(87 days)
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No
The device description and performance studies focus on the mechanical properties and surgical application of a physical implant, with no mention of AI/ML terms or data processing.
No.
The device is used to fixate structures during cosmetic surgery (browplasty), which is not considered a therapeutic use as it doesn't treat a disease or condition for health benefit.
No
The device is described as an implant used for fixation in browplasty surgery. Its function is to secure tissue, not to collect, analyze, or interpret data about a patient's condition for diagnosis.
No
The device description explicitly states it is fabricated from L-PLA and includes physical components like a post, barbs, and requires installation instruments, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Endotine Device Function: The Endotine Device is a surgical implant used to physically fixate tissue (sub-dermis) to bone (cranial bone) during a surgical procedure (browplasty). It does not analyze or test any bodily fluids or tissues in vitro (outside the body).
The description clearly indicates a device used in vivo (within the body) for a surgical purpose, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Endotine Device is intended for use in browplasty surgery. The Endotine device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Endotine Device is a device fabricated from L-PLA that is intended for use in browplasty procedures. The device is molded with a post that is inserted directly into the cranial bone. A series of barbs along its face provides a feature that allows for the direct fixation the sub-dermis without the use of suture. The device is inserted into the bone with the use of an installation instrument. Additional instruments include a stepped drill and sterilization tray.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cranial bone
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Bench Testing: Comparison of the shear strength of the Endotine Device In-Vitro compared to the predicate device.
- Animal Testing: The testing demonstrated the acceptability of the Endotine Device and confirmed that the device functions adequately to meet its intended use.
- Tissue Interface: Comparison of the device to tissue interface of the Endotine Device to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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