NOVAPROBE LED LIGHT SOURCE

K131226 · Novaprobe Incorporated · FCW · Jul 24, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K131226
• Device Name: NOVAPROBE LED LIGHT SOURCE
• Applicant: Novaprobe Incorporated
• Product Code: FCW · Gastroenterology, Urology
• Decision Date: Jul 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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), 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 Story

The NovaProbe LED LEUKOS 175 is a cold light source for endoscopic procedures. It generates 6500K white light via LED technology, providing illumination for single-chip, three-chip, and HD cameras. The device is operated by healthcare professionals in clinical settings. Light intensity is controlled digitally. The system transmits light through an optical cable and scope to the surgical site. By using LED technology, the device eliminates skin-burning risks associated with traditional arc lamps. The device is non-sterile and intended for use with fiber-optic cables and rigid/flexible endoscopes.

Clinical Evidence

No clinical data was required to confirm safety and effectiveness. Bench testing and design verification were performed to demonstrate that the device functions as intended and meets safety standards.

Technological Characteristics

LED-based cold light source; 6500K color temperature; digital intensity control; non-sterile; compatible with fiber-optic cables and rigid/flexible endoscopes; intended for minimally invasive surgery.

Indications for Use

Indicated for illumination of surgical sites during minimally invasive procedures including arthroscopy, laparoscopy, and endoscopy (general, gynecological, gastroenterological, and ENT surgery).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LED Light Source L9000 (K082813)
• LED Light Source SOPRO 281 (K103813)
• 5160 ENDOLIGHT light Source (K121724)

Reference Devices

• LLS-050 LED light Source (K093792)

Submission Summary (Full Text)

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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: [phone] http://www.NovaProbe.com Email: [e-mail]

## 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:<br>Manish Ingle | | | |
| Contact Title:<br>President | | | |
| Product Information: | | | |
| Trade Name: | Model number: | | |
| NOVAPROBE LED Light Source | LEUKOS 175 | | |
| Common Name: | Classification: | | |
| Light source, Fiber Optic, Routine<br>LED Light Source | Endoscope and Accessories, Class II<br>(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 Source<br>SOPRO 281 | | 2 SOPRO. |
| 3 K121724 | 3 5160 ENDOLIGHT light Source | | 3 Richard Wolf Medical Instruments Corporation Inc. |

© 2014 NovaProbe Inc. Confidential and Proprietary Information

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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: [phone] http://www.NovaProbe.com Email: [e-mail]

## 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:

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.

## 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.

© 2014 NovaProbe Inc. Confidential and Proprietary Information

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: [phone] http://www.NovaProbe.com Email: [e-mail]

## DEVICE COMPARISONS:

| Device | 510K<br>Number | Intended Use | Lamp | Color<br>Temperature |
|--------------------------------------------------------------------------------------------|----------------|---------------------------------------------------------------------------------------------------|------|----------------------|
| NOVAPROBE INC.<br>LED LEUKOS 175 | K131226 | Cold Light Sources are<br>Designed to supply light for<br>endoscopic and diagnostic<br>procedures | LED | 6500K |
| Stryker Endoscopy<br>LED Light Source<br>L9000 | K082813 | Cold Light Sources are<br>Designed to supply light for<br>endoscopic and diagnostic<br>procedures | LED | 6500K |
| SOPRO<br>LED Light Source<br>SOPRO 281 | K103813 | Cold Light Sources are<br>Designed to supply light for<br>endoscopic and diagnostic<br>procedures | LED | 6000K |
| Richard Wolf Medical<br>Instruments<br>Corporation Inc..<br>5160 ENDOLIGHT<br>light Source | K121724 | Cold Light Sources are<br>Designed to supply light for<br>endoscopic and diagnostic<br>procedures | LED | 6000K |
| Sunoptic Technologie<br>LLS-050 LED light<br>Source | K093792 | Cold Light Sources are<br>Designed to supply light for<br>endoscopic and diagnostic<br>procedures | LED | 6000K |

| Device | 510K<br>Number | Bio<br>compatibility | Used with | Light source Safety |
|------------------------------------------------|----------------|----------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------|
| NOVAPROBE INC.<br>LED LEUKOS 175 | K131226 | N/A | Fiber-optic light<br>cable, Rigid and<br>Flexible<br>Endoscope | Light Source output<br>identical to LED light<br>source K121724 and<br>K082813 |
| Stryker Endoscopy<br>LED Light Source<br>L9000 | K082813 | N/A | Fiber-optic light<br>cable, Rigid and<br>Flexible<br>Endoscope | Light Source Safety<br>demonstrated in 510k<br>submission |
| SOPRO<br>LED Light Source<br>SOPRO 281 | K103813 | N/A | Fiber-optic light<br>cable, Rigid and<br>Flexible<br>Endoscope | Light Source Safety<br>demonstrated in 510k<br>submission |
| Richard Wolf<br>Medical Instruments | K121724 | N/A | Fiber-optic light<br>cable, Rigid and<br>Flexible | Light Source Safety<br>demonstrated in 510k |

© 2014 NovaProbe Inc. Confidential and Proprietary Information

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: [phone] http://www.NovaProbe.com Email: [e-mail]

| Corporation Inc..<br>5160 ENDOLIGHT<br>light Source | | | Flexible<br>Endoscope | submission |
|---------------------------------------------------------|---------|-----|----------------------------------------------------------------|-----------------------------------------------------------|
| Sunoptic<br>Technologies<br>LLS-050 LED light<br>Source | K093792 | N/A | Fiber-optic light<br>cable, Rigid and<br>Flexible<br>Endoscope | Light Source Safety<br>demonstrated in 510k<br>submission |

### 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.

© 2014 NovaProbe Inc. Confidential and Proprietary Information

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: [phone] http://www.NovaProbe.com Email: [e-mail]

## 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: [e-mail]

© 2014 NovaProbe Inc. Confidential and Proprietary Information

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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.

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#### 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'

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