(121 days)
No
The description focuses on the physical characteristics and electrical configurations of a disposable stimulator probe, with no mention of AI or ML capabilities. The performance studies described are bench tests and sterilization validation, not related to algorithmic performance.
No.
This device is designed for localized stimulation to identify and monitor nerves during surgery, which is a diagnostic or procedural aid function, not a therapeutic treatment.
Yes
The device is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery, which are diagnostic functions.
No
The device description clearly details physical probes with electrodes and insulation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery." This describes a device used in vivo (within a living organism) for direct interaction with neural tissue.
- Device Description: The description details probes with electrodes designed for electrical stimulation of tissue. This is consistent with an in vivo device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnostic purposes. The description of the Cadwell Disposable Stimulator Probe does not involve the analysis of such specimens.
Therefore, the Cadwell Disposable Stimulator Probe is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
Cadwell Disposable Stimulator Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
The Cadwell Disposable Stimulator Probe is a single patient use device.
Product codes
GXZ, ETN
Device Description
Cadwell Disposable Stimulator Probes come sterilized in three electrical configurations and multiple lengths to accommodate stimulating through cannulas during minimally invasive surgeries:
Disposable Concentric Probes -Localized stimulation due to coaxial nature of active and reference electrodes. Tip diameter approx 1mm. Particularly useful when working with a microscope. Disposable Concentric Probes may be bent by user to facilitate viewing access under a microscope.
Disposable Bipolar Probes -Both active and return electrode are built into the probe. Both tips of the Disposable Bipolar Probe must be in contact with tissue for stimulation current to flow. The Bipolar Probe will stimulate a small amount of tissue, more than Concentric Probes, but less than Monopolar probes. Disposable Bipolar Probes may be bent to facilitate viewing access under a microscope.
Disposable Monopolar Probe -The Monopolar Probe has a single active electrode and must be used in conjunction with a remote return electrode connected to the patient. The Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed. Disposable Monopolar Probes may be bent to facilitate viewing access under a microscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neural tissue, cranial motor nerves, peripheral 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)
The Cadwell Disposable Stimulator Probes were bench tested using standard measurement equipment to assure substantial equivalence in dimensions and construction to the predicate devices. This establishes safety and effectiveness equal to the predicate devices. The sterilization process was validated following EN ISO11135:2007 to demonstrate that bioburden is reduced to no survivors and a sterility assurance level (SAL) of at least 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K050325, K063729, K992869, K062549
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word is a circular graphic with a line running horizontally through the middle and a curved line intersecting it. A small registered trademark symbol is located to the right of the word.
510k Summary
| Submitter: | Cadwell Laboratories, Inc. | FEB 2 3 2011 |
|---|---|---|
| Contact Person: | Chris Bolkan | |
| Safety / Regulatory Specialist | ||
| Cadwell Laboratories, Inc. | ||
| 909 N. Kellogg Street | ||
| Kennewick, Washington 99336 | ||
| Date Prepared: | January 25, 2011 | |
| Trade Name: | Cadwell Disposable Stimulator Probes | |
| Classification Name And Number: | Class II, 21 CFR 874.1820 | |
| Product Code: | GXZ, ETN | |
| Classification Panel: | Ear, Nose and Throat | |
| Predicate Device: | Technomed .................... K050325 | |
| Technomed .................... K063729 | ||
| Axon .................... K062996 | ||
| XOMED .................... K992869 | ||
| XLTEK .................... K062549 | ||
| Medtronic Xomed .................... K031003 | ||
| Medtronic Xomed .................... K014165 | ||
| Substantial Equivalence: | The following device characteristics were compared for substantial equivalence between the predicate devices and Cadwell devices: | |
| Shaft lengthHandle LengthLead LengthTip Diameter/ExposureShaft MaterialShaft InsulationHandle MaterialLead Wire Material |
- . Lead Wire Insulation
:
1
Image /page/1/Picture/0 description: The image shows the word "CADWELL" in a bold, sans-serif font. To the left of the word is a circular graphic with a line running through it. A registered trademark symbol is located to the right of the word.
The comparison was performed for the following Cadwell / predicate combinations and the Cadwell devices were found to be substantially equivalent:
| | Cadwell Probe
Description | Axon Part
number | Medtronic
Sofamor Danik
P/N |
|--------------------------|------------------------------|---------------------|-----------------------------------|
| Part
Number/Probe→ | Ball Tip, 160 | PSP1001 | 945PSP1001 |
| 510(k) Number→ | | K062996 | K014165 |
| Feature ↓ | | | |
| Shaft length | 150-220mm | 150-220mm | 150-220mm |
| Handle Length | 110mm | 110mm | 110mm |
| Lead Length | 2000mm | 2000mm | 2000mm |
| Tip
Diameter/Exposure | Ø2.3mm | Ø2.3mm | Ø2.3mm |
| Shaft Material | SST 316 | SST 316 | SST 316 |
| Shaft Insulation | PTFE | PTFE | PTFE |
| Handle Material | Medical Grade ABS | Medical Grade ABS | Medical Grade ABS |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper | Tin Plated Copper |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | Medical Grade PVC |
| Part
| Number/Probe → | Ball Tip, 90 | PSP1000 | 945PSP1000 |
|---|---|---|---|
| 510(k) Number→ | K062996 | K014165 | |
| Feature ↓ | |||
| Shaft length | 80-150mm | 80-150mm | 80-150mm |
| Handle Length | 110mm | 110mm | 110mm |
| Lead Length | 2000mm | 2000mm | 2000mm |
| Tip | |||
| Diameter/Exposure | Ø2.3mm | Ø2.3mm | Ø2.3mm |
| Shaft Material | SST 316 | SST 316 | SST 316 |
| Shaft Insulation | PTFE | PTFE | PTFE |
| Handle Material | Medical Grade ABS | Medical Grade ABS | Medical Grade ABS |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper | Tin Plated Copper |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | Medical Grade PVC |
2
| | Cadwell Probe
Description | Axon Part
number | Medtronic
Sofamor
Danik P/N |
|--------------------------|------------------------------|---------------------|-----------------------------------|
| Part
Number/Probe→ | Standard Monopolar | MNP1001 | 945MNP1001 |
| 510(k) Number→ | | K062996 | K031003 |
| Feature ↓ | | | |
| Shaft length | 80-340mm | 80-120mm | 80-120mm |
| Handle Length | 110mm | 110mm | 110mm |
| Lead Length | 2000mm | 2000mm | 2000mm |
| Tip
Diameter/Exposure | Ø0.8 x 0.8mm exp. | Ø0.8 x 0.8mm exp. | Ø0.8 x 0.8mm exp. |
| Shaft Material | SST 316 | SST 316 | SST 316 |
| Shaft Insulation | PTFE | PTFE | PTFE |
| Handle Material | Medical Grade ABS | Medical Grade ABS | Medical Grade ABS |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper | Tin Plated Copper |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | Medical Grade PVC |
| Part
| Number/Probe→ | Bipolar | BNP2001 | 945BNP2001 |
|---|---|---|---|
| 510(k) Number→ | K062996 | K031003 | |
| Feature ↓ | |||
| Shaft length | 80-120mm | 80-120mm | 80-120mm |
| Handle Length | 110mm | 110mm | 110mm |
| Lead Length | 2000mm | 2000mm | 2000mm |
| Tip | |||
| Diameter/Exposure | 2mm exp. | 2mm exp. | 2mm exp. |
| Shaft Material | SST 316 | SST 316 | SST 316 |
| Shaft Insulation | PTFE | PTFE | PTFE |
| Handle Material | Medical Grade ABS | Medical Grade ABS | Medical Grade ABS |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper | Tin Plated Copper |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | Medical Grade PVC |
3
Image /page/3/Picture/0 description: The image shows the word "CADWELL" in a bold, sans-serif font. To the left of the word is a circular graphic with a stylized waveform inside. A registered trademark symbol is present to the right of the word. The text and graphic are all in black against a white background.
| | Cadwell Probe
Description | Axon Part
number | Medtronic
Sofamor
Danik P/N |
|--------------------------|------------------------------|--------------------------|-----------------------------------|
| Part
Number/Probe→ | Flush Tip
Monopolar | FTP1001 | 945FTP1001 |
| 510(k) Number→ | | K062996 | K031003 |
| Feature ↓ | | | |
| Shaft length | 80-150mm | 80-150mm | 80-150mm |
| Handle Length | 110mm | 110mm | 110mm |
| Lead Length | 2000mm | 2000mm | 2000mm |
| Tip
Diameter/Exposure | Ø0.8mm x 0-0.3mm exp. | Ø0.8mm x 0-0.3mm
exp. | Ø0.8mm x 0-0.3mm
exp. |
| Shaft Material | SST 316 | SST 316 | SST 316 |
| Shaft Insulation | PTFE | PTFE | PTFE |
| Handle Material | Medical Grade ABS | Medical Grade ABS | Medical Grade ABS |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper | Tin Plated Copper |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | Medical Grade PVC |
| Part
| Number/Probe → | Concentric | CNP2001 | 945CNP2001 |
|---|---|---|---|
| 510(k) Number→ | K062996 | K031003 | |
| Feature ↓ | |||
| Shaft length | 80-120mm | 80-120mm | 80-120mm |
| Handle Length | 110mm | 110mm | 110mm |
| Lead Length | 2000mm | 2000mm | 2000mm |
| Tip | |||
| Diameter/Exposure | Ø1.3mm x 0-0.3mm exp. | Ø1.3mm x 0-0.3mm | |
| exp. | Ø1.3mm x 0-0.3mm | ||
| exp. | |||
| Shaft Material | SST 316 | SST 316 | SST 316 |
| Shaft Insulation | PTFE | PTFE | PTFE |
| Handle Material | Medical Grade ABS | Medical Grade ABS | Medical Grade ABS |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper | Tin Plated Copper |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | Medical Grade PVC |
ﺮ ﺍ
4
Device Testing: The Cadwell Disposable Stimulator Probes were bench tested using standard measurement equipment to assure substantial equivalence in dimensions and construction to the predicate devices. This establishes safety and effectiveness equal to the predicate devices. The sterilization process was validated following EN ISO11135:2007 to demonstrate that bioburden is reduced to no survivors and a sterility assurance level (SAL) of at least 10-6. Device Description: Cadwell Disposable Stimulator Probes come sterilized in three electrical configurations and multiple lengths to accommodate stimulating through cannulas during minimally invasive surgeries: Disposable Concentric Probes -Localized stimulation due to coaxial nature of active and reference electrodes. Tip diameter approx 1mm. Particularly useful when working with a microscope. Disposable Concentric Probes may be bent by user to facilitate viewing access under a microscope. Disposable Bipolar Probes -Both active and return electrode are built into the probe. Both tips of the Disposable Bipolar Probe must be in contact with tissue for stimulation current to flow. The Bipolar Probe will stimulate a small amount of tissue, more than Concentric Probes, but less than Monopolar probes. Disposable Bipolar Probes may be bent to facilitate viewing access under a microscope. Disposable Monopolar Probe -The Monopolar Probe has a single active electrode and must be used in conjunction with a remote return electrode connected to the patient. The Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed. Disposable Monopolar Probes may be bent to facilitate viewing access under a microscope.
5
510k Summary
Indications for Use: Cadwell Disposable Stimulator Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery. The Cadwell Disposable Stimulator Probe is a single patient use device. Conclusion: Cadwell's Disposable Stimulator Probe is equivalent to chosen devices in design, materials and packaging and other characteristics of the predicate devices.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cadwell Labs, Incorporated c/o Mr. Chris Bolkan Product Safety/Regulatory Affairs 909 North Kellogg Street Kennewick, Washington 99336
FEB 2 3 2011
Re: K103128
Trade/Device Name: Cadwell Disposable Monopolar/Bipolar/Concentric/ Flush Tip/ Ball
Tip Probe Regulation Number: 21 CFR 874.1820 Regulation Name: Nerve Stimulator Regulatory Class: Class II Product Code: ETN Dated: December 16, 2010 Received: December 21, 2010
Dear Mr. Bolkan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
7
Page 2 - Mr. Chris Bolkan
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourceforYourIndustry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/7/Picture/7 description: The image contains a handwritten word "for" in cursive script. The letter 'f' has a descending loop that extends below the baseline, and the 'o' and 'r' are connected with a smooth curve. The writing appears to be done with a pen or marker, and the strokes vary in thickness.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/8/Picture/0 description: The image shows the word "CADWELL" in a bold, sans-serif font. To the left of the word is a circular symbol with a white line running through it, resembling an electrocardiogram (ECG) waveform. The letters of the word are closely spaced together, creating a solid block of text.
Cadwell Disposable Stimulator Probe Indications for Use
510(k) Number (if known): K_103128
Cadwell Disposable Stimulator Probe Device Name:
Indications for Use:
Cadwell Disposable Stimulator Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.
The Cadwell Disposable Stimulator Probe is a single patient use device.
Prescription Use___ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Hoffman
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page_l_of_l_
K103128 510(k) Number