(8 days)
No
The document describes a physical implanted port device and its function, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device facilitates therapeutic interventions (e.g., infusion of medications), but it is not a therapeutic device itself. It is a vascular access device.
No
Explanation: The device is described as a vascular access device for infusion of medications, fluids, nutrition, and blood products, and for withdrawal of blood samples. It acts as a conduit for fluids into and out of the central venous system. There is no mention of it being used to diagnose conditions or processes.
No
The device description clearly outlines a physical, implanted vascular access device with components like a port body, septum, and catheter, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide long-term repeated access to the vascular system for infusion of substances and withdrawal of blood samples. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes in vivo.
- Device Description: The description details a physical implantable device (port and catheter) that is inserted into the body to facilitate access to blood vessels. This is a medical device used on or in the patient.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any analysis or testing of specimens outside the body.
Therefore, the X-Port duo™ Implanted Port is a medical device, specifically a vascular access device, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The X-Port duo™ Implanted Port is a totally implantable vascular access device designed to provide long term repeated access to the vascular system.
This is the identical intended use for the predicate MRI® Dual port.
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.
Product codes
LJT
Device Description
There are no new operating principles. The X-Port duo™ port has the same basic, fundamental scientific technology as the predicate MRI® Dual port. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone rubber septum. The access path to the vascular system is provided through a catheter attached to the base of the port. The port system serves as a conduit for fluids into, and out of, the central venous system.
The port body consists of an oblong shaped plastic base and top. The silicone septa are compressed between the port base and top. The port body profile incorporates smooth transitions. There are two suture holes adjacent to the stem and a third suture hole placed opposite the stem on the tapered nose. All suture holes are filled with silicone plugs. All catheters and catheter/port connection systems used on the X-Port duo port are previously qualified legally marketed configurations covered by the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system, central venous system
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
The appropriate design verification tests were performed in accordance with Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990. Design validation was also performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997. Performance data gathered in design verification and validation testing demonstrated that the X-Port duo™ port is substantially equivalent to the predicate MRI® Dual port and/or met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA. Clinical performance testing was not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
JUL 1 0 2003
X-Port duo™ Implanted Port Premarket Notification [510(k)]
Section 6
510(k) Summary X-Port duo™ Implanted Port
510(k) Summary of Safety and Effectiveness Information 21CFR 807.92
6.1 Submitter Information
| 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. 5439 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | John Knorpp |
| Date of Preparation: | 1 July 2003 |
Device Name 6.2
Device Name: | Plastic Dual Port |
---|---|
Trade Name: | X-Port duo™ Port |
Common/Usual Name: | Plastic Subcutaneous Port & Catheter |
Classification Name: | 80LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular |
21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular Infusion | |
Port and Catheter, Class II | |
Classification Panel: | General Hospital |
6.3 Predicate Device Name
Device Name: | Plastic Attachable Dual Port |
---|---|
Trade Name: | MRI® Dual Port |
Common/Usual Name: | Plastic 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: | K912702, concurrence date - 18 September 1991. |
6.4 Device Description
Principles of Operation
There are no new operating principles. The X-Port duo™ port has the same basic, fundamental scientific technology as the predicate MRI® Dual port. Access to the port is made percutaneously with a non-coring needle that enters the port reservoir via the silicone rubber septum. The access path to the vascular system is provided through a catheter attached to the base of the port. The port system serves as a conduit for fluids into, and out of, the central venous system.
1
Port Body
- The port body consists of an oblong shaped plastic base and top .
- The silicone septa are compressed between the port base and top. .
- The port body profile incorporates smooth transitions. .
- There are two suture holes adjacent to the stem and a third suture hole placed opposite the stem . on the tapered nose. All suture holes are filled with silicone plugs.
Catheters, Stems and Catheter Locks
- All catheters and catheter/port connection systems used on the X-Port duo port are previously ● qualified legally marketed configurations covered by the predicate device.
6.5 Intended Use
The X-Port duo™ Implanted Port is a totally implantable vascular access device designed to provide long term repeated access to the vascular system.
This is the identical intended use for the predicate MRI® Dual port.
Summary of Technological Characteristics in Relation to the Predicate Device 6.6
The X-Port duo™ port design has some minor differences from the predicate MRI® Dual port, however the basic fundamental scientific technology of the port has not changed. The primary differences include the following: Larger separate two-piece septa, a lower profile port body with smooth transitions and three silicone filled suture holes.
6.7 Nonclinical Performance Testing
The appropriate design verification tests were performed in accordance with Guidance on 510(k) Submission for Implanted Infusion Ports, dated October 1990. Design validation was also performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997.
Performance data gathered in design verification and validation testing demonstrated that the X-Port duo™ port is substantially equivalent to the predicate MRI® Dual port and/or met predetermined acceptance criteria, and the risks associated with use of the new device were found acceptable when evaluated by FMEA.
6.8 Clinical Performance Testing
Clinical performance testing was not required.
6.9 Conclusion
Based on FDA's decision tree, the X-Port duo™ port is substantially equivalent to the predicate device MRI® Dual port, K912702, cleared September 18, 1991.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble an abstract human figure.
JUL 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Knorpp Senior Regulatory Affairs Specialist Bard Access Systems, Incorporated 5425 W. Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K032044
Trade/Device Name: BardPort®, SlimPort™ and X-Port™ Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 1, 2003 Received: July 2, 2003
Dear Mr. Knorpp:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Mr. Knorpp
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. 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 Division 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/dsma/dsmamain.html
Sincerely yours.
Sasa Ruano
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 1.2
INDICATION(S) FOR USE STATEMENT*
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.
Signature of 510(k) Submitter:
Printed Name of Submitter:
John L. Knapp
John C. Knorpp Senior Regulatory Affairs Specialist
Date:
6-19-03
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Concurrence of Office of Device Evaluation
510(k) Number: K032044
Division Sign-Off: Office of Device Evaluation
Patricia Crescenti
v. General Hospital
510(k) Number: K032044
- OR - Over-The-Counter Use: _______________________________________________________ Prescription Use: ____________________________________________________________________________________________________________________________________________________________