(182 days)
No
The device description and performance studies focus on the physical and mechanical properties of an implanted port system, with no mention of AI or ML technologies.
Yes
The device is described as "implanted ports ... indicated for patient therapies requiring repeated access to the vascular system" and "can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples", which are all part of medical treatment.
No
Explanation: The device is an implanted port system used for infusion of substances (medications, fluids, nutrition, blood products) and withdrawal of blood samples, which are therapeutic and access functions, not diagnostic.
No
The device description clearly indicates that the device is a physical, implanted port system consisting of a rigid housing, self-sealing septum, and catheters. The performance studies also focus on physical properties and connections of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "patient therapies requiring repeated access to the vascular system" for infusion and withdrawal of blood samples. This describes a device used in vivo (within the body) for direct patient treatment and access to the circulatory system.
- Device Description: The description details an "implanted port" consisting of a rigid housing, septum, and catheter, designed for "repeated access to the vascular system." This further confirms its in vivo nature.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The provided text does not mention any such use or function.
The device is an implanted vascular access device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BardPort®, SlimPort®, and X-Port® Implanted Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.
The BardPort®, SlimPort®, and X-Port® Implantable Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Product codes
LJT
Device Description
BardPort®, SlimPort®, and X-Port® Implanted Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. BardPort®, SlimPort®, and X-Port® Implanted Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Groshong® catheters are attached to the port by the physician during implantation. BardPort®, SlimPort®, and X-Port® Implanted Ports can be used for routine vascular access using a non-coring access needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel
Central venous system - lower 1/3 of superior vena cava preferred
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)
Verification and validation activities were designed and performed in accordance with design controls (per 21 CFR §820.30) and risk analysis (per ISO 14971:2009). A declaration of conformity to design controls is located within the 510(k).
The risk analysis method utilized to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA) per the applicable in-house procedures. The risk analysis activities did not identify any new types of safety or efficacy questions for the subject BardPort®, SlimPort®, and X-Port® Implantable Ports. The risk analysis activities performed was conducted as appropriate based upon the following guidance documents and standards in conjunction with in-house protocols for evaluating the performance of the device to mitigate the risks identified:
- . FDA Guidance - Guidance on 510(k) Submissions for Implanted Infusion Ports; October, 1990
- FDA Guidance Guidance on 510(k) Submissions for Short-Term and Long-Term Intravascular Catheter~, March 16, 1990
- · FDA Guidance Bundling Multiple Devices or Multiple Indications in a single submission, dated June 22, 2007
Performance Tests
- . FDA Guidance - Establishing safety and compatibility of passive implants in the magnetic resonance environment, dated August 21, 2008
- ISO 10555-1 Second Edition 2013-07-01, Sterile, Single-Use Intravascular . Catheters, Part 1: General Requirements
- ISO 10555-3 Second Edition 2013-06-15. Sterile, Single-Use Intravascular Catheters, Part 3: Central Venous Catheters
- · AAMI/ANSI/ISO 11135-1: 2007. Sterilization of Healthcare Products Ethvlene Oxide
- AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of Medical . Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- · ISO 10993-7 Second Edition 2008-10-15. Biological Evaluation for Medical Devices: Part 7 - Ethylene Oxide Sterilization Residuals
- · AAMI/ANSI/ISO 11607:2006/(R)2010, Packaging for Terminally Sterilized Medical Devices
- AAMI / ANSI ST72:2011: Bacterial Endotoxins-Test Methodologies, Routine . Monitoring, and Alternatives to Batch Testing
- · ASTM F2503-13 (2014), Standard Practice for marketing Medical Devices and Other Items for Safety in the Magnetic Resonance (MR) Environment
- Design Control Guidance for Medical Device Manufacturers. March 11, 1997 .
As a result of the risk analysis activities, the following verification tests were conducted:
• Stem-Catheter Connection Leak Test
• Stem-Catheter Connection Tensile Test
• Stem-Catheter Connection Burst Test
• Connection Assembly Damage Test
• Connection Assembly Damage Tensile Test
• Groshong® Catheter Valve Crack Pressure
• Tensile Strength of Catheter Body
• Catheter Stiffness
• Catheter Elongation
• Catheter Burst Pressure
• Catheter Collapse
• Catheter Priming Volume
• Groshong® Catheter Tip Tensile Test
• Tunneler Connection Test
• Catheter Radiopacity
• Catheter Fluid Leak
• Catheter Air Leak
The results of the testing performed demonstrates that the subject devices performance is substantially equivalent to the predicate devices and the risk identified as a result of the risk analysis activities were properly mitigated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K022983, K924250, K880571, K873213, K870260
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
0
Image /page/0/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that features a stylized representation of three human profiles facing to the right, with flowing lines beneath them that could represent water or fabric.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
C.R. Bard, Inc. Mr. James Davis Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K153359
Trade/Device Name: BardPort®, SlimPort®, and X-Port® Implanted Ports Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: April 21, 2016 Received: April 22, 2016
Dear Mr. Davis:
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.
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 devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
for Erin I. Keith, M.S. 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): K153359
Device Name: BardPort®, SlimPort®, and X-Port® Implanted Ports
Indications for Use:
The BardPort®, SlimPort®, and X-Port® implanted ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Prescription Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary 21 CFR 807.92
BardPort , SlimPort , and X-Port Implanted Ports
| General
Provisions | Submitter Name:
Address: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116 |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person | James R. Davis
Regulatory Affairs Specialist
James.R.Davis@crbard.com
T: 801.522.5456
F: 801.522.5425 |
| | Date of Preparation: | February 5th, 2016 |
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name:
Product Code:
Regulation: | BardPort®, SlimPort®, and X-Port® Implanted Ports
Implanted Infusion Port & Catheter
Subcutaneous, Implanted, Intravascular Infusion Port
and Catheter
LJT
21 CFR 880.5965 |
| Predicate
Devices | Current Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | X-Port® Implanted Ports
Subcutaneous, Implanted, Intravascular Infusion Port
and Catheter
K022983: BardPort® X-Port® isp Port
Bard Access Systems, Inc. |
| | Current Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | BardPort® and SlimPort® Implanted Ports
Subcutaneous, Implanted, Intravascular Infusion Port
and Catheter
K924250: Plastic Low Profile Subcutaneous Port
Bard Access Systems, Inc. |
| | Current Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | BardPort® Implanted Ports
Subcutaneous, Implanted, Intravascular Infusion Port
and Catheter
K880571: Cath-Tech Port Implantable Vascular Access
System
Bard Access Systems, Inc. |
| Predicate
Devices
(continued) | Current Trade Name: | BardPort® Implanted Ports |
| | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port
and Catheter |
| | Premarket Notification:
Manufacturer: | K873213: Hickman Plastic Subcutaneous Port
Bard Access Systems, Inc. |
| | Current Trade Name: | BardPort® Implanted Ports |
| | Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Port
and Catheter |
| | Premarket Notification:
Manufacturer: | K870260: Hickman Titanium Subcutaneous Port
Bard Access Systems, Inc. |
| Bundled 510(k)
Submission
Justification | Multiple Predicate Devices are provided because a Bundled 510(k) Submission is
appropriate for the subject devices since the scientific and regulatory issues are
most efficiently addressed during one review. The same changes are being
performed to all of the Predicate Device baselines. Additionally, following the
criteria given within the Bundled 510(k) FDA Guidance: the performance data is
the same for the subject devices, the General Hospital review branch is the only
branch involved with the review process and all of the Predicate Devices have the
same indications for use. | |
| Reference
Device | Current Trade Name:
Classification Name: | PowerPort® Implanted Ports with Groshong® Catheter
Subcutaneous, Implanted, Intravascular Infusion Port
and Catheter |
| | Premarket Notification:
Manufacturer: | K081311: PowerPort® Implanted Ports with Groshong®
Catheter
Bard Access Systems, Inc. |
| Reference
Devices
Justification | The references device is provided because the exact same changes in
dimensions to the Port-Catheter Stem and Catheter Lock as well as the exact
same Groshong® Catheter formulation change and Catheter Lock radiopaque
material were cleared within the K081311 clearance. These exact same design
features cleared in K081311 are being adapted to the BardPort®, SlimPort®, and
X-Port® Implanted Ports. | |
| Device
Description | BardPort®, SlimPort®, and X-Port® Implanted Ports are designed to provide
repeated access to the vascular system without the need for repeated
venipuncture or daily care of an external catheter. BardPort®, SlimPort®, and X-
Port® Implanted Ports consist of a rigid housing and a self-sealing septum. The
catheters used with infusion ports are essentially the same design as
externalized, stand-alone intravascular catheters. Groshong® catheters are
attached to the port by the physician during implantation.
BardPort®, SlimPort®, and X-Port® Implanted Ports can be used for routine
vascular access using a non-coring access needle. | |
| Intended Use | BardPort®, SlimPort®, and X-Port® Implanted Ports are intended to be an
implanted vascular access device designed to provide long-term, repeated
access to the vascular system. | |
| Indications for
Use | The BardPort®, SlimPort®, and X-Port® Implantable Ports are indicated for patient
therapies requiring repeated access to the vascular system. The port system can
be used for infusion of medications, I.V. fluids, parenteral nutrition solutions,
blood products, and for the withdrawal of blood samples. | |
| Technological
Characteristics | Technological characteristics of the subject BardPort®, SlimPort®, and X-Port®
Implantable Ports are substantially equivalent with respect to basic design and
function to those of the predicate devices. The Port-Catheter Stem and Catheter
Lock design changes have different dimensions in comparison to the predicate
device. Additionally, the Groshong® Catheter formulation is different from the
predicate device to make a solid blue extrusion and the Catheter Lock
radiopaque material is different so that the radiopaque band can be printed onto
the subject Catheter Lock. The differences are not critical to the intended use of
the device. | |
4
5
| Subject and Predicate Device Comparison (K022983) | ||
|---|---|---|
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE |
| X-Port® Implanted Ports | BardPort® X-Port® isp Port | |
| Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. | |
| Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | ||
| Owner | Same | Bard Access Systems, Inc. |
| 510(k) Status | Subject of this Premarket Notification | K022983 |
| Concurrence Date: September 25, 2002 | ||
| Classification | Same | 21 CFR 880.5965 - Class II |
| LJT - Subcutaneous, implanted, intravascular infusion port and catheter | ||
| Intended Use | Same | Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. |
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. |
| Duration of Use | Same | Long term (>30 days) |
| Insertion Site | Same | Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel |
| Catheter Tip Location | Same | Central venous system - lower 1/3 of superior vena cava preferred |
| Catheter Dimensions | Same | Usable Length: 45cm |
| French Size: 8 | ||
| Port Body Dimensions | Same | Reservoir Volume: 0.6 mL |
| Septum Diameter: 12.7 mm | ||
| Port-Catheter Stem Dimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter Lock Dimensions | Total Length: 0.405" | |
| Lock Step Ø: .100" | Total Length: 0.552" | |
| Lock Step Ø: 0.100" | ||
| Catheter Material | Silicone with a solid blue extrusion | Silicone with a striped blue extrusion |
| Port Body Material | Same | Port Base & Top: Delrin |
| Suture Plug(s) & Septum: Silicone | ||
| Port-Catheter Stem Material | Same | Titanium |
| Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve |
6
| Subject and Predicate Device Comparison (K924250) | ||
|---|---|---|
| Attribute | SUBJECT DEVICE | |
| BardPort® and SlimPort® | ||
| Implanted Ports | PREDICATE DEVICE | |
| Plastic Low Profile Subcutaneous Port | ||
| Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. | |
| Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | ||
| Owner | Same | Bard Access Systems, Inc. |
| 510(k) Status | Subject of this Premarket | |
| Notification | K924250 | |
| Concurrence Date: October 4, 1993 | ||
| Classification | Same | 21 CFR 880.5965 – Class II |
| LJT - Subcutaneous, implanted, intravascular | ||
| infusion port and catheter | ||
| Intended Use | Same | Non Power-Injectable Implantable Ports are intended |
| to be an implanted vascular access device designed | ||
| to provide long-term, repeated access to the vascular | ||
| system. | ||
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted |
| Ports are indicated for patient therapies requiring | ||
| repeated access to the vascular system. The port | ||
| system can be used for infusion of medications, I.V. | ||
| fluids, parenteral nutrition solutions, blood products, | ||
| and for the withdrawal of blood samples. | ||
| Duration of Use | Same | Long term (>30 days) |
| Insertion Site | Same | Port is implanted subcutaneously with catheter |
| tunneled and inserted in blood vessel | ||
| Catheter Tip | ||
| Location | Same | Central venous system - lower 1/3 of superior vena |
| cava preferred | ||
| Catheter | ||
| Dimensions | Same | Usable Length: 45cm |
| French Size: 8 | ||
| Port Body | ||
| Dimensions | Same | Reservoir Volume: 0.3 mL |
| Septum Diameter: 10.7 mm | ||
| Port-Catheter Stem | ||
| Dimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter Lock | ||
| Dimensions | Total Length: 0.405" | |
| Lock Step Ø: .100" | Total Length: 0.552" | |
| Lock Step Ø: 0.100" | ||
| Catheter Material | Silicone with a solid blue | |
| extrusion | Silicone with a striped blue extrusion | |
| Port Body Material | Same | Port Base & Top: Delrin |
| Suture Plug(s) & Septum: Silicone | ||
| Port-Catheter Stem | ||
| Material | Same | Titanium |
| Catheter Lock | ||
| Material | Polycarbonate with radiopaque | |
| Polycarbonate with radiopaque sleeve |
7
| Subject and Predicate Device Comparison (K880571) | ||
|---|---|---|
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE |
| BardPort® Implanted Ports | Cath-Tech Port Implantable Vascular Access System | |
| Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. | |
| Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | ||
| Owner | Same | Bard Access Systems, Inc. |
| 510(k) Status | Subject of this Premarket Notification | K880571 |
| Concurrence Date: September 18, 1991 | ||
| Classification | Same | 21 CFR 880.5965 – Class II |
| LJT - Subcutaneous, implanted, intravascular infusion port and catheter | ||
| Intended Use | Same | Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system. |
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. |
| Duration of Use | Same | Long term (>30 days) |
| Insertion Site | Same | Port is implanted subcutaneously with catheter tunneled and inserted in blood vessel |
| Catheter Tip Location | Same | Central venous system - lower 1/3 of superior vena cava preferred |
| Catheter Dimensions | Same | Usable Length: 45cm |
| French Size: 8 | ||
| Port Body Dimensions | Same | Reservoir Volume: 0.5 mL |
| Septum Diameter: 13.0 mm | ||
| Port-Catheter Stem Dimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter Lock Dimensions | Total Length: 0.405" | |
| Lock Step Ø: .100" | Total Length: 0.552" | |
| Lock Step Ø: 0.100" | ||
| Catheter Material | Silicone with a solid blue extrusion | Silicone with a striped blue extrusion |
| Port Body Material | Same | Port Base & Top: Titanium |
| Suture Plug(s) & Septum: Silicone | ||
| Port-Catheter Stem Material | Same | Titanium |
| Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve |
8
| Subject and Predicate Device Comparison (K873213) | ||
|---|---|---|
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE |
| BardPort® Implanted Ports | Hickman Plastic Subcutaneous Port | |
| Note | Bold red font: Difference between the subject device and the current regulatory baseline of the predicate device. | |
| Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | ||
| Owner | Same | Bard Access Systems, Inc. |
| 510(k) Status | Subject of this Premarket | |
| Notification | K873213 | |
| Concurrence Date: October 27, 1987 | ||
| Classification | Same | 21 CFR 880.5965 – Class II |
| LJT – Subcutaneous, implanted, intravascular | ||
| infusion port and catheter | ||
| Intended Use | Same | Non Power-Injectable Implantable Ports are intended |
| to be an implanted vascular access device designed | ||
| to provide long-term, repeated access to the vascular | ||
| system. | ||
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted |
| Ports are indicated for patient therapies requiring | ||
| repeated access to the vascular system. The port | ||
| system can be used for infusion of medications, I.V. | ||
| fluids, parenteral nutrition solutions, blood products, | ||
| and for the withdrawal of blood samples. | ||
| Duration of Use | Same | Long term (>30 days) |
| Insertion Site | Same | Port is implanted subcutaneously with catheter |
| tunneled and inserted in blood vessel | ||
| Catheter Tip | ||
| Location | Same | Central venous system - lower 1/3 of superior vena |
| cava preferred | ||
| Catheter | ||
| Dimensions | Same | Usable Length: 45cm |
| French Size: 8 | ||
| Port Body | ||
| Dimensions | Same | Reservoir Volume: 0.6 mL |
| Septum Diameter: 12.5 mm | ||
| Port-Catheter Stem | ||
| Dimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter Lock | ||
| Dimensions | Total Length: 0.405" | |
| Lock Step Ø: .100" | Total Length: 0.552" | |
| Lock Step Ø: 0.100" | ||
| Catheter Material | Silicone with a solid blue | |
| extrusion | Silicone with a striped blue extrusion | |
| Port Body Material | Same | Port Base & Top: Delrin |
| Suture Plug(s) & Septum: Silicone | ||
| Port-Catheter Stem | ||
| Material | Same | Titanium |
| Catheter Lock | ||
| Material | Polycarbonate with radiopaque | |
| Polycarbonate with radiopaque sleeve |
9
| Subject and Predicate Device Comparison (K870260) | ||
|---|---|---|
| Attribute | SUBJECT DEVICE | PREDICATE DEVICE |
| BardPort® Implanted Ports | Hickman Titanium Subcutaneous Port | |
| Note | Difference between the subject device and the current regulatory baseline of the predicate device. | |
| Normal font: No difference between the subject device and the current regulatory baseline of the predicate device. | ||
| Owner | Same | Bard Access Systems, Inc. |
| 510(k) Status | Subject of this Premarket | |
| Notification | K870260 | |
| Concurrence Date: April 15, 1987 | ||
| Classification | Same | 21 CFR 880.5965 – Class II |
| LJT - Subcutaneous, implanted, intravascular | ||
| infusion port and catheter | ||
| Intended Use | Same | Non Power-Injectable Implantable Ports are intended |
| to be an implanted vascular access device designed | ||
| to provide long-term, repeated access to the vascular | ||
| system. | ||
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® Implanted |
| Ports are indicated for patient therapies requiring | ||
| repeated access to the vascular system. The port | ||
| system can be used for infusion of medications, I.V. | ||
| fluids, parenteral nutrition solutions, blood products, | ||
| and for the withdrawal of blood samples. | ||
| Duration of Use | Same | Long term (>30 days) |
| Insertion Site | Same | Port is implanted subcutaneously with catheter |
| tunneled and inserted in blood vessel | ||
| Catheter Tip | ||
| Location | Same | Central venous system - lower 1/3 of superior vena |
| cava preferred | ||
| Catheter | ||
| Dimensions | Same | Usable Length: 45cm |
| French Size: 8 | ||
| Port Body | ||
| Dimensions | Same | Reservoir Volume: 0.6 mL |
| Septum Diameter: 12.7 mm | ||
| Port-Catheter Stem | ||
| Dimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter Lock | ||
| Dimensions | Total Length: 0.405" | |
| Lock Step Ø: .100" | Total Length: 0.552" | |
| Lock Step Ø: 0.100" | ||
| Catheter Material | Silicone with a solid blue | |
| extrusion | Silicone with a striped blue extrusion | |
| Port Body Material | Same | Port Base & Top: Titanium |
| Suture Plug(s) & Septum: Silicone | ||
| Port-Catheter Stem | ||
| Material | Same | Titanium |
| Catheter Lock | ||
| Material | Polycarbonate with radiopaque | |
| Polycarbonate with radiopaque sleeve |
10
Verification and validation activities were designed and performed in accordance with design controls (per 21 CFR §820.30) and risk analysis (per ISO 14971:2009). A declaration of conformity to design controls is located within the 510(k).
The risk analysis method utilized to assess the impact of the modifications was a Failure Modes and Effects Analysis (FMEA) per the applicable in-house procedures. The risk analysis activities did not identify any new types of safety or efficacy questions for the subject BardPort®, SlimPort®, and X-Port® Implantable Ports. The risk analysis activities performed was conducted as appropriate based upon the following guidance documents and standards in conjunction with in-house protocols for evaluating the performance of the device to mitigate the risks identified:
- . FDA Guidance - Guidance on 510(k) Submissions for Implanted Infusion Ports; October, 1990
- FDA Guidance Guidance on 510(k) Submissions for Short-Term and Long-Term Intravascular Catheters, March 16, 1990
- · FDA Guidance Bundling Multiple Devices or Multiple Indications in a single submission, dated June 22, 2007
Performance Tests
- . FDA Guidance - Establishing safety and compatibility of passive implants in the magnetic resonance environment, dated August 21, 2008
- ISO 10555-1 Second Edition 2013-07-01, Sterile, Single-Use Intravascular . Catheters, Part 1: General Requirements
- ISO 10555-3 Second Edition 2013-06-15. Sterile, Single-Use Intravascular Catheters, Part 3: Central Venous Catheters
- · AAMI/ANSI/ISO 11135-1: 2007. Sterilization of Healthcare Products Ethvlene Oxide
- AAMI/ANSI/ISO 10993-1:2009/(R) 2013, Biological Evaluation of Medical . Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- · ISO 10993-7 Second Edition 2008-10-15. Biological Evaluation for Medical Devices: Part 7 - Ethylene Oxide Sterilization Residuals
- · AAMI/ANSI/ISO 11607:2006/(R)2010, Packaging for Terminally Sterilized Medical Devices
- AAMI / ANSI ST72:2011: Bacterial Endotoxins-Test Methodologies, Routine . Monitoring, and Alternatives to Batch Testing
- · ASTM F2503-13 (2014), Standard Practice for marketing Medical Devices and Other Items for Safety in the Magnetic Resonance (MR) Environment
- Design Control Guidance for Medical Device Manufacturers. March 11, 1997 .
11
| As a result of the risk analysis activities, the following verification tests were conducted: | |
|---|---|
| Performance | |
| Tests | |
| (continued) | • Stem-Catheter Connection Leak Test |
| • Stem-Catheter Connection Tensile Test | |
| • Stem-Catheter Connection Burst Test | |
| • Connection Assembly Damage Test | |
| • Connection Assembly Damage Tensile Test | |
| • Groshong® Catheter Valve Crack Pressure | |
| • Tensile Strength of Catheter Body | |
| • Catheter Stiffness | |
| • Catheter Elongation | |
| • Catheter Burst Pressure | |
| • Catheter Collapse | |
| • Catheter Priming Volume | |
| • Groshong® Catheter Tip Tensile Test | |
| • Tunneler Connection Test | |
| • Catheter Radiopacity | |
| • Catheter Fluid Leak | |
| • Catheter Air Leak | |
| Testing | |
| Conclusion | The results of the testing performed demonstrates that the subject devices performance is substantially equivalent to the predicate devices and the risk identified as a result of the risk analysis activities were properly mitigated. |
| Summary of | |
| Substantial | |
| Equivalence | Based on the indications for use, technological characteristics, and actions taken as a result of the risk analysis activities, the BardPort®, SlimPort®, and X-Port® Implantable Ports meets the requirements that are considered sufficient for its intended use and demonstrates that the subject devices are substantially equivalent to the predicate device baselines cited. |