(131 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of an implantable venous access system and needle, with no mention of AI or ML capabilities.
Yes
The device is used for repeated vascular access for injection, infusion therapy, and/or venous blood sampling, which are therapeutic medical procedures.
No
The device is an implantable venous access system and an associated needle used for repeated vascular access for injection, infusion therapy, venous blood sampling, and power injection of contrast media. Its primary function is therapeutic and interventional, not diagnostic.
No
The device description clearly outlines physical components (portal, septa, catheter, needle) and their intended use for physical access to the venous system. There is no mention of software as a component or the primary function of the device.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly describes the devices as being used for repeated vascular access for injection or infusion therapy and/or venous blood sampling, and for power injection of contrast media. These are procedures performed on the patient's body, not on samples taken from the patient outside the body for diagnostic purposes.
- Device Description: The description details implantable systems and needles designed to access the venous system for delivering substances and withdrawing blood from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances in samples, or providing diagnostic information based on testing biological specimens in vitro.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are for accessing the vascular system for therapeutic and imaging purposes.
N/A
Intended Use / Indications for Use
Intended Use:
PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems: The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are implantable vascular access devices designed to provide long term repeated access to the vascular system.
GRIPPER PLUS® POWER P.A.C. Needle: The GRIPPER PLUS® POWER P.A.C. needle is designed for the administration into or withdrawal of fluids from implanted ports.
Indications for Use:
PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems: "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. needle, the PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec."
GRIPPER PLUS® POWER P.A.C. Needle: "The GRIPPER PLUS® POWER P.A.C. needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. When used with the PORT-A-CATH® POWER P.A.C. and POWER PORT-A-CATH® II POWER P.A.C. implantable venous access systems, the GRIPPER PLUS® POWER P.A.C. needle is also indicated for power injection of contrast media into the central venous system. The maximum recommended infusion rate is 5 ml/sec. for 19 and 20 gauge needles and 3ml/sec. for 22 gauge needles."
Product codes (comma separated list FDA assigned to the subject device)
LJT, FPA
Device Description
PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems: The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are similar to the current PORT-A-CATH® and PORT-A-CATH® II implantable venous access systems. They both 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. However, when used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® 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® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems can be placed in the chest or arm.
The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are supplied sterile and non-pyrogenic. All PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are designed and intended for single patient use only. A system consists of a portal with one or two self-sealing septa and a single or dual lumen catheter and is accessible by percutaneous puncture with a non-coring needle.
GRIPPER PLUS® POWER P.A.C. Needle: The GRIPPER PLUS® POWER P.A.C. needle is similar to the current GRIPPER PLUS® needle, with the addition of an added indication. Both are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from implanted ports. In addition, they both have a passive needle stick protection feature that is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission.
The difference between the two however, is when used with a PORT-A-CATH® and/or PORT-A-CATH® II POWER P.A.C. implantable venous access system; the GRIPPER PLUS® POWER P.A.C. needle is indicated for power injection of contrast media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest or arm (for placement of PORT-A-CATH systems), central venous system (for power injection of contrast media)
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)
A. Functional Testing: The PORT-A-CATH® POWER P.A.C. implantable venous access system, PORT-A-CATH® II POWER P.A.C. implantable venous access system, and GRIPPER PLUS® POWER P.A.C. needle met all established acceptance criteria for performance testing and design verification testing.
Packaging and Sterilization systems are unchanged from predicate devices.
B. Clinical Studies: Clinical studies for the PORT-A-CATH® POWER P.A.C. implantable venous access system, PORT-A-CATH® II POWER P.A.C. implantable venous access system, and GRIPPER PLUS® POWER P.A.C. needle were deemed not necessary due to their similarity in materials, design and function to current Smiths Medical MD, INC. devices and other commercially available systems.
C. Conclusions Drawn from the Studies: Based upon the information provided; the PORT-A-CATH® POWER P.A.C. implantable venous access system, PORT-A-CATH® II POWER P.A.C. implantable venous access system, and GRIPPER PLUS® POWER P.A.C. needle met all acceptance criteria for performance testing and design verification testing. Therefore, these products are considered acceptable for human use.
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.
K864446, K875276, K932095, K942024, K060036, K932840, K962695, K060812, K021999
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
070116
PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle
510(k) Summary
MAY 2 3 2007
I. Applicant (Sponsor) Name and Address
Smiths Medical MD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 Establishment Reg. No.: 2183502
II. Contact Name and Phone
Phil Neururer
Senior Regulatory Affairs Specialist
Company Phone: (651) 628-7592
Company Fax: (651) 628-7457
III. Device Trade/Proprietary Name
-
Catheter/Port
PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems -
Needle
GRIPPER PLUS® POWER P.A.C. needle
IV. Device Classification/Common Name/Panel
Catheter/Port
21 CFR Reference: §880.5965 21 CFR Common Name: Implanted Infusion Port Classification: Class II Product Code: LJT Panel: General Hospital
Needle
21 CFR Reference: §880.5440 21 CFR Common Name: Huber Needle Intravascular Administration Set Classification: Class II Product Code: FPA Review Panel: General Hospital and Personal Use
V. Identification of Predicate Device
Smiths Medical MD, Inc. believes the PORT-A-CATH® POWER P.A.C. implantable venous access system, PORT-A-CATH® II POWER P.A.C. implantable venous access system, and GRIPPER PLUS® POWER P.A.C. needle are substantially equivalent to the following devices and thus may market the devices under these equivalencies.
Confidential
1
PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle
510(k) Summary
Catheter/Port
Device Name/510(k) number:
PORT-A-CATH® implantable venous access system (K864446, K875276, K932095, K942024. and K060036) PORT-A-CATH® II implantable venous access system (K932840, K942024, K962695, and K060036) PowerPort™ Implanted Titanium Port with 8Fr. ChronoFlex® (K060812)
Needle
Device Name/510(k) number:
GRIPPER PLUS® needle (K021999)
VI. Device Description
PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems
The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are similar to the current PORT-A-CATH® and PORT-A-CATH® II implantable venous access systems. They both 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. However, when used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® 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® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems can be placed in the chest or arm.
The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are supplied sterile and non-pyrogenic. All PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are designed and intended for single patient use only. A system consists of a portal with one or two self-sealing septa and a single or dual lumen catheter and is accessible by percutaneous puncture with a non-coring needle.
GRIPPER PLUS® POWER P.A.C. Needle
The GRIPPER PLUS® POWER P.A.C. needle is similar to the current GRIPPER PLUS® needle, with the addition of an added indication. Both are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from implanted ports. In addition, they both have a passive needle stick protection feature that is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission.
The difference between the two however, is when used with a PORT-A-CATH® and/or PORT-A-CATH® II POWER P.A.C. implantable venous access system; the GRIPPER PLUS® POWER P.A.C. needle is indicated for power injection of contrast media.
2
PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle
510(k) Summary
VII. Intended Use of the Device
The intended use of each device has not changed from that of the predicate.
PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems
The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are implantable vascular access devices designed to provide long term repeated access to the vascular system.
GRIPPER PLUS® POWER P.A.C. Needle
The GRIPPER PLUS® POWER P.A.C. needle is designed for the administration into or withdrawal of fluids from implanted ports.
VIII. Indications for Use
The Indications for Use of each device has changed from that of the predicate with the addition of power injection.
PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems
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. needle, the PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.
GRIPPER PLUS® POWER P.A.C. Needle
The GRIPPER PLUS® POWER P.A.C. needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
When used with the PORT-A-CATH® and/or PORT-A-CATH® II POWER P.A.C. implantable venous access system, the GRIPPER PLUS® POWER P.A.C. needle is indicated for power injection of contrast media into the central venous system. The maximum recommended infusion rate is 5 ml/sec. for 19 and 20 gauge needles and 3ml/sec. for 22 gauge needles.
3
PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle
510(k) Summary
IX. Summary of Studies
A. Functional Testing
The PORT-A-CATH® POWER P.A.C. implantable venous access system, PORT-A-CATH® II POWER P.A.C. implantable venous access system, and GRIPPER PLUS® POWER P.A.C. needle met all established acceptance criteria for performance testing and design verification testing.
Packaging and Sterilization systems are unchanged from predicate devices.
B. Clinical Studies
Clinical studies for the PORT-A-CATH® POWER P.A.C. implantable venous access system, PORT-A-CATH® II POWER P.A.C. implantable venous access system, and GRIPPER PLUS® POWER P.A.C. needle were deemed not necessary due to their similarity in materials, design and function to current Smiths Medical MD, INC. devices and other commercially available systems.
C. Conclusions Drawn from the Studies
Based upon the information provided; the PORT-A-CATH® POWER P.A.C. implantable venous access system, PORT-A-CATH® II POWER P.A.C. implantable venous access system, and GRIPPER PLUS® POWER P.A.C. needle met all acceptance criteria for performance testing and design verification testing. Therefore, these products are considered acceptable for human use.
4
Image /page/4/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2007
Mr. Phil Neururer Senior Regulatory Affairs Specialist Smiths Medical MD, Incorporation 1265 Grey Fox Road St. Paul, Minnesota 55112
Re: K070116
Trade/Device Name: PORT-A-CATH and PORT-A-CATH II Power P.A.C. Implantable Venous Access Systems and Gripper Plus Power P.A.C. Needle Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT, FPA Dated: April 18, 2007 Received: April 19, 2007
Dear Mr. Neururer:
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.
5
Page 2 - Mr. Neururer
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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Liu, Ph.D.
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
Enclosure
6
PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle
Indications for Use
510(k) Number (if known): K070116
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 injection or infusion therapy and/or venous blood sampling.
When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec."
OR X Prescription Use 21 CFR 801.109)
Over-The Counter Use ------Per
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cinta D. Munoz
ംാ വ്യൂർ-Off) Ision of Anesthesiology, General Hospital, Jon Control, Dental Devices
3(k) Number: k 474116
Confidential
7
PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle
Indications for Use
510(k) Number (if known): K070116
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 system is 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. needle, the PORT-A-CATH® II POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec."
Prescription Use ※ 21 CFR 801.109)
OR
Over-The Counter Use Per
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cutan Van
300 PLOBOR FOR tion of Anes ----------------------------------------------------------------------------------------------------------------------------------------------------------------John Control, Dencer Devices
Number. Ky7911
TAB 2 - Page 2 of 3
Confidential
8
PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle
Indications for Use
510(k) Number (if known): K070116
Device Name: GRIPPER PLUSTM POWER P.A.C. Needle
Indications for Use:
"The GRIPPER PLUS® POWER P.A.C. needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
When used with the PORT-A-CATH® POWER P.A.C. and POWER PORT-A-CATH® II POWER P.A.C. implantable venous access systems, the GRIPPER PLUS® POWER P.A.C. needle is also indicated for power injection of contrast media into the central venous system. The maximum recommended infusion rate is 5 ml/sec. for 19 and 20 gauge needles and 3ml/sec. for 22 gauge needles."
Prescription Use 21 CFR 801.109)
OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cunten
ia Cign-OW) tion of Anesthasiology, General Hospital. Jon Control, Dental Devices
10(k) Number _________________________________________________________________________________________________________________________________________________________________
Confidential
TAB 2 - Page 3 of 3