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.

Device Description

Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes (8, 13, 18, 22 and 22mm Grooved). They are supplied sterile, are non-pyrogenic, and are intended for single use only. The 8 mm dilators are made of stainless steel and are visible under fluoroscopy, while the remaining sizes are made of aluminum alloy and are radiolucent.

AI/ML Overview

The provided document appears to be a 510(k) premarket notification for a medical device called "Phantom XL Insulated Dilators." It details various performance tests conducted to demonstrate the device's safety and effectiveness and its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Electrical Safety	Impedance of current carrying connections	To have sufficiently low impedance so that they will not interfere with any stimulator signal passed through them.	Met applicable requirements (per IEC 60601-1)
	Dielectric Strength Test	To be 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.	Met applicable requirements (per IEC 60601-1)
	Temperature Test	Not to introduce any additional heating to the patient as part of the stimulation process.	Met applicable requirements (per IEC 60601-1)
	Waveform capture	Not to significantly alter the waveform of the stimulator output.	Met applicable requirements (per IEC 60601-1)
Electromagnetic Compatibility	Emissions tests	Not to impact the emission profile of electrical stimulus and medical monitoring equipment.	Met applicable requirements (per IEC 60601-1-2)
	Immunity tests	Not to increase the sensitivity to adverse conditions of electrical stimulus and medical monitoring equipment.	Met applicable requirements (per IEC 60601-1-2)
Biocompatibility	Cytotoxicity (ISO Elution Method)	Biological reactivity must be less than or equal to a grade 2.	No evidence of causing lysis or toxicity. Reactivity is less than grade 2. (Non-Cytotoxic)
	ISO Intracutaneous Study (Irritation)	The difference between the test extract overall mean score and corresponding control overall mean score is 1.0 or less.	Difference between test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.2. (Non-irritant)
	ISO Guinea Pig Maximization Sensitization Test	No evidence of causing delayed dermal contact sensitization.	Showed no evidence of causing delayed dermal contact sensitization. (Non-Sensitizer)
	ISO Systemic Toxicity (acute)	No mortality or evidence of systemic toxicity from the extracts.	No mortality or evidence of systemic toxicity from the extracts. (Non-Toxic)
Sterilization & Residuals	Sterilization Validation	A minimum Sterility Assurance Level (SAL) of 1 x 10-6.	Completed to assure a minimum SAL of 1 x 10-6.
	Bacterial Endotoxin	FDA criteria for medical device: maximum of 20 EU/device. (Also criteria for device contacting cerebrospinal fluid: maximum of 2.15 EU/device, though noted as N/A for this device).	0.720 EU/Device, 0.880 EU/Device, < 0.200 EU/Device. (Passes FDA criteria)
	Ethylene Oxide residual	4 mg/device.	Range: <0.12 - 0.15 mg/device. (Passes)
	Ethylene Chlorohydrin residual	(Implicitly, to be within acceptable limits for a residual).	Range: <0.10 - <0.15 mg/device.

2. Sample size used for the test set and the data provenance:

The document does not specify sample sizes for most performance tests (e.g., how many dilators were tested for electrical safety, EMC, or sterilization residuals).
For biocompatibility, the tests were conducted consistent with ISO 10993 standards, which generally outline sample size requirements, but the specific numbers for each test are not explicitly stated in this summary.
Data provenance: Prospective, as these tests were performed specifically for the 510(k) submission to demonstrate the device's characteristics. The country of origin of the data is not specified, but the testing adhered to international standards (IEC, ISO) and U.S. GLP regulations (21 CFR 58), implying a globally recognized testing methodology.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable (N/A) to the types of studies described. The studies are engineering and biological bench tests/laboratory tests, not diagnostic studies that would require expert human review for ground truth establishment. For example, for cytotoxicity, the "ground truth" is determined by observing cell lysis or toxicity in a lab setting, not by expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image-based diagnostic studies where human experts are making judgments that need to be reconciled for ground truth. The studies described here are objective, quantifiable physical and biological tests.

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:

This information is N/A. The "Phantom XL Insulated Dilators" are a surgical instrument for nerve localization during spine surgery using electrical stimulation. They are not an AI-powered diagnostic device, nor are they a device that involves human "readers" or interpretations in the way an AI diagnostic tool would. Therefore, an MRMC study or an assessment of AI-assisted human performance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is N/A. As explained above, this is a physical medical device (surgical dilators) and not an algorithmic or AI-based system that would have "standalone" performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the electrical safety, EMC, and sterilization studies, the "ground truth" is established by objective measurements against predefined technical standards (e.g., specific voltage limits, impedance values, temperature increases, bacterial endotoxin concentration, residual levels).
For biocompatibility, the "ground truth" is established through laboratory observations and measurements of biological responses (e.g., cell lysis, erythema, edema, signs of sensitization or systemic toxicity in animal models) compared against documented acceptable biological response criteria from international standards.

8. The sample size for the training set:

This information is N/A. The device is not an AI/ML-based system that requires a "training set." It's a physical medical device.

9. How the ground truth for the training set was established:

This information is N/A for the same reason as point 8.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, possibly representing health and well-being. The logo is black and white.

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

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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

Indications for Use

510(k) Number (if known) K140088

Device Name Phantom XL Insulated Dilators

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

Assigned 510(k) number:	K140088
Company:	TeDan Surgical Innovations, LLC12615 W Airport Blvd, Suite 200Sugar Land, TX USA 77478Phone: 650-631-4515Fax: 650-631-4555
Contact:	Dionicia ReblandoPhone: 858-472-5160Email: jreblando@yahoo.com
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 deliverelectrical stimulation to tissue during intraoperative neurologicalmonitoring. The Phantom XL Insulated Dilators are available inmonopolar configuration and four diameter sizes (8, 13, 18, 22 and22mm Grooved). They are supplied sterile, are non-pyrogenic, andare intended for single use only. The 8 mm dilators are made ofstainless steel and are visible under fluoroscopy, while theremaining sizes are made of aluminum alloy and are radiolucent.
Intended Use:	Phantom XL Insulated Dilators are indicated for use duringsurgery of the spine to deliver an electrical stimulus to the tissueand nerves at the operative site, to assist in locating those nerves atrisk during the surgical procedure.
TechnologicalComparison to PredicateDevice:	Phantom XL Insulated Dilators are similar to the predicate device.Both are needle electrodes used to deliver an electrical stimulus totissues and nerves at the operative site. Additionally, both use thesame fundamental scientific technology and principle of operation.Performance test results confirm that design, material, and

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

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.
1. 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.
1. 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.
1. 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
1. Immunity tests

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

{5}------------------------------------------------

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-ISOElution Method(ISO 10993-5:2009)	No evidence of causinglysis or toxicity. Reactivityis less than grade 2	Non-Cytotoxic.(acceptance criteria:biological reactivitymust be less than orequal a grade 2
ISO IntracutaneousStudy- Irritation(ISO 10993-10:2010)	Observations forerythema and edema. Thedifference between eachtest article extract overallmean score andcorresponding controlextract overall mean scorewas 0.0 and 0.2	Non-irritant.(acceptance criteria: thedifference between thetest extract overallmean score andcorresponding controloverall mean score is1.0 or less).
ISO Guinea PigMaximizationSensitization Test(ISO 10993-10:2010)	The test article extractsshowed no evidence ofcausing delayed dermalcontact sensitization	Non-Sensitizer
ISO SystemicToxicity (acute)(ISO 10993-11:2010)	There was no mortality orevidence of systemictoxicity from the extracts	Non-Toxic (acute-systemic)

{6}------------------------------------------------

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
BacterialEndotoxin	0.720 EU/Device	a. The results passes FDA criteria forboth: medical device - maximum of20 EU/device
	0.880 EU/Device	b. device contacting cerebrospinalfluid-maximum of 2.15 EU/deviceNote: This device does not contactcerebrospinal fluid.
	< 0.200 EU/Device'
Ethylene Oxideresidual	Range: <0.12 – 0.15mg/device	Pass the requirements of 4 mg/device
	EthyleneChlorohydrinresidual	Range: <0.10 -<0.15 mg/device

Regulation Number and Section

§ 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.