Who is the manufacturer of Litho?

Quanta System Spa filed the 510(k) submission for Litho (K163009).

What is the FDA product code for Litho?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Litho?

510(k) clearance (submission type: Special).

What are the predicate devices for Litho?

Litho (K141101); Lumenis Pulse 120h (K140388).

Who can help prepare an FDA 510(k) submission like Litho?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Litho

K163009 · Quanta System Spa · GEX · Dec 1, 2016 · General, Plastic Surgery

Device Facts

Record ID	K163009
Device Name	Litho
Applicant	Quanta System Spa
Product Code	GEX · General, Plastic Surgery
Decision Date	Dec 1, 2016
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

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, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery.

Device Story

Litho is a laser surgical system utilizing fiber optic delivery for soft tissue procedures. It functions by delivering laser energy to perform incision, resection, ablation, vaporization, coagulation, and haemostasis. Operated by physicians in clinical settings (OR, endoscopic suites), the device allows for precise tissue interaction. The system is controlled via software that manages laser emission parameters (power, energy, frequency). Healthcare providers use the laser to treat various conditions, including urinary calculi, benign prostatic hypertrophy, and soft tissue lesions. The device benefits patients by providing a minimally invasive surgical tool for tissue removal and haemostasis, reducing the need for traditional open surgery. The current modification expands the range of emission parameters to enhance clinical versatility.

Clinical Evidence

Bench testing only. The device underwent electrical safety and performance testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1. No clinical data was required or provided for this 510(k) modification.

Technological Characteristics

Laser surgical instrument; fiber optic delivery system. Energy source: Laser. Connectivity: Not specified. Sterilization: Not specified. Software: Embedded control for laser emission parameters (power, energy, frequency). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (laser equipment), IEC 60825-1 (laser safety).

Indications for Use

Indicated for patients requiring soft tissue incision, resection, ablation, vaporization, coagulation, or haemostasis in urology (e.g., urethral strictures, BNI, bladder/ureteral tumors, BPH, HoLRP, HoLEP, HoLAP, condylomas), urinary lithotripsy (urethral, ureteral, bladder, renal calculi), gastroenterology (e.g., polyps, ulcers, neoplasms, vascular malformations), arthroscopy (e.g., ligament release, chondroplasty, meniscectomy), minimally invasive spinal surgery (disc decompression), gynaecology, ENT (e.g., sinus surgery, turbinectomy), and general surgery.

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 (K141101)
Lumenis Pulse 120h (K140388)

Related Devices

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K192990 — Litho Evo · Quanta System Spa · Dec 20, 2019
K170331 — Cyber Ho · Quanta System Spa · Mar 3, 2017
K172025 — Litho 60 · Quanta System Spa · Jul 31, 2017
K180423 — Empower H65 · Quanta System Spa · Mar 15, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES - USA Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 16, 2018 Ouanta System S.p.A. Francesco Dell'antonio V.P Regulatory Affairs & Quality Assurance Via acquedotto. 109 Samarate, 20826 Italy Re: K163009 Trade/Device Name: Litho 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: November 3, 2016 Received: November 4, 2016 Dear Francesco Dell'antonio: This letter corrects our substantially equivalent letter of December 1, 2016. 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. 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. {1}------------------------------------------------ Page 2 - Francesco Dell'antonio 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 devicerelated 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, # Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### 510(k) Number (if known) K163009 Device Name Litho #### Indications for Use (Describe) The Litho laser system and its fiber optic delivery system are in surgical procedures using open. laparoscopic and endoscopic incision. resection. ablation. vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectonly, 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 (BHP), - · 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 FORM FDA 3881 (1/14) {3}------------------------------------------------ #### · 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-SI lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy - Percutaneous Thoracic Disc Decompression/Discectorny #### Gynaecology Open and laparoscopic gynaecological surgery (incision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue #### ENT Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue and cartilage) including: - Endonasal/sinus Surgery - · Partial turbinectomy - Polypectomy - Dacryocystorhinostomy FORM FDA 3881 (1/14) {4}------------------------------------------------ #### · 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 of partial resection of internal organs, tumors and lesions - · Biopsy Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) ا_ Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ ## 5. Special 510(K) SUMMARY – Device Modifications ## Introduction: This document contains the 510(k) Summary for the device Litho. The basis of this submission is Modifications to a Device already cleared. The content of this summary is based on the requirements of 21 CFR 807.92(c). | Applicant / Manufacturer Name and Address: | Quanta System SPA Via Acquedotto, 109 Samarate (VA) Italy, 21017 | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Contact Person: | Francesco Dell'Antonio Vice President Regulatory Affairs and QA Quanta System SPA Email: francesco.dellantonio@quantasystem.com Phone: +39-0331-376797 Fax: +39-0331-367815 | | Date Prepared: | October 26 th 2016 | | Device Name: | Litho | | 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 modifications | | Legally Marketed Device | Litho (K141101) - Quanta System SPA Lumenis Pulse 120h (K140388) - Lumenis LTD | ### Performance Standards: There are no mandatory performance standards for this device. {6}------------------------------------------------ #### Description of the modifications: This Special 510(k) of the modified device Litho is submitted due to Device Modifications of the already cleared device (K141101) due to the broadening of the range of some laser emission parameters such as power, energy and frequency. The modified device has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications. The modified and unmodified devices are exactly the same except for the available range of emission parameters. A change to the software determined the differences between the modified and unmodified versions. There are not incremental changes from the original clearance K141101 to be taken into account other than the differences between modified and unmodified devices. Based on the nature of the changes implemented, the device underwent and successfully passed electrical safety and performance testing according to IEC 60601-1 and its collateral standards. #### Intended Use/Indications for Use The modified device Litho has the same intended use of the unmodified device, as follows: The LITHO laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coaqulation and haemostasis of soft tissue 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 (BHP), - . 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 5-2 {7}------------------------------------------------ - . 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 - Polvps . - 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 - o 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: ર-3 {8}------------------------------------------------ - 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 - Partial turbinectomy . - . Polypectomy - . Dacrvocystorhinostomy - 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 of partial resection of internal organs, tumors and lesions . - Biopsy . {9}------------------------------------------------ #### Substantial Equivalence: The modified and unmodified devices have the same components, the same laser sources and the same controlling principles, but some differences in the range of emission parameters. Another predicate device, Lumenis Pulse 120h (K140388), has been considered in order to demonstrate the safety and effectiveness of the parameters combinations not included in the unmodified device. The modified and unmodified devices have the same intended use. Thus the modified device Litho is substantially equivalent to the previously legally marketed device, cleared under K141101. #### Performace testing The modified device Litho was subjected to performance testing in accordance with the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances: - IEC 60601-1:2012. Medical Electrical Equipment Part 1: General Requirements For -Basic Safety And Essential Performance - -IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests. - -IEC 60601-2-22 Third Edition 2007-05, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment - . IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products Part 1: Equipment Classification, And Requirements The modified device Litho passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.