(191 days)
Plasdent Disposable Barrier Sleeves and Barrier Film are intended to be used as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient one time use only.
Plasdent Disposable Barrier Sleeves and Barrier Film are made of polyethylene film (PE), and come in various shapes and sizes as dental accessories intended to fit over and cover dental instruments and equipment. The Disposable Barrier Sleeves cover small hand-held dental instruments such as air/water syringes, curing lights, hand pieces, computers, sensors, dental instrument trays, and other similar handheld instruments to provide as a physical barrier or cover during a dental procedure. In other forms, the Disposable Barrier Film Covers are used to cover equipment, such as dental chairs, headrests, X-Ray heads, and other devices. The device is non-sterile, prepackaged, and is disposable, for single patient and one time use only.
This document is a 510(k) Premarket Notification from the FDA for a medical device: "Plasdent Disposable Barrier Sleeves and Barrier Film." It is primarily focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
It is important to note that this document does NOT describe the validation of an AI/ML powered medical device. It describes the testing of a physical barrier device. Therefore, many of the requested elements for an AI/ML device validation (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, sample size for training set, ground truth for training set) are not applicable or present in this context.
However, I can extract the relevant information for the physical device based on the provided text, focusing on acceptance criteria and performance data from the non-clinical testing.
Acceptance Criteria and Device Performance (for a physical barrier device)
The document presents non-clinical testing results to demonstrate that the Plasdent Disposable Barrier Sleeves and Barrier Film are substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Standard | Purpose | Acceptance Criteria | Reported Device Performance | Results Summary |
|---|---|---|---|---|---|
| BIOCOMPATIBILITY TESTING: | |||||
| In-Vitro Cytotoxicity | ANSI/AAMI/ISO 10993-5 | Evaluate the cytotoxicity of a test article extract. | If viability is reduced to 0.5 indicate irritation. | Overall Test Group Mean: 0 | Irritation response category of test article classified as Negligible. |
| PERFORMANCE TESTING: | |||||
| Tensile Strength | ASTM D882-18 | Determine the tensile properties of Subject device's disposable barrier sleeve compared to that of Predicate device disposable barrier sleeve. | Transverse: 35-45 MPa | ||
| Lengthways: 23-28 MPa | HL181201: T 39.46, L 26.26 | ||||
| HL20190601: T 39.84, L 26.46 | |||||
| HL20190605: T 40.32, L 26.52 | The tensile strength of both products is in the same range. | ||||
| Puncture Resistance | ASTM F1342-05 | Determine the puncture resistance of Subject device's disposable barrier sleeve compared to that of Predicate device's disposable barrier sleeve. | 4N-5N | 20190528: 4.56N | |
| 20190601: 4.58N | |||||
| 20190605: 4.56N | The puncture resistance of both products is in the same range. | ||||
| Tear Resistance | ASTM D1004-13 | Determine the tear resistance of Subject device's disposable barrier sleeve compared to that of Predicate device's disposable barrier sleeve. | 4N-6N | HL20190605: 5.026N | |
| HL20190610: 5.046N | |||||
| HL20190615: 5.032N | The tear resistance of both products is in the same range. | ||||
| Synthetic Blood Penetration | ASTM F1670 | Evaluate the resistance of test material to penetration by synthetic blood under conditions of continuous liquid contact. | Pass determination based on no visual detection of synthetic blood penetration. | Material: no synthetic blood penetration seen | Pass. Test material resistant to synthetic blood penetration. |
| Synthetic blood penetration at seams and non-continuous components | ASTM F1670 | Evaluate the resistance of test material at seams to penetration by synthetic blood under conditions of continuous liquid contact. | Pass determination based on no visual detection of synthetic blood penetration. | Material seams: no synthetic blood penetration seen | Pass. Test material seams resistant to synthetic blood penetration. |
| Viral Penetration | ASTM F1671 | Evaluate the barrier performance of test material which are intended to protect against blood borne pathogen hazards. | Pass determination based on no visual detection of viral penetration and assay titer value |
§ 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.