(251 days)
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No
The summary describes a mechanical infusion set with a safety shield and does not mention any AI or ML components or functionalities.
No
Explanation: The device is an infusion set used for administering fluids and drugs and drawing blood, which are diagnostic and supportive functions, not directly therapeutic.
No
This device is described as an infusion set for administering fluids and drugs, and for blood sampling, through implantable vascular ports. This is a therapeutic and drug delivery function, not a diagnostic one.
No
The device description explicitly mentions a "Huber Infusion Set" and a "passive needle safety shield," which are physical hardware components. The intended use also describes the administration of fluids and drugs and blood sampling, which are physical actions performed by hardware.
Based on the provided information, the AutoSafe Safety Huber Infusion Set is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "administration of fluids and drugs as well as blood sampling through implantable vascular ports." This describes a device used for direct patient care and intervention, not for testing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
- Focus on Delivery and Safety: The description emphasizes fluid/drug administration, blood sampling, and needle safety, which are all characteristics of a medical device used for treatment and patient management.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. The AutoSafe Safety Huber Infusion Set does not fit this description.
N/A
Intended Use / 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.
Product codes
FPA, FMI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars above its head, representing the three levels of government: federal, state, and local. The text "U.S. DEPARTMENT OF HEALTH &" is visible on the left side of the logo, and the text "HUMAN SERVICES" is visible on the right side.
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 (800) 638-2041 or (301) 796-7100 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