(64 days)
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No
The summary describes a standard implantable port and catheter system with associated accessories, and there is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is described as an implantable port and catheter system used for delivering fluids, medications, and withdrawing blood samples. While it facilitates therapy, it does not directly treat a disease or condition itself; rather, it is a tool for delivering therapeutic agents or for diagnostic purposes.
No
The device is described as an implantable port and catheter system used for repeated intravascular injection, continuous infusion of fluids, medications, antibiotics, nutritionals, and withdrawal of venous blood samples. These functions are therapeutic and for substance delivery/collection, not for diagnosing medical conditions.
No
The device description clearly lists physical components like an implantable port, catheter, needles, and guidewire, 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 describes the implantation of a port and catheter for administering substances and withdrawing blood from the patient's body. This is a direct interaction with the patient for therapeutic and diagnostic purposes in vivo.
- Device Description: The device components are all related to the physical implantation and use of the port and catheter within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro) to diagnose a condition, monitor a treatment, or screen for diseases. IVDs typically involve reagents, analyzers, or other components used to test biological samples like blood, urine, or tissue in a laboratory setting.
Therefore, this device is a medical device used for direct patient care and treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Implantation of a port and catheter is indicated 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 port kit provides an implantable port and polyurethane catheter, an introducer sheath/dilator, a 22 Ga. non-coring needle, a 21 Ga. entry needle, a 20 Ga. blunt needle, and 0.018" guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
OCT 20 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.
A. GENERAL INFORMATION
| Owner Operator Submitting
this Premarket Notification: | Boston Scientific Corporation
480 Pleasant Street
Watertown, MA 02172
(508) 650.8292 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Contact Person: | Christine M. Harris
Regulatory Affairs Department |
| Device Generic Name: | Venous Access Port |
| Device Classification: | 80 LJT, Implanted Subcutaneous Port and Catheter |
B. INDICATIONS FOR USE
Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.
C. DESCRIPTIVE CHARACTERISTICS
The port kit provides an implantable port and polyurethane catheter, an introducer sheath/dilator, a 22 Ga. non-coring needle, a 21 Ga. entry needle, a 20 Ga. blunt needle, and 0.018" guidewire.
D. SUBSTANTIAL EQUIVALENCE
The proposed venous access port and polyurethane catheter has been shown to be substantially equivalent to the original R-Port Premier and the Gerard Medical TrimPort.
E. PACKAGING, STERILIZATION, AND PYROGENICITY
Components comprising the kit are assembled in a PETG blister tray with a snap-fit lid. The tray is placed in a Tyvek/mylar pouch, which is then heat sealed. The kit is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes.
F. CONCLUSION
Based on the information presented, Boston Scientific Corporation believes that the proposed venous access port meets the minimum requirements that are considered acceptable for its intended use.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three wavy lines representing the body. The figure is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 1998
Ms. Laura Mondano Manager, Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re : K982888 Trade Name: Vaxcel Implantable Vascular Access System Regulatory Class: Unclassified Product Code: LJT Dated: August 14, 1998 Received: August 17, 1998
Dear Ms. Mondano:
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 Vaxcel Implantable Vascular 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 Vaxcel Implantable Vascular Access System. 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 Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set
2
Paqe 2 - Ms. Mondano
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 assumptions. Failure to comply with the GMP regulation may result in requlatory 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 Requlations.
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 regulation (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. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
New Application
Device Name:
Modified Vascular Access Port and Catheter
Indications for Use: The Vascular Access Port and Catheter is indicated 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 OF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Patricia Cuenente
Division Sign-Off
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number