DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES

K972471 · Smith & Nephew, Inc. · GCJ · Oct 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972471
• Device Name: DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES
• Applicant: Smith & Nephew, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories 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 Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liguid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.

Device Story

System comprises digital 3-chip color video camera, camera control unit (D-3), PEEK camera head, illuminators, and liquid or fiberoptic light guides. Device mates with endoscopes or thoracoscopes to provide illumination and visualization of surgical sites. Used in clinical/surgical settings by physicians. Light guides deliver light from illuminator to surgical site via endoscope; camera captures video for display. Facilitates minimally invasive surgery by providing real-time visualization of internal cavities and organs.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, function, and compliance with electrical safety standards.

Technological Characteristics

System includes D-3 Camera Control Unit and PEEK camera head. Uses liquid or fiberoptic light guides. Complies with UL544, EN 55011, IEC 601-1, and IEC 601-2-18. Electromechanical design; standard video processing.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures requiring visualization and illumination 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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Smith & Nephew current product offerings
• Snowden Pencer DSP surgical cameras/video components/illuminators
• Stryker Endoscopy surgical cameras/video components/illuminators
• Olympus surgical cameras/video components/illuminators

Submission Summary (Full Text)

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Endoscopy Division

Smith & Nephew, Inc. 160 Dascomb Road, Andover, MA 01810 U.S.A Telephone: [phone] Telefax: 508-749-1599

#### 510(k) Summary Smith & Nephew Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories

Smith = Nephew

OCT 2 4 1997

# 1972471

#### Substantial Equivalence

The Smith & Nephew Images Surgical Camera, Illuminators, Video Components and Accessories are substantially equivalent in both design and intended use to surgical cameras, video components and illumination products offered by Snowden Pencer DSP, Strvker Endoscopy and Olympus.

The Video Components, Surgical Cameras, Illuminators and accessories for all of the above referenced manufacturers mate with an endoscope to allow for visualization during various surgical procedures. The Illuminators, Light Guides and accessories mate to the endoscope and deliver light to the surgical site.

#### Predicate Device:

The predicate devices for this submission are the current product offerings from Smith & Nephew as well as video components, surgical cameras, illuminators and accessories manufactured by Snowden Pencer DSP, Stryker Endoscopy and Olympus.

#### Summary of Device Function:

The Smith & Nephew Images Digital 3-Chip Color Video Camera and Video components mate with the endoscope to allow for visualization during various surgical procedures.

Smith & Nephew Images Illuminators, Light Guides and accessories are designed to supply light to the surgical site through the endoscope. The light guides mate to the endoscope and light source with instrument specific adapters.

#### Intended Use of Device:

Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories 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 Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liguid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity when used in conjunction with an appropriately indicated thoracoscope.

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### Comparison of Technological Characteristics of Predicate Devices:

The basic design and function of the Smith & Nephew Images Surgical Camera, Illuminators, Video Components and Accessories are unchanged compared to information provided in previous submissions. All electromechanical equipment complies with UL544, EN 55011, IEC 601-1 and IEC 601-2-18. The Smith & Nephew Images Digital 3-Chip Color Video Camera Head complies with the appropriate electrical safety standards for use in the thoracic cavity. Smith & Nephew Images Surgical Camera, Illuminators, Video Components and Accessories are substantially equivalent in both design and intended use to surgical cameras, video components and illumination products offered by Snowden Pencer DSP, Stryker Endoscopy and Olympus.

Webnak Conne

Deborah Connors Regulatory Affairs Department

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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 a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 1997

Ms. Deborah J. Connors Regulatory Affairs Specialists Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810

Re: K972471

> Trade Name: Smith & Nephew Endoscopy Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories Regulatory Class: II Product Code: GCJ Dated: September 23, 1997 Received: September 24, 1997

Dear Ms. Connors:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Deborah J. Connors

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

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number :

Device Name : Smith & Nephew, Inc., Endoscopy Division Images Digital 3-Chip Color Video Camera, Illuminators, Video Components and Accessories

Indications for Use :

Smith & Nephew Images Digital 3-Chip Color Video Camera System, illuminators, video components and accessories 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 Smith & Nephew Images Digital 3-Chip Color Video Camera System, consisting of the D-3 Camera Control Unit (REF. 7205292), PEEK Camera Head (REF. 7205208), Smith & Nephew Images Illuminator and Smith & Nephew Images liquid or fiberoptic light guide is indicated for use in endoscopic surgical procedures in the thoracic cavity 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)

| | <div style="text-align:center;">(Division Sign-Off)</div> |
|-----------------------------------------|-----------------------------------------------------------|
| Division of General Restorative Devices | |
| 510(k) Number | K972471 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter |
|---------------------------------------|----|------------------|
| X | | |

(Optional Format 1-2-96)