CLL- V1 LIGHT SOURCE

K130819 · Olympus Winter & Ibe GmbH · NTN · Jun 19, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K130819
• Device Name: CLL- V1 LIGHT SOURCE
• Applicant: Olympus Winter & Ibe GmbH
• Product Code: NTN · Gastroenterology, Urology
• Decision Date: Jun 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Device Story

The Olympus CLL-V1 is a desktop LED light source designed for use with Olympus-designated endoscopes, camera heads, and video system centers. It provides illumination for endoscopic diagnosis, treatment, and video observation. The device utilizes LED technology, which offers higher contrast and brightness compared to traditional Halogen bulbs while reducing energy consumption. The design eliminates the need for additional fan cooling, resulting in silent operation. It is intended for use by healthcare professionals in clinical settings where endoscopic procedures are performed. The light source integrates into the existing endoscopic imaging chain to facilitate visualization for the clinician, thereby supporting diagnostic and therapeutic decision-making.

Clinical Evidence

Bench testing only. Risk analysis performed per ISO-14971:2007. Software validation conducted per FDA guidance. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and IEC 60601-1-6 standards.

Technological Characteristics

Desktop LED light source. Features long-lasting LED bulb, fanless cooling system. Complies with ISO 14971:2007, IEC 60601-1:1990 (plus amendments), IEC 60601-1-2:2007, IEC 60601-2-18:1996 (plus amendment), and IEC 60601-1-6:2006. Designed for integration with Olympus endoscopic systems.

Indications for Use

Indicated for use with Olympus-designated endoscopes, camera heads, video system centers, and ancillary equipment to provide illumination for endoscopic diagnosis, treatment, and video observation in patients undergoing endoscopic procedures.

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 (K082813)
• Storz LED Nova 100 Cold Light Fountain (K091968)

Submission Summary (Full Text)

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JUN 1 9 2013

### K130819

# ATTACHMENT 19

# 510(k) Summary

1

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### K130819

### 510(k) Summary of Safety and Effectiveness

#### 1. General information

- Applicant: 트
Olympus Winter & Ibe GmbH Kuehnstrasse 61 22045 Hamburg Germany

- Official Correspondent: Sheri L. Musgnung 트
Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: [phone] FAX: [phone] Email: [e-mail] Establishment Registration No .: 2429304

Olympus Winter & Ibe GmbH 1 Manufacturer: Kuehnstrasse 61 22045 Hamburg / Germany

- Registration number: 9610773 I
- Mr. Jan Schueller-lwersen . Contact person: Phone: [phone] [phone] Fax: Email: [e-mail]

#### 2. Device identification

- CLL-V1, LED Light Source Proprietary name: 로
- l Common name: LED Light Source
- Requlations Number: 21 CFR 876.1500
- Class II ■ Regulatory class:
- Product code: NTN. FCW
- Gastroenterology/Urology Device panel:

#### 3 Predicate devices

를

l

트

| Device Name: | Stryker L9000 | Storz LED Nova 100 Cold Light Fountain |
|---------------|---------------|----------------------------------------|
| Manufacturer: | Stryker | Karl Storz |
| 510(k) No.: | K082813 | K091968 |

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#### K130819

#### 4 Description of device

The Olympus CLL-V1 is a desk top device which consists of a LED light source designed and intended to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

#### 5 Indications of use

This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

#### 6 Comparison of Technological characteristics

LED is the advancing technology therefore the new light source CLL-V1 is based on the latest LED technology. The LED light source features a long lasting LED "bulb" with reduced energy consumption having no need for additional fan cooling therefore being silent in its use. The optimized light intensity allows higher contrast to existing Halogen bulbs resulting in higher brightness.

#### 7 Summary of non-clinical testing

Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.

The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."

The following standards have been applied to the CLL-V1:

ISO 14971:2007 IEC 60601-1:1990 + A1:1993 + A2:1995 + A13:1996 IEC 60601-1-2:2007 IEC 60601-2-18:1996 +A1.2000 IEC 60601-1-6:2006

#### 8 Conclusion

In summary, we believe the CLL-V1 is substantially equivalent with the predicate devices with respect to the general design approach, function, and the indications for use. The CLL-V1 raises no new concerns of safety or efficacy when compared to the predicate device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 ·Silver Spring, MD 20993-002

June 19, 2013

Olympus Winter and Ibe GmbH % Olympus Corporation of the Americas Ms. Sheri L. Musgnung 3500 Corporate Parkway - P.O. Box 610 Center Valley, Pennsylvania 18034-0610

Re: K130819

Trade/Device Name: CLL-VI Light Source Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NTN, FCW Dated: March, 22, 2013 Received: April 01, 2013

Dear Ms. Musgnung:

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. Sheri L. Musgnung

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 (OS) 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/ucm1 15809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

# Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

K130819 510(k) Number (if known):

Device Name: CLL-V1, LED Light Source

Model Numbers: WA97020A

Indications For Use:

This light source has been designed to be used with Olympus-designated endoscopes, camera heads, video system center, and other ancillary equipment for endoscopic diagnosis, treatment and video observation.

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 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 Ogdens 2013.06.14 11:23:45 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

K130819 510(k) Number

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