(121 days)
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.
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.
The information primarily discusses the substantial equivalence of Cadwell Disposable Stimulator Probes to predicate devices. It provides detailed comparisons of physical characteristics.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a device that provides an output like a diagnostic algorithm. Instead, it defines "substantial equivalence" as the acceptance criterion, which is met by demonstrating that the Cadwell probes have similar physical and material characteristics to existing predicate devices.
| Feature | Acceptance Criteria (Predicate Devices) | Reported Device Performance (Cadwell Probe) |
|---|---|---|
| Shaft length | 80-340mm (varies by probe type) | 80-340mm (varies by probe type) |
| Handle Length | 110mm | 110mm |
| Lead Length | 2000mm | 2000mm |
| Tip Diameter/Exposure | Varies by probe type (e.g., Ø2.3mm, Ø0.8x0.8mm exp.) | Varies by probe type (e.g., Ø2.3mm, Ø0.8x0.8mm exp.) |
| Shaft Material | SST 316 | SST 316 |
| Shaft Insulation | PTFE | PTFE |
| Handle Material | Medical Grade ABS | Medical Grade ABS |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC |
| Sterility Assurance Level (SAL) | Not explicitly stated for predicates, but implied safe | At least 10^-6 (validated following EN ISO11135:2007) |
2. Sample Size Used for the Test Set and Data Provenance:
The study is not a clinical trial or algorithm performance study with a "test set" in the traditional sense of AI/diagnostic device evaluation. It is a comparison of physical device specifications. Therefore, information about "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The "test" involved bench testing of the Cadwell probes themselves against the specifications of the predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Ground truth in this context means the established specifications of the predicate devices. These specifications are likely derived from engineering designs and regulatory approvals, not from expert consensus on medical images or patient outcomes. Therefore, information about "number of experts" and their "qualifications" for establishing ground truth is not applicable.
4. Adjudication Method:
Since the study is a comparison of physical specifications rather than an interpretation task, an "adjudication method" (like 2+1 or 3+1) is not applicable. The comparison is against objective measurements and declared specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study is focused on the physical characteristics and materials of a stimulator probe, not on the interpretative performance of human readers or AI algorithms. As such, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.
6. Standalone (Algorithm Only) Performance Study:
No, a standalone performance study was not done. This device is a physical medical instrument (a stimulator probe), not an AI algorithm or software device.
7. Type of Ground Truth Used:
The "ground truth" for this study is the established specifications and characteristics of legally marketed predicate devices as declared in their 510(k) notifications or product documentation, combined with bench testing measurements of the Cadwell device's physical attributes and functionality (like sterility). It is not expert consensus, pathology, or outcomes data, as this is a device for stimulation, not diagnosis.
8. Sample Size for the Training Set:
This concept is not applicable as the document describes the substantial equivalence of a physical medical device, not an AI model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This concept is not applicable for the same reason as point 8.
In summary, the provided document describes a 510(k) submission for substantial equivalence based on a comparison of physical device characteristics and materials, supported by bench testing and sterilization validation, rather than a performance study of a diagnostic algorithm or AI system.
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510k Summary
| Submitter: | Cadwell Laboratories, Inc. | FEB 2 3 2011 |
|---|---|---|
| Contact Person: | Chris BolkanSafety / Regulatory SpecialistCadwell Laboratories, Inc.909 N. Kellogg StreetKennewick, 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 .................... K050325Technomed .................... K063729Axon .................... K062996XOMED .................... K992869XLTEK .................... K062549Medtronic Xomed .................... K031003Medtronic 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
:
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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 ProbeDescription | Axon Partnumber | MedtronicSofamor DanikP/N | |
|---|---|---|---|
| PartNumber/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 |
| TipDiameter/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 |
| PartNumber/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 |
| TipDiameter/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 |
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| Cadwell ProbeDescription | Axon Partnumber | MedtronicSofamorDanik P/N | |
|---|---|---|---|
| PartNumber/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 |
| TipDiameter/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 |
| PartNumber/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 |
| TipDiameter/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 |
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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 ProbeDescription | Axon Partnumber | MedtronicSofamorDanik P/N | |
|---|---|---|---|
| PartNumber/Probe→ | Flush TipMonopolar | 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 |
| TipDiameter/Exposure | Ø0.8mm x 0-0.3mm exp. | Ø0.8mm x 0-0.3mmexp. | Ø0.8mm x 0-0.3mmexp. |
| 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 |
| PartNumber/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 |
| TipDiameter/Exposure | Ø1.3mm x 0-0.3mm exp. | Ø1.3mm x 0-0.3mmexp. | Ø1.3mm x 0-0.3mmexp. |
| 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
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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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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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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
§ 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.