560 HIGH DEFINITION CAMERA SYSTEM

K070266 · Smith & Nephew, Inc. · GCJ · Feb 22, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070266
• Device Name: 560 HIGH DEFINITION CAMERA SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 22, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals when used with an appropriately indicated endoscope. Additionally, when used in conjunction with a Smith & Nephew light source and Iight cable the Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

Device Story

Smith & Nephew HD Camera System captures and transmits high-definition video images during endoscopic surgical procedures. System comprises camera control unit and camera head. Operates by continuous transmission of high-resolution output from camera head to control unit. Used in OR settings by surgeons to visualize internal anatomy; output displayed for real-time surgical guidance. Facilitates minimally invasive procedures; improves visualization of surgical field.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, EMDEMC testing, UL safety testing, and software verification and validation.

Technological Characteristics

High-definition camera system consisting of camera control unit and camera head. Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL 60601-1, and CAN/CSA 22.2 No. 601.1 standards. Electrical medical equipment.

Indications for Use

Indicated for endoscopic surgical visualization of articular cavities, body cavities, hollow organs, canals, and thoracic cavity (when used with compatible light source/cable and thoracoscope). Prescription use only.

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

• DYONICS Vision 325Z DV 3-CCD Hermes-Ready Camera System (K031379)

Submission Summary (Full Text)

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Endoscopy Smith & Nephew, Inc. 150 Minutemen Road Andover, MA 01810 USA

1. 578-749-1000 F 978-749-1443 www.smith-nephew.com

- We are smith&nephew

Ko70266

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as

required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

# Smith & Nephew HD Camera System

Date Prepared: January 26, 2007

FEB 2 2 2007

### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810 USA

### B. Company Contact

Janice Haselton Sr. Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

### C. Device Name

| Trade Name: | Smith & Nephew HD Camera System |
|----------------------|----------------------------------------|
| Common Name: | Endoscopes and accessories |
| Classification Name: | Laparoscope, General & Plastic Surgery |

#### D. Predicate Devices

The Smith & Nephew HD Camera System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution:

#### E. Description of Device

The Smith & Nephew HD Camera System is used in endoscopic surgical procedures to capture and transmit video images. The Smith & Nephew HD Camera System consists of a camera control unit and a camera head. The camera system has been designed to be capable of outputting a true high definition picture. The high definition picture is maintained by continuous transmission of high resolution ourput from the camera head to the camera control unit.

#### F. Intended Use

The Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs and canals when used with an appropriately indicated endoscope.

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Additionally, when used in conjunction with a Smith & Nephew light source and Iight cable the Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

# G. Comparison of Technological Characteristics

The Smith & Nephew HD Camera System similarities to the predicate device are:

- has the same Indications for Use .
- utilizes the same operating principle
- incorporates the same basic design .
- it is manufactured under a Quality System ♥
- incorporates the same technological characteristics as the predicate ●

### H. Summary Performance Data

The performance testing, EMDEMC testing, UL Safety testing and the software verification and validation conducted on the Smith & Nephew HD Camera System demonstrates substantial equivalence to the DYONICS Vision 325Z DV 3-CCD Hermes-Ready Camera System cleared in K031379. The testing also demonstrates that any differences in the new device and the predicate device do not raise any new issues of safety and efficacy and that the Smith & Nephew HD Camera System performs as well as the legally marketed device.

The Smith & Nephew HD Camera System conforms to the following voluntary standards:

IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1998) + Amendment 1 (1991) + Amendment 2 (1995) (UL 2601-1)

IEC 60601-1-1 Medical Electrical Equipment -- Part 1: General Requirements for Safety; Safety Requirements for Medical Electrical Systems (1992) + Amendment 1 (1995), (2000)

IEC 60601-1-2 (2001-09) 2nd Edition Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility - Requirements & Tests (2001)

UL 60601-1 (2003): Medical Electrical Equipment - Part 1: General Requirements for Safety

CAN/CSA 22.2 No. 601.1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1990) + Supplements No. 1-94 (1994)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the left and has a sleek, modern design. The text is in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Smith & Nephew % Ms. Janice Haselton Senior Regulatory Affairs Specialist 1 50 Minuteman Road Andover, Massachusetts 01810

FEB 2 2 2007

Re: K070266

Trade/Device Name: 560 High Definition Camera System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: January 26, 2007 Received: January 29, 2007

Dear Ms. Haselton:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Howard M. Holstein

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

sincerely yours,

Mark A. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: ________________________________________________________________________________________

Indications For Use:

The Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the atticular cavities, body cavities, hollow organs and canals when used with an appropriately indicated endoscope.

Additionally, when used in conjunction with a Smith & Nephew light source and light cable the Smith & Nephew HD Camera System is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

Mark A. Malkerson

(Division Sign-Off) Division of General. Restorative, and Neurological Devices

510(k) Number

K070266

Prescription Use __ × (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

SI.G