← Product Code [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ) · K970754 # INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP (K970754) _Innerdyne, Inc. · GCJ · Apr 21, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K970754 ## Device Facts - **Applicant:** Innerdyne, Inc. - **Product Code:** [GCJ](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GCJ.md) - **Decision Date:** Apr 21, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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. The subject Open-Step® device is configured to be used with the open laparoscopic surgical approach. ## Device Story Open-Step® is an access device for open laparoscopic surgery. It consists of a cannula and a locking adjustable cone. Surgeon makes an incision, verifies cavity entry with a finger, and inserts the device. The adjustable cone is slid into the incision to create a seal. The cannula provides a port for diagnostic and operative instruments. The device allows for adjustable depth positioning within the cavity. It facilitates access without the need for a radially expanding sheath or access needle used in other Step® family products. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on design, material, and functional comparison to predicate devices. ## Technological Characteristics Medical grade materials; components molded and machined; assembled via adhesives, welds, and mechanical interlocks. Features a cannula barrel with a locking adjustable cone. Manual insertion and operation. ## Regulatory 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](/device/K943253.md), [K940232](/device/K940232.md), [K950632](/device/K950632.md), and [K950658](/device/K950658.md)) - Ethicon ENDOPATH Blunt-Tip Disposable Surgical Trocar - United States Surgical Corporation BLUNTPORT Disposable VERSAPORT Trocar System - Hasson Stable Access Cannula (SAC) of Marlow Surgical Technologies, Inc. - Core Dynamics Entree Blunt Tip Trocar & Adaptor ([K932020](/device/K932020.md)) - Linvatec Hasson Open Laparoscopy Cannula ([K942447](/device/K942447.md)) ## Related Devices - [K982417](/device/K982417.md) — INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP · Innerdyne, Inc. · Oct 7, 1998 - [K172038](/device/K172038.md) — Trocar · Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd · Oct 27, 2017 - [K981941](/device/K981941.md) — MULTAPORT CANNULA REDUCER AND ACCESSORIES · Dexide, Inc. · Jul 29, 1998 - [K150705](/device/K150705.md) — FloShield 10mm Endoscopic Cannula and Conical Blunt Obturator, FloShield 10mm Endoscopic Cannula, FloShield 10mm Conical Blunt Obturator · Minimally Invasive Devices, Inc. · Apr 13, 2015 - [K152565](/device/K152565.md) — Auto Suture Locking Trocar · Covidien · Oct 9, 2015 ## Submission Summary (Full Text) {0} APR 21 1997 K970754 # SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION Submitter: InnerDyne, Inc. 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116 (801) 350-3600 Date Prepared: 28 February 1997 Contact: Rick Gaykowski Vice President, Regulatory Affairs and Quality Assurance Classification Name: Dilator (Other) Common/Usual Name: Percutaneous Dilator with Locking Cone Trade/Proprietary Name: InnerDyne Step Trocar Expandable Port, "Open-Step®" 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. The subject Open-Step® system configuration allows the user to access the desired region through open laparoscopic surgical techniques for passage of small diagnostic instruments accomplished without a radially expanding sheath. An incision is made at the target insertion site using standard technique. The surgeon places a finger into the previously created incision to ensure that a free cavity has been entered. The Open-Step® access device is inserted into the incision with the adjustable cone secured against the bottom of the cannula/dilator. The adjustable cone is slid down the cannula assembly and into the incision, helping to form an adequate seal. Position the desired cannula depth into the cavity by advancing or retracting the cannula assembly. The dilator cannula can then be removed from the lumen of the cannula while leaving the cannula inserted through the tissues creating an access/passage route for 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 InnerDyne, Inc. Open-Step® Device Premarket Notification Page-10 {1} assembled and secured by adhesives, welds, and mechanical interlocks. The subject InnerDyne, Inc., Open-Step® device is substantially equivalent to the predicate InnerDyne, Inc., Step® devices (K943253, K940232, K950632, and K950658), as well as the Ethicon, ENDOPATH, Blunt-Tip Disposable Surgical Trocar, the United States Surgical Corporation, BLUNTPORT, Disposable VERSAPORT Trocar System for Open Laparoscopy, the Hasson Stable Access Cannula (SAC) of Marlow Surgical Technologies, Inc., the Core Dynamics Entree Blunt Tip Trocar & Adaptor (K932020), and the Linvatec Hasson Open Laparoscopy Cannula (K942447). The subject Open-Step® device is similar to the referenced predicates in size, function, product dimensions and general indications for 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. The subject Open-Step® device is configured to be used with the open laparoscopic surgical approach. The basic design principles for the subject InnerDyne, Inc., Open-Step® 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., Open-Step® 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. Additionally, the Open-Step® device is substantially equivalent to the aforementioned competitive predicates in basic principles of operation as well. The subject device differs from the referenced Step® predicates only through elimination of the reducer cap, expandable sleeve, access needle, presentation style of the product, and adoption of a locking adjustable cone which is attached to the cannula barrel. From the foregoing, we conclude that the Open-Step® device is as safe and effective as currently marketed devices for the stated indications. InnerDyne, Inc. Open-Step® Device Premarket Notification Page-11 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K970754](https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K970754) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-b%E2%80%94diagnostic-devices/GCJ/K970754