LITHO LASER SYSTEM
Device Facts
| Record ID | K091909 |
|---|---|
| Device Name | LITHO LASER SYSTEM |
| Applicant | Quanta System Spa |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Jul 9, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic, 3rd-Party Reviewed |
Indications for 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 Story
LITHO Laser System is a surgical Ho:YAG laser (2.1um wavelength) used for soft tissue surgery and lithotripsy. Device comprises high-voltage power supply, internal water-to-air cooling system, laser rod, optical fiber delivery system, and control electronics. Operated by physicians in clinical settings (OR, endoscopic suites). User selects parameters via control panel; laser energy delivered via fiber optic to target tissue for incision, ablation, or coagulation. Safety features include remote interlock, emergency stop, and footswitch. Provides precise tissue interaction for various specialties, including urology (e.g., prostatectomy, stone fragmentation), gastroenterology, orthopedics, and dermatology. Benefits include minimally invasive access and effective hemostasis.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Ho:YAG laser; 2.1um wavelength; up to 20 Hz frequency. Five subsystems: high-voltage power supply, internal water-to-air cooling, laser rod, optical fiber delivery, and display/control electronics. Safety features: remote interlock, emergency stop, footswitch, key switch.
Indications for Use
Indicated for patients requiring surgical incision, excision, resection, ablation, vaporization, coagulation, or hemostasis of soft, cartilaginous, or bony tissue across urological, gastroenterological, orthopedic, pulmonary, gynecological, ENT, dermatological, and general surgical specialties. Includes lithotripsy for urinary calculi and spinal disc decompression.
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
- AllMed System Sphinx Laser System (K033437)
Submission Summary (Full Text)
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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:
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.
### 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
{1}------------------------------------------------
- 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
{2}------------------------------------------------
- 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
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# 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:
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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.
# 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.
{5}------------------------------------------------
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.
{6}------------------------------------------------
### 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
{7}------------------------------------------------
# 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:
{8}------------------------------------------------
- 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
{9}------------------------------------------------
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
{10}------------------------------------------------
# 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_
