Who is the manufacturer of Phantom XL Insulated Dilators?

TeDan Surgical Innovations, Inc. filed the 510(k) submission for Phantom XL Insulated Dilators (K231691).

What is the FDA product code for Phantom XL Insulated Dilators?

GXZ. It is classified under 21 CFR 882.1350 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Phantom XL Insulated Dilators?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Phantom XL Insulated Dilators?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Phantom XL Insulated Dilators

Q: What are the predicate devices for Phantom XL Insulated Dilators?

Phantom XL Insulated Dilators (K140088).

K231691 · TeDan Surgical Innovations, Inc. · GXZ · Jun 29, 2023 · Neurology

Device Facts

Record ID	K231691
Device Name	Phantom XL Insulated Dilators
Applicant	TeDan Surgical Innovations, Inc.
Product Code	GXZ · Neurology
Decision Date	Jun 29, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.1350
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 tissues 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 single-use, sterile, monopolar instruments used during spinal surgery. The device delivers electrical stimulation to tissues and nerves at the operative site to assist surgeons in identifying nerves at risk during procedures. The device is operated by a surgeon in an intraoperative setting. The output is the delivery of electrical current, which the surgeon uses to monitor neurological responses and guide surgical navigation. The device is provided in four diameter sizes and is designed to facilitate safe surgical access by helping avoid nerve injury.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including packaging integrity, seal strength, shipping container performance, and accelerated aging studies to validate the 5-year shelf life. Sterilization validation was performed per ISO 11135 and related standards.

Technological Characteristics

Monopolar needle electrode; sterile; single-use; EtO sterilized. Compliant with IEC 60601-1 (electrical safety) and ISO 10993 (biocompatibility). Packaging compliant with ASTM F1886, F2096, F88, D4169, and ISO 11607. Shelf life: 5 years.

Indications for Use

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

Regulatory Classification

Identification

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

Predicate Devices

Phantom XL Insulated Dilators (K140088)

Related Devices

K140088 — PHANTOM XL INSULATED DILATORS · Tedan Surgical Innovations, LLC · Sep 25, 2014
K090838 — STIMULUS/DISSECTION INSTRUMENTS · Axon Systems, Inc. · Jul 20, 2009
K132373 — BIOMET ACCESS SYSTEM · Biomet Spine (Aka Ebi, LLC) · Mar 27, 2014
K110419 — AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS · Stryker Spine · Jul 28, 2011
K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT · Rhythmlink International, LLC · Sep 22, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) not assigned 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ K231691 | | 510(k) Summary | |----------------------|-------------------------------------------------------------------------------------------------------------| | Submitter: | TeDan Surgical Innovations, Inc. 12320 Cardinal Meadow Drive Suite 150 Sugar Land, Texas 77478 USA | | Contact Person | Lynne Davies Vice 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 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. ## 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. {4}------------------------------------------------ ## 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 Device Phantom XL Insulated Dilators K140088 | Subject Device Phantom XL Insulated Dilators K231619 | |----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | TeDan Surgical Innovations | 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 to PDQ | PDQ | | Regulation description | Needle electrode | Surgical nerve stimulator/locator. | | Classification | Class II | Class II | | Indication for use and Intended use | 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. | 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. | | Biocompatibility | Compliant with ISO 10993 for contact of limited duration | Compliant with ISO 10993 for contact of limited duration | | Sterile | Yes; EtO | Yes; EtO | | Single Use | Yes | Yes | | Shelf Life | 2 years | 5 years | | Device Name | Predicate Device Phantom XL Insulated Dilators K140088 | Subject Device Phantom XL Insulated Dilators K231619 | | Principle of Operation | Used as instrument to deliver electrical stimulation to tissue during neurological monitoring | Used as instrument to deliver electrical stimulation to tissue during neurological monitoring | | Polarity of stimulation | Monopolar | Monopolar | | Exposed area of stimulation | Tissues and nerves at the operative site selected by the user | Tissues and nerves at the operative site selected by the user | | Electrical Safety | Compliant with IEC 60601-1 | Compliant with IEC 60601-1 | | Packaging | Product is loaded into backer cards and sealed in a Tyvek Pouch; Pouch is placed in Shelf Box; compliant with applicable ASTM standards | Product is loaded into preformed tray and sealed in a Tyvek Lid; Tray is placed in Shelf Box; compliant with applicable ASTM standards | {5}------------------------------------------------ {6}------------------------------------------------ # 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 of Seals for Medical Packaging by Visual Inspection | | | ASTM F2096-11, Standard test method for detecting Gross Leaks in Packaging by internal Pressurization | | | ASTM F88/F88M-21,2021, Standard Test Method for Seal Strength of Flexible Barrier Materials | | | (Dupont Medical Packaging, Description of Documents Supporting the Compliance of Tyvek to ISO 11607 Standard) | | | ASTM D4169:2022, Standard Practices for Performance Testing of Shipping Containers and Systems | | | ISTA 3A: 2018, Packaged-Products for Parcel Delivery System Shipments 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 Medical Device 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 and packaging systems | | | AAMI/ISO TIR16775: 2014, Technical Information Report, Packaging for terminally sterilized medical devices-Guidance on the application of ISO 11607-1 and ISO 11607-2 | | | AAMI TIR28:2016, Product adoption and process equivalency for ethylene 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 routine control 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, routine monitoring, and alternatives to batch testing | {7}------------------------------------------------ {8}------------------------------------------------ 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 - 2. Bench testing for new expiration dating in compliance with the standards cited above - 3. 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.