Fiber Dust PRO 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

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
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.

Device Description

Fiber Dust PRO is a laser system 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 um. The main subsystems of the device are the 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.

AI/ML Overview

The provided document does not contain acceptance criteria or a study proving the device meets acceptance criteria in the typical format of a clinical trial or performance study with specific metrics, sample sizes, and ground truth establishment.

Instead, this is a 510(k) summary for the device "Fiber Dust PRO," indicating it's a premarket notification to the FDA. The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device (FiberDust - Quanta System S.p.A. (K210142)).

Here's a breakdown of the information available, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or other quantitative measures typically associated with device performance in clinical studies for diagnostic or AI-driven devices.

Instead, the "Performance data" section (page 7) states:

"Based on the nature of the modified device was subjected to performance testing in accordance with the following recognized consensus standards:
- IEC 60601-1:2005 MOD Medical Electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests"
"The modified device passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."

This indicates that the "acceptance criteria" were compliance with these safety and performance standards for medical electrical equipment, which the device reportedly met. These standards typically cover aspects like electrical safety, electromagnetic compatibility, mechanical safety, and basic operational performance, not clinical efficacy or diagnostic accuracy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on compliance with engineering standards and comparison to a predicate device, not on a clinical trial with a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set or ground truth established by experts is described for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-driven or diagnostic device undergoing an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a laser surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The performance reported is adherence to electrical and electromagnetic compatibility standards, not clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Study and Device Claim:

The "study" presented here is a premarket notification (510(k)) aimed at demonstrating substantial equivalence to a previously cleared predicate device (FiberDust, K210142). The Fiber Dust PRO is a powered laser surgical instrument.

The key aspects of the "study" are:

Device Comparison: The Fiber Dust PRO is described as a modified version of the predicate device, primarily differing in its configuration (mobile vs. desktop). Key technical specifications (laser source, wavelength, emission, pulse duration, frequency, max average power, delivery system, aiming beam) are stated to be "Same or similar" to the predicate.
Intended Use: The intended use and indications for use are "exactly the same" as the predicate device.
Performance Data: The device underwent testing to ensure compliance with recognized international safety and performance standards for medical electrical equipment (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that the device "passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards."
Software Verification and Validation: Software testing was conducted according to FDA guidance for medical device software.
Biocompatibility: No new patient-contacting materials were introduced that would adversely affect biocompatibility, implying reliance on the predicate's biocompatibility assessment.
Conclusion: The submission concludes that the modifications "do not raise new types of questions regarding the safety and effectiveness" and that the performance testing supports its safe and effective use, thus establishing substantial equivalence to the predicate.

In essence, the "acceptance criteria" here are compliance with established safety and general performance standards for medical devices and demonstration that the changes from the predicate do not alter its safety or effectiveness profile. This is typical for a 510(k) submission for a non-diagnostic, non-AI device where engineering and safety standards are the primary focus of performance evaluation, rather than clinical efficacy studies with patient data.

Summary

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March 16, 2022

Quanta System Spa Dario Bandiera RA Manager Via Acquedotto, 109 Samarate, 21017 Italy

Re: K220426

Trade/Device Name: Fiber Dust PRO 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: February 7, 2022 Received: February 14, 2022

Dear Dario Bandiera:

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.

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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 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 (QS) 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 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).

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

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Indications for Use

510(k) Number (if known) K220426

Device Name Fiber Dust PRO

Indications for Use (Describe)

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

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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)

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K220426

510(K) SUMMARY

Applicant /ManufacturerName and Address:	Quanta System S.p.A.Via Acquedotto, 109Samarate (VA) Italy,21017
510(k) Contact Person:	Dario BandieraRegulatory Affairs ManagerQuanta System S.p.A.
	Email: dario.bandiera@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	7thFebruary 2022
Trade Name:	Fiber Dust PRO
Device:	Powered Laser Surgical Instrument
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Basis for submission:	Addition of a new model
Predicate Device	FiberDust - Quanta System S.p.A. (K210142)

Description of the device:

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Device comparison

The proposed modified version is a mobile console configuration and the predicate device is a desktop configuration.

Technical specifications are the same or similar

	Proposed device	Predicate device	Comparison topredicate device
model name	Fiber Dust PRO	Fiber Dust	-
manufacturer	Quanta System S.p.A.	Quanta System S.p.A.	-
510(k)	-	K210142	-
Laser Source	Thulium laser	Thulium laser	Same technology
Wavelength (nm)	1.94 μm	1.94 μm	Same
Emission	CW/pulsed	CW/pulsed	Same
Pulse duration	Up to 15ms	Up to 15ms	Same
Frequency	Up to 2500 Hz	Up to 2500 Hz	Same
Max average power	60 W	60 W	Same
Configuration	Mobile	Desktop	Conformance withIEC 60601-1 and IEC60601-1-2performancestandards
Delivery system	Optical fibers	Optical fibers	Same
Aiming beam	532nm laser < 5 mW	532nm laser < 5 mW	Same

Intended use

The intended use and the indications for use of the modified device and the unmodified device are exactly the same, as follows.

Fiber Dust PRO is intended for incision, excision, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

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K220426

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, 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

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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

Performance data:

Based on the nature of the modified device was subjected to performance testing in accordance with the following recognized consensus standards:

i IEC 60601-1:2005 MOD Medical Electrical equipment Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

The modified device passed all the required testing and is in compliance will all applicable sections of the above mentioned performance standards.

Software Verification and Validation Testing

Software verification and validation 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".

Biocompatibility:

There are no new patient-contacting materials used in the K210142 device compared to those used in the Fiber Dust PRO device that adversely affect biocompatibility.

Substantial Equivalence:

The modifications made to produce the Fiber Dust PRO do not raise new types of questions regarding the safety and effectiveness of the device for the proposed indications for use, and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The device is considered to be substantially equivalent to the predicate device K210142.

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.