(179 days)
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.
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 provided text is a 510(k) Summary for the Vygon Midline Catheters. It details the device's characteristics, intended use, and a comparison to a predicate device to demonstrate substantial equivalence. However, it does not describe a study involving an AI/Machine Learning device.
Therefore, I cannot extract information regarding:
- Sample sizes for test or training sets
- Data provenance (country of origin, retrospective/prospective)
- Number of experts or their qualifications for ground truth establishment
- Adjudication methods
- MRMC comparative effectiveness studies or effect sizes
- Standalone algorithm performance
- Type of ground truth (expert consensus, pathology, outcomes)
- How ground truth for the training set was established
The document explicitly states under "Clinical Testing": "No Clinical Testing was performed." This further confirms that the type of study you are asking about (related to AI performance, human reader improvement, and ground truth establishment) was not conducted for this medical device.
The study described is primarily bench testing and biocompatibility testing to demonstrate that the Vygon Midline Catheters are substantially equivalent to a previously cleared predicate device.
Here's the relevant information that can be extracted, pertaining to acceptance criteria and performance for this non-AI medical device:
1. A table of acceptance criteria and the reported device performance
The document lists various bench tests and biocompatibility tests along with their results. The "Acceptance Criteria" are implied by the "Result" column consistently stating "Passed" or specific equivalent findings.
Table of Acceptance Criteria (Implied) and Reported Device Performance
| Standard | Sterile Device Test / Test Name | Reported Device Performance (Result) |
|---|---|---|
| ISO 9626:2016 | Dimensional Inspections | Passed |
| ISO 10555-1:2014 | Catheter Conditioning (Saline) | Passed |
| ISO 10555-1:2014 | Leak Test | Passed |
| Internal Requirement | Priming Volume Test | Passed |
| ISO 10555-1:2014 | Gravity Flow Test | Passed |
| ISO 10555-1:2014 | Pump Flow Test | Passed |
| ISO 10555-1:2014 | Tensile Test | Passed |
| FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters Section II. D. b. (Mechanical Specifications) | Catheter Stiffness | Passed |
| ISO 10555-1:2014 | Burst Test | Passed |
| ISO 10555-1:2014 | Catheter Flexural Fatigue | Passed |
| ISO 10555-1:2014 | Power Injection Conditioning | Passed |
| Internal Requirement | Printing Font Size | Passed |
| ASTM F1842-15 | Ink Permanence | Passed |
| ISO 594-1: 1986 Via ISO 80369-7:2016 | Luer Taper Test | Passed |
| ASTM F1842-15 | Ink Integrity Test | Passed |
| Internal Requirement | Aspiration Flow Test | Passed |
| Internal Requirement | Luer Color/Orientation Test | Passed |
| Internal Requirement | Clamp Closure Maintenance | Passed |
| Internal Requirement | Clamp and ID Tag Fit Test | Passed |
| Internal Requirement | Clamp Actuation Test | Passed |
| ISO 10555-1:2014 (Aged) | Power Injection Conditioning | Passed |
| ISO 10555-1:2014 (Aged) | Burst Test | Passed |
| ISO 10993-5:2009/(R)2014 | Cytotoxicity | Non-cytotoxic |
| AAMI/ANSI/ISO 10993-10:2010/(R)2014 | Sensitization | Non-sensitizer |
| AAMI/ANSI/ISO 10993-10:2010/(R)2014 | Irritation | Non-irritant |
| ISO 10993-11:2006 | Acute Systemic Injection | Non-toxic |
| USP37 | Material Mediated Pyrogen | Non-pyrogenic |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Hemolysis (extract) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Hemolysis (direct) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Complement Activation (Predicate: PowerPICC® Catheter) | Similar when compared to predicate |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Partial Thromboplastin Time (PTT) (Predicate: PowerPICC® Catheter) | Minimal activator (same as predicate) |
| ISO 10993-4: 2002/(R) 2013 & A1: 2006/ (R) 2013 | Dog Thrombogenicity | Equivocal similar |
| AAMI/ANSI/ISO 10993-6:2007/(R)2014 | Implantation | Non-irritant |
| ISO 10993-18 (Nelson Labs Report does not specify year.) | Extractable/Leachable Analysis | Summarized in project #MJ16357-BIO01 |
| ISO 10993-17:2008 | Subacute/Subchronic Toxicity, Genotoxicity, Chronic Toxicity and Carcinogenicity | Evaluated in Toxicological Risk Assessment |
2. Sample sizes used for the test set and the data provenance
The document does not explicitly state the sample sizes (number of devices tested) for each bench or biocompatibility test, nor does it specify data provenance as this is not a study involving human data or image data as typically seen with AI devices. The testing is laboratory-based "bench testing" of the physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is a physical medical device clearance, not an AI/ML device where expert ground truth is established. Performance is determined by standardized laboratory tests adhering to ISO standards and internal requirements.
4. Adjudication method
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, this type of study was not performed. The document explicitly states "No Clinical Testing was performed."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used
Not applicable for the reasons stated above. The "ground truth" for this device's performance is compliance with international and national standards for medical devices (e.g., ISO, ASTM, FDA guidance) and internal requirements, demonstrated through bench and biocompatibility testing.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
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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 (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
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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 InjectionFlow 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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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.
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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:
-
- 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.
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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.
-
- Length of contact is short term (<30 days) with intravenous indwelling and skin contact.
| Device Description | |||
|---|---|---|---|
| Vygon Midline 3 Fr SL(Subject Device 1) | Vygon Midline 4 Fr SL(Subject Device 2) | Vygon Midline 5 Fr DL(Subject Device 3) | |
| Number ofLumens | 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.H & 0.020 in. W) |
| EffectiveLength | 20 cm | 20 cm | 20 cm |
| MaximumPowerInjectionFlow Rate | 5 ml/s | 7 ml/s | 7 ml/s |
| Material | • Luer – QPLAST(Rigid TPU)• Gauge Marking -Marabu TampastarTPR (970) White• Extension Leg -QFLEX (ARE-TPU)• Extension LegPrinting - MarabuTampastar TPR (970)White• Clamp - Acetal(POM) Clamp• Clamp Printing -Biocompatible Ink• Junction - QFLEX(ALE-TPU)• Inner Junction – N/AJunction Printing -Marabu Tampastar TPRWhite (970) | • Luer – QPLAST(Rigid TPU)• Gauge Marking -Marabu TampastarTPR (970) White• Extension Leg -QFLEX (ARE-TPU)• Extension LegPrinting – MarabuTampastar TPR (970)White• Clamp - Acetal(POM) Clamp• Clamp Printing -Biocompatible Ink• Junction - QFLEX(ALE-TPU)• Inner Junction – N/AJunction Printing -Marabu Tampastar TPRWhite (970) | • Luer – QPLAST(Rigid TPU)• Gauge Marking -Marabu TampastarTPR (970) White• Extension Leg -QFLEX (ARE-TPU)• Extension LegPrinting - MarabuTampastar TPR (970)White• Clamp - Acetal(POM) Clamp• Clamp Printing -Biocompatible Ink• Junction - QFLEX(ALE-TPU)• Inner Junction – N/AJunction Printing -Marabu Tampastar TPRWhite (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) -QFLEX(ALE-TPU)• Extrusion (Shaft)Printing - Marabu | • Extrusion (Shaft) -QFLEX(ALE-TPU)• Extrusion (Shaft)Printing - Marabu | • Extrusion (Shaft) -QFLEX(ALE-TPU)• Extrusion (Shaft)Printing - Marabu | |
| Tampapur TPU (980)Black | Tampapur TPU (980)Black | Tampapur TPU (980)Black | |
| Colorant /Concentrations | • Luer - RV43631224PAN 2607C, 4%(Purple)• Luer Ink - MarabuTampastar TPR (970)White• Extension Leg - MC-90570TPU, 4%(Trans. Purple Ext.Leg)• Extension Leg Ink -Marabu TampastarTPR (970) White• Junction - ClariantOM4M664821 4%Purple 2587C• Junction Ink - MarabuTampastar TPR White(970)• Shaft - ClariantOM4M664821 Purple2587C, 4%• Shaft Ink - MarabuTampapur TPU (980)Black | • Luer - RV43631224PAN 2607C, 4%(Purple)• Luer Ink - MarabuTampastar TPR (970)White• Extension Leg - MC-90570TPU, 4%(Trans. Purple Ext.Leg)• Extension Leg Ink -Marabu TampastarTPR (970) White• Junction - ClariantOM4M664821 4%Purple 2587C• Junction Ink - MarabuTampastar TPR White(970)• Shaft - ClariantOM4M664821 Purple2587C, 4%• Shaft Ink - MarabuTampapur TPU (980)Black | • Luer - RV43631224PAN 2607C, 4%(Purple)• Luer Ink - MarabuTampastar TPR (970)White• Extension Leg - MC-90570TPU, 4%(Trans. Purple Ext.Leg)• Extension Leg Ink -Marabu TampastarTPR (970) White• Junction - ClariantOM4M664821 4%Purple 2587C• Junction Ink - MarabuTampastar TPR White(970)• Shaft - ClariantOM4M664821 Purple2587C, 4%• Shaft Ink - MarabuTampapur TPU (980)Black |
| Ink Material | • Marabu TampastarTPR White (970)• Marabu TampapurTPU (980) Black | • Marabu TampastarTPR White (970)• Marabu TampapurTPU (980) Black | • Marabu TampastarTPR White (970)• Marabu TampapurTPU (980) Black |
| Duration of Use | Short term (<30 days) | Short term (<30 days) | Short term (<30 days) |
| Device Description | |||
| Vygon Midline 3 Fr SL(Subject Device 1) | Vygon Midline 4 Fr SL(Subject Device 2) | Vygon Midline 5 Fr DL(Subject Device 3) | |
| Tip PlacementLocation | Peripheralvenoussystem, withcatheter tipterminatingprior to theaxilla | Peripheralvenoussystem, withcatheter tipterminatingprior to theaxilla | Peripheralvenoussystem, withcatheter tipterminatingprior to theaxilla |
| Insertion Site | Peripheral | Peripheral | Peripheral |
| Catheter BaseMaterials | Shaft TubingPolyurethane | Shaft TubingPolyurethane | Shaft TubingPolyurethane |
| Catheter JunctionPolyurethane | Catheter JunctionPolyurethane | Catheter JunctionPolyurethane | |
| Extension LegPolyurethane | Extension LegPolyurethane | Extension LegPolyurethane | |
| Luer HubPolyurethane | Luer HubPolyurethane | Luer HubPolyurethane | |
| Extension Leg ClampPolyurethane | Extension Leg ClampPolyurethane | Extension Leg ClampPolyurethane | |
| DepthMarkings | "0" depth indicatorlocated 1 cm fromcatheter junction onreverse taper shaft tubing;catheter marked every 1cm, with numericindicators every 5 cm | "0" depth indicatorlocated 1 cm fromcatheter junction onreverse taper shaft tubing;catheter marked every 1cm, with numericindicators every 5 cm | "0" depth indicatorlocated 1 cm fromcatheter junction onreverse taper shaft tubing;catheter marked every 1cm, with numericindicators every 5 cm |
| PowerInjectionMaximumFlow 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 SLPowerMidline™Catheter | VygonMidline 3 FrSL (SubjectDevice 1) | VygonMidline 4 FrSL (SubjectDevice 2) | VygonMidline 5 FrDL (SubjectDevice 3) | |
| 510(k)Number | K153393 | K181208 | K181208 | K181208 | N/A |
| 510(k)Submitter | Bard AccessSystems (BAS) | Vygon USA | Vygon USA | Vygon USA | N/A |
| Trade Name | 3 Fr SLPowerMidline™Catheter | VygonMidline 3 FrSL Catheter | VygonMidline 4 FrSL Catheter | VygonMidline 5 FrDL Catheter | Substantially Equivalent to Predicate |
| CommonName | Midline Catheter | MidlineCatheter | MidlineCatheter | MidlineCatheter | Identical to Predicate |
| ClassificationName | Midline Catheter | MidlineCatheter | MidlineCatheter | MidlineCatheter | Identical to Predicate |
| RegulatoryClass | 2 | 2 | 2 | 2 | Identical to Predicate |
| ClassificationRegulation | 21 CFR880.5200 | 21 CFR880.5200 | 21 CFR880.5200 | 21 CFR880.5200 | Identical to Predicate |
| Attribute | Predicate Device | SubjectDevice 1 | SubjectDevice 2 | SubjectDevice 3 | |
| Device Name | 3 Fr SLPowerMidline™Catheter | VygonMidline 3 FrSL (SubjectDevice 1) | VygonMidline 4 FrFr SL (SubjectDevice 2) | VygonMidline 5DL (SubjectDevice 3) | SubstantiallyEquivalent orIdentical toPredicate |
| Product Code | PND | PND | PND | PND | Identical toPredicate |
| Review Panel/ Division | General Hospital | GeneralHospital | GeneralHospital | GeneralHospital | Identical toPredicate |
| Intended Use | ThePowerMidline™Catheter isintended forshort termperipheral accessfor selectedintravenoustherapies, bloodsampling, andpower injectionof contrastmedia. | The catheteris intendedfor short termperipheralaccess forselectedintravenoustherapies,bloodsampling, andpowerinjection ofcontrastmedia. | The catheteris intendedfor short termperipheralaccess forselectedintravenoustherapies,bloodsampling, andpowerinjection ofcontrastmedia. | The catheteris intendedfor short termperipheralaccess forselectedintravenoustherapies,bloodsampling, andpowerinjection ofcontrastmedia. | SubstantiallyEquivalent toPredicate |
| Indicationsfor Use | ThePowerMidline™Catheters areindicated forshort term accessto the peripheralvenous systemfor selectedintravenoustherapies, bloodsampling, andpower injectionof contrastmedia. Thesecatheters may beused for anypatientpopulation withconsiderationgiven to | The catheters are indicated for short termaccess to the peripheral venous system forselected intravenous therapies, blood sampling,and power injection of contrast media. Thesecatheters may be used for any patientpopulation with consideration given toadequacy of vascular anatomy andappropriateness of the procedure. Thecatheters are suitable for use with powerinjectors. | SubstantiallyEquivalent toPredicate | ||
| Catheter SizeMaximum PowerInjection Flow RateVygon Midline 35 ml/sFr SLVygon Midline 47 ml/sFr SLVygon Midline 47 ml/sFr DL | |||||
| Attribute | Predicate Device | Subject Device 1 | Subject Device 2 | Subject Device 3 | Substantially Equivalent or Identical to Predicate |
| DeviceName | 3 Fr SLPowerMidlineTM Catheteradequacy ofvascularanatomy andappropriatenessof theprocedure. ThePowerMidlineTM Cathetersare suitable foruse with powerinjectors. | VygonMidline 3 FrSL (SubjectDevice 1) | VygonMidline 4 FrSL (SubjectDevice 2) | VygonMidline 5 FrDL (SubjectDevice 3) | |
| Means ofInsertion | Percutaneous,using ModifiedSeldingerTechnique andguidewire | Percutaneous, usingModified SeldingerTechnique andguidewire | Percutaneous,using ModifiedSeldingerTechnique andguidewire | Percutaneous,using ModifiedSeldingerTechnique andguidewire | Identical toPredicate |
| TipPlacementLocation | Midlines areinserted in aperipheral veinin the arm, suchas the cephalicvein, basilicvein or brachialvein, and thenadvancedproximallytoward theshoulder, untilthe tip restsdistally to theshoulder at orbelow theaxillary line. | Midlines areinserted in aperipheral vein inthe arm, such asthe cephalic vein,basilic vein orbrachial vein, andthen advancedproximallytoward theshoulder, until thetip rests distally tothe shoulder at orbelow the axillaryline. | Midlines areinserted in aperipheral vein inthe arm, such asthe cephalic vein,basilic vein orbrachial vein, andthen advancedproximallytoward theshoulder, untilthe tip restsdistally to theshoulder at orbelow theaxillary line. | Midlines areinserted in aperipheral vein inthe arm, such asthe cephalic vein,basilic vein orbrachial vein,and thenadvancedproximallytoward theshoulder, untilthe tip restsdistally to theshoulder at orbelow theaxillary line. | Identical toPredicate |
| Insertion Site | Peripheral | Peripheral | Peripheral | Peripheral | Identical toPredicate |
| ComponentsMaterials | • Luer – Isoplast(Rigid TPU)• Gauge Marking- BiocompatibleInk• Extension Leg -Tecothane(ARE-TPU)• Extension LegPrinting -BiocompatibleInk• Clamp - AcetalPolyoxymethylene (POM)• Clamp• Clamp Printing- BiocompatibleInk• Junction -QFLEX (ALE-TPU)• Inner Junction -Rigid TPU• Junction Printing- BiocompatibleInk• Extrusion(Shaft) - QFLEX(ALE-TPU)• Extrusion(Shaft) Printing- BiocompatibleInk | • Luer – QPLAST(Rigid TPU)• Gauge Marking- MarabuTampastar TPR(970) White• Extension Leg -QFLEX (ARE-TPU)• Extension LegPrinting -MarabuTampastar TPR(970) White• Clamp - Acetal(POM) Clamp• Clamp Printing- BiocompatibleInk• Junction -QFLEX (ALE-TPU)• Inner Junction -N/A• JunctionPrinting -MarabuTampastar TPRWhite (970)• Extrusion(Shaft) -QFLEX(ALE-TPU)• Extrusion (Shaft)Printing - MarabuTampapur TPU(980) Black | • Luer -QPLAST(Rigid TPU)• Gauge Marking- MarabuTampastar TPR(970) White• Extension LegQFLEX (ARE-TPU)• Extension LegPrinting -MarabuTampastar TPR(970) White• Clamp - Acetal(POM) Clamp• Clamp Printing- BiocompatibleInk• Junction -QFLEX (ALE-TPU)• Inner Junction -N/A• JunctionPrinting -MarabuTampastar TPRWhite (970)• Extrusion(Shaft) -QFLEX(ALE-TPU)• Extrusion(Shaft) Printing- MarabuTampapur TPU(980) Black | • Luer -QPLAST(Rigid TPU)• Gauge Marking- MarabuTampastar TPR(970) White• Extension Leg -QFLEX (ARE-TPU)• Extension LegPrinting -MarabuTampastar TPR(970) White• Clamp - Acetal(POM) Clamp• Clamp Printing- BiocompatibleInk• Junction -QFLEX (ALE-TPU)• Inner Junction -N/A• JunctionPrinting -MarabuTampastar TPRWhite (970)• Extrusion(Shaft) -QFLEX(ALE-TPU)• Extrusion (Shaft)Printing -MarabuTampapur TPU(980) Black | SubstantiallyEquivalent toPredicate |
| Attribute | Predicate Device | Subject Device 1 | Subject Device 2 | Subject Device 3 | |
| Device Name | 3 Fr SL PowerMidlineTM Catheter | Vygon Midline 3 Fr SL (Subject Device 1) | Vygon Midline 4 Fr SL (Subject Device 2) | Vygon Midline 5 Fr DL (Subject Device 3) | Substantially Equivalent or Identical to Predicate |
| Catheter Proximal Configuration | Luer Connection | Luer Connection | Luer Connection | Luer Connection | Identical to Predicate |
| Catheter Distal Configuration | Open Ended | Open Ended | Open Ended | Open Ended | Identical to Predicate |
| Catheter Dimensions | 3F SL x 20 cm usable length | 3F SL x 20 cm usable length | 4F SL x 20 cm usable length | 5F DL x 20 cm usable length | Identical to Predicate |
| Number/Shape of Lumens | Single Lumen (one)/ Round | Single Lumen (one)/ Round | Single Lumen (one)/ Round | Dual Lumen (two)/ D,D | Identical to Predicate |
| Maximum Power Injection Flow Rate | 3 ml/s | 5 ml/s | 7 ml/s | 7 ml/s | Substantially Equivalent to Predicate |
| Sterility | 100% Ethylene Oxide, SAL of 10-6 | 100% Ethylene Oxide, SAL of 10-6 | 100% Ethylene Oxide, SAL of 10-6 | 100% Ethylene Oxide, SAL of 10-6 | Identical to Predicate |
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Image /page/9/Picture/0 description: The image shows the Vygon logo. The word "VYGON" is written in white letters on a green rounded rectangle. Above the word "VYGON" is a red triangle pointing downwards. Below the green rectangle are the words "Value Life" in a smaller font.
2750 Morris Road, Suite A200 • Lansdale, PA 19446 • Telephone: 215-390-2002 • Fax: 215-672-6740 Email: email@vygonus.com • Website: www.vygonusa.com
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Image /page/10/Picture/0 description: The image shows the Vygon logo. The word "VYGON" is written in white letters on a green background. Above the word "VYGON" is a red triangle pointing downwards. Below the logo, the words "Value Life" are written in gray.
2750 Morris Road, Suite A200 • Lansdale, PA 19446 • Telephone: 215-390-2002 • Fax: 215-672-6740 Email: email@vygonus.com • Website: www.vygonusa.com
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Image /page/11/Picture/0 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white letters inside a green rounded rectangle. Above the "V" is a small red triangle. Below the logo is the text "Value Life".
2750 Morris Road, Suite A200 • Lansdale, PA 19446 • Telephone: 215-390-2002 • Fax: 215-672-6740 Email: email@vygonus.com • Website: www.vygonusa.com
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Image /page/12/Picture/0 description: The image shows the Vygon logo. The word "VYGON" is written in white letters on a green background. Above the "V" is a red triangle pointing downwards. Below the logo is the text "Value Life".
Table 1: Substantial Equivalence Comparison Table
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Image /page/13/Picture/0 description: The image shows the Vygon logo. The logo consists of the word "VYGON" in white, with a red triangle above the "V". The word is set against a green, rounded rectangle. Below the rectangle, the words "Value Life" are written in a smaller, gray font.
Statements on differences between subject and predicate devices
Materials: the differences in materials do not raise different questions of safety and effectives. The materials used to construct the subject devices do not impact device performance, as demonstrated by bench testing. And the biocompatibility of the devices has been demonstrated with testing.
Dimensions: the subject devices are available in 3, 4, and 5 Fr sizes. The predicate is available in 3Fr only. The 4Fr and 5Fr sizes do not raise different questions of safety and effectiveness as these sizes are commonly used sizes, clinically, and there are other cleared Midline Catheters in this regulation at these sizes.
Number and Shape of Lumens: The subject devices are available in single and double lumen configurations in both round and "D" shapes respectively . While the predicate is only available in single lumen round shape configuration. The double lumen "D" shape does not raise different questions of safety and effectiveness as this configuration is commonly used clinically, and there are other cleared Midline Catheters in the regulation in this configuration.
Max Power Injection Flow Rate: The subject devices have the capability of max power injection flow rate of 5mL/sec (3Fr) and 7mL/sec (4Fr and 5Fr). While the predicate has the capability of 3mL/sec (3Fr). The max power injection flow rates of the subject device do not raise questions of safety and effectiveness as these flow rates are commonly used clinically, and these flow rates have been demonstrated in performance bench testing, Additionally, there are other cleared Midline Catheters in the regulation with these max power injection flow rates.
VII. PERFORMANCE DATA
Vygon Midlines were tested per Table 2 and Table 3 below. See Section 18 Performance Testing - Bench for test objectives, test articles, methods, procedures, endpoints, acceptance criteria, data analysis, and conclusions.
Bench Testing
Bench tests are listed below. Table 2 includes tests conducted before aging. Table 3 includes tests conducted after aging (accelerated 12 months). Justification for testing pre- aging is included in the Design Verification Reports, M069-006R Design Verification Report Vygon PICC, Attachments 1, 4, and 6, and M070-006R Design Verification Report Vygon Midline, Attachments 1-7a.
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Image /page/14/Picture/0 description: The image shows the logo for Vygon. The logo consists of the word "VYGON" in white, bold letters, with a red triangle above the "V". The word "VYGON" is set against a green, rounded rectangle. Below the rectangle, the words "Value Life" are written in a smaller, gray font.
| Standard | Sterile Device Test | Result |
|---|---|---|
| ISO 9626:2016 | Dimensional Inspections | Passed |
| ISO 10555-1:2014 | Catheter Conditioning (Saline) | Passed |
| ISO 10555-1:2014 | Leak Test | Passed |
| Internal Requirement | Priming Volume Test | Passed |
| ISO 10555-1:2014 | Gravity Flow Test | Passed |
| ISO 10555-1:2014 | Pump Flow Test | Passed |
| ISO 10555-1:2014 | Tensile Test | Passed |
| FDA Guidance on Premarket Notification[510(k)] Submission for Short-Term andLong-Term Intravascular Catheters SectionII. D. b. (Mechanical Specifications) | Catheter Stiffness | Passed |
| ISO 10555-1:2014 | Burst Test | Passed |
| ISO 10555-1:2014 | Catheter Flexural Fatigue | Passed |
| ISO 10555-1:2014 | Power Injection Conditioning | Passed |
| Internal Requirement | Printing Font Size | Passed |
| ASTM F1842-15 | Ink Permanence | Passed |
| ISO 594-1: 1986 Via ISO 80369-7:2016 | Luer Taper Test | Passed |
| ASTM F1842-15 | Ink Integrity Test | Passed |
| Internal Requirement | Aspiration Flow Test | Passed |
| Internal Requirement | Luer Color/Orientation Test | Passed |
| Internal Requirement | Clamp Closure Maintenance | Passed |
| Internal Requirement | Clamp and ID Tag Fit Test | Passed |
| Internal Requirement | Clamp Actuation Test | Passed |
Table 2: Vygon Midline Catheters Performance Testing
| Standard | Sterile, Aged (Accelerated 12 Months)Device Test | Result |
|---|---|---|
| ISO 10555-1:2014 | Power Injection Conditioning | Passed |
| ISO 10555-1:2014 | Burst Test | Passed |
Table 3: Vygon Midline Catheters Aged Performance Testing
Clinical Testing
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Image /page/15/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 green rectangle is the text "Value Life" in a light gray color.
No Clinical Testing was performed.
Biocompatibility Testing
Biocompatibility tests are listed below in Table 4.
| Standard | Test Name | Result |
|---|---|---|
| ISO 10993-5:2009/(R)2014 | Cytotoxicity | Non-cytotoxic |
| AAMI/ANSI/ISO 10993-10:2010/(R)2014 | Sensitization | Non-sensitizer |
| AAMI/ANSI/ISO 10993-10:2010/(R)2014 | Irritation | Non-irritant |
| ISO 10993-11:2006 | Acute Systemic Injection | Non-toxic |
| USP37 | Material Mediated Pyrogen | Non-pyrogenic |
| ISO 10993-4: 2002/(R) 2013 &A1: 2006/ (R) 2013 | Hemolysis (extract) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013 &A1: 2006/ (R) 2013 | Hemolysis (direct) | Non-hemolytic |
| ISO 10993-4: 2002/(R) 2013 &A1: 2006/ (R) 2013 | Complement ActivationPredicate: PowerPICC®Catheter | Similar when compared topredicate |
| ISO 10993-4: 2002/(R) 2013 &A1: 2006/ (R) 2013 | Partial ThromboplastinTime (PTT)Predicate: PowerPICC®Catheter | Minimal activator (same aspredicate) |
| ISO 10993-4: 2002/(R) 2013 &A1: 2006/ (R) 2013 | Dog Thrombogenicity | Equivocal similar |
| AAMI/ANSI/ISO 10993-6:2007/(R)2014 | Implantation | Non-irritant |
| ISO 10993-18 (Nelson LabsReport does not specify year.) | Extractable/LeachableAnalysis | Summarized in project#MJ16357-BIO01 |
| ISO 10993-17:2008 | Subacute/SubchronicToxicity, Genotoxicity,Chronic Toxicity andCarcinogencity | Evaluated in ToxicologicalRisk Assessment |
Table 4: Vygon Midline Catheters Biocompatibility Testing
VIII. CONCLUSIONS
Through performance bench testing, it has been demonstrated that the subject device is substantially equivalent to the predicate device, 3 FR SL PowerMidline™ Catheter, K153393.
§ 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).