(130 days)
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.
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 the devices used during dental procedures. Barrier Sleeves act as a physical barrier, augmenting existing infection control techniques, and facilitate clean-up.
The provided text describes the 510(k) premarket notification for "Barrier Sleeves" by Ivoclar Vivadent, AG. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's independent efficacy through a "study that proves the device meets the acceptance criteria" in the context of, for example, an AI/ML medical device.
The "acceptance criteria" here are based on the similarity to the predicate device and meeting established performance standards for surgical drapes/barrier materials. The study described is a series of non-clinical bench tests and biocompatibility assessments.
Here's how to structure the information based on your request, with the understanding that this is not an AI/ML device study, but rather a traditional medical device submission for substantial equivalence:
Device: Barrier Sleeves (K191448)
Intended Use: "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."
The claim of substantial equivalence is supported by demonstrating that the Barrier Sleeves have the same intended use, fundamental technology, working principle, material composition, and comparable performance properties to the predicate device (Disposable Barrier Sleeves and Covers, K160232) manufactured by the same supplier.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, "acceptance criteria" are implied by demonstrating equivalence to a legally marketed predicate device and meeting relevant industry standards for barrier materials. The study is a series of physical and biological tests.
| Category | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Barrier Sleeves) |
|---|---|---|
| Indications for Use | Same as predicate (disposable barrier for dental instruments and equipment) | Same as predicate |
| Working Principle | Same as predicate (polyethylene film slipping over devices as physical barrier) | Same as predicate |
| Material Composition | Same as predicate (Low density polyethylene film from same supplier) | Identical (Low density polyethylene film from Minitube AB, Sweden) |
| Biocompatibility | Non-cytotoxic, Non-sensitizing, Non-irritating (per ISO 10993-5, -10) | Non-cytotoxic, Non-sensitizing, Non-irritating (Met requirements) |
| Synthetic Blood Penetration (ASTM F1670/F1670M) | Pass | Pass |
| Synthetic Blood Penetration at seams/non-continuous components (ASTM F1670/F1670M) | Pass | Pass |
| Viral Penetration (ASTM F1671/F1671M) | Pass | Pass |
| Viral Penetration at seams/non-continuous components (ASTM F1671/F1671M) | Pass | Pass |
| Tensile Strength (ASTM D882) | Acceptable for 0.03mm (comparable to predicate) | 0.03mm - Comparable to Predicate |
| Puncture Resistance (ASTM F1342/F1342M) | Acceptable for 0.03mm (comparable to predicate) | 0.03mm - Comparable to Predicate |
| Tear Resistance (ASTM D1004) | Acceptable for 0.03mm (comparable to predicate) | 0.03mm - Comparable to Predicate |
| Device Characteristics (Thickness, Color, Sterile, Single Use) | Same as predicate (0.03mm, clear, non-sterile, single use) | Same as predicate (except shape/dimensions to fit different devices) |
| Shelf Life | Not specified for predicate, but new device is 5 years | 5 years (as recommended by manufacturer, storage stability report provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each non-clinical test (e.g., how many sleeves were tested for blood penetration). It refers to "the samples" for mechanical properties.
- Sample Size: Not explicitly stated for each test, generally referred to as "the samples."
- Data Provenance: Non-clinical bench testing conducted by the manufacturer for the purpose of this 510(k) submission. The document doesn't specify country of origin for the testing itself, but the submitter (Ivoclar Vivadent) is based in New York, USA, and the parent company in Liechtenstein. The material supplier is Minitube AB, Sweden. The tests are prospective, conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable for this type of medical device submission. Ground truth, in the context of AI/ML or diagnostic devices, is typically established by medical professionals reviewing images or patient data. For a barrier sleeve, "ground truth" refers to meeting the chemical, physical, and biological performance standards, which are evaluated by laboratory testing under defined ASTM and ISO standards, not by expert medical review of "cases."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human reviewers of medical data (e.g., radiologists interpreting images). The "test set" here involves laboratory measurements against established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are performed to assess the impact of AI on human reader performance, typically in diagnostic imaging. This device is a physical barrier and does not involve human interpretation or AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithmic or software device.
7. The Type of Ground Truth Used
For this device, the "ground truth" is defined by established engineering and biocompatibility standards (e.g., ASTM F1670/F1670M for synthetic blood penetration, ISO 10993-5 for cytotoxicity). The device performance is measured against these standards and compared to the predicate device. It is not based on medical outcomes data or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As per point 8, there is no training set for this device.
§ 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.