Litho laser system and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, excision, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectorny, 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.

Gastroenterology
Open and endoscopic Gastroenterology surgery (incision, 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
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-S1 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
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 or partial resection of internal organs, tumors and lesions
• Biopsy

Device Description

Litho family includes surgical laser devices that are used by health care professionals in professional healthcare environments. Litho family includes the following models: Litho 60, Litho 100 and Litho 150. They differ only for the maximum power: 60, 105 and 152, respectively.

Litho devices are connected to optical fibers accessories (separately FDA cleared: K131473, K160513, K200234).

The device is equipped with a graphical user interface through which the user can set energy, frequency and pulse duration level. Different pre-sets are available among which the so called "special effects": Virtual Basket and Magneto. Virtual basket and Magneto are optional configurations.

Virtual basket had been introduced with K192600 (for Litho 100) and already included in Litho 150 510K (K201455). While, Magneto is the object of the present 510K.

Virtual basket consists of two sub-pulses separated by a certain delay. The first pulse generates a cavitation bubble and the second one is emitted when the first bubble reaches its maximum expansion. This allows the stone to be "caught" to be fragmentated. The set energy is the sum of the two sub-pulses. While Magneto consists of a pulse with a duration higher than standard one (2000 μs vs 1100 μs). Devices with Magneto configuration installed are characterized by black covers and Magneto logos.

The device can be divided into four main sections:

. Power electronics: they manage power supplied to all device compartments;
. Control electronics: they mainly consist of a microcontroller board where device main firmware (FW) is resident and a PC embedded with graphical user interface where device software (SW) runs;
Cooling system: it cools the laser source pumping chamber;
. Optical bench.

AI/ML Overview

Here's an analysis of the provided text to extract information about acceptance criteria and the study proving device performance.

It's important to note that the provided text is an FDA 510(k) clearance letter and an accompanying 510(k) summary for a medical laser device. This type of document primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than outlining a detailed clinical or performance study with acceptance criteria in the way one might for a novel AI/ML device.

Therefore, many of the typical questions asked about acceptance criteria and proving device performance for AI/ML devices (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies) are not directly applicable or explicitly detailed in this type of submission.

The "performance" described here is primarily in terms of technical specifications and demonstrating that the device's optical and safety characteristics are similar to or within acceptable limits compared to predicates.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Overview: The submission describes the "Litho 60; Litho 100; Litho 150" laser systems. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices (Litho 60, Litho 100 (K192600), Litho 150 (K201455)) and a reference device (MultiPulse HoPlus (K161257)). The change addressed in this submission is the introduction of a new "Magneto" configuration, which alters the pulse duration.

The "acceptance criteria" in this context are not performance metrics for an AI/ML algorithm (like sensitivity/specificity), but rather the demonstration that the modified device's technical specifications (e.g., laser wavelength, power, pulse width) and safety profiles remain substantially equivalent to, or are a sub-set of, the predicate/reference devices, and that it continues to meet relevant medical device safety standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria/Parameter (Implied)	Reported Device Performance (Subject Device)	Rationale for Acceptance (from document)
Product Code Equivalence (GEX)	Subject device shares the same product code (GEX) as predicates and reference.	"The same" as predicate/reference devices.
Laser Source & Wavelength Equivalence (CTH:YAG, 2100 nm)	Subject device uses CTH:YAG laser source with 2100 nm wavelength.	"The same" as predicate/reference devices.
Indications for Use Equivalence	Litho laser system for incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue in Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynecology, ENT, and General Surgery.	Subject device's indications are a sub-set of the reference device indications (MultiPulse HoPlus). No changes to the intended use have been implemented.
Maximum Pulse Width (Standard) (1100 µs)	1100 µs	"The same" as predicate device.
Maximum Pulse Width (with Magneto)	2000 µs (Litho 100, Litho 150)	"very similar to the reference device (they differ less than 20%)" compared to reference device's 1700 µs. This difference is deemed acceptable.
Maximum Repetition Rate	Litho 60: 60 Hz; Litho 100: 80 Hz; Litho 150: 100 Hz	"The same" as predicate devices and matching the reference device's 100 Hz (for Litho 150).
Maximum Energy (5 J)	5 J	"The same of unmodified device and lower than the reference device (20% of difference)" (reference is 6 J). This difference is deemed acceptable/favorable.
Maximum Power	Litho 60: 60 W; Litho 100: 105 W; Litho 150: 152 W	"The same of unmodified device and very similar to the reference (less than 20% of difference)" (reference is 140 W). This difference is deemed acceptable.
Safety and Performance Standards Compliance (e.g., IEC 60601-1, IEC 60601-2-22)	Verified through non-clinical bench testing. Specific tests repeated for pulse duration accuracy (IEC 60601-2-22:2019) and SW verification/validation due to SW/FW update (IEC 62304:2006/AMD1:2015). Other standards not affected by the change.	"The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively." "Non-clinical tests conducted support that the used safely and effectively. The differences in technological characteristics between the subject and predicate/reference devices do not raise regarding safety and effectiveness..."

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

This document does not describe a "test set" in the context of an AI/ML model's performance on patient data.
The "testing" mentioned refers to non-clinical bench testing to confirm the device's technical specifications and compliance with safety standards (e.g., electrical safety, electromagnetic compatibility, laser safety).
Data provenance for such bench tests is typically internal laboratory data, not patient data from specific countries or retrospective/prospective studies.

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

Not applicable. There is no "ground truth" derived from expert review in this type of submission. Performance is measured against engineering specifications and international standards.

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

Not applicable. No expert adjudication process foreseen for this type of device and submission.

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 applicable. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is a laser surgical instrument, not an algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" here is the adherence to engineering specifications, validated physical measurements (e.g., laser power, pulse width), and compliance with the requirements of recognized safety and performance standards (e.g., IEC 60601 series).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

In summary, this 510(k) demonstrates substantial equivalence for a medical laser device based on engineering specifications, compliance with international safety standards, and comparison of its performance characteristics (like laser parameters) and indications for use to previously cleared devices. It does not involve AI/ML performance testing or studies with human readers/cases.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sempterber 3, 2024

Quanta System SpA Bandiera Dario Regulatory Affairs Manager Via Acquedotto 109 Samarate, VA 21017 Italy

Re: K242251

Trade/Device Name: Litho 60; Litho 100; Litho 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: June 17, 2024 Received: July 31, 2024

Dear Bandiera Dario:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Digitally signed by Yan Fu -S
Yan Fu -S Date: 2014.09.03 16:21:36
-04'00'

for

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical & Infection Control Devices, Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242251

Device Name Litho 60: Litho 100: Litho 150

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, 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, 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

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· 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-S1 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
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

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· Excision of external and internal lesions

· Complete or partial resection of internal organs, tumors and lesions

• Biopsy

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K242251

Applicant /manufacturer:	Quanta System S.p.A., Via Acquedotto 109, 21017Samarate (VA), Italy
Contact person:	Dario BandieraRA ManagerQuanta System S.p.A.Email: dario.bandiera@quantasystem.comPhone: +39-0331-376797
Date Prepared:	17th June 2024
Model name:	Litho 60, Litho 100, Litho 150
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general andplastic surgery and in dermatology
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Basis for submission:	Device technical modifications
Predicate (original unmodified)device	Litho 60, Litho 100 (K192600) and Litho 150(K201455) manufactured by Quanta System
Reference device	MultiPulse HoPlus (K161257) manufactured byAsclepion Laser Technologies GmbH

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Abbreviations 1

FW= firmware SW= software

Device description 2

Litho devices are connected to optical fibers accessories (separately FDA cleared: K131473, K160513, K200234).

Virtual basket had been introduced with K192600 (for Litho 100) and already included in Litho 150 510K (K201455). While, Magneto is the object of the present 510K.

The device can be divided into four main sections:

. Power electronics: they manage power supplied to all device compartments;
. Control electronics: they mainly consist of a microcontroller board where device main firmware (FW) is resident and a PC embedded with graphical user interface where device software (SW) runs;
Cooling system: it cools the laser source pumping chamber;
. Optical bench.

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3 Comparison with predicate

In Table 1 the main specifications of the subject device are summarized and compared to the predicate/reference devices.

	Subject device			Predicate (original unmodified) device			Reference device	Equivalence rationale
Model n°	Litho 60	Litho 100	Litho 150	Litho 60	Litho 100	Litho 150	MultiPulse HoPlus
510K	-	-	-	K192600	K192600	K201455	K161257	-
Product Code	GEX	-	-	The same			The same	-
Laser Sources	CTH:YAG	-	-	The same			The same	-
LaserWavelength(nm)	2100	-	-	The same			The same	-
Indications for use	Litho laser system and its fiber optic delivery system areintended for use in surgical procedures using open,laparoscopic and endoscopic incision, excision, resection,ablation, vaporization, coagulation and haemostasis of softtissue in use in medical specialties including: Urology, UrinaryLithotripsy, Gastroenterology, Arthroscopy, Discectomy,Gynaecology, ENT and General Surgery.UrologyOpen 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			The same			The MULTIPULSE HOPLUSlaser system and its fiber opticdelivery system are intended for use insurgical procedures using open,laparoscopic and endoscopic, to performincision, excision, resection, ablation,vaporization, coagulation and haemostasisof soft tissue in use in medical specialtiesincluding: Urology, Urinary Lithotripsy,Gastroenterology, Arthroscopy,Discectomy, Pulmonary, Gynaecology, ENT,Dermatology, Plastic surgery and GeneralSurgery.UrologyOpen and endoscopic surgery (incision,excision, resection, ablation, vaporization,coagulation and haemostasis) including:Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection ofBladder Tumors, UretheralTumors and Ureteral Tumors	Subject vs reference:Indications of the subject device are a sub-set of the reference.Additional indications of the reference device are highlighted in green.
	Subject device			Predicate (original unmodified) device			Reference device	Equivalence rationale
Model n°	Litho 60	Litho 100	Litho 150	Litho 60	Litho 100	Litho 150	MultiPulse HoPlus
	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.						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.


	GastroenterologyOpen 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						GastroenterologyOpen and endoscopic Gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy Polys Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers



	Subject device			Predicate (original unmodified)device		Reference device	Equivalencerationale
Model n°	Litho 60	Litho 100	Litho 150	Litho 60	Litho 100	Litho 150	MultiPulse HoPlus
	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, 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						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 Plica Removal Meniscectomy Loose Body Debridement	-
	Partial turbinectomy
	Subject device				Predicate (original unmodified) device			Reference device	Equivalence rationale
Model n°	Litho 60	Litho 100	Litho 150	Litho 60	Litho 100	Litho 150	MultiPulse HoPlus
	Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery General SurgeryOpen, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy						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 PulmonaryOpen and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemsoatis of soft tissue)GynaecologyOpen and laparoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue.ENTEndoscopic 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	-
	Subject device			Predicate (original unmodified) device			Reference device	Equivalence rationale
Model n°	Litho 60	Litho 100	Litho 150	Litho 60	Litho 100	Litho 150	MultiPulse HoPlus
							Functional endoscopic sinus surgery Dermatology and plastic surgeryIncision, excision, resection, ablation, vaporization, coagulation, hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal cell carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port wine stains Papillomas
							General SurgeryOpen, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete or partial resection of internal organs, tumors and lesions Biopsy
Pulse widthmax (μs)	1100	1100	1100	The same				Subject vs reference:
Pulse widthmax (μs) with Magneto	-	2000	2000	-	Not available	Not available	1700	very similar to the reference device (they differ less than 20%)
	Subject device			Predicate (original unmodified) device			Reference device	Equivalence rationale
Model n°	Litho 60	Litho 100	Litho 150	Litho 60	Litho 100	Litho 150	MultiPulse HoPlus	-
Repetitionratemax (Hz)	60	80	100	The same			The same: 100	-
Energymax (J)	5	5	5	The same			6	The same of unmodified device and lower than the reference device (20% of difference).
Powermax (W)	60	105	152	The same			140	The same of unmodified device and very similar to the reference (less than 20% of difference).
With Virtual basket
Energymax (J) per single pulse	2.5	2.5	2.5	The same			Not available	-
Repetitionratemax (Hz)	55	70	70	The same			Not available	-
Powermax (W)	60	92	92	The same			Not available	-

Table 1: Main specifications comparison table.

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Indication for use ব

Litho laser system and its fiber optic delivery system are in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastreenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Urology

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

•
. Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors

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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, 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

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. 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 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

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Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-Sl 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 haemostas) of soft tissue

ENT

Endoscopic endonasal surgery (incision, resection, ablation, vaporization 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, resection, ablation, vaporization, coagulation and haemostasis) including:

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

5 Non-clinical tests

The present device was subject to non-clinical bench testing according to the following standards:

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Table 2: Applied standards.

Standard	Discussion
IEC 60601-1:2005+AMD1:2012+AMD2:2020Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance	The present change doesn't affect IEC 60601-1test reports.
IEC 60601-1-2:2014+AMD1:2020Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard:Electromagnetic disturbances - Requirements andtests.	The present change doesn't affect IEC 60601-1-2test reports.
IEC 60601-1-6:2010/AMD1:2013Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essentialperformance - Collateral standard: Usability	The present change doesn't affect device usability.
IEC 62366-1:2015Medical devices - Part 1: Application of usabilityengineering to medical devices
IEC 62304:2006/AMD1:2015Medical device software - Software life cycleprocesses	SW verification and validation activities have beenrepeated as the present change involves SW/FWupdate.
IEC 60601-2-22:2007+AMD1:2012Medical electrical equipment - Part 2-22: Particularrequirements for basic safety and essentialperformance of surgical, cosmetic, therapeutic anddiagnostic laser equipment	IEC 60601-2-22 tests have been repeated to checkpulse duration accuracy (according to IEC 60601-2-22: 2019).
IEC 60825-1: 2014Safety of laser products - Part 1: Equipmentclassification and requirements	The present change doesn't affect IEC 60825-1report.

The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively.

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Substantial equivalence discussion റ

No changes to the intended use have been implemented but a change to laser specifications (pulse width) that are comparable to the ones of the predicate/reference devices as shown in Table 1.

7 Conclusions

Non-clinical tests conducted support that the used safely and effectively. The differences in technological characteristics between the subject and predicate/reference devices do not raise regarding safety and effectiveness (see Table 1). Thus, the subject device is considered substantially equivalent to the predicate/reference devices.

Revision history 8

Rev00: First release.

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.