(282 days)
The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope.
The intended use and clinical applications are described in the User Manual of the corresponding Laser.
SLI Laser Probes are medical optical fibers to transfer the radiation emitted by a medical laser to its target at or in the patient. The laser beam conducted to pathological tissue destroys it thermally. The probes do not change the physical properties of the laser beam emitted by the laser device. The devices are sold sterile (EO) and are ready to use.
Fiber core and cladding for the applied device are made of silica glass, coated with a hard fluoropolymer. Fiber jacket consists of highly biocompatible polymers such as ETFE. The medical device is offered in various core diameters. Laser light is coupled into the fiber via a standard SMA connector. The cannula of the endoprobes is made of 1.4301 stainless steel.
This document is a 510(k) premarket notification for the SLI-Laser Fibers. It aims to demonstrate substantial equivalence to previously cleared predicate devices. The information provided is about the device itself, its intended use, technological characteristics, and non-clinical testing performed.
The document does not contain information about acceptance criteria or a study that specifically proves the device meets (or fails to meet) acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert ground truth, MRMC studies, or standalone performance).
Instead, the submission relies on demonstrating substantial equivalence to predicate devices and provides a summary of non-clinical bench testing and biocompatibility testing. The "Performance Data" section explicitly states, "Since the performance of the SLI-Laser fibers is well established and documented on soft tissue, no performance testing is being specifically included in this submission. Validation reports can be submitted on demand."
Therefore, I cannot fill in the requested table and answer the specific questions about acceptance criteria and performance studies because that information is not present in the provided text.
Based on the document, I can provide the following:
Device Description and Claims:
- Device Name: SLI-Laser Fibers, including Endoprobes, Bare Fibers, Dental Bare Fibers, Lateral Firing Fibers, SLI Endoprobe, SLI Dent Bare Fiber, SLI Ho Bare Fiber, SLI Hcs Bare Fiber, SLI Lateral Firing Fiber, SLI Lateral Contact Fiber.
- Intended Use/Indications for Use: The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope.
- Technological Characteristics: Optical fibers to transfer radiation from a medical laser to a target. They do not change the physical properties of the laser beam. Supplied sterile (EO) and ready to use. Fiber core and cladding are silica glass, coated with hard fluoropolymer. Fiber jacket is made of biocompatible polymers like ETFE. Laser light is coupled via a standard SMA connector. Cannula of endoprobes is made of 1.4301 stainless steel.
- Predicates:
Non-Clinical Testing Summary (not acceptance criteria performance):
- Bench testing: Characterization of optical transmission at given powers. Tests performed with recommended wavelength and powers up to the indicated input power. All tests "passed successfully." (No specific acceptance criteria or quantitative results are provided).
- Biocompatibility testing:
- Cytotoxicity (ISO elution method according to ISO 10993-5, L929-Proliferation method acc. to ISO 10993-5, -12, ISO 9363-1)
- Hemolysis (elution method acc. to ISO 10993-4, -12)
- Chemical analysis (characterization of leachables acc. to ISO 10993-1, -12, -18)
- Hemocompatibility (Resonance-Trombography) acc. to ISO 10993-4
- Biological Safety-Toxicology (acc. to ISO 10993-1, 93/42/MDD (Summary))
- "These tests have been successfully performed with different materials (all tests passed)." (No specific acceptance criteria or quantitative results are provided).
Regarding your specific questions:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "Validation reports can be submitted on demand" for performance data. The non-clinical tests mention "passed successfully" but without specific criteria or quantitative results.
- Sample sized used for the test set and the data provenance: Not provided for performance studies. Non-clinical tests were performed but detailed sample sizes are not given.
- Number of experts used to establish the ground truth... and the qualifications of those experts: Not applicable, as performance studies in this format were not submitted.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, this is a physical medical device (laser fiber), not an algorithm or AI.
- The type of ground truth used: Not applicable, as performance studies in this format were not submitted.
- The sample size for the training set: Not applicable, this is a physical medical device.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
Surgical Laser Incorporated % F. Kettenbaum F. Kettenbaum Ltd. Tal-bonzu - Triq L - Imghazel Swieqi, SWQ 3141 MT
Re: K151855
Trade/Device Name: Sli Endoprobe, Sli Dent Bare Fiber, Sli Ho Bare Fiber, Sli Hcs Bare Fiber, Sli Lateral Firing Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: II Product Code: GEX Dated: March 29, 2016 Received: March 29, 2016
Dear F. Kettenbaum:
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
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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
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
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Indications for Use
510(k) Number (if known) K151855
Device Name
SLI-LAser Fibers,
including Endoprobes, Bare Fibers, Dental Bare Fibers Lateral FiringFibers
Indications for Use (Describe)
The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi.
The fibers can be used manually or in combination with an approved, compatible endoscope or resectoscope. The intended use and clinical applications are described in the User Manual of the corresponding Laser.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo for a company called "surgical laser Incorporated". The word "surgical laser" is written in green, and the word "Incorporated" is written in blue. There is a green arc above the text, and there are three blue lines that extend from the bottom left corner of the image to the top right corner.
510(k) Summary
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Surgical Laser Incorporated
Suite 337 - 7950 NW 53rd Street
Miami, FL 33166
Phone: (905) 717 0508
FAX: (866)-480-9591
Contact Person: Mr. Gordon Willox, CEO
Date Prepared: January 29th, 2015, last updated: 2013-03-31
Name of Device and Name/Address of Sponsor:
Common names:
SLI-Laser fibers or SLI-Laser probes: with following trade name:
- SLI Bare Fiber .
- . SLI Endoprobe
- . SLI Dent Bare Fiber
- . SLI HO Bare Fiber reusable
- . SLI HCS Bare Fiber
- SLI Lateral Firing Fiber .
- SLI Lateral Contact Fiber
Address of Sponsor:
Surgical Laser Incorporated
Suite 337 - 7950 NW 53rd Street
Miami, FL 33166
Classification Name:
General Surgical Laser & accessories
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Image /page/4/Picture/0 description: The image shows a logo with the text "surgicallaser Incorporated". The word "surgicallaser" is in green, and the word "Incorporated" is in blue. There is a green arc above the text, and there are three blue lines extending from the bottom left corner of the image.
Legally marketed / FDA cleared laser fibers:
For demonstration of substantial equivalence, we refer to 2 selected, FDA cleared ranges of laser fibers that are actively marketed in US with sufficient feedback on its usage / safety and efficacy:
Predicate Devices:
| Type | Product | Company | 510(k) Number |
|---|---|---|---|
| Surgical Laser Fibers | FIBEROPTIC LASER DELIVERYSYSTEM | FiberopticFabrications Inc. | K120810 |
| Surgical Laser Fibers | Oberon: Laser Surgery Fiber,Atraumatic Surgery Fiber, SideFire Fiber, Radial Emission Fiber,Dental Surgery Fiber | Oberon GmbH FiberTechnologies | K140470 |
Description of the device.
SLI Laser Probes are medical optical fibers to transfer the radiation emitted by a medical laser to its target at or in the patient. The laser beam conducted to pathological tissue destroys it thermally. The probes do not change the physical properties of the laser beam emitted by the laser device. The devices are sold sterile (EO) and are ready to use.
Intended Use/Indications for Use
The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope.
The intended use and clinical applications are described in the User Manual of the corresponding Laser.
Product code, regulation and classification
Regulatory Class: Class II Regulation: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Product Code: GEX
Technological Characteristics
All components and patient-contact materials of the SLI-laser fibers are equivalent to those of the cleared predicate devices.
The fibers are supplied ready-to-use, sterile (EO) and are intended for single use, except of the reusable HO-Fibers. The quality of the emitted Laser beams and the application security do not differ from the predicate devices.
Fiber core and cladding for the applied device are made of silica glass, coated with a hard fluoropolymer. Fiber jacket consists of highly biocompatible polymers such as ETFE. The medical device is offered in
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Image /page/5/Picture/1 description: The image shows a logo for a company called "Surgical Laser Incorporated". The word "surgical laser" is written in green, with "surgical" stacked on top of "laser". The word "Incorporated" is written in blue below "surgical laser". The logo also includes a blue dot and three blue lines that extend from the dot. A green arc is above the text and lines.
various core diameters. Laser light is coupled into the fiber via a standard SMA connector. The cannula of the endoprobes is made of 1.4301 stainless steel.
Performance Data
Since the performance of the SLI-Laser fibers is well established and documented on soft tissue, no performance testing is being specifically included in this submission. Validation reports can be submitted on demand.
Non-clinical testing:
Non-clinical tests have been performed with FDA cleared lasers as listed below.
Bench testing:
Laser fibers are characterized by their optical transmission at given powers. Bench tests have been performed with the recommended Wavelength and powers up to the indicated input power. All tests passed successfully.
Biocompatibility testing:
Cytotoxicity; ISO elution method according to ISO 10993-5 Hemolysis, elution method acc. to ISO 10993-4, -12 Cytotoxicity, L929-Proliferation method acc. to ISO 10993-5, -12, ISO 9363-1 Chemical analysis, characterization of leachables acc. to ISO 10993-1, -12, -18 Hemocompatibility (Resonance- Trombography) acc. to ISO 10993-4 Biological Safety-Toxicology acc. to ISO 10993-1, 93/42/MDD (Summary) Cytotoxicity, L929-Proliferation method acc. to ISO 10993-5, -12, ISO 9363-1 Chemical analysis, characterization of leachables acc. to ISO 10993-1, -12, -18 These tests have been successfully performed with different materials (all tests passed).
Substantial Equivalence
Indications, characteristics and technologies and medical applications of the SLI-Laser fibers are fully substantially equivalent to the predicate devices, including with regard to safety and efficacy.
Conclusion:
The technical comparison and the non-clinical data demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.
§ 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.