(18 days)
The Vaxcel TM 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™ 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.
Unfortunately, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them, as the provided text from K032375 does not contain any information about acceptance criteria or performance studies.
This document is a 510(k) premarket notification summary for a medical device (Vaxcel™ Low Profile Port-8F Non-Valved- Polysulfone). The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove the device meets specific performance criteria through new clinical or non-clinical studies.
Here's what the document does state, which explains why your requested information isn't present:
- "Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act": This explicitly states that there are no FDA-mandated performance standards that this device needs to meet.
- "Summary of Substantial Equivalence: The Vaxcel™ 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.": This is the core of a 510(k) submission. The "study" here is a comparison to a predicate device (Vaxcel™ with PASV Port (K031844)), not an independent performance study against acceptance criteria. The claim is that it's "substantially equivalent," meaning it's as safe and effective as the predicate, which has already been cleared.
- "Biocompatibility: The Vaxcel™ Port system have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use.": This is the only type of "testing" mentioned, and it's for biocompatibility, not overall device performance against specific acceptance criteria.
Therefore, I cannot generate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not provided in the document. The 510(k) process for this device did not require such detailed performance studies as it relied on demonstrating equivalence to an existing device.
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AUG 1 9 2003
Vaxcel™ Low Profile Port – 8F Non Valved- Polysulfone July 31, 2003
Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: Vaxcel™ Port system |
|---|---|
| Classification Name: Implanted Subcutaneous Port and Catheter, 80 LJT | |
| Name ofPredicateDevices | Vaxcel™ with PASV Port (K031844) |
| Classification | Class II |
| PerformanceStandards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Useand DeviceDescription | The Vaxcel™ 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™ Port system have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Summary ofSubstantialEquivalence | The Vaxcel™ 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. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an abstract emblem featuring a stylized depiction of a human figure and an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2003
Boston Scientific Corporation Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager 10 Glens Falls Technical Park, Dix Avenue Glens Falls, New York 12801
Re: K032375
Trade/Device Name: Vaxcel™ Low Profile Port-8F Non- Valved- Polysulfone Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 31, 2003 Received: August 1, 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.
Super Kunn Susan Runner, DDS, MA Interim Direction Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
| 510(k) Number (if known) | Unknown K032375 |
|---|---|
| Device Name: | Vaxcel TM Port system |
| Indications for Use | The Vaxcel TM 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. |
Patricia Cusack
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032375
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (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.