K Number

Device Name

LITHO LASER SYSTEM

Manufacturer

QUANTA SYSTEM, S.P.A.

Date Cleared

2009-07-09

(14 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The 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 hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotnpsy. Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Device Description

The LITHO Laser System is a surgical laser instrument for use in general surgery and dermatology. The LITHO Laser System includes 1 model. The LITHO laser system is designed with five major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: an Ho:YAG laser rod, capable of generating laser pulses at 2.1um wavelength and a frequency up to 20 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and focusing hand piece; (5) Display and Control Electronics: a display with control electronics, which regulates the functions of the laser and allows parameter selection by the user. In addition to the five subsystems, the LITHO laser system incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K033437

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the hardware components and basic control electronics of a surgical laser system, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is intended for surgical procedures, including cutting, removing, and coagulating tissue, which are therapeutic actions aimed at treating diseases or injuries.

Diagnostic

The device description and intended use clearly state that the LITHO laser system is designed for surgical procedures such as incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue. These are all therapeutic and interventional actions, not diagnostic ones. There is no mention of the device being used to identify, analyze, or monitor medical conditions.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including a power supply, cooling system, laser system (Ho:YAG rod), delivery system (optical fiber and hand piece), and display/control electronics. This is a physical laser system, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, the LITHO laser system is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the device is for surgical procedures involving direct interaction with soft tissue within the body (incision, excision, resection, ablation, vaporization, coagulation, and hemostasis). This is a therapeutic and surgical application, not an in vitro diagnostic one.
Device Description: The description details a surgical laser system that delivers energy via a fiber optic cable to the patient. This is consistent with a surgical tool, not a device used to examine samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD device.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The LITHO laser system performs surgical procedures directly on the patient's tissue.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Urethral Strictures .
Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors, ● Uretheral Tumors and Ureteral
Tumors,
Ablation of Benign Prostatic Hypertrophy (BHP),
Transurethral incision of the prostate (TUIP)
Holmiurn Laser Resection of the Prostrate (HoLRP)
Holmium Laser Enuculeation of the Prostate (HoLEP)
Holmiurm 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.

Gasteroenterlogy
Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:

Appendectomy .
Polyps ●
Biopsv .
Gall Bladder calculi .
Biliary/Bile duct calculi .
Ulcers ●
Gastric ulcers .
Duodenal ulcers .
Non Bleeding Ulcers ●
Pancreatitas .
Hemorrhoids
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/Orthopedic 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
Countouring 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 Debuidement ◆
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 hemostasis of soft tissue)

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

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

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

Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and 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 hemostasis) including:

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

Product codes

GEX

Device Description

The LITHO laser system is designed with five major sub-systems, including: (1) Power Supply: a high voltage power supply, which converts and rectifies the AC mains current to provide regulated power for the flash lamp simmer current and main triggering pulse; (2) Cooling System: a cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger; (3) Laser System: an Ho:YAG laser rod, capable of generating laser pulses at 2.1um wavelength and a frequency up to 20 Hz; (4) Delivery System: an optical delivery system, interfacing the energy from the laser to the patient via an optical fiber and focusing hand piece; (5) Display and Control Electronics: a display with control electronics, which regulates the functions of the laser and allows parameter selection by the user.

In addition to the five subsystems, the LITHO laser system incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Urethral, ureteral, bladder, renal, kidney, soft tissue, cartilaginous tissue, small and large joints of the body (excluding spine), L4-5 and L5-SI lumbar discs, cervical disc, thoracic disc, nasal, sinus, skin, subcutaneous tissue, external genitalia, external lesions, internal lesions, internal organs.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Performance Data: None

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K033437

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

K091909

Title:

510(k) SUMMARY Quanta System LITHO Laser System

JUL - 9 2009

Quanta System SpA via IV Novembre, 116 21058 Solbiate Olona VA / Italy

Contact:

Submitter:

Dr. Isabella Carrer Medical Division Manager

Quanta System LITHO Laser System

Instrument, surgical, powered, laser

Date Prepared: April 10, 2009

Device Trade Name:

Common Name:

Laser surgical instrument for use in general surgery and dermatology

Classification Name:

Predicate Devices:

AllMed System Sphinx Laser System (K033437):

Intended Use / Indications for Use:

2.1 um Applications:

Urology

Open and endoscopic surgery (incision, excision, resection, ablation,

vaporization, coagulation and hemostasis) including:

Urethral Strictures .
Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors, ● Uretheral Tumors and Ureteral

Tumors,
Ablation of Benign Prostatic Hypertrophy (BHP),
Transurethral incision of the prostate (TUIP)
Holmiurn Laser Resection of the Prostrate (HoLRP)
Holmium Laser Enuculeation of the Prostate (HoLEP)
Holmiurm 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.

Gasteroenterlogy

Open and endoscopic gasteroenterlogy surgery (incision, excision, resection,

ablation, vaporization, coagulation and hemostasis ) including:

Appendectomy .
Polyps ●
Biopsv .
Gall Bladder calculi .
Biliary/Bile duct calculi .
Ulcers ●
Gastric ulcers .
Duodenal ulcers .
Non Bleeding Ulcers ●
Pancreatitas .
Hemorrhoids
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/Orthopedic 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
Countouring 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 Debuidement ◆
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 hemostasis of soft tissue)

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

ENT

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

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

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, vaporization, coagulation and 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 hemostasis) including:

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

The LITHO Laser Systemis a surgical laser instrument for use in general surgery and dermatology. The LITHO Laser Systemi includes 1 model:

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Technological Characteristics:

In addition to the five subsystems, the LITHO laser system incorporates several safety features, including a remote interlock, an emergency red push button, a footswitch and a key switch.

Performance Data

None

Substantial Equivalence: The Quanta System LITHO Laser System is as safe and effective as the predicate device. The LITHO Laser System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the LITHO Laser System and its predicate devices raise no new issues of safety or effectiveness. Thus, the LITHO Laser System is substantially equivalent to the predicate device.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/14 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K091909

Trade/Device Name: LITHO Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery

JUL - 9 2009

and in dermatology

Regulatory Class: II Product Code: GEX Dated: June 24, 2009 Received: June 25, 2009

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 - Mr. Mark Job

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millerson

Mark N.Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use Statement

510(k) Number (if known):_K 09 | 9 0 9

LITHO Laser System Device Name:

Indications for Use:

2.1 um Applications:

The 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 hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotnpsv. Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.

Ürology

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

Urethral Strictures t
Bladder Neck Incisions (BNI)
Ablation and resection of Bladder Tumors. Uretheral Tumors and Ureteral
Tumors,
Ablation of Benign Prostatic Hypertrophy (BHP), ( ßPH)
Transurethral incision of the prostate (TUIP)
Holmiurn Laser Resection of the Prostrate (HoLRP)
Holmium Laser Enuculeation of the Prostate (HoLEP)
Holmiurm 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 g 800 be passed.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Gasteroenterlogy

510(k) Number.

Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:

Appendectomy
Polyps
Biopsv
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitas
Hemorrhoids
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/Orthopedic 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
Countouring 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 Debuidement
Lateral retinecular release

N.A. Rf. Ogle for mxm
(Division Sign-Off)

Division of Surgical, Orthonedic, and Restorative Devices

510(k) Number K091909

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 hemostasis of soft tissue)

Gynecology

Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue

ENT

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

Endonasal/sinus Surgery
Partial turbinectomy
Polypectomy
Dacrvocystorhinostomy
· Frontal Sinusotomy
Ethmoidectomy
Maxillary antrostomy
Functional endoscopic sinus surgery

Dermatology and Plastic Surgery

Incision, excision, resection, ablation, vàporization, coagulation and 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

Nail R. Dale
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091909

General Surgery

Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil ke Oglin for nkn
(Division Sign-Off)

Division of Surpical, Orihopedic, and Restorative Devices

Kog1909 510(k) Number_