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The MDU5 PLUS Sterile Baq is intended to cover the motordrive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

The MDU5 PLUSTM Sterile Bag is supplied to the user as a sterile device and is intended for single use only. The MDU5 PLUS™ Sterile Bag is intended to cover the motor drive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker. The product consists of a long, narrow bag made of low density polyethylene with one open end. There is a face plate with a covered opening that is attached to the Sterile Bag. Once the Sterile Bag is covering the motordrive unit, the face plate connects to the nose of the motordrive. The face plate is uncovered when the operator is ready to insert the catheter into the motordrive. The bag has been designed to be large enough and flexible enough to cover the motordrive unit while not impeding the 10cm of travel required by the pull-back sled that the motordrive attaches to. The MDU5 PLUSTM Sterile Bag is sufficiently clear as to not impede viewing the motordrive display. The MDU5 PLUSTM Sterile Bag is sold separately as a stand-alone product but is also included as an accessory in the package with each compatible catheter. The materials used in the design of the MDUJ5 PLUS™ Sterile Bag have been selected to be compatible with electron beam sterilization (e-beam sterilization). The MDU5 PLUS™ Sterile Bag is folded and packaged in a Tyvek/Nylon or equivalent medical device packaging that is suitable for E-Beam sterilization.

This is a 510(k) premarket notification for a Class II medical device, the Boston Scientific MDU5 PLUS™ Sterile Bag. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information provided for acceptance criteria and supporting studies will differ significantly from what would be expected for a novel device, especially one involving AI.

Summary of Acceptance Criteria and Device Performance for MDU5 PLUS™ Sterile Bag

The provided document describes a device intended to maintain a sterile field during intravascular ultrasound procedures. As such, the "acceptance criteria" and "device performance" are primarily related to its physical integrity, sterility, and compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests designed to demonstrate substantial equivalence to the predicate device.

• Study Title: Not explicitly named, but described as "Performance testing" or "Non-Clinical Data."
• Study Type: Comprehensive bench testing, sterilization validation, and packaging validation.
• Study Objective: To demonstrate that the MDU5 PLUS™ Sterile Bag is safe and effective for its intended use and substantially equivalent to the predicate device (CIVCO Poly Ultrasound Transducer Cover, K970513).

Specific Information Requested (as applicable for this device type):

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many bags were tested for liquid barrier, how many packages for seal strength). For bench testing, it mentions evaluation "at T=0 and T=13mo AA" (Accelerated Aging), implying multiple time points. For packaging and sterilization, multiple units would have been tested.
• Data Provenance: The data is generated from benchtop laboratory testing and validation studies conducted by Boston Scientific Corporation. This is retrospective in the sense that the studies were completed before the 510(k) submission, but it is not "clinical retrospective data." The origin is likely in-house or contracted laboratory testing. No country of origin for patients/data is applicable as this is not a clinical study.

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 to this type of medical device submission. Ground truth, in the context of diagnostic AI or image analysis, refers to the definitive determination of a condition or measurement, typically established by highly qualified medical experts.
• For the MDU5 PLUS™ Sterile Bag, the "ground truth" for acceptance is determined by meeting pre-defined scientific and engineering specifications (e.g., a specific barrier integrity value, a specific seal strength, a specific sterility assurance level). Expert involvement would be in the design and execution of the tests and interpretation of raw data by engineers, microbiologists, and quality control specialists, not in establishing a "ground truth" as medical consensus on a case.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or expert review panels to resolve discrepancies in diagnoses or interpretations among multiple readers. For non-clinical bench and validation testing, results are typically objective measurements against a pre-established standard or specification. Any discrepancies in test results would be resolved through re-testing, investigation of methodology, or quality control procedures, not through a formal expert adjudication process as described.

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 device is a sterile bag, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. This device is a passive sterile barrier, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's acceptance is based on engineering specifications, standardized test methods (e.g., ISO standards), and internal quality control criteria. Examples include:
  • Demonstrating a specific level of microbial impermeability.
  • Achieving a defined sterility assurance level (e.g., 10^-6 for SAL).
  • Meeting pre-established tensile strength for seals or puncture resistance for the material.
  • Confirming compatibility with the motor drive unit's physical dimensions and operation.
• It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set

• This question is not applicable. This device is a physical product, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable. As no AI model is involved, there is no training set or ground truth for a training set.

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