Fiber Dust

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March 11, 2021 Quanta System Spa Francesco Dell'Antonio Vice President Regulatory Affairs and QA via Acquedotto 109 Samarate (Va), 21017 Italy Re: K210142 Trade/Device Name: Fiber Dust 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: December 29, 2020 Received: January 19, 2021 Dear Francesco Dell'Antonio: 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. 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 located 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. {1}------------------------------------------------ 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-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). Sincerely. Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210142 Device Name Fiber Dust Indications for Use (Describe) Fiber Dust is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology - · Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] - · Laser Resection of the Prostrate (LRP) - · Laser Enucleation of the Prostate (LEP) - · Laser Ablation of the Prostate (LAP) - · Transurethral Incision of the Prostate (TUIP) - Condylomas - · Urethral strictures - Lesions of external genitalia - · Bladder neck incisions (BNI) - · Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors - · Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi - · Treatment of distal impacted fragments remaining in the ureters following lithotripsy Lithotripsy and Percutaneous Urinary Lithotripsy Indications - · Endoscopic fragmentation of ureteral, bladder and renal calculi including cystine, calcium oxalate, - monohydrate and calcium oxalate dehydrate stones - Endoscopic fragmentation of renal 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 - · Angiodysplasia - · Polyps - · Colorectal cancer - · Biopsy - · Telangiectasias - Gall Bladder calculi - · Telangiectasias of the Osler-Weber-Renu disease - Biliary/Bile duct calculi - Vascular Malformation - Ulcers - · Gastritis - · Gastric ulcers - · Esophagitis - · Duodenal ulcers - · Esophageal ulcers {3}------------------------------------------------ - Non Bleeding Ulcers - · Varices - Pancreatitis - Colitis - Haemorrhoids - Mallory-Weiss tear - ·Cholecystectomy - · Gastric Erosions - ·Benign and Malignant Neoplasm ## Gynecology Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) of soft tissue. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {4}------------------------------------------------ # K210142 ## 5. 510(K) SUMMARY | Applicant /<br>Manufacturer<br>Name and Address: | Quanta System SPA<br>Via Acquedotto, 109<br>Samarate (VA)<br>Italy, 21017 | |--------------------------------------------------|-------------------------------------------------------------------------------------------------| | 510(k) Contact Person: | Francesco Dell'Antonio<br>Vice President Regulatory Affairs and QA<br>Quanta System SPA | | | Email: francesco.dellantonio@quantasystem.com<br>Phone: +39-0331-376797<br>Fax: +39-0331-367815 | | Date Prepared: | 4th March 2021 | | Device Name: | Fiber Dust | | Common name: | Surgical laser | | Classification: | Class II | | Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology. | | Regulation Number: | 21 CFR 878.4810 | | Product Code: | GEX | | Predicate Device | SOLTIVE Laser System - Olympus Surgical Technologies America<br>(K183647) | ## Description of the device: The Fiber Dust laser device includes a diode laser that emits a wavelength of 1940 nm with a laser output power up to 60W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 μm. The main subsystems of the device are the diode laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user select device settings. Laser emission is triggered by a footswitch. {5}------------------------------------------------ ## Summary of the technological characteristics | | Subject device | Predicate device(s) | Comparison to predicate devices | |-------------------|--------------------|------------------------------------------|-----------------------------------------| | model name | Fiber Dust | SOLTIVE Laser System | - | | manufacturer | Quanta System SpA | Olympus Surgical Technologies<br>America | - | | 510(k) | - | K183647 | - | | Laser Source | Thulium laser | Thulium laser | Same<br>technology | | Wavelength (nm) | 1.94 μm | 1.94 μm | Same | | Emission | CW/pulsed | CW/pulsed | Same | | Pulse duration | 0.1 to 15ms | 0.2 to 50ms | Within the<br>range of the<br>predicate | | Pulse energy | 0.02 to 6J | 0.025 to 6J | Within the<br>range of the<br>predicate | | Frequency | 1 to 2500 Hz | 1 to 2400 Hz | Similar | | Max average power | 60 W | 60 W | Same | | Delivery system | Optical fibers | Optical fibers | Same as | | Aiming beam | 532nm laser < 5 mW | 500-550nm laser < 5 mW | Equivalent | | Cooling system | Air cooling system | Air cooling system | Equivalent | ## Indications for Use Fiber Dust is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. #### Urology - Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] - Laser Resection of the Prostrate (LRP) - Laser Enucleation of the Prostate (LEP) - Laser Ablation of the Prostate (LAP) - Transurethral Incision of the Prostate (TUIP) - Condylomas - Urethral strictures - Lesions of external genitalia - Bladder neck incisions (BNI) - Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors - Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi - Treatment of distal impacted fragments remaining in the ureters following lithotripsy {6}------------------------------------------------ ## Lithotripsy and Percutaneous Urinary Lithotripsy Indications • Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones - Endoscopic fragmentation of renal 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 - Angiodysplasia - Polyps - Colorectal cancer - Biopsy - Telangiectasias - Gall Bladder calculi - Telangiectasias of the Osler-Weber-Renu disease - Biliary/Bile duct calculi - Vascular Malformation - Ulcers - Gastritis - Gastric ulcers - Esophagitis - Duodenal ulcers - Esophageal ulcers - Non Bleeding Ulcers - Varices - Pancreatitis - Colitis - Haemorrhoids - Mallory-Weiss tear - •Cholecystectomy - Gastric Erosions - •Benign and Malignant Neoplasm #### Gynecology Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue #### Accessories This device is intended to be used together with delivery optical fiber that separately received an FDA clearance for an intended use compatible with the one of this device. {7}------------------------------------------------ #### Performance testing The subject device was subject to testing according to the following recognized consensus standards related to electromagnetic compatibility, electrical safety and performances. - -IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety And Essential Performance - -IEC 60601-1-2:2014, ed 4, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements And Tests. - -IEC 60601-2-22: 2012, ed 3.1, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment - -IEC 60825-1:2014, ed 3.0, Safety of laser products – Part 1: Equipment classification and requirements - -IEC60601-1-6:2013, ed 3.1, Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability - -Software Verification and Validation Testing: Software verification testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The results of the non-clinical performance standards testing support that the device can be used safely and effectively. #### Comparison with predicate device: The subject device's technological characteristics and indications for use are similar to the predicate device, and its laser output ranges are equivalent to those of the predicate device. Other differences between the subject and predicate device to not raise new types of questions regarding the subject device's safety and efficacy. #### Conclusions The non-clinical performance testing conducted supports that the device can be used safely and effectively. The differences in the indications for use and technological characteristics between the subject and predicate device do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.