(43 days)
No
The device description focuses on mechanical components and their function for surgical access. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as providing temporary dilation access for surgical instruments during minimally invasive surgery; it does not treat or cure a disease or condition.
No.
The device is intended for providing access for diagnostic and operative instruments into the abdominal and thoracic cavities, not for performing the diagnosis itself. Its purpose is to create a sealed port for the passage of instruments, some of which may be diagnostic.
No
The device description clearly details physical components such as a dilator sheath assembly, access needle, blunt obturator, dilation cannula, and pneumo valve, indicating it is a hardware device used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating temporary access ports during minimally invasive surgery to allow passage of diagnostic and operative instruments into the abdominal and thoracic cavities. This is a surgical access device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a mechanical device for tissue dilation and instrument passage. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of reagents, assays, or any process related to in vitro testing.
The device is clearly designed for surgical access and manipulation within the body, which falls under the category of surgical instruments or accessories, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal/thoracic cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K943253, K940232, K950632, K950658
Reference Device(s)
Imagyn Microlap Introducer, K943810, USSC AutoSuture MiniSite Introducer
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
SUMMARY OF SAFETY & EFFECTIVENESS INFORMATION
InnerDyne, Inc. Submitter: 5060 West Amelia Earhart Drive Salt Lake City, Utah 84116 (801) 350-3600
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.
1
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.