(55 days)
Not Found
No
The summary describes a physical implantable port and catheter system for vascular access. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on physical and material properties, not algorithmic performance.
Yes
The device is designed to facilitate the administration of various patient therapies (e.g., infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products) and withdrawal of blood samples, which are therapeutic actions or support therapeutic actions.
No
This device is an implantable vascular access device used for infusion and blood withdrawal, not for diagnosis.
No
The device description explicitly states it consists of a "hard plastic port and 8F polyurethane catheter," which are physical hardware components. The performance studies also detail testing related to physical properties and interactions (e.g., MR compatibility, sterilization), further indicating it is not a software-only device.
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 the infusion of substances and withdrawal of blood samples. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes within the body.
- Device Description: The description details an implantable port and catheter, which are physical devices inserted into the body.
- 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.
The device is a vascular access device, which is a type of medical device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter is intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.
The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter is 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. When used with a PowerLoc® Safety Infusion Set (SIS), the PowerPort® device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
Product codes
LIT
Device Description
The PowerPort® ClearVUE® Slim with 8F Polyurethane Catheter is a member of the PowerPort® series of power-injectable implanted ports. The subject device consists of a hard plastic port and 8F polyurethane catheter that is attached to the port with a catheter lock compression fitting. The subject device is distinguishable as a member of BAS's power-injectable port series by the triangular body shape and three palpation bumps on the septum.
PowerPort® implanted ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing has been performed in accordance with Design Controls per 21 CFR §820.30. The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device. Risk management, including a failure modes and effects analysis (FMEA) of the subject device, was conducted in accordance with ISO 14971: 2009, Medical Devices - Risk Management for Medical Devices. Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerPort ClearVUE® Slim Implantable Port Summary of with 8F Polyurethane Catheter meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation, and indications for use to the predicate device cited.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
ﮯ
Section 5 – 510(k) Summary
Bard Access Systems, Inc.
PowerPort® ClearVUE® Slim Implantable Port
with 8F Polyurethane Catheter
Traditional 510(k) Premarket Notification
Image /page/0/Picture/3 description: The image shows the logo for BARD ACCESS SYSTEMS. The word "BARD" is in large, bold, sans-serif font. Below it, in a smaller font, are the words "ACCESS SYSTEMS."
NOV 15 2012
510(k) Summary 21 CFR 807.92(a)
| General
| Provisions | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| Contact Person: | Amy J. Honey | |
| Regulatory Affairs Specialist | ||
| Telephone Number: | (801) 522-5671 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | September 19, 2012 | |
| Subject | ||
| Device | Trade Name: | PowerPort® ClearVUE® Slim Implantable Port with 8F |
| Common Name: | Polyurethane Catheter | |
| Classification Name: | Implanted Infusion Port & Catheter | |
| Product Code/ | ||
| Regulation: | LIT/21 CFR §880.5965 | |
| Predicate Device | Trade Name: | Titanium PowerPort® isp with 8F Polyurethane Catheter |
| Common Name: | Implanted Infusion Port & Catheter | |
| Classification Name: | LIT - Subcutaneous, Implanted, Intravascular Infusion | |
| Port & Catheter | ||
| Product Code/ | ||
| Regulation: | LIT/21 CFR §880.5965 | |
| Device | ||
| Description | The PowerPort® ClearVUE® Slim with 8F Polyurethane Catheter is a member of | |
| the PowerPort® series of power-injectable implanted ports. The subject device | ||
| consists of a hard plastic port and 8F polyurethane catheter that is attached to | ||
| the port with a catheter lock compression fitting. The subject device is | ||
| distinguishable as a member of BAS's power-injectable port series by the | ||
| triangular body shape and three palpation bumps on the septum. | ||
| PowerPort® implanted ports can be used for routine vascular access using a non- | ||
| coring access needle. However, for power injection procedures, PowerPort® ports | ||
| must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a | ||
| power-injectable system. | ||
| Intended Use | The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter | |
| is intended to be an implanted vascular access device designed to provide long- | ||
| term, repeated access to the vascular system. | ||
| Indications For | ||
| Use | The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter | |
| is 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. When used with a PowerLoc® Safety Infusion Set (SIS), the PowerPort® | ||
| device is indicated for power injection of contrast media. For power injection of | ||
| contrast media, the maximum recommended infusion rate is 5 mL/s. | ||
| Technological | ||
| Characteristics | Technological characteristics of the PowerPort® ClearVUE® Slim Implantable Port | |
| with 8F Polyurethane Catheter are substantially equivalent with respect to basic | ||
| design and function of the Titanium PowerPort® isp with 8F Polyurethane | ||
| Catheter. The differences between the two devices do not impact the intended | ||
| use, and do not raise any new questions regarding safety or efficacy. | ||
| Safety & | ||
| Performance | ||
| Tests | Verification testing has been performed in accordance with Design Controls per | |
| 21 CFR §820.30. The following guidance documents and standards in conjunction | ||
| with in-house protocols were used to determine appropriate methods for | ||
| evaluating the performance of the device: | ||
| Guidance on 510(k) Submissions for Implanted Infusion Ports; | ||
| October, 1990 Guidance – Establishing Safety and Compatibility of Passive Implants | ||
| in the Magnetic Resonance (MR) Environment; August 21, 2008 ASTM F2503: 2008, Standard Practice for Marking Medical Devices | ||
| and Other Items for Safety in the Magnetic Resonance (MR) | ||
| Environment ASTM F 2052: 2006, Standard Test Methods for Measurement of | ||
| Magnetically Induced Displacement Force on Medical Devices in the | ||
| Magnetic Resonance Environment ASTM F2119: 2007, Standard Test Method for Evaluation of MR | ||
| Image Artifacts from Passive Implants ASTM F2182 Rev A: 2011, Standard Test Method for Measurement of | ||
| Radio Frequency Induced Heating On or Near Passive Implants During | ||
| Magnetic Resonance Imaging ASTM F2213: 2006 (R2011),Standard Test Method for Measurement | ||
| of Magnetically Induced Torque on Medical Devices in the Magnetic | ||
| Resonance Environment ISO 10555-1/Amd 1/ Amd 2: 1195/1999/2009, Sterile, Single-Use | ||
| Intravascular Catheters, Part 1: General Requirements BS/EN/ISO 10555-3: 1996 Cor 1:2002, Sterile, Single-Use Intravascular |
1
2
Catheters, Part 3: Central Venous Catheters AAMI/ANSI/ISO 11135-1: 2007, Sterilization of Healthcare Products – . Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices AAMI/ANSI/ISO 10993-1/Cor 1: 2009/2010, Biological Evaluation of . Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile AAMI/ANSI/ISO 10993-7:2008, Biological Evaluation for Medical . Devices; Part 7 - Ethylene Oxide Sterilization Residuals USP: Sept. 8, 2009, Transfusion and Infusion Assemblies and ● Similar Medical Devices AAMI ST72, Jan. 1, 2001 (R 2010): Bacterial Endotoxins—Test . Methodologies, Routine Monitoring, and Alternatives to Batch Testing The subject device met all predetermined acceptance criteria derived from the above listed references and demonstrated substantially equivalent performance as compared to the cited predicate device. Risk management, including a failure modes and effects analysis (FMEA) of the subject device, was conducted in accordance with ISO 14971: 2009, Medical Devices - Risk Management for Medical Devices. Based on the indications for use, technological characteristics, and safety and performance testing, the subject PowerPort ClearVUE® Slim Implantable Port Summary of with 8F Polyurethane Catheter meets the minimum requirements that are Substantial considered adequate for its intended use and is substantially equivalent in design, Equivalence materials, sterilization, principles of operation, and indications for use to the predicate device cited.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 15, 2012 .
C.R. Bard, Incorporated Ms. Amy Honey Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K122899
Trade/Device Name: PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter
Regulatory Class: II Product Code: LJT Dated: September 19, 2012 Received: September 21, 2012
Dear Ms. Honey:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely vours.
DN: c=US, o=U.S. Government, ou=HHS, DA. ou=People. cn=Anthony D. Watson 342.19200300.100.1.1=1300092402 Date: 2012.11.15 14:01:44 -05'00
Anthony D. Watson, B.S., M.S., M.B.A Director
Division of Anesthesiology, General Hospital, Respiratory. Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
5
Section 4 - Indications for Use Statement
Bard Access Systems, Inc.
PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter Traditional 510(k) Premarket Notification
Indications for Use
K122899
510(k) Number (if known):
PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter
Device Name:
Indications for Use:
The PowerPort® ClearVUE® Slim Implantable Port with 8F Polyurethane Catheter is indicated for The PowerPort" Clear VDE "Sim Insplantable Per The vascular system. The port system can be
patient therapies requiring repeated access to the vascular system. Incoducts a patient therapies requiring repeated access to the rate to nutions, blood products, and used for infusion of medications, I.V. halas; perchers a PowerLoce" Safety infusion Set (SS), the
for the withdrawal of blood samples. When used with a Power interion of for the withdrawal of blood samples. When ease in edia. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
Prescription Use __ (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 if needed
Concurrence of CDRH, Office of Device Evaluation (ODE) Digitally signed by Sajjad H. Syed
DN: c=US, o=U.S. Government, ou=HHS, Sajjad H. Syed ou=FDA, ou=People, cn=Sajjad H. Syed, 0.9 2342.19200300.100.1.1=2000601742 Date: 2012.11.15 16:07:57 -05'00' (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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