V. MUELLER CAMERA CONTROLLER WITH STORAGE CART

K093616 · Carefusion 2200 · OCV · Dec 23, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K093616
• Device Name: V. MUELLER CAMERA CONTROLLER WITH STORAGE CART
• Applicant: Carefusion 2200
• Product Code: OCV · Gastroenterology, Urology
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

Device Story

Manually operated, mechanical surgical device; provides one-handed control for positioning/repositioning endoscopes during surgery. Eliminates need for surgeon or assistant to continuously hold endoscope. Includes storage cart for setup, storage, and transport. Used in surgical settings by surgeons.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

Manually operated mechanical device; no energy source or software. Designed for rigid endoscopes 5-10 mm in diameter. Includes storage cart.

Indications for Use

Indicated for surgeons to hold rigid endoscopes (5-10 mm diameter) during diagnostic and therapeutic surgical 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

• Statarius Endoscope Holder, K061292

Submission Summary (Full Text)

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K093616
Page 1 of 2

# Appendix 8 – Summary of Safety and Effectiveness

Image /page/0/Picture/2 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon contains a stylized letter "C" inside a shield shape. The text is in a bold, sans-serif font.

1500 Waukegan Road McGaw Park, Illinois 60085-6787 PHONE: [phone] FAX: [phone]

DEC 2 3 2009

## SMDA REQUIREMENTS

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c) V.Mueller Camera Controller with Storage Cart

| Sponsor: | CareFusion<br>1500 Waukegan Road<br>McGaw Park, IL 60085 |
|-----------------------------|----------------------------------------------------------|
| Regulatory Affairs Contact: | Gina Rajterowski |
| Telephone: | [phone] |
| Fax: | [phone] |
| Date Summary Prepared: | November 2009 |
| Device Name | V.Mueller Camera Controller with Storage Card |
| Common Name | Endoscope Holder |
| Classification Name | Endoscope Holder<br>(21 CFR, 876.1500, Product Code OCV) |
| Predicate Device(s) | Statarius Endoscope Holder, K061292 |

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Description:

K093616

Page 2 of 2

The V.Mueller Camera Controller with Storage Cart is a manually operated, mechanical surgical device. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The V.Mueller Camera Controller eliminates the need for the surgeon or assistant to continuously hold the endoscope during surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

The proposed device and the predicate devices are composed of the same or similar principals of operation, design, materials and manufacturing characteristics.

The V.Mueller Camera Controller with Storage Cart was evaluated in non-clinical tests under various conditions to assess the design performance and conformance to design specifications.

Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate device with regard to functional characteristics.

Intended Use:

Summary of Technological Characteristics:

Summary of Testing:

Non-Clinical Testing

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## DEC 2 3 2009

Ms. Gina Rajterowski Regulatory Affairs Manager CareFusion, 2200 1500 Waukegan Road WAUKEGAN IL 60085

Re: K093616

Trade/Device Name: V.Mueller Camera Controller with Storage Cart Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCV Dated: November 3, 2009 Received: November 19, 2009

Dear Ms. Rajterowski:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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

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

Singerely vours

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for CareFusion. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon contains a stylized letter "C" inside a circle. The text is in a sans-serif font and is black.

CareFusion 1500 Waukegan Road McGaw Park, Illinois 60085-6787 PHONE: [phone] FAX: [phone]

#### Indication for Use

510(k) Number (if known):

093616

Device Name:

V.Mueller Camera Controller With Storage Cart

Indications For Use:

The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.

Prescription Use X

Over-The Counter Use

· (Per 21 CFR 801.109)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

or

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(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devi 510(k) Number _

108