(157 days)
The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/section of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The Vygon PICCs are sterile, single-use, polyurethane PICCs with the same intended use, indications for use, similar design, similar sizes, similar or the same materials, and similar properties as the predicate device.
The provided document details the Vygon PICCs device, its intended use, and substantial equivalence to a predicate device, focusing on various performance and safety tests. However, the document does not describe an algorithm or AI-driven device, nor does it present acceptance criteria and performance data in the context of such a device.
Therefore, many of the requested items (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this submission, as it pertains to a physical medical device (Vygon PICCs) and not a software or AI-based diagnostic/screening tool.
The document primarily focuses on bench testing, sterilization testing, and biocompatibility testing to demonstrate that the Vygon PICCs are substantially equivalent to the predicate device (5 Fr DL PowerPICC® Catheter).
Here's an attempt to extract the relevant information based on the provided document, addressing the prompt's categories where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like a PICC, the "acceptance criteria" are typically the satisfactory completion of standardized tests and meeting the requirements outlined in those standards. The "reported device performance" is whether the device "Passed" each test.
| Test Standard / Requirement | Acceptance Criteria (Implied: "Pass" per standard) | Reported Device Performance |
|---|---|---|
| Bench Testing | ||
| ISO 9626:2016 (Dimensional) | Meets dimensional specifications | Passed |
| ISO 10555-1:2014 (Conditioning Saline) | Maintains integrity after conditioning | Passed |
| ISO 10555-1:2014 (Leak Test) | No leaks detected | Passed |
| Internal Requirement (Priming Volume) | Meets specified priming volume | Passed |
| ISO 10555-1:2014 (Gravity Flow) | Achieves specified flow rate | Passed |
| ISO 10555-1:2014 (Pump Flow) | Achieves specified flow rate | Passed |
| ISO 10555-1:2014 (Tensile) | Withstands specified tensile force | Passed |
| ISO 10555-1:2014 (Burst) | Withstands specified burst pressure | Passed |
| ISO 10555-1:2014 (Power Injection Conditioning) | Maintains integrity after power injection conditioning | Passed |
| Internal Requirement (Printing Font Size) | Meets specified font size | Passed |
| ASTM F1842-15 (Ink Permanence) | Ink remains permanent | Passed |
| ISO 594-1: 1986 Via / ISO 80369-7:2016 (Luer Taper) | Complies with Luer taper standards | Passed |
| ASTM F1842-15 (Ink Integrity) | Ink integrity maintained | Passed |
| Vygon Internal (Aspiration Flow) | Achieves specified aspiration flow | Passed |
| Vygon Internal (Luer Color/Orientation) | Correct color and orientation | Passed |
| Vygon Internal (Clamp Closure Maintenance) | Clamp maintains closure | Passed |
| Vygon Internal (Clamp and ID Tag Fit) | Clamp and ID tag fit correctly | Passed |
| Vygon Internal (Clamp Actuation) | Clamp actuates correctly | Passed |
| Aged Performance Testing | ||
| ISO 10555-1:2014 (Power Injection Conditioning) | Maintains integrity after conditioning (aged) | Passed |
| ISO 10555-1:2014 (Burst) | Withstands specified burst pressure (aged) | Passed |
| Sterilization Testing | ||
| ASTM F88 / F88M-15 (Seal Strength) | Packaging seal strength maintained | Passed |
| ASTM F2096-11 (Bubble Leak) | No leaks in packaging | Passed |
| ANSI/AAMI ST72:2011 (LAL) | Meets endotoxin limits | Passed |
| ISO 10993-7:2008 (EO Residual) | Meets EO residual limits | Passed |
| Biocompatibility Testing | ||
| ISO 10993-5:2009 (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| AAMI/ANSI/ISO 10993-10 (Sensitization) | Non-sensitizing | Non-sensitizer |
| AAMI/ANSI/ISO 10993-10 (Irritation) | Non-irritating | Non-irritant |
| ISO 10993-11:2006 (Acute Systemic) | Non-toxic | Non-toxic |
| USP37 (Material Mediated Pyrogen) | Non-pyrogenic | Non-pyrogenic |
| ISO 10993-4 (Hemolysis, extract) | Non-hemolytic | Non-hemolytic |
| ISO 10993-4 (Hemolysis, direct) | Non-hemolytic | Non-hemolytic |
| ISO 10993-4 (Complement Activation) | Similar to predicate | Similar when compared to predicate |
| ISO 10993-4 (Partial Thromboplastin Time) | Minimal activator (same as predicate) | Minimal activator (same as predicate) |
| ISO 10993-4 (Dog Thrombogenicity) | Similar to predicate | Equivocal similar |
| AAMI/ANSI/ISO 10993-6 (Implantation) | Non-irritating | Non-irritant |
| ISO 10993-18 (Extractable/Leachable) | Analysis summarized | Summarized in project #MJ16357-BIO01 |
| ISO 10993-17 (Toxicity) | Evaluated satisfactorily | Evaluated in Toxicological Risk Assessment |
2. Sample sized used for the test set and the data provenance:
For a physical device, "sample size" refers to the number of units tested. The document does not explicitly state the sample sizes for each bench, sterilization, or biocompatibility test. The data provenance is internal testing performed by Vygon USA (the submitter). The context implies these are prospective tests conducted on the final device. No country of origin for the data is specified beyond the submitter's location (Lansdale, PA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is subjected to standardized physical and chemical tests, not an assessment requiring expert "ground truth" derived from clinical cases or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or image interpretations. The tests performed are objective, pass/fail criteria based on adherence to international standards and internal requirements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-driven device or study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device is compliance with established engineering and biological standards and specifications.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
February 26, 2018
Vygon USA Jillian Mikovich Regulatory Affairs Manager 2750 Morris Rd. Suite A200 Lansdale, Pennsylvania 19460
Re: K172899
Trade/Device Name: Vygon PICCs Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: January 26, 2018 Received: January 29, 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. 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.
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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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Tina
Kiang-S
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) K172899
Device Name
Vygon PICCs
Indications for Use (Describe)
The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/section of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
| 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 background, with a red triangle above the "V". Below the main logo, the words "Value Life" are written in a smaller, gray font.
K172899 510(k) Summary (21 CFR 807.92(c))
I. Submitter Information
| Submitter Name: | Vygon |
|---|---|
| Address: | 2750 Morris Road, Suite A200Lansdale, PA 19446 |
| Telephone: | 215-390-2002 |
| Fax: | 215-672-6740 |
| Contact Person: | Jillian Mikovich |
|---|---|
| Email of Contact: | jmikovich@vygonus.com |
| Date Prepared: | February 23, 2018 |
II. Device
| Device Name: | Vygon PICCs |
|---|---|
| Common Name: | Vygon PICCs |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Percutaneous, Implanted, Long-Term Intravascular |
| Catheter | |
| Classification Panel: | General Hospital |
| Regulation Device Name: | Catheter, Intravascular, Therapeutic, Long-Term Greater |
| Than 30 Days | |
| Regulation Number: | 21 CFR 880.5970 |
| Regulatory Class: | 2 |
| Product Code: | LIS |
III. Predicate Device
| Predicate Name: | 5 Fr DL PowerPICC® Catheter |
|---|---|
| Trade Name: | 5 Fr DL PowerPICC® Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | LJS - Percutaneous, Implanted, Long-Term IntravascularCatheter |
| Premarket Notification: | K051672 |
| 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 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.
IV. Indications for Use
The catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allow(s) for central venous pressure monitoring. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5mL/sec for power injection of contrast media. For central venous pressure monitoring, it is recommended that catheter lumen of 20 gauge or larger be used.
The Indications for Use statement for the Vygon PICCs is not identical to the predicate device, 5 Fr DL PowerPICC® Catheter, Indications for Use; however, the differences do not alter the intended therapeutic use of the device. Both the subject and predicate devices have the same intended use for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
V. Technological Characteristics
All characteristics of the Vygon PICCs are substantially equivalent to the predicate device, the Bard Access Systems 5 Fr DL PowerPICC® catheter. Both the subject and the predicate catheters are sterile, single-use, polyurethane PICCs 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:Predicate DeviceDL | Subject Device 1SL | Subject Device 2DL | Subject Device 3TL |
|---|---|---|---|---|
| Device Name | 5 Fr DLPowerPICC®Catheter | Vygon PICC 4 FrSL | Vygon PICC 5 FrDL | Vygon PICC 6 FrTL |
| 510(k) Number | K051672 | K172899 | K172899 | K172899 |
| 510(k)Submitter | Bard AccessSystems (BAS) | Vygon USA | Vygon USA | Vygon USA |
| Trade Name | 5 Fr DLPowerPICC®Catheter | Vygon PICC 4 FrSL | Vygon PICC 5 FrDL | Vygon PICC 6 FrTL |
| CommonName | PeripherallyInserted CentralCatheter (PICC) | Same as Predicate | Same as Predicate | Same as Predicate |
| Attribute | Predicate:Predicate DeviceDL | Subject Device 1SL | Subject Device 2DL | Subject Device 3TL |
| Device Name | 5 Fr DLPowerPICC®Catheter | Vygon PICC 4 FrSL | Vygon PICC 5 FrDL | Vygon PICC 6 FrTL |
| ClassificationName | Catheter,Intravascular,Therapeutic, Long-Term IntravascularCatheter | Same as Predicate | Same as Predicate | Same as Predicate |
| RegulatoryClass | 2 | Same as Predicate | Same as Predicate | Same as Predicate |
| ClassificationRegulation | 21 CFR 880.5970 | Same as Predicate | Same as Predicate | Same as Predicate |
| Product Code | LJS | Same as Predicate | Same as Predicate | Same as Predicate |
| Review Panel /Division | General Hospital | Same as Predicate | Same as Predicate | Same as Predicate |
| Indications forUse | The PowerPICC®catheter isindicated for shortor long term | The catheter isindicated for shortor long termperipheral access tothe central venoussystem forintravenoustherapy, powerinjection of contrastmedia, and allow(s)for central venouspressuremonitoring. Forblood sampling,infusion or therapy,use 4 French orlarger catheter. Themaximumrecommendedinfusion rate is5mL/sec for powerinjection of contrastmedia. For centralvenous pressuremonitoring, it is | The catheter isindicated for shortor long termperipheral access tothe central venoussystem forintravenoustherapy, powerinjection of contrastmedia, and allow(s)for central venouspressuremonitoring. Forblood sampling,infusion or therapy,use 4 French orlarger catheter. Themaximumrecommendedinfusion rate is5mL/sec for powerinjection of contrastmedia. For centralvenous pressuremonitoring, it is | The catheter isindicated for shortor long termperipheral access tothe central venoussystem forintravenoustherapy, powerinjection of contrastmedia, and allow(s)for central venouspressuremonitoring. Forblood sampling,infusion or therapy,use 4 French orlarger catheter. Themaximumrecommendedinfusion rate is5mL/sec for powerinjection of contrastmedia. For centralvenous pressuremonitoring, it is |
| Attribute | Predicate:Predicate DeviceDL | Subject Device 1SL | Subject Device 2DL | Subject Device 3TL |
| Device Name | 5 Fr DLPowerPICC®Catheter | Vygon PICC 4 FrSL | Vygon PICC 5 FrDL | Vygon PICC 6 FrTL |
| catheter may notexceed 300 psi. | catheter lumen of20 gauge or largerbe used. | catheter lumen of20 gauge or largerbe used. | catheter lumen of20 gauge or largerbe used. | |
| Intended Use | The catheters areintended for shortor long termperipheral accessto the centralvenous system forintravenoustherapy and bloodsampling. | Same as Predicate | Same as Predicate | Same as Predicate |
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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 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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Table 1: Substantial Equivalence Comparison Table
VI. Performance Testing
Vygon PICCs were tested per Table 2 and Table 3 below.
Special controls for the Product Code LJS include the guidance document "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters" and the consensus standards:
- ISO 10555-1 Second edition 2013-06-15 Intravascular catheters -- Sterile and single-● use intravascular catheters -- Part 1: General requirements
- ISO 10555-3 Second edition 2013-06-15 Intravascular catheters -- Sterile and singleuse catheters -- Part 3: Central venous catheters
- . ISO 10555-1 and ISO 10555-3 requirements have been addressed and met.
Other requirements listed in the guidance document "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters" have been met in the development of the device and are described below.
Bench Testing
Bench tests are listed below.
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Image /page/7/Picture/0 description: The image is a logo for Vygon. The logo consists of the word "VYGON" in white letters on a green rounded rectangle. There is a red triangle above the "V" in Vygon. Below the green rectangle, the words "Value Life" are written in gray.
| 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 |
| ISO 10555-1:2014 | Burst Test | 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 | Luer Taper Test | Passed |
| ISO 80369-7:2016 | ||
| Functional Testing | ||
| ASTM F1842-15 | Ink Integrity Test | Passed |
| Vygon InternalRequirement | Aspiration Flow Test | Passed |
| Vygon InternalRequirement | Luer Color/Orientation Test | Passed |
| Vygon InternalRequirement | Clamp Closure Maintenance Test | Passed |
| Vygon InternalRequirement | Clamp and ID Tag Fit Test | Passed |
| Vygon InternalRequirement | Clamp Actuation Test | Passed |
Table 2: Vygon PICCs 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 PICCs Aged Performance Testing
Sterilization Testing
Sterilization tests are listed in Table 4 and Table 5 below.
| Standard | Sterile, Aged (Accelerated 13 Months)Packaging Test | Result |
|---|---|---|
| ASTM F88 / F88M-15 | Seal Strength | Passed |
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/8/Picture/0 description: The image shows the Vygon logo. The word "VYGON" is in white letters on a green background. Above the "V" is a red triangle pointing downwards. Below the logo is the text "Value Life" in a smaller, gray font.
| ASTM F2096-11 | Bubble Leak | Passed |
|---|---|---|
| Table 4: Vygon PICCs Aged Packaging Testing |
| Standard | Sterile Device Test | Result |
|---|---|---|
| ANSI/AAMI ST72:2011 | LAL Testing | Passed |
| ISO 10993-7:2008 | EO Residual Testing | Passed |
Table5: Vygon PICCs Sterile Testing
In addition, performance testing for catheter stiffness and catheter flexural fatigue tolerance was completed on the final finished sterile devices with acceptable results.
Clinical Testing
No clinical testing was performed.
Biocompatibility Testing
Biocompatibility tests are listed below in Table 6.
| 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 Thromboplastin Time(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 |
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Image /page/9/Picture/0 description: The image shows the Vygon logo. The logo features the word "VYGON" in white letters on a green, rounded rectangle. Above the "V" is a small, red triangle. Below the logo is the text "Value Life" in a smaller, gray font.
| Standard | Test Name | Result |
|---|---|---|
| ISO 10993-18 (Nelson LabsReport does not specifyyear.) | Extractable/Leachable Analysis | Summarized in project#MJ16357-BIO01 |
| ISO 10993-17:2008 | Subacute/Subchronic Toxicity,Genotoxicity, Chronic Toxicityand Carcinogencity | Evaluated in ToxicologicalRisk Assessment |
Table 6: Vygon PICCs Biocompatibility Testing
VII. Conclusion
Through performance bench testing the subject devices have demonstrated that they are substantially equivalent to the predicate device, 5 Fr DL PowerPICC® Catheter, K051672.
§ 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.”