(30 days)
No
The description focuses on the laser technology and its physical components, with no mention of AI or ML capabilities. The software is described as controlling device functions and allowing user settings, which is typical for medical devices and does not imply AI/ML.
Yes
The device is intended for various medical procedures such as incision, excision, ablation, coagulation, and hemostasis of soft tissue in urology, lithotripsy, gastroenterological, and gynecological surgeries, all of which are considered therapeutic interventions.
No
The device description and intended use clearly state that it is a surgical laser system used for various soft tissue modifications (incision, excision, resection, ablation, coagulation, hemostasis, vaporization) and fragmentation of calculi. It does not describe any function related to diagnosing medical conditions.
No
The device description explicitly states that Fiber Dust PRO is a "laser system" with physical components like a laser, power electronics, optical delivery system, control electronics, and cooling system. While software controls functions, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Fiber Dust PRO Function: The Fiber Dust PRO is a laser system designed for surgical procedures involving the direct interaction with soft tissue within the body (incision, excision, ablation, etc.). It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly describes surgical interventions in various medical fields.
- Device Description: The description details a laser system for delivering energy to tissue, not for analyzing biological samples.
Therefore, the Fiber Dust PRO is a surgical laser system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue. Specific sites mentioned include: prostate, urethra, ureters, bladder, kidneys, colon, stomach, esophagus, gallbladder, biliary/bile duct, female reproductive organs (gynecological surgery).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The modified device was subjected to performance testing in accordance with IEC 60601-1:2005 MOD (Medical Electrical equipment Part 1: General requirements for basic safety and essential performance) and 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 with all applicable sections of the above mentioned performance standards. 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".
Key Metrics
Not Found
Predicate Device(s)
FiberDust - K210142
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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); 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)
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
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)
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510(K) SUMMARY
| Applicant /
Manufacturer
Name and Address: | Quanta System S.p.A.
Via Acquedotto, 109
Samarate (VA) Italy,
21017 |
|--------------------------------------------------|------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Dario Bandiera
Regulatory Affairs Manager
Quanta System S.p.A. |
| | Email: dario.bandiera@quantasystem.com
Phone: +39-0331-376797
Fax: +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 plastic
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.
5
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
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
IEC 60601-1 and IEC
60601-1-2
performance
standards |
| Delivery system | Optical fibers | Optical fibers | Same |
| Aiming beam | 532nm laser