(223 days)
A polyethylene cover/drape kit used as an accessory to an ultrasound transducer. The sterile cover/drape acts as a barrier as 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.
Drapes on Ultrasound Transducers used as protective coverings to isolate a site of surgical incisions from microbial and other contaminations.
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 Polyethylene film, with a thickness of .001inches-.003inches, Conductivity Gel, Elastic Bands, and Plastic Medical Tape.
The provided document describes a 510(k) premarket notification for a Polyethylene Ultrasound Transducer Surgical Drape Kit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data as would be found for novel technologies or higher-risk devices.
Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types beyond basic material testing) are not applicable in the context of this 510(k) submission for a surgical drape kit. The primary 'study' is a comparison to a predicate device and adherence to recognized standards.
Here's a breakdown of the information that is available in the provided text, mapped to your request:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by showing substantial equivalence to the predicate device (Civco Medical K844472) and adherence to industry standards for materials and performance. The 'reported device performance' is therefore its equivalence to the predicate and its compliance with specified standards.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (PROTEX Medical Products Inc.) |
|---|---|
| Indications for use: Ultrasound transducer covers | Ultrasound transducer covers |
| Target Population: Sonographers, Doctors, Technicians | Sonographers, Doctors, Technicians |
| Design: Sizes & Shapes Varies | Sizes & Shapes Varies |
| Materials: Polyethylene .001-.003 inches | Polyethylene .001-.003 inches |
| Additional Kit Components: Conductivity Gel, Elastic Bands | Conductivity Gel, Elastic Bands, Plastic Medical Tape |
| Performance Standard: ASTM - F1671-95 (Resistance to Penetration) | ASTM - F1671-95 |
| Sterility: ETO | ETO |
| Biocompatibility Standard: ISO-10993 | ISO-10993 |
| Mechanical Safety (Tensile Strength): 2400-3500 PSI | Tensile Strength: 2400-3500 PSI |
| 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 |
| 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable (N/A) for a 510(k) of this nature. This submission demonstrates substantial equivalence through material and performance specifications rather than a clinical trial-like test set. The 'test' involves demonstrating the device meets specified material and performance standards (e.g., ASTM F1671-95 for resistance to penetration, ISO-10993 for biocompatibility, tensile strength). The data provenance refers to the standards themselves and internal testing results, not patient data.
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)
N/A. The "ground truth" here is compliance with established engineering and safety standards, and the specifications of the predicate device. This doesn't involve expert medical review of images or clinical outcomes in the same way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. The assessment is against material properties and performance specifications, not subjective clinical adjudication.
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
N/A. This is a medical device (surgical drape), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is based on:
- Material specifications: Polyethylene thickness, properties.
- Performance standards: Adherence to ASTM F1671-95 (standard test method for resistance of materials used in protective clothing to penetration by blood-borne pathogens using Phi-X174 bacteriophage penetration as a test system).
- Safety standards: ISO-10993 (biological evaluation of medical devices), 29CFR 1910,1200 (hazard communication standard for chemical safety).
- Predicate device characteristics: Demonstrating that the new device has the same design, materials, performance, sterility, etc., as the legally marketed Civco Medical device (K844472).
8. The sample size for the training set
N/A. As this is a physical medical device applying for 510(k) equivalence, there is no AI model or "training set" in the computational sense. The 'training' would refer to the historical data and manufacturing processes that led to the development and standardization of such surgical drapes, but this is not specified in the document.
9. How the ground truth for the training set was established
N/A. See point 8.
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.