S-52 ELECTRONIC VIDEO LAPAROSCOPE

K962651 · Del Medical Systems Corp. · GCJ · Sep 30, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962651
• Device Name: S-52 ELECTRONIC VIDEO LAPAROSCOPE
• Applicant: Del Medical Systems Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 30, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The S-52 Electronic Video Laparoscope is intended for use in laparoscopic procedures.

Device Story

S-52 Electronic Video Laparoscope; distal end CCD (Charged-coupled Device) technology. Input: optical images captured via distal CCD sensor. Transformation: conversion of optical signals to electronic video output for display. Usage: clinical/surgical settings; operated by trained physicians. Output: real-time video feed for visualization during laparoscopic procedures. Clinical utility: enables minimally invasive visualization of internal anatomy; assists physician in surgical navigation and decision-making. Benefit: provides high-quality video guidance for laparoscopic surgery.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design, technological, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Distal end CCD (Charged-coupled Device) laparoscope. Rigid form factor. Electronic video imaging system. No specific materials or software algorithms described.

Indications for Use

Indicated for use by trained physicians in laparoscopic 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

• Fujinon EVL-F (K902197/B, K912859/A)

Reference Devices

• Smith & Nephew distal end CCD devices
• Welch Allyn distal end CCD devices

Submission Summary (Full Text)

{0}

K962651

Revised Summary for S-52
S10(k)
Summary (Revision 1)

SEP 30 1996

Del Medical Systems feels the S-52 Electronic Video Laparoscope is substantially equivalent to the EVL-F marketed by Fujinon under K-902197/B and K912859/A in terms of technology and intended use. DMS also feels that the device is similar to the device marketed by Smith and Nepherw in terms of technology, shape, size and composition and intended use.

The design of the S-52 is virtually identical to the Smith & Nephew device and comparative to the Fujinon device. Since the design is comparable, technology virtually identical, the specifications, apart from, the flexible vs rigid issue, which makes no difference when operated by a trained physician the devices are very similar, and the intended use the same. DMS feels that these minor differences have no impact on the safe use and/or effectiveness of the device.

The wide use of the same or very similar instruments has lead to the safe use of the device in many practitioner's hands.

Confirmation of Substantial Equivalence Determination made by Del Medical Systems. The device is virtually identical to the devices in commercial distribution, such as the Fujion filed under EVL-F- K902197/B and K912859/A, which the FDA has reviewed and sent Fujinon the appropriate paperwork, allowing for the marketing of this product. We also cite Smith & Nephew and Welch Allyn as makers/marketers of "distal end CCD devices" (Charged-coupled Device Laparoscopes) as other devices of comparison. Each of the predicate devices has the same intended use.

RECEIVED
27 SEP 96 11 11
FDA/CORN/COE/DMC