(19 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 device is available in standard and mini port configurations made of either Titanium or Polysulfone materials.
The presented text is a 510(k) summary for the Vaxcel™ with PASV® implantable port system. This document outlines the device's intended use, classification, and a summary of substantial equivalence to predicate devices, focusing on biocompatibility and performance. It does not provide details of a clinical study with acceptance criteria and device performance in the way a diagnostic or treatment efficacy study would.
Instead, the submission demonstrates substantial equivalence to already legally marketed predicate devices. This means the device is considered as safe and effective as a legally marketed device that does not require premarket approval.
Therefore, many of the specific questions about clinical study details, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, and standalone performance, are not applicable in the context of this 510(k) submission.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Demonstrated Equivalency) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility: Meet ISO 10993 standards | All data demonstrate this device is biocompatible for its intended use. |
| Substantial Equivalence: To predicate devices | All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
| Intended Use: As per predicate devices | Intended for long-term central venous access for administration of fluids and blood specimen withdrawal. |
| Performance: As per predicate devices | (Implicitly, the device performs similarly to the predicate devices for its intended use.) |
2. Sample size used for the test set and the data provenance: Not applicable. This is a 510(k) substantial equivalence submission, not a stand-alone clinical study with a defined test set as would be for a diagnostic or treatment device. The "testing" referred to is likely in-vitro testing for biocompatibility and engineering performance comparisons to the predicate, rather than human subject testing in the traditional sense for effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for a substantial equivalence submission of this nature. The determination of "ground truth" here is based on regulatory assessment of the device's design, materials, and intended use compared to predicate devices, supported by engineering and biocompatibility data.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is an implantable port system, not a software algorithm.
7. The type of ground truth used:
- Predicate Device Performance: The primary "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate devices (Vaxcel™ Implantable port system, PASV® implantable port system, Vaxcel™ with PASV® PICC).
- Biocompatibility Standards: ISO 10993 standards serve as the "ground truth" for biocompatibility assessment.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" in this type of device submission.
9. How the ground truth for the training set was established: Not applicable.
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JAN 2 8 2003
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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 systemPASV® implantable port systemVaxcel™ 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. |
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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. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| 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) | |
| ConfidentialBoston Scientific Corporation | Division of Anesthesiology, General Hospital,Infection Control, Dental Devices |
| 510(k) Number: | K030083 |
§ 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.