(119 days)
Not Found
No
The summary describes a purely mechanical implantable venous access system with no mention of software, data processing, or any AI/ML related terms.
No
The device is an implantable venous access system used for repeated access to the venous system for delivery of medications, fluids, nutritional solutions, and blood sampling. It facilitates therapy but does not directly provide a therapeutic effect itself.
No
This device is designed for repeated vascular access for injection, infusion therapy, and blood sampling, not for diagnosing medical conditions.
No
The device description clearly states it is a "totally implantable venous access system" consisting of physical components like a portal, septa, and catheter connector, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The PORT-A-CATH® and P.A.S Port® systems are implantable devices designed for direct access to the venous system for administering substances (medications, fluids, contrast media) and for drawing blood from the patient.
- Intended Use: The intended use clearly states repeated vascular access for injection, infusion, and venous blood sampling. While blood sampling is mentioned, the device itself is not performing a diagnostic test on the blood sample in vitro. It's a tool for obtaining the sample.
The device is a tool for accessing the body for therapeutic and sampling purposes, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media.
The PORT-A-CATH" II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec.
The PORT-A-CATH" POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec.
The P.A.S Port® T2 POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the P.A.S. Port® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. When used with a power indicated Huber needle, the PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated for power injection of contrast media.
The PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems can be placed in the chest or arm, are supplied sterile, are non-pyrogenic and intended for single patient use only. The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems consists of a portal with one or two self-sealing septa, and catheter connector that are assembled during implantation. The systems are offered in either a kit or a tray configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest or arm
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)
The non-clinical testing included assessment of the physical properties of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access System and its ability to achieve its intended use. Bench testing of the device confirmed the suitability of the device for its intended use.
Biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to the predicate devices commercially marketed by Smiths Medical ASD, Inc.
MR safety testing was performed on selected ports in accordance with established American Society for Testing and Materials (ASTM) standards. This testing was performed to establish the safety of the listed medical devices in the MR environment. The devices selected represent the entire product line of the devices listed. Testing was performed in the presence of a 3 Tesla MR imaging device.
The devices listed were determined to be MR Conditional according to the terminology specified in the ASTM Designation F2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems.
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
smiths medical
bringing technology to life
510(k) Number: Ko 934/ 4
Page 1 of 3
Date Prepared October 29, 2009
Submitter Information
MAR - 1 2010
| Submitter's Name: | Smiths Medical ASD, Inc. |
|---|---|
| Address: | 1265 Grey Fox Road |
| St. Paul, MN 55112 |
Establishment Registration: 2183502
| Contact Person: | Rachelle Parsons, RAC
Sr. Regulatory Affairs Associate | |
|-----------------|-----------------------------------------------------------|--|
| | Phone: (651) 628-7018
Fax: (651) 628-7457 | |
Device Information
| Trade Name: | PORT-A-CATH® POWER P.A.C. Implantable Venous
Access Systems |
|----------------------|----------------------------------------------------------------------|
| Common Name: | Subcutaneously Implanted Intravascular Infusion Port and
Catheter |
| Classification Name: | Port and Catheter, Implanted, Subcutaneous, Intravascular |
| Product Code: | LJT |
| Regulation: | 21 CFR §880.5965 |
| | |
| Trade Name: | PORT-A-CATH® II POWER P.A.C. Implantable Venous
Access Systems |
| Common Name: | Subcutaneously Implanted Intravascular Infusion Port and
Catheter |
| Classification Name: | Port and Catheter, Implanted, Subcutaneous, Intravascular |
| Product Code: | LJT |
| Regulation: | 21 CFR §880.5965 |
Submission Page 19
:" ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1
510(k) Summary
Page 2 of 3
Predicate Device(s)
The predicate devices are the above currently marketed devices. The reference 510(k) numbers for these devices are as follows:
| Device | 510(k) |
|---|---|
| PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems | K070116 |
| PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems | and |
| K072657 |
Device Descriptions
PORT-A-CATH®, PORT-A-CATH® II POWER P.A.C. line of Access Ports
The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. When used with a power indicated Huber needle, the PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated for power injection of contrast media.
The PORT-A-CATH® POWER P.A.C. and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems can be placed in the chest or arm, are supplied sterile, are non-pyrogenic and intended for single patient use only. The PORT-A-CATH® POWER P.A.C and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems consists of a portal with one or two self-sealing septa, and catheter connector that are assembled during implantation. The systems are offered in either a kit or a tray configuration.
Intended Use/Indications for Use
The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media.
2
510(k) Summary
Page 3 of 3
Summary of Non-Clinical Testing
The non-clinical testing included assessment of the physical properties of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access System and its ability to achieve its intended use. Bench testing of the device confirmed the suitability of the device for its intended use.
Biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible based on the similarity of the materials of construction to the predicate devices commercially marketed by Smiths Medical ASD, Inc.
MR safety testing was performed on selected ports in accordance with established American Society for Testing and Materials (ASTM) standards. This testing was performed to establish the safety of the listed medical devices in the MR environment. The devices selected represent the entire product line of the devices listed. Testing was performed in the presence of a 3 Tesla MR imaging device.
The devices listed were determined to be MR Conditional according to the terminology specified in the ASTM Designation F2503-05 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.
Summary of Clinical Testing
Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems.
Statement of Equivalence
The PORT-A-CATH® POWER P.A.C. Implantable Venous Access System is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on a comparison of the indications for use and the technological characteristics of the device.
Conclusion
The PORT-A-CATH® POWER P.A.C. Implantable Venous Access System is substantially equivalent to the currently marketed Power PAC Implantable Venous Access System based on the technological characteristics of the device. Bench tests confirmed the suitability of the device for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Rachelle Parsons Senior, Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grev Fox Road Saint Paul, Minnesota 55112
MAR - 1 2010
Re: K093414
Trade/Device Name: PORT-A-CACH® II POWER P.A.C. Implantable Venous Access Systems, PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems, P.A.S. Port® T2 POWDER PAC Implantable Venous Access Systems Regulation Number: 21CFR 880.5965
Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT
Dated: February 17, 2010 Received: February 18, 2010
Dear Ms. Parsons:
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 practive, 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/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure -
5
Indications for Use
510(k) Number:
Device Name: PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems
Indications for Use:
"The PORT-A-CATH" II POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec."
Prescription Use X (Per 21 CFR 801.109)
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)
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
510(k) Number: K093414
6
Indications for Use
510(k) Number:
Device Name: PORT-A-CATH® POWER P.A.C. Implantable Venous Access Systems
Indications for Use:
"The PORT-A-CATH" POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec."
Prescription Use X (Per 21 CFR 801.109)
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)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093414
7
Indications for Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: P.A.S. Port® T2 POWER.P.A.C. Implantable Venous Access Systems
Indications for Use:
"The P.A.S Port® T2 POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable Huber needle, the P.A.S. Port® POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injections of contrast media, the maximum recommended infusion rate is 5 ml/sec."
Prescription Use >