(84 days)
Not Found
No
The summary describes a laser device with software control for user-selected settings and triggering via a footswitch. There is no mention of AI, ML, image processing, or data-driven decision-making. The performance studies focus on electrical safety, electromagnetic compatibility, and software verification/validation according to standard medical device guidance, not AI/ML specific performance metrics or training/test data.
Yes
The device is clearly indicated for "surgical procedures" involving various soft tissue manipulations like "incision, resection, ablation, vaporization, coagulation and hemostasis," which are all therapeutic actions. Additionally, one of the performance standards it adheres to is specific to "Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment," explicitly mentioning 'Therapeutic'.
No
The device is described for use in surgical procedures (incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue), which are therapeutic, not diagnostic.
No
The device description explicitly details hardware components including diode lasers, power electronics, optical delivery system, control electronics, and a cooling system, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical procedures using open, laparoscopic and endoscopic incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue." This describes a device used on the patient's body for surgical intervention.
- Device Description: The description details a laser device that delivers energy via a fiber optic cable for surgical purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is used to directly treat or alter tissue within the body.
N/A
Intended Use / Indications for Use
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. Specifically:
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
- · 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
- · 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
Product codes
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethral, Bladder, Urethral, Ureteral, Prostate, External genitalia, Endonasal/sinus, Oral, nasal, glossal, pharyngeal, laryngeal, Tonsil, Adenoid, Gall Bladder, Biliary/Bile duct, Gastric, Duodenal, Pancreas, Hemorrhoids, Colorectal, Larynx, Uterus, Endometrial, Cervix, Skin, Internal Organs, Breast, Liver, Pancreas, Spleen, Thyroid, Parathyroid, Hernia, Lymph nodes, Kidney, Pilonidal, Lipoma, Decubitus Ulcer, Spinal, Disc, Soft and cartilaginous tissue, Bony tissue.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 (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
2
Indications for Use
510(k) Number (if known) K202041
Device Name Opera Evo
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.
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)
3
- · 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
4
• 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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5
5. 510(K) SUMMARY
| Applicant /
Manufacturer
Name and Address: | Quanta System SPA
Via Acquedotto, 109
Samarate (VA)
Italy, 21017 | | |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|--|--|
| 510(k) Contact Person: | Francesco Dell'Antonio
Vice President Regulatory Affairs and QA
Quanta System SPA | | |
| | Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +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 surgery
and 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:
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
6
| Subject device | Predicate device(s) | Comparison to predicate devices | |
|---|---|---|---|
| model name | Opera Evo | MultiPulse TM+1470 | - |
| manufacturer | Quanta System SpA | Asclepion Laser | |
| Technologies Gmbh | - | ||
| 510(k) | - | K133891 | |
| Laser Source | diode lasers | Thulium:YAG laser and | |
| diode laser | The differences | ||
| in technology | |||
| result in the | |||
| same laser | |||
| output | |||
| parameters | |||
| range | |||
| 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 range |
| of the predicate | |||
| Frequency | Up to 250 Hz | Up to 1000 Hz | Within the range |
| of the predicate | |||
| Max average | |||
| power | 40 W | 150 W | Within the range |
| of the predicate | |||
| - | - | ||
| Delivery | |||
| system | Optical fibers | Optical fibers | Same as |
| Aiming beam | 520nm laser |