(119 days)
Minitube Dentasleeve Protective Barrier Sleeves are intended to serve as a disposable barrier for dental instruments and equipment. This device is non-sterile and intended for single patient use only
Minitube Dentasleeve Protective Barrier Sleeves are made of polyethylene film and are used as accessories to dental instruments and equipment used during dental procedures. These disposable barrier sleeves are offered in various shapes and sizes to fit over and cover the intended dental instruments and equipment. The disposable Barrier Sleeves slip over the ends of the respective devices, allowing for the attachment of those parts of the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean up. The Minitube Dentasleeve Protective Barrier Sleeves are available in below sizes. All sizes below are provided in millimeters (mm, approx.) and excluding paper liner, i.e. actual sleeve only:
- . 1 ml Width: 29 mm Length: 148 mm
- 5 ml Width: 43 mm Length: 195 mm
- 50ml Width: 63 mm Length: 126 mm
This document, a 510(k) Premarket Notification from the FDA, details the equivalence of the Minitube Dentasleeve Protective Barrier Sleeves to a predicate device. The information provided is for a medical device (dental barrier sleeves), not an AI/algorithm-based device. Therefore, a significant portion of your request regarding AI model validation (e.g., training set, test set, ground truth for AI, MRMC studies, expert consensus, etc.) is not applicable to this document.
The acceptance criteria and study proving the device meets them are based on bench testing and material property comparisons rather than clinical performance or AI algorithm assessment.
Here's an attempt to answer your questions based on the provided document, highlighting where the information is not applicable (N/A) due to the nature of the device:
Device Name: Minitube Dentasleeve Protective Barrier Sleeves
Regulation Number: 21 CFR 878.4370 (Surgical Drape and Drape Accessories)
Regulatory Class: Class II
Product Code: PEM
1. Table of Acceptance Criteria and Reported Device Performance
This device is cleared based on substantial equivalence to a predicate device (Barrier Sleeves, K191448). The "acceptance criteria" are implied by the performance characteristics of the predicate device, which the new device must match or perform equivalently.
| Acceptance Criteria (Predicate Performance) | Reported Device Performance (Subject Device) |
|---|---|
| Indications for Use: Disposable barrier for dental instruments and equipment; non-sterile; single patient use only. | Identical |
| Material: Polyethylene film (low density) | Identical |
| Shelf Life: 5 years | 5 years |
| Color: Clear | Clear |
| Paper backing: Yes | Yes |
| Single Use: Yes | Yes |
| Sterility: Non-sterile | Non-sterile |
| Synthetic Blood Penetration Test (ASTM F1670): Pass | Pass |
| Synthetic Blood Penetration at seams (ASTM F1670/F1670M): Pass | Pass |
| Viral Penetration Test (ASTM F1671): Pass | Pass |
| Viral Penetration at seams (ASTM F1671/F1671M): Pass | Pass |
| Biocompatibility (Cytotoxicity - ISO 10993-5): Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (Sensitization - ISO 10993-10): Non-sensitizing, non-irritating | Non-sensitizing, non-irritating |
| Biocompatibility (Irritation - ISO 10993-10): Non-irritating (from Intracutaneous Study) | Non-irritating |
| Biocompatibility (Systemic Toxicity - ISO 10993-11): N/A (implied acceptable performance) | Passed Systemic Toxicity Study |
| Tensile Strength (ASTM D882): 0.03mm - acceptable | 0.03mm - identical to predicate |
| Puncture Resistance (ASTM F1342/F1342M): 0.03mm - acceptable | 0.03mm - identical to predicate |
| Tear Resistance (ASTM D1004): 0.03mm - acceptable | 0.03mm - identical to predicate |
Note on Dimensions: While the predicate device had sizes 29x148mm and 36x279mm, the subject device offers 29x148mm, 43x195mm, and 63x126mm, stating these "will fit perfectly over a 1ml, 5ml and 50ml syringe, respectively." This is deemed "SE" (Substantially Equivalent) as it still fulfills the same barrier function for dental instruments, albeit with different specific sizes.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each mechanical or biocompatibility test. It indicates that "samples of the proposed devices" were tested and that the "results are included in this submission."
- Data Provenance: The tests were conducted to support the 510(k) submission. The supplier (Minitube AB, Sweden) manufactures both the predicate and subject devices. This implies the bench testing was done by or for the manufacturer. The data is prospective as it's generated specifically for this premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is a physical barrier device, and its "ground truth" is established through standardized laboratory bench tests, not through expert human interpretation of medical images or data. The standards (ASTM, ISO) themselves define the methodology and "ground truth" for material performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 are relevant for subjective evaluations, typically in clinical studies or AI performance assessment. Here, the assessment is based on objective, quantitative measurements from standardized laboratory tests.
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 device is a physical barrier, not an AI or imaging device. Therefore, MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Testing Standards and Predicate Device Performance: The "ground truth" is established by compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, ASTM F1670, F1671, D882, F1342, D1004 for material properties) and by demonstrating identical or equivalent performance to the legally marketed predicate device.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device; therefore, there is no training set in that context.
9. How the ground truth for the training set was established
- N/A. As above, no training set for an AI model. For the device itself, the manufacturing process is regulated by Quality Systems (21 CFR Part 820), ensuring consistency and adherence to product specifications, which can be thought of as the "ground truth" for uniform product characteristics.
§ 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.