SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM

K060777 · Smith & Nephew, Inc. · GCJ · Apr 13, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060777
• Device Name: SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Apr 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Smith & Nephew 660HD Image Management System is intended to capture intraoperative still and motion images.

Device Story

Computer-based system for intraoperative image management; interfaces with medical camera systems, A/V equipment, printers, and monitors. Captures still and motion video data; archives to removable storage media; transfers data to network locations; imports/exports procedure information with hospital repository systems. Used in clinical/surgical settings by medical staff. Facilitates documentation and archival of surgical procedures.

Clinical Evidence

Bench testing only. Verification and validation data demonstrate the device performs as intended and conforms to applicable safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL 60601-1, CAN/CSA 22.2 No. 601.1).

Technological Characteristics

Computer-based image management system. Interfaces with medical cameras, A/V equipment, and hospital networks. 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. Connectivity includes network data transfer and removable storage media support.

Indications for Use

Indicated for capturing intraoperative still and motion images during 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

• Dyonics Vision 635 Image Management System

Submission Summary (Full Text)

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06077

We are amont is nones

Endoscopy Sinith & Nephew, Inc 15) Minuteman Road Presser MA 01810

smith-nephew.com

Page 1 of 2

APR 1 3 2006

# 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 660HD Image Management System

Date Prepared: March 17, 2006

# A. Submitter's Name:

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

# B. Company Contact

Kathleen Burns Regulatory Affairs Specialist Phone: [phone] [phone] Fax:

### C. Device Name

Trade Name: Common Name: Classification Name: Smith & Nephew 660HD Image Management System Smith & Nephew 660HD Image Management System Endoscope and Accessory, Image Capture

#### D. Predicate Devices

The Smith & Nephew 660 Image Management System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed devices in commercial distribution: Dyonics Vision 635 Image Management System.

#### نا Description of Device

The Smith & Nephew 660HD Image Management System is a computer based system which interacts with medical camera systems and non-medical devices such as A/V equipment, audio equipment, printers and monitors. The 660HD System provides a convenient means to capture video data from the medical camera system and archive it to removable storage media. In addition the 660HD System provides a mechanism to transfer data to a network location and to import/export procedure information from certain repository systems that are already part of the Hospital Information System.

#### u Intended Use

The Smith & Nephew 660HD Image Management System is intended to capture intraoperative still and motion images.

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Kobo77

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#### Comparison of Technological Characteristics G.

Smith & Nephew 660HD Image Management System has the same fundamental scientific technology and substantially equivalent as the predicate device identified above.

#### H. Summary Performance Data

All verification and validation data demonstrates that the device is safe and effective and performs as intended.

The Smith & Nephew 660HD Image Management 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) 200 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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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2006

Smith & Nephew, Inc. Endoscopy Division c/o Ms. Kathleen Burns Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

Re: K060777

Trade/Device Name: Smith & Nephew 660HD Image Management System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 17, 2006 Received: March 22, 2006

Dear Ms. Burns:

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

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# Page 2 - Ms. Kathleen Burns

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. 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,
demall

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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K060777

### Indications for Use

510(k) Number (if known):

Device Name: Smith & Nephew 660HD Image Management System

Indications For Use:

The Smith & Nephew 660HD Image Management System is intended to capture intraoperative still and motion images.

| Prescription Use | X |
|----------------------------|---|
| Use | |
| (Per 21 CFR 801 Subpart D) | |
| C) | |

AND/OR

| Over-The-Counter | |
|---------------------|--|
| (21 CFR 807 Subpart | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_ *******