(179 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description and testing focus on material properties and substantial equivalence to a predicate device.
No
The device is indicated for short-term access to the peripheral venous system for intravenous therapies, blood sampling, and power injection of contrast media. These are procedural aids and not therapeutic interventions.
No
The device is described as a catheter for accessing the peripheral venous system for therapies, blood sampling, and power injection, which are interventional or treatment-related uses, not diagnostic. There is no mention of it being used to analyze or interpret physiological data for diagnostic purposes.
No
The device description clearly states it is a physical catheter made of polyurethane, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the catheters are for "short term access to the peripheral venous system intravenous therapies, blood sampling, and power injection of contrast media." This describes a device used for direct patient intervention and access to the circulatory system, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical catheter made of polyurethane for accessing veins. This is consistent with a medical device used for patient treatment and procedures, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are designed to perform tests on these samples.
Therefore, this device falls under the category of a medical device used for patient access and therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PND
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:
-
- The Vygon Midline Catheters are EO sterilized, single-use, polyurethane catheters. They include materials containing barium sulfate for radiopacity.
-
- Catheter sizes, lengths, and lumen configurations are in the table that follows. Catheter gauge sizes are printed on the hubs.
-
- The catheter luer hub material is made of Quadraplast (Rigid Thermoplastic Polyurethane (TPU)) and may contain red, white, gray, or purple colorant.
-
- Purple colorants were added to select catheter materials to indicate power injectable functionality per generally accepted clinical use.
-
- 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.
-
- A molded suture wing is integrated with the over-molded junction and is compatible with StatLock® securement device.
-
- 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.
-
- 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.
-
- The catheter has a reverse taper design.
-
- The catheter shaft tubing is marked with depth indicators as a reference for catheter insertion.
-
- The environment of use of the device is a regulated clinical environment.
-
- Midlines operate by allowing intravenous access through one or more lumens.
-
- Length of contact is short term (
§ 880.5200 Intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
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
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: 215-390-2002 Fax: 215-672-6740
Contact Person: Jillian Mikovich jmikovich@vygonus.com 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.
4
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:
-
- The Vygon Midline Catheters are EO sterilized, single-use, polyurethane catheters. They include materials containing barium sulfate for radiopacity.
-
- Catheter sizes, lengths, and lumen configurations are in the table that follows. Catheter gauge sizes are printed on the hubs.
-
- The catheter luer hub material is made of Quadraplast™ (Rigid Thermoplastic Polyurethane (TPU)) and may contain red, white, gray, or purple colorant.
-
- Purple colorants were added to select catheter materials to indicate power injectable functionality per generally accepted clinical use.
-
- 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.
-
- A molded suture wing is integrated with the over-molded junction and is compatible with StatLock® securement device.
-
- 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.
-
- 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.
-
- The catheter has a reverse taper design.
-
- The catheter shaft tubing is marked with depth indicators as a reference for catheter insertion.
-
- The environment of use of the device is a regulated clinical environment.
-
- Midlines operate by allowing intravenous access through one or more lumens.
5
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.
-
- Length of contact is short term (