The Optical Integrity General Shaped Fibers with LaserGuard™ are intended to be used as an accessory to a medical laser. For specific applications, refer to the Instructions for Use documentation supplied with the laser system being used with the LaserGuard™ system.

Device Description

The product submitted herein is, in fact, the predicate device fitted with a LaserGuard™ device as an accessory. The basic device is a wave guide for laser light sources and will transmit light between 532 and 2100 nanometer wavelengths. The cladding of the fibers is either doped silica or a polymer. The outer buffer material is either Nylon or Tefzel.

The LASERGUARD™ accessory included with the submitted product is an electronic device that will detect heat generated as a result of the fiber overheating anywhere along the light path and will disengage the foot switch of the laser thereby putting the laser in standby mode. The LASERGUARD™ will also indicate by an audible alarm and a light that the fiber has overheated.

Both the predicate device and the submitted products are capable of delivering laser radiation from a laser instrument to the surgical site with minimal loss. Both deliver wavelengths from 532 to 2100 nanometers as, for example, is generated by Ho:YAG or Nd:YAG lasers. The laser energy is emitted through a flat, orbed or conical tip located at the distal end of the fiber. Both the predicate and submitted products are offered in a range of core sizes from 145 to 940 micrometer silica cores and are from 2.5 to 5.0 meters in length. The products are supplied in sterile and non-sterile as well as single-use and re-usable versions.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided for the "Optical Integrity General Shaped Fiber with LaserGuard™" device, based on the given text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative numerical acceptance criteria in a pass/fail format with defined thresholds. Instead, it describes performance expectations and the results of bench testing.

Acceptance Criteria (Inferred from product description and intended function)	Reported Device Performance
Energy Delivery Equivalence (with and without LaserGuard™): The device should deliver laser energy equivalently to the predicate device when undamaged.	"Bench testing demonstrated that Optical Integrity's General Shaped Fiber with LASERGUARD™ performed the same as the predicate device, Optical Integrity's General Shaped Fiber (without the LASERGUARD™ accessory). I.E. there was no difference in the energy delivered by the undamaged fiber with or without the LASERGUARD™ accessory in place."
Automatic Laser Shutdown upon Fiber Break: The LaserGuard™ accessory must automatically shut down the laser when a fiber break occurs.	"Additionally, the test results establish that the LASERGUARD™ will shut down the laser, as intended, when a fiber break occurs..."
Audible Alarm upon Fiber Break: The LaserGuard™ accessory must provide an audible alarm upon fiber break.	"...and indicate such by an audible alarm..."
Indicator Light upon Fiber Break: The LaserGuard™ accessory must provide an indicator light upon fiber break.	"...and an indicator light."
Automatic Laser Shutdown upon Thermal Runaway (e.g., contaminated tip): The LaserGuard™ must put the laser in standby and alert the operator if the fiber heats up due to contamination.	"Additionally, if the fiber is used as a bare fiber for tissue ablation and the tip of the fiber becomes contaminated and as a result the fiber heats up, then the LASERGUARD™ will likewise, put the laser in standby and alert the operator that a thermal runaway event has occurred."

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

Sample Size: The document does not specify a numerical sample size (e.g., number of fibers tested, number of simulated breaks). It only mentions "Bench testing."
Data Provenance: The data is described as "Bench testing," indicating it was conducted in a controlled laboratory environment. The country of origin is not explicitly stated, but the submission is from Optical Integrity, Inc. in Panama City Beach, Florida, USA, implying the testing likely occurred in the USA or under their supervision. The study appears to be prospective in the sense that the testing was designed and executed to evaluate the new device's performance.

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

This information is not provided in the document. The testing described is bench testing of the device's physical and functional performance, not an evaluation requiring human expert interpretation of clinical data where a ground truth would typically be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. The described study focuses on the technical function of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on the standalone performance of the device and its equivalence to a predicate device in terms of energy delivery, and the added safety features of the LaserGuard™ accessory. It does not involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, a standalone study (bench testing) was performed. The described study evaluates the device (including the LaserGuard™ accessory as an electronic device) in isolation. It verifies its ability to:

Deliver energy comparably to the predicate device.
Automatically detect and respond to fiber breaks (shut down laser, alarm, indicator light).
Automatically detect and respond to thermal runaway events.

There is no "human-in-the-loop" aspect to the performance evaluation described, as the LaserGuard™'s primary function is described as automatic. The surgeon's role is to "determine what course of action to take" after the system has already alerted them.

7. The Type of Ground Truth Used

The "ground truth" for this engineering-focused bench test would be the expected functional behavior of the device based on its design specifications. For example:

For Energy Delivery: The ground truth is that the undamaged fiber with LaserGuard™ should transmit the same energy as the undamaged fiber without it. This would be measured directly using calibrated power meters.
For Laser Shutdown on Break: The ground truth is that the laser must shut down when a fiber break is induced. This is a direct observation of the device's response.
For Alarms/Lights: The ground truth is that the audible alarm and indicator light must activate in response to a detected event. This is a direct observation.

In essence, the ground truth is derived from the engineering design specifications and the known physics of laser light transmission and thermal detection, rather than from expert consensus on clinical findings or pathology.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical medical device with an electronic accessory (LaserGuard™). It is not an AI/ML algorithm that requires a training set in the conventional sense.

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

This information is not applicable and not provided, as the device is not an AI/ML algorithm requiring a training set.

Summary

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MAY 2 0 2010

510(k) Summary Prepared on 20 July 2009

Submitted By: Optical Integrity, Inc.,Location: 7500 McElvey Road, Panama City Beach, Florida, Zip 32408.Contact: Ron Bowman at (850) 233-5312 ext. 209
Trade Name:Common Name:Classification name:	Optical Integrity General Shaped Fiber with LaserGuard(tm)surgical laser fiberLaser surgical instrument for use in general and plastic surgery and indermatology
Product Code:CFR reference:	GEX21 CFR 878.4810
Predicate device:	Optical Integrity, Inc. General Shaped Fiber, 510(k) number K022338and Dornier Midelas laser EPS mode.
Product Description:TechnologicalCharacteristics:	The product submitted herein is, in fact, the predicate device fitted witha LaserGuard™ device as an accessory. The basic device is a waveguide for laser light sources and will transmit light between 532 and2100 nanometer wavelengths. The cladding of the fibers is either dopedsilica or a polymer. The outer buffer material is either Nylon or Tefzel.
	The LASERGUARD™ accessory included with the submitted product is anelectronic device that will detect heat generated as a result of the fiberoverheating anywhere along the light path and will disengage the footswitch of the laser thereby putting the laser in standby mode. TheLASERGUARD™ will also indicate by an audible alarm and a light that thefiber has overheated.
	Both the predicate device and the submitted products are capable ofdelivering laser radiation from a laser instrument to the surgical site withminimal loss. Both deliver wavelengths from 532 to 2100 nanometersas, for example, is generated by Ho:YAG or Nd:YAG lasers. The laserenergy is emitted through a flat, orbed or conical tip located at the distalend of the fiber. Both the predicate and submitted products are offeredin a range of core sizes from 145 to 940 micrometer silica cores and arefrom 2.5 to 5.0 meters in length. The products are supplied in sterileand non-sterile as well as single-use and re-usable versions.
Indications for Use:for both thesubmitted productand the predicatedevice.	The Optical Integrity General Shaped Fibers with LaserGuard™ are intended tobe used as an accessory to a medical laser. For specific applications, refer tothe Instructions for Use documentation supplied with the laser system beingused with the LaserGuard™ system.
Comparison ofsubmitted product topredicate device,technologicalcharacteristics:	The submitted product, Optical Integrity General Shaped Fiber withLASERGUARD™, is the predicate device fitted with an accessory capableof detecting when the fiber material experiences a rapid rise intemperature. This rapid rise in temperature occurs, for example, whenthe fiber breaks as a result of a small bend radius. With the predicatedevice, an operator must detect such a break by observing the changesin energy delivery at the fiber tip and then respond to them by releasingthe foot or hand held switch in order to stop damage to the endoscopeor hand piece. With the LASERGUARD™ detector, the laser isautomatically put in standby, thereby limiting damage to endoscopes orother fiber containing devices.Additionally, if the fiber is used as a bare fiber for tissue ablation and thetip of the fiber becomes contaminated and as a result the fiber heats up,then the LASERGUARD™ will likewise, put the laser in standby and alertthe operator that a thermal runaway event has occurred. The surgeoncan then determine what course of action to take. That way, thesubmitted device can assist the surgeon in delivering the appropriateenergy to ablate the desired tissue while minimizing collateral damage.
Summary ofPerformance Data	Bench testing demonstrated that Optical Integrity's General ShapedFiber with LASERGUARD™ performed the same as the predicate device,Optical Integrity's General Shaped Fiber (without the LASERGUARD™accessory). I.E. there was no difference in the energy delivered by theundamaged fiber with or without the LASERGUARD™ accessory in place.Additionally, the test results establish that the LASERGUARD™ will shutdown the laser, as intended, when a fiber break occurs and indicatesuch by an audible alarm and an indicator light. (Test report is inSection 18, Bench Tests)

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and tail. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 2 0 2010

Optical Integrity, Inc. % Mr. Ronald E. Bowman 7500 McElvey Road Panama City Beach, Florida 32408

Re: K100194

Trade/Device Name: Optical Integrity General ShapedFiber with LaserGuard™ 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: May 17, 2010 Received: May 18, 2010

Dear Mr. Bowman: .

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

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Page 2 - Mr. Ronald E. Bowman

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

Sincerely yours,

for

Mark N. Melkerson

Mark N. Mel Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

510(K) Number: K100194

Device Name: Optical Integrity General Shaped Fiber with LaserGuard™

Indications for Use:

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

_or Over-the-Counter Use _

Neil K. Oden for mxm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100194

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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.