XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES

K112426 · Xian Friendship Medical Electronics Co., Ltd. · ETN · Apr 2, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K112426
• Device Name: XIAN FRIENDSHIP DISPOSABLE NERVE STIMULATOR PROBES
• Applicant: Xian Friendship Medical Electronics Co., Ltd.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Apr 2, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Disposable nerve stimulator probes deliver electrical stimulation to tissue during intraoperative neurological monitoring. Probes feature plastic handles, stainless steel (SST 304) active electrode shafts insulated with PTFE, and DIN 42802 touch-proof safety connectors. Configurations include monopolar, bipolar, concentric, and hook (double/triple) designs. Surgeons use probes to locate, identify, and monitor motor nerves and spinal nerve roots; bipolar probes may also record nerve action potentials. Probes are used in surgical settings; the shaft may be bent for microscopic access. Output is electrical stimulation current. Benefits include improved nerve identification and functional assessment during surgery, reducing risk of nerve damage.

Clinical Evidence

Bench testing only. Mechanical and electrical performance testing verified design specifications and confirmed substantial equivalence to predicate devices.

Technological Characteristics

Insulated stainless steel (SST 304) probe shaft; PTFE insulation; medical grade ABS handle; tin-plated copper lead wire with medical grade PVC insulation; DIN 42802 touch-proof connector. Configurations: monopolar, bipolar, concentric, tripolar. Sterilization: EtO. Single-patient use.

Indications for Use

Indicated for localized stimulation of neural tissue to locate, identify, and monitor cranial motor nerves, peripheral nerves, and spinal nerve roots during surgery. For use in patients undergoing surgical procedures requiring nerve monitoring.

Regulatory Classification

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.

Predicate Devices

• Axon Systems Disposable Stimulator Probes (K062996)
• Stimulus/Dissection Instruments, Ball-Tip Probes (K031003)
• Cadwell Disposable Stimulator Probes (K103128)

Submission Summary (Full Text)

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# K112426

APR - 2 2012

## 510(k) Summary (rev.02) (per 21 CFR 807.92.(c))

### 1. Submitter's information

2.

.

| 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 88236285<br>[e-mail] |
| Date Prepared | 3/27/2012 |
| Trade name | Xian Friendship Disposable Nerve Stimulator Probes |
| Devices type | 1. Disposable Monopolar Direct Nerve Stimulator Probe<br>2. Disposable Flush Tip Direct Nerve Stimulator Probe<br>3. Disposable Ball Tip Direct Nerve Stimulator Probe<br>4. Disposable Direct Concentric Nerve Stimulator Probe<br>5. Disposable Bipolar Direct Nerve Stimulator Probe<br>6. 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 Disposable<br>Stimulator Probes |
| Medtronic Xomed, Inc. | K031003 | Stimulus/Dissection Instruments<br>Ball-Tip Probes |
| Cadwell Laboratories, Inc. | K103128 | Cadwell Disposable Stimulator<br>Probes |

#### 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 Disposable<br>Stimulator Probes | Stimulus/Dissection<br>Instruments, Ball-Tip<br>Probes | Cadwell Disposable<br>Stimulator Probes | Xian Friendship Disposable<br>Nerve Stimulator Probes |
| 510(K) clearance<br>numbers | K062996 | K031003 | K103128 | |
| Manufacture | Axon Systems, Inc. | Medtronic Xomed, Inc. | Cadwell Laboratories, Inc. | Xi'an Friendship Medical<br>Electronics Co., Ltd. |
| Intend for use | To locate, identify and<br>monitor cranial motor<br>nerves, peripheral<br>nerves and spinal nerve<br>roots during surgery. | The Stimulus-Dissection<br>Instruments are indicated<br>for tissue dissection and<br>stimulation of cranial and<br>peripheral motor nerves<br>for location and<br>identification during<br>surgery, including spinal<br>nerve roots. | Cadwell Disposable<br>Stimulator Probe is used to<br>perform localized<br>stimulation of neural tissue<br>and to locate, identify and<br>monitor cranial motor<br>nerves, peripheral nerves<br>and spinal nerve roots<br>during surgery. | Xian Friendship Disposable<br>Nerve Stimulator Probes is<br>used to perform localized<br>stimulation of neural tissue<br>and to locate, identify and<br>monitor cranial motor nerves,<br>peripheral nerves and spinal<br>nerve roots during surgery.<br>Xian Friendship Disposable<br>Nerve Stimulator Probes are<br>sterile (EtO),<br>single-patient-use device. |
| Configuration | | Monopolar probe<br>Bipolar probe<br>Concentric probe | The Cadwell Disposable<br>Stimulator Probe is a<br>single patient use device. | Monopolar probe<br>Bipolar probe<br>Concentric probe<br>Tripolar 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,<br>ball,<br>Flush Tip | Standard tip,<br>Ball,<br>Flush Tip<br>Hook |
| Connector | DIN 42802"touch-proof' safety | Same as "Predicate Device" |
| Shaft | Stainless steel<br>SST 304 | Stainless steel<br>SST 304 |
| Shaft<br>Insulation | PTFE | PTFE |
| Material<br>Handle | Medical Grade ABS | Medical Grade ABS |
| Lead Wire | Tin Plated Coppe | Tin Plated Coppe |
| Lead Wire<br>Insulation | 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 |

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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 [phone] or [phone] 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