INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP

K961940 · Innerdyne, Inc. · GCJ · Jul 10, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961940
• Device Name: INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
• Applicant: Innerdyne, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Step® family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick.

Device Story

Expandable dilator sheath assembly with integrated Veress-type needle; used for minimally invasive surgery. Device inserted into abdominal/thoracic cavity; needle removed after insufflation. Dilator cannula assembly (blunt obturator, dilation cannula, pneumo valve) inserted through sheath lumen; sheath expands radially to accommodate cannula and dilate surrounding tissue. Obturator removed to provide sealed port for diagnostic/surgical instruments. Allows sequential placement of different diameter cannulas through same sheath. Used in OR by surgeons. Benefits include smaller tissue defects compared to conventional trocars and reduced tissue ecchymosis.

Clinical Evidence

Bench testing and porcine model studies performed. Porcine studies demonstrated effective access for laparoscopic cholecystectomy and tissue anchoring. Independent literature indicates Step® devices leave significantly smaller tissue defects and reduced tissue ecchymosis compared to conventional trocars, potentially reducing trocar-related complications.

Technological Characteristics

Expandable dilator sheath assembly; medical grade materials; assembly via adhesives, welds, and mechanical interlocks. Features internal valve system. Radial expansion mechanism for tissue dilation. No electronic components or software.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring temporary dilation access to abdominal or thoracic cavities for instrument passage.

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

• InnerDyne, Inc., Step® devices (K943253)
• InnerDyne, Inc., Step® devices (K940232)
• InnerDyne, Inc., Step® devices (K950632)
• InnerDyne, Inc., Step® devices (K950658)

Reference Devices

• InnerDyne, Inc., MiniStep® device

Submission Summary (Full Text)

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k961940

# SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION

Submitter: InnerDyne, Inc.
5060 West Amelia Earhart Drive
Salt Lake City, Utah 84116
[phone]
JUL 10 1996

Date Prepared: 17 May 1996

Contact: Rick Gaykowski
Director, Regulatory Affairs
and Quality Assurance

Classification Name: Dilator (Other)
Common/Usual Name: Percutaneous Dilator With Sheath
Trade/Proprietary Name: InnerDyne Step Trocar Expandable Port, "OneStep®"

The Step® family of products consist of an expandable dilator sheath assembly with an access (Veress-type) needle mounted within its lumen. The tubular member of the dilator sheath is configured so as to be axially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expanding dilator sheath/needle assembly is inserted through the abdominal/thoracic tissue into the abdominal/thoracic cavity. After insufflation of the cavity, (if deemed necessary), the access needle is removed. The dilator cannula assembly, which consists of a blunt obturator, dilation cannula, and a pneumo valve, is inserted through the lumen of the dilator sheath which expands radially to accommodate it. This process in turn, radially expands the walls of the surrounding tissue. Following dilation the obturator is removed, leaving the expanding dilation sheath and dilator cannula in place to provide a sealed port for passage of diagnostic and surgical instruments.

This system configuration allows the user to initially place a small diameter dilator cannula for passage of small diagnostic instruments. The dilator cannula can then be removed from the lumen of the dilator sheath while leaving the sheath inserted through the tissues. A larger diameter dilation cannula can then be inserted through the dilator sheath to create a larger port for passage of the larger operative instruments.

The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

The subject InnerDyne, Inc., OneStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658). The subject OneStep® device is similar to the referenced predicates in size, function, product dimensions and indications for use.

InnerDyne, Inc.
OneStep® Device Premarket Notification
Page-9

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The Step® family of products are intended for use during minimally invasive surgery for temporary dilation access to the abdominal and thoracic cavities for passage of diagnostic and operative instruments into the abdominal and thoracic cavities. The device is configured to be used as either a primary or secondary stick.

The basic design principles for the subject InnerDyne, Inc., OneStep® device and the predicate Step® devices (K943253, K940232, K950632, and K950658) are similar, and remain essentially unchanged from information previously provided to the Agency. The product configuration, composition, and utilized materials are similar in each of the products. The principles of operation for the InnerDyne, Inc., MiniStep® device, and the predicate Step® devices (K943253, K940232, K950632, and K950658) are similar. That is, each of these products employs a similar insertion technique, indications for use, contraindications for use, warnings and precautions. The subject device differs from the referenced Step® predicates only with incorporation of an internal valve system, elimination of the reducer cap, and presentation style of the product.

The Step® device design has been widely tested in porcine models to provide the access for instruments employed in surgical procedures; laparoscopic cholecystectomy has been used as typical. Since the device incorporates a Veress-type needle for access, both the primary and secondary sticks have been made without difficulty. The radial expansion achieved during dilation of product sizes provides effective anchoring within the tissue throughout the procedure.

The residual tissue defects from the use of the Step® devices and the defects left by standard surgical trocars have been studied and published by independent investigators, who observed that the Step® device leaves significantly smaller defects than conventional trocars with reduced tissue ecchymosis. It has also been independently expressed that use of Step® devices should reduce the risk of trocar related complications. Additional clinical overviews have been published within the literature by other users outlining their experience with Step® products.

From the foregoing, we conclude that the Step® device is as safe and effective as currently marketed devices for the stated indications.

InnerDyne, Inc.
OneStep® Device Premarket Notification
Page-10