(28 days)
No
The summary describes a device that delivers electrical stimulation for nerve monitoring during surgery. There is no mention of AI or ML in the intended use, device description, or performance studies. The device's function is based on electrical current delivery and mechanical support, not data analysis or learning algorithms.
No
This device is for nerve monitoring during surgical procedures and delivers stimulating current for location and identification of nerves, not for treating a disease or condition.
No
The device is used to stimulate nerves for identification and monitoring during surgery, not to diagnose a medical condition.
No
The device description clearly states it is a sterile, single-use hardware component that locks onto a handpiece and delivers electrical current. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Stimulating Bur Guard is a surgical tool used during a surgical procedure to stimulate nerves in vivo (within the living body) for identification and monitoring. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes its function in stimulating nerves during surgical procedures involving tissue and bone removal.
- Device Description: The description details its mechanical function in delivering electrical current to a surgical bur/blade.
Therefore, the Stimulating Bur Guard is a surgical instrument used for nerve monitoring during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.
The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.
Product codes (comma separated list FDA assigned to the subject device)
ETN, ERL, HWE
Device Description
The Stimulating Bur Guard is a sterile, single use device used in conjunction with the XPS 3000 BF Powered Drill System and the Medtronic Xomed Nerve Monitoring System. It locks onto a handpiece and has an opening on the anterior end to accept a standard bur / blade. The primary purpose of the Stimulating Bur Guard is to deliver the stimulating current from the Nerve Monitoring console to the standard bur / blade on the drill handpiece. The second purpose of the Stimulating Bur Guard is to provide support for the extended length burs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, peripheral motor nerves, spinal nerve roots
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)
Bench Testing: The device met the acceptance criteria for: Reliability and Useful life, Bur / blade Compatibility, Current delivery, Current delivery compared to 2.3mm ball tip probe, Noise, Temperature, Current drop out, Electrical Isolation.
Electromagnetic Compatibility and Electrical Safety Testing: The Stimulating Guard is not a source of electromagnetic interference in and of itself. However, the devices are evaluated for EMC as a system with the nerve monitoring and drill system consoles in accordance with EN 60601-1-2. Electrical safety testing is conducted in accordance with EN / IEC 60601-1 and electrical safety is achieved through levels of protection built within the BF Rated Consoles. Both the XPS 3000 and NIM systems are BF rated.
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
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
0
510(k) Summary
NOV 2 9 2006
| 510(k) Owner | Medtronic Xomed, Inc
6743 Southpoint Drive North
Jacksonville, Florida 32216-0980 USA
904-296-9600
904-296-2386 (FAX) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name | Antoine Kouchakjy
Senior Regulatory Affairs Specialist
Medtronic Xomed, Inc |
| Date Summary Prepared | October 31, 2006 |
| Proprietary Name | Stimulating Bur Guard (Final name TBD) |
| Common Name | Stimulator, Nerve |
| Classification Name | Primary · Surgical nerve stimulator / locator
(21 CFR 874.1820, Product Code ETN, Class II)
Secondary · Drill, Surgical, ENT (electric or pneumatic) including
handpiece
(21 CFR 874.4250, Product Code ERL, Class II)
Secondary · Surgical instrument motors & accessories / attachments
(21 CFR 878.4820, Product Code HWE, Class I) |
Marketed device claiming equivalence to:
The Stimulating Bur Guard is equivalent to the Medtronic Xomed Monopolar Stimulator Probe, K992869. The guard is also an accessory to the XPS 3000 Drill System covered under K041523.
Device Description
The Stimulating Bur Guard is a sterile, single use device used in conjunction with the XPS 3000 BF Powered Drill System and the Medtronic Xomed Nerve Monitoring System. It locks onto a handpiece and has an opening on the anterior end to accept a standard bur / blade. The primary purpose of the Stimulating Bur Guard is to deliver the stimulating current from the Nerve Monitoring console to the standard bur / blade on the drill handpiece. The second purpose of the Stimulating Bur Guard is to provide support for the extended length burs.
Intended Use
When used with both the Medtronic Nerve Integrity Monitor (NIM) and XPS Drill Systems, the Stimulating Bur Guard is intended to stimulate cranial and peripheral motor nerves, including spinal nerve roots, with a standard bur / blade for location and identification during the incision and removal of soft and hard tissue or bone.
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Image /page/1/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K063305". The characters are written in a cursive style, with some connections between the numbers.
Indications for Use
The Stimulating Bur Guard is indicated for nerve monitoring during the incision and removal of soft and hard tissue or bone with a standard bur / blade during otology, neurotology, sinus, laryngeal, nasopharyngeal, head and neck, general and plastic, and orthopedic surgical procedures, including spinal applications.
| Characteristic | New Device:
Medtronic Xomed
Stimulating Guard | Predicate:
Medtronic Xomed Ball-Tip
Monopolar Stimulating
Probe [K992869] |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | When used with both the Medtronic
Nerve Integrity Monitor (NIM) and
XPS Drill Systems, the Stimulating
Guard is intended to stimulate cranial
and peripheral motor nerves,
including spinal nerve roots, with a
standard bur / blade for location and
identification during the incision and
removal of soft and hard tissue or
bone. | To stimulate cranial and
peripheral motor nerves for
location and identification
during surgery, including
spinal nerve roots |
| Insulated | Yes | Yes |
| Stimulator connector | Yes | Yes |
| Biocompatible | Yes | Yes |
| Sterile | Yes | Yes |
| Sterilization Method | ETO | ETO |
| Shelf Life | 3 months (initially) | 8-year |
| Single Use | Yes | Yes |
| Monopolar | Yes | Yes |
Summary of Technological Characteristics
Biocompatibility
The Stimulating Guard is considered biocompatible for use as an external communicating device with tissue / bone contact of limited duration (