(268 days)
Not Found
No
The description focuses on using cardiac electrical activity (ECG) to determine catheter tip location, which is a standard physiological signal processing technique, not explicitly mentioning or implying the use of AI/ML for analysis or interpretation. The testing described also does not include typical AI/ML validation methods.
No
The device is indicated for use in positioning PICCs and providing real-time catheter tip location information, serving as an alternative to chest X-ray or fluoroscopy for confirmation of PICC tip placement. It does not treat or cure any medical condition.
Yes
The device is described as providing "real-time catheter tip location information" and being "indicated for use as an alternative method to chest X-ray or fluoroscopy confirmation of PICC tip placement". This function of confirming the location of a medical device within the body is a diagnostic use.
No
The device description explicitly lists hardware components such as a medical tablet, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory. The performance studies also include testing for electrical safety, electromagnetic compatibility, and biocompatibility, which are relevant to hardware components.
Based on the provided information, the Pilot TLS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to obtain information for diagnostic or monitoring purposes.
- Pilot TLS Function: The Pilot TLS operates by analyzing the patient's in vivo cardiac electrical activity (ECG) to determine the position of a PICC line. It does not process or analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "positioning of PICCs" and provides "real-time catheter tip location information by displaying changes in the patient's cardiac electrical activity." This is a procedural guidance and confirmation tool, not a diagnostic test performed on a specimen.
Therefore, the Pilot TLS falls under the category of a medical device used for procedural guidance and confirmation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
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)
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, and Software Verification and Validation Testing. A Human Factors study assessing the usability of the Pilot TLS was conducted, utilizing independent clinician participants to assess primary operating functions against predetermined usability criteria. The results 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 and the results support substantial equivalence, including Biocompatibility (ISO 10993-1, ISO 10993-5, ISO 10993-4, ISO 10993-10), ISO 10555-1, ISO 80369-7, and ISO 80369-20.
Clinical Performance Data: No human clinical data was provided to support substantial equivalence.
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.
C3 Wave (K170934)
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
§ 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.”
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)
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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
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.
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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
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 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.
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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) | Substantially
Equivalent
comparison |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ECG signal
transmission | Pilot TLS uses an adaptor for
the ECG signal transmission.
This adaptor can be either an
ECG clip cable, as the
predicate, or Vygocard, which
is a saline column connector. | C3 Wave uses a stylet.
Indeed, C3 wave uses a "ECG
Clip Cable" to transmit the
patient's ECG waves by
connecting the PICC stylet to
the Hub. Connections are
made using the stereo jack
(for the Hub) and the alligator
clip (for the PICC stylet). The
alligator clip is placed on the
metal portion of the stylet
wire. | Same and different
methods, C3 wave
only works with
conductive metal
stylet for ECG signal
transmission, while
Pilot TLS works with
both
conductive
metal stylet and a
saline
column
connector. |
| ECG Data
Transmission | Pilot TLS uses an USB cable
for the ECG data transmission
between the Pilot TLS patient
module and the Operator
module (tablet). | C3 Wave uses wireless
technology
(Bluetooth)
instead of a USB cable for the
ECG data transmission
between the Patient module
(Hub) and the tablet. | Similar |
| Computer
Platform | Pilot TLS uses a mobile
platform (Windows tablet) | C3 Wave uses a
mobile
platform (iPad tablet) | Similar |
| Software:
Method for
catheter tip
placement
confirmation | Catheter tip placement
confirmation via the patient's
cardiac electrical activity,
based upon identification of a
maximum P-wave in the
patient's intravascular ECG
signal collected via the saline
column or the conductive
stylet with 3Fr or larger
CVADs | Catheter tip placement
confirmation via the patient's
cardiac electrical activity,
based upon identification of a
maximum P-wave in the
patient's intravascular ECG
signal
collected
via
conductive stylets. | Similar: C3 wave
only works with
conductive
metal
stylet for ECG signal
transmission, while
Pilot TLS works with
both
conductive
metal stylet and a
saline
column
connector. |
| Components | • ECG Cable
• Pilot TLS Patient Module
• Tablet computer with its
medical AC power supply
• Pilot TLS Software
• VYOCARD (can be
replaced by an ECG clip
cable if the user prefers to
use a metal stylet method)
• Stabilization base | • C3 Wave Hub
• iPad + C3 Wave software
application
• Remote
• ECG Clip Cable
• ECG Snap Lead Set
• Power Supply | Similar |
Table 1: Design Comparison matrix
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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.
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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.