VAXCEL WITH PASV PORT, MODEL 45-213

• K Number: K032008
• Device Name: VAXCEL WITH PASV PORT, MODEL 45-213
• Manufacturer: BOSTON SCIENTIFIC CORP.
• Date Cleared: 2003-07-14 ( 14 days)
• Product Code: LJT
• Regulation Number: 880.5965

Intended 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.

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.

Predicate Devices

Vaxcel™ Implantable port system, PASV® implantable port system, Vaxcel™ with PASV® PICC

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard implantable port system for central venous access and does not mention any AI or ML components or functionalities.

Therapeutic

Yes.
The device facilitates the administration of various therapeutic substances (antibiotics, chemotherapy, analgesics, nutritional therapy, blood products) directly into the central venous system, which constitutes a therapeutic function.

Diagnostic

No
The device is used for long-term central venous access for administration of fluids and blood specimen withdrawal, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "implantable port system," which is a physical medical device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a device used for administering fluids and withdrawing blood from the central venous system in vivo (within the living body). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
• Device Description: The description reinforces the intended use of accessing the central venous system for therapeutic and diagnostic purposes in vivo.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.

This device is a medical device used for accessing the central venous system, not for performing diagnostic tests on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

LJT

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

central venous system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

Vaxcel™ Implantable port system, PASV® implantable port system, Vaxcel™ with PASV® PICC

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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 of
Predicate
Devices	Vaxcel™ Implantable port system
PASV® implantable port system
Vaxcel™ 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.
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.

1

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.

2

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 [phone]. 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 [phone] or [phone] 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

3

Indications For Use

| 510(k)
Number

(if known)	Unknown R032008
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.

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)