(234 days)
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood products, drug administration and blood sampling.
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is composed of a peripherally inserted central venous catheter, obturator, wire guide, Peel-Away® introducer, access needle, syringe, catheter securement device, thumb scalpel, drape, and tape measure. Additional set configurations may also include a dilator, gauze, Lidocaine, Monoject needles, and other convenience accessories. The catheter is available in a single (3.0, 4.0, 5.0 French) or dual lumen (7.0 French) configuration with lengths of 50 and 60 centimeters. The catheter shaft is manufactured from silicone radiopaque tubing, which is connected to a silicone winged manifold. Proximally, the winged manifold is attached to one or two silicone extension tubes with a pre-molded acetal hub. Additionally, removable polypropylene clamps are attached to each extension tube. The obturator is manufactured from stainless steel and has a hydrophilic coating. It is designed to fit in the catheter and is manufactured with a proximal Luer hub that can be locked into the proximal hub of the corresponding catheter. The wire guide is manufactured with either stainless steel or a nitinol mandril with a platinum tip. The introducer is composed of a radiopaque tetrafluoroethylene (TFE) Peel-Away® sheath and a polyethylene dilator matched for transitional fit. The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is sterilized by ethylene oxide and intended for one-time use.
The provided text describes a 510(k) premarket notification for a medical device and evaluates its substantial equivalence to predicate devices, rather than presenting a study proving a device meets acceptance criteria for an AI or imaging diagnostic tool. Therefore, much of the requested information (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable or cannot be extracted from this document.
However, I can provide the acceptance criteria and performance data for the physical device based on the bench testing conducted.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Bench Testing) | Reported Device Performance (Silicone Peripherally Inserted Central Venous Catheter Set/Tray) |
|---|---|
| Catheter Tensile Testing (per applicable ISO standards) | Met the acceptance criteria. |
| Catheter Liquid Leakage | Catheters did not leak. |
| Catheter Air Leakage (per BS EN ISO 10555-1) | Catheters met the air leak requirements. |
| Catheter Kink Radius (flow rate impact during kinking) | Flow rate was not impacted. |
| Catheter Gravity Flow Rate | Catheters have an acceptable flow rate for the clinical application. |
| Catheter Radiopacity | Devices are visible in the radiographic image. |
| MR Testing (per ASTM F2503) | Catheters are MR Conditional. |
| Dimensional Verification | Test specimens' dimensions are within specified tolerances, and markings are clearly marked on shrink tube. |
| PICC Set Components Compatibility | PICC set components are compatible. |
| Obturator Corrosion (per Annex B of ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Obturator Hub-to-Wire Tensile | Devices met the acceptance criteria. |
| Wire Guide Corrosion (per Annex B of ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Wire Guide Tensile (per BS EN ISO 11070:2014, Annex H) | Predetermined acceptance criteria were met. |
| Wire Guide Fracture (per Annex F of BS EN ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Wire Guide Flex (per Annex G of BS EN ISO 11070:2014) | Predetermined acceptance criteria were met. |
| Peel-Away Introducer Hub-to-Shaft Tensile | Devices met the acceptance criteria. |
| Biocompatibility (per ISO 10993-1 and FDA guidance - cytotoxicity, sensitization, intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, hemocompatibility) | Demonstrated biocompatibility. |
| Sterilization Validation (per ISO 11135-1:2007, BS EN 556-1:2001) | Established method used to validate the sterilization cycle is consistent; complies with BS EN 556-1:2001. |
| Sterility Assurance Level (SAL) | 10-6 |
| EO Residual Level (per ISO 10993-7:2008) | EO (Average Daily Dose): ≤ 4 mg; ECH (Average Daily Dose): ≤ 9 mg |
| Bacterial Endotoxin Test Method (LAL) | Maximum testing limit being 20 EU/device (recommended for blood contacting devices). |
| Shelf-Life (three-year equivalency by accelerated methods) | Successful testing of performance characteristics on devices aged to a minimum of three-year equivalency. |
Details Not Applicable or Not Provided in the Document:
- Sample size used for the test set and the data provenance: The document refers to "test specimens" for bench testing, but specific sample sizes for each test are not provided. The data provenance is Cook Incorporated's internal testing. This is not clinical data, but rather engineering and materials testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes physical device testing, not a diagnostic or AI-driven medical device requiring expert ground truth for a test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 or diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical device performance tests, the "ground truth" refers to established engineering standards (e.g., ISO, ASTM, BS EN) and their respective acceptance criteria.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2018
Cook Incorporated Johnathan Liu Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K171994
Trade/Device Name: Silicone Peripherally Inserted Central Venous Catheter Set/Tray Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: January 22, 2018 Received: January 23, 2018
Dear Johnathan Liu:
We have reviewed vour 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.
{1}------------------------------------------------
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 (QS) 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171994
Device Name
Silicone Peripherally Inserted Central Venous Catheter Set/Tray
Indications for Use (Describe)
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood products, drug administration and blood sampling.
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, white, sans-serif letters on a red background. Below the word "COOK" is the word "MEDICAL" in smaller, white, sans-serif letters. The logo is simple and clean, and the red and white colors are eye-catching.
2.0 510(k) SUMMARY
K171994 Silicone Peripherally Inserted Central Venous Catheter Set/Tray 21 CFR §807.92(c) Date Prepared: February 21, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated750 Daniels WayBloomington, IN 47404 |
| Contact: | Johnathan Liu |
| Email: | regsubmissions@cookmedical.com |
| Contact Phone Number: | (812) 335-3575 x104509 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Silicone Peripherally Inserted Central Venous CatheterSet/Tray |
|---|---|
| Common Name: | Catheter, Intravascular, Therapeutic, Long-Term GreaterThan 30 Days |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter |
| Regulation: | 21 CFR §880.5970 |
| Product Code: | LJS |
| Device Class: | II |
| Classification Panel: | General Hospital |
Predicate Devices:
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is substantially equivalent to the following:
- Primary Predicate: Medcomp Vascu-PICC™ Catheter cleared on April 11, 2003 -(K030270).
- Secondary Predicate: Cook Spectrum Silicone Catheter cleared on May 30, 2003 -(K021557).
{4}------------------------------------------------
Device Description:
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is composed of a peripherally inserted central venous catheter, obturator, wire guide, Peel-Away® introducer, access needle, syringe, catheter securement device, thumb scalpel, drape, and tape measure. Additional set configurations may also include a dilator, gauze, Lidocaine, Monoject needles, and other convenience accessories. The catheter is available in a single (3.0, 4.0, 5.0 French) or dual lumen (7.0 French) configuration with lengths of 50 and 60 centimeters. The catheter shaft is manufactured from silicone radiopaque tubing, which is connected to a silicone winged manifold. Proximally, the winged manifold is attached to one or two silicone extension tubes with a pre-molded acetal hub. Additionally, removable polypropylene clamps are attached to each extension tube. The obturator is manufactured from stainless steel and has a hydrophilic coating. It is designed to fit in the catheter and is manufactured with a proximal Luer hub that can be locked into the proximal hub of the corresponding catheter. The wire guide is manufactured with either stainless steel or a nitinol mandril with a platinum tip. The introducer is composed of a radiopaque tetrafluoroethylene (TFE) Peel-Away® sheath and a polyethylene dilator matched for transitional fit. The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is sterilized by ethylene oxide and intended for one-time use.
Indications for Use:
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood or blood products, drug administration and blood sampling.
Comparison to Primary Predicate Device:
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray and the primary predicate device, the Medcomp Silicone Vascu-PICC™ Catheter (K030270), are substantially equivalent in that these devices are identical in principles of operation and fundamental technologies. Through performance testing the subject device and predicate device have demonstrated substantial equivalence. The substantial equivalence comparison of the subject device to the predicate is summarized in the table below.
{5}------------------------------------------------
| PRIMARY PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| Medcomp Silicone Vascu-PICC™Catheter (K030270) | Silicone Peripherally InsertedCentral Venous Catheter Set/Tray | |
| Regulation | 880.5970 | Identical |
| Product Code | LJSCatheter, Intravascular, Therapeutic,Long-Term Greater Than 30 Days | Identical |
| Classification | II | Identical |
| Indications for Use | For long term central venouscatheterization or prolonged intravenousadministration of fluids, medicationsand/or when nutritional therapy isprescribed. The catheter may beinserted via basilica or cephalic vein. | Silicone Peripherally Inserted CentralVenous Catheter (PICC) Sets areintended for delivery of whole blood orblood products, drug administration andblood sampling. |
| Device is for One-time Use | Yes | Identical |
| Catheter Insertion Method | Percutaneous via Seldinger | Identical |
| Catheter Tip Target Anatomy | Superior vena cava (SVC) | Identical |
| Catheter Tip Location | X-ray | Identical |
| Confirmation Method | Identical | |
| Catheter Shaft Material | Radiopaque Silicone | Identical |
| Catheter Outer Diameter | Single: 3.0, 4.0, 5.0 FrDual: 4.0, 5.0, 6.0 Fr | Single: 3.0, 4.0, 5.0 FrDual: 7.0 Fr |
| Catheter Length | 60 cm | 50, 60 cm |
| Catheter Lumen Number | Single, Dual | Identical |
| Catheter LumenConfiguration | Unknown | Single: RoundDual: D-shaped |
| Catheter Distal EndConfiguration | Straight | Identical |
| Incremental Markings | 5 cm increments | None |
| Extension Tube Clamps | Yes | Identical |
| Packaging | Tray | Tray with Tyvek Lidstock |
| Sterilization Method | EtO | Identical |
| Sterility Assurance Level | Unknown | 10-6 |
| Components and Accessories | PICC w/ StyletWire Guide | PICC w/ ObturatorWire Guide |
| Peelable Sheath Introducer | Peel-Away Introducer | |
| Needle | Dilator | |
| Syringe | Needle | |
| Scalpel | Syringe | |
| Tape Measure | Thumb Scalpel | |
| Catheter Securement Device | Tape Measure | |
| Drape | Catheter Securement Device | |
| Lidocaine | Drape | |
| Safety Needles | Lidocaine | |
| Gauze | Monoject Needles | |
| ChlorhexidineNeedle Stick Pad | GauzeChloraPrepNeedle HolderFemale Luer-locksSuture with NeedlePVP OintmentCSR Wrap | |
| SECONDARY PREDICATEDEVICE | SUBJECT DEVICE | |
| Cook Spectrum® Silicone Catheter(K021557) | Silicone Peripherally InsertedCentral Venous Catheter Set/Tray | |
| Regulation | 880.5970 | Identical |
| Product Code | LJSCatheter, Intravascular, Therapeutic,Long-Term Greater Than 30 Days | Identical |
| Classification | II | Identical |
| Indications for Use | The Cook Spectrum Silicone Catheter isused for intravenous administration ofnutrient fluids, chemotherapeutic agentsand other drugs for therapy, bloodsampling, blood delivery, and venouspressure monitoring. The catheter isimpregnated with the antimicrobialsminocycline and rifampin to helpprovide protection against catheter-related bloodstream infections (CRBSI).It is not intended to be used as atreatment for existing infections.Catheters are available in single anddouble lumen PICC; and single, doubleand triple lumen CVC. | Silicone Peripherally Inserted CentralVenous Catheter (PICC) Sets areintended for delivery of whole blood orblood products, drug administration andblood sampling. |
| Device is for One-time Use | Yes | Identical |
| Catheter Insertion Method | Percutaneous via Seldinger | Identical |
| Catheter Tip Target Anatomy | Superior vena cava (SVC) | Identical |
| Catheter Tip LocationConfirmation Method | X-ray | Identical |
| Catheter Shaft Material | Radiopaque Silicone | Identical |
| Antimicrobial Material | Minocycline and Rifampin | None |
| Catheter Outer Diameter | Single: 4.0, 5.0 FrDual: 6.0, 7.0 Fr | Single: 3.0, 4.0, 5.0 FrDual: 7.0 Fr |
| Catheter Length | 50, 60 cm | Identical |
| Catheter Lumen Number | Single, Dual | Identical |
| Catheter LumenConfiguration | Single: RoundDual: D-shaped | Identical |
| Catheter Distal EndConfiguration | Straight | Identical |
| Incremental Markings | None | Identical |
| Extension Tube Clamps | Yes | Identical |
| Packaging | Tray with Tyvek Lidstock | Identical |
| Sterilization Method | EtO | Identical |
| Sterility Assurance Level | 10-6 | Identical |
| Components and Accessories | PICC w/ ObturatorWire GuidePeel-Away IntroducerDilatorNeedleSyringeThumb ScalpelTape MeasureCatheter Securement DeviceDrapeLidocaineMonoject NeedlesGauzeChloraPrepNeedle HolderFemale Luer-locksSuture with NeedlePVP OintmentCSR Wrap | Identical |
{6}------------------------------------------------
Comparison to Secondary Predicate Device:
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray and the secondary predicate device, Cook Spectrum Silicone Catheter (K021557), are substantially equivalent in that these devices are identical in principles of operation and fundamental technologies. The substantial equivalence comparison of the subject device to the predicate is summarized in the table below.
{7}------------------------------------------------
Cook Spectrum Silicone Catheter, cleared under K021557 is being used as a secondary predicate device for having the same technology as the subject device of not having incremental markings on the catheter shaft. The labeling and instructions for use for K021557 and the subject device are similar and both state "catheter tip position should be verified by x-ray and monitored on a routine basis with periodic lateral-view x-ray".
Technological Characteristics:
The subject device, the Silicone Peripherally Inserted Central Venous Catheter Set/Tray, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:
Bench Testing (including time zero and applicable three year accelerated aged testing)
- . Catheter
- Tensile Testing performed on the various joints of the catheter per applicable ISO . standards demonstrated that the devices met the acceptance criteria.
- . Liquid Leakage - Testing performed on the catheters demonstrated that the catheters did not leak.
- Air Leakage Testing demonstrated the catheters meet the air leak requirements of . BS EN ISO 10555-1.
- . Kink Radius - Testing demonstrated that flow rate was not impacted during kinking of the catheter.
{8}------------------------------------------------
- Gravity Flow Rate - Testing demonstrated that the catheters have an acceptable flow rate for the clinical application.
- . Radiopacity - Testing performed demonstrated that the devices are visible in the radiographic image.
- . MR Testing - Testing in accordance with ASTM F2503 showed that the catheters are MR Conditional.
- . Dimensional Verification - Testing performed demonstrated that the test specimens' dimensions are within the specified tolerances and markings are clearly marked on shrink tube.
- . Compatibility - Testing performed demonstrated that the PICC set components are compatible.
- Obturator ●
- . Corrosion - Tested in accordance with Annex B of ISO 11070:2014. The predetermined acceptance criteria were met.
- . Hub-to-Wire Tensile - Testing performed on the joint of hub and wire demonstrated that the devices met the acceptance criteria.
- Wire Guide
- Corrosion Tested in accordance with Annex B of ISO 11070:2014. The pre-. determined acceptance criteria were met.
- Tensile Tested in accordance with the applicable values of BS EN ISO . 11070:2014, Annex H. The pre-determined acceptance criteria were met.
- . Fracture - Tested in accordance with Annex F of BS EN ISO 11070:2014. The predetermined acceptance criteria were met.
- Flex Tested in accordance with the Annex G of BS EN ISO 11070:2014. The pre-. determined acceptance criteria were met.
- Peel-Away Introducer ●
- Hub-to-Shaft Tensile Testing performed on the joint of hub and wire demonstrated . that the devices met the acceptance criteria.
Biocompatibility Testing:
- Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility demonstrated the biocompatibility of the subject devices.
{9}------------------------------------------------
Sterility Testing and Shelf-Life:
- . Sterilization Validation: The established method used to validate the sterilization cycle is consistent with the half-cycle method as described in ISO 11135-1:2007. In addition, Cook complies with BS EN 556-1:2001.
- . Sterility Assurance Level (SAL): 10-6
- . Sterilization Method: The subject device is sterilized using Ethylene Oxide (EO) gas in a fixed chamber.
- EO Residual Level: In accordance with ISO 10993-7:2008, the maximum allowable . limits for EO and ECH was less than or equal to the suggested sterilant residual limits for a permanent contact device (> 30 days):
- o EO (Average Daily Dose): 4 mg
- o ECH (Average Daily Dose): 9 mg
- . Bacterial Endotoxin Test Method (LAL): Endotoxin testing is performed with the maximum testing limit being 20 EU/device, as recommended by the sterility guidance (Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile) for blood contacting devices.
- Shelf-Life: The three-year shelf-life of the subject device is based on successful testing . of performance characteristics on devices aged to a minimum of three-year equivalency by accelerated methods.
Conclusion:
The results of these tests confirm that the Silicone Peripherally Inserted Central Venous Catheter Set/Tray meets the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the primary predicate device, Medcomp Silicone Vascu-PICC" Catheter (K030270), and the secondary predicate device, Cook Spectrum Silicone Catheter (K021557).
§ 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.”