(182 days)
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.
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.
The provided text is a 510(k) Pre-Market Notification for BardPort®, SlimPort®, and X-Port® Implanted Ports. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance testing. It does not describe an AI/ML device or its acceptance criteria and study data in the typical sense of diagnostic performance metrics like sensitivity, specificity, or AUC.
Therefore, many of the requested elements for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth used, effect size of human improvement) are not applicable or cannot be extracted from this document, as it pertains to a physical medical device (implanted infusion ports).
However, I can extract information related to the performance tests conducted to demonstrate the substantial equivalence of the device, which serves as the "study" proving the device meets its "acceptance criteria" in the context of this 510(k) submission.
Here's the closest interpretation of your request based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of medical device are typically defined by engineering specifications and recognized standards, which are evaluated through physical performance tests. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria (Measured by Test) | Reported Device Performance (Test Conclusion) |
|---|---|
| Stem-Catheter Connection functionality (e.g., no leaks, sufficient tensile strength, resistance to burst) | Successfully passed "Stem-Catheter Connection Leak Test", "Stem-Catheter Connection Tensile Test", "Stem-Catheter Connection Burst Test", "Connection Assembly Damage Test", "Connection Assembly Damage Tensile Test". |
| Catheter valve integrity and functionality | Successfully passed "Groshong® Catheter Valve Crack Pressure". |
| Catheter material strength and integrity | Successfully passed "Tensile Strength of Catheter Body", "Catheter Burst Pressure", "Catheter Collapse", "Catheter Fluid Leak", "Catheter Air Leak". |
| Catheter physical properties (e.g., stiffness, elongation, priming volume, radiopacity) | Successfully passed "Catheter Stiffness", "Catheter Elongation", "Catheter Priming Volume", "Catheter Radiopacity". |
| Catheter tip strength | Successfully passed "Groshong® Catheter Tip Tensile Test". |
| Tunneler connection integrity | Successfully passed "Tunneler Connection Test". |
| Overall device safety and performance | "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." (This is the overarching conclusion of the study/testing.) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify the exact number of units/samples tested for each performance test. It only lists the types of tests conducted.
- Data Provenance: Not applicable in the context of a physical device's engineering and performance testing. The "data" comes from in-house laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for a physical device like an implanted port is determined by objective engineering measurements and adherence to specified performance standards, not expert interpretation of diagnostic images or clinical outcomes. The "experts" in this context would be the engineers and quality control personnel performing and evaluating the tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Performance tests for physical devices typically rely on objective measurements against pre-defined thresholds, rather than subjective adjudication.
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/ML device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- In the context of this device, the "ground truth" is established through objective physical and chemical properties testing against defined engineering specifications and recognized standards. Examples include measurements of tensile strength, burst pressure, leak rates, material composition, and dimensional accuracy, as outlined by standards like ISO 10555-1, ISO 10555-3, and ASTM F2503-13.
8. The sample size for the training set
- Not applicable. There is no AI/ML model being "trained" for this device. The development process for the device involved design controls and risk analysis, with modifications based on prior cleared devices (predicates).
9. How the ground truth for the training set was established
- Not applicable. There is no AI/ML model for which a "training set" ground truth would be established. The "ground truth" for the device's design and performance validation relies on established engineering principles, material science, and adherence to medical device standards.
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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.
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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 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
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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)
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510(k) Summary 21 CFR 807.92
BardPort , SlimPort , and X-Port Implanted Ports
| GeneralProvisions | Submitter Name:Address: | Bard Access Systems, Inc.605 North 5600 WestSalt Lake City, UT 84116 |
|---|---|---|
| Contact Person | James R. DavisRegulatory Affairs SpecialistJames.R.Davis@crbard.comT: 801.522.5456F: 801.522.5425 | |
| Date of Preparation: | February 5th, 2016 | |
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name:Product Code:Regulation: | BardPort®, SlimPort®, and X-Port® Implanted PortsImplanted Infusion Port & CatheterSubcutaneous, Implanted, Intravascular Infusion Portand CatheterLJT21 CFR 880.5965 |
| PredicateDevices | Current Trade Name:Classification Name:Premarket Notification:Manufacturer: | X-Port® Implanted PortsSubcutaneous, Implanted, Intravascular Infusion Portand CatheterK022983: BardPort® X-Port® isp PortBard Access Systems, Inc. |
| Current Trade Name:Classification Name:Premarket Notification:Manufacturer: | BardPort® and SlimPort® Implanted PortsSubcutaneous, Implanted, Intravascular Infusion Portand CatheterK924250: Plastic Low Profile Subcutaneous PortBard Access Systems, Inc. | |
| Current Trade Name:Classification Name:Premarket Notification:Manufacturer: | BardPort® Implanted PortsSubcutaneous, Implanted, Intravascular Infusion Portand CatheterK880571: Cath-Tech Port Implantable Vascular AccessSystemBard Access Systems, Inc. | |
| PredicateDevices(continued) | Current Trade Name: | BardPort® Implanted Ports |
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Portand Catheter | |
| Premarket Notification:Manufacturer: | K873213: Hickman Plastic Subcutaneous PortBard Access Systems, Inc. | |
| Current Trade Name: | BardPort® Implanted Ports | |
| Classification Name: | Subcutaneous, Implanted, Intravascular Infusion Portand Catheter | |
| Premarket Notification:Manufacturer: | K870260: Hickman Titanium Subcutaneous PortBard Access Systems, Inc. | |
| Bundled 510(k)SubmissionJustification | Multiple Predicate Devices are provided because a Bundled 510(k) Submission isappropriate for the subject devices since the scientific and regulatory issues aremost efficiently addressed during one review. The same changes are beingperformed to all of the Predicate Device baselines. Additionally, following thecriteria given within the Bundled 510(k) FDA Guidance: the performance data isthe same for the subject devices, the General Hospital review branch is the onlybranch involved with the review process and all of the Predicate Devices have thesame indications for use. | |
| ReferenceDevice | Current Trade Name:Classification Name: | PowerPort® Implanted Ports with Groshong® CatheterSubcutaneous, Implanted, Intravascular Infusion Portand Catheter |
| Premarket Notification:Manufacturer: | K081311: PowerPort® Implanted Ports with Groshong®CatheterBard Access Systems, Inc. | |
| ReferenceDevicesJustification | The references device is provided because the exact same changes indimensions to the Port-Catheter Stem and Catheter Lock as well as the exactsame Groshong® Catheter formulation change and Catheter Lock radiopaquematerial were cleared within the K081311 clearance. These exact same designfeatures cleared in K081311 are being adapted to the BardPort®, SlimPort®, andX-Port® Implanted Ports. | |
| DeviceDescription | BardPort®, SlimPort®, and X-Port® Implanted Ports are designed to providerepeated access to the vascular system without the need for repeatedvenipuncture or daily care of an external catheter. BardPort®, SlimPort®, and X-Port® Implanted Ports consist of a rigid housing and a self-sealing septum. Thecatheters used with infusion ports are essentially the same design asexternalized, stand-alone intravascular catheters. Groshong® catheters areattached to the port by the physician during implantation.BardPort®, SlimPort®, and X-Port® Implanted Ports can be used for routinevascular access using a non-coring access needle. | |
| Intended Use | BardPort®, SlimPort®, and X-Port® Implanted Ports are intended to be animplanted vascular access device designed to provide long-term, repeatedaccess to the vascular system. | |
| Indications forUse | The BardPort®, SlimPort®, and X-Port® Implantable Ports are indicated for patienttherapies requiring repeated access to the vascular system. The port system canbe used for infusion of medications, I.V. fluids, parenteral nutrition solutions,blood products, and for the withdrawal of blood samples. | |
| TechnologicalCharacteristics | Technological characteristics of the subject BardPort®, SlimPort®, and X-Port®Implantable Ports are substantially equivalent with respect to basic design andfunction to those of the predicate devices. The Port-Catheter Stem and CatheterLock design changes have different dimensions in comparison to the predicatedevice. Additionally, the Groshong® Catheter formulation is different from thepredicate device to make a solid blue extrusion and the Catheter Lockradiopaque material is different so that the radiopaque band can be printed ontothe subject Catheter Lock. The differences are not critical to the intended use ofthe device. |
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| 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 | K022983Concurrence Date: September 25, 2002 |
| Classification | Same | 21 CFR 880.5965 - Class IILJT - 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: 45cmFrench Size: 8 |
| Port Body Dimensions | Same | Reservoir Volume: 0.6 mLSeptum 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: DelrinSuture Plug(s) & Septum: Silicone |
| Port-Catheter Stem Material | Same | Titanium |
| Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve |
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| Subject and Predicate Device Comparison (K924250) | ||
|---|---|---|
| Attribute | SUBJECT DEVICEBardPort® and SlimPort®Implanted Ports | PREDICATE DEVICEPlastic 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 PremarketNotification | K924250Concurrence Date: October 4, 1993 |
| Classification | Same | 21 CFR 880.5965 – Class IILJT - Subcutaneous, implanted, intravascularinfusion port and catheter |
| Intended Use | Same | Non Power-Injectable Implantable Ports are intendedto be an implanted vascular access device designedto provide long-term, repeated access to the vascularsystem. |
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® ImplantedPorts are indicated for patient therapies requiringrepeated access to the vascular system. The portsystem 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 cathetertunneled and inserted in blood vessel |
| Catheter TipLocation | Same | Central venous system - lower 1/3 of superior venacava preferred |
| CatheterDimensions | Same | Usable Length: 45cmFrench Size: 8 |
| Port BodyDimensions | Same | Reservoir Volume: 0.3 mLSeptum Diameter: 10.7 mm |
| Port-Catheter StemDimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter LockDimensions | Total Length: 0.405"Lock Step Ø: .100" | Total Length: 0.552"Lock Step Ø: 0.100" |
| Catheter Material | Silicone with a solid blueextrusion | Silicone with a striped blue extrusion |
| Port Body Material | Same | Port Base & Top: DelrinSuture Plug(s) & Septum: Silicone |
| Port-Catheter StemMaterial | Same | Titanium |
| Catheter LockMaterial | Polycarbonate with radiopaqueprint | Polycarbonate with radiopaque sleeve |
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| 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 | K880571Concurrence Date: September 18, 1991 |
| Classification | Same | 21 CFR 880.5965 – Class IILJT - 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: 45cmFrench Size: 8 |
| Port Body Dimensions | Same | Reservoir Volume: 0.5 mLSeptum 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: TitaniumSuture Plug(s) & Septum: Silicone |
| Port-Catheter Stem Material | Same | Titanium |
| Catheter Lock Material | Polycarbonate with radiopaque print | Polycarbonate with radiopaque sleeve |
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| 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 PremarketNotification | K873213Concurrence Date: October 27, 1987 |
| Classification | Same | 21 CFR 880.5965 – Class IILJT – Subcutaneous, implanted, intravascularinfusion port and catheter |
| Intended Use | Same | Non Power-Injectable Implantable Ports are intendedto be an implanted vascular access device designedto provide long-term, repeated access to the vascularsystem. |
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® ImplantedPorts are indicated for patient therapies requiringrepeated access to the vascular system. The portsystem 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 cathetertunneled and inserted in blood vessel |
| Catheter TipLocation | Same | Central venous system - lower 1/3 of superior venacava preferred |
| CatheterDimensions | Same | Usable Length: 45cmFrench Size: 8 |
| Port BodyDimensions | Same | Reservoir Volume: 0.6 mLSeptum Diameter: 12.5 mm |
| Port-Catheter StemDimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter LockDimensions | Total Length: 0.405"Lock Step Ø: .100" | Total Length: 0.552"Lock Step Ø: 0.100" |
| Catheter Material | Silicone with a solid blueextrusion | Silicone with a striped blue extrusion |
| Port Body Material | Same | Port Base & Top: DelrinSuture Plug(s) & Septum: Silicone |
| Port-Catheter StemMaterial | Same | Titanium |
| Catheter LockMaterial | Polycarbonate with radiopaqueprint | Polycarbonate with radiopaque sleeve |
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| 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 PremarketNotification | K870260Concurrence Date: April 15, 1987 |
| Classification | Same | 21 CFR 880.5965 – Class IILJT - Subcutaneous, implanted, intravascularinfusion port and catheter |
| Intended Use | Same | Non Power-Injectable Implantable Ports are intendedto be an implanted vascular access device designedto provide long-term, repeated access to the vascularsystem. |
| Indications for Use | Same | The BardPort®, SlimPort®, and X-Port® ImplantedPorts are indicated for patient therapies requiringrepeated access to the vascular system. The portsystem 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 cathetertunneled and inserted in blood vessel |
| Catheter TipLocation | Same | Central venous system - lower 1/3 of superior venacava preferred |
| CatheterDimensions | Same | Usable Length: 45cmFrench Size: 8 |
| Port BodyDimensions | Same | Reservoir Volume: 0.6 mLSeptum Diameter: 12.7 mm |
| Port-Catheter StemDimensions | Total Length: 0.570" | Total Length: 0.565" |
| Catheter LockDimensions | Total Length: 0.405"Lock Step Ø: .100" | Total Length: 0.552"Lock Step Ø: 0.100" |
| Catheter Material | Silicone with a solid blueextrusion | Silicone with a striped blue extrusion |
| Port Body Material | Same | Port Base & Top: TitaniumSuture Plug(s) & Septum: Silicone |
| Port-Catheter StemMaterial | Same | Titanium |
| Catheter LockMaterial | Polycarbonate with radiopaqueprint | Polycarbonate with radiopaque sleeve |
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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 .
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| As a result of the risk analysis activities, the following verification tests were conducted: | |
|---|---|
| PerformanceTests(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 |
| TestingConclusion | 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 ofSubstantialEquivalence | 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. |
§ 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.