(69 days)
Not Found
No
The device description and performance studies focus on the physical components and material properties of an implanted port system, with no mention of AI or ML capabilities.
Yes.
It is used for infusion of medications, I.V. fluids, parenteral nutrition solutions, and blood products, which are all therapeutic interventions.
No
Explanation: The device is an implanted port system used for infusion and blood withdrawal, acting as a conduit to the vascular system. Its function does not involve diagnosing conditions or diseases.
No
The device description clearly details physical components made of titanium and silicone, indicating it is a hardware device, not software-only.
Based on the provided information, the BardPort® Implanted Port is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "patient therapies requiring repeated access to the vascular system" for infusion and withdrawal of substances directly into and out of the patient's body. This is an in-vivo application.
- Device Description: The description details a physical implantable device (port and catheter) designed to be placed within the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting. The BardPort® is a device for delivering and withdrawing substances directly from the patient's bloodstream.
N/A
Intended Use / Indications for Use
The BardPort® Implanted Ports are totally implantable vascular access devices designed to provide long term repeated access to the vascular system.
The BardPort® 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.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
There are no new operating principles. The Titanium Low Profile Ports have the same basic, fundamental scientific technology as the predicate devices. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone 13 made perculaneously with a not vering might system is provided through a catheter attached to the port. The port system serves as a conduit for fluids into, and out of, the central venous system.
Port
- The Titanium Implanted Port is the largest of the BardPort® single lumen titanium port . family. The port body consists of titanium base and top with a round shape design. The port has four suture slots and two suture holes that are silicone encapsulated.
- The Titanium Low Profile Implanted Port is a modified, slightly smaller version of the . Titanium Implanted Port. The port body consists of titanium base and top with a round shape design. The port has six unfilled suture holes.
Catheter
- The Titanium Implanted Port is available with attachable or pre-attached 6.6 and 9.6 Fr . open-ended silicone intravascular catheters.
- The Titanium Low Profile Port is available with attachable or pre-attached 6.6 Fr open-. ended silicone intravascular catheter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 testing was performed according to protocols based on ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters and Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for a long term implanted device that exhibits tissue contact (port and catheter), indirect blood contact (port) and direct blood contact (catheter), as well as in accordance with in-house protocols.
Performance data gathered in design verification testing demonstrated that the Titanium and Titanium Low Profile Ports with 6.6 Fr and 9.6 Fr silicone catheters are substantially equivalent to the predicate Titanium and Titanium Low Profile Ports and met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
The Titanium Port with 6.6 Fr and 9.6 Fr open-ended silicone intravascular catheters and Titanium Low Profile Port with 6.6 Fr open-ended silicone intravascular catheter meet all predetermined performance acceptance criteria of the testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5965 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
APR 1 8 2005
Single Lume Special 510
Section 6
510(k) Summary
Single Lumen Titanium Implanted Ports
510(k) Summary of Safety and Effectiveness Information 21CFR 807.92
Submitter Information 6.1
| Submitter Name: | Bard Access Systems, Inc. (BAS) |
|---|---|
| [Subsidiary of C.R. Bard, Inc.] | |
| Address: | 5425 W. Amelia Earhart Drive |
| Salt Lake City, UT 84116 | |
| Telephone Number: | (801) 595-0700, Ext. 5541 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Michaela Rivkowich |
| Date of Preparation: | February 7, 2005 |
6.2 Device Name
| Device Name: | BardPort® Implanted Port |
|---|---|
| Trade Name: | Titanium Port, Titanium Low-Profile Port |
| Catheter: | 6.6 Fr and 9.6 Fr Open-Ended Silicone Intravascular Catheters |
| Common/Usual Name: | Titanium Subcutaneous Port & Catheter |
| Classification Name: | 80LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 21 CFR 880.5965 -- Subcutaneous, Implanted, Intravascular | |
| Infusion Port and Catheter, Class II ' |
Predicate Device Name 6.3
| Device Name: | BardPort ® Implanted Port |
|---|---|
| Trade Name: | Titanium Port, Titanium Low-Profile Port |
| Catheter: | 6.6 Fr and 9.6 Fr Open-Ended Silicone Intravascular Catheters |
| Common/Usual Name: | Titanium Subcutaneous Port & Catheter |
| Classification Name: | 80LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular |
| 21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular | |
| Infusion Port and Catheter, Class II | |
| Premarket Notification: | K870260, concurrence date - April 15, 1987 |
Device Description 6.4
Principle of Operation
I Thiciple of Operation
There are no new operating principles. The Titanium Low Profile Ports have the same basic, fundamental scientific technology as the predicate devices. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone 13 made perculaneously with a not vering might system is provided through a catheter attached to the port. The port system serves as a conduit for fluids into, and out of, the central venous system.
1
Image /page/1/Picture/0 description: The image shows the text "K080310 Page 2 of 3 Single Lumen Titanium Ports Special 510(k)". The text appears to be part of a document or report. The text "Page 2 of 3" indicates that the image is from the second page of a three-page document. The text "Special 510(k)" suggests that the document is related to a medical device or product.
Port
- The Titanium Implanted Port is the largest of the BardPort® single lumen titanium port . family. The port body consists of titanium base and top with a round shape design. The port has four suture slots and two suture holes that are silicone encapsulated.
- The Titanium Low Profile Implanted Port is a modified, slightly smaller version of the . Titanium Implanted Port. The port body consists of titanium base and top with a round shape design. The port has six unfilled suture holes.
Catheter
- The Titanium Implanted Port is available with attachable or pre-attached 6.6 and 9.6 Fr . open-ended silicone intravascular catheters.
- The Titanium Low Profile Port is available with attachable or pre-attached 6.6 Fr open-. ended silicone intravascular catheter
6.5 Intended Use
The BardPort® Implanted Ports are totally implantable vascular access devices designed to provide long term repeated access to the vascular system.
હ. ર Indications for Use
The BardPort® 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.
6.7 Summary of Technological Characteristics in Relation to the Predicate Device
Does the new device have the same technological characteristics, e.g. design, material, etc.?
Yes with the exception of differences in the catheter depth marking configuration as compared to the predicate Titanium Port with 6.6 Fr and 9.6 Fr open-ended silicone catheters and Titanium Low Profile Port with 6.6 Fr open-ended silicone catheter. However, the basic fundamental scientific technology of the ports has not changed.
Could the new characteristics affect safety or effectiveness?
Yes. The above features could affect safety or effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions?
No. There are no new issues of safety and effectiveness.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. The following international standard was used to evaluate the device's performance:
- . ISO 10555-3:1997, Sterile, Single-Use Intravascular Catheters, Central venous catheters
Biocompatibility requirements of ISO 10993 Biological Evaluation of Medical Devices Part-1: Evaluation and Testing and the FDA Modified ISO 10993 Test Profile for a long term implanted device that exhibits tissue contact (port and catheter), indirect blood contact (port)
2
Image /page/2/Picture/0 description: The image shows the text "K050310 Page 3 of 3 Single Lumen Titanium Ports Special 510(k)". The text appears to be part of a document or report. The text "Page 3 of 3" indicates that this is the third page of a three-page document. The text "Single Lumen Titanium Ports" suggests that the document is related to medical devices.
and direct blood contact (catheter) were met. All materials used in the manufacture of the subject devices were previously cleared for similar applications by Bard Access Systems,
Are performance data available to assess effects of new characteristics?
Yes. Verification testing was performed according to protocols based on the above referenced international standard, as well as in accordance with in-house protocols.
Do performance data demonstrate equivalence?
Yes. Performance data gathered in design verification testing demonstrated that the Titanium and Titanium Low Profile Ports with 6.6 Fr and 9.6 Fr silicone catheters are substantially equivalent to the predicate Titanium and Titanium Low Profile Ports and met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
Conclusion
The Titanium Port with 6.6 Fr and 9.6 Fr open-ended silicone intravascular catheters and Titanium Low Profile Port with 6.6 Fr open-ended silicone intravascular catheter meet all predetermined performance acceptance criteria of the testing performed and, based on FDA 's decision tree, are substantially equivalent to the predicate Titanium and Titanium Low Profile Ports, covered by K870260, concurrence date April 15, 1987.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, consisting of three curved lines that suggest a head, body, and legs.
APR ] & 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Michaela Rivkowich Senior Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 West Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K050310
Trade/Device Name: Bardport® Single Lumen Titanium Implanted Ports Regulation Number: 880.5965 Regulation Namber Scubcutaneous Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: April 5, 2005 Received: April 6, 2005
Dear Ms. Rivkowich:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined the device is substantially equivalent (for the referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device merstate commerce prior contribute been reclassified in accordance with the provisions of Amendinents, or to de rood Cosmetic Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Ooou may, therefore, market the device, subject to the general approval appreation (the Act. The general controls provisions of the Act include controls provisions of an annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classinod (500 houlditional controls. Existing major regulations affecting (I MA), it may of subject to Bach ade of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Ecderal Register.
4
Page 2 – Ms. Rivkowich
Please be advised that FDA's issuance of a substantial equivalence determination does not I Ticast be advised that 1 Da determination that your device complies with other requirements modi mat 1 DT mas made a works and regulations administered by other Federal agencies. Of the Act of ally I oderal backs is requirements, including, but not limited to: registration r out inust compry with art 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF Real 007), as ality systems (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality is nontrol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow you to obja finding of substantial equivalence of your device to a premarket notification. The PDF results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), rryou desire specific at 110 Tompliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stren Vunnes
Chiu Lin, Ph.D. Director Division of Ancsthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 1.2
INDICATION(S) FOR USE STATEMENT
510(k) Number (if known): KOS 6310
Device Name: Single Lumen Titanium Implanted Ports
Indications for Use:
The BardPort® 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 X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
Division Sign-Off
Seneral Hospital, svices
510(K) No.: K42543/4
Orsision of Ano-
Infection Con
0000000