Opera Evo laser device and its fibre optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical Traditionalties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, General Surgery and Arthroscopy.

Device Description

The Opera Evo laser device includes a diode laser that emits a wavelength of 1940 nm and includes a diode laser that emits a wavelength of 1470 nm, with a combined cumulated laser output power up to 40W. 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 two diode lasers, 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

This document is a 510(k) premarket notification for the Opera Evo laser device. It outlines the device's indications for use, technological characteristics, and compares it to a predicate device to demonstrate substantial equivalence.

Here's an analysis of the provided information concerning acceptance criteria and study details:

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

The document does not explicitly state quantitative acceptance criteria or a direct table of reported device performance values against those criteria. Instead, it relies on demonstrating compliance with recognized consensus standards. The "performance" assessment is qualitative, asserting that the device meets safety and effectiveness standards.

Acceptance Criteria (Inferred from standards)	Reported Device Performance (Summary)
Electrical Safety	Complies with IEC 60601-1:2012, ed 3.1
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014, ed 4
Laser Specific Safety & Performance	Complies with IEC 60601-2-22:2012, ed 3.1
Laser Product Classification & Safety	Complies with IEC 60825-1:2014, ed 3.0
Usability	Complies with IEC60601-1-6:2013, ed 3.1
Software Verification & Validation	Conducted and documented as per FDA guidance
Overall Safety and Effectiveness	Non-clinical testing supports safe and effective use
Substantial Equivalence	Technologies and indications are similar to predicate; differences do not raise new safety/effectiveness questions.

2. Sample size used for the test set and the data provenance

The document describes non-clinical performance testing only. It does not refer to a "test set" in the context of patient data or clinical samples. Therefore, information regarding sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided in this 510(k) summary. The testing was likely conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes non-clinical performance testing against engineering and safety standards, not a study involving human experts establishing ground truth on clinical data.

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

This information is not applicable for the reasons stated above.

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

No such study was conducted or is referenced in this document. The Opera Evo is a surgical laser device, not an AI-assisted diagnostic or interpretive device.

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

This information is not applicable as the device is a medical laser and doesn't involve an algorithm operating independently in a diagnostic or interpretive capacity. Its "performance" is about its physical characteristics and adherence to safety standards.

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

For the non-clinical performance testing, the "ground truth" refers to the established requirements and limits defined within the specified IEC and other consensus standards. For instance, ground truth for electrical safety would be adherence to specific voltage/current limits, or for laser safety, compliance with defined emission levels.

8. The sample size for the training set

This information is not applicable. The document describes a medical device, not a machine learning model that requires a training set. The "Software Verification and Validation Testing" refers to standard software development and testing practices, not the training of an AI algorithm.

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

This information is not applicable as there is no training set for an AI/machine learning model mentioned.

Summary

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October 15, 2020

Quanta System SpA Francesco Dell'Antonio Vice President Regulatory Affairs and QA Via Acquedotto 109 Samarate, Varese 21017 Italy

Re: K202041

Trade/Device Name: Opera Evo 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: July 20, 2020 Received: July 23, 2020

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.

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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 (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 Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202041

Device Name Opera Evo

Urology:

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including:

· Urethral Strictures
· Bladder Neck Incisions (BNI)
· Ablation and Resection of Bladder Tumors, Urethral and Ureteral Tumors
· Ablation of Benign Prostatic Hypertrophy (BPH)
· Transurethral Incision of the Prostate (TUIP)
· Laser Resection of the Prostate
Laser Enucleation of the Prostate
Laser Ablation of the Prostate
· Condylomas
Lesions of external genitalia

ENT:

Endoscopic endonasal surgery (incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:

· Endonasal/sinus Surgery
Partial turbinectomy
Polypectomy
Dacryocystorhinostomy
Frontal sinusotomy
· Ethmoidectomy
Maxillary antrostomy
· Functionale endoscopic sinus surgery
· Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal area
· Tonsillectomy
Adenoidectomy

Gastroenterology:

Open and endoscopic gastroenterology surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including:

Polyps
· Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
· Duodenal ulcers

FORM FDA 3881 (1/14)

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· Non-bleeding ulcers
· Pancreatitis
Hemorrhoids
· Cholecystectomy
· Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
· Telangiectasias
· Telangiectasias of the Osler-Weber-Rendu disease (OWRD)
Vascular Malformation
· Gastritis
· Esophagitis
· Esophageal ulcers
· Varices
· Colitis
· Mallory-Weiss tear
· Gastric erosion

Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue including:

· Laryngeal lesions

Gynecology:

Open and laparoscopic gynecological surgery (incision, excision, ablation, vaporization, coagulation and hemostasis) including:

Intra-uterine treatment of submucous fibroids
· Benign endometrial polyps and uterine septum by incision, ablation and vessel coagulation
· Soft tissue excision procedures such as excisional conization of the cervix

General Surgery:

Open laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including:

· Cholecystectomy
· Lysis of adhesion
Appendectomy
· Biopsv
Skin incision
· Tissue dissection
· Excision of external tumors and lesions
· Complete or partial resection of internal organs, tumors and lesions
Mastectomy
· Hepatectomy
· Pancreatectomy
· Splenectomy
Thyroidectomy
· Parathyroidectomy
· Herniorrhaphy
· Tonsillectomy
Lymphadenectomy
· Partial Nephrectomy
Pilonidal Cystectomy
Resection of lipoma
Debridement of Decubitus Ulcer

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• Hemorrhoids

· Debridement of Statis Ulcer

Arthroscopy:

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) Ablation of soft, cartilaginous and bony tissue in Minimal invasive Spinal Surgery including:

· Percutaneous Laser Disc Decompression/Discectomy

· Foraminoplasty

· Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasi ve spinal surgery

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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K202041

5. 510(K) SUMMARY

Applicant /ManufacturerName and Address:	Quanta System SPAVia Acquedotto, 109Samarate (VA)Italy, 21017
510(k) Contact Person:	Francesco Dell'AntonioVice President Regulatory Affairs and QAQuanta System SPA
	Email: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	June 30th 2020
Device Name:	Opera Evo
Common name:	Surgical laser
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgeryand in dermatology.
Regulation Number:	21 CFR 878.4810
Product Code:	GEX
Predicate Device	MultiPulse TM+1470 - Asclepion Laser Technologies Gmbh(K133891)

Description of the device:

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	Subject device	Predicate device(s)	Comparison to predicate devices
model name	Opera Evo	MultiPulse TM+1470	-
manufacturer	Quanta System SpA	Asclepion LaserTechnologies Gmbh	-
510(k)	-	K133891
Laser Source	diode lasers	Thulium:YAG laser anddiode laser	The differencesin technologyresult in thesame laseroutputparametersrange
Wavelength(nm)	1.94 µm and 1.47 µm	1.94 µm and 1.47 µm	Same as
Emission	CW/pulsed	CW/pulsed	Same as
Pulse duration	1 ms up to CW	0.5 ms up to CW	Within the rangeof the predicate
Frequency	Up to 250 Hz	Up to 1000 Hz	Within the rangeof the predicate
Max averagepower	40 W	150 W	Within the rangeof the predicate
	-	-
Deliverysystem	Optical fibers	Optical fibers	Same as
Aiming beam	520nm laser < 5 mW	635nm laser < 5 mW	Equivalent

Summary of the technological characteristics

Indications for Use

Urology:

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Urethral Strictures
Bladder Neck Incisions (BNI)
. Ablation and Resection of Bladder Tumors, Urethral and Ureteral Tumors
Ablation of Benign Prostatic Hypertrophy (BPH)
Transurethral Incision of the Prostate (TUIP)
Laser Resection of the Prostate
Laser Enucleation of the Prostate
. Laser Ablation of the Prostate
Condylomas
Lesions of external genitalia ●

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ENT:

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:

Endonasal/sinus Surgery
Partial turbinectomy ●
Polypectomy
Dacryocystorhinostomy
Frontal sinusotomy
Ethmoidectomy
Maxillary antrostomy
Functionale endoscopic sinus surgery
Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal area ●
Tonsillectomy
Adenoidectomy

Gastroenterology:

Open and endoscopic gastroenterology surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including:

Polyps
Biopsy ●
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non-bleeding ulcers
. Pancreatitis
Hemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm
Angiodysplasia
Colorectal cancer
Telangiectasias
Telangiectasias of the Osler-Weber-Rendu disease (OWRD) ●
Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric erosion

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Thoracic and Pulmonary

Open and endoscopic thoracic and pulmonary surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue including:

. Laryngeal lesions

Gynecology:

Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including:

. Intra-uterine treatment of submucous fibroids
. Benign endometrial polyps and uterine septum by incision, ablation and vessel coagulation
. Soft tissue excision procedures such as excisional conization of the cervix

General Surgery:

Open laparoscopic and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including:

Cholecystectomy
Lysis of adhesion
Appendectomy
Biopsy
Skin incision
Tissue dissection
Excision of external tumors and lesions
Complete or partial resection of internal organs, tumors and lesions
Mastectomy
Hepatectomy
Pancreatectomy
Splenectomy
Thyroidectomy
Parathyroidectomy
Herniorrhaphy
Tonsillectomy
Lymphadenectomy
Partial Nephrectomy
Pilonidal Cystectomy
Resection of lipoma
Debridement of Decubitus Ulcer
Hemorrhoids
Debridement of Statis Ulcer

Arthroscopy:

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) Ablation of soft, cartilaginous and bony tissue in Minimal invasive Spinal Surgery including:

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Percutaneous Laser Disc Decompression/Discectomy
Foraminoplasty
Ablation and coagulation of soft vascular and nonvascular tissue in minimally invasi ve spinal surgery

Accessories

This device is intended to be used together with delivery optical fiber that separately received a FDA clearance for an intended use compatible with the one of this device.

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 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".

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 within the those of the predicate device. Other differences between the subject and predicate device to not raise new types of questions regarding the subject

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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 considered substantially equivalent to the predicate device.

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.