(105 days)
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
| Acceptance Criteria Category | Specific Criteria / Test Type | Reported Device Performance / Evaluation Method |
|---|---|---|
| Physical Integrity & Functionality (Bench/Performance Testing) | Liquid Barrier Evaluation | Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed. |
| Pathogen Penetration Resistance | Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed. | |
| Resistance to Penetration by Synthetic Blood | Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed. | |
| Resistance to Common Cleaning Agents | Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed. | |
| Seal Strength | Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed. | |
| Label/Sticker Orientation and Durability | Bench testing conducted to evaluate physical integrity and functionality at T=0 and T=13 months (Accelerated Aging). Specific results are not detailed, but the submission states this testing was completed. | |
| Interface and Compatibility with Ancillary Devices (e.g., motor drive, catheter insertion) | Designed to be large and flexible enough to cover the motordrive unit without impeding 10cm of travel by the pull-back sled. Face plate connects to the nose of the motordrive. Sufficiently clear to not impede viewing the motordrive display. Bench testing included interface and compatibility. Specific results not detailed, but the submission states this testing was completed. | |
| User Interface Requirements | Bench testing conducted. Specific results are not detailed, but the submission states this testing was completed. | |
| Environmental Requirements | Bench testing conducted. Specific results are not detailed, but the submission states this testing was completed. | |
| Sterilization Validation | Sterility Assurance Level (SAL) per ISO 11137-2:2012 (Electron Beam Sterilization) | Sterilization studies (including Bioburden) were conducted according to ISO 11137-2:2012. The device is supplied as sterile. |
| Packaging Validation | Integrity of packaging configuration after e-beam sterilization, climatic conditioning, and distribution challenge | Tested in accordance with ISO 11607-1 and ISO 11607-2. Test criteria included visual inspections, sterile barrier integrity, and sterile barrier seal strength. Testing was conducted on fully packaged units after being subjected to electron beam sterilization, climatic conditioning, and distribution challenge conditioning. Specific results are not detailed, but the submission states this testing was completed. |
| Material & Design Equivalence | Comparability to predicate device (CIVCO Poly Ultrasound Transducer Cover, K970513) in material, design, and dimensions | The MDU5 PLUS™ Sterile Bag is made of low-density polyethylene (LDPE), similar to the predicate device. It has a long, narrow bag shape with a faceplate for attachment, similar to the predicate device. The submission states a comparison was made to the predicate device in Section IV (not provided here) and that the design specifications were compared. |
| Biocompatibility | (Implicit from material selection and intended use of a sterile barrier) | Materials selected were compatible with electron beam sterilization. Not explicitly stated as a separate acceptance criterion with detailed results in this summary, but generally implied for a device of this nature. |
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.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.