(15 days)
Not Found
No
The provided text describes a standard implantable port device for central venous access and does not mention any AI or ML capabilities.
No
The device is described as a port for long-term central venous access to administer various fluids and withdraw blood specimens, which are functions for patient care rather than direct therapeutic treatment.
No
The device is described as providing long-term access for fluid administration and blood specimen withdrawal, which are therapeutic and collection functions, not diagnostic.
No
The device description clearly indicates a physical implantable port system intended for long-term access to the central venous system, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the central venous system for administering fluids and withdrawing blood specimens from the patient. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic sampling purposes, not for testing samples outside the body.
- Device Description: The description reiterates the intended use, focusing on accessing the central venous system.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances in samples, or any other activity that would be performed in vitro (outside the living organism).
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used to obtain the specimen and administer substances to the body.
N/A
Intended Use / Indications for Use
The Vaxcel™ and 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 (comma separated list FDA assigned to the subject device)
LJT
Device Description
The Vaxcel™ and 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.
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™ and 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): 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
SEP - 9 2003
Summary of Safety and Effectiveness
| General
Provisions | Trade Name: Vaxcel™ and Vaxcel™ with PASV® implantable port system
Classification Name: Implanted Subcutaneous Port and Catheter, 80 LJT |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Vaxcel™ with PASV Port (K032008, K031844)
Vaxcel™ Port (K032375) |
| 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™ and 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. |
| Biocompatibility | The Vaxcel™ and 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™ and 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 shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Public Health Service
SEP - 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation 10 Glens Falls Technical Park Glens Falls, New York 12801-3864
Re: K032600
Trade/Device Name: Vaxcel™ and Vaxcel™ with PASV® Implantable Port System Regulation Number: 21CFR 880. 5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: August 21, 2003 Received: August 25, 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 vour 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.
2
Page 2 -Ms. Greenizen
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 (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.
Patricia Cucente//or
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
Enclosure
3
Indications For Use
| 510(k) Number (if known) | Unknown |
|---|---|
| Device Name: | Vaxcel™ and Vaxcel™ with PASV® implantable port system |
| Indications for Use | The Vaxcel™ and 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. |
Susa Ruon
(Division Sign-Off) (Division Sign-Oll)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
Confidential Boston Scientific Corporation