumably on materials relevant to laser-tissue interaction or stone fragmentation) and software verification and validation. No patient-specific test set is described.
Data Provenance: Not applicable. The tests are technical/engineering in nature (bench testing, software V&V) rather than clinical studies using patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. There is no mention of human experts establishing a "ground truth" for a test set, as this submission is not about an AI/ML diagnostic or prognostic device requiring expert annotation. It's about a laser surgical instrument and a new emission mode.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication by experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study was not done. The device is a surgical laser, not an imaging analysis or diagnostic AI/ML device that assists readers. The document only mentions "Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original device".

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable in the typical sense of AI/ML. The "Virtual Basket" mode is an emission mode of a laser; it's always used by a human surgeon. The "software verification and validation testing" would assess the software's standalone functionality.

7. The Type of Ground Truth Used:

For Bench Testing: Likely physical measurements, observations, and objective assessment against engineering specifications related to laser power, pulse characteristics, and effects on target materials (e.g., stone fragmentation efficiency, tissue ablation depth).
For Software Verification and Validation: Software requirements specifications, design specifications, and coding standards. The "ground truth" would be whether the software performs as designed and intended, free of critical defects.

8. The Sample Size for the Training Set:

Not applicable. This submission doesn't describe an AI/ML model that requires a training set of data. The "Virtual Basket" mode is a predefined pulse modulation algorithm, not a machine learning model trained on data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. (See point 8.)

Summary of what the document does tell us about the device and its assessment:

Device: Holmium laser surgical system (Cyber Ho 60/100, Litho 60/100).
Modification: Addition of a "Virtual Basket" emission mode via software update.
Basis for Submission: Device modifications (Special 510(k)).
Predicate Devices: Litho 60 (K172025) and Litho 100 (K180922).
Testing Performed:
- Bench testing comparing the new "Virtual Basket" mode to the standard emission mode.
- Software Verification and Validation testing (according to FDA guidance).
Tests Not Repeated (as there was no hardware or architecture change that could affect them): Electromagnetic compatibility, electrical safety, and general performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1).
Conclusion: The device is considered substantially equivalent to its predicate devices, indicating the modifications (including the new Virtual Basket mode) do not raise new questions of safety or effectiveness.

Summary

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Image /page/0/Picture/0 description: The image contains 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 FDA logo 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 It

Re: K192600

Trade/Device Name: Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 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: November 21, 2019 Received: November 22, 2019

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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,

Jessica Mavadia-Shukla, 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) K192600

Device Name

Litho 100, Cyber Ho 100, Litho 60, Cyber Ho 60

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 urethral, 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
· Duodenal ulcers

FORM FDA 3881 (1/14)

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· 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, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including:

· Endonasal/sinus Surgery
· Partial turbinectomy
Polypectomy
Dacryocystorhinostomy

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· 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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K192600 510(K) SUMMARY

Applicant /ManufacturerName and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy, 21017
510(k) ContactPerson:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPA
	Email: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	September 12th 2019
Brand Names:	Litho 100, Cyber Ho 100, Litho 60, Cyber Ho 60
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 60 (K172025) – Quanta System SPA
Predicate Device	Litho 100 (K180922) — Quanta System SPA
Reference Device	Family of Holmium Surgical Lasers (K170121) - Lumenis LTD

The subject device is derived from the legally marketed (predicate) deviced Litho 60 (K172025) and Litho 100 (K180922).

Performance Standards:

There are no mandatory performance standards for this device.

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Description of the device:

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.

This Special 510(k) is submitted due to Device Modifications of the original device due to a change to the software, adding an emission mode (Virtual Basket) based on pulse modulation.

The modified device has the same intended use of the predicate 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 software verifications and validation according to the relevant standards.

	Subject deviceLitho 60/100	K172025 K180922
Laser Source	Unchanged	-
Laser cavity	Unchanged	-
Maximum outputpower	Unchanged	-
Maximum emissionfrequency power	Unchanged	-
Hardware	Unchanged	-
Software	Updated to support the new emissionmode	-
External appearance	Unchanged	-
Graphic userinterface	Unchanged	-
Virtual basket mode	Added	Not present

Summary of the technological characteristics

	Subject device	predicate device(s)	additional referencedevice
510(k)	-	K172025/ K180922	K170121
model name	Litho 100, Cyber Ho 100, Litho 60,Cyber Ho 60	Litho 100, Cyber Ho 100 /Litho 60, Cyber Ho 60	Holmium Surgical Lasers
manufacturer	Quanta System SpA	Quanta System SpA	Lumenis LTD
Laser Source	Pulsed Holmium laser (CHT:YAG)	Pulsed Holmium laser(CHT:YAG)	Pulsed Holmium laser(CHT:YAG)

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Wavelength(nm)	2.1 µm	2.1 µm	2.1 µm
Emission	pulsed	pulsed	pulsed
Pulse duration	up to 1100 µs	up to 1100 µs	up to 1300 us
Energy perpulse	up to 5.0 Joule	up to 5.0 Joule	up to 6.0 J
Frequency	from 3 to 80 Hz (100W version)from 3 to 60 Hz (60W version	from 3 to 80 Hz (100Wversion)from 3 to 60 Hz( 60Wversion	from 5 to 80 Hz
Max averagepower	105 W (100W version)60W (60W version)	105 W (100W version)60W (60W version)	120 W
Pulsemodulationmode	Virtual basket mode		Moses effect

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

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

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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
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

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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, 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
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

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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.

Performance testing

The subject device was subject to changes that do not affect the compliance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances.

The following testing were not repeated on the modified device, as there was no hardware or architecture change that could affect the following standards:

-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:

-Bench testing comparing the Virtual Basket emission mode to the standard emission mode of the original 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 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.