INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP

K961430 · Innerdyne, Inc. · GCJ · May 28, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961430
• Device Name: INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP
• Applicant: Innerdyne, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 28, 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 tissue; needle removed after insufflation. Dilator cannula with blunt obturator and pneumo valve inserted through sheath; sheath expands radially to accommodate cannula and dilate surrounding tissue. Obturator removed to provide sealed port for instruments. Allows sequential placement of different diameter cannulas through same sheath. Used by surgeons in OR. Benefits include smaller tissue defects and reduced ecchymosis compared to conventional trocars; provides effective anchoring via radial expansion.

Clinical Evidence

Bench testing and porcine model studies provided. Porcine models demonstrated effective access and tissue anchoring. Comparative study by Bhoyrul, Mori, and Way (UCSF) evaluated residual tissue defects; observed significantly smaller defects and reduced tissue ecchymosis compared to conventional trocars. Literature reviews from other users support safety and efficacy.

Technological Characteristics

Expandable dilator sheath assembly; Veress-type needle; blunt obturator; dilation cannula; pneumo valve. Medical grade materials; components secured via adhesives, welds, and mechanical interlocks. Manufactured under GMP/ISO conditions. Radial expansion mechanism for tissue dilation.

Indications for Use

Indicated for patients undergoing minimally invasive surgery requiring temporary access to abdominal or thoracic cavities for diagnostic or operative 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 Step® devices (K943253, K940232, K950632, K950658)
• Imagyn Microlap Introducer (K943810)
• USSC AutoSuture MiniSite Introducer

Submission Summary (Full Text)

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MAY 28 1996
K961430

# SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION

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

Date Prepared: 31 March 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, "MiniStep®"

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., MiniStep® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), the Imagyn Microlap Introducer, K943810, and the USSC AutoSuture MiniSite Introducer. The subject MiniStep® device is similar to the referenced predicates in size, function, product dimensions and indications for use.

InnerDyne, Inc.
MiniStep® Device Premarket Notification
Page-7

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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., MiniStep® 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. In comparative terms of working channel diameter, the subject MiniStep® device is substantially equivalent to the Imagyn and USSC predicates as well. 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 in consideration of lowering the working diameter range down to 2mm from the previously cleared 5mm size.

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 by Drs. Bhoyrul, Mori, and Way at the University of California, San Francisco. They have observed that the Step® device leaves significantly smaller defects than conventional trocars with reduced tissue ecchymosis. They also conclude that the use of Step® 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.
MiniStep® Device Premarket Notification
Page-8