ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.

Device Description

ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket.

ProFlex CO2 Laser Fibers are packaged in a coiled and tubular, high-density polyethylene (HDPE) carrier providing improved ease of dispensing within the surgical field while maintaining sterility. Coils are contained within non-woven/impermeable polymer, e.g. Tyvek/Mylar, sterile pouches, validated for three-year shelf life, and protected with an outer, nonsterile fiberboard carton. Both sterile pouch and carton are labeled.

All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO) sterilization.

ProFlex CO2 Laser Fibers are for prescription use only.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for the ProFlex CO2 Laser Fiber. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving independent performance against acceptance criteria in the manner typically associated with novel AI/ML medical devices or complex diagnostic tools.

Therefore, the document does not contain the information requested regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test/training sets, expert qualifications, ground truth establishment, or effect sizes for human reader improvement.

The document primarily shows:

Device Name: ProFlex CO2 Laser Fiber (Model: S-COF500)
Intended Use: Ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
Predicate Device: CO2 Laser WaveGuide (K100384) from Lumenis Ltd.
Demonstration of Substantial Equivalence: Achieved through a comparison of technical characteristics and non-clinical bench testing.

Specifically, regarding the requested information:

A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria or reported device performance in the context of a clinical study or specific performance metrics typically associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). It focuses on physical and functional characteristics matching the predicate.
Sample sizes used for the test set and the data provenance: Not applicable. The "testing" referred to is non-clinical bench testing, not clinical studies with "test sets" in the diagnostic sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for this type of device and submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable. This device does not involve machine learning or AI with training sets.
How the ground truth for the training set was established: Not applicable.

Instead, the document details:

Non-Clinical Testing (Section 8): This "testing" served to verify that the proposed device met design specifications and was substantially equivalent. It included:
- Bench Testing for labeling and performance verification (e.g., Instructions for Use, Fiber Design Verification, Packaging Design Verification).
- Performance Qualification for sterility (ISO 11135:2014) and ethylene oxide sterilization residuals (ISO 10993-7:2008).
Clinical Testing (Section 9): "No clinical study is included in this submission." This explicitly states that clinical performance data was not part of this 510(k).

In summary, the provided document is a regulatory clearance for a physical medical device (laser fiber), not a study report for an AI/ML or diagnostic device that would feature the requested criteria.

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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2021

InnovaQuartz LLC Stephen Griffin Chief Technology Officer 23030 N. 15th Ave Phoenix, Arizona 85027

Re: K203799

Trade/Device Name: ProFlex CO2 Laser Fiber (Model: S-COF500) 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: August 18, 2021 Received: August 20, 2021

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. 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 U. Pandya -S

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203799

Device Name ProFlex CO2 Laser Fiber (Model: S-COF500)

Indications for Use (Describe)

ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 201 Subpart D)	☐ Over-The-Counter Use (21 CFR 201 Subpart C)
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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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of 21CFR Section 807.92.

The assigned 510(k) Number: K203799

1. Date of Preparation	09/17/2021
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2. Applicant
Name:	InnovaQuartz, LLC.
Address:	23030 N 15th Ave, Phoenix, AZ 85027-1315
Phone:	623-434-1895

Registration #:	3010933841
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Contact Person:	Stephen Griffin, CTO
Telephone:	623-434-1895 (main) x101, 623-229-5174 (mobile)
Email:	steveg@innovaquartz.com

1. Identification of the Proposed Device

Trade Name:	ProFlex CO2 Laser Fiber
Common Name:	Laser Fiber
Model(s):	S-COF500
Classification Name:	Laser surgical instrument for use in general and plastic surgery and in dermatology
Classification:	II
Product Code:	GEX
Regulation Number:	21 CFR 878.4810
Review Panel:	General & Plastic Surgery

Identification of Predicate Device 4.

510(k) Number:	K100384
Product Name:	CO2 Laser WaveGuide
Manufacturer:	Lumenis Ltd., 13 Hayetzira St. (POB 240), Yokneam Industrial Park Yokneam, 20692 Israel

1. Device Description
  ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket.

All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO) sterilization.

ProFlex CO2 Laser Fibers are for prescription use only.

1. Indications for Use
  ProFlex CO2 Laser Fiber is indicated for the ablation, excision, incision, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.

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7. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate Device K161926	Remark
Product Code	GEX	GEX	SE
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SE
Class	2	2	SE
Intended Use	ProFlex CO2 Laser Fiber is indicated forthe ablation, coagulation, excision,incision, and vaporization of soft tissue inopen, endoscopic, and laparoscopicsurgical procedures.	The fiberlase CO2 laser waveguide isintended for use in surgical proceduresrequiring ablation, vaporization, excision,incision and coagulation of soft tissue. Thefiberlase CO2 laser waveguide is indicatedfor use in open surgical procedures such asent surgery and laparoscopy and endoscopicprocedures. The device is limited to carbondioxide lasers having a sma-905 connector.	SE

Tab 1 General Comparison

The technical characteristics of the subject and predicate devices are compared in the table below.

Device & Predicate Device(s):	K203799(Subject Device)	K100384(Primary Predicate)
General Device Characteristics
Laser Type and wavelength (nm)	CO2, 10600	CO2, 10600
Inner diameter (µm)	500	500
Outer diameter (µm)	1040	1040
Length (m)	2	2
Maximum Input Power (W, CW)	40	40
Maximum Input Power (W, super-pulsemode)	15	15
Operative Bending	40mm radius @ 45°, 40 W40mm radius @ 90°, 30 W	40mm radius @ 45°, 40 W40mm radius @ 90°, 30 W
Transmission Efficiency (Loss)	≥ 60% (< 40%)	> 60% (< 40 %)

The materials used in the construction of the subject and predicate devices are compared below.

Description:Component	Subject Device:ProFlex CO2 Laser Fiber	Predicate Device:FiberLase CO2 Laser WaveGuideK100384
Package	HDPE tube with clips	Paper Card
X-Nut	Blue anodized aluminum	Nylon
Capillary cladding	Fluoropolymer	Fluoropolymer
Capillary buffer	Clear ETFE	Clear ETFE
Capillary base	Fused silica	Fused silica
Dielectric coating	Silver/Silver Iodide	Silver/Silver Iodide
Laser connector	Stainless Steel 905 SMA	Stainless Steel 905 SMA
Strain Relief	Black Santoprene rubber boot	Rubber boot
Proximal Cap	White Santoprene vented cap	Vented dust cap
Distal Cap	Silicone cap	Silicone cap
Bend Limiter	Polyolefin heat shrink	Heat shrink
Capillary Adhesive	USP VI Epoxy	Epoxy
Sterile package	Tyvek/Mylar film chevron pouch	Tyvek/Mylar film chevron pouch

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Non-Clinical Testing 8.

Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The following tests were conducted:

Bench Testing to support labeling and verify the performance (e.g., ProFlex CO2 Laser Fiber Instructions for use and labels, Fiber Design Verification, Packaging Design Verification)
Performance Qualification of ProFlex CO2 with Hoop Insert Packaging to Demonstrate 10t6 Sterility per ISO 11135:2014 and Ethylene Oxide sterilization residuals per ISO 10993-7:2008

9. Clinical Testing

No clinical study is included in this submission.

1. Conclusion
  Based on the comparison and analysis above, the proposed subject device is determined to be Substantially Equivalent (SE) to the predicate device.

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.