LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS

K955845 · Surgical Image Laboratories, Inc. · GCJ · Jul 5, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K955845
• Device Name: LL 100, 103, 104 DIAGNOSTIC LAPAROSCOPE RIGID ROD LENS
• Applicant: Surgical Image Laboratories, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Surgical Image Laboratories Laparoscope is intended for use in surgical procedures to provide visualization of the interior of the body through a small incision.

Device Story

Laparoscope provides visualization of internal body cavities during surgery; inserted through small incision. Device consists of stainless steel outer tube, optical glass distal tip, fiber optic light transmission system, and camera/eye connection adapter. Operated by qualified surgical personnel in clinical/OR settings. Provides optical image to surgeon for diagnostic or surgical guidance. Benign, non-powered instrument; relies on optical transmission of light and images.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through material safety and design comparison to existing predicate devices.

Technological Characteristics

Materials: 304 stainless steel (outer/optic tubes), plated brass (block/light adapter), anodized aluminum (I.D. ring), optical glass (distal tip), acetal plastic (eye shield/adapter). Design: Blunt/rounded distal tip, smooth/polished surfaces. Principle: Optical visualization via fiber optic light transmission. Sterilization: Compatible with standard surgical cleaning/sterilization protocols.

Indications for Use

Indicated for use by qualified, trained professionals for visualization of internal body cavities 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.

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

• Dyonics 8000 Laparoscope

Reference Devices

• Olympus Corporation laparoscopes
• Richard Wolf Medical Instruments Corporation laparoscopes
• Karl Storz Endoscopy laparoscopes
• Stryker Endoscopes laparoscopes

Submission Summary (Full Text)

{0}

K 955845

6 West Newport Center Dr. · Deerfield Beach, FL 33442 · [phone] · Tel: [phone] · Fax: [phone]

JUL - 5 1996

# 510(k) SUMMARY

"This summary of 510(k) safely and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92"

The Surgical Image Laboratories Laparoscope is equivalent in materials, intended use, safety and effectiveness to the Dyonics 8000 Laparoscope

The outer tube of the Surgical Image Laparoscope are fabricated from 304 stainless steel. This stainless steel, often referred to as "Surgical Steel" has been used in various medical and surgical procedures for many years, including existing laparoscopes, as was chosen for the Surgical Image Laparoscope because it is non-reactive with the human body, is easy to clean and sterilize, and poses no danger to the patients as long as it is prepared for use appropriately and used by a qualified professional trained technician.

The block and light adapter are made from plated brass and the I.D. ring from anodized aluminum.

As with laparoscopes existing before Surgical Image's Laparoscope, the distal end tip of the laparoscope that is inserted into the body through a small incision during surgery is fabricated from optical glass which may be coated with an anti-reflective coating to reduce or eliminate glare during the surgical procedure. The glass and the coating applied thereto also are non-reactive with the human body and pose no danger to the patient.

As with laparoscopes existing before Surgical Image's Laparoscope, the optic tube which fits within the outer tube is fabricated from stainless steel. Although this tube is covered at the tip by the distal window and therefore does not come into contact with internal body organs, it is still fabricated from a material that is non-reactive with human tissue and which poses no danger to the patient.

As with laparoscopes existing before Surgical Image's Laparoscopes, the distal fiber which transmits light from the light source through the fiber cone, around the optic tube, and on to the surgical area is fabricated from optical fibers and sealed at the distal end with adhesive. Nevertheless, these materials are again non-reactive with human tissue and pose no danger to the patient.

As with laparoscopes existing before Surgical Image's Laparoscopes, the eye shield or camera connection adapter is made from acetal plastic or an FDA accepted equivalent.

119

{1}

As with laparoscopes existing before Surgical Image's Laparoscopes, all surfaces of the Surgical Image's Laparoscope are smooth and polished or bead blasted to provide a cosmetically accepted surface. The end of the instrument that is inserted into the human body through an incision is blunt or rounded with no sharp edges.

The Surgical Image's Laparoscope is a totally benign instrument that in and of itself does not and cannot put a patient at any risk of injury when it is used for its intended purpose by properly trained and qualified personnel.

The Surgical Image's Laparoscope is substantially equivalent to laparoscopes that are manufactured by such companies as Olympus Corporation, Richard Wolf Medical Instruments Corporation, Karl Storz Endoscopy, Smith & Nephew Dyonics, and Stryker Endoscopes, and which have now been in the marketplace in the United States and throughout the world for many years.

Zelda Balazs
President

120.