Pilot TLS is designed to support quidance and tip positioning of Peripherally Inserted Central Catheters (PICCs) of at least 3 Fr in size. Pilot TLS provides real-time catheter tip location information by using the patient's cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation for adults. The device includes a medical tablet preloaded with Pilot software, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory.

The device is only provided in one configuration, and non-sterile. The system is composed of:

. A medical tablet with a kickstand attached on the back
. The medical tablet's power supply
. A Pilot TLS module attached to a USB-A cable
A stabilization base (option to maintain the black ECG lead for its connection to Vygocard saline connector
An ECG cable with 4 leads (red, white, green, black)
2 USB flash drives

Vygocard is an accessory provided sterile.

AI/ML Overview

This document, a 510(k) Premarket Notification for the "Pilot TLS" device, primarily focuses on demonstrating substantial equivalence to a predicate device, the "C3 Wave," rather than presenting a standalone study with detailed acceptance criteria and performance data in the format requested.

However, based on the provided text, here's what can be extracted and inferred regarding performance and testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists various non-clinical tests conducted to verify performance requirements. These tests are generally designed to ensure compliance with standards and safety, not necessarily to quantify specific performance metrics against a defined acceptance criterion for a clinical study.

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary from text)
Electrical Safety (IEC 60601-1, 3rd Ed.)	Testing conducted, results support substantial equivalence.
Electromagnetic Compatibility (IEC 60601-1-2, 3rd Ed.)	Testing conducted, results support substantial equivalence.
Software Verification and Validation Testing	Testing conducted, results support substantial equivalence.
Usability/Human Factors (CDRH guidance, IEC 62366-1)	Human factors study assessed usability against predetermined criteria; results compiled and assessed according to guidance.
Biocompatibility (ISO 10993-1, -4, -5, -10)	Testing conducted for cytotoxicity, hemocompatibility, sensitization, irritation, and pyrogenicity of Vygocard; results support substantial equivalence.
Intravascular Catheter Standards (ISO 10555-1, ISO 80369-7, ISO 80369-20)	Testing conducted, results support substantial equivalence.
Confirmation of PICC tip placement via P-wave detection (fundamental technology)	Device provides real-time catheter tip location information by displaying changes in patient's cardiac electrical activity, based on identification of a maximum P-wave. This is considered similar to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details on a specific test set size for clinical performance evaluation. It explicitly states: "No human clinical data was provided to support substantial equivalence."

The "human factors study" mentioned could be considered a usability test set, but details about its size or provenance (country, retrospective/prospective) are not disclosed in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

As "No human clinical data was provided," there is no information about experts used to establish ground truth for a clinical test set. For the human factors study, the participants are referred to as "independent clinician participants," but their number or specific qualifications (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

Not applicable, as "No human clinical data was provided" for a clinical test set that would require ground truth adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, the document explicitly states: "No human clinical data was provided to support substantial equivalence." Therefore, no MRMC study or effect size for AI assistance is reported.

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

The document describes the "Pilot TLS" as a device providing "real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity." This implies human interaction as "displaying" information requires interpretation by a user. The software verification and validation would test the algorithm's functionality, but a formal "standalone" performance study in a clinical context (without human interaction) is not described. The device is intended as an "alternative method to chest X-ray or fluoroscopy confirmation," which inherently involves a human interpreting the device's output.

7. The Type of Ground Truth Used

Given the statement "No human clinical data was provided to support substantial equivalence," there is no mention of ground truth established through expert consensus, pathology, or outcomes data for clinical performance. The comparison to chest X-ray or fluoroscopy implies these are the traditional "ground truth" methods for PICC tip placement confirmation, but no data is presented where the Pilot TLS's output is validated against these.

8. The Sample Size for the Training Set

Not applicable. The document does not describe the development or training of a machine learning algorithm, and thus no training set sample size is mentioned. This device relies on "identification of a maximum P-wave in the patient's intravascular ECG signal," which is a known physiological principle, not a machine learning model requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set for a machine learning model is mentioned.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.

February 26, 2025

Vygon Corporation Chris Steinke Quality Assurance and Regulatory Affairs Manager 2750 Morris Road, Suite A200 Lansdale, Montgomery, Pennsylvania 19446

Re: K241587

Trade/Device Name: pilot TLS Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: May 31, 2024 Received: June 3, 2024

Dear Chris Steinke:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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

Sincerely,

Aneesh S. Deoras -S

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K241587

Device Name Pilot TLS

Indications for Use (Describe)

The Pilot TLS is indicated for use in positioning of PICCs. The Pilot TLS provides real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity. Pilot TLS is indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement in adult patients. Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave:

Atrial fibrillation
Atrial flutter
Severe tachycardia
Pacemaker-Driven Rhythm
Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional method is necessary to confirm catheter tip location.

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

X 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."

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

Image /page/4/Picture/0 description: The image shows the word "MEDWIN" in a stylized, sans-serif font. The letters are all connected, and the bottom of the letters are connected by a horizontal line. The color of the text is a dark blue.

Image /page/4/Picture/1 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters inside a green rounded rectangle with a red triangle above the "V". Below the rectangle, the words "Value Life" are written in a light gray color. The logo is simple and modern, and the colors are bright and eye-catching.

510 (k) Summary

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

VYGON CORPORATION 2750 Morris Road Lansdale Montgomerv PA 19446 United States Phone: (603)743-5988 Contact Person: Chris Steinke, Director of Quality Assurance, Regulatory Affairs, and Engineering Initial Date Prepared: 31st May 2024

The device is manufactured by Medwin which is the legal manufacturer.

MEDWIN France 9, Allée de la Vigne Grande 34600 Les Aires, FRANCE Tél.: +33 (0) 4 67 95 74 72 Fax: +33 (0) 4 67 95 75 54

Name of Device

Pilot TLS

Common or Usual Name

Percutaneous, implanted long-term intravascular catheter.

Classification Name

Class II, 21 CFR Section 880.5970- LJS (Catheter, intravascular, Therapeutic Long-Term Greater Than 30 Days).

Predicate Device

C3 Wave (K170934) manufactured by Medcomp (dba Medical Components Inc.).

Device Description

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

Image /page/5/Picture/0 description: The image shows the word "MEDWIN" in a stylized font. The letters are all capitalized and in a dark blue color. The "M" is designed with sharp, angular lines, and a horizontal line extends from the bottom of the "M" to below the "W", underlining the last three letters of the word.

Image /page/5/Picture/1 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters on a green rounded rectangle. Above the "V" is a red triangle pointing downwards. Below the green rectangle are the words "Value Life" in a smaller font.

The device is only provided in one configuration, and non-sterile. The system is composed of:

. A medical tablet with a kickstand attached on the back
. The medical tablet's power supply
. A Pilot TLS module attached to a USB-A cable
A stabilization base (option to maintain the black ECG lead for its connection to Vygocard saline connector
An ECG cable with 4 leads (red, white, green, black)
2 USB flash drives

Vygocard is an accessory provided sterile.

Indications for Use

Note: Limited, but not contraindicated, situations for this technique are patients where cardiac rhythms may change presentation of the P-wave:

Atrial fibrillation
Atrial flutter
Severe tachycardia
Pacemaker-Driven Rhythm
Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of additional methods is necessary to confirm catheter tip location.

Comparison of Technological Characteristics with The Predicate Device:

The subject and predicate devices have similar technological characteristics, and the minor differences do not raise any new issues of safety and effectiveness. The following characteristics are identical between the subject device and predicate devices:

. Fundamental technology
Principle of operation
Technological characteristics (material, sterilization) ●

The design comparison matrix below summarizes the technological differences between Pilot TLS and the predicate devices.

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

Image /page/6/Picture/0 description: The image shows the word "MEDWIN" in blue. The letters are stylized with sharp angles, and a line extends from the bottom of the "M" to underline the "WIN" portion of the word. The font is sans-serif and appears to be a logo.

Image /page/6/Picture/1 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters on a green background, with a red triangle above the "V". Below the logo, the words "Value Life" are written in gray.

Criterion	Proposed Device:Pilot TLS	Predicate Device:C3 Wave (K170934)	SubstantiallyEquivalentcomparison
ECG signaltransmission	Pilot TLS uses an adaptor forthe ECG signal transmission.This adaptor can be either anECG clip cable, as thepredicate, or Vygocard, whichis a saline column connector.	C3 Wave uses a stylet.Indeed, C3 wave uses a "ECGClip Cable" to transmit thepatient's ECG waves byconnecting the PICC stylet tothe Hub. Connections aremade using the stereo jack(for the Hub) and the alligatorclip (for the PICC stylet). Thealligator clip is placed on themetal portion of the styletwire.	Same and differentmethods, C3 waveonly works withconductive metalstylet for ECG signaltransmission, whilePilot TLS works withbothconductivemetal stylet and asalinecolumnconnector.
ECG DataTransmission	Pilot TLS uses an USB cablefor the ECG data transmissionbetween the Pilot TLS patientmodule and the Operatormodule (tablet).	C3 Wave uses wirelesstechnology(Bluetooth)instead of a USB cable for theECG data transmissionbetween the Patient module(Hub) and the tablet.	Similar
ComputerPlatform	Pilot TLS uses a mobileplatform (Windows tablet)	C3 Wave uses amobileplatform (iPad tablet)	Similar
Software:Method forcatheter tipplacementconfirmation	Catheter tip placementconfirmation via the patient'scardiac electrical activity,based upon identification of amaximum P-wave in thepatient's intravascular ECGsignal collected via the salinecolumn or the conductivestylet with 3Fr or largerCVADs	Catheter tip placementconfirmation via the patient'scardiac electrical activity,based upon identification of amaximum P-wave in thepatient's intravascular ECGsignalcollectedviaconductive stylets.	Similar: C3 waveonly works withconductivemetalstylet for ECG signaltransmission, whilePilot TLS works withbothconductivemetal stylet and asalinecolumnconnector.
Components	• ECG Cable• Pilot TLS Patient Module• Tablet computer with itsmedical AC power supply• Pilot TLS Software• VYOCARD (can bereplaced by an ECG clipcable if the user prefers touse a metal stylet method)• Stabilization base	• C3 Wave Hub• iPad + C3 Wave softwareapplication• Remote• ECG Clip Cable• ECG Snap Lead Set• Power Supply	Similar

Table 1: Design Comparison matrix

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "MEDWIN" in a stylized font. The letters are all capitalized and connected with a thin, blue line. The bottom of the word is underlined with a straight, blue line that extends from the "M" to the "N".

Image /page/7/Picture/1 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters inside a green rounded rectangle with a red triangle above the "V". Below the rectangle, the words "Value Life" are written in gray.

Non-Clinical Performance Data

Testing verifying the performance requirements of Pilot TLS system was conducted and included in this premarket notification and the results support substantial equivalence.

Testing included:

IEC 60601-1, 3rd Edition - Electrical Safety
. IEC 60601-1-2, 3rd Edition - Electromagnetic Compatibility
Software Verification and Validation Testing ●
Human Factors: A human factors study assessing the usability of the Pilot TLS was conducted. The study utilized independent clinician participants to assess the primary operating functions of the proposed device aqainst the predetermined usability criteria. The results of the human factors study were compiled and assessed in accordance with CDRH

guidance, Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff (February 3, 2016) as well as with IEC 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices.

Testing verifying the performance requirements of the Vygocard was conducted in this premarket notification and the results support substantial equivalence.

Testing included:

Biocompatibility: According to the requirements identified in ISO 10993-1, biocompatibility testing on . the patient contacting devices subject to this premarket notification is included. Testing was conducted for the assessment of cytotoxicity (ISO 10993-5), hemocompatibility (ISO 10993-4), sensitization and irritation (ISO 10993-10), and pyrogenicity of the Vygocard.
ISO 10555-1: Intravascular catheters Sterile and single-use catheters for the corrosion ●
. ISO 80369-7
. ISO 80369-20

Clinical Performance Data

No human clinical data was provided to support substantial equivalence.

Substantial Equivalence

Pilot TLS is substantially equivalent to the predicate devices. Pilot TLS has the same intended use as the predicate device. The subject and predicate device are intended to display patient's ECG waveforms to provide real time tip location information of a central venous catheter,

Regarding the technological characteristics, the subject device and the predicate incorporate both electronic circuitry and software to acquire and display the patient's intravascular and external ECG waveforms to facilitate the confirmation of final central catheter tip placement as an alternative to radiographic confirmation.

Therefore, Pilot TLS is substantially equivalent to the currently marketed predicate device.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the word "MEDWIN" in a stylized font. The letters are all in uppercase and are a dark blue color. A horizontal line extends from the bottom of the "E" to the bottom of the "N", underlining the last three letters.

Image /page/8/Picture/1 description: The image shows the logo for Vygon. The logo consists of the word "VYGON" in white letters on a green background, with a red triangle above the "V". Below the green background is the text "Value Life" in a light gray color.

Conclusion

The information included in this premarket notification supports the substantial equivalence of the subject Pilot TLS to the C3 Wave Form. The subject device has the same intended use, similar indications for use and incorporates the same fundamental technology as the legally marketed predicate devices to which it was compared.

Performance and biocompatibility data were included to verify the performance of the subject device against its physical design, functional, and safety requirements. The resting included in this premarket notification support a determination of substantial equivalence.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”