PHANTOM XL INSULATED DILATORS

K140088 · Tedan Surgical Innovations, LLC · PDQ · Sep 25, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K140088
• Device Name: PHANTOM XL INSULATED DILATORS
• Applicant: Tedan Surgical Innovations, LLC
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Sep 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

Phantom XL Insulated Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissue and nerves at the operative site, to assist in locating those nerves at risk during the surgical procedure.

Device Story

Phantom XL Insulated Dilators are surgical instruments used to deliver electrical stimulation to tissues and nerves during spinal surgery. The device functions as a needle electrode, allowing surgeons to identify nerves at risk of injury during the procedure. It is available in monopolar configuration with multiple diameter sizes (8mm, 13mm, 18mm, 22mm, and 22mm grooved). The 8mm version is stainless steel (fluoroscopy-visible), while larger sizes are aluminum alloy (radiolucent). The device is supplied sterile, non-pyrogenic, and for single use. It is operated by surgeons in an operating room environment. By delivering electrical stimuli, the device helps the surgeon map nerve locations, potentially reducing the risk of iatrogenic nerve damage during spinal access and instrumentation.

Clinical Evidence

Bench testing only. Performance testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993). Electrical testing confirmed low impedance, dielectric strength, temperature safety, and waveform integrity. Biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity) confirmed the device is non-cytotoxic, non-irritant, and non-toxic. Sterilization validation (ANSI/AAMI/ISO 11135-1) achieved a Sterility Assurance Level of 1x10^-6.

Technological Characteristics

Needle electrode for electrical stimulation. Materials: Stainless steel (8mm) and aluminum alloy (13-22mm). Dimensions: 8, 13, 18, 22, and 22mm grooved diameters. Sterilization: Ethylene Oxide (ANSI/AAMI/ISO 11135-1). Electrical safety: IEC 60601-1. EMC: IEC 60601-1-2. Biocompatibility: ISO 10993. Single-use, sterile, non-pyrogenic.

Indications for Use

Indicated for patients undergoing spinal surgery to assist in locating nerves at risk during the procedure.

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

• AVS® ARIA Probe Dilators (K110419)

Submission Summary (Full Text)

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

September 25, 2014

TeDan Surgical Innovations, LLC Ms. Dionicia Reblando 12615 W. Airport Blvd., Suite 200 Sugar Land, TX 77478

Re: K140088

Trade/Device Name: Phantom XL Insulated Dilators Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDQ Dated: August 25, 2014 Received: August 27, 2014

Dear Ms. Reblando:

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.

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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Carlos L. Pena -SFD/△

Carlos L. Peña, Ph.D. M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K140088

Device Name Phantom XL Insulated Dilators

Indications for Use (Describe)

Phantom XL Insulated 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.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Arial;"> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </span> |

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# 510(k) Summary

| Assigned 510(k) number: | K140088 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company: | TeDan Surgical Innovations, LLC<br>12615 W Airport Blvd, Suite 200<br>Sugar Land, TX USA 77478<br>Phone: [phone]<br>Fax: [phone] |
| Contact: | Dionicia Reblando<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | July 23, 2014 |
| Proprietary Names: | Phantom XL Insulated Dilators |
| Classification Name: | Needle electrode |
| Classification: | 21 CFR 882.1350, Class II, Product Code GXZ |
| Predicate Device: | K110419 AVS® ARIA Probe Dilators |
| Device Description: | Phantom XL Insulated Dilators are used as instruments to deliver<br>electrical stimulation to tissue during intraoperative neurological<br>monitoring. The Phantom XL Insulated Dilators are available in<br>monopolar configuration and four diameter sizes (8, 13, 18, 22 and<br>22mm Grooved). They are supplied sterile, are non-pyrogenic, and<br>are intended for single use only. The 8 mm dilators are made of<br>stainless steel and are visible under fluoroscopy, while the<br>remaining sizes are made of aluminum alloy and are radiolucent. |
| Intended Use: | Phantom XL Insulated Dilators are indicated for use during<br>surgery of the spine to deliver an electrical stimulus to the tissue<br>and nerves at the operative site, to assist in locating those nerves at<br>risk during the surgical procedure. |
| Technological<br>Comparison to Predicate<br>Device: | Phantom XL Insulated Dilators are similar to the predicate device.<br>Both are needle electrodes used to deliver an electrical stimulus to<br>tissues and nerves at the operative site. Additionally, both use the<br>same fundamental scientific technology and principle of operation.<br>Performance test results confirm that design, material, and |

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sterilization differences do not pose new issues of safety or effectiveness. Both devices attain a minimum Sterility Assurance Level of 1 X 10°

#### ELECTRICAL SAFETY TESTING Performance Testing:

Electrical safety testing was performed for the Phantom XL Insulated Dilators in accordance with the standard: IEC 60601-1 (2012) Ed 3.1; Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The following applicable tests were performed:

- 1. Impedance of current carrying connections. This test was performed to demonstrate that the Phantom XL Insulated Dilators have sufficiently low impedance so that they will not interfere with any stimulator signal passed through them.
- 2. Dielectric Strength test. This test was performed to demonstrate that the insulated portions of the Phantom XL Insulated Dilators are sufficiently separated from the conductive portions to prevent any stimulator signal from reaching any part of the Phantom XL Insulated Dilators except the intended delivery point.
- 3. Temperature test. This test was performed to demonstrate that the Phantom XL Insulated Dilators will not introduce any additional heating to the patient as part of the stimulation process.
- 4. Waveform capture. Waveform of the stimulator output was capture on an oscilloscope in 3 modes of operation. The tests were performed to demonstrate that the Phantom XL Insulated Dilators will not significantly alter the waveform.

The Phantom XL Insulated Dilators met applicable requirements set forth in the referenced standard. Electrical Safety Report 261304 for IEC 60601-1 compliance, is provided in Attachment 4.

## ELECTROMAGNETIC COMPATIBILITY

The Phantom XL Insulated Dilators underwent electromagnetic compatibility (EMC) testing in accordance with IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2:2007 General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests. The following applicable tests were performed:

- 1. Emissions tests
- 2. Immunity tests

The above tests were conducted to evaluate and verify that the Phantom XL Dilators/accessories do not impact the emission

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profile or increase the sensitivity to adverse conditions of electrical stimulus and medical monitoring equipment.

The Phantom XL Insulated Dilators met applicable requirements set forth in the referenced standard. EMC Test Report Number 2014 261304 EMC for IEC 60601-1-2:2007 compliance, is provided in Attachment 5.

## BIOCOMPATIBILITY

The biocompatibility tests for the Phantom XL Dilators were selected in accordance with blue book memorandum G95-1 entitled Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing". Biocompatibility tests were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR 58. The Table below summarizes the results of the biocompatibility testing.

| Test | Results | Conclusions |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity-ISO<br>Elution Method<br>(ISO 10993-5:2009) | No evidence of causing<br>lysis or toxicity. Reactivity<br>is less than grade 2 | Non-Cytotoxic.<br>(acceptance criteria:<br>biological reactivity<br>must be less than or<br>equal a grade 2 |
| ISO Intracutaneous<br>Study- Irritation<br>(ISO 10993-10:2010) | Observations for<br>erythema and edema. The<br>difference between each<br>test article extract overall<br>mean score and<br>corresponding control<br>extract overall mean score<br>was 0.0 and 0.2 | Non-irritant.<br>(acceptance criteria: the<br>difference between the<br>test extract overall<br>mean score and<br>corresponding control<br>overall mean score is<br>1.0 or less). |
| ISO Guinea Pig<br>Maximization<br>Sensitization Test<br>(ISO 10993-10:2010) | The test article extracts<br>showed no evidence of<br>causing delayed dermal<br>contact sensitization | Non-Sensitizer |
| ISO Systemic<br>Toxicity (acute)<br>(ISO 10993-11:2010) | There was no mortality or<br>evidence of systemic<br>toxicity from the extracts | Non-Toxic (acute-<br>systemic) |

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## STERILIZATION, BACTERIAL ENDOTOXIN AND ETHYLENE OXIDE RESIDUALS

A sterilization validation of the Phantom XL insulated dilators based on the requirements of ANSI/AAMI/ISO 11135-1:2007 was completed to assure a minimum Sterility Assurance Level of 1X106. The Table below summarizes the results of the Bacterial Endotoxin and the residual levels

| Test | Results | Conclusions |
|----------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Bacterial<br>Endotoxin | 0.720 EU/Device | a. The results passes FDA criteria for<br>both: medical device - maximum of<br>20 EU/device |
| | 0.880 EU/Device | b. device contacting cerebrospinal<br>fluid-maximum of 2.15 EU/device<br>Note: This device does not contact<br>cerebrospinal fluid. |
| | < 0.200 EU/Device' | |
| Ethylene Oxide<br>residual | Range: <0.12 – 0.15<br>mg/device | Pass the requirements of 4 mg/device |
| | Ethylene<br>Chlorohydrin<br>residual | Range: <0.10 -<br><0.15 mg/device |