(15 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Tested per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| Substantial Equivalence | Tested and compared to predicate devices (K032008, K031844, K032375). All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
Important Note: The provided document is a 510(k) premarket notification summary. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing new performance criteria or conducting extensive clinical trials to "prove" a device meets them in the way a PMA (Premarket Approval) submission for novel devices might. The acceptance criteria here are largely framed around equivalence and biocompatibility, as opposed to specific clinical performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" with a particular sample size for performance evaluation. The substantial equivalence argument relies on comparison to predicate devices, which likely involved in vitro testing or mechanical performance assessments rather than a clinical human subject test set.
- Data Provenance: Not specified, but likely refers to lab-generated data from retrospective testing performed by the manufacturer to compare the new device to its predicates. There is no mention of prospective clinical studies or country of origin for any human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. Given the nature of a 510(k) summary relying on substantial equivalence and biocompatibility, the concept of "ground truth" as established by medical experts for a clinical test set is not present. The assessment for substantial equivalence would have been performed by the manufacturer's engineers and quality control personnel.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring expert adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document does not mention any multi-reader multi-case studies or any studies involving human readers, either with or without AI assistance. This device is a medical implant, not an imaging or diagnostic device that would typically involve human reader performance.
- Effect Size of Human Readers with AI vs. without AI: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device is a physical implantable port system and does not involve an algorithm or AI. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
- Type of Ground Truth: For biocompatibility, the ground truth would be established by standardized laboratory testing protocols (ISO 10993) and the assessment against established biological safety limits. For substantial equivalence, the "ground truth" is adherence to design specifications and performance characteristics that are comparable to the predicate devices, likely verified through engineering specifications, in vitro testing parameters, and material analyses. There is no mention of pathology, expert consensus, or outcomes data used to establish "ground truth" in a clinical sense for this 510(k) submission.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The development and testing would involve engineering prototypes and manufacturing samples.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth was Established: Not applicable, as there is no training set for this type of device.
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SEP - 9 2003
Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: Vaxcel™ and Vaxcel™ with PASV® implantable port systemClassification Name: Implanted Subcutaneous Port and Catheter, 80 LJT |
|---|---|
| Name ofPredicateDevices | Vaxcel™ with PASV Port (K032008, K031844)Vaxcel™ Port (K032375) |
| 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™ and Vaxcel™ w/ PASV® Port device is intended for use inpatients who require long-term access to the central venous system foradministration 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 beentested for biocompatibility per ISO 10993. All data demonstrate this device isbiocompatible for its intended use. |
| Summary ofSubstantialEquivalence | The Vaxcel™ and Vaxcel™ with PASV® implantable port system have beentested and compared to the predicate device. All data gathered demonstratethis device as substantially equivalent. No new issues of safety or efficacyhave been raised. |
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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, 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.
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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 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
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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
§ 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.