(43 days)
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 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.
This document is a Summary of Safety & Effectiveness Information for a medical device called the InnerDyne Step Trocar Expandable Port, "MiniStep®". It's a 510(k) submission, comparing the MiniStep® to existing predicate devices to demonstrate substantial equivalence.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided text, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum insertion force, specific clinical outcomes) are not explicitly stated. Instead, the submission focuses on substantial equivalence to predicate devices. The "performance" is largely described in qualitative terms and by referencing studies that show similarity or improvement over existing methods.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device operates without causing undue harm; leaves minimal tissue damage. | "Significantly smaller defects than conventional trocars with reduced tissue ecchymosis." "Should reduce the risk of trocar related complications." |
| Effectiveness: Provides temporary dilation access for surgical instruments; allows for primary and secondary sticks. | "Successfully provides the access for instruments employed in surgical procedures; laparoscopic cholecystectomy has been used as typical." "Both the primary and secondary sticks have been made without difficulty." |
| Functionality: Similar design, configuration, materials, principles of operation, and indications for use as predicate devices. | "Similar design principles," "product configuration, composition, and utilized materials are similar." "Similar basic principles of operation," "similar insertion technique, indications for use, contraindications for use, warnings and precautions." |
| Working Diameter: Capable of creating ports down to 2mm. | Differs from predicates "only in consideration of lowering the working diameter range down to 2mm from the previously cleared 5mm size." |
| Anchoring: Device remains securely in place during procedures. | "The radial expansion achieved during dilation of product sizes provides effective anchoring within the tissue throughout the procedure." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: The primary testing mentioned utilized porcine models. The text does not specify a numerical sample size (e.g., how many pigs, how many insertions).
- Data Provenance: The studies mentioned were conducted at the University of California, San Francisco. The studies appear to be prospective in nature, as they involve actively using the device in a controlled setting (porcine models, clinical overviews of user experiences). The study examining tissue defects by Drs. Bhoyrul, Mori, and Way seems to be a specific prospective study comparing the Step® devices with conventional trocars.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Study on Tissue Defects: Conducted by Drs. Bhoyrul, Mori, and Way at the University of California, San Francisco. The text does not explicitly state their specializations (e.g., "radiologist with 10 years of experience") but implies they are medical professionals and researchers involved in surgical or related fields, given their focus on "tissue defects" and "trocar related complications." The number of experts stated is three.
- Clinical Overviews: "Additional clinical overviews have been published within the literature by other users outlining their experience with Step® products." The number and specific qualifications of these "other users" are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The text does not describe an adjudication method for establishing ground truth, such as 2+1 or 3+1 consensus. The studies mentioned appear to be direct observations and comparisons by the researchers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC comparative effectiveness study was not done. This document is for a mechanical surgical device (trocar), not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. As mentioned above, this is a mechanical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the specific study mentioned by Drs. Bhoyrul, Mori, and Way, the ground truth appears to be based on:
- Direct observation and measurement of tissue defects: This would likely involve macroscopic and potentially microscopic examination of the tissue after device use, which is a form of pathology/histology or direct anatomical assessment.
- Clinical assessment of ecchymosis: This is a form of outcomes data related to tissue trauma.
- Clinical observation of functionality and ease of use: In porcine models ("access for instruments," "primary and secondary sticks made without difficulty").
For the "additional clinical overviews," the ground truth would be based on clinical experience and outcomes data reported by other users.
8. The sample size for the training set:
- Not applicable / Not mentioned. This document describes a surgical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable / Not mentioned. (See point 8).
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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.
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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.
§ 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.