BIOMET ACCESS SYSTEM
Device Facts
| Record ID | K132373 |
|---|---|
| Device Name | BIOMET ACCESS SYSTEM |
| Applicant | Biomet Spine (Aka Ebi, LLC) |
| Product Code | PDQ · Ear, Nose, Throat |
| Decision Date | Mar 27, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
Indications for Use
The Biomet probes/guidewires and dilators are intended for tissue dilation and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
Device Story
Biomet Probes/Guidewires and Dilators are surgical instruments used during spinal surgery for tissue dilation and nerve localization. The device consists of insulated probes/guidewires and dilators that connect to commercially available intraoperative neuromonitoring (IONM) equipment. The physician uses the device to deliver an electrical stimulus to peripheral nerves and spinal nerve roots. The IONM equipment detects the nerve response, allowing the surgeon to identify nerve locations and avoid injury during surgical procedures. The device is used in an operating room setting by a surgeon. The output is an electrical signal processed by the IONM system, which provides feedback to the surgeon to guide surgical navigation and decision-making, potentially reducing the risk of nerve damage.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included total resistance, system impedance, current density, and mechanical/electrical performance. Biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) performed per ISO 10993-1.
Technological Characteristics
Stainless steel construction (ASTM F899:2012) with polymeric dielectric coating. Monopolar stimulation design. Probes: 305mm length, 2.6mm OD, 0.167 cm² exposed area. Dilators: 229-254mm length, 5.8-13.8mm OD. Passive electrical connection to external IONM equipment. Sterilization via radiation (AAMI/ANSI/ISO 11137-2) or ethylene oxide (ANSI/AAMI/ISO 11135-1).
Indications for Use
Indicated for tissue dilation and stimulation of peripheral nerves, including spinal nerve roots, for location and identification during spinal surgery.
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
- Cadwell Disposable Probes (K103128)
- Cadwell Disposable Probes (K123589)
- AVS® ARIA Neuromonitoring Probe & Dilators (K110419)
- Stimulation/Dissection Instruments (K112709)
Submission Summary (Full Text)
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MAR 2 7 2014
Image /page/0/Picture/1 description: The image shows the words "BIOMET SPINE" stacked on top of each other. The word "BIOMET" is in a larger, bolder font than the word "SPINE". The words are black and the background is white.
K132373
# 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | March 24, 2014 | |
|----------------------------------|----------------------------------------------------------------------------------------------|--|
| Applicant/Sponsor: | Biomet Spine<br>399 Jefferson Road<br>Parsippany, NJ 07054 | |
| Contact Person: | Debra Bing<br>Director, Regulatory Affairs<br>Phone: 973-299-9300 x3964<br>Fax: 973-887-1347 | |
| Trade name: | Biomet Probes/Guidewires and Dilators | |
| Device Class | Class II | |
| Common Name: | Nerve Stimulator | |
| Classification Name/Product Code | Surgical Nerve Stimulator/Locator - ETN PDQ | |
| Device Panel - Regulation No.: | Ear, Nose & Throat - 21 CFR 874.1820 | |
### Device Description:
· The Biomet insulated probes/guidewires and dilators are intended to dilate tissue and be used as intraoperative neuromonitoring (IONM) stimulation accessories by connectially available IONM equipment for locating and identifying peripheral nerves including spinal nerve roots during spinal surgery. The Biomet insulated probes/guidewires have a length of 305mm, an exposed stimulation area of .167 cm², and an outer diameter of 2.6mm. The Biomet insulated dilators have a length ranging from 229mm to 254mm, an exposed stimulation are of .167 cm², an inner diameter ranging from 3.2mm to 9.8mm, and an outer diameter ranging from 5.8mm to 13.8mm.
| Predicate Device | Company Name | 510(k) # |
|--------------------------------------------|-------------------|----------|
| Cadwell Disposable Probes | Cadwell Labs Inc. | K103128 |
| Cadwell Disposable Probes | Cadwell Labs Inc. | K123589 |
| AVS® ARIA Neuromonitoring Probe & Dilators | Stryker Spine | K110419 |
| Stimulation/Dissection Instruments | Nuvasive Inc. | K112709 |
### Indications for Use:
The Biomet probes/guidewires and dilators are intended for tissue dilation and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
### Summary of Technologies:
The proposed nerve stimulators are substantially equivalent to the predicate systems with respect to intended use and indications, materials, technological characteristics, and principles of operation. The predicate nerve stimulators are used with commercially available neuromonitoring equipment to deliver an electrical stimulus to locate peripheral and spinal nerve roots during spinal surgery. They are fabricated from similar biocompatible materials and are coated with an insulating material.
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Subtantial Equivalee:
The proposed probes/guident and dilizors are substantialy equily marked neves in unakted aceves in regards to
intended use, findamental technology, mar
| Substantial Equivalency Table | | | | |
|-------------------------------------------|-----------------------|---------------------------|--------------------------------------|------------------------------------|
| | Biomet Access System | Cadwell Disposable Probes | AVS® ARIA Neuromon. Probe & Dilators | Stimulation/Dissection Instruments |
| Device Information | Subject Device | Predicate Device | Predicate Device | Predicate Device |
| Manufacturer | Biomet Spine (EBI LP) | Cadwell Labs, Inc. | Stryker Spine | Nuvasive, Inc |
| 510(k) Number | K132373Pending | K103128 / K123589 | K110419 | K112709 |
| Nerve Stimulation | ✓ | ✓ | ✓ | ✓ |
| Tissue dilation/dissection | ✓ | ✓ | ✓ | ✓ |
| Shaft Diameter | Ø2.6mm | Ø2.3mm | Ø2.1mm | n/a |
| Overall Length | 305mm | 215mm to 330mm | n/a | n/a |
| Electrical Connection | Passive | DIN | DIN | Passive |
| Monopolar | ✓ | ✓ | ✓ | ✓ |
| Outer Diameter | Ø5.8mm to Ø13.8mm | n/a | Ø6.4mm to Ø22.5mm | Ø6mm to Ø12mm |
| Inner Diameter | Ø3.2mm to Ø9.8mm | n/a | unknown | unknown |
| Overall Length | 229mm to 254mm | n/a | ~186mm to 206mm | unknown |
| Direct Electrical Connection | Passive | n/a | DIN | Passive |
| Monopolar | ✓ | n/a | ✓ | ✓ |
| Materials | | | | |
| Stainless steel | ✓ | ✓ | ✓ | ✓ |
| Polymeric dielectric coating | ✓ | ✓ | ✓ | n/a |
| Plastic handle | ✓ | n/a | n/a | n/a |
| Sterility Information | | | | |
| Sterile packed | ✓ | ✓ | ✓ | ✓ |
| Sold non-sterile | ✓ | ✓ | ✓ | ✓ |
| Principles of Operation | | | | |
| Single use | ✓ | ✓ | ✓ | ✓ |
| Neuromonitoring during surgery | ✓ | ✓ | ✓ | ✓ |
| Tissue dilation/dissection during surgery | ✓ | ✓ | ✓ | ✓ |
| Uncoated Conducting Surface Area | .167 cm² | .167 cm² | unknown | unknown |
| Charge Density Average (max) | 6.21 µC/in² | 6.21 µC/in² | unknown | unknown |
| Current Density Average (max) | 6.21 mA/in² | 6.21 mA/in² | unknown | unknown |
n/a=not applicabl denotes substantial equivalence
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## Biocompatibility:
Biocompatibility testing was conducted on the Biomet insulated probes/guidewires and dilators in accordance with the testing recommendations in ISO 10993-1 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing). The test results are summarized in the table below.
| Tests | Results | Conclusion |
|-------------------|------------------------------|-----------------------|
| Cytotoxicity | No evidence of cytotoxicity | Non-cytotoxic |
| Sensitization | No evidence of sensitization | Non-sensitizing |
| Irritation | No evidence of irritation | Non-irritant |
| Systemic Toxicity | No signs of toxicity | No systemically toxic |
| Pyrogen Test | No signs of pyrogens | Non-pyrogenic |
As shown in the table, biocompatibility testing found the Biomet insulated probes/guidewires and dilators to be non-cytotoxic, non-irritant, non-sensitizing, no systemically toxic, and non-pyrogenic.
## Performance Data:
Bench testing was conducted to demonstrate that the subject nerve stimulators are substantially equivalent to the predicate devices. The following bench testing was performed:
- . Total Resistance,
- . System Impedance,
- Current Density, and .
- Mechanical/Electrical Testing .
The results demonstrate that the subject nerve stimulators are equivalent the predicate device and do not raise any issues of safety or effectiveness. In addition, biocompatibility testing was conducted and has demonstrated that the subject nerve stimulators are biocompatible.
The Biomet probes/guidewires and dilators conform to the following standards:
### Materials
ASTM F899:2012 - Standard Specification for Wrought Stainless Steels for Surgical Instruments (Recognition List 030, Recognition No. 332)
## Sterilization
AAMI/ANSVISO 11137-2:2006 - Sterilization of Healthcare Products: Radiation- Part 2: Establishing Sterilization Dose (Recognition List 028, Recognition No. 14-225)
ANSI/AAMI ST79: 2010 & A1:2010 (Consolidated Text) - Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities (Recognition List 027. Recognition No. 14-312)
AAMI TIR 30: 2003 - A Compendium of Processes, materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices (Note: This not a FDA recognized standard but it is considered a relevant standard.)
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ANSI/AAMI/ISO 11135-1:2007 - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices (Recognition List 028, Recognition No. 14-228)
# Testing
ASTM D149: 2009 - Standard Test Method for Dielectric Breakdown Voltage and Dielectric Strength of Solid Electrical Insulating Materials at Commercial Power Frequencies (Not recognized)
ASTM D4169: 2009 - Standard Practice for Performance Testing of Shipping Containers and Systems (Recognition List 030, Recognition No. 14-300) 9-8 ASTM D5276: 1998 (2009) - Standard Test Method for Drop Test of Loaded Containers by Free Fall (Not recognized)
ASTM D999: 2008 - Standard Test Methods for Vibration Testing of Shipping Containers (Not recognized)
## Biocompatibility
ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11, Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity
FDA Good Laboratory Practice (GLP) Regulations, 21 CFR 58
"ISO 10993-1. Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing Within a Risk Management Process. 4tt ed. 2009-10-15"
## Conclusion:
The subject devices are substantially equivalent to the predicates, when used in as tissue dilators and nerve stimulators. Mechanical and electrical testing along with other supporting information sufficiently demonstrates the substantial equivalence of the subject device to the other commercially available nerve stimulators. Based on this information, the subject devices do not raise any new issues regarding the safety or efficacy, when used to dilate tissue or as a nerve locator.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20903-0002
March 27, 2014
Biomet Spine Ms. Vivian Kelly Regulatory Affairs Project Manager 399 Jefferson Road Parsippany, New Jersey 07054
Re: K132373
Trade/Device Name: Biomet Access System Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ Dated: 2/6/2014 Received: 2/7/2014
Dear Ms. Kelly:
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 mislcading.
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 device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set
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Page 2 - Ms. Vivian Kelly
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
Joyce M. Whang -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Slatement on last page.
510(k) Number (if known) K132373
#### Device Name
Biomet Probes/Guidewires and Dilators
Indications for Use (Describe)
The Biomet probestguidewires and dilators are intended for tissue dilation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[] Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line – continue on a separate page if needed.
## FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
FORM FDA 3881 (1/14)
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