STRYKER SAPHENOUS VEIN HARVEST SCOPE

K964930 · Stryker Endoscopy · GCJ · Feb 28, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K964930
• Device Name: STRYKER SAPHENOUS VEIN HARVEST SCOPE
• Applicant: Stryker Endoscopy
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Stryker Saphenous Vein Harvest Laparoscope is intended for use in endoscopic saphenous vein harvesting procedures.

Device Story

Rigid endoscope used for visualization during saphenous vein harvesting; provides optical access to surgical site. Device inputs: ambient light transmitted via fiber optics; outputs: visual image for surgeon. Used in OR by surgeons. Facilitates minimally invasive vein harvesting; reduces surgical trauma compared to open procedures. Compatible with Ethicon Subcu-Retractor.

Clinical Evidence

Bench testing only. Biocompatibility demonstrated per Tripartite scheme, ISO 10993, and G95-1. Cleanability, disinfection, and re-sterilization validated for EtO, Cidex, and Steris processes. Autoclavable models validated per AAMI guidelines.

Technological Characteristics

Rigid endoscope. Materials: stainless steel, plated brass, anodized aluminum, optical glass, adhesives, braze alloys. Light transmission via fibers. Reusable. Sterilization: 100% EtO, Cidex, Steris, or autoclave per AAMI guidelines. Biocompatibility: ISO 10993, G95-1.

Indications for Use

Indicated for use in endoscopic saphenous vein harvesting procedures in patients requiring vein graft harvesting for surgical bypass.

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

• Snowden Pencer Saphenous Vein Endoscope

Reference Devices

• Stryker 5mm Laparoscopes
• Ethicon Subcu-Retractor

Submission Summary (Full Text)

{0}

Stryker

K964930

2590 Walsh Avenue
Santa Clara, CA 95051

[phone]
[phone] Fax

FEB 28 1997

Device Name: Stryker Saphenous Vein Harvest Laparoscope
Classification: Rigid Endoscope
Sponsor: Stryker Endoscopy
2590 Walsh Ave.
Santa Clara, CA 95051
FDA Registration # 2936485

Regulatory Class: Class II

Safety and Effectiveness Summary:

The Stryker Saphenous Vein Harvest Laparoscope is identical in terms of materials and modes of construction, optical performance and safety to the existing line of Stryker 5mm Laparoscopes, differing only in working length. The Stryker Saphenous Vein Harvest Laparoscope is substantially equivalent to the Snowden Pencer Saphenous Vein Endoscope in intended use and is compatible for use with the Ethicon Subcu-Retractor for this purpose.

Materials of construction coming into patient contact, including structural components and cannula components which are of stainless steel, plated brass, and anodized aluminum, joined with adhesives and braze alloys, are demonstrated to be bio-compatible per the Tripartite scheme, and/or ISO 10993 and G95-1. The optical system consisting of optical glass, adhesives and coated brass components for spacing and mounting, and light transmission fibers are identical to those currently used in Stryker cleared laparoscopes.

Stryker Saphenous Vein Harvest laparoscopes are reusable, and sold non-sterile, and are validated for cleanability, disinfection and re-sterilization. Sterilization methods include 100% EtO, Cidex® and Steris® processes. Those endoscopes labeled as “Autoclavable” will be validated for durability, cleanability, and sterilizability under specified cycles per appropriate AAMI guidelines.

The Stryker Saphenous Vein Harvest Laparoscopes present no additional safety or effectiveness issues when compared to current Stryker laparoscopes and Snowden Pencer Saphenous Vein Endoscopes. Therefore, the Stryker Saphenous Vein Harvest Laparoscopes are substantially equivalent to these devices.

Bob Dahla
R&D Project Engineer

10