VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 by BOSTON SCIENTIFIC CORP.

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.

Device Description

AI/ML Overview

The provided text describes a Special 510(k) submission for the Vaxcel™ with PASV® Port implantable port system, indicating that the new device is substantially equivalent to a previously cleared predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the traditional sense of a clinical performance study with specific metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-powered device.

Instead, the submission focuses on substantial equivalence to a predicate device. This means the device's safety and effectiveness are established by demonstrating that it is as safe and effective as a legally marketed device that FDA has already cleared.

Therefore, for your request, I will explain why most of the fields are not applicable in this context and what "acceptance criteria" and "study" mean in the context of a 510(k) for an implantable port system.

Summary of Device Acceptance Criteria and Performance (in the context of Substantial Equivalence):

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for Substantial Equivalence)	Reported Device Performance (as demonstrated for 510(k))
Intended Use Equivalence: The device has the same intended use as the predicate.	Met: The Vaxcel™ w/ PASV® Port device has the same intended use: long-term central venous access for fluid administration (hydration, antibiotics, chemotherapy, analgesics, nutritional therapy, blood products) and blood specimen withdrawal.
Technological Characteristics Equivalence (or differences do not raise new safety/effectiveness concerns): The device has similar technological characteristics to the predicate, or any differences do not raise new questions of safety or effectiveness.	Met: The Vaxcel™ with PASV® implantable port system was "tested and compared to the predicate device." The submission states, "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." The device is available in "standard and mini port configurations made of either Titanium or Polysulfone materials," similar to existing devices.
Performance Standards/Biocompatibility: The device meets any applicable performance standards and demonstrates biocompatibility for its intended use.	Met: 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." Performance Standards: "Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act" for this specific device classification, so none are applicable to meet beyond general controls.

Regarding the specific questions about "study" details, most are not applicable for this type of 510(k) submission, which relies on substantial equivalence rather than a de novo clinical performance study for a diagnostic AI device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (N/A): This type of information is pertinent to a clinical performance study or an AI/diagnostic software validation. For an implantable port system seeking 510(k) clearance via substantial equivalence, the "test set" would primarily refer to data, testing, and comparisons made to demonstrate equivalence to the predicate device, not a patient cohort in a diagnostic AI study. The document mentions "All data gathered," but specifics on sample size for these comparative tests are not provided. Biocompatibility testing often uses standardized methods and laboratory samples, not human clinical test sets in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable (N/A): This is relevant for diagnostic accuracy studies, particularly in AI. Ground truth for an implantable medical device's safety and effectiveness in a 510(k) context is typically established through engineering tests, material science evaluations, biocompatibility assessments, and comparison to the predicate device's known performance, rather than expert consensus on diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable (N/A): Adjudication methods are used in diagnostic studies (especially in AI) to resolve disagreements among multiple expert readers establishing ground truth. This is not relevant for the type of safety and effectiveness evaluation described in this 510(k) summary.

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 (N/A): This device is an implantable port system, not an AI or diagnostic tool designed to assist human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable (N/A): Again, this question applies to AI algorithms or diagnostic software, not to an implantable medical device like a port system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable (N/A) in the diagnostic sense: The "ground truth" for this device's safety and effectiveness in the 510(k) context would be established by:
- Biocompatibility testing per ISO 10993 standards: Demonstrating that the materials are safe for implantation.
- Engineering and functional testing: Verifying the device performs its intended functions (e.g., maintain patency, permit fluid flow, withdraw blood).
- Comparison to predicate device: Evidence that the new device performs equivalently to the already legally marketed predicate in terms of safety and effectiveness.
  The document emphasizes that "All data demonstrate this device is biocompatible for its intended use" and that "All data gathered demonstrate this device as substantially equivalent" to the predicate.

8. The sample size for the training set

Not Applicable (N/A): This is a term used in machine learning and AI development. This document describes an implantable medical device, not an AI model.

9. How the ground truth for the training set was established

Not Applicable (N/A): As with the training set itself, the concept of establishing ground truth for a training set is specific to AI/machine learning, not a medical device seeking clearance via substantial equivalence for its physical properties and intended use.

Summary

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C > / 8 4

JUL 15 2003

Special 510(k)
Vaxcel™ with PASV® Port June 13, 2003

Summary of Safety and Effectiveness

GeneralProvisions	Trade Name: Vaxcel™ with PASV® implantable port systemClassification Name: Implanted Subcutaneous Port and Catheter, 80 LJT
Name ofPredicateDevices	Vaxcel™ with PASV Port (K030083)
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™ 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 ofSubstantialEquivalence	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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Public Health Service

JUL 15 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager One Boston Scientific Place Natick, Massachusetts 01760 -1536

Re: K031844

Trade/Device Name: Vaxcel™ with PASV® Implantable Port System Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter. Regulatory Class: LJT Product Code: II Dated: June 13, 2003 Received: June 16, 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 (OS) 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 vour 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 Runne

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

Enclosure

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Indications For Use

510(k) Number (if known)	Unknown 031844
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.

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number ._______________________________________________________________________________________________________________________________________________________________ 844

(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)

Over-The Counter Use (Optional Format 1-2-96)

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Regulation Number and Section

§ 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.