The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.

Device Description

The NOVAPROBE LED LEUKOS 175 is specifically designed to provide the cold light intensity required for modern day Endoscopic procedures. The LED light provides the color temp of 6500 deg K also known as white light. The white light offers unmatched quality for the single chip, three chip and HD cameras. The LED light intensity is controlled digitally. Using LED nullifies any skin burning problems that may occur due to the use of arc lamps. The NovaProbe LED Light source assures that the light passing through the fiber optic cable is a cold light.

AI/ML Overview

The provided text is a 510(k) summary for the NovaProbe LED Light Source (LEUKOS 175). This document focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than providing unique performance data or clinical study results for the new device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, detailed study design, or specific performance metrics in the way a clinical trial report would.

Here's the breakdown of what can be extracted based on the provided text, and what cannot:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it states that "Design verification testing demonstrates that the devices function as intended, and the Performance did not raise any new issues of safety and effectiveness, and that formal user training is not required." It also mentions that the device "performs to its specifications, operates as intended, is safe and effective, and is substantially equivalent to legally marketed devices."

The "performance" information provided is primarily comparative to predicate devices, focusing on technological characteristics like:

Characteristic	NovaProbe LED Light Source (LEUKOS 175)	Predicate Devices (Stryker L9000, SOPRO 281, Richard Wolf 5160, Sunoptic LLS-050)
Lamp Type	LED	LED
Color Temperature	6500K	6500K (Stryker L9000), 6000K (SOPRO 281, Richard Wolf 5160, Sunoptic LLS-050)
Intended Use	Cold Light Sources for endoscopic and diagnostic procedures	Cold Light Sources for endoscopic and diagnostic procedures
Safety	Light Source output identical to K121724 and K082813	Safety demonstrated in 510k submission

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

The document explicitly states: "No clinical data was required to confirm safety and effectiveness." Therefore, there is no test set, sample size, or data provenance as would be found in a clinical study report. The evaluation was based on non-clinical design verification testing and comparison to predicate devices.

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, as no clinical data or test set involving expert review was utilized for this 510(k) submission.

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

Not applicable, as no clinical data or test set requiring adjudication was performed.

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. The device is an LED light source, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. The device is a physical light source, not an algorithm.

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

The concept of "ground truth" as typically defined in diagnostic algorithm studies is not applicable here. The evaluation of this device relies on non-clinical design verification testing to ensure it functions as intended and meets safety standards, and on its substantial equivalence to predicate devices which have already established their safety and effectiveness through their own approval processes.

8. The sample size for the training set

Not applicable. This device is a physical medical device (LED light source), not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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K131226 JUL 2 4 2014

Image /page/0/Picture/1 description: The image shows the word "NovaProbe" in a stylized font. The word is in black and has a line above the "Nova" portion. There is a symbol above the "o" in "Probe" and a registered trademark symbol to the right of the "e" in "Probe".

2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter		Date of Preparation: June 27, 2014
Company Name/ Institution Name:		FDA Establishment Registration Number:
NovaProbe Incorporated		3010120217
Division Name(If Applicable)		Phone Number ( include area code):
N/A		215-259-3673
Street Address:		FAX number (include area code):
2333 W. Main Street Suite 210		267-295-8411
City:	State/Province:	Country:	Zip / Postal code
Lansdale	Pennsylvania	USA	19446
Contact Person:Manish Ingle
Contact Title:President
Product Information:
Trade Name:	Model number:
NOVAPROBE LED Light Source	LEUKOS 175
Common Name:	Classification:
Light source, Fiber Optic, RoutineLED Light Source	Endoscope and Accessories, Class II(21CFR 876.1500, Product Code FCW, NTN)
Information on devices to which substantial equivalence is claimed:
510(K) Number	Trade or Proprietary or Model Name		Manufacturer
1 K082813	1. LED Light Source L9000		1. Stryker Endoscopy
2 K103813	2. LED Light SourceSOPRO 281		2 SOPRO.
3 K121724	3 5160 ENDOLIGHT light Source		3 Richard Wolf Medical Instruments Corporation Inc.

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Image /page/1/Picture/0 description: The image shows the word "NovaProbe" in a stylized font. The word is written in black, with the first letter "N" being outlined in white. There is a symbol above the "o" in "Probe" that looks like a plus sign, and there is a registered trademark symbol next to the "e" in "Probe".

2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com

Introduction:

Device Trade Name: NOVAPROBE LED Light Source (LEUKOS 175)

Common Name: Light source, Fiber Optic, Routine

Classification Name: Endoscope and accessories ------

Regulation Number: 21 CER 876.1500

Product Code: FCW, NTN

Device Description:

Intended Use:

The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery a Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.

Comparison of Technological Characteristics:

The technology of the NOVAPROBE LED LEUKOS 175 Light Source System is similar to the referenced predicate devices of LED Light Sources as they utilize the similar components as shown below.

Section 4 Page 2 of 5

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Image /page/2/Picture/0 description: The image shows the logo for NovaProbe. The logo is in black and white, with the word "NovaProbe" in a stylized font. There is a line going through the top of the "v" in Nova. There is also a small cross above the "b" and a registered trademark symbol next to the "e".

2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com

DEVICE COMPARISONS:

Device	510KNumber	Intended Use	Lamp	ColorTemperature
NOVAPROBE INC.LED LEUKOS 175	K131226	Cold Light Sources areDesigned to supply light forendoscopic and diagnosticprocedures	LED	6500K
Stryker EndoscopyLED Light SourceL9000	K082813	Cold Light Sources areDesigned to supply light forendoscopic and diagnosticprocedures	LED	6500K
SOPROLED Light SourceSOPRO 281	K103813	Cold Light Sources areDesigned to supply light forendoscopic and diagnosticprocedures	LED	6000K
Richard Wolf MedicalInstrumentsCorporation Inc..5160 ENDOLIGHTlight Source	K121724	Cold Light Sources areDesigned to supply light forendoscopic and diagnosticprocedures	LED	6000K
Sunoptic TechnologieLLS-050 LED lightSource	K093792	Cold Light Sources areDesigned to supply light forendoscopic and diagnosticprocedures	LED	6000K

Device	510KNumber	Biocompatibility	Used with	Light source Safety
NOVAPROBE INC.LED LEUKOS 175	K131226	N/A	Fiber-optic lightcable, Rigid andFlexibleEndoscope	Light Source outputidentical to LED lightsource K121724 andK082813
Stryker EndoscopyLED Light SourceL9000	K082813	N/A	Fiber-optic lightcable, Rigid andFlexibleEndoscope	Light Source Safetydemonstrated in 510ksubmission
SOPROLED Light SourceSOPRO 281	K103813	N/A	Fiber-optic lightcable, Rigid andFlexibleEndoscope	Light Source Safetydemonstrated in 510ksubmission
Richard WolfMedical Instruments	K121724	N/A	Fiber-optic lightcable, Rigid andFlexible	Light Source Safetydemonstrated in 510k

Section 4 Page 3 of 5

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Image /page/3/Picture/0 description: The image shows the logo for NovaProbe. The logo is in black and white, with the word "NovaProbe" in a stylized font. There is a four-pointed star above the "b" in "Probe", and a small circle with a dot in the center above the "e". The logo is simple and modern.

2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com

Corporation Inc..5160 ENDOLIGHTlight Source			FlexibleEndoscope	submission
SunopticTechnologiesLLS-050 LED lightSource	K093792	N/A	Fiber-optic lightcable, Rigid andFlexibleEndoscope	Light Source Safetydemonstrated in 510ksubmission

Sterilization:

This system is a non-sterile system. The Light Source is to be cleaned with a soft cloth moistened with surface disinfectant, alcohol or spirit as defined in instruction manual.

Rational for Substantial Equivalence:

The NovaProbe Inc. LED LEUKOS 175 Light Source is substantially equivalent to Stryker Endoscopy LED light Source L9000 (K0828813), SOPRO LED light source 281 (K103813), Richard Wolf ENDOLIGHT light source (K121724) and Sun optic Technologies LLS-050 LED(K093792) light Source due to the fact that they appliutilize similar components and technology as the NovaProbe Inc. LED LEUKOS 17511 ight Source for the same approved intended uses. Further, the NovaProbe Inc. J ED LEUKOS 175 Light Source introduces no new patient risks or concerns.

The NovaProbe Inc. LED LEUKOS 175 Light Sources were non-clinically tested to determine the safety and efficacy under the indications for use and meet affected ioned safety standards, same as the predicate devices.

Performance Data:

Design verification testing demonstrates that the devices function as intended, and the Performance did not raise any new issues of safety and effectiveness, and that formal user training is not required.

No applicable mandatory performance standards or special controls exists for this device.

Clinical Data:

No clinical data was required to confirm safety and effectiveness.

Section 4 Page 4 of 5

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Image /page/4/Picture/0 description: The image shows the logo for NovaProbe. The logo is in black and white, with the word "NovaProbe" in a stylized font. There is a line going through the word "Nova" and a plus sign above the "o" in Probe. The logo also has the registered trademark symbol.

2333 W. Main Street Suite 210 Lansdale PA 19446 Tel: 215-259-3673 http://www.NovaProbe.com Email: ingle@novaprobe.com

Conclusion:

Testing has shown that the NovaProbe Inc. LED LUEKOS 175 Light Source performs to its specifications, operates as intended, is safe and effective, and is substantially equivalent to legally marketed devices.

Contact:

Date:

27 June 2014

Manish Ingle President NovaProbe Inc. 2333 W. Main Street Suite 210 Lansdale PA 19446 USA 215-259-3673 ext 801 Email: ingle@novaprobe.com

Section 4 Page 5 of 5

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's seal. The seal features an abstract image of an eagle with its wings spread, along with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 24, 2014

NovaProbe Incorporated Mr. Manish Ingle President 2333 West Main Street, Suite 210 Lansdale, Pennsylvania 19446

Re: K131226

Trade/Device Name: NovaProbe LED Light Source (LEUKOS 175) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCW Dated: June 18, 2014 Received: June 24, 2014

Dear Mr. Ingle:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Manish Ingle

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David Krause -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131226

Device Name

NovaProbe LED Light Source (LEUKOS 175)

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.07.23 16:48:01 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.