(156 days)
No
The summary describes a standard implantable vascular access system with no mention of AI or ML capabilities.
Yes
The device is used for "patient therapy" requiring "repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples," all of which are part of medical treatment.
No
The device is an implantable access system for repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. It is used for therapy, not for diagnosing conditions.
No
The device description explicitly states that the system includes implantable hardware components: a portal, a radiopaque catheter, and a locking catheter connector.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as providing repeated access to the vascular system for the delivery of fluids and the withdrawal of blood samples. This is a therapeutic and diagnostic access function, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description focuses on the physical components of the implantable system (portal, catheter, connector) used for accessing the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on the properties of the blood sample itself. The blood withdrawal is for obtaining a sample, not for the device to perform a diagnostic test on that sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device facilitates the collection of such a specimen, but it doesn't perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
Our TrimPort Systems are indicated for use whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
Product codes (comma separated list FDA assigned to the subject device)
LJT
Device Description
The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood. The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector. The small veins in one's arms and hands can become severely damaged when subjected to frequent needle punctures and/or irritating fluids. Usage of a TrimPort device, which is implanted beneath the skin, frees patients from the discomfort and potential damage to veins from repeated injections into them. The TrimPort catheter is implanted into a large blood vessel so that fluids can be introduced or blood withdrawn without the necessity for repeated injections into the patient's vein.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system / large blood vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or nurse
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)
Not Found
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
7 1998 MAY
C. 1
Summary of Safety and Effectiveness Information
Gerard Medical, Inc. Company Name and Address: 6 City Depot Rd. P.O. Box 940 ー Charlton City, MA 01508
Company Telephone No.: (508) 248-1562
Richard Cayer, Jr. Company Contact Name:
November 29, 1997 Summary Date:
Proprietary Name: TrimPort
Implanted Vascular Access System Common or Usual Name:
Implanted Subcutaneous IV Catheter Classification Name:
Class: '
Legally Marketed Substantially Equivalent Devices:
MiniPort Implantable Vascular Access System (Re: K942623). Manufactured by Gerard Medical, Inc.
Device Description and Intended Usage:
The Gerard Medical, Inc. TrimPort Implantable Access System is precision engineered to provide repeated access to the vascular system for both parenteral delivery of fluids and the withdrawal of venous blood.
The implantable segments of the TrimPort System and comparable devices are the portal, the radiopaque catheter, and a locking catheter connector.
The small veins in one's arms and hands can become severely damaged when subjected to frequent needle punctures and/or irritating fluids. Usage of a TrimPort device, which is implanted beneath the skin, frees patients from the discomfort and potential damage to veins from repeated injections into them.
The TrimPort catheter is implanted into a large blood vessel so that fluids can be introduced or blood withdrawn without the necessity for repeated injections into the patient's vein.
1
Once the implanted TrimPort is ready for use, the physician or nurse will cleanse the skin at the implantation site and will pinpoint the device's location by simply feeling the unobtrusive but clear outline of its top rim. A needle specific to this purpose will be inserted gently through the skin into the portal of the TrimPort, where it will remain throughout the fluid delivery-withdrawal process.
Device Design, Testing, and Potential Adverse Occurrences:
We have reviewed a great quantity of information regarding our own and many competitive implantable vascular access systems. Based on our analysis, we feel that there are specific occurrences that would negatively affect the safety and effectiveness of these devices. The following is a list of these potential adverse occurrences and a summary of what we have done to minimize the risks.
-
- Catheter Disconnection:
We designed an excellent catheter locking mechanism that remains intact, even under extreme conditions. To ensure that the surgeon implanting our TrimPort assembles the locking device properly, we provide clear and complete instructions and diagrams in our "Instructions for Use".
- Catheter Disconnection:
-
- System Leak:
We precisely engineered our TrimPort vascular access systems so that they perform properly (Re: two-way flow, leak tight), even under extreme misuse conditions. To ensure this, we mandate that all new designs must be able to pass each of our standard usage and extreme misuse tests. To minimize the possibility of misuse, we instruct those who
- System Leak:
access the device to use syringes that are 10cc or larger. This helps to prevent the emission of damaging pressure into Our recommendations to use 10cc or larger the system. syringes and not to exceed 40 psi when using the system is stated several times in our "Instructions for Use". Note that this is also a standard warning in the competitive instruction manuals we have reviewed.
- System Occlusions:
We make numerous references, and provide much direction, in our "Instructions for Use" relative to flushing our device and clearing system occlusions.
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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1888 MAT
Mr. Richard Cayer, Jr. ·President Gerard Medical, Incorporated 6 City Depot Road P.O. Box 940 Charlton City, Massachusetts 01508
Re : K974533 TrimPort® Implantable Access System Trade Name: Regulatory Class: Unclassified Product Code: LJT Dated: April 23, 1998 April 27, 1998 Received:
Dear Mr. Cayer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the TrimPort® Implantable Access System have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨੇ substantially equivalent determination assumes compliance with
3
Page 2 - Mr. Cayer
the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such Failure to comply with the GMP regulation may assumptions. result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 the labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
RE: REVISED INDICATIONS FOR USE
1 Page of
K974533 510(k) Number (if known):
Device Name: TrimPort Implantable Access System
Indications For Use:
Our TrimPort Systems are indicated for use whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Palacio Crescente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K974533
Prescription Use ) (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)