Litho 60; Litho 100; Litho 150

K242251 · Quanta System Spa · GEX · Sep 3, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K242251
• Device Name: Litho 60; Litho 100; Litho 150
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 3, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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, Discectomy, Gynaecology, ENT and General Surgery.

Device Story

Litho 60, 100, and 150 are surgical Ho:YAG laser systems used by healthcare professionals in clinical environments. Devices deliver laser energy via optical fibers to perform soft tissue surgery and lithotripsy. Users interact via a graphical user interface to set energy, frequency, and pulse duration. The system includes optional 'special effects' presets: 'Virtual Basket' (two sub-pulses for stone fragmentation) and 'Magneto' (extended pulse duration of 2000 μs). The device comprises power electronics, control electronics (microcontroller FW and PC-based SW), cooling system, and optical bench. Output is laser energy for tissue interaction; clinical benefit includes precise tissue ablation, coagulation, and stone fragmentation. The device is operated by physicians in OR or clinic settings.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included verification of pulse duration accuracy per IEC 60601-2-22:2007+AMD1:2012 and software verification/validation per IEC 62304:2006/AMD1:2015.

Technological Characteristics

Ho:YAG laser source (2100 nm wavelength). Models differ by max power (60W, 105W, 152W). Features include 'Virtual Basket' and 'Magneto' pulse modes. Connectivity via optical fibers. Software/firmware-controlled via embedded PC and microcontroller. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 60601-2-22, and IEC 60825-1.

Indications for Use

Indicated for surgical procedures (incision, excision, resection, ablation, vaporization, coagulation, haemostasis) of soft tissue in Urology (e.g., BPH, tumors, strictures, lithotripsy), Gastroenterology (e.g., polyps, ulcers, tumors), Arthroscopy (small/large joints, excluding spine), Gynaecology, ENT (endonasal/sinus), and General Surgery. Patient population includes adults requiring soft tissue surgery or lithotripsy.

Regulatory Classification

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.

Predicate Devices

• Litho 60 (K192600)
• Litho 100 (K192600)
• Litho 150 (K201455)

Reference Devices

• MultiPulse HoPlus (K161257)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

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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 /<br>manufacturer: | Quanta System S.p.A., Via Acquedotto 109, 21017<br>Samarate (VA), Italy |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dario Bandiera<br>RA Manager<br>Quanta System S.p.A.<br>Email: [e-mail]<br>Phone: [phone] |
| 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 and<br>plastic surgery and in dermatology |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Basis for submission: | Device technical modifications |
| Predicate (original unmodified)<br>device | Litho 60, Litho 100 (K192600) and Litho 150<br>(K201455) manufactured by Quanta System |
| Reference device | MultiPulse HoPlus (K161257) manufactured by<br>Asclepion Laser Technologies GmbH |

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#### Abbreviations 1

FW= firmware SW= software

#### Device description 2

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.

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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 | - | |
| Laser<br>Wavelength<br>(nm) | 2100 | - | - | The same | | | The same | - | |
| Indications for use | Litho laser system and its fiber optic delivery system are<br>intended for use in surgical procedures using open,<br>laparoscopic and endoscopic incision, excision, resection,<br>ablation, vaporization, coagulation and haemostasis of soft<br>tissue in use in medical specialties including: Urology, Urinary<br>Lithotripsy, Gastroenterology, Arthroscopy, Discectomy,<br>Gynaecology, ENT and General Surgery.<br><br>Urology<br>Open and endoscopic surgery (incision, excision, resection,<br>ablation, vaporization, coagulation and haemostasis) including:<br>Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors,<br>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 HOPLUS<br>laser system and its fiber optic<br>delivery system are intended for use in<br>surgical procedures using open,<br>laparoscopic and endoscopic, to perform<br>incision, excision, resection, ablation,<br>vaporization, coagulation and haemostasis<br>of soft tissue in use in medical specialties<br>including: Urology, Urinary Lithotripsy,<br>Gastroenterology, Arthroscopy,<br>Discectomy, Pulmonary, Gynaecology, ENT,<br>Dermatology, Plastic surgery and General<br>Surgery.<br><br>Urology<br>Open and endoscopic surgery (incision,<br>excision, resection, ablation, vaporization,<br>coagulation and haemostasis) including:<br>Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of<br>Bladder Tumors, Uretheral<br>Tumors and Ureteral Tumors | Subject vs reference:<br>Indications of the subject device are a sub-set of the reference.<br>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. | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | Gastroenterology<br>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 | | | | | | Gastroenterology<br>Open 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)<br>device | | Reference device | Equivalence<br>rationale | | |
| 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-<br>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…