(223 days)
Xian Friendship Disposable Nerve Stimulator Probes 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. Xian Friendship Disposable Nerve Stimulator Probes are sterile (EtO), single-patient-use device.
Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in three electrical configurations such as monopolar, bipolar and concentric forms according to the required application. The probes are supplied sterile and are for single use only. The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof' safety connector(s) on the distal end. Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve. The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope. Concentric Probes is designed with an outer anode pole and center cathode pole separated by insulation. Tip diameter approx 1mm. Monopolar electrodes require a separate stimulator return electrode and the Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed. Bipolar probe has a fully insulated probe shaft with two 1 mm exposed flush tips. The anode and cathode tips can spread up to 3 mm apart and will penetrate tissue for stimulation current to flow.
This device is a nerve stimulator probe, not an AI/ML device. Therefore, the requested information elements related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, training/test set sample sizes, and expert qualification for ground truth) are not applicable and cannot be extracted from the provided text.
The provided document describes a 510(k) premarket notification for a traditional medical device. The study performed is a bench test to verify that the device meets design specifications and performance characteristics, and to demonstrate substantial equivalence to predicate devices.
Here's the relevant information about the acceptance criteria and study, as it pertains to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific quantitative acceptance criteria or detailed reported performance values. Instead, it states that "Bench testing for mechanical and electrical performance was conducted to verify that the device meets design specifications and performance characteristics in accordance with Xian Friendship Disposable Nerve Stimulator Probe's internal specifications." and also to demonstrate substantial equivalence to predicate devices.
The acceptance criteria are implicitly tied to the general performance characteristics of nerve stimulator probes and the characteristics of the predicate devices. These characteristics include:
| Feature/Description | Acceptance Criteria (Implicit, based on predicates) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Perform localized stimulation of neural tissue; locate, identify, and monitor cranial motor nerves, peripheral nerves, and spinal nerve roots during surgery. | Device performs as intended, substantially equivalent to predicate devices. |
| Mechanical Performance | Meet internal design specifications for integrity, durability, and functionality (e.g., handle, shaft, tip). | Verified through bench testing against internal specifications. |
| Electrical Performance | Meet internal design specifications for electrical conductivity, insulation, and stimulation delivery. | Verified through bench testing against internal specifications. |
| Material Composition | Stainless steel (SST 304) for shaft, PTFE for insulation, Medical Grade ABS for handle, Tin Plated Copper for lead wire, Medical Grade PVC for lead wire insulation. | Same materials as predicate devices. |
| Sterilization Method | EtO | EtO |
| Single Patient Use | Yes | Yes |
| Shelf Life | 36 months | 36 months |
| Connector Type | DIN 42802 "touch-proof" safety connector | Same as predicate devices. |
| Tip Shapes | Standard tip, Ball, Flush Tip, Hook (comparable to predicates) | Standard tip, Ball, Flush Tip, Hook |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size used for the bench testing. In typical medical device bench testing for substantial equivalence, a representative sample of devices is tested, but the precise number is rarely detailed in the 510(k) summary.
- Data Provenance: The testing was conducted internally by Xi'an Friendship Medical Electronics Co., Ltd. The provenance is internal company testing, specifically for the purpose of this 510(k) submission. It is retrospective in the sense that the data was collected for assessing the manufactured device against existing specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not applicable as the study involves bench testing of a hardware device's physical and electrical properties, not clinical data requiring expert interpretation for ground truth. "Ground truth" in this context refers to engineering specifications and performance standards.
4. Adjudication Method for the Test Set
- This concept does not apply. Bench testing for mechanical and electrical performance typically involves objective measurements against predefined engineering specifications, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC study was not done. This is a traditional medical device (nerve stimulator probe) and does not involve AI or human "readers" in the context of image interpretation or similar diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is not an algorithm or AI.
7. The Type of Ground Truth Used
- The "ground truth" for this type of device study is primarily engineering specifications and established performance standards for nerve stimulator probes, as well as the characteristics and performance of the predicate devices. Compliance with these specifications (e.g., material composition, electrical output, mechanical integrity) serves as the ground truth.
8. The Sample Size for the Training Set
- This is not applicable. There is no "training set" as this device does not involve AI/ML.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable. There is no "training set" or corresponding ground truth establishment process in the context of AI/ML for this device.
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K112426
APR - 2 2012
510(k) Summary (rev.02) (per 21 CFR 807.92.(c))
1. Submitter's information
.
| Company Name | Xi'an Friendship Medical Electronics Co., Ltd. |
|---|---|
| Company Address | No.9 Gao Xin 1st Road, High-Tech Development Zone, Xi'an, Shaanxi, 710075 P.R.China |
| Contact Person | Zhai Tao (Sales Department Manager) |
| Phone Numbers | 86 29 88225200 Ext. 602 |
| Fax Numbers | 86 29 88236285georgezhai2616@163.com |
| Date Prepared | 3/27/2012 |
| Trade name | Xian Friendship Disposable Nerve Stimulator Probes |
| Devices type | 1. Disposable Monopolar Direct Nerve Stimulator Probe2. Disposable Flush Tip Direct Nerve Stimulator Probe3. Disposable Ball Tip Direct Nerve Stimulator Probe4. Disposable Direct Concentric Nerve Stimulator Probe5. Disposable Bipolar Direct Nerve Stimulator Probe6. Disposable Hook Nerve Probe(Double Hook/ Triple Hook) |
| Common Name: | Surgical Nerve Stimulator/Locator |
| Classification | Stimulator, Nerve (21. CFR 874.1820) |
| Product Code: | ETN, |
| Classification: | Class II (Performance Standards) |
| Panel: | Ear, Nose and Throat Devices |
3. Predicate Device
| Company | 510(k) number | Device Name |
|---|---|---|
| Axon Systems, Inc. | K062996 | Axon Systems DisposableStimulator Probes |
| Medtronic Xomed, Inc. | K031003 | Stimulus/Dissection InstrumentsBall-Tip Probes |
| Cadwell Laboratories, Inc. | K103128 | Cadwell Disposable StimulatorProbes |
4. Devices Description
Stimulator probes are used as the medium to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The probes are available in three electrical
.
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configurations such as monopolar, bipolar and concentric forms according to the required application. The probes are supplied sterile and are for single use only.
The probes are connected to an electrical stimulator using a flexible lead wire(s) and a "touch-proof' safety connector(s) on the distal end.
Stimulator probes are used by the surgeon to locate and identify motor nerves and spinal nerve roots and to assess nerve function. Bipolar probes may also be used to record nerve action potentials directly from the nerve.
The probes are designed with a plastic handle and stainless steel active electrode shaft insulated to the tip. The probe shaft may be bent to allow viewing access under a microscope.
Concentric Probes is designed with an outer anode pole and center cathode pole separated by insulation. Tip diameter approx 1mm.
Monopolar electrodes require a separate stimulator return electrode and the Monopolar probe is insulated to the tip with only a stimulating "ball" or "tip" exposed.
Bipolar probe has a fully insulated probe shaft with two 1 mm exposed flush tips. The anode and cathode tips can spread up to 3 mm apart and will penetrate tissue for stimulation current to flow.
5. Indications for Use
Xian Friendship Disposable Nerve Stimulator Probes 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.
Xian Friendship Disposable Nerve Stimulator Probes are sterile (EtO), single-patient-use device.
હ. Technological characteristics
Xian Friendship Disposable Nerve Stimulator Probes consist of an insulated probe shaft of various lengths mounted to plastic handle. The probe shaft is electrically connected to a DIN 42802"touch-proof' safety connector on the other end. The probe is supplied in a sterile pouch. Materials used are the same as in the predicate devices.
Xian Friendship Disposable Nerve Stimulator Probes are substantially equivalent to the predicate devices with regard to the design, construction, material, mechanical and electrical performance and application. More detail information on the Table 1.
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| Features & Description | Predicate Device | Subject Device | ||
|---|---|---|---|---|
| Product name | Axon Systems DisposableStimulator Probes | Stimulus/DissectionInstruments, Ball-TipProbes | Cadwell DisposableStimulator Probes | Xian Friendship DisposableNerve Stimulator Probes |
| 510(K) clearancenumbers | K062996 | K031003 | K103128 | |
| Manufacture | Axon Systems, Inc. | Medtronic Xomed, Inc. | Cadwell Laboratories, Inc. | Xi'an Friendship MedicalElectronics Co., Ltd. |
| Intend for use | To locate, identify andmonitor cranial motornerves, peripheralnerves and spinal nerveroots during surgery. | The Stimulus-DissectionInstruments are indicatedfor tissue dissection andstimulation of cranial andperipheral motor nervesfor location andidentification duringsurgery, including spinalnerve roots. | Cadwell DisposableStimulator Probe is used toperform localizedstimulation of neural tissueand to locate, identify andmonitor cranial motornerves, peripheral nervesand spinal nerve rootsduring surgery. | Xian Friendship DisposableNerve Stimulator Probes isused to perform localizedstimulation of neural tissueand to locate, identify andmonitor cranial motor nerves,peripheral nerves and spinalnerve roots during surgery.Xian Friendship DisposableNerve Stimulator Probes aresterile (EtO),single-patient-use device. |
| Configuration | Monopolar probeBipolar probeConcentric probe | The Cadwell DisposableStimulator Probe is asingle patient use device. | Monopolar probeBipolar probeConcentric probeTripolar probe |
able 1 Product Comparison Table(1
Section 5-3(rev.02)
:
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fable 1 Product Comparison Table(2)
| Features & Description | Predicate Device | Subject Device |
|---|---|---|
| Shape of tip | standard tip,ball,Flush Tip | Standard tip,Ball,Flush TipHook |
| Connector | DIN 42802"touch-proof' safety | Same as "Predicate Device" |
| Shaft | Stainless steelSST 304 | Stainless steelSST 304 |
| ShaftInsulation | PTFE | PTFE |
| MaterialHandle | Medical Grade ABS | Medical Grade ABS |
| Lead Wire | Tin Plated Coppe | Tin Plated Coppe |
| Lead WireInsulation | Medical Grade PVC | Medical Grade PVC |
| Single Patient Use | Sterile-Single Patient Use | Sterile-Single Patient Use |
| Method of Sterilization | EtO | EtO |
| Packaging | 1059B coating TYVEK layer+ PE/PET Medical film pouch | Same as "Predicate Device" |
| Shelf life | 36 months | 36 months |
.
Section 5-4(rev.02)
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7. Summary of Performance Data
Bench testing for mechanical and electrical performance was conducted to verify that the device meets design specifications and performance characteristics in accordance with Xian Friendship Disposable Nerve Stimulator Probe's internal specifications. In addition, bench testing was also performed to demonstrate that the Xian Friendship Disposable Nerve Stimulator Probe is substantially equivalent to the predicate devices.
8. Safety & Effectiveness
Xian Friendship Disposable Nerve Stimulator Probes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised or evident.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
APR - 2 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Xian Friendship Medical Electronics Co., Ltd. c/o Mr. Chu Xiaoan Beijing Easy Link Company Rm 1606, Bldg. 1 Jianxiang Yuan No. 209 Bei Si Hu Zhong Rd. Haidian Dis Beijing, 100083, P.R. China
Re: K112426
Trade/Device Name: Xian Friendship Disposable Nerve Stimulator Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: March 28, 2012 Received: March 28, 2012
Dear Mr. Chu Xiaoan:
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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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.
Sincerely yours,
Rea U. Thon MD
Melvin R. Feldhaus, M.D.
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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Section 4.0 Indications for Use Statement
INDICATIONS FOR USE
| Applicant: | Xi'an Friendship Medical Electronics Co., Ltd. |
|---|---|
| 510(k) Number (if known): * | K112426 |
| Device Name: | Xian Friendship Disposable Nerve Stimulator Probes |
Indications For Use:
Xian Friendship Disposable Nerve Stimulator Probes 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.
Disposable Nerve Stimulator Probes are sterile (EtO), Xian Friendship 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Z. McAlts
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Number K112426
Section 4-1
§ 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.