ENVIEW (TM)

K102179 · Carefusion 2200 · OCV · Dec 2, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K102179
• Device Name: ENVIEW (TM)
• Applicant: Carefusion 2200
• Product Code: OCV · Gastroenterology, Urology
• Decision Date: Dec 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.

Device Story

EnView™ camera controller is a manually operated mechanical surgical device; designed to hold rigid endoscopes (5-10mm) during diagnostic and therapeutic surgeries. Surgeon uses a control handle to position and reposition the endoscope with one hand; eliminates need for surgeon to manually hold endoscope throughout procedure. Used in surgical settings (e.g., OR) by surgeons or designees. Benefits include reduced surgeon fatigue and stable endoscopic visualization.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing and comparison to predicate devices. Bench testing included assessment of design performance and conformance to ISO 10993:2003 and ISO 17664:2004 standards.

Technological Characteristics

Manually operated mechanical and hydraulic surgical device. No electrical components; IEC 60601 testing not required. Materials conform to ISO 10993:2003 (biocompatibility) and ISO 17664:2004 (sterilization).

Indications for Use

Indicated for surgeons and designees to hold rigid endoscopes (5-10mm diameter) during diagnostic and therapeutic surgical procedures, including laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, and radical prostatectomy.

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

• V.Mueller Camera Controller with Storage Cart (K093616)
• Prosurgics Freehand (K090340)

Submission Summary (Full Text)

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## k102179

## CareFusion EnView™ Camera Controller 510(k) Summary

DEC - 2 2010

- Submitter: CareFusion 6215 Ferris Square, Suite 100 San Diego, CA 92121
- Patricia Avers Contact Person: Regulatory Affairs
- Date Prepared: July 30, 2010
- EnView™ Trade Name:
- Common Name: Camera controller

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- 78 OCV. Endoscope Holder and Accessories Classification: 21 CFR §876.1500
- Class:
- V.Mueller Camera Controller with Storage Cart, K093616 Predicate Devices: Prosurgics Freehand, K090340
- Intended Use: The EnView™ camera controller is intended for use by surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures.

A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectomy, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.

- Device Description: The EnView™ camera controller is a manually operated mechanical surgical device. It is designed to hold an endoscope during diagnostic and therapeutic surgical procedures. A surgeon can, with one hand, position and

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| | reposition the placement of an endoscope during a surgical<br>procedure by simple movements of a control handle. This<br>camera controller eliminates the need for the surgeon to<br>continually hold the endoscope during a surgical<br>procedure. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence: | The EnView™ camera controller is substantially equivalent<br>in operation, design, materials, and manufacturing<br>characteristics as the V.Mueller Camera Controller and<br>Storage Cart, and is substantially equivalent with respect to<br>indications for use as the Prosurgics Freehand. |
| Non-Clinical<br>Testing: | Testing was performed under various conditions to assess<br>the design performance and conformance to design<br>specifications. In addition, the EnView™ camera controller<br>met ISO 10993:2003 and ISO 17664:2004 standards. As<br>with the V.Mueller Camera Controller, IEC 60601 testing<br>was not required for the EnView camera controller due to<br>the mechanical and hydraulic mode of operation. |
| Clinical Testing: | Clinical studies were not required as the EnView™ camera<br>controller is substantially equivalent to the legally marketed<br>predicate devices with respect to operation and indications<br>for use. |
| Safety and<br>Efficacy: | The EnView™ camera controller is equivalent in safety and<br>efficacy to the legally marketed predicate devices. |

ﺑ

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three stripes emanating from its head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

CareFusion % Ms. Patricia Avers 6215 Ferris Square, Suite 100 San Diego, California 92121

.

DEC - 2 2010

Re: K102179

Trade/Device Name: EnView™ camera controller Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCV Dated: October 12, 2010 Received: October 14, 2010

Dear Ms. Ayers:

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

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Page 2 - Ms. Patricia Avers

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 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.html 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/Resourcesfor You/Industry/default.htm. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication for Use Statement

510(k) Number (if known): Pending K I O 21 79

DEC = 2 2010

Device Name: EnView™ camera controller

The EnView™ camera controller is intended for use by Indications for Use: surgeons and their designees to hold rigid endoscopes with diameters from 5 - 10mm during diagnostic and therapeutic surgical procedures.

> A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, hernia repair, fundoplication, splenectomy, appendectomy, hemicolectorny, sympathectomy, lymph node dissection, hysterectomy, gastric banding, gastric bypass, nephrectomy, radical prostatectomy.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Beale for nkm
Division Sign Off

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102179

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