(34 days)
No
The document describes a laser system with different pulse configurations ("Virtual Basket" and "Magneto") controlled via a graphical user interface. There is no mention of AI or ML being used for image processing, data analysis, or decision-making within the device's operation. The "special effects" are described as pre-set pulse patterns, not adaptive or learning algorithms.
Yes
Explanation: The device performs various surgical procedures like incision, excision, ablation, vaporization, coagulation, and haemostasis to treat medical conditions, which falls under the definition of a therapeutic device designed to cure, mitigate, or treat diseases or conditions.
No
The device is described as a "surgical laser system" used for various surgical procedures, including incision, excision, ablation, vaporization, coagulation, and haemostasis of soft tissue and calculi. These are therapeutic actions, not diagnostic ones. The "Intended Use / Indications for Use" section lists a wide range of surgical applications across multiple medical specialties, none of which involve diagnosis.
No
The device description clearly outlines hardware components including power electronics, control electronics (microcontroller board and embedded PC), a cooling system, and an optical bench. It is a physical laser system with software controlling its operation, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside the body.
- Device Function: The description clearly states that the Litho laser system is used in surgical procedures for incision, excision, ablation, vaporization, coagulation, and haemostasis of soft tissue and calculi within the body. It is a surgical tool used directly on the patient.
- Intended Use: The intended use lists various surgical applications across multiple medical specialties, all involving direct intervention on the patient's tissues or stones.
- Device Description: The description details the components of a surgical laser system, including power electronics, control electronics, a cooling system, and an optical bench, all designed for delivering laser energy for surgical purposes.
The device's function and intended use are entirely focused on performing surgical procedures in vivo (within the living body), which is the opposite of the in vitro (outside the living body) nature of IVDs.
N/A
Intended Use / Indications for 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, 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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, Urethra, Bladder, Ureter, Prostate, External genitalia, Urinary tract, Kidney, Gastrointestinal tract, Joints (excluding spine), L4-5 and L5-S1 lumbar discs, Cervical discs, Thoracic discs, Spinal column, Gynecological organs, Nasal cavity, Sinuses, Skin, Internal organs, Tumors, Lesions, Tissue.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals in professional healthcare environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted according to the following standards:
- IEC 60601-1:2005+AMD1:2012+AMD2:2020: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. The present change doesn't affect IEC 60601-1 test reports.
- IEC 60601-1-2:2014+AMD1:2020: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. The present change doesn't affect IEC 60601-1-2 test reports.
- IEC 60601-1-6:2010/AMD1:2013: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. The present change doesn't affect device usability.
- IEC 62366-1:2015: Medical devices - Part 1: Application of usability engineering to medical devices.
- IEC 62304:2006/AMD1:2015: Medical device software - Software life cycle processes. SW verification and validation activities have been repeated as the present change involves SW/FW update.
- IEC 60601-2-22:2007+AMD1:2012: Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60601-2-22 tests have been repeated to check pulse duration accuracy (according to IEC 60601-2-22: 2019).
- IEC 60825-1: 2014: Safety of laser products - Part 1: Equipment classification and requirements. The present change doesn't affect IEC 60825-1 report.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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"
1
2
(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).
2
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
3
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
4
- · 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
5
· 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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6
510(k) Summary K242251
| Applicant /
manufacturer: | Quanta System S.p.A., Via Acquedotto 109, 21017
Samarate (VA), Italy |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Dario Bandiera
RA Manager
Quanta System S.p.A.
Email: dario.bandiera@quantasystem.com
Phone: +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 and
plastic 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 by
Asclepion Laser Technologies GmbH |
7
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.
8
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 | |||||||||
| Wavelength | |||||||||
| (nm) | 2100 | - | - | The same | The same | - | |||
| Indications for use | Litho laser system and its fiber optic delivery system are | ||||||||
| intended for use in surgical procedures using open, | |||||||||
| laparoscopic and endoscopic incision, excision, resection, | |||||||||
| ablation, vaporization, coagulation and haemostasis of soft | |||||||||
| tissue in use in medical specialties including: Urology, Urinary | |||||||||
| Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, | |||||||||
| Gynaecology, ENT and General Surgery. |
Urology
Open and endoscopic surgery (incision, excision, resection,
ablation, vaporization, coagulation and haemostasis) including:
Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors,
Uretheral Tumors and Ureteral Tumors Ablation of Benign Prostatic Hypertrophy (BPH) Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enucleation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia | | | The same | | | The MULTIPULSE HOPLUS
laser system and its fiber optic
delivery system are intended for use in
surgical procedures using open,
laparoscopic and endoscopic, to perform
incision, excision, resection, ablation,
vaporization, coagulation and haemostasis
of soft tissue in use in medical specialties
including: Urology, Urinary Lithotripsy,
Gastroenterology, Arthroscopy,
Discectomy, Pulmonary, Gynaecology, ENT,
Dermatology, Plastic surgery 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 | 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. | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | 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 | | | | | | Gastroenterology
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)
device | | Reference device | Equivalence
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-
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 Surgery
Open, 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 Pulmonary
Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and haemsoatis of soft tissue)
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 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 surgery
Incision, 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 Surgery
Open, 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 | - | |
| Repetition
ratemax (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 | - | |
| Repetition
ratemax (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+AMD2:2020 | |
| Medical electrical equipment - Part 1: General | |
| requirements for basic safety and essential | |
| performance | The present change doesn't affect IEC 60601-1 |
| test reports. | |
| IEC 60601-1-2:2014+AMD1:2020 | |
| Medical electrical equipment - Part 1-2: General | |
| requirements for basic safety and essential | |
| performance - Collateral Standard: | |
| Electromagnetic disturbances - Requirements and | |
| tests. | The present change doesn't affect IEC 60601-1-2 |
| test reports. | |
| IEC 60601-1-6:2010/AMD1:2013 | |
| Medical electrical equipment - Part 1-6: General | |
| requirements for basic safety and essential | |
| performance - Collateral standard: Usability | The present change doesn't affect device usability. |
| IEC 62366-1:2015 | |
| Medical devices - Part 1: Application of usability | |
| engineering to medical devices | |
| IEC 62304:2006/AMD1:2015 | |
| Medical device software - Software life cycle | |
| processes | SW verification and validation activities have been |
| repeated as the present change involves SW/FW | |
| update. | |
| IEC 60601-2-22:2007+AMD1:2012 | |
| Medical electrical equipment - Part 2-22: Particular | |
| requirements for basic safety and essential | |
| performance of surgical, cosmetic, therapeutic and | |
| diagnostic laser equipment | IEC 60601-2-22 tests have been repeated to check |
| pulse duration accuracy (according to IEC 60601-2- | |
| 22: 2019). | |
| IEC 60825-1: 2014 | |
| Safety of laser products - Part 1: Equipment | |
| classification and requirements | The present change doesn't affect IEC 60825-1 |
| report. |
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.