(85 days)
K-834363
Not Found
No
The provided 510(k) summary contains no information about the device description, intended use, or any mention of AI, ML, or related concepts. The only information present is the predicate device, which is a physical implant (bio-ceramic pin) and not indicative of AI/ML technology.
No
The device is listed with a predicate device that is a bio-ceramic pin, which is typically a medical implant used for treatment, indicating the current device is also likely for treatment and thus therapeutic.
No.
The provided text does not contain an "Intended Use / Indications for Use" section, nor does it explicitly state that the device is for diagnostic purposes. The only information available is a predicate device that is a "Radicular Bio-Ceramic Pin," which sounds like a therapeutic or restorative device rather than a diagnostic one.
No
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use. The only information available is a predicate device which is a physical medical device (a bio-ceramic pin), suggesting the subject device might also be hardware. Without a description of the device itself, it's impossible to determine if it's software-only.
Based on the information provided, it is highly unlikely that this device is an IVD.
Here's why:
- Lack of IVD-specific information: The provided text contains none of the typical information you would expect to find for an IVD, such as:
- Intended Use/Indications for Use describing a diagnostic purpose (e.g., detecting a disease, measuring a substance in a sample).
- Device Description detailing how it interacts with biological samples.
- Information about input imaging modality, anatomical site, or patient age range, which are often relevant for devices used in clinical settings, but not necessarily for IVDs.
- Details about training and test sets, performance studies, and key metrics, which are crucial for demonstrating the analytical and clinical performance of an IVD.
- Predicate Device: The listed predicate device, "Radicular Bio-Ceramic Pin," cleared under K-834363, strongly suggests a device used in a dental or surgical context, not an in vitro diagnostic test.
Conclusion:
Without any information pointing towards the analysis of biological samples outside the body for diagnostic purposes, and with a predicate device that is clearly not an IVD, it is safe to conclude that this device is not an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes
76ELS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K-834363
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3890 Endodontic stabilizing splint.
(a)
Identification. An endodontic stabilizing splint is a device made of a material, such as titanium, intended to be inserted through the root canal into the upper or lower jaw bone to stabilize a tooth.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
XIII. SAFE MEDICAL DEVICES ACT SUMMARY OF SAFETY AND EFFECTIVENESS DATA. (Separate Page)
- I. Classification Name and Number: Endodontic Splint (76ELS)
- II. Common/Usual Name: Dental Anchor Post, titanium or titanium alloy.
- III. Proprietary Name: Dentatus MTI™ Anchor Post.
- IV. Classification: These devices were classified by the Dental Devices Panel (Title 21 CFR 872.3890.
- Brief Literature Review: Endodontic splints made of titanium or titanium alloy have V. been proved safe and effective through the years. A Medline literature search under endodontic-splint, or anchor, produced 32 pertinent articles. These were reviewed and summarized showing that this is not an active research field. The literature summarized showed that the endodontic splint is an old, well-known dental device with a broad area of safe and effective uses.
- VI. Substantial Equivalence: The Dentatus products are substantially equivalent to the pre-amendment devices classified under CFR 872.3890, to many endodontic splints manufactured before May 28, 1976, and to devices cleared by the 510(k) process such as the Biotechnics, Inc.,"Radicular Bio-Ceramic Pin," cleared under K-834363 and assigned the code ELS.
- VII. Technology: These devices are manufactured from the titanium materials proved effective by the above summarized years of clinical usage, may be sterilized by the standard methods including radiation or ethylene oxide and autoclaving in the dental office, and are constructed according to methods in the cited substantially equivalent products. Thus, they involve no new types of technology and no new technological questions.
- The "510(k) Substantial Equivalence Decision-Making Process VIII. Decision Tree: (Detailed)" from ODE Guidance Memo #86-3 was followed.
End of Summary
18b