DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM

K023053 · Smith & Nephew, Inc. · GCJ · Oct 3, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K023053
• Device Name: DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Dyonics Vision 635 Image Management System - HERNES™-Ready is designed to be used to capture intraoperative still and motion images using the camera head, the optional footswitch, the front panel of the system, the keyboard, or with optional voice-activated of touch panel control via HERMES. Images are then stored in one of several standard image formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.

Device Story

The Dyonics Vision 635 Image Management System (DV 635) captures intraoperative still images and motion video. It connects to standard video output devices, providing video throughput to monitors and peripherals. Surgeons or clinical staff operate the system via front panel switches, camera head buttons, keyboard, footswitch, or HERMES™ voice/touch control. Inputs are processed and stored on an internal hard disk drive. Data is transferred to removable media (CD-R, ZIP™ disks), network drives, or printers via Ethernet. The system facilitates archival, retrieval, and presentation of surgical imagery, supporting clinical documentation and decision-making.

Clinical Evidence

Bench testing only. The device was tested for compliance with medical electrical equipment safety and electromagnetic compatibility standards (UL2601-1, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, CAN/CSA C22.2 No. 601.1-M90).

Technological Characteristics

Image management system for surgical video/still capture. Connectivity via standard video inputs/outputs and Ethernet. Storage on internal hard drive, removable media (CD-R, ZIP), or network. Operates via keyboard, footswitch, or HERMES™ control. Compliant with UL2601-1 and IEC 60601-1 safety standards.

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 (K011944)

Submission Summary (Full Text)

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K023053

# 510(k) Summary Dyonics Vision 635 Image Management System

Page 1 of 2

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

### A. Submitter

Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Rd. Andover, MA 01810

OCT 0 3 2002

### B. Company Contact

Steven Jackson Manager, Regulatory Affairs Smith & Nephew, Inc. Endoscopy Division 3600 NW 138" St. Oklahoma City, OK 73134 Phone - [phone] Fax - [phone]

## C. Device Name

| Trade Name: | Dyonics Vision 635 Image Management System |
|----------------------|---------------------------------------------|
| Common Name: | Dyonics Vision 635 Image Management System |
| Classification Name: | Picture Archiving and Communications System |

#### D. Predicate Devices

The Smith & Nephew Dyonics Vision 635 Image Management System is substantially equivalent in design, materials, function and intended use to the following devices in commercial distribution: Dyonics Vision 635 Image Management System, K011944, Sept. 19. 2001.

#### Description of Device E.

The Dyonics Vision 635 Image Management System (DV 635) is designed to provide surgeons the ability to capture still images and motion video during surgical procedures in various file formats for archival and presentation purposes. The DV 635 connects to any device with standard video outputs via standard video connections, and provides video throughput to video monitors, and other video peripheral devices. The DV 635 utilizes an external keyboard for input of basic patient and case information, and to set the system configuration. To capture images, the DV 635 utilizes user inputs from front panel switches, camera head buttons, the keyboard, optional footswitch, or optional voiceactivated or touch panel central control via HERMES™. Images and motion video clips are stored on an internal hard disk drive, and later transferred to a removable storage media, including CD-R and ZIP™ disks, or to an network drive or printer via a Ethernet connection. The DV 635 may also print images directly to a postscript printer via a print server.

#### F. Intended Use

The Dyonics Vision 635 Image Management System - HERNES™-Ready is designed to be used to capture intraoperative still and motion images using the camera head, the optional

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footswitch, the front panel of the system, the keyboard, or with optional voice-activated of touch panel control via HERMES. Images are then stored in one of several standard image formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.

# G. Comparison of Technological Characteristics

Dyonics Vision 635 Image Management System has the same technological characteristics as the predicate device identified above.

The Dyonics Vision 635 Image Management System has been tested and found compliant with the following domestic and international standards:

- · UL2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
- · IEC 60601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety + Amendment 1 + Amendment 2
- · IEC 60601-1-1: Medical Electrical Equipment General Requirements for Safety 1. Collateral Standard: Safety Requirements for Medical Electrical Systems
- · IEC 60601-1-2: Medical Electrical Equipment General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- · CAN/CSA C22.2 No. 601.1-M90 Medical Electrical Equipment General Requirements for Safety: A National Standard for Canada.

Stinfort

Steven Jackson Manager, Regulatory Affairs

9-12-02

CO210

Date

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. The bird faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 03 2002

Smith & Nephew, Inc. Steven Jackson Manager, Regulatory Affairs Endoscopy Division 3600 Northwest 13801 Street Oklahoma City, Oklahoma 73134

Re: K023053

Trade/Device Name: Dyonics Vision 635 Image Management System Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 10, 2002 Received: September 13, 2002

Dear Mr. Jackson:

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. Steven Jackson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Celia M. Witten, Ph.D., M.D.

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 Statement |
|-----------------------------|----------------------------------------------------|
| 510(k) Number<br>(if known) | |
| Device Name | Dyonics Vision 635 Image Management System |
| Indications for Use | To capture intraoperative still and motion images. |

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)


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

| 510(k) Number | K023053 |
|---------------|---------|
|---------------|---------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

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