Surgical Laser Fibers are indicated for use in general surgical applications for: incision, excision, vaporization, ablation, haemostasis or coagulation of soft tissue in a contact or non-contact mode (with a compatible laser marketed for use in the desired application).

Surgical Laser Fibers (surgical fiber optic laser delivery devices) are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.

Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.

Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.

Device Description

The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue. The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations (flat and ball shaped) and several core diameter sizes (from 200 to 1000 microns) are offered.

AI/ML Overview

The provided text is a 510(k) premarket notification for "Surgical Laser Fibers" (K180158). This document primarily focuses on establishing substantial equivalence to a predicate device and does not describe a study proving the device meets specific acceptance criteria in the way a diagnostic algorithm or predictive model would.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present quantitative acceptance criteria or device performance data in the typical sense of a diagnostic or predictive device. Instead, it relies on demonstrating compliance with recognized consensus standards and "substantial equivalence" to a predicate device.

Acceptance Criterion	Reported Device Performance
Sterilization	Complies with EN 556-1:2006, ISO 11135-1:2007, ISO 11138-2:2006, EN ISO 17665:2006 (for moist heat sterilization).
Biocompatibility	Complies with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010. Materials are unchanged from predicate, assumed biocompatible.
Packaging & Labeling	Complies with ISO 15223-1:2012, EN 1041:2008, ISO 11607-1:2006, ISO 11607-2:2006.
Risk Management	Complies with ISO 14971:2007.
Microbiological Methods	Complies with ISO 11737-1:2006.
Fiber Optic Connectors	Complies with IEC 61754-22:2005.
Intended Use & Technological Characteristics	Stated as having the "same intended use and the same technological characteristics" as the predicate device (K160513).

2. Sample Size for Test Set and Data Provenance

Not applicable. This device is a surgical tool, not a diagnostic or AI-driven system that would typically have a "test set" in the context of algorithm performance. The "testing" involved compliance with established medical device standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth, in the sense of expert consensus on medical findings, is not relevant for this type of device submission. Compliance with standards is typically assessed by engineers and regulatory experts.

4. Adjudication Method

Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The device is a surgical laser fiber, not an AI-assisted diagnostic tool. Therefore, there's no concept of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is its compliance with internationally recognized consensus standards for medical device safety, performance, sterilization, biocompatibility, and packaging. The claim of "substantial equivalence" to a predicate device (K160513) also serves as a form of "ground truth" regarding its safety and effectiveness profile.

8. Sample Size for Training Set

Not applicable. This is not an AI/ML device trained on data.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of the Study/Evidence Provided:

The "study" or evidence provided in this 510(k) submission is primarily a declarative statement of compliance with consensus standards and a comparison to a legally marketed predicate device. The manufacturer asserts that the modified device (K180158) is "substantially equivalent" to its predicate (K160513) because:

It has the same intended use.
It has the same technological characteristics.
Any minor labeling differences do not raise new questions of safety or effectiveness.
The device (both predicate and subject) complies with a comprehensive list of recognized international and European standards covering aspects like sterility, biocompatibility, packaging, risk management, and fiber optic connector specifications.

Therefore, the "proof" the device meets acceptance criteria lies in its adherence to these established standards and its demonstrated equivalence to a previously cleared device. There are no clinical trials, diagnostic performance metrics, or expert consensus reviews detailed in this document for this specific device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 14, 2018

Quanta System SPA Francesco Dell'Antonio Vice President Regulatory Affairs and QA via acquedotto 109 Samarate (Va), 21017 Italy

Re: K180158

Trade/Device Name: Surgical Laser fibers 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: January 8, 2018 Received: January 19, 2018

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. 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.

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); good

{1}------------------------------------------------

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180158

Device Name

EMPOWER Sterile Surgical Optical Fiber

Indications for Use (Describe)

Surgical Laser Fibers are intended to be used in conjunction with cleared surgical lasers equipped with SMA 905 or SMA 906 or compatible connector.

Surgical Laser Fibers are indicated for use in general surgical applications for: incision, vaporization, ablation, haemostasis or coagulation of soft tissue in a contact mode (with a compatible laser marketed for use in the desired application).

Surgical Laser Fibers (surgical fiber optic laser delivery devices) are in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are also indicated for use in open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are also intended as an aid for otologic procedures, for use in incision, coagulation and vaporization of soft and fibrous tissue including osseous tissue with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 mm, with pulsed and continuous wave (CW) emission mode.

Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Tm:YAG pulsed and continuous wave CW laser devices.

Surgical Laser Fibers may be used in surgical specialty or procedures for which compatible lasers have received regulatory clearance: for a complete informations, contraindications, precautions and warnings when using fiber optic it is necessary to refer to the applicable laser device User Manual.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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 SPAEmail: francesco.dellantonio@quantasystem.comPhone: +39-0331-376797Fax: +39-0331-367815
Date Prepared:	January 8th 2018
Trade Name:	EMPOWER Sterile Surgical Optical Fiber
Common Name:	Sterile Surgical Optical Fiber
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
Basis for Submission:	change to labeling information
Primary predicate device	Surgical Laser fibers (K160513), Quanta System SpA

The modified device Surgical Laser fibers is derived from the legally marketed (unmodified) device Surgical Laser fibers (K160513).

Performance Standards:

There are no mandatory performance standards for this device.

Description of the device:

The Description of the modified device and the unmodified device is exactly the same, as follows. The Surgical Laser Fibers are a Fiber Optic Laser Delivery System meaning a device intended for the delivery of laser radiation to soft tissue.

{5}------------------------------------------------

The Surgical Laser Fibers are surgical fiber optic laser delivery devices based on a silica core/silica clad fiber jacketed with ethylene tetrafluoroethylene (ETFE). The devices are 3.0 meters (9.8 ft) long and are terminated with a laser specific SMA 905 connector plus a strain relief on the proximal end. Different distal tip configurations (flat and ball shaped) and several core diameter sizes (from 200 to 1000 microns) are offered.

Intended use

Surgical Laser Fibers are intended to be used in conjunction with cleared surgical lasers equipped with SMA 905 or SMA 906 or compatible connector.

Surgical Laser Fibers are also indicated for use in lithotripsy with an approved compatible laser marketed for use in the desired application.

Surgical Laser Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode.

Surgical Laser Fibers are indicated, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.

{6}------------------------------------------------

The wording differs from the one of the predicate device (K160513) limitedly to the removal of the restriction of use with Quanta System laser devices.

Performance data:

Same as the unmodified device, the Surgical Laser fibers devices comply with the following recognized consensus standards:

EN 556-1:2001/AC:2006 Sterilization of medical devices -Requirements for medical devices to be designated "STERILE" – Part 1: requirements for terminally sterilized medical devices.

ISO 15223-1:2012Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements

EN 1041:2008 Information supplied by the manufacturer of medical devices.

ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.

ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.

ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Test for irritation and delayed-type hypersensitivity.

ISO 11135-1:2007 Sterilization of health-care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization processes for medical devices.

ISO 11138-2:2006 Sterilization of health-care products – Biological indicators – Part 2: biological indicators for moist heat sterilization processes .

ISO 11607-1:2006 Packaging for terminally sterilized medical devices – Part 1: requirements for materials, sterile barrier systems and packaging systems.

ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part 2: validation requirements for forming, sealing and assembly processes.

ISO 11737-1:2006 Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorgamisms on product.

ISO 14971:2007 Medical devices - Application of risk management to medical devices.

IEC 61754-22:2005 Fibre optics connector interfaces – Part 22: type SMA connector family.

EN ISO 17665:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.

{7}------------------------------------------------

Biocompatibility:

The materials of the subject and unmodified device have no differences that affect biocompatibility.

Comparison with predicate device:

The subject device and its predicate (K160513) have the same intended use and the same technological characteristics.

Any minor differences to the labeling do not present any new types of safety or effectiveness questions.

Summary

Surgical Laser Fibers are substantially equivalent to the legally marketed predicate device (K160513).

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.