Fiber Dust PRO

K220426 · Quanta System Spa · GEX · Mar 16, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220426
• Device Name: Fiber Dust PRO
• Applicant: Quanta System Spa
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 16, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Fiber Dust PRO is a Thulium laser surgical system (1940 nm, up to 60W) for soft tissue surgery and lithotripsy. It delivers laser energy via quartz optical fibers (up to 1000 um) to target tissues or calculi. The system comprises a laser source, power electronics, optical delivery, control electronics, and a cooling system. Operated by a physician in clinical settings (OR/clinic) via a footswitch, the device allows selection of settings for incision, ablation, or fragmentation. The output is laser radiation; the physician uses this to perform surgical procedures or stone fragmentation. The device benefits patients by providing a minimally invasive tool for urological, gastroenterological, and gynecological conditions. The PRO model is a mobile console version of the desktop predicate.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (general safety) and IEC 60601-1-2 (electromagnetic compatibility) confirmed. Software verification and validation performed per FDA guidance. Biocompatibility remains unchanged from predicate.

Technological Characteristics

Thulium laser source; 1.94 μm wavelength; 60W max average power; CW/pulsed emission; 532nm aiming beam (<5 mW). Quartz optical fiber delivery (up to 1000 um). Mobile console form factor. Standards: IEC 60601-1, IEC 60601-1-2. Software-controlled functions.

Indications for Use

Indicated for soft tissue incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in urology (BPH, LRP, LEP, LAP, TUIP, condylomas, strictures, lesions, BNI, tumors, calculi fragmentation), lithotripsy (ureteral, bladder, renal calculi), gastroenterology (appendectomy, polyps, cancer, biopsy, ulcers, etc.), and gynecology (open/laparoscopic 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

• FiberDust (K210142)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

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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 /<br>Manufacturer<br>Name and Address: | Quanta System S.p.A.<br>Via Acquedotto, 109<br>Samarate (VA) Italy,<br>21017 |
|--------------------------------------------------|------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Dario Bandiera<br>Regulatory Affairs Manager<br>Quanta System S.p.A. |
| | Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| 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 plastic<br>surgery 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:

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.

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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 to<br>predicate 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 with<br>IEC 60601-1 and IEC<br>60601-1-2<br>performance<br>standards |
| 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.