(14 days)
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 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 provided document is a 510(k) premarket notification summary and FDA clearance letter for a medical device (Vaxcel™ with PASV® implantable port system). It describes the device's intended use and claims substantial equivalence to predicate devices.
However, this document does not contain information about acceptance criteria for device performance, nor does it detail any specific study proving the device meets such criteria.
The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing features, materials, general performance, and intended use against the predicate, rather than establishing new performance benchmarks through clinical trials or detailed performance studies with acceptance criteria.
The sections you requested for information about acceptance criteria and a study design are therefore not applicable or available in this document. The document explicitly states:
- "Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act" for this device type. This means there are no predefined regulatory performance criteria the device must meet for this specific submission.
- The "Summary of Substantial Equivalence" indicates that the device has been tested and compared to the predicate device, and that "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This comparison forms the basis for clearance, not a study demonstrating achievement of specific performance acceptance criteria.
Therefore, I cannot provide the requested information from this document. If such studies were performed, they would be part of a more detailed 510(k) submission that is generally not made public in its entirety, or they might be internal company testing used to support the substantial equivalence claim.
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JUL 1 4 2003
Special 510(k) Vaxcel™ with PASV® Port - 6F (product code 45-213) June 27, 2003
Summary of Safety and Effectiveness
Summary of Safety and Effectiveness
K03 2008
| General Provisions | Trade Name: Vaxcel™ with PASV® implantable port system |
|---|---|
| Classification Name: Implanted Subcutaneous Port and Catheter, 80 LJT | |
| Name ofPredicateDevices | Vaxcel™ Implantable port systemPASV® implantable port systemVaxcel™ with PASV® PICC |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | The Vaxcel™ w/ PASV® Port device is intended for use in patients whorequire long-term access to the central venous system for administration offluids including but not limited to hydration fluids, antibiotics, chemotherapy,analgesics, nutritional therapy, and blood products.The device is alsoindicated for blood specimen withdrawal. |
| Biocompatibility | The Vaxcel™ with PASV® implantable port system have been tested forbiocompatibility per ISO 10993. All data demonstrate this device isbiocompatible for its intended use. |
| Summary ofSubstantialEquivalence | The Vaxcel™ with PASV® implantable port system have been tested andcompared to the predicate device. All data gathered demonstrate this deviceas substantially equivalent. No new issues of safety or efficacy have beenraised. |
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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-like symbol with three wavy lines representing the department's mission of promoting health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
JUL 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K032008
Trade/Device Name: Vaxcel™ with PASV® Implantable port system Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: June 27, 2003 Received: June 30, 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 - 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 yours.
Susan Runse
Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosúre
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Indications For Use
| 510(k)Number(if known) | Unknown R032008 |
|---|---|
| Device Name: | Vaxcel™ with PASV® implantable port system |
| Indicationsfor Use | The Vaxcel™ w/ PASV® Port device is intended for use in patients whorequire long-term access to the central venous system for administration offluids including but not limited to hydration fluids, antibiotics, chemotherapy,analgesics, nutritional therapy, and blood products. The device is alsoindicated for blood specimen withdrawal. |
Pallone Vincente
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K032008
(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)
§ 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.