(19 days)
Not Found
Not Found
No
The summary describes a standard implantable port system for central venous access and does not mention any AI or ML components or functionalities.
No
The device is a port for administering fluids and withdrawing blood, not for treating a disease or condition itself.
No
Explanation: The device is intended for administering fluids, chemotherapy, and blood products, and for blood specimen withdrawal, indicating it is a therapeutic and access device, not a diagnostic one.
No
The device description explicitly states it is made of Titanium or Polysulfone materials, indicating it is a physical implantable port, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Intended Use: The Vaxcel™ w/ PASV® Port device is intended for accessing the central venous system for administering fluids and withdrawing blood specimens. This is a procedure performed on the patient's body, not a test performed on a sample taken from the body.
The device is a medical device used for patient treatment and monitoring, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal.
Product codes
LJT
Device Description
The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal. The device is available in standard and mini port configurations made of either Titanium or Polysulfone materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous 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)
The Vaxcel™ with PASV® implantable port system have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Vaxcel™ Implantable port system, PASV® implantable port system, Vaxcel™ with PASV® PICC
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
JAN 2 8 2003
Image /page/0/Picture/1 description: The image shows the text "KO30083" in a handwritten style. The text is written in black ink on a white background. To the right of the text is the word "VaxcelTM".
Summary of Safety and Effectiveness
| General Provisions | Trade Name: Vaxcel™ with PASV® implantable port system |
|---|---|
| Classification Name: Implanted Subcutaneous Port and Catheter, 80 LJT | |
| Name of Predicate Devices | Vaxcel™ Implantable port system |
| PASV® implantable port system | |
| Vaxcel™ with PASV® PICC | |
| Classification | Class II |
| Performance Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Use and Device Description | The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal. The device is available in standard and mini port configurations made of either Titanium or Polysulfone materials. |
| Biocompatibility | The Vaxcel™ with PASV® implantable port system have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Summary of Substantial Equivalence | The Vaxcel™ with PASV® implantable port system have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
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 an eagle with three lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2003
·Ms. Jodi L. Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation NAMIC Technology Center 10 Glens Falls Technical Park, Dix Avenue Glens Falls, New York 12801
Re: K030083
Trade/Device Name: Vaxcel™ with PASV® Implantable Port System Regulation Number: 880. 5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port Catheter Regulatory Class: II Product Code: LJT Dated: January 8, 2003 Received: January 9, 2003
Dear Ms. Greenizen:
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.
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Page 2 - Greenizer
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 annlicable, 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Susan Runpe
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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·
Indications For Use
| 510(k) Number (if known) | Unknown K 030083 |
|---|---|
| Device Name: | Vaxcel™ with PASV® implantable port system |
| Indications for Use | The Vaxcel™ w/ PASV® Port device is intended for use in patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. The device is also indicated for blood specimen withdrawal. |
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use | OR | Over-The Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| Patricia Cucente | |
|---|---|
| (Division Sign-Off) | |
| Confidential | |
| Boston Scientific Corporation | Division of Anesthesiology, General Hospital, |
| Infection Control, Dental Devices | |
| 510(k) Number: | K030083 |