(20 days)
Not Found
No
The description focuses on the device's function as an electrical stimulator and mentions no AI/ML capabilities or related performance metrics.
No.
The device is used to assist in locating nerves at risk during spinal surgery by delivering electrical stimulus, which is a diagnostic or assistive function, not a direct therapeutic treatment.
Yes
This device is used to locate nerves at risk during surgical procedures by delivering electrical stimulus. This function of identifying and locating specific anatomical structures that could be at risk during surgery serves a diagnostic purpose, as it provides real-time information to guide the surgical intervention and prevent complications.
No
The device description explicitly states it is a physical instrument ("Phantom XL Insulated Dilators") used to deliver electrical stimulation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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." This is a direct interaction with the patient's body during surgery, not a test performed on samples taken from the body.
- Device Description: The device is described as an "instrument" used "during intraoperative neurological monitoring." This further reinforces its use within the surgical setting on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PDQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
- Packaging tests: ASTM F1886:2016 (Determining Integrity of Seals for Medical Packaging by Visual Inspection), ASTM F2096-11 (Detecting Gross Leaks in Packaging by internal Pressurization), ASTM F88/F88M-21,2021 (Seal Strength of Flexible Barrier Materials), Dupont Medical Packaging (Compliance of Tyvek to ISO 11607 Standard), ASTM D4169:2022 (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 tests: ASTM F1980; 2021 (Guide to Accelerated Aging of Sterile Medical Device Packages).
- Sterilization tests: 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).
- Additional verification and validation testing in compliance with 21 CFR Part 820.30: bench testing for sterility, new expiration dating, and packaging integrity.
Key Results: No new risks were identified for the modifications to the devices. All risk mitigations were satisfactorily verified and validated. The non-clinical performance data demonstrates that the TSI Phantom XL Dilators are safe for use and perform comparably to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 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
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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 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:
-
- Bench testing for sterility in compliance with the standards cited above
-
- Bench testing for new expiration dating in compliance with the standards cited above
-
- 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.