VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER

K980566 · Boston Scientific Corp · FOZ · Sep 14, 1998 · General Hospital

Device Facts

• Record ID: K980566
• Device Name: VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
• Applicant: Boston Scientific Corp
• Product Code: FOZ · General Hospital
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.

Device Story

Peripherally Inserted Central Catheter (PICC) for central venous access; facilitates prolonged IV administration of fluids, medications, or nutrition. Catheter shaft features 5 cm incremental markings for trim length adjustment; optional plastic clamps on proximal extension tubes. Inserted by healthcare professionals into peripheral veins (e.g., basilic vein) with distal tip positioned to ensure maximum dilution and vascular access. Device provides a conduit for therapy delivery; benefits patient by enabling long-term venous access while minimizing repeated venipuncture.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Polyurethane catheter shaft; 5 cm incremental markings for length adjustment; optional plastic clamps; ethylene oxide sterilization; heat-sealed Tyvek/mylar packaging.

Indications for Use

Indicated for patients requiring central venous catheterization or prolonged IV administration of fluids, medications, or nutritional therapy. Suitable for various insertion sites, most commonly the basilic vein.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• PICC catheter (Cook Inc.)
• PICC catheter (Luther Medical)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters and numbers. The sequence appears to be 'K9805266'. The characters are written in a dark color, possibly black ink, against a light background. The style of writing is somewhat rough, giving it a hand-drawn appearance.

### SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.

## A. GENERAL INFORMATION

| | Owner Operator Submitting Boston Scientific Corporation |
|------------------------|----------------------------------------------------------|
| | this Premarket Notification: One Boston Scientific Place |
| | Natick, MA 01757 |
| | [phone] |
| Contact Person: | Wanda M. Carpinella |
| | Regulatory Affairs Department |
| Device Generic Name: | Peripherally Inserted Central Catheter |
| Device Classification: | 80 FOZ, Intravascular Catheter |

#### B. INDICATIONS FOR USE

The PICC catheter system is designed for use when central venous catheterization or prolonged intravenous administration of fluids, medications, and/or nutritional therapy is prescribed. A variety of insertion sites may be utilized, depending upon the patient involved and the catheter size selected. While any vessel suitable for insertion may be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for whatever therapy becomes necessary and assurance of a continued, uncompromised vascular access.

# C. DESCRIPTIVE CHARACTERISTICS

The subject PICC catheter is made from polyurethane material. The catheter shaft has 5 cm incremental markings, which are used to determine the exact catheter trim length. The PICC catheter is offered with or without plastic clamps on the proximal extension tubes.

### D. SUBSTANTIAL EQUIVALENCE

The subject PICC catheter has been shown to be substantially equivalent to the PICC catheter offered by Cook Inc. and Luther Medical.

### E. PACKAGING, STERILIZATION, AND PYROGENICITY

The PICC catheter is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes.

#### F. CONCLUSION

Based on the information presented, Boston Scientific Corporation believes that the PICC catheter meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed PICC catheters.

{1}------------------------------------------------

Public Health Service

SEP 1 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Wanda M. Carpinella Project Manager, Regulatory Affairs Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537

Re: K980566 Vaxess Peripherally Inserted Central Trade Name: Catheter Regulatory Class: II Product Code: FOZ Dated: July 21, 1998 Received: July 23, 1998

Dear Ms. Carpinella:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{2}------------------------------------------------

Paqe 2 - Ms. Carpinella

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general -information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices __ _ _ Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known):

14980566 New Application

Device Name:

Peripherally Inserted Central Catheter

The PICC catheter system is designed for use when Indications for Use: indications for 800.
central venous catheterization or prolonged intravenous administration of fluids, Central verious catherenzation of profession in the mariety of insertion sites may medications, and/or harmond the patient involved and the catheter size selected. While be utilized, dopending apon the pay be used, the basilic vein is the most commonly used vein. Location of the distal catheter tip must provide maximum dilution for used voin: Eoodtion of the alstarssary and assurance of a continued, uncompromised vascular access.

(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)

Concurrence of CDRH, Office of Device Evaluaiton (ODE)

(Division Sign-Off) 75 . 1 Division of Deneral Infection Control, and General Hospital Devices 510(k) Number K 9 8 0

Prescription Use
(Per 21 CRF 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)