The LO-50 LED Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a surgical headlight for general surgical or examination procedures.

Device Description

The LO-50 Light Source is a fiber optic light source using a single solid state light emitting element to produce visible light required to illuminate surgical sites for indirect visualization during medical procedures. The LED produces white light by electroluminescence (as in a tungsten filament lamp) or fluorescence (as in a xenon lamp.) Both of the latter technologies use large amounts of electricity and generate significant heat in creating light. LED generates a greater light output as a percentage of energy input to the lamp. It uses Pulse Width Modulation to control the on/off time of the LED at full output to determine brightness. The LO-50 light source uses a small optical element to capture and direct the light to a port into which one of many common medical light guides may be fitted to conduct the light where needed. The unit consists of the aforementioned LED, cooling fan, light port, sheet metal covers, plastic front and rear covers, and front mounted power switch and dimming control. The unit is very similar in design, format, functionality and size to other light sources including the predicate device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the LO-50 LED Light Source, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (LO-50 LED Light Source)
Safety Standards	UL60601-1 compliance	Conforms
	CAN/CSA 22.2 No. 601.1 compliance	Conforms
	EN60601-1-2 (EMC Standard) compliance	Conforms
Operational Equivalence	User interface and controls	Essentially equivalent to predicate device
	Ease of connection of common light guides	Essentially equivalent to predicate device
Light Quality	Brightness of emitted light (with reference light guide)	Essentially equivalent to predicate device (equivalent brightness)
	Brightness and quality of illumination (with typical fiber optic headlight system and arthroscope)	Essentially equivalent to predicate device (equivalent brightness and quality of light)
Safety During Use	Operating temperatures of light sources, accessible parts, and lighted instruments	Essentially equivalent to predicate device
Technological Equivalence	LED technology	Nearly identical to predicate device
	Power supply	Nearly identical to predicate device
	User interface	Nearly identical to predicate device
	Connectivity	Nearly identical to predicate device

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

Sample Size for Test Set: Not explicitly stated. The document mentions "non-clinically tested" and comparisons using "a reference light guide," "a typical fiber optic headlight system," and "arthroscope," implying a limited number of units or setups were used for testing.
Data Provenance: The testing was conducted by the manufacturer, Fiberoptics Technology, Inc., likely at their facility in Pomfret, CT, USA. The data is retrospective in the sense that it's reported after the testing was completed for the 510(k) submission.

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

This information is not provided. The study was a non-clinical comparison focusing on objective performance metrics and safety standards rather than a clinical study requiring expert assessment of outcomes or interpretations.

4. Adjudication Method for the Test Set

Not applicable. The study involved objective measurements and comparisons against a predicate device and established technical standards, not subjective assessments requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. The document describes a non-clinical comparison to a predicate device, focusing on technical and safety equivalence, not on human reader performance with or without AI assistance.

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

Yes, in spirit. While not an "algorithm" in the typical sense of AI, the performance of the device itself (LO-50 LED Light Source) was evaluated standalone against the predicate device and established standards. There was no human-in-the-loop performance component or AI involved.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was primarily based on:
- Predicate device performance: The Sunoptics Technologies LLS-050 LED Light Source (K093792) served as the benchmark for "equivalent brightness and quality of light," "similar control and operation," and "interfaced correctly and effectively."
- Industry Safety and Performance Standards: UL60601-1, CAN/CSA 22.2 No. 601.1, and EN60601-1-2 provided objective thresholds for safety and electromagnetic compatibility.
- Objective Measurement: Direct measurements of brightness, temperature, and verification of user interface and connectivity.

8. Sample Size for the Training Set

Not applicable. This device is a hardware light source, not a software algorithm that undergoes training.

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

Not applicable. As stated above, this is not an AI/ML device requiring a training set.

Summary

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510(k) Summary of Safety and Effectiveness Statement

Device Name;

AUG 1 7 2010

Proprietary Name: Common and Usual Name: Classification Name;

LO-50 LED Light Source Light Source, Illuminator Light Source, Fiberoptic, Routine, CFR 21 §876.1500

Manufacturer Information:

Fiberoptics Technology, Inc. 1 Quassett Road Pomfret, CT 06258 USA

Establishment Registration Number: 1222275

FDA Device Classification

Device Description:	Gastroenterology - Endoscope and Accessories
Medical Specialty:	General and Plastic Surgery
Product Code:	FCW
510(k) Exempt?	No
Regulation Number:	876.1500

Product Description: The LO-50 Light Source is a fiber optic light source using a single solid state light emitting element to produce visible light required to illuminate surgical sites for indirect visualization during medical procedures. The LED produces white light by electroluminescence (as in a tungsten filament lamp) or fluorescence (as in a xenon lamp.) Both of the latter technologies use large amounts of electricity and generate significant heat in creating light. LED generates a greater light output as a percentage of energy input to the lamp. It uses Pulse Width Modulation to control the on/off time of the LED at full output to determine brightness. The LO-50 light source uses a small optical element to capture and direct the light to a port into which one of many common medical light guides may be fitted to conduct the light where needed. The unit consists of the aforementioned LED, cooling fan, light port, sheet metal covers, plastic front and rear covers, and front mounted power switch and dimming control. The unit is very similar in design, format, functionality and size to other light sources including the predicate device.

Indications for Use;_The LO-50 Light Source is intended to provide light via an accessory fiber optic light guide to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), and for use with a headlight for general surgical or examination procedures.

Voluntary Safety and Performance Standards; The LO-50 LED Light Source conforms to the following Medical Device Safety Standards: UL60601-1, CAN/CSA 22.2 No. 601.1. The LO-50 Light Source conforms to the Medical Device EMC Standard EN60601-1-2.

Predicate Device:

The LO-50 LED Light Source is substantially equivalent in terms of safety and effectiveness to the currently marketed predicate device: Sunoptics Technologies LLS-050 LED Light Source (K093792).

Performance and Safety Comparison to Predicate Device:

Both light sources were non-clinically tested to determine the safety and efficacy under the indications for use. The units were tested for operation, user interface, light quality and safety during use. User controls and operations were examine and compared, as well as ease of connection of common light guides. The brightness of light emitted by a reference light guide from each unit was measured. Brightness and quality of illumination from a typical fiber optic headlight system and arthroscope was examined and compared. Operating temperatures of the light sources, accessible parts and lighted instruments were measured and compared. Each unit had essentially equivalent performance and temperature characteristics.

Fiberoptics Technology, Inc. LO-50 510k Submission

Page 6

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Substantial Equivalence:

The technological differences between the LO-50 Light Source and Sunoptics Technologies LLS-050 LED Light Source do not raise new questlons of safety or effectiveness. Both light sources produced equivalent brightness and quality of light, were similar in control and operation, interfaced correctly and effectively to the arthroscope and surgical headlight used to test and verify performance. The LED technology, power supply, user interface and connectivity are nearly identical. Therefore, the LO-50 Light Source is substantially equivalent to the predicate marketed device.

Contact:

Allan Guillotte the text "Allan Guillotte" is a signature, and the date is 08/17/10

Fiberoptics Technology, Inc. 1 Quassett Road Pomfret, CT 06258 (860) 928-0443 {phone}; (860) 928-7664 (fax); or e-mail aguillotte@fibeoptix.com

Fiberoptics Technology, Inc. LO-50 510k Submission

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is horizontally oriented and appears to be part of a document or official letterhead. The ampersand symbol (&) is also present in the text.

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a serpent winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

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

Fiberoptics Technology, Inc. % Regulatory Technology Services, Inc. Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

AUG 1 7 2010

Re: K102167

Trade/Device Name: LO-50 LED Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NTN, FCW Dated: July 30, 2010 Received: August 02, 2010

Dear Mr. Job:

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

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Page 2 - Mr. Mark Job

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 (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/ReportaProblem/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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A. Mckenna

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

Enclosure

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K102167

Indications for Use

510(k) Number (if known):

Device Name: LO-50 LED Light Source

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.E. Ogden formx

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102167

Page 1 of _

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.