(196 days)
Not Found
No
The description focuses on electrical stimulation and standard intraoperative neuromonitoring techniques (triggered EMG) without mentioning any AI/ML components for data analysis, interpretation, or decision-making.
No
Explanation: The device is indicated for tissue dilation and nervous tissue stimulation to assess the location and identification of motor nerves for avoidance during surgery, not for treating a condition or disease. It is an intraoperative neuromonitoring tool.
Yes
The device is used to "assess location and identification of motor nerves" by stimulating them and recording the muscle group response (triggered EMG), which provides information about the state or location of the nervous tissue.
No
The device description explicitly states it is comprised of physical probes made of stainless steel and PEEK, which are hardware components. It also connects to conventional hardware stimulators.
Based on the provided information, the SeaSpine Monopolar Probe System 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. They are used to provide information for diagnosis, monitoring, or screening.
- SeaSpine Monopolar Probe System Function: The description clearly states that the device is used for "tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves... during a routine surgical approach to the spine." This is an in vivo procedure, meaning it is performed directly on the living body during surgery.
- No Sample Analysis: The device does not analyze any samples taken from the body. It directly interacts with and stimulates tissue within the surgical field.
Therefore, the SeaSpine Monopolar Probe System falls under the category of a surgical instrument used for intraoperative nerve monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.
Product codes (comma separated list FDA assigned to the subject device)
ETN
Device Description
The SeaSpine Monopolar Probes conduct electrical stimulation to nervous tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine Monopolar Probes are insulated by a biocompatible PEEK (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to a standard intraoperative neuromonitoring monopolar stimulator that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, nervous tissue (motor nerves, spinal nerve roots), associated muscle groups
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.
Not Found
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
SeaSpine Monopolar Probe System 510(k)
510(k) Summary In accordance with 21CFR807.92 21CFR807.92(a){1}: Company Name: SeaSpine, Inc. 2302 La Mirada Drive Vista, CA 92081 Contact person: Dan Miller e-mail: dmiller@seaspine.com Phone: (760) 727-8399 Ext: 239, Fax: (760) 727-8809 Date prepared: June 13, 2011 21CFR807.92(a)(2): SeaSpine Monopolar Probe System Trade name: (Trade name has not been finalized at this time) Common name: Nerve Stimulator Surgical Nerve Stimulator/locator Classification: 21 CFR 874.1820 Class II Product Code: ETN 21CFR807.92(a)(3): Predicate Device: Manufacturer: Medtronic Xomed Trade Name: Stimulus Dissection Instruments Product Code: ETN 510(k): K014165 Manufacturer: Nuvasive Trade Name: Nuvasive Neurovision JJB System Product Code: ETN, GWF 510(k): K051718 21CFR807.92(d){4}: The SeaSpine Monopolar Probes conduct electrical stimulation to nervous Device Description: tissue that may be present in close proximity of the surgical corridor to the spine. This system is not comprised of a nerve stimulator or recorder; instead it will use conventional stimulators found in the market. The SeaSpine are insulated by a biocompatible PEEK Monopolar Probes (polyetheretherketone) layer all around one or more conductive stainless steel wire(s) with the exception of the distal and proximal ends. The distal end contacts the target tissue and the proximal end connects to standardi intraoperative neuromonitoring monopolar stimulator) that offers triggered electromyography (EMG) capability. Triggered EMG is a standard intraoperative practice where motor nerves are stimulated and their
1
21CFR807.92(0)(5): Intended use:
2.1CFR807.92(a){6}: Substantial Equivalence: corresponding muscle group response is recorded, allowing for avoidance of nervous tissue during surgical approach. The proximal connector design meets the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.
KII671
The SeaSpine Monopolar Probe System is indicated for tissue dilation and nervous tissue stimulation by means of electrical current to assess location and identification of motor nerves (including spinal nerve roots) for nervous tissue avoidance during a routine surgical approach to the spine.
The SeaSpine Monopolar Probe System has indications for use which are substantially equivalent to those of the predicate devices and other legally marketed devices. The SeaSpine Monopolar Probe System is manufactured from similar or identical materials as the predicate devices. The design features and function of the SeaSpine Monopolar Probe System are substantially equivalent or the same to predicate devices and other legally marketed devices, and the SeaSpine Monopolar Probe System does not raise any new safety or effectiveness issues.
| Technological
Characteristic | Subject Device | Medtronic
Xomed
Stimulus
Dissection
Instruments
(K014165) | Nuvasive
NeuroVision JJB
System
(K051718) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
For Use | The SeaSpine
Monopolar Probe
System is
indicated for
tissue dilation and
nervous tissue
stimulation by
means of
electrical current
to assess location
and identification
of motor nerves
(including spinal
nerve roots) for
nervous tissue
avoidance during
a routine surgical
approach to the
spine. | Tissue dissection
and stimulation of
cranial and
peripheral motor
nerves for
location and
identification
during surgery,
including spinal
nerve roots. | The NeuroVision
JJB System is used
for intraoperative
monitoring and
neurological
status assessment
by the
administration of
brief electrical
stimulus pulses to
neural tissues and
the EMG
monitoring of the
associated muscle
groups. The
system is used in
conjunction with
other Nuvasive
devices to assist
in gaining
controlled access
to, and
visualization of,
the spine. |
2
| Design | Electrical Conduit
insulated all
around with
exception to
distal tip and
proximal
connector | Electrical Conduit
insulated all
around with
exception to
distal tip and
proximal
connector | Electrical Conduit
insulated all
around with
exception to
distal tip and
proximal
connector |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Electrical
Conduction
Material | Stainless Steel | Stainless Steel | Stainless Steel
or Aluminum |
| Electrical
Patient
Contact
Surface | Stainless Steel | Stainless Steel | Stainless Steel
or Aluminum |
| Proximal
Stimulator
Connector | Yes | Yes | Yes |
| Biocompatible
plastic
electrical
insulation | Yes | Yes | Yes |
| Steam
Sterilizable
Reusable | Yes | Yes | Yes* |
*also cleared for disposable probes.
The biocompatibility of the subject device was assessed per ISO 10993. The biocompatibility of the adhesive used internally was assessed per USP Class VI testing. The probes are manufactured from stainless steel and PEEK with a long track record of use in the medical device industry and in instruments that directly contact tissue. The tissue contact duration of the SeaSpine Monopolar Probe System is brief (