AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS

K110419 · Stryker Spine · GXZ · Jul 28, 2011 · Neurology

Device Facts

• Record ID: K110419
• Device Name: AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
• Applicant: Stryker Spine
• Product Code: GXZ · Neurology
• Decision Date: Jul 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2

Intended Use

The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.

Device Story

AVS® ARIA Neuromonitoring Probe and Probe Dilators are single-use, sterile-processed instruments used during spinal surgery. Devices deliver electrical stimulation to tissues and nerves to assist surgeons in intraoperative nerve localization. NM Probe features a male 1.5mm DIN connector for integration with external neuromonitoring systems. Operated by surgeons in the OR. Output is electrical stimulus; healthcare providers use the device to identify nerve proximity, helping to avoid nerve injury during surgical procedures. Devices are provided clean and require user-performed steam sterilization prior to use.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included electromagnetic compatibility (IEC 60601-1-2:2007) and validation of steam sterilization cycles (gravity and pre-vacuum) to achieve a Sterility Assurance Level (SAL) of 10^-6 per AAMI ST79, AAMI A1, AAMI TIR 12, and ISO 17665-1.

Technological Characteristics

Monopolar electrode needles. Materials: Stainless steel (ASTM F899), PTFE (ASTM D4895), and polyphenylsulfone. Connectivity: 1.5mm DIN connector. Sterilization: Steam (prevacuum or gravity).

Indications for Use

Indicated for use during spinal surgery to deliver electrical stimulation to tissues and nerves at the operative site to assist in locating nerves at risk.

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Predicate Devices

• XPAK & XPAK II (K090838)
• Disposable Stimulator Probes (K062996)
• Probes (K850107)

Submission Summary (Full Text)

{0}------------------------------------------------

K 110419

P.1 of 2

510(k) Summary

Contact:

Date Prepared:

Device Trade Name:

Submitter:

Manufacturer:

Common Name:

Classification:

Class:

Product Code:

Kimberly Lane
Sr. Regulatory Affairs Specialist
Stryker Spine
2 Pearl Court
Allendale, NJ 07401

July 22, 2011

AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe
Dilators

Stryker Spine
2 Pearl Court
Allendale, NJ 07430

Stryker Spine
ZI de Marticot, 33610
Cestas - FRANCE

Electrode needle

21 CFR § 882.1350

II

GXZ

JUL 28 2011

#### Indications For Use:

The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.

#### Device Description:

The AVS® ARIA Neuromonitoring Probe (NM Probe) and AVS® ARIA Probe Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The NM Probe and probe dilators are available in monopolar configuration. These are made from stainless steel (NM Probe) insulated with either polytetrafluoroethylene or polyphenylsulfone (dilator tubes). The NM probe has a male 1.5mm DIN connector. The components are provided clean to users for sterilization prior to use. The components are not intended for cleaning, reprocessing, or reuse.

{1}------------------------------------------------

110419 p.2 of 2

| Reference Number | Device Name |
|------------------|------------------------------|
| 48755006 | NM Probe/Guide Wire |
| 48755001 | Dilator 1 - 6.4mm |
| 48755002 | Probe Dilator 2, NM - 14.4mm |
| 48755003 | Probe Dilator 3, NM - 22.5mm |

The NM Probe and probe dilators are provided by Stryker Spine non-sterily and must be sterilized by the end user prior to use and subsequently disposed of after use in a single case. These devices are not labeled non-pyrogenic.

## Predicate Device(s):

The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators were shown to be substantially equivalent to the below previously cleared devices and have the same indications for use, design, function, and materials used.

| 510(k) | Company Name | Device Name |
|---------|----------------------|------------------------------|
| K090838 | Axon Systems, Inc. | XPAK & XPAK II |
| K062996 | Axon Systems, Inc. | Disposable Stimulator Probes |
| K850107 | Carefusion (Nicolet) | Probes |

## Performance Standards:

The device was tested in accordance with IEC 60601-1-2: 2007 and the test results indicate that the AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are substantially equivalent to predicate devices. All stainless steel components, comply with ASTM F899 and all PTFE components comply with ASTM D4895. All devices have been validated, in both gravity and pre-vacuum, in their surgical case set for a Sterility Assurance Level (SAL) of 10 according to AAM ST 79: 2010, AAMI A1:2010, AAMI TIR 12:2010, and ISO 17665-1: 2006. The steam sterilization parameters are:

# Prevacuum (Porous Load) steam sterilization autoclave:

- Temperature: 132°C (270°F) .
- Exposure Time: ◆ 4 Minutes
- Dry Time: 20 Minutes .

# Gravity Displacement steam sterilization autoclave:

- Temperature: 132°C (270°F) .
- Exposure Time: . 15 Minutes
- Dry time: 30min. .

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in a simple, bold line drawing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Stryker Spine c/o Ms. Tiffani Rogers Regulatory Affairs Manager 2 Pearl Court Allendale, NJ 07401

JUL 28 2011

Re: K110419

Trade/Device Name: AVS ARIA Neuromonitoring Probe and AVS ARIA Probe Dilators Regulation Number: 21 CFR 882.1350 Regulation Name: Electrode Needle Regulatory Class: Class II Product Code: GXZ Dated: July 14, 2011 Received: July 15, 2011

Dear Ms. Rogers:

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. Ilsting 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.

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

{3}------------------------------------------------

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Keria Alexander

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K110419

# Device Name: AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators

The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.

Prescription Use V (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)

John Doucet

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurological and Ear,
Levices of Ophthalmic, Neurological and Ear,
Levices LTbroat (Division Sign-Off)
(Division Sign-Off) Division of Opinal Devices
Nose and Throat Devices

Nose and
510(k) Number k110419

Prescription Use

(Per 21 CFR 801.109)