ProFlex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:Y AG) lasers, ProFlex laser fibers may be used with any laser wavelength between 500 nm and 2200 nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: Y AG (KTP) lasers, argon lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.

Device Description

Subject devices and primary predicate devices are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, doubly step index clad optical fiber (fluoroacrylate over fluorine doped fused silica) with an ethylene tetrafluorethylene (ETFE, Tefzel™) protective jacket and are available in five nominal fiber core diameters (200 um, 273 µm, 365 µm, 550 um, 910 um, and 940 um), three nominal lengths (3 meters, 3.5 meters and 4.25 meters) and two laser-formed working tips (flat and orb). Subject devices and primary predicate devices are equipped with spatial and angular laser launch overfill protection -- a protective and guiding quartz ferrule, fused about the fiber input face upon which an input lens is laser-formed for high laser and physical damage threshold and for collimation of the laser focus energy within the optical fiber - and ruggedized output tips designed for ease of transit in flexible ureteroscopes and stone basket channels. Smaller fibers (where base fiber cores are smaller than laser foci) are equipped with tapered inputs where larger fibers are straight terminations.

Subject devices are packaged in a coiled high density polyethylene (HDPE) tube carrier providing ease of dispensing within the surgical field while maintaining sterility. All materials of construction are USP Class VI biocompatible and are compatible with flash autoclave and ethylene oxide (EtO) sterilization.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a medical device called "ProFlex® Laser Fibers." It's a regulatory clearance letter, not a study report demonstrating the device meets acceptance criteria.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided from this document. This letter states that the device is substantially equivalent to a predicate device, meaning it has similar indications, technological characteristics, and performs as well as a legally marketed device. It does not contain a detailed report of a study designed to prove specific acceptance criteria against a defined performance metric.

However, I can extract the relevant information that is present regarding performance and comparison:

1. A table of acceptance criteria and the reported device performance:

This document does not specify quantitative acceptance criteria. Instead, it relies on substantial equivalence. The reported performance is a comparative statement.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance
Safe and Effective (at least as good as predicate)	"Subject devices performed as well than the predicate devices in all cases." "Subject devices are as safe, as effective and perform as well the predicate devices."
Laser Power Delivery (relaxed configuration)	Performed as well as predicate
Laser Power Delivery (strained/bent configuration)	Performed as well as predicate
Shelf Life	Determined to be 2 years (per accelerated aging tests)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not explicitly stated. The document mentions "Subject and predicate fibers were laser power tested," implying a sample of fibers was used, but the quantity is not provided.
Data Provenance: The testing was conducted by InnovaQuartz, whose manufacturing facility is in Phoenix, Arizona, USA. The document doesn't specify if the testing was prospective or retrospective, but typically, premarket testing for substantial equivalence would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a technical performance study of a physical device (laser fibers), not an assessment requiring expert interpretation of medical images or patient outcomes for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a technical performance study, not a ground truth establishment process involving multiple readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a laser fiber, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" here is the measured performance of the laser fibers (e.g., laser power delivery) compared to a predicate device. This is based on bench testing/empirical measurements of physical characteristics, not medical "ground truth" typically established in diagnostic studies.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

April 20, 2018

InnovaQuartz LLC Stephen Griffin Chief Technology Officer 23030 North 15th Ave Phoenix, Arizona 85027-1315

Re: K180140

Trade/Device Name: ProFlex® 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 1, 2018 Received: January 18, 2018

Dear Stephen Griffin:

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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K180140

Device Name ProFlex® Laser Fibers

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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 contains a logo for InnovaQuartz LLC. The logo features the letters "IQ" in a stylized font, with the "Q" encircling the letters. The letters "LLC" are written to the right of the "IQ", and the word "InnovaQuartz" is written below the letters "LLC".

23030 North Fifteenth Avenue
Phoenix, Arizona 85027-1315
623-434-1895
innovaquartz.com

510(k) Summary

Sponsor/Owner/Holder:

InnovaQuartz LLC 23030 N 15th Ave Phoenix, AZ 85027-1315 623-434-1895

Contact:

Stephen Griffin, CTO 623-434-1895 (main) x101 623-229-5174 mobile steveg@innovaquartz.com

Registration Number: 3010933841

Date: 4/19/2016

Subject Device Name:

Trade Name:	ProFlex® Laser Fibers
Common Name:	Laser Fiber
Classification:	Laser Instrument, Surgical, Powered Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulation:	21 CFR §878.4810
Product Code:	GEX
Product Class:	II
Panel:	General and Plastic Surgery

Subject devices are substantially equivalent to the primary predicate devices.

Predicate Device(s):

Primary Predicate Device:

ProFlex® Laser Fibers

Reference Predicate:

EndoBeam™ Holmium Laser Fibers (K120926)

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Device Description:

Intended Use:

The intended use of the subject device is identical to the intended use of the primary predicate device.

"Proflex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:YAG) lasers, ProFlex fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to frequency doubled Nd:YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers."

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Technological Characteristics:

Subject devices are provided in longer available lengths than the primary predicate devices to accommodate greater distances that must be traversed in modern laser surgery where laser ports on some lasers have been lowered, access to anatomical lumen may be less direct and endoscopic device working channels are longer.

Performance Testing (Bench and User Evaluation):

Subject and predicate fibers were laser power tested in relaxed and strained (bent) configurations using a cleared surgical holmium laser generator. Subject devices performed as well than the predicate devices in all cases. Accordingly, subject devices are determined to be as safe and as effective as the predicate devices.

The shelf life of the subject device is determined to be 2 years per accelerated aging tests.

Manufacturing, Packaging and Sterilization Facility:

Subject devices are designed, manufactured, packaging and sterilized within the InnovaQuartz manufacturing facility at Phoenix, Arizona. All manufacturing equipment has been validated as appropriate for the intended functions and sterilization is complaint with ISO 11135:2014 standards.

Conclusion:

A direct comparison of key characteristics demonstrates that subject device are substantially equivalent to the primary predicate device in terms of materials of construction, intended uses, technological considerations and performance characteristics. Subject devices are as safe, as effective and perform as well the predicate devices.

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.