(147 days)
The SlimPort™ Dual Low Profile Implanted Port is indicated for patient therapies requiring repeated access to the vascular system can be used for infusion of medications. I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
The SlimPort™ Dual Low Profile Implanted Port has a small, narrow, low, smoothly-shaped profile which minimizes port pocket size, incision size, and tissue displacement. It has an inner titanium dual reservoir assembly with two distinct isolated reservoirs; a one-piece, dual, peanutshaped solid silicone septum; and a two piece plastic port shell which secures the inner reservoir and septum. The port stem is oriented axially (in line) with the two port reservoirs.
The port will be distributed with two (2) different dual lumen attachable catherers: either a silicone 7 Fr Groshong® (valved, closed tip) dual lumen catheter or a silicone 7 Fr open-ended dual lumen catheter. Port access is performed by percutaneous needle insertion using a non-coring needle. The port may be placed in the chest or arm with the catheter tip located at the junction of the superior vena cava and the right atrium. The device placement site is determined by the clinician, based on medical judgement and patient anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SlimPort™ Dual Low Profile Implanted Port, based on the information available in the 510(k) summary:
Given that this is a 510(k) summary for a medical device (Implanted Port) and not an AI/ML diagnostic device, many of the requested fields (like number of experts, adjudication methods, MRMC studies, training set details) are not applicable as they pertain to clinical or diagnostic studies, not device performance testing focused on physical and mechanical properties.
Acceptance Criteria and Device Performance Study for SlimPort™ Dual Low Profile Implanted Port
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary states that "The SlimPort™ Dual Low Profile Implanted Port system meets all the acceptance criteria of the testing performed". However, specific numerical acceptance criteria are not explicitly detailed in the provided text. The document lists the types of tests performed. For the purpose of this response, "Reported Device Performance" is understood as the general statement that the device met those criteria, as specific performance values are not given.
| Port Guidance Testing | Catheter Guidance Testing | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|---|
| 150% Elongation and Leak Test | (Catheter elongation) | Meet requirements for elongation and leak integrity (implied by "meets all acceptance criteria") | Met criteria |
| Pull to Failure Test | (Tensile strength of catheter) | Meet requirements for pull strength/tensile strength (implied) | Met criteria |
| Non-Cyclic Creep Test | NA | Meet requirements for non-cyclic creep (implied) | Met criteria |
| Cyclic Creep Test | (Catheter flexural fatigue tolerance) | Meet requirements for cyclic creep/flexural fatigue (implied) | Met criteria |
| Connection Burst Test | (Catheter burst pressure) | Meet requirements for connection burst pressure (implied) | Met criteria |
| Septum Puncture Life Test | NA | Meet requirements for septum puncture life (implied) | Met criteria |
| Septum Pressure Integrity Test | NA | Meet requirements for septum pressure integrity (implied) | Met criteria |
| Clearance Kinetics Test | NA | Meet requirements for clearance kinetics (implied) | Met criteria |
| Gravity Flow Rates Test | (Catheter flow rate) | Meet requirements for gravity flow rates/catheter flow rate (implied) | Met criteria |
| Priming Volume Test | NA | Meet requirements for priming volume (implied) | Met criteria |
| Test Device Conditioning | NA | Meet requirements for device conditioning (implied) | Met criteria |
| Summary | |||
| Physical Characterization | (Dimensions) | Meet specific dimensional requirements (implied) | Met criteria |
2. Sample size used for the test set and data provenance
- Sample Size: Not specified in the provided text. The document refers to "bench testing" but does not give the number of units tested for each criterion.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective for bench testing. The data originates from bench testing conducted by the manufacturer, Bard Access Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is undergoing performance testing for its physical and mechanical properties against pre-defined engineering and safety standards, not a clinical diagnostic assessment requiring expert ground truth establishment.
4. Adjudication method for the test set
- Not Applicable. As no expert clinical assessment or diagnostic interpretation is involved, there is no need for an adjudication method.
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 a physical medical device, not an AI/ML-powered diagnostic tool. No human reader studies or AI assistance are involved in its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering/Performance Standards and Predicate Device Equivalence. The "ground truth" for this type of device testing is adherence to established FDA Guidance documents (Draft October 1990 "Guidance on 510(k) Submissions for Implanted Infusion Ports" and Draft March 16, 1995 "Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters") and demonstration of substantial equivalence to a predicate device (Plastic Dual Attachable Port, K912702). The "ground truth" is that the device performs safely and effectively according to these predefined technical specifications and comparable to the predicate.
8. The sample size for the training set
- Not Applicable. This is a physical device undergoing performance testing, not an AI/ML model requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study was a series of bench tests (laboratory-based physical and mechanical performance evaluations) conducted by Bard Access Systems, Inc. The testing was performed according to:
- FDA's Draft October 1990 "Guidance on 510(k) Submissions for Implanted Infusion Ports"
- FDA's Draft March 16, 1995 "Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters."
The specific tests included evaluations of material properties (elongation, tensile strength), structural integrity (pull to failure, non-cyclic creep, cyclic creep, connection burst), functional aspects (septum puncture life, septum pressure integrity, clearance kinetics, gravity flow rates, priming volume), and physical dimensions.
The conclusion drawn from these tests was that the SlimPort™ Dual Low Profile Implanted Port system met all the acceptance criteria derived from these guidance documents and demonstrated substantial equivalence to the predicate device (Plastic Dual Attachable Port, K912702). While specific numerical results or the exact number of units tested are not provided in this 510(k) summary, the overall statement is that the product passed these performance evaluations.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
A. Submitter Information:
| Submitter Name: | Bard Access Systems, Inc. (Division of C.R. Bard, Inc.) |
|---|---|
| Address: | 5425 W. Amelia Earhart DriveSalt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700 ex 4903 |
| Fax Number: | (801) 595 4979 |
| Contact Person: | Peggy Keiffer |
| Date of Preparation: | September 30, 1996 |
| Device Name: | SlimPort™ Dual Low Profile Implanted Port |
| Trade Name: | SlimPort™ Dual Low Profile Implanted Port |
B. Common/Usual Name: Intravascular implanted port Classification Name: Port & Catheter, Infusion. Intravascular, Subcutaneous, Implanted (80 LJT)
C. Predicate Device Name: Plastic Attachable Dual Port Trade Name: M.R.I.® Dual Port
D. Device Description:
The SlimPort™ Dual Low Profile Implanted Port has a small, narrow, low, smoothly-shaped profile which minimizes port pocket size, incision size, and tissue displacement. It has an inner titanium dual reservoir assembly with two distinct isolated reservoirs; a one-piece, dual, peanutshaped solid silicone septum; and a two piece plastic port shell which secures the inner reservoir and septum. The port stem is oriented axially (in line) with the two port reservoirs.
The port will be distributed with two (2) different dual lumen attachable catherers: either a silicone 7 Fr Groshong® (valved, closed tip) dual lumen catheter or a silicone 7 Fr open-ended dual lumen catheter. Port access is performed by percutaneous needle insertion using a non-coring needle. The port may be placed in the chest or arm with the catheter tip located at the junction of the superior vena cava and the right atrium. The device placement site is determined by the clinician, based on medical judgement and patient anatomy.
E. Intended Use:
The SlimPort™ Dual Low Profile Implanted Port is indicated for patient therapies requiring repeated access to the vascular system can be used for infusion of medications. I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
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F. Technological Characteristics Summary
Does the new device have same indication statements? 1.
Yes. The SlimPort™ Dual Low Profile Implanted Port has the same indication for use as the Plastic Dual Port. Both port systems are indicated for patient therapies requiring repeated access to the vascular system. Both port systems can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
Does the new device have the same technological characteristics, e.g. Design, 2. materials, etc?
No. The SlimPort™ Dual Low Profile Implanted Port design differs from the plastic port predicate device in that it has an external, plastic outer shell encasing two titanium reservoirs with a titanium stem. The reservoirs are axially oriented (in line) with the port stem. The fluid path from the proximal reservoir (farthest from the stem) is a channel that extends around one side of the circumference of the distal reservoir insert and connects to one side of the dual stem. Dual septa are provided by a one piece, molded, silicone peanut-shaped piece with two raised areas which are secured in place by the plastic port shell. The in-line port design creates a small, narrow, low, smoothly-shaped profile which minizes port pocket size, incision size and tissue displacement. The principles of operation of the SlimPort™ Dual Low Profile Implanted Port are unchanged from the predicate device.
The 7 Fr dual lumen catheters used with the "Dual SlimPort" are smaller in diameter than the predicate catheter (12 Fr). However, they are within the current range of catheter sizes manufactured by BAS (5 to 13.5 Fr dual lumen ). The open-ended catheter differs only in size from the predicate 12 Fr catheter. The tapered D-shaped lumens of the 7 Fr Groshong catheter are a minor shape modification that optimizes connection of the catheter to the port. The Groshong® catheter remains unchanged from existing Groshong® catheters in regards to manufacturing process, materials and infusion/aspiration performance and specifications.
3. Could the new characteristics affect safety or effectiveness?
Yes. All the above unique features could affect the safety or effectiveness of the device.
4. Do the new characteristics raise new types of safety or effectiveness questions?
The safety and effectiveness questions are the same for all central venous port/catheter No. systems.
5. Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. The FDA's Draft October 1990 "Guidance on 510(k) Submissions for Implanted Infusion Ports" and Draft March 16, 1995 "Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters." were used to evaluate the device's performance.
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Are performance data available to assess effects of new characteristics? 6.
Yes, bench testing was performed on the SlimPort™ Dual Low Profile Implanted Port according to the FDA's Draft October 1990 "Guidance on 510(k) Submissions for Implanted Infusion Ports" and relevant requirements of the Draft March 16, 1995 "Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters. "
7. Do performance data demonstrate equivalence?
Yes. Performance data demonstrate that the SlimPort™ Dual Low Profile Implanted Port is substantially equivalent to the currently marketed Plastic (M.R.I.®) Dual Port System.
Based on FDA's decision tree, the SlimPort™ Dual Low Profile Implanted Port is substantially equivalent to the predicate device, the Plastic Dual Attachable Port, K912702, cleared for market September 18, 1991.
G. Performance Data (if applicable)
Testing was performed using the FDA's Draft October 1990 "Guidance on 510(k) submissions for Implanted Infusion Ports" and Draft March 16, 1995 "Guidance on Premarket Notification [510(k)] Submission for Short-term and Long-term Intravascular Catheters." The following guidance testing was performed:
| Port Guidance Testing | Catheter Guidance Testing (covered by thereferenced port test) |
|---|---|
| 150% Elongation and Leak Test | (Catheter elongation) |
| Pull to Failure Test | (Tensile strength of catheter) |
| Non-Cyclic Creep Test | NA |
| Cyclic Creep Test | (Catheter flexural fatigue tolerance) |
| Connection Burst Test | (Catheter burst pressure) |
| Septum Puncture Life Test | NA |
| Septum Pressure Integrity Test | NA |
| Clearance Kinetics Test | NA |
| Gravity Flow Rates Test | (Catheter flow rate) |
| Priming Volume Test | NA |
| Test Device Conditioning | NA |
| Summary | |
| Physical Characterization | (Dimensions) |
The SlimPort™ Dual Low Profile Implanted Port system meets all the acceptance criteria of the testing performed and, based on FDA's decision tree, the SlimPort™ Dual Low Profile Implanted Port is substantially equivalent to the predicate device, the Plastic Attachable Dual Port, K912702, cleared for market on September 18, 1991.
§ 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.