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.

AI/ML Overview

This device is a Laser Surgical Instrument. The device is a Class II device with product code GEX.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail table format common for AI/ML devices. Instead, the performance is demonstrated through non-clinical performance testing against recognized consensus standards, which essentially serve as the acceptance criteria for safety and effectiveness for this type of device.

Acceptance Criterion (Standard)	Reported Device Performance
ISO 14971:2007 (Medical devices - Application of risk management)	Compliance demonstrated through testing and adherence to design control practices.
ISO-10993-10:2010 (Biological evaluation - Tests for irritation & skin sensitization)	Compliance demonstrated through non-clinical testing.
ISO 10993-7:2008 (Biological evaluation - Ethylene oxide sterilization residuals)	Compliance demonstrated through non-clinical testing.
USP <161> (Medical Devices - Bacterial Endotoxin and Pyrogen Tests)	Compliance demonstrated through non-clinical testing.
ISO 11135:2014/Amd.1:2018 (Sterilization of health-care products - Ethylene oxide)	Compliance demonstrated through non-clinical testing.
ISO 11138-2:2017 (Sterilization - Biological indicators for ethylene oxide)	Compliance demonstrated through non-clinical testing.
ISO 11737-1:2018 (Sterilization - Microbiological methods)	Compliance demonstrated through non-clinical testing.
ISO 11607-1:2019 (Packaging for sterilized devices - Materials)	Compliance demonstrated through non-clinical testing.
ISO 11607-2:2019 (Packaging for sterilized devices - Validation)	Compliance demonstrated through non-clinical testing.
Intended Use, Technological Characteristics, Requirement Specifications, Risk Management Results	"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." (Conclusion: Sufficient to support intended use and demonstrate safety/effectiveness.)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of an AI/ML device. For this type of medical device (laser fiber), the "test set" would encompass the physical units subjected to the non-clinical performance and biological evaluation tests. The document indicates that "Non-clinical testing was performed on InnoVoyce Laser Fiber."
Data Provenance: Not applicable in the same way as AI/ML software. The data provenance would refer to the materials and methodology used in the laboratory and bench testing, which are governed by the listed ISO and USP standards. This is not retrospective or prospective patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not applicable. The "ground truth" for this device is established by adherence to recognized international and FDA standards for medical device safety and performance (e.g., biocompatibility limits, sterilization efficacy, material properties). These standards are developed through consensus by experts in various fields. The testing itself is conducted by qualified personnel in accredited laboratories.
Qualifications of Experts: Not explicitly stated for specific individuals involved in this submission, as the "experts" are the collective bodies that establish the standards and the qualified personnel performing the laboratory tests.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. This is not a study requiring expert adjudication of interpretations (like imaging studies). Compliance with the performance standards is typically determined by objective measurements and analyses performed during bench and laboratory testing.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical surgical tool, not an AI/ML diagnostic aid that would involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study: Not applicable. This is not an algorithm or software device. The "performance" is inherent to the physical device's characteristics and its ability to deliver laser energy safely and effectively as intended.

7. The Type of Ground Truth Used:

Type of Ground Truth: The ground truth for this device is established by objective measurements against predefined scientific and engineering specifications and consensus standards. This includes physical properties, biological safety (e.g., lack of irritation, endotoxin levels), and sterilization efficacy, as outlined by the ISO and USP standards. It is not expert consensus on interpretations of images or pathology.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

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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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

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.

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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 (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

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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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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5.0 TRADITIONAL 510(K) SUMMARY

I. Submitter Information

Submitted by:	Labcorp
Contact Person:	Cori RaganPrincipal AdvisorLabcorp5353 Wayzata Boulevard, Suite 505Minneapolis, Minnesota 55416Telephone: 612-268-8746Cori.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 plasticsurgery 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 plasticsurgery and in dermatology.
Class:	2
Product Code:	GEX
Review Panel:	General & Plastic Surgery

IV. Device Description

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.

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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 –InnoVoyce LaserFiber	Predicate Device –LISA Laser SurgicalFibers (K220189)	Equivalence
Indications orintended use	InnoVoyce LaserFiber is intended foruse inincision/excision,vaporization,ablation, andcoagulation of softtissue.	Omni-Guide Holdings,Inc. single-use LISALaser Surgical Fibersare indicated for use inall surgical specialties inwhich compatible lasersystems with operationalwavelengths between500nm - 2200nm havereceived regulatoryclearance.Omni-Guide Holdings,Inc. single-use LISALaser Surgical Fibersdevices are intended foruse with any clearedsurgicallaser with an SMA 905connector, SMA 906connector, ormanufacturer specificconnectors andadapters.	Similar/Equivalent
Product Code	GEX	GEX	Same
ClassificationName	878.4810 - Lasersurgical instrumentfor use in generaland plastic surgeryand in dermatology.	878.4810 - Lasersurgical instrument foruse in general andplastic surgery and indermatology.	Same
Classification	Class II	Class II	Same
Use of Device	Rx Only	Rx Only	Same
Laser Source	Aura XP surgicallaser console	Use with any clearedsurgical laser with anSMA 905 connector,SMA 906 connector, ormanufacturer specificconnectors andadapters.	Different.No new or increase riskand no impact to safetyand effectiveness whenused with applicable lasersource.

Table 5-1: Substantial Equivalence

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Connectors	Proprietary	SMA 905 and SMA 906	Different.No new or increase riskand equivalent safety andeffectiveness when usedwith a compatible lasersystem containing anapplicable connector.
Wavelength	532 nm	532nm–2100nm	Same (within range ofpredicate)
MaximumPower	15W	1-300 Watts	Same (within range ofpredicate)
Fiber Sizes	300, 400, and 600microns	Fibers are offered in arange of sizes suitable touser needs	Similar/Equivalent
OuterDiameter	300 = 1.2 Fr400 = 1.7 Fr600 = 2.3 Fr	Core diameters areoffered in a range ofsizes suitable to userneeds	Similar/Equivalent
Fiber CoreMaterial	Silica Glass	Fused Silica	Similar/Equivalent
JacketMaterial	ETFE	Nylon, Polyimide, orTeflon	Similar/Equivalent
Single Use	Yes	Yes	Same
Sterile	Yes	Yes	Same
Sterilizationmethod	EO	EO	Same

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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.

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.