DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905

K003710 · Smith & Nephew, Inc. · FET · Feb 2, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K003710
• Device Name: DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048; DYONICS AUTOCLAVABLE CAMERA COUPLER MODEL 7207905
• Applicant: Smith & Nephew, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Feb 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope. Additionally, the Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.

Device Story

The Dyonics Vision 337 is an autoclavable camera head and coupler system used in endoscopic surgery. The device attaches to an endoscope or thoracoscope to capture real-time video images of the surgical site. These images are transmitted to a camera control unit for processing and display on a monitor or recording media. The system is operated by surgeons or clinical staff in an operating room or clinical setting. The hermetically sealed design allows for sterilization via autoclaving. By providing high-quality visualization of internal cavities, the device assists the surgeon in performing minimally invasive procedures, potentially reducing patient trauma compared to open surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device consists of a camera head and coupler. Key feature is a hermetic seal to enable autoclavability. It functions as an accessory to endoscopes, video-endoscopes, control units, light sources, and monitors. It is a non-sterile, reusable device.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures requiring visualization of articular cavities, body cavities, hollow organs, canals, and the thoracic cavity.

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 Digital 3-Chip Color Video Camera (K972471)
• Dyonics DyoCam Video Camera (K914919)
• Dyonics Camera Coupler (K972471)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

JUL 2 7 2015

Smith & Nephew, Inc. Endoscopy Division Ms. Janice Haselton Regulatory Affairs Specialist 160 Dascomb Road Andover, MA 01810

Re: K003710

> Trade/Device Name: Dynonics Vision 337 Autoclavable Camera Head and Camera Coupler Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET, GCJ Dated (Date on orig SE ltr): November 30, 2000 Received (Date on orig SE ltr): December 1, 2000

Dear Ms. Haselton,

This letter corrects our substantially equivalent letter of February 2, 2001.

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

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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 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 contact 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. 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.

Sincerely yours,

# Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: Koo3710

Device Name : Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler

Indications for Use :

The Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.

Additionally, the Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures in the thoracic cavitity when used in conjunction with an appropriately indicated thoracoscope.

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Phrost

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number R003710

OR

Prescription Use V (Per 21 CFR 801.109) Over-the-Counter

· (Optional Format 1-2-96)

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Image /page/3/Picture/1 description: The image shows the text "K003710" in a handwritten style. The text is slightly slanted upwards from left to right. The characters are bold and have a somewhat rough, uneven appearance, suggesting they were written with a thick marker or pen.

#### Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A. Telephone: [phone] Telefax: 978-749-1599

mith - Nephew

### 510(k) Summary Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler Date Prepared: November 30, 2000

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 Road

Andover, MA 01810

B. Company Contact Janice Haselton Regulatory Affairs Specialist

#### C. Device Name

Trade Name: Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler Common Name: Camera Head and Camera Coupler Classification Name: Endoscope and/or Accessories

#### D. Predicate Devices

Dyonics Digital 3-Chip Color Video Camera K972471 Dyonics DyoCam Video Camera K914919 Dyonics Camera Coupler K972471

#### E. Description of Device

The proposed Dyonics Vision 337 Autoclavable Camera Coupler can be used in conjunction with any direct-view endoscope or appropriate video-endoscope, control unit, light source, and monitor to allow illumination and visualization of articular cavities, body cavities, hollow cavities and canals. The camera head acts to transmits real time video images of the surgical site to the camera control unit. It then processes and displays the image to a viewing system or recording media.

The camera head attaches to the endoscope by means of a camera coupler.

The camera head and the camera coupler are hermetically sealed to allow for autoclavability.

Dyonics Vision 337 Page 94 of 95

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#### F. Intended Use

The Dyonics Vision 337 Autoclavable Camera Head and Camera Coupler are indicated for use in endoscopic surgical procedures to provide illumination and allow visualization of articular cavities, body cavities, hollow organs and canals when used in conjunction with an appropriately indicated endoscope.

Additionally, the Dyonics Vision 337 Autoclavable Camera Coupler are indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.

#### G. Comparison of Technological Characteristics

The Dyonics Vision 337 Autoclavable Camera Coupler are substantially equivalent in design, materials of construction, and function and intended use as to the Smith & Nephew Images Digital 3-Chip Color Video Camera and Dyonics Camera Coupler.

Janice Haselton

Regulatory Affairs Specialist