(261 days)
The Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing are used in conjunction with the CrossFlow Integrated Arthroscopy Pump (K123441) to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle, and wrist joint cavities during diagnostic and operative arthroscopic procedures.
The Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing (hereafter referred to as "proposed device") is an accessory to the FDA-cleared CrossFlow Integrated Arthroscopy Pump, cleared under K123441, which provides fluid to the surgical site. CrossFlow Day-Use Inflow Cassette Tubing includes an inflow cassette with spikes for irrigation fluid units and connector. The Patient-Use Tubing includes a connector that attaches the Patient-Use Tubing to Day-Use Tubing, and luer-lock connector that attaches the Patient-Use Tubing to an inflow cannula. The Stryker CrossFlow Day-Use Inflow Cassette Tubing is a 24-hour multi-patient device that remains in the arthroscopy pump throughout a day of cases (no more than 10 cases, 8 hours of active use, or 24 hours from the point of first use). Day-Use Inflow Cassette Tubing provides an alternate to complete replacement of the irrigation tubing after each patient. The backflow check valve of the Patient-Use Tubing prevents contaminated fluid from reaching the Day-Use Tubing and permits its use for a day of cases. Patient-Use Tubing is a single-use device that is discarded after every case.
The provided text describes the regulatory clearance for the Stryker® CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing. This device is an irrigation tubing set used during arthroscopic procedures. The documentation focuses on demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission.
The "acceptance criteria" and "device performance" in this context refer to the successful completion of various bench performance tests designed to ensure the safety and effectiveness of the device, particularly regarding its multi-patient use claim and prevention of cross-contamination.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly that the device "Pass"ed the test, indicating it met the design specifications and applicable standards. The specific quantitative acceptance criteria are not detailed in the provided summary but are generally implied by the nature of the tests.
| Test | Description | Reported Device Performance |
|---|---|---|
| Microbial Ingress | Confirms ability to maintain sterility of inner tubing during lifetime of device | Pass |
| Day-Use Inflow Cassette Tubing Disinfection | Confirms safety of the device over multiple uses by achieving disinfection of the Day-Use Tubing to Patient-Use Tubing connection | Pass |
| Backflow Valve | Confirms no cross contamination occurs between cases by analyzing if microorganisms can breach the backflow valve | Pass |
| Backflow Valve Limit of Quantification | Measures limit of quantification for backflow valve test method | Pass |
| Backflow Valve Time to Close | Ensures adequate closure of backflow valve to prevent backwards movement of fluid | Pass |
| Backflow Valve Failure | Confirms complete backflow valve failure is not a risk to the patient | Pass |
| Regurgitation | Ensures fluid moving in the opposite direction to the normal direction does not pose risk of cross contamination | Pass |
| General requirements and performance | Verified all components against their design specifications | Pass |
| Viral Pathogens | Confirms no cross contamination occurs between cases by analyzing if viral pathogens can breach the backflow valve based on model system | Pass |
| Biocompatibility | Verified the biocompatibility of all patient contacting materials in accordance with ISO 10993-1:2009 | Pass |
| Sterilization | Ensured the EO sterilization process for all single-use, sterile components in accordance with ISO 11135-1:2014 to a sterility assurance level (SAL) of 10-6 and verified that the EO and ECH residuals are within the limits defined in ISO 10993-7:2008 | Pass |
| Real Time Aging | Verified functionality of all single-use, sterile components and integrity of all packaging after claimed shelf life | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units tested) for each of the performance tests listed. It states that "Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria based off of predicate data." It further indicates that "Full test summaries and results can be found in Section 18 - Performance Testing -Bench," but this section is not included in the provided text.
The data provenance is from bench testing conducted by the manufacturer, Stryker Corporation. It is retrospective in the sense that it's part of a submission for an already developed device. The country of origin for the data is implicitly the USA, where Stryker is headquartered and the submission was made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" for this device is established by engineering specifications, recognized standards (like ISO 10993-1, ISO 11135, ISO 10993-7), and the ability of the device to perform its intended function without failure, particularly regarding preventing contamination. There's no clinical trial or diagnostic outcome being assessed that would require expert consensus on clinical findings.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical trials, especially for imaging or diagnostic devices, where multiple readers interpret data and a final "ground truth" decision is made through a consensus process. For bench testing of a medical device like an irrigation tubing set, the results are typically objectively measured against predefined engineering specifications (e.g., presence/absence of microbial growth, flow rate, pressure, integrity). There's no subjective interpretation requiring an adjudication process.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation where AI assistance could augment human reader performance. This device is a tubing set for arthroscopy, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device described is a physical medical device (tubing), not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept related to this submission.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" in this context is based on predefined engineering specifications, recognized international standards (e.g., ISO for biocompatibility and sterilization), and objective physical/microbiological measurements. For instance:
- Microbial Ingress/Backflow Valve tests: Ground truth is the absence of microbial or viral breach.
- Biocompatibility: Ground truth is compliance with ISO 10993-1.
- Sterilization: Ground truth is achieving a sterility assurance level (SAL) of 10-6 and meeting ISO 10993-7 residuals limits.
- Functional tests (Regurgitation, Time to Close, General requirements): Ground truth is successful operation within design parameters.
8. The Sample Size for the Training Set
This is not applicable. This device is a physical product and not an AI/algorithm-based device that would require a "training set" for machine learning.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above (not an AI/algorithm device).
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.