(17 days)
No
The document describes a standard implanted vascular access device and does not mention any AI or ML components or functionalities.
Yes
The device is a vascular access device used for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples, indicating its role in patient therapies.
No
The device is described as a vascular access device for infusion and withdrawal of fluids, not for diagnosing conditions.
No
The device description clearly outlines physical components like a port body, catheter, and septum, 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 the device is for "long term repeated access to the vascular system" for infusion of substances and withdrawal of blood samples. This describes a device used in vivo (within the body) for direct patient treatment and monitoring, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The description details an implanted port and catheter system designed to be placed within the vascular system. This is consistent with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect specific analytes, or provide diagnostic information based on in vitro testing.
Therefore, the X-Port duo™ Implanted Port is a vascular access device used for patient therapy and sample collection in vivo, 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.
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 with 9.5 Fr. polyurethane catheter has the same basic, fundamental scientific technology as the predicate X-Port duo™ port. Access to the port is made percutaneously with a non-coring needle that enters the port reservour 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.
Port Body:
- The port body consists of a lightweight plastic base and top with a tapered nose and farge . silicone septa.
Catheter:
- . The catheter is a 9.5 Fr. dual lumen polyurethane catheter.
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
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 and other applicable guidance documents and standards. 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 with 9.5 Fr. nolyurethane catheter is substantially equivalent to the predicate X-Port duo™ port with 10 Fr. silicone catheter 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:
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
X-Port duo™ Implanted Port with 9.5 Fr. Polyurethane Catheter Premarket Notification [510(k)]
Section 6
510(k) Summary X-Port duo™ Implanted Port with 9.5 Fr. Polyurcthane Catheter
510(k) Summary of Safety and Effectiveness Information 21 CFR 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. 5470 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Angela Brady |
| Date of Preparation: | 24 December 2003 |
Device Name 6.2
| Device Name: | Plastic Dual Port |
|---|---|
| Trade Name: | X-Port duo Port |
| Catheter: | 9.5 Fr. open ended dual lumen polyurethane |
| 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 |
Predicate Device Name 6.3
| Device Name: | Plastic Dual Port |
|---|---|
| Trade Name: | X-Port duo port |
| Catheter: | 10 Fr. open ended dual lumen silicone |
| 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: | K032044, concurrence date - 10 July 2003. |
Device Description 6.4
Principles of Operation
There are no new operating principles. The X-Port duo™ port with 9.5 Fr. polyurethane catheter has the same basic, fundamental scientific technology as the predicate X-Port duo™ port. Access to the port is made percutaneously with a non-coring needle that enters the port reservour 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.
Image /page/0/Picture/15 description: The image shows the number 000028. The number is written in a bold, sans-serif font. The digits are evenly spaced and aligned horizontally. The number is likely a serial number or identification code.
1
Port Body
- The port body consists of a lightweight plastic base and top with a tapered nose and farge . silicone septa.
Catheter
- . The catheter is a 9.5 Fr. dual lumen polyurethane catheter.
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 device.
6.6 Summary of Technological Characteristics in Relation to the Predicate Device
The primary difference between predicate and subject device is the catheter material. The predicate port catheter is composed of silicone and the subject port catheter is composed of polyurethane. The basic fundamental scientific technology has not changed.
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 and other applicable guidance documents and standards. 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 with 9.5 Fr. nolyurethane catheter is substantially equivalent to the predicate X-Port duo™ port with 10 Fr. silicone catheter 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 6.8
Clinical performance testing was not required.
6.9 Conclusion
Based on FDA 's decision tree, the X-Port duo™ port with 9.5 Fr. polyurethane catheter is substantially equivalent to the predicate device X-Port duo™ port with 10 Fr. silicone catheter, K032044, cleared 10 July 2003.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's seal, which includes an abstract image of an eagle or bird-like figure with three stylized wings or feathers. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 J 2004
Subsidiary of C.R. Bard, Incorporated Ms. Angela Brady Engineer-Regulatory Affairs Bard Access Systems, Incorporated (BAS) 5425 W. Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K034065
Trade/Device Name: Modification to X-Port Duo Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: December 30, 2003 Received: December 31, 2003
Dear Ms. Brady:
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 - Ms. Brady
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 your device to proceed to the market.
If vou 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,
Clus
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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:
Angela Brady
Printed Name of Submitter:
Angela Brady Engineer - Regulatory Affairs
Date:
12|24|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: K034065
Division Sign-Off: Office of Device Evaluation
Prescription Use:
Over-The-Counter Use: - OR -
Neil Hubbard, Interim Branch Chief, GHOB
v. General Hospital. of Anesthesioloo
510(k) Number: K034065
000002