(287 days)
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments consists of a handle, shaft and insert. The insert contains an end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments:
Based on the provided 510(k) Summary (K151036), this document describes a medical device modification (design change from single-piece to take-apart) rather than an AI/algorithm-based product. Therefore, many of the requested points related to AI/algorithm studies (like human-in-the-loop performance, training sets, etc.) are not applicable to this submission.
The acceptance criteria and supporting study are focused on ensuring the modified physical device maintains its safety and effectiveness compared to its predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard / Test / FDA Guidance) | Reported Device Performance |
|---|---|---|
| Instrument strength (resistance to breakage/flexing) | Strength Tests | PASS |
| Inadvertent disassembly (during use) | Pull Strength Test | PASS |
| Ease of disassembly/reassembly (user convenience) | Force Tests | PASS |
| Handle reusability | Reliability Test | PASS |
| Handle compatibility with existing shafts and inserts | Handle ability to connect to worst case shafts and inserts | PASS |
| Device cleanability and sterilizability | AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665 | PASS |
| Biocompatibility of device materials | ISO 10993 | PASS |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes (e.g., number of instruments tested) for each non-clinical performance test. It only states that the tests were conducted and the device "PASSED" the criteria.
Data provenance: Not explicitly stated, but these are typically retrospective non-clinical engineering and laboratory tests conducted by the manufacturer, CareFusion 2200 Inc. The country of origin of the data would likely be the location where CareFusion performs its product testing, which can be global, but typically for FDA submissions, the testing adheres to international (ISO) and US (AAMI, ANSI) standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable. The "ground truth" for physical device performance tests like strength, pull, force, reliability, cleaning validation, and biocompatibility is established by engineering specifications, recognized national and international standards (e.g., AAMI, ANSI, ISO), and regulatory requirements, not by expert medical opinion in the same way an AI model's diagnostic accuracy might be judged. These tests are objective measurements against defined thresholds.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's ambiguity in classifying clinical data for ground truth establishment. For the objective non-clinical performance tests mentioned, the results are typically quantitative measurements that either meet or fail pre-defined acceptance limits based on standards and engineering requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "N/A - No clinical tests were conducted for this submission." MRMC studies are typically for evaluating diagnostic accuracy or clinical effectiveness, often involving human readers and AI assistance, neither of which is present in this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (referring to an algorithm's performance) was not done. This submission is for a physical surgical instrument, not an AI or algorithm-based device.
7. Type of Ground Truth Used
The "ground truth" for the performance tests undertaken are:
- Engineering Specifications and Design Requirements: For parameters like instrument strength, inadvertent disassembly, ease of disassembly/reassembly, handle reusability, and handle compatibility. These are defined by the manufacturer based on expected operational loads and user interaction.
- National and International Standards: For aspects like cleanability and sterilizability (e.g., AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665) and biocompatibility (ISO 10993). These standards provide objective criteria and methodologies for testing.
8. Sample Size for the Training Set
This question is not applicable. There is no AI/algorithm, so there is no training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no AI/algorithm and thus no training set.
§ 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.