(56 days)
The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or without visualization for primary and secondary insertions.
The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, B5ST, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) are sterile, single patient use instruments consisting of a radiolucent sleeve (cannula) and obturators in sizes ranging from 5-12 mm in diameter. There different obturators; Bladeless, Dilating Tip (Bladed) and Blunt Tip. The bladeless obturator contains a clear, tapered optical element, and when used with an endoscope provides visibility of individual tissue layers during insertion. The Dilating Tip (Bladed) obturator has a sharp, flat-bladed tip and spring-loaded shield. The shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The Blunt Tip obturator has a blunt plastic tip which gently moves aside any viscera that may be adjacent to abdominal or thoracic wall.
The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm bladeless trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Trocars with Optiview Technology incorporates a design enhancement that reduces the incidence of trocar induced endoscope lens smudging during endoscope insertion.
The Reprocessed Sleeves are sterile, single patient use devices with a radiolucent sleeve (cannula). The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize qas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
The provided text is a 510(k) summary for the reprocessing of endoscopic trocars and sleeves. It outlines the device description, indications for use, and a comparison to predicate devices, focusing on the equivalence of the reprocessed devices to the original, new devices. However, the document does NOT contain information about a study proving the device meets acceptance criteria in the way one might expect for a digital health or AI/ML-enabled medical device, as it's not evaluating algorithm performance.
Instead, this document describes the validation of reprocessing for a physical medical device. The "acceptance criteria" here refer to the performance standards that the reprocessed physical device must meet to demonstrate it is "at least as safe and effective" as the original, new device.
Therefore, I will interpret the request in the context of the provided document, addressing the closest equivalents to the requested information. It's important to note that many of the requested fields (e.g., number of experts for ground truth, MRMC study, training set sample size) are not applicable to the type of device and study described in this 510(k) summary.
Acceptance Criteria and Study for Reprocessed Endoscopic Trocars and Sleeves
The document describes the regulatory submission for the reprocessing of Endoscopic Trocars and Sleeves, asserting their substantial equivalence to predicate (new) devices. The acceptance criteria and the "study" proving this equivalence are based on a set of bench and laboratory tests designed to demonstrate that the reprocessed devices maintain their original performance, safety, and effectiveness.
1. A table of acceptance criteria and the reported device performance
The document does not provide a quantitative table of acceptance criteria and reported numerical performance values for each test. Instead, it lists the types of performance tests conducted and then makes a general statement about their outcome. The implicit acceptance criterion for each test is that the reprocessed device performs comparably to the new device and maintains its safety and effectiveness.
| Category | Specific Test / Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatibility testing. (Implicit criterion: no unacceptable biological risk introduced by reprocessing). | Conducted. (Implicitly: The reprocessed devices meet biocompatibility standards and are as safe as the predicate devices). |
| Reprocessing Valid. | Validation of Reprocessing (e.g., cleaning efficacy, material compatibility after reprocessing cycles). (Implicit criterion: reprocessing effectively cleans and does not degrade the device below performance standards, with a limit of 1 reprocessing cycle). | Conducted. The devices are reprocessed no more than one (1) time. Each reprocessed device is tracked and rejected if it reaches the maximum number of cycles. Reprocessing is restricted to devices not previously reprocessed by others. (Implicitly: Validated as effective). |
| Sterilization Valid. | Sterilization Validation (e.g., sterility assurance level, material compatibility with sterilization method). (Implicit criterion: device maintains sterility after reprocessing and sterilization without degradation). | Conducted. (Implicitly: Devices are sterile by Ethylene Oxide and maintain their integrity). |
| Functional Performance | - Device Aesthetics |
- Peak Insertion Force
- Stability Plug Clip Integrity
- Stability Plug Clamp Integrity
- Trocar Leak Test
- Obturator Engagement
- Cannula Housing Integrity
- Obturator Housing Integrity
- Cannula Sleeve Integrity
- Insertion/Withdrawal Forces - Obturator to Cannula
- Device Integrity
- Peak Insertion Force
- Obturator Engagement
- Shield Lock Engagement Force
- Blade Shield Engagement | Bench and laboratory testing were conducted to demonstrate performance. The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended. |
| Aging/Durability | (Implicit criterion: device functions after reprocessing and maintains properties for intended shelf life). | Reprocessed no more than one (1) time; implies that performance is maintained for this single reprocessing cycle. |
| Packaging Validation | Packaging Validation. (Implicit criterion: packaging maintains sterility and device integrity). | Conducted. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each of the conducted tests (e.g., number of reprocessed trocars tested for leak, insertion force, etc.).
The data provenance is from bench and laboratory testing conducted by Stryker Sustainability Solutions. It is prospective in the sense that the tests were specifically performed to support this 510(k) submission, not retrospectively analyzed from existing data. The country of origin for the testing is not explicitly stated but can be inferred as the United States, given the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device and study. The "ground truth" for a reprocessed physical device is established by engineering specifications, material properties, and functional performance benchmarks derived from the original, new predicate devices. It does not involve expert readers reviewing images or clinical data for diagnosis. The "experts" involved are likely engineers, quality assurance personnel, and regulatory affairs specialists who designed and executed the tests and evaluated the results against objective performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing medical images) to establish a consensus ground truth. For physical device performance testing, acceptance is determined by meeting pre-defined quantitative or qualitative engineering specifications, not human consensus on a clinical outcome.
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
This question is not applicable. This is a submission for a reprocessed physical medical device, not an AI/AI-assisted device. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications and functional performance characteristics of the original, new predicate devices. The reprocessed devices are tested to ensure they maintain these validated characteristics. This includes:
- Physical dimensions and integrity
- Mechanical function (e.g., insertion force, leak tests, engagement of components)
- Material properties (implied by biocompatibility and sterilization validation)
- Sterility
Essentially, the ground truth is the "performance profile of a new, unused device."
8. The sample size for the training set
This question is not applicable. This is a physical medical device undergoing reprocessing validation, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.