The Sentient Manufacturing Laser Fiber System is intended to deliver the laser radiation to the target tissue when used with any cleared certified surgical laser with operational wavelength between 500nm - 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.

Device Description

The Sentient Manufacturing Laser Fiber System is a fiber optic delivery device, with the intended use of delivering laser radiation to soft tissue via contact and non-contact procedures, with any compatible laser system. The Sentient Manufacturing Laser Fibers consist of a fiber optic core, cladding, coating, laser specific compatible connector (proximal end), and optional tip configurations on the distal end (sometimes left bare). The device length can vary from 3 - 5 meters in length with core diameter sizes of 200, 400, 605, 800 and 1000 microns. The device also includes a fiber stripper, fiber cleaver, canula and hand piece to prepare and use the fibers in specific procedures. The proximal end of the fiber optic is connected to the laser system via SMA-905 or compatible connector type. This connection between the fiber and the laser system allows for the laser radiation to transmit through the fiber core and output at the distal end of the fiber optic. The fiber connector also keeps the laser centered on the fiber optic surface to ensure proper power transmission throughout the fiber optic. The fiber optic itself is multilayer; comprised of a core, cladding, and a coating. The fiber cladding and coating provide a protective laver around the core. They also have a low refractive index to keep the power confined inside of the fiber core. The distal end of the laser fiber can have multiple configurations to fit the needs of the treatment application. The most common configuration of the distal end is primarily a bare fiber, with a polished surface.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Sentient Manufacturing Laser Fiber System, aiming to demonstrate its substantial equivalence to a predicate device (K200234 Quanta System Surgical Laser Fibers). This type of submission relies on comparative data rather than a detailed clinical effectiveness study with human subjects, making some of the requested information (like MRMC studies, human reader improvement, and extensive expert ground truthing) not directly applicable or reported in this document.

The acceptance criteria in this context are primarily based on demonstrating a comparable performance to the predicate device across several non-clinical parameters.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test / Acceptance Criteria	Reported Device Performance (Sentient Manufacturing Laser Fiber System)
Power Output Percentage (Comparable to Predicate)	"The Performance testing included power output percentage... The performance is nearly identical with the predicate device." Implicitly, the power output percentage was within acceptable limits compared to the predicate.
Long Duration Power Stability (Comparable to Predicate)	"10 individual power stability tests were done on the Predicate Device (K200234) and the Sentient Manufacturing Laser Fibers to provide a direct data comparison. A Power Fluctuation percentage was calculated." The results implicitly demonstrated comparable stability to the predicate. After 10 sterilization cycles, "re-ran the power test 10 times." and still demonstrated expected performance.
Tensile Strength Testing (Comparable to Predicate)	"Each fiber had 2 feet of length mounted to a folding bracket and was collapsed until the fiber core broke. Data was collected by looking at degree of bend. We discovered that each device had very similar results in the maximum bend radius due in part to having similar composition of fiber core, cladding, and coating." Implicitly, the tensile strength was comparable to the predicate.
Beam Profile Check (Visually Identical to Predicate)	"The distal end of the fiber was then pointed at a ceramic disk so it could be analyzed using an Infrared camera. Beam consistency and mode of the Sentient Manufacturing Laser Fibers were then visually compared to the predicate device and showed them to be as expected virtually identical."
Durability - Heat Testing (No Defects after 12h @ 150°C)	"Both fibers were placed into the fiber oven for a 12-hour duration at 150 degrees C and inspected for defects." Implicitly, no significant defects were detected, meeting a comparable durability standard to the predicate, or at least showing acceptable performance. The text states "none of note were detected" for sterilization durability, implying this was also true for heat testing.
Durability - Sterilization Durability (No Defects after 20 Autoclave Cycles)	"running each fiber optic assembly through 20 autoclave cycles and inspected for defects of which none of note were detected."

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

Sample Size (Test Set): For the performance tests:
- Power Stability: 10 individual power stability tests were performed on the Sentient Manufacturing Laser Fibers and 10 on the Predicate Device. After sterilization, the power test was re-run 10 times.
- Tensile Strength: Each fiber (Sentient and Predicate) was tested, implying at least one sample of each, likely more for robust data, but specific number not stated beyond "Each fiber".
- Beam Profile: At least one sample of each (Sentient and Predicate) was analyzed.
- Durability (Heat & Sterilization): "Both fibers" (Sentient and Predicate) were subjected to heat testing. "Each fiber optic assembly" for sterilization duration, implying at least one of each type.
Data Provenance: The tests described are "Internal Performance Testing," meaning they were conducted by the manufacturer, Sentient Manufacturing LLC. The origin (country/location) of the testing facility is not specified, but the company is based in Park City, UT, USA. The data is prospective in the sense that these specific tests were conducted to demonstrate equivalence for this submission, rather than being collected from prior clinical use.

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

This type of 510(k) submission for a laser fiber system does not typically involve expert clinical reads or establishment of ground truth by clinicians. The "ground truth" for the performance tests mentioned (power output, stability, tensile strength, beam profile, durability) is established by physical measurements and comparisons against a well-characterized predicate device. There is no mention of external experts or their qualifications in establishing the "ground truth" for these engineering and performance tests.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of clinical findings or diagnostic outputs from multiple readers. The performance data is objective (e.g., power measurements, physical characteristics, visual comparison of beam profile by technical personnel).

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 is not an AI-assisted diagnostic device and therefore an MRMC study with human readers is not relevant to this submission.

6. 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 system), not a software algorithm. The "standalone performance" refers to the device's inherent physical and optical characteristics as measured in the performance tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Physical and Optical Measurements: For power output, power stability, tensile strength, and beam profile.
Comparative Performance to a Legally Marketed Predicate Device: The primary "ground truth" for substantial equivalence is the demonstrated "nearly identical" or "very similar" performance compared to the K200234 Quanta System Surgical Laser Fibers. This type of submission relies on the predicate having already been deemed safe and effective.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI or machine learning algorithm. There is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable for the reason above.

Summary

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

February 2, 2022

Sentient Manufacturing LLC % Kevin Morningstar Senior Consultant Morningstar Consulting Group LLC 20319 E Costilla Ave Centennial, Colorado 80016

Re: K213554

Trade/Device Name: Sentient Manufacturing Laser Fiber System 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: October 29, 2021 Received: November 8, 2021

Dear Kevin Morningstar:

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 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) K213554

Device Name

Sentient Manufacturing Laser Fiber System

Indications for Use (Describe)

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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Sentient Laser Fiber 510(k) Summary

I. SUBMITTER:

Jim Mousseau, President/COO Sentient Manufacturing, LLC 4383 N Forestdale Drive Park City, UT 84098, USA i.mousseau@sentientlasers.com

Contact Person: Kevin Morningstar, Regulatory Consultant (510k Preparer and FDA correspondent) Morningstar Consulting Group LLC 20319 E Costilla Ave Centennial. CO 80016 (720) 940-8271 kevin.morningstar@gmail.com

Date Prepared: 26 January 2022

II. DEVICE Name of Device: Sentient Manufacturing Laser Fiber System Common or Usual Name: Laser Fiber Optical Delivery System Classification Name: Powered Laser Surgical Instrument Requlation Number: 21 CFR Part 878.4810 Requlatory Class: Class II Product Code: GEX

III. PREDICATE DEVICE K200234 Quanta System Surgical Laser Fibers This predicate has not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

The Sentient Manufacturing Laser Fibers consist of a fiber optic core, cladding, coating, laser specific compatible connector (proximal end), and optional tip configurations on the distal end (sometimes left bare). The device length can vary from 3 - 5 meters in length with core diameter sizes of 200, 400, 605, 800 and 1000 microns. The device also includes a fiber stripper, fiber cleaver, canula and hand piece to prepare and use the fibers in specific procedures.

The proximal end of the fiber optic is connected to the laser system via SMA-905 or compatible connector type. This connection between the fiber and the laser system allows for the laser radiation to transmit through the fiber core and output at the distal end of the fiber optic. The

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fiber connector also keeps the laser centered on the fiber optic surface to ensure proper power transmission throughout the fiber optic.

The fiber optic itself is multilayer; comprised of a core, cladding, and a coating. The fiber cladding and coating provide a protective laver around the core. They also have a low refractive index to keep the power confined inside of the fiber core.

The distal end of the laser fiber can have multiple configurations to fit the needs of the treatment application. The most common configuration of the distal end is primarily a bare fiber, with a polished surface.

V. INDICATIONS FOR USE

The Sentient Manufacturing Laser Fiber System is intended to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelength between 500nm - 2200nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

	K200234 Quanta SystemSurgical Laser Fibers(Predicate)	Sentient Manufacturing LaserFiber(New)	Comparison
Trade/Proprietary Name	Quanta System Surgical LaserFibers	Sentient Manufacturing LaserFiber	Similar
Generic/Common Name	Laser Fiber Optical DeliverySystem	Laser Fiber Optical DeliverySystem	Identical
Classification Name	Powered Laser SurgicalInstrument	Powered Laser SurgicalInstrument	Identical
Regulation Name	Laser surgical instrument for usein general and plastic surgery andin dermatology	Laser surgical instrument for usein general and plastic surgeryand in dermatology	Identical
Regulatory Class	II	II	Identical
Product Code	GEX	GEX	Identical
Regulation Number	21 CFR Part 878.4810	21 CFR Part 878.4810	Identical
Review Panel	General & Plastic Surgery	General & Plastic Surgery	Identical
Indications for use	Surgical Laser fibers are intendedto deliver the laser radiation to thetarget tissue when usedwith any cleared/certified surgicallaser with operational wavelengthsbetween 500nm - 2200nmequipped with SMA 905 or SMA906 or compatible connector, asper the indications of the laserdevice used with.	The Sentient ManufacturingLaser Fiber is intended to deliverthe laser radiation to the targettissue when used with anycleared/certified surgical laserwith operational wavelengthbetween 500nm - 2200nmequipped with SMA 905 or SMA906 or compatible connector, asper the indications of the laserdevice used with.	Identical
Operating Wavelength	500-2200 nm	500-2200 nm	Identical

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	K200234 Quanta SystemSurgical Laser Fibers(Predicate)	Sentient Manufacturing LaserFiber(New)	Comparison
Diameter of Core(microns)	200-1000	200, 400, 605, 800, 1000	Similar
Length	3m or 5m	3 to 5 m	Identical
Connector Type	SMA 905	SMA 905	Identical
Construction Materials	Standard Silica CoreFluoropolymer or Silica CladdingAcrylate, Teflon, Nylon, orPolyimide Buffer	Standard Silica CoreSilica CladdingPolyimide (ETFE) Buffer	Similar
Patient ContactingMaterials	ETFE or Nylon	Polyimide (ETFE)304 Stainless	Similar
Provided Sterile	Yes (EtO)	No	Different
Number of Uses	Single Use or Reusable 10x	Single Use or Reusable 10x	Identical

VII. PERFORMANCE DATA

The Sentient Manufacturing Laser Fiber has successfully passed our Internal Performance Testing Parameters. Realtime testing was completed by side comparisons of the predicate device listed. The performance is nearly identical with the predicate device.

The Performance testing included power output percentage, long duration power stability, tensile strength testing, beam profile check, and durability tests.

Power stability testing was completed using a Deka Smartlipo 18W Nd:YAG laser, which is a compatible and FDA cleared laser system. Testing was done on the same laser system to ensure stability control. 10 individual power stability tests were done on the Predicate Device (K200234) and the Sentient Manufacturing Laser Fibers to provide a direct data comparison. A Power Fluctuation percentage was calculated. The power stability tests involved performing a mock clinical treatment with the typical duration of 30 minutes. The Smartlipo laser was pulsing at the maximum power of 18 watts and continuously monitored by an external laser energy power meter. A power sample was then taken every 3 minutes to provide 10 data points. After each power stability test, we performed an industry standard sterilization cycle through the autoclave and re-ran the power test 10 times. This was done to mimic the maximum life expectancy of the Sentient Manufacturing Laser Fibers.

Tensile strength testing was performed by analyzing the maximum bend radius of both the Predicate Device (K200234) and the Sentient Manufacturing Laser Fiber . Each fiber had 2 feet of length mounted to a folding bracket and was collapsed until the fiber core broke. Data was collected by looking at degree of bend. We discovered that each device had very similar results in the maximum bend radius due in part to having similar composition of fiber core, cladding, and coating.

The beam profile of both fibers was analyzed using a 1,064 nm Nd:YAG Deka Smartlipo laser. The 1,064 nm laser emits a Near Infrared beam that is focused and fired at the proximal end of the laser fibers. This laser then transmits through the fiber core and emits out of the distal end. The distal end of the fiber was then pointed at a ceramic disk so it could be analyzed using an Infrared camera. Beam consistency and mode of the Sentient Manufacturing Laser Fibers were then visually compared to the predicate device and showed them to be as expected virtually identical.

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Durability tests were performed on both the Predicate Device (K200234) and the Sentient Manufacturing Laser Fibers. These tests include heat testing and sterilization durability. Both fibers were placed into the fiber oven for a 12-hour duration at 150 degrees C and inspected for defects. Our sterilization inspection was completed by running each fiber optic assembly through 20 autoclave cycles and inspected for defects of which none of note were detected.

VIII. CONCLUSION

The non-clinical data support the safety of the device, and design verification and validation demonstrate that the Sentient Manufacturing Laser Fiber System performs as intended in the specified use conditions. The Sentient Manufacturing Laser Fiber System does not raise new types of questions regarding safety or effectiveness and is considered to be substantially equivalent to the legally marketed predicate device (K200234).

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.