InnoVoyce Laser Fiber

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May 25, 2022 InnoVoyce LLC % Cori Ragan Principal Advisor, Regulatory and Quality System Labcorp 5353 Wayzata Boulevard, Suite 505 Minneapolis, Minnesota 55416-1334 Re: K220793 Trade/Device Name: InnoVoyce Laser Fiber 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: March 16, 2022 Received: March 18, 2022 Dear Cori Ragan: 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, D.Eng. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220793 Device Name InnoVoyce Laser Fiber ### Indications for Use (Describe) Inno Voyce Laser Fiber is intended for use in incision, vaporization, ablation, and coagulation of soft tissue. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-.052z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitter Information | Submitted by: | Labcorp | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Cori Ragan<br>Principal Advisor<br>Labcorp<br>5353 Wayzata Boulevard, Suite 505<br>Minneapolis, Minnesota 55416<br>Telephone: 612-268-8746<br>Cori.Ragan@labcorp.com | | Date of Summary: | May 23, 2022 | #### II. Device Information | Device Trade Name: | InnoVoyce Laser Fiber | |-----------------------|----------------------------------------------------------------------------------------------------| | Common or Usual Name: | Surgical laser instrument | | Classification Name: | 878.4810 - Laser surgical instrument for use in general and plastic<br>surgery and in dermatology. | | Class: | 2 | | Product Code: | GEX | | Review Panel: | General & Plastic Surgery | | Model Number: | S-00102-300, S-00103-400, S-00104-600 | #### lll. Predicate Information | Predicate Information | | |-----------------------|----------------------------------------------------------------------------------------------------| | Predicate Device: | LISA Laser Surgical Fiber | | Company: | Omni-Guide Holding, Inc. | | 510(k) Number: | K220189 | | Common or Usual Name: | Surgical laser instrument | | Classification Name: | 878.4810 - Laser surgical instrument for use in general and plastic<br>surgery and in dermatology. | | Class: | 2 | | Product Code: | GEX | | Review Panel: | General & Plastic Surgery | #### IV. Device Description The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser. They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers. The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer. {4}------------------------------------------------ #### V. Indication for Use InnoVoyce Laser Fiber is intended for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. #### Substantial Equivalence VI. A comparison of the technological characteristics of the predicate and subject device is given in Table 5-1 below: | Device | Subject Device –<br>InnoVoyce Laser<br>Fiber | Predicate Device –<br>LISA Laser Surgical<br>Fibers (K220189) | Equivalence | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Indications or<br>intended use | InnoVoyce Laser<br>Fiber is intended for<br>use in<br>incision/excision,<br>vaporization,<br>ablation, and<br>coagulation of soft<br>tissue. | Omni-Guide Holdings,<br>Inc. single-use LISA<br>Laser Surgical Fibers<br>are indicated for use in<br>all surgical specialties in<br>which compatible laser<br>systems with operational<br>wavelengths between<br>500nm - 2200nm have<br>received regulatory<br>clearance.<br>Omni-Guide Holdings,<br>Inc. single-use LISA<br>Laser Surgical Fibers<br>devices are intended for<br>use with any cleared<br>surgical<br>laser with an SMA 905<br>connector, SMA 906<br>connector, or<br>manufacturer specific<br>connectors and<br>adapters. | Similar/Equivalent | | Product Code | GEX | GEX | Same | | Classification<br>Name | 878.4810 - Laser<br>surgical instrument<br>for use in general<br>and plastic surgery<br>and in dermatology. | 878.4810 - Laser<br>surgical instrument for<br>use in general and<br>plastic surgery and in<br>dermatology. | Same | | Classification | Class II | Class II | Same | | Use of Device | Rx Only | Rx Only | Same | | Laser Source | Aura XP surgical<br>laser console | Use with any cleared<br>surgical laser with an<br>SMA 905 connector,<br>SMA 906 connector, or<br>manufacturer specific<br>connectors and<br>adapters. | Different.<br>No new or increase risk<br>and no impact to safety<br>and effectiveness when<br>used with applicable laser<br>source. | | Table 5-1: Substantial Equivalence | | |------------------------------------|--| | | | {5}------------------------------------------------ | Connectors | Proprietary | SMA 905 and SMA 906 | Different.<br>No new or increase risk<br>and equivalent safety and<br>effectiveness when used<br>with a compatible laser<br>system containing an<br>applicable connector. | |-------------------------|----------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Wavelength | 532 nm | 532nm–2100nm | Same (within range of<br>predicate) | | Maximum<br>Power | 15W | 1-300 Watts | Same (within range of<br>predicate) | | Fiber Sizes | 300, 400, and 600<br>microns | Fibers are offered in a<br>range of sizes suitable to<br>user needs | Similar/Equivalent | | Outer<br>Diameter | 300 = 1.2 Fr<br>400 = 1.7 Fr<br>600 = 2.3 Fr | Core diameters are<br>offered in a range of<br>sizes suitable to user<br>needs | Similar/Equivalent | | Fiber Core<br>Material | Silica Glass | Fused Silica | Similar/Equivalent | | Jacket<br>Material | ETFE | Nylon, Polyimide, or<br>Teflon | Similar/Equivalent | | Single Use | Yes | Yes | Same | | Sterile | Yes | Yes | Same | | Sterilization<br>method | EO | EO | Same | {6}------------------------------------------------ #### VII. Performance Data ## Non-Clinical Performance Testing: Non-clinical testing was performed on InnoVoyce Laser Fiber, (the subject device) and demonstrates compliance with the following International and FDA-recognized consensus standards: - ISO 14971:2007 Medical devices Application of risk management to medical devices . - ISO-10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and ● skin sensitization - . ISO 10993-7:2008 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - . USP <161> - MEDICAL DEVICES-BACTERIAL ENDOTOXIN AND PYROGEN TESTS - . ISO 11135:2014/Amd.1:2018 - Sterilization of health-care products-Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices - AMENDMENT 1: Revision of Annex E, Single batch release - . ISO 11138-2:2017 - Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes - ISO 11737-1:2018 - Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products - . ISO 11607-1:2019 - Packaging for terminally sterilized medical devices – Part 1: requirements for materials, sterile barrier systems and packaging systems - . ISO 11607-2:2019 - Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes. The subject device was tested in accordance with Verification and Validation processes in accordance with design control practices. Testing has been performed to address intended use, the technological characteristics, requirement specifications, and the risk management results. # Clinical Data: No clinical testing was required to demonstrate safety or effectiveness for the subject device as the device's non-clinical (bench) testing was sufficient to support the intended use of the device. #### VIII. Conclusion The InnoVoyce single-use optical fibers that are the subject of this premarket notification use identical or similar technology as that of the single-use fibers of the K220189 510(k). Differences between the proposed and predicate fibers do not raise new types of concerns for safety and effectiveness, and performance testing demonstrates that the InnoVoyce single-use optical fibers can be used safely and effectively for the proposed indications for use. The InnoVoyce single-use optical fibers are considered to be substantially equivalent to the predicate K220189.