(223 days)
A polyurethane cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as it is placed on the instrument prior to coming in contact with the human bodies internal and external services. The following is an abbreviated list of known uses;
- General Purpose: Ultrasound scanning.
- Cord cover for an extended sterile field on ultrasound transducer cords.
- Rectal and vaginal scanning.
- Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contamination.
A variety of kits, ranging in sizes, containing a disposable, single use, sterile instrument cover/drape, gel, bands and tape. The sterile bag is placed over a non-sterile ultrasound transducer probe during a sterile procedure, acting as a barrier between the patient and the ultrasound probe.
Each kit contains one cover/drape, ranging in sizes from 2"x24" to 5"x100", made from extruded Polyurethane film, with a thickness of .001-. 003 inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
The provided document is a 510(k) premarket notification for a medical device: a Polyurethane Ultrasound Transducer Surgical Drape Kit. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device submission would.
Therefore, the document does not contain information typically required to describe acceptance criteria and a study proving device performance for an AI/ML diagnostic or prognostic device. The context is a physical medical device (surgical drape), not a software algorithm.
However, I can extract information related to the "performance" of this physical device in the context of its 510(k) submission, comparing it to its predicate device. This "performance" refers to physical and biological properties, not diagnostic accuracy.
Here's an interpretation based on the provided text, recognizing the different nature of the device:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are implicitly the characteristics of the predicate device, which the new device must be "substantially equivalent" to (or exceed for safety/effectiveness). The "reported device performance" are the characteristics of the PROTEK device.
| Characteristic | Acceptance Criteria (Predicate: Civco Medical K844472) | Reported Device Performance (PROTEK Medical Products Inc.) |
|---|---|---|
| Indications for use | Ultrasound transducer covers | Ultrasound transducer covers |
| Target Population | Sonographers, Doctor's and Technicians | Sonographers, Doctor's and Technicians |
| Design | Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials | Polyurethane .001"-.003" | Polyurethane .001"-.003" |
| Additional Kit Components | Conductivity Gel, Elastic Bands | Conductivity Gel, Elastic Bands, Plastic Medical Tape |
| Performance | Microbial Challenge | Microbial Challenge |
| Sterility | ETO | ETO |
| Biocompatibility | ISO-10993 | ISO-10993 |
| Mechanical Safety | Tensile Strength 6250 PSI @ Break | Tensile Strength 6250 PSI @ Break |
| Chemical Safety | No Hazardous Components 29CFR 1910,1200 | No Hazardous Components 29CFR 1910,1200 |
| Anatomical Sites | Where Ultrasound is Used | Where Ultrasound is Used |
| Disposition | Disposable | Disposable |
| Where Used | Hospitals & Clinics | Hospitals & Clinics |
| Standards Met | Global Test Methods for Resistance to Penetration | Global Test Methods for Resistance to Penetration |
| Electrical Safety | No Electrical Components | No Electrical Components |
| Manufacturing Method | Vertrod Heat Sealer | Vertrod Heat Sealer |
| Packaging | TYVEK "Chevron Peel Pouch" | TYVEK "Chevron Peel Pouch" |
| Human Factor | No Known Adverse Effects | No Known Adverse Effects |
Regarding the "study that proves the device meets the acceptance criteria":
The document states: "These new products have the same intended use as legally marketed devices. The same end users. The same material manufactures and the same tests and processes as Civco's legally marketed devices under 510(k) K844472." This indicates that the claim of meeting the "acceptance criteria" (i.e., substantial equivalence) is based on a direct comparison of characteristics and the assertion that similar materials, tests, and processes were used. The document lists "Microbial Challenge," "Biocompatibility (ISO-10993)," "Mechanical Safety (Tensile Strength)," and "Standards Met (Global Test Methods for Resistance to Penetration)" as performance aspects where the new device is equivalent to the predicate. However, it does not provide details of specific studies conducted or their results for the PROTEK device beyond listing these categories. It's a statement of equivalence rather than a report of specific test outcomes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this 510(k) submission for a physical surgical drape. There is no "test set" in the context of an AI/ML algorithm evaluation. The evaluation is based on material and design comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth is not established in this manner for a physical device like a surgical drape. Equivalence is based on material specifications, manufacturing processes, and adherence to recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no "test set" or adjudication method for a physical device in this context.
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 information is not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information 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)
This information is not applicable in the AI/ML sense. For a physical device like this, "ground truth" implicitly refers to established material properties, sterilization efficacy, biocompatibility, and mechanical strength evaluated against recognized standards and the performance of the predicate device. For example, "Microbial Challenge" implies testing against microbial penetration, and "ISO-10993" refers to biocompatibility standards.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes "training."
9. How the ground truth for the training set was established
This information is not applicable. As above, there is no "training set" for this type of device.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.