AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET

K090117 · Autosafe-Reflex, Inc. · FMI · Sep 29, 2009 · General Hospital

Device Facts

• Record ID: K090117
• Device Name: AUTOSAFE-REFLEX SAFETY HUBER INFUSION SET, AUTOSAFE ADVANTAGE SAFETY HUBER INFUSION SET
• Applicant: Autosafe-Reflex, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Sep 29, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AutoSafe Safety Huber Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implantable vascular ports Additionally, the passine needle safety shield is designed to help prevent needlestick injuries by shielding the needle between steps and after use.

Device Story

AutoSafe-Reflex® Safety Huber Infusion Set is a sterile, single-use medical device for accessing implantable vascular ports. It facilitates fluid/drug administration and blood sampling. The device features a passive needle safety shield mechanism that automatically covers the needle during withdrawal and after use to mitigate the risk of accidental needlestick injuries. Operated by healthcare professionals in clinical settings, the device functions as a standard infusion set with an integrated safety component. It does not involve electronic processing, software, or automated analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular infusion set with passive needle safety shield. Mechanical design for port access. Sterile, single-use. No electronic components, software, or energy source.

Indications for Use

Indicated for patients requiring fluid/drug administration or blood sampling via implantable vascular ports. Designed for clinician use to facilitate access while providing passive needle shielding to prevent needlestick injuries.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Submission Summary (Full Text)

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SEP 2 9 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. John Stephens Chief Executive Officer AutoSafe-Reflex Incorporated 1025 Nine North Drive, Suite K Alpharetta, Georgia 30004\

Re: K090117

Trade/Device Name: AutoSafe-Reflex® Safety Huber Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: FPA, FMI Dated: September 3, 2009 Received: September 4, 2009

Dear Mr. Stephens:

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 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- Mr. Stephens

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); medical device rep. ting (reporting of medical device-related adverse events) (21 CFR 803); good manytfracting 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 531-51 -512 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Anise D. Watson for
Susan Runner, D.D.S., M.A.

Acting Division 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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K090117 AutoSafe-Reflex® Safety Huber Infusion Set

## 4. INDICATIONS FOR USE

KDFI

510(k) Number (if known): Unknown Device Name:

AutoSafe-Reflex® Safety Huber Infusion Set

Indications for Use:

AutoSafe Safety Huber Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implantable vascular ports Additionally, the passine needle safety shield is designed to help prevent needlestick injuries by shielding the needle between steps and after use.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cinthia L. Duarte

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

510(k) Number: 15994117