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

TSI's Phantom XL Insulated Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. Phantom XL Insulated Dilators are available in monopolar configuration and four diameter sizes. They are supplied sterile, are non-pyrogenic, and are intended for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Phantom XL Insulated Dilators". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific performance metrics like sensitivity, specificity, or AUC.

Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device performance studies (which would involve metrics like sensitivity, specificity, human reader performance, etc.) is not applicable to this submission.

This submission focuses on engineering-level performance testing to demonstrate that changes made to the existing predicate device (Phantom XL Insulated Dilators, K140088) do not raise new questions of safety or effectiveness. The changes are minor:

Change in packaging: from backer card/Tyvek pouch/Shelf Box to preformed tray sealed in Tyvek Lid placed in Shelf Box.
Extended shelf life: from 2 years to 5 years.

The acceptance criteria and studies described relate to these specific physical changes and their impact on the device's ability to maintain sterility, packaging integrity, and functionality over its extended shelf life.

Here's a breakdown of the information provided, reframed to fit the context of this 510(k) submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way one might expect for a diagnostic or AI device (e.g., sensitivity > X%, specificity > Y%). Instead, it lists the types of changes made to the device and the standards/tests performed to ensure these changes do not negatively impact safety and effectiveness. The "acceptance criteria" are implied by compliance with the referenced ASTM, ISO, and AAMI standards. The "reported device performance" is that the device "demonstrates that the TSI Phantom XL Dilators are safe for use perform comparably to the predicate device that is currently marketed for the same intended use" after these tests.

Type of Change	Description of Tests Performed (Implied Acceptance Criteria: Compliance with these standards)	Reported Device Performance (Summary)
Packaging	- ASTM F1886:2016 (Visual Inspection for Seal Integrity)	The new packaging design maintains integrity and sterility, demonstrating satisfactory verification and validation in compliance with Design Control Process.
	- ASTM F2096-11 (Gross Leaks by Internal Pressurization)
	- ASTM F88/F88M-21, 2021 (Seal Strength of Flexible Barrier Materials)
	- Dupont Medical Packaging (Compliance of Tyvek to ISO 11607)
	- ASTM D4169:2022 (Performance Testing of Shipping Containers and Systems)
	- ISTA 3A: 2018 (Packaged-Products for Parcel Delivery System Shipments)
	- ISO 11607-2:2019 (Validation requirements for sealing and assembly processes)
	- ISO 16269-6:2014 (Statistical tolerance intervals)
Expiration Date	- ASTM F1980; 2021 (Accelerated Aging of Sterile Medical Device Packages)	Extended shelf life from 2 to 5 years is supported by accelerated aging studies, showing safety and effectiveness are maintained over the longer period.
Sterilization	- ISO 11607-1:2019 (Requirements for materials, sterile barrier systems, packaging)	Sterility (maintaining SAL) with the new packaging and extended shelf life is confirmed through bench testing and compliance with relevant standards.
	- AAMI/ISO TIR16775: 2014 (Guidance on application of ISO 11607-1 & 11607-2)
	- AAMI TIR28:2016 (Product adoption and process equivalency for EtO sterilization)
	- ANSI/AAMI ST67:2019 (Selecting a sterility assurance level (SAL))
	- ANSI/AAMI/ISO 11135:2014 (Ethylene oxide sterilization process validation)
	- ANSI/AAMI ST72; 2019 (Bacterial Endotoxins-Test methods)
General	- Bench testing for sterility (as per standards above)	No new issues of safety or effectiveness were identified. All risk mitigations were satisfactorily verified and validated.
	- Bench testing for new expiration dating (as per standards above)
	- Bench testing for packaging integrity (as per standards above)
	- Compliance with company's Design Control process (21 CFR Part 820.30)
	- Risk analysis per ISO 14971 Standard

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

The document does not specify exact sample sizes for each test listed (e.g., how many packages were tested for seal strength). The studies mentioned are engineering/bench tests on the device and its packaging components, not human subject studies. Therefore, "data provenance" in terms of country of origin or retrospective/prospective is not relevant here.

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

This is not applicable. The "ground truth" for this type of submission is defined by the technical specifications of the device and its packaging, and ensuring compliance with recognized industry standards (ASTM, ISO, AAMI). There is no "ground truth" to be established by medical experts (e.g., radiologists interpreting images) as this is not a diagnostic device with performance metrics relying on human interpretation. The testing is performed by engineers and technicians following standard protocols.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when there's ambiguity in establishing a ground truth (e.g., for disease diagnosis from images) or for resolving disagreements among multiple human readers. This submission describes physical and performance tests against standards, not diagnostic performance.

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 is not applicable. This device is a surgical instrument (an insulated dilator used for nerve stimulation/localization during spine surgery), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

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

This is not applicable. As stated above, this is a surgical instrument, not an algorithm or AI device.

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

The "ground truth" in this context is the compliance with established engineering and medical device standards (ASTM, ISO, AAMI). For example, for packaging, the "ground truth" is that the seal strength meets the requirements specified by ASTM F88, or that the sterility assurance level (SAL) meets the requirements of ANSI/AAMI ST67 after ethylene oxide sterilization. It's about meeting predefined technical specifications and standards, not a medical condition.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI or machine learning model. There is no "training set."

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

This is not applicable. As there is no training set for an AI or ML model, this question does not apply.

Summary

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June 29, 2023

TeDan Surgical Innovations, Inc. Lynne Davies Vice President, Regulatory Affairs and Quality Assurance 12320 Cardinal Meadow Dr. Ste. 150 Sugar Land, TX 77478

Re: K231691

Trade/Device Name: Phantom XL Insulated Dilators Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: PDQ Dated: June 7, 2023 Received: June 9, 2023

Dear Lynne Davies:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) not assigned

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)

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K231691

	510(k) Summary
Submitter:	TeDan Surgical Innovations, Inc.12320 Cardinal Meadow DriveSuite 150Sugar Land, Texas 77478 USA
Contact Person	Lynne DaviesVice President, Regulatory Affairs and Quality Assurance
Telephone:	713-726-0886
Submission Date:	June 7, 2023
Device Name:	Phantom XL Insulated Dilators
Common Name:	Needle electrode
Regulatory Class:	II
Classification Name:	Neurosurgical nerve locator, 21 CFR 874.1820 (PDQ)

A. Predicate Device

The predicate device is the Phantom XL Insulated Dilators (K140088) also manufactured by TeDan Surgical Innovations, Inc.

B. Device Description

C. Indications for Use

TSI's 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.

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D. Comparison of Technological Characteristics with the Predicate Device

The following technological differences exist between the subject and predicate devices:

. Change in packaging from backer card/Tyvek pouch/Shelf Box configuration to preformed tray sealed in Tyvek Lid placed in Shelf Box
Extended shelf life from 2 years to 5 years .

Device Name	Predicate DevicePhantom XL InsulatedDilatorsK140088	Subject DevicePhantom XL Insulated DilatorsK231619
Manufacturer	TeDan SurgicalInnovations	TeDan Surgical Innovations
510(k) number	K140088	K231619
Regulation	21CFR 882.1350,(GZX)and 21 CFR 874.1820(PDQ)	21 CFR 874.1820
Review panel	Neurology	Neurology
Product code	Initially filed as GXZ,subsequently changed toPDQ	PDQ
Regulationdescription	Needle electrode	Surgical nerve stimulator/locator.
Classification	Class II	Class II
Indication for useand Intended use	Phantom XL InsulatedDilators are indicatedfor use during surgery ofthe spine to deliver anelectrical stimulus to thetissues and nerves at theoperative site, to assistin locating those nervesat risk during thesurgical procedure.	Phantom XL Insulated Dilators areindicated for use during surgery of thespine to deliver an electrical stimulus tothe tissues and nerves at the operativesite, to assist in locating those nerves atrisk during the surgical procedure.
Biocompatibility	Compliant with ISO10993 for contact oflimited duration	Compliant with ISO 10993 forcontact of limited duration
Sterile	Yes; EtO	Yes; EtO
Single Use	Yes	Yes
Shelf Life	2 years	5 years
Device Name	Predicate DevicePhantom XL InsulatedDilatorsK140088	Subject DevicePhantom XL Insulated DilatorsK231619
Principle of Operation	Used as instrument todeliver electricalstimulation to tissueduring neurologicalmonitoring	Used as instrument to deliver electricalstimulation to tissue during neurologicalmonitoring
Polarity ofstimulation	Monopolar	Monopolar
Exposedarea ofstimulation	Tissues and nerves at theoperative site selected bythe user	Tissues and nerves at the operative siteselected by the user
ElectricalSafety	Compliant with IEC60601-1	Compliant with IEC 60601-1
Packaging	Product is loaded intobacker cards and sealedin a Tyvek Pouch; Pouchis placed in Shelf Box;compliant with applicableASTM standards	Product is loaded into preformed trayand sealed in a Tyvek Lid; Tray isplaced in Shelf Box; compliant withapplicable ASTM standards

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E. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Type of change	Description of Tests
Packaging	ASTM F1886:2016, Standard Test Method for Determining Integrity ofSeals for Medical Packaging by Visual Inspection
	ASTM F2096-11, Standard test method for detecting Gross Leaks inPackaging by internal Pressurization
	ASTM F88/F88M-21,2021, Standard Test Method for Seal Strength ofFlexible Barrier Materials
	(Dupont Medical Packaging, Description of Documents Supporting theCompliance of Tyvek to ISO 11607 Standard)
	ASTM D4169:2022, Standard Practices for Performance Testing ofShipping Containers and Systems
	ISTA 3A: 2018, Packaged-Products for Parcel Delivery SystemShipments 70kg (150lb) or Less
	ISO 11607-2:2019, Packaging for terminally sterilized medical devices-Part 2: Validation requirements for sealing and assembly processes
	ISO 16269-6:2014, Statistical interpretation of data – Part 6:Determination of statistical tolerance intervals
Expiration Date	ASTM F1980; 2021, Guide to Accelerated Aging of Sterile MedicalDevice Packages
Type of change	Description of Tests
Sterilization	ISO 11607-1:2019, Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile barrier systems andpackaging systems
	AAMI/ISO TIR16775: 2014, Technical Information Report, Packagingfor terminally sterilized medical devices-Guidance on the application ofISO 11607-1 and ISO 11607-2
	AAMI TIR28:2016, Product adoption and process equivalency forethylene oxide sterilization
	ANSI/AAMI ST67:2019 – Sterilization of health care products -Requirements and guidance for selecting a sterility assurance level(SAL) for products labeled sterile
	ANSI/AAMI/ISO 11135:2014, Sterilization of health care products -Ethylene oxide - Requirements for development, validation and routinecontrol of a sterilization process for medical devices- Part 1,Sterilization of health care products, Ethylene oxide, Part 1
	ANSI/AAMI ST72; 2019, Bacterial Endotoxins-Test methods, routinemonitoring, and alternatives to batch testing

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Additional verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, including the following:

1. Bench testing for sterility in compliance with the standards cited above
1. Bench testing for new expiration dating in compliance with the standards cited above
1. Bench testing for packaging integrity in compliance with the standards cited above

F. Conclusion

Potential risks were identified according to the ISO 14971 Standard. The risks were analyzed with regard to risk/benefit category and mitigations were implemented and tested as part of the performance testing described above for the changes submitted. No new risks were identified for the modifications to the devices. All risk mitigations were satisfactorily verified and validated in compliance with the company's Design Control Process. Where there were differences from the predicate, these were shown not to result in any new issues of safety or effectiveness according to the performance data submitted. Therefore, the non-clinical performance data provided demonstrates that the TSI Phantom XL Dilators are safe for use perform comparably to the predicate device that is currently marketed for the same intended use.

Regulation Number and Section

§ 882.1350 Needle electrode.

(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).