(123 days)
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Not Found
No
The 510(k) summary describes a mechanical device (infusion set) and makes no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML.
No
The device is used to administer fluids and withdraw blood from vascular ports, facilitate safe needle removal, and inject contrast media. While these actions are part of medical treatment, the device itself doesn't directly treat a disease or condition; it's an accessory to therapeutic or diagnostic procedures.
No
The device is described as an infusion set used for administering fluids, withdrawing blood, and injecting contrast media, none of which indicate a diagnostic function. Its purpose is for access and delivery, not for identifying a disease or condition.
No
The device description and intended use clearly describe a physical medical device (infusion sets) and its function, with no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood from the patient, and for power injection of contrast media into the patient.
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
This device is used on the patient for direct access to the vascular system, which is an in vivo application, not an in vitro one.
N/A
Intended Use / Indications for Use
The All Safe Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The All Safe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries. The All Safe Huber Safety Infusion Sets are also indicated for power injection of contrast media into the central venous system with implanted vascular ports indicated for power injection. The maximum recommended infusion rate at 11.8 cps is 5 ml/sec for 19 and 20 gauge. Maximum pressure is 325 psi for all gauge sizes.
Product codes
FPA
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
central venous system, vascular ports
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2015
Nexus Medical, LLC Ms. Heather Turner Director of Quality and Regulatory 11315 Strang Line Road Lenexa, KS 66215
Re: K142590
Trade/Device Name: All Safe Huber Safety Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: December 15, 2014 Received: December 17, 2014
Dear Ms. Turner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing 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 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142590
Device Name All Safe Huber Safety Infusion Sets
Indications for Use (Describe)
The All Safe Huber Safety Infusion Sets are used to access surgically implanted vascular ports for the administration of fluids and withdrawal of blood. The All Safe Huber Safety Infusion Sets facilitate the safe removal of the needle and may aid in the prevention of needle stick injuries. The All Safe Huber Safety Infusion Sets are also indicated for power injection of contrast media into the central venous system with implanted vascular ports indicated for power injection. The maximum recommended infusion rate at 11.8 cps is 5 ml/sec for 19 and 20 gauge. Maximum pressure is 325 psi for all gauge sizes.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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