1.4 FR MAPCATH SENSOR STYLET

K973057 · Navion Biomedical Corp. · LJS · Nov 12, 1997 · General Hospital

Device Facts

• Record ID: K973057
• Device Name: 1.4 FR MAPCATH SENSOR STYLET
• Applicant: Navion Biomedical Corp.
• Product Code: LJS · General Hospital
• Decision Date: Nov 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the catheter locator instrument to aid in the placement of central venous catheters (CVCs) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.

Device Story

1.4 Fr MAPCath sensor stylet; used with catheter locator instrument; provides real-time positional and directional feedback of central venous catheter (CVC) tip during insertion. Device inserted into CVC; sensor detects position within body; locator instrument processes signal; displays information to clinician. Used in clinical settings during CVC placement procedures. Assists clinicians in accurate catheter tip positioning; reduces risk of malpositioning; improves procedural efficiency.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design and technological characteristics to predicate devices.

Technological Characteristics

1.4 Fr sensor stylet; designed for use with catheter locator instrument; physical dimensions and materials identical to predicate K935380.

Indications for Use

Indicated for use as an aid in the placement of central venous catheters (CVCs) by providing real-time positional and directional information of the CVC tip during insertion procedures.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• 1.4 Fr sensor stylet (K935380)
• Navion SMART-WIRE sensor (K901263)

Submission Summary (Full Text)

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K97-305:7

NOV 1 2 1997

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

The design, use and function of the 1.4 Fr MAPCath sensor stylet described in this pre-market notification are substantially equivalent (same product) to the 1.4 Fr sensor stylet described in Bard Access Systems submission K935380 and substantially equivalent in design, use and function to the Navion SMART-WIRE sensor described in submission K901263.

A table comparing the physical features of the proposed 1.4 Fr MAPCath sensor stylet to the one that received concurrence under K935380 and the original sensor stylet in K901263 is shown in Exhibit 6.

The 510(k) "Substantial Equivalence Decision-Making Process" decision tree (exhibit 7) was used to make the substantial equivalence determination. The decision tree questions and answers are as follows:

## 1.0 Does the new device have same indication statements?

Yes. The sensor stylet described in this 510(k) submission has the same indications for use as the current Navion MAPCath (SMART-WIRE) sensor stylet and the current Bard Access Systems sensor stylet. They are designed, when used in conjunction with the catheter locator instrument, to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure

## 2.0 Does new device have same technological characteristics, e.g., design, material, etc.?

Yes. The sensor stylet described in this 510(k) submission is the same product described in Bard Access Systems 510(k) (reference K935380).

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## Are the descriptive characteristics precise enough to ensure equivalence? 3.0

Yes. The sensor stylet described in this 510(k) submission is the same product that received concurrence under K935380.

Sandy A. Kay

Donald A Kay President, Navion Biomedical Corp.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard NOV | 2 |9:9g ville MD 20850

Mr. Donald A. Kay ·President Navion Biomedical Corporation 312 Tosca Drive Stoughton, Massachusetts 02072

K973057 Re : 1.4 Fr MAPcath Sensor Stylet Trade Name: Regulatory Class: Unclassified Product Code: LJS Dated: August 7, 1997 Received: August 15, 1997

Dear Mr. Kay:

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 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 The general controls provisions of the Act 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 (Premarket Approval), it may Existing major be subject to such additional controls. regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Kay

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 diaqnostic 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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

Enclosure

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Page l of

וכענ K97 510(k) Number (if known):

SENSOR STYLET 1.4 FR MAPCATH Device Name:__

Indications For Use:

The 1.4 Fr MAPCath Sensor Stylet is designed to be used with the The 1.4 FF MAPCath Sensor Directument to aid in the placement of NAVIGATOR Cathotors (CVCc) by indicating the position and direction of the CVC tip inside the body during the catheter insertion procedure.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrucia Cucente

Deision Sign-Off) Dission of Dental, Infection Control, and General Hospital Devices

, 10(k) Number________________________________________________________________________________________________________________________________________________________________

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)