(113 days)
No
The summary describes surgical drills, a mechanical device, and makes no mention of AI, ML, image processing, or any software-driven features.
No
The device is a surgical drill used for the placement of a dental implant, which is a tool for a procedure rather than a device for direct therapeutic effect.
No
The device is described as surgical drills for placement of dental implants, which is a therapeutic rather than diagnostic function.
No
The device description explicitly states the device is made of "titanium nitrade coated stainless steel," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the drills are for use in the placement of a dental implant. This is a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details surgical drills, which are instruments used in surgical procedures.
- Lack of IVD Characteristics: The description does not mention any components or functions related to testing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Implant Integration Systems Surgical Drills are intended to be used in the placement of the "Dual Integrator" Dental Implant (K944225).
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Implant Integration S
6161 Clark Road, Suite 8 • Paradise, CA 95969 USA • (916) 872-1020 • Fax: (916) 877-7555
OCT 11 1996
Summary of Safety and Effectiveness Information
The Implant Integration Systems Surgical Drills are intended to be used in the placement of the "Dual Integrator" Dental Implant (K944225).
This product is similar in design, composition (titanium nitrade coated stainless steel) and function to the Implant Innovations, Inc. Surgical Drills (K891615), the Impla-Med Corp. Titanium/Stainless Steel Dental Implant Drills (K902158) and the Steri-oss Drills and Taps (K915733).
Cory D. Henosh, Sales Manager
Cory D Hanosh, Sales Manager
6-19-96
Date