LED LIGHT SOURCE

K093792 · Sunoptic Technologies, LLC · FCW · Mar 18, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093792
• Device Name: LED LIGHT SOURCE
• Applicant: Sunoptic Technologies, LLC
• Product Code: FCW · Gastroenterology, Urology
• Decision Date: Mar 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery. The light is transmitted from the light source through a fiber optic cable and a scope.

Device Story

LED Light Source (LLS-050) provides illumination for minimally invasive surgical procedures. Device generates light transmitted via fiber optic cable to a surgical scope. Used in OR settings by surgeons and clinical staff. Provides consistent surgical site visualization to facilitate minimally invasive interventions. No complex processing or software-driven decision support; purely an illumination tool.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

LED-based light source; fiber optic output; conforms to UL60601-1, CAN/CSA C22.2 No.601.1, and EN 60601-1-2 (EMC).

Indications for Use

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

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

• Stryker L9000 LED Light Source (K082813)

Submission Summary (Full Text)

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K093792

# 510 (k) Summary of Safety and Effectiveness Statement

### Device Name:

Proprietary Name: Common and Usual Name: Classification Name:

LED Light Source (LLS-050 LED Illuminator) Light Source, Illuminator Light Source, Fiberoptic, Routine, CFR 21 § 876.1500

### Manufacturer Information:

Sunoptic Technologies®, LLC 6018 Bowdendale Avenue Jacksonville, FL 32216 USA

MAR 1 8 2010

#### Establishment Registration Number: 1035968 FDA Device Classification

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

### Product Description:

Indications for Use: The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery. The light is transmitted from the light source through a fiber optic cable and a scope.

Voluntary Safety and Performance Standards: The LED Light Source will conform to the Medical Safety Stds .: UL60601-1, CAN/CSA C22.2 No.601.1 (SUP1+AM2), Medical EMC Stds. EN 60601-1-2 and CE marked

#### Predicate Device:

The LED Light Source is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the predicate device Stryker L9000 LED Light Source (K082813).

#### Substantial Equivalence

The technological differences between the LED Light Source (LLS-050) and the Styker LED Light Source (L9000) do not raise new questions of safety or effectiveness. Therefore, the LED Light Source (LLS-050) is substantially equivalent to the predicate marketed device. Refer to section IV for a detailed comparison.

Contact:

Janice G. Lee

2/24/10
**Date**

Sunoptic Technologies®, LLC 6018 Bowdendale Avenue Jacksonville, FL 32216 USA 904 737 7611 (phone); 904 733 4832 (fax); or e-mail [e-mail].

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

# MAR 1 8 2010

Sunoptic Technologies, LLC % Ms. Janice G. Lee Director, OA & Regulatory Affairs 6018 Bowdendale Avenue Jacksonville, Florida 32216-6042

Re: K093792

Trade/Device Name: LED Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FCW Dated: March 15, 2010 Received: March 16, 2010

Dear Ms. Lee:

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 - Ms. Janice G. Lee

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 [phone] or [phone] or at its Internet address

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

Sincerely yours

Radiological Health

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

Enclosure

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## Indications for Use

510(k) Number (if known): K093792

Device Name: LED Light Source

Indications for Use: The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.

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 OF NEEDED)

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Uilal for Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K093792 Page ① of ①