NEO MAPCATH SENSOR STYLET

K083121 · Corpak Medsystems · OMF · Feb 11, 2009 · General Hospital

Device Facts

• Record ID: K083121
• Device Name: NEO MAPCATH SENSOR STYLET
• Applicant: Corpak Medsystems
• Product Code: OMF · General Hospital
• Decision Date: Feb 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2

Intended Use

The NEO MAPCath sensor stylet, when used in conjunction with the NAVIGATOR locator instrument, is designed 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.

Device Story

NEO MAPCath Sensor Stylet functions as an accessory to the NAVIGATOR locator instrument to assist clinicians in central venous catheter (CVC) placement. The device provides real-time positional feedback of the catheter tip within the patient's vasculature during the insertion procedure. By monitoring the catheter's location, the system helps ensure accurate placement, potentially reducing complications associated with malpositioned catheters. It is intended for use in clinical settings by healthcare professionals performing CVC insertion.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and technological comparison.

Technological Characteristics

Sensor stylet designed for use with the NAVIGATOR locator instrument. Functions as an accessory for real-time intravascular catheter positioning. Class II device (OMF).

Indications for Use

Indicated for use as an accessory to aid in the placement of central venous catheters by providing real-time positional information 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.”

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Stephanie Wasielewski Vice President, Regulatory Affairs/Ouality Corpak Medsystems 100 Chaddick Drive Wheeling, Illinois 60090

Re: K083121

> Trade/Device Name: NEO MAPcath Sensor Stylet Model 60-2008 Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter · Accessory for catheter position Regulatory Class: II Product Code: OMF Dated: January 7, 2009 Received: January 8, 2009

Dear Ms. Wasielewski:

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. Wasielewski

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Anthony Le. Anater for
Ginette Y. Michaud, M.D.

Acting 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): K083121

Device Name: NEO MAPCath Sensor Stylet

Indications for use:

The NEO MAPCath sensor stylet, when used in conjunction with the NAVIGATOR locator instrument, is designed 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.

Prescription Use ﺎ (Per 21 CFR 801.109)

or Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

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

510(k) Number: K983121