Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter

K181208 · Vygon USA · PND · Nov 2, 2018 · General Hospital

Device Facts

• Record ID: K181208
• Device Name: Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter
• Applicant: Vygon USA
• Product Code: PND · General Hospital
• Decision Date: Nov 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The catheters are suitable for use with power injectors.

Device Story

Vygon Midline Catheters are single-use, EO-sterilized, polyurethane catheters designed for short-term (<30 days) peripheral venous access. The device features a reverse taper shaft with depth indicators, a molded suture wing compatible with StatLock securement, and luer hubs. Available in 3 Fr (single lumen), 4 Fr (single lumen), and 5 Fr (dual lumen) configurations. The device is inserted percutaneously using the Modified Seldinger Technique with a guidewire. The catheter tip terminates distally to the shoulder at or below the axillary line. The device allows for intravenous therapy, blood sampling, and power injection of contrast media. It is used in regulated clinical environments by healthcare professionals. The device benefits patients by providing reliable, short-term peripheral venous access for various therapies and diagnostic imaging procedures.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including dimensional inspections, leak tests, flow tests (gravity/pump/aspiration), tensile/burst/flexural fatigue testing, power injection conditioning, and biocompatibility assessments (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, and thrombogenicity).

Technological Characteristics

Materials: Polyurethane (shaft, junction, extension leg, luer hub), Acetal (clamp), barium sulfate (radiopacity). Dimensions: 3 Fr, 4 Fr, 5 Fr; 20 cm length. Connectivity: None. Sterilization: 100% Ethylene Oxide (SAL 10^-6). Standards: ISO 9626:2016, ISO 10555-1:2014, ISO 594-1:1986/ISO 80369-7:2016, ASTM F1842-15, ISO 10993 series.

Indications for Use

Indicated for short-term peripheral venous access for intravenous therapy, blood sampling, and power injection of contrast media in any patient population, provided vascular anatomy is adequate.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• 3 Fr SL PowerMidline™ Catheter (K153393)

Reference Devices

• PowerPICC® Catheter

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.

November 2, 2018

Vygon USA Jillian Mikovich Regulatory Affairs Manager 2750 Morris Rd, Suite A200 Lansdale, Pennsylvania 19460

Re: K181208

Trade/Device Name: Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: September 24, 2018 Received: September 28, 2018

Dear Jillian Mikovich:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K181298

Device Name Vygon Midline Catheters

### Indications for Use (Describe)

The catheters are indicated for short term access to the peripheral venous system intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient with consideration given to adequacy of vascular anatomy and appropriateness of the catheters are suitable for use with power injectors.

| Catheter Size | Maximum Power Injection<br>Flow Rate |
|-----------------------|--------------------------------------|
| Vygon Midline 3 Fr SL | 5 ml/s |
| Vygon Midline 4 Fr SL | 7 ml/s |
| Vygon Midline 4 Fr DL | 7 ml/s |

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

| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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Image /page/3/Picture/0 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 logo is the text "Value Life" in a smaller, light gray font.

## 510(k) Summary (21 CFR 807.92) K181208

#### I. SUBMITTER

Submitter Name: Vygon Address: 2750 Morris Road, Suite A200 Lansdale, PA 19446 Telephone: [phone] Fax: [phone]

Contact Person: Jillian Mikovich [e-mail] Email of Contact: 05/04/2018 Date Prepared:

#### II. DEVICE

Device Name: Common Name: Common/Usual Name: Classification Name: Classification Panel: Regulation Device Name: Regulation Number: Regulatory Class: Product Code:

Vygon Midline Catheters Vygon Midline Catheters Midline Catheter Intravascular Catheter General Hospital Intravascular Catheter 21 CFR 880.5200 2 PND

### III. PREDICATE DEVICE

| Predicate Name: | 3 Fr SL PowerMidline™ Catheter |
|-------------------------|--------------------------------|
| Trade Name: | 3 Fr SL PowerMidline™ Catheter |
| Common/Usual Name: | Midline Catheter |
| Classification Name: | PND – Intravascular Catheter |
| Premarket Notification: | K153393 |
| Manufacturer: | Bard Access Systems. Inc. |

Per the FDA Medical Device Recalls Database, this predicate has not been subject to a design related recall.

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Image /page/4/Picture/0 description: The image shows the Vygon logo. The word "VYGON" is in white letters on a green rounded rectangle. Above the "V" is a small red triangle. Below the logo is the phrase "Value Life" in gray letters.

## IV. DEVICE DESCRIPTION

The Vygon Midline Catheters are EO sterilized, single-use, polyurethane, reverse taper, short-term, peripheral venous system access catheters. They include materials containing barium sulfate for radiopacity.

The device description of the Vygon Midline Catheters is as follows:

- 1. The Vygon Midline Catheters are EO sterilized, single-use, polyurethane catheters. They include materials containing barium sulfate for radiopacity.
- 2. Catheter sizes, lengths, and lumen configurations are in the table that follows. Catheter gauge sizes are printed on the hubs.
- 3. The catheter luer hub material is made of Quadraplast™ (Rigid Thermoplastic Polyurethane (TPU)) and may contain red, white, gray, or purple colorant.
- 4. Purple colorants were added to select catheter materials to indicate power injectable functionality per generally accepted clinical use.
- 5. The catheter extension leg material is made of Quadraflex™ (Aromatic Polyether (ARE-TPU)) and extension leg colors are listed in the table that follows.
- The catheter junction material (Aliphatic Polyether (ALE-TPU)) is molded such that 6. the catheter extension leg and the shaft tubing are joined.
- 7. A molded suture wing is integrated with the over-molded junction and is compatible with StatLock® securement device.
- 8. The catheter extension leg(s) are over-molded over the proximal end(s) of the shaft. Extension leg lengths can be found in the table that follows.
- 9. The catheter extension leg(s), junction, and ID tag(s) on clamp are all printed with markings to include information to facilitate proper use of the device.
- 10. The catheter has a reverse taper design.
- 11. The catheter shaft tubing is marked with depth indicators as a reference for catheter insertion.
- 12. The environment of use of the device is a regulated clinical environment.
- 13. Midlines operate by allowing intravenous access through one or more lumens.

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Image /page/5/Picture/0 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 smaller, gray font.

- 14. Length of contact is short term (<30 days) with intravenous indwelling and skin contact.

| Device Description | | | |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Vygon Midline 3 Fr SL<br>(Subject Device 1) | Vygon Midline 4 Fr SL<br>(Subject Device 2) | Vygon Midline 5 Fr DL<br>(Subject Device 3) |
| Number of<br>Lumens | Single Lumen (one) | Single Lumen (one) | Dual Lumen (two) |
| Lumen Shape | Round | Round | D, D |
| Outer Diameter | 3 Fr (0.044 in.) | 4 Fr (0.055 in.) | 5 Fr (0.069 in.) |
| Inner Diameter | 20 Ga (0.027 in.) | 18 Ga (0.032 in.) | 18 Ga / 18 Ga (0.041 in.<br>H & 0.020 in. W) |
| Effective<br>Length | 20 cm | 20 cm | 20 cm |
| Maximum<br>Power<br>Injection<br>Flow Rate | 5 ml/s | 7 ml/s | 7 ml/s |
| Material | • Luer – QPLAST<br>(Rigid TPU)<br>• Gauge Marking -<br>Marabu Tampastar<br>TPR (970) White<br>• Extension Leg -<br>QFLEX (ARE-TPU)<br>• Extension Leg<br>Printing - Marabu<br>Tampastar TPR (970)<br>White<br>• Clamp - Acetal<br>(POM) Clamp<br>• Clamp Printing -<br>Biocompatible Ink<br>• Junction - QFLEX<br>(ALE-TPU)<br>• Inner Junction – N/A<br>Junction Printing -<br>Marabu Tampastar TPR<br>White (970) | • Luer – QPLAST<br>(Rigid TPU)<br>• Gauge Marking -<br>Marabu Tampastar<br>TPR (970) White<br>• Extension Leg -<br>QFLEX (ARE-TPU)<br>• Extension Leg<br>Printing – Marabu<br>Tampastar TPR (970)<br>White<br>• Clamp - Acetal<br>(POM) Clamp<br>• Clamp Printing -<br>Biocompatible Ink<br>• Junction - QFLEX<br>(ALE-TPU)<br>• Inner Junction – N/A<br>Junction Printing -<br>Marabu Tampastar TPR<br>White (970) | • Luer – QPLAST<br>(Rigid TPU)<br>• Gauge Marking -<br>Marabu Tampastar<br>TPR (970) White<br>• Extension Leg -<br>QFLEX (ARE-TPU)<br>• Extension Leg<br>Printing - Marabu<br>Tampastar TPR (970)<br>White<br>• Clamp - Acetal<br>(POM) Clamp<br>• Clamp Printing -<br>Biocompatible Ink<br>• Junction - QFLEX<br>(ALE-TPU)<br>• Inner Junction – N/A<br>Junction Printing -<br>Marabu Tampastar TPR<br>White (970) |
| Device Description | | | |
| | Vygon Midline 3 Fr SL | Vygon Midline 4 Fr SL | Vygon Midline 5 Fr DL |
| | (Subject Device 1) | (Subject Device 2) | (Subject Device 3) |
| | • Extrusion (Shaft) -<br>QFLEX<br>(ALE-TPU)<br>• Extrusion (Shaft)<br>Printing - Marabu | • Extrusion (Shaft) -<br>QFLEX<br>(ALE-TPU)<br>• Extrusion (Shaft)<br>Printing - Marabu | • Extrusion (Shaft) -<br>QFLEX<br>(ALE-TPU)<br>• Extrusion (Shaft)<br>Printing - Marabu |
| | Tampapur TPU (980)<br>Black | Tampapur TPU (980)<br>Black | Tampapur TPU (980)<br>Black |
| Colorant /<br>Concentrations | • Luer - RV43631224<br>PAN 2607C, 4%<br>(Purple)<br>• Luer Ink - Marabu<br>Tampastar TPR (970)<br>White<br>• Extension Leg - MC-<br>90570TPU, 4%<br>(Trans. Purple Ext.<br>Leg)<br>• Extension Leg Ink -<br>Marabu Tampastar<br>TPR (970) White<br>• Junction - Clariant<br>OM4M664821 4%<br>Purple 2587C<br>• Junction Ink - Marabu<br>Tampastar TPR White<br>(970)<br>• Shaft - Clariant<br>OM4M664821 Purple<br>2587C, 4%<br>• Shaft Ink - Marabu<br>Tampapur TPU (980)<br>Black | • Luer - RV43631224<br>PAN 2607C, 4%<br>(Purple)<br>• Luer Ink - Marabu<br>Tampastar TPR (970)<br>White<br>• Extension Leg - MC-<br>90570TPU, 4%<br>(Trans. Purple Ext.<br>Leg)<br>• Extension Leg Ink -<br>Marabu Tampastar<br>TPR (970) White<br>• Junction - Clariant<br>OM4M664821 4%<br>Purple 2587C<br>• Junction Ink - Marabu<br>Tampastar TPR White<br>(970)<br>• Shaft - Clariant<br>OM4M664821 Purple<br>2587C, 4%<br>• Shaft Ink - Marabu<br>Tampapur TPU (980)<br>Black | • Luer - RV43631224<br>PAN 2607C, 4%<br>(Purple)<br>• Luer Ink - Marabu<br>Tampastar TPR (970)<br>White<br>• Extension Leg - MC-<br>90570TPU, 4%<br>(Trans. Purple Ext.<br>Leg)<br>• Extension Leg Ink -<br>Marabu Tampastar<br>TPR (970) White<br>• Junction - Clariant<br>OM4M664821 4%<br>Purple 2587C<br>• Junction Ink - Marabu<br>Tampastar TPR White<br>(970)<br>• Shaft - Clariant<br>OM4M664821 Purple<br>2587C, 4%<br>• Shaft Ink - Marabu<br>Tampapur TPU (980)<br>Black |
| Ink Material | • Marabu Tampastar<br>TPR White (970)<br>• Marabu Tampapur<br>TPU (980) Black | • Marabu Tampastar<br>TPR White (970)<br>• Marabu Tampapur<br>TPU (980) Black | • Marabu Tampastar<br>TPR White (970)<br>• Marabu Tampapur<br>TPU (980) Black |
| Duration of Use | Short term (<30 days) | Short term (<30 days) | Short term (<30 days) |
| Device Description | | | |
| | Vygon Midline 3 Fr SL<br>(Subject Device 1) | Vygon Midline 4 Fr SL<br>(Subject Device 2) | Vygon Midline 5 Fr DL<br>(Subject Device 3) |
| Tip Placement<br>Location | Peripheral<br>venous<br>system, with<br>catheter tip<br>terminating<br>prior to the<br>axilla | Peripheral<br>venous<br>system, with<br>catheter tip<br>terminating<br>prior to the<br>axilla | Peripheral<br>venous<br>system, with<br>catheter tip<br>terminating<br>prior to the<br>axilla |
| Insertion Site | Peripheral | Peripheral | Peripheral |
| Catheter Base<br>Materials | Shaft Tubing<br>Polyurethane | Shaft Tubing<br>Polyurethane | Shaft Tubing<br>Polyurethane |
| | Catheter Junction<br>Polyurethane | Catheter Junction<br>Polyurethane | Catheter Junction<br>Polyurethane |
| | Extension Leg<br>Polyurethane | Extension Leg<br>Polyurethane | Extension Leg<br>Polyurethane |
| | Luer Hub<br>Polyurethane | Luer Hub<br>Polyurethane | Luer Hub<br>Polyurethane |
| | Extension Leg Clamp<br>Polyurethane | Extension Leg Clamp<br>Polyurethane | Extension Leg Clamp<br>Polyurethane |
| Depth<br>Markings | "0" depth indicator<br>located 1 cm from<br>catheter junction on<br>reverse taper shaft tubing;<br>catheter marked every 1<br>cm, with numeric<br>indicators every 5 cm | "0" depth indicator<br>located 1 cm from<br>catheter junction on<br>reverse taper shaft tubing;<br>catheter marked every 1<br>cm, with numeric<br>indicators every 5 cm | "0" depth indicator<br>located 1 cm from<br>catheter junction on<br>reverse taper shaft tubing;<br>catheter marked every 1<br>cm, with numeric<br>indicators every 5 cm |
| Power<br>Injection<br>Maximum<br>Flow Rate | 5 ml/sOpen Ended | 7 ml/sOpen Ended | 7 ml/sOpen Ended |

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Image /page/6/Picture/0 description: The image shows the logo for Vygon. The logo consists of the word "VYGON" in white letters on a green background. Above the "V" is a small red triangle pointing downwards. Below the green background are the words "Value Life" in a light gray color.

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Image /page/7/Picture/0 description: The image contains the word "VYGON" in white letters inside of a green rounded rectangle. Above the "V" is a red triangle pointing downwards. Below the green rectangle is the phrase "Value Life" in gray letters.

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Image /page/8/Picture/0 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 rectangle are the words "Value Life" in a smaller font.

#### INDICATIONS FOR USE V.

The catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The catheters are suitable for use with power injectors.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

All characteristics of the Vygon Midline Catheters are substantially equivalent to the predicate device, the Bard Access System 3 Fr SL PowerMidline™ Catheter. Both the subject and the predicate catheters are sterile, single-use, polyurethane Midlines with the same intended use, indications for use, similar design, similar sizes, similar or the same materials, and similar properties. See comparison table below.

| Attribute | Predicate Device | Subject Device 1 | Subject Device 2 | Subject Device 3 | Substantially Equivalent or Identical to Predicate |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Device Name | 3 Fr SL<br>PowerMidline™<br>Catheter | Vygon<br>Midline 3 Fr<br>SL (Subject<br>Device 1) | Vygon<br>Midline 4 Fr<br>SL (Subject<br>Device 2) | Vygon<br>Midline 5 Fr<br>DL (Subject<br>Device 3) | |
| 510(k)<br>Number | K153393 | K181208 | K181208 | K181208 | N/A |
| 510(k)<br>Submitter | Bard Access<br>Systems (BAS) | Vygon USA | Vygon USA | Vygon USA | N/A |
| Trade Name | 3 Fr SL<br>PowerMidline™<br>Catheter | Vygon<br>Midline 3 Fr<br>SL Catheter | Vygon<br>Midline 4 Fr<br>SL Catheter | Vygon<br>Midline 5 Fr<br>DL Catheter | Substantially Equivalent to Predicate |
| Common<br>Name | Midline Catheter | Midline<br>Catheter | Midline<br>Catheter | Midline<br>Catheter | Identical to Predicate |
| Classification<br>Name | Midline Catheter | Midline<br>Catheter | Midline<br>Catheter | Midline<br>Catheter | Identical to Predicate |
| Regulatory<br>Class | 2 | 2 | 2 | 2 | Identical to Predicate |
| Classification<br>Regulation | 21 CFR<br>880.5200 | 21 CFR<br>880.5200 | 21 CFR<br>880.5200 | 21 CFR<br>880.5200 | Identical to Predicate |
| Attribute | Predicate Device | Subject<br>Device 1 | Subject<br>Device 2…