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510(k) Data Aggregation
(183 days)
Protective cover placed over diagnostic ultrasound transducer/ probe/scanhead instruments.The cover allows use of the transducer in scanning procedures for body surface, endocavity, and intra-operative diagnostic ultra-sound, while helping to prevent transfer of microorganisms, body-fluids, and material to the patient and healthcare worker during reuse of the transducer.
Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable.
The intended use and indications for use place Ultra-Cover® PU-transducer covers in device body contact categories as follows:
- a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration . (
Ultra-Cover® PU-transducer covers provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries. The cover helps prevent the transmission of pathogens from one patient to another.
Ultrasound imaging is not impaired by use of the cover as it is intended. Adequate coupling between the cover and the transducer is required transmission gel onto the transducer face or into open end of cover, inserting ultrasound transducer into closed end of cover. The removal process is a reverse method from the application.
Various sizes and shapes of covers are offered in order to customize the fit to specific transducer geometries.
Covers are packaged in both sterile and non-sterile procedure kit form for single patient/procedure, disposable use.
Product categories/models include:
General Purpose Ultra-Cover® PU-transducer covers (sterile and non sterile) Intraoperative Ultra-Cover® PU-kits (sterile)
The document provided is a 510(k) summary for a medical device called "Ultra-Cover® PU-transducer cover." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study outlining acceptance criteria and performance against those criteria in the way a clinical study would for efficacy.
Therefore, much of the requested information (like specific quantitative acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, or MRMC studies) is not typically found in this type of regulatory submission for a device like a transducer cover. The "performance" here is primarily related to safety (biocompatibility) and functional aspects (material strength, elasticity, and not impairing ultrasound imaging).
However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in the document.
Acceptance Criteria and Device Performance for Ultra-Cover® PU-transducer cover (K981069)
The provided submission primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device (Civco Medical Instruments Poly Ultrasound Transducer Cover, K970513), as such, the "acceptance criteria" are more about demonstrating that the new device shares fundamental safety and efficacy characteristics with the predicate.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance / Evaluation |
|---|---|---|
| Material Safety (Biocompatibility) | Non-toxic, non-sensitizing, non-irritating for specified contact durations and types. (In accordance with ISO 10993) | "Testing has demonstrated subject materials/devices to be non-toxic, non-sensitizing, and non-irritating." |
| Physical Integrity/Functionality | Adequate material strength and elasticity to prevent tearing or pinholing during application, removal, and scanning. | "material strength and elasticity is adequate to allow use without tearing or pinholing the cover during application and removal of cover from transducer and during scanning under intended uses." |
| Impact on Ultrasound Imaging | Ultrasound imaging is not impaired by the use of the cover. | "Ultrasound imaging is not impaired by use of the cover as it is intended." |
| Sterile/Non-sterile Options | Availability of both sterile and non-sterile options. | "Covers are packaged in both sterile and non-sterile procedure kit form." "Ultra-Cover® PU-transducer covers are furnished sterile; single use patient/procedure, disposable." (Note the slight discrepancy in 'furnished sterile & non-sterile' on the Indications For Use vs. 'furnished sterile' on page 1) |
| Fit to Transducer Geometries | Ability to provide an efficient, conformal covering to fit various & specific ultrasound transducer geometries. | "Ultra-Cover® PU-transducer covers provides an efficient, conformal covering to fit various & specific ultrasound transducer geometries." |
| Prevention of Pathogen Transmission | Helps prevent the transmission of pathogens from one patient to another. | This is the intended use and implicitly an accepted outcome if other criteria are met, particularly physical integrity. The document states: "The cover helps prevent the transmission of pathogens from one patient to another." |
| Contact Duration & Type Classification | Meets defined body contact categories for limited duration. | Classified as: a) surface devices, intact skin/mucosal membranes/ breached surfaces, limited contact duration ( |
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