(147 days)
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No
The device description and performance studies focus on the physical components and mechanical performance of an implanted port and catheter system, with no mention of AI or ML capabilities.
No
The device is an implanted port and catheter system used for repeated vascular access for infusion of medications, fluids, nutrition solutions, blood products, and withdrawal of blood samples; it does not directly provide therapy but facilitates its delivery.
No
The SlimPort™ Dual Low Profile Implanted Port is designed for repeated access to the vascular system for infusion of medications, fluids, and blood products, and for withdrawal of blood samples. It facilitates therapeutic interventions rather than diagnosing conditions.
No
The device description clearly details a physical, implanted port with a titanium reservoir, silicone septum, and plastic shell, along with attachable catheters. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The SlimPort™ Dual Low Profile Implanted Port is a device that is implanted into the body to provide repeated access to the vascular system for the infusion of substances and withdrawal of blood samples. It is a device used in vivo (within the body) for therapeutic and diagnostic access, not for performing diagnostic tests on samples outside the body.
The description clearly states its purpose is for "patient therapies requiring repeated access to the vascular system" and for "infusion of medications, I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples." While blood samples are withdrawn using this device, the device itself does not perform any diagnostic testing on those samples. The testing would be done separately, likely using IVD devices.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
chest or arm with the catheter tip located at the junction of the superior vena cava and the right atrium.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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."
The testing performed included:
- Port Guidance Testing: 150% Elongation and Leak Test, Pull to Failure Test, Non-Cyclic Creep Test, Cyclic Creep Test, Connection Burst Test, Septum Puncture Life Test, Septum Pressure Integrity Test, Clearance Kinetics Test, Gravity Flow Rates Test, Priming Volume Test, Test Device Conditioning, Physical Characterization.
- Catheter Guidance Testing: Catheter elongation, Tensile strength of catheter, Catheter flexural fatigue tolerance, Catheter burst pressure, Catheter flow rate, Dimensions.
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.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 Drive |
| Salt 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.
E
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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 the
referenced 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.