VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233

K032600 · Boston Scientific Corp · LJT · Sep 9, 2003 · General Hospital

Device Facts

• Record ID: K032600
• Device Name: VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
• Applicant: Boston Scientific Corp
• Product Code: LJT · General Hospital
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Implantable subcutaneous port and catheter system; provides long-term central venous access. Used for infusion of fluids/medications and blood withdrawal. Operated by clinicians in clinical settings. Device functions as a passive conduit; PASV® models include valve technology to manage flow. Biocompatible materials used per ISO 10993. System facilitates patient therapy by providing reliable venous access, reducing need for repeated venipuncture.

Clinical Evidence

Bench testing only; biocompatibility testing performed per ISO 10993.

Technological Characteristics

Implantable subcutaneous port and catheter. Materials tested for biocompatibility per ISO 10993. Passive fluid delivery/withdrawal system. No electronic components or software.

Indications for Use

Indicated for patients requiring long-term central venous access for fluid administration (hydration, antibiotics, chemotherapy, analgesics, nutrition, blood products) and blood specimen withdrawal.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• Vaxcel™ with PASV Port (K032008)
• Vaxcel™ with PASV Port (K031844)
• Vaxcel™ Port (K032375)

Submission Summary (Full Text)

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SEP - 9 2003

## Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: Vaxcel™ and Vaxcel™ with PASV® implantable port system<br>Classification Name: Implanted Subcutaneous Port and Catheter, 80 LJT |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of<br>Predicate<br>Devices | Vaxcel™ with PASV Port (K032008, K031844)<br>Vaxcel™ Port (K032375) |
| Classification | Class II |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514<br>of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The Vaxcel™ and Vaxcel™ w/ PASV® Port device is intended for use in<br>patients who require long-term access to the central venous system for<br>administration of fluids including but not limited to hydration fluids,<br>antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products.<br>The device is also indicated for blood specimen withdrawal. |
| Biocompatibility | The Vaxcel™ and Vaxcel™ with PASV® implantable port system have been<br>tested for biocompatibility per ISO 10993. All data demonstrate this device is<br>biocompatible for its intended use. |
| Summary of<br>Substantial<br>Equivalence | The Vaxcel™ and Vaxcel™ with PASV® implantable port system have been<br>tested and compared to the predicate device. All data gathered demonstrate<br>this device as substantially equivalent. No new issues of safety or efficacy<br>have 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 [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 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