(234 days)
Not Found
No
The description focuses on the physical components and materials of a standard medical device (PICC line) and its performance characteristics through bench and biocompatibility testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
This device is a catheter set intended for delivery of substances into the body and blood sampling, not for treating a disease or condition itself.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "intended for delivery of whole blood products, drug administration and blood sampling." These are therapeutic and interventional functions, not diagnostic ones. The device's components and testing described also support its use as a medical implement for fluid delivery and sampling, not for identifying a disease or condition.
No
The device description clearly lists multiple physical components made of various materials (silicone, stainless steel, nitinol, TFE, polyethylene, acetal, polypropylene) and describes physical testing (tensile, leakage, kink radius, flow rate, radiopacity, MR testing, dimensional verification, etc.), indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "delivery of whole blood products, drug administration and blood sampling." This describes a device used in vivo (within the body) for therapeutic and diagnostic procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter and associated components designed for insertion into a vein and placement in the superior vena cava. This is consistent with a medical device used for direct patient care, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic testing of biological samples.
Therefore, the Silicone Peripherally Inserted Central Venous Catheter Set/Tray is a medical device used for patient treatment and sample collection in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Silicone Peripherally Inserted Central Venous Catheter Set/Tray is intended for delivery of whole blood products, drug administration and blood sampling.
Product codes (comma separated list FDA assigned to the subject device)
LJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Superior vena cava (SVC)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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.
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):
- EO (Average Daily Dose): 4 mg
- 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.
Key results: 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
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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 Incorporated |
| 750 Daniels Way | |
| Bloomington, 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 Catheter
Set/Tray |
|-----------------------|-------------------------------------------------------------------------|
| Common Name: | Catheter, Intravascular, Therapeutic, Long-Term Greater
Than 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 Inserted | |
| Central Venous Catheter Set/Tray | ||
| Regulation | 880.5970 | Identical |
| Product Code | LJS | |
| Catheter, Intravascular, Therapeutic, | ||
| Long-Term Greater Than 30 Days | Identical | |
| Classification | II | Identical |
| Indications for Use | For long term central venous | |
| catheterization or prolonged intravenous | ||
| administration of fluids, medications | ||
| and/or when nutritional therapy is | ||
| prescribed. The catheter may be | ||
| inserted via basilica or cephalic vein. | Silicone Peripherally Inserted Central | |
| Venous Catheter (PICC) Sets are | ||
| intended for delivery of whole blood or | ||
| blood products, drug administration and | ||
| blood 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 Fr | |
| Dual: 4.0, 5.0, 6.0 Fr | Single: 3.0, 4.0, 5.0 Fr | |
| Dual: 7.0 Fr | ||
| Catheter Length | 60 cm | 50, 60 cm |
| Catheter Lumen Number | Single, Dual | Identical |
| Catheter Lumen | ||
| Configuration | Unknown | Single: Round |
| Dual: D-shaped | ||
| Catheter Distal End | ||
| Configuration | 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/ Stylet | |
| Wire Guide | PICC w/ Obturator | |
| Wire 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 | |
| Chlorhexidine | ||
| Needle Stick Pad | Gauze | |
| ChloraPrep | ||
| Needle Holder | ||
| Female Luer-locks | ||
| Suture with Needle | ||
| PVP Ointment | ||
| CSR Wrap | ||
| SECONDARY PREDICATE | ||
| DEVICE | SUBJECT DEVICE | |
| Cook Spectrum® Silicone Catheter | ||
| (K021557) | Silicone Peripherally Inserted | |
| Central Venous Catheter Set/Tray | ||
| Regulation | 880.5970 | Identical |
| Product Code | LJS | |
| Catheter, Intravascular, Therapeutic, | ||
| Long-Term Greater Than 30 Days | Identical | |
| Classification | II | Identical |
| Indications for Use | The Cook Spectrum Silicone Catheter is | |
| used for intravenous administration of | ||
| nutrient fluids, chemotherapeutic agents | ||
| and other drugs for therapy, blood | ||
| sampling, blood delivery, and venous | ||
| pressure monitoring. The catheter is | ||
| impregnated with the antimicrobials | ||
| minocycline and rifampin to help | ||
| provide protection against catheter- | ||
| related bloodstream infections (CRBSI). | ||
| It is not intended to be used as a | ||
| treatment for existing infections. | ||
| Catheters are available in single and | ||
| double lumen PICC; and single, double | ||
| and triple lumen CVC. | Silicone Peripherally Inserted Central | |
| Venous Catheter (PICC) Sets are | ||
| intended for delivery of whole blood or | ||
| blood products, drug administration and | ||
| blood 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 | ||
| Confirmation Method | X-ray | Identical |
| Catheter Shaft Material | Radiopaque Silicone | Identical |
| Antimicrobial Material | Minocycline and Rifampin | None |
| Catheter Outer Diameter | Single: 4.0, 5.0 Fr | |
| Dual: 6.0, 7.0 Fr | Single: 3.0, 4.0, 5.0 Fr | |
| Dual: 7.0 Fr | ||
| Catheter Length | 50, 60 cm | Identical |
| Catheter Lumen Number | Single, Dual | Identical |
| Catheter Lumen | ||
| Configuration | Single: Round | |
| Dual: D-shaped | Identical | |
| Catheter Distal End | ||
| Configuration | 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/ Obturator | |
| Wire Guide | ||
| Peel-Away Introducer | ||
| Dilator | ||
| Needle | ||
| Syringe | ||
| Thumb Scalpel | ||
| Tape Measure | ||
| Catheter Securement Device | ||
| Drape | ||
| Lidocaine | ||
| Monoject Needles | ||
| Gauze | ||
| ChloraPrep | ||
| Needle Holder | ||
| Female Luer-locks | ||
| Suture with Needle | ||
| PVP Ointment | ||
| CSR 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).