(49 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 subject Open-Step® device is configured to be used with the open laparoscopic surgical approach.
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 assembled and secured by adhesives, welds, and mechanical interlocks.
This document is a 510(k) submission for a medical device (InnerDyne Open-Step®), which focuses on demonstrating substantial equivalence to existing devices rather than presenting a study with specific acceptance criteria and detailed performance metrics in the way a clinical trial or algorithm validation study would for a diagnostic or AI device.
Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and expert involvement are not applicable in this context. The document does not describe a study to prove the device meets specific performance criteria in terms of accuracy, sensitivity, specificity, etc., as it's a device for surgical access, not a diagnostic tool or an AI algorithm.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | "The Open-Step® device is as safe and effective as currently marketed devices for the stated indications." |
(This is a high-level conclusion based on substantial equivalence, not detailed quantitative metrics.) |
| Material Quality | "Assembled from medical grade materials under GMP and ISO conditions."
"Components are molded and machined by qualified suppliers." |
| Design Principles | "Similar basic design principles for the subject InnerDyne, Inc., Open-Step® device and the predicate Step® devices... remain essentially unchanged." |
| Product Configuration, Composition, Materials | "Similar in each of the products [subject and predicate devices]." |
| Principles of Operation | "Similar insertion technique, indications for use, contraindications for use, warnings and precautions" to predicate devices. |
| Function, Product Dimensions, General Indications for Use | "Similar to the referenced predicates." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not applicable. No specific test set in the sense of a clinical or observational study is described. The demonstration of safety and effectiveness relies on substantial equivalence to existing devices through comparison of design, materials, and intended use.
- Data Provenance: Not applicable. No specific data set is mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. Ground truth, in the context of device performance testing, is not established through expert consensus as there's no diagnostic or measurement outcome to evaluate this way.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. This is not
the type of device or regulatory submission that would typically involve an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a physical surgical tool, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is the established safety and effectiveness profile of the predicate devices. The submission asserts that the Open-Step® device is substantially equivalent to these predicates, implying it shares their safety and effectiveness characteristics. This isn't a "ground truth" derived from patient outcomes or pathology in a study specific to the Open-Step® device.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This document does not describe an AI/ML algorithm or a dataset used for training.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable. As there is no training set mentioned, this question is irrelevant to the provided text.
Summary of the Document's Approach:
The document leverages the concept of substantial equivalence to existing, legally marketed predicate devices (K943253, K940232, K950632, K950658, and others). The "study" here is essentially a comparison of the new Open-Step® device to these predicates based on:
- Similarities in Design Principles: The fundamental way the device is constructed and intended to operate.
- Similarities in Function, Product Dimensions, and General Indications for Use: What it does, its size, and its intended applications.
- Similarities in Material Composition: The types of materials used.
- Similarities in Operating Principles: How it's used, including insertion technique, indications, contraindications, warnings, and precautions.
- Minor Differences: Identifying that the differences (e.g., elimination of reducer cap, expandable sleeve, access needle, and adoption of a locking adjustable cone) do not raise new questions of safety or effectiveness.
The conclusion is that, because of these similarities and the nature of the differences, the Open-Step® device is as safe and effective as the predicate devices already on the market. This is a common pathway for regulatory clearance of medical devices, especially for those that are evolutions of existing designs, rather than novel technologies requiring extensive clinical trial data for initial clearance.
§ 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.