(139 days)
No
The device description details a standard intravascular administration set with mechanical components for fluid delivery and flow control. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No.
The device's intended use is to deliver sterile infusion fluid from a container to the patient; it does not itself provide a therapeutic effect on the patient.
No
The device description clearly states its intended use is to "deliver sterile, infusion fluid from a container to the patient," which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple physical components made of various materials (ABS, PVC, EVA, silicone, PP) such as spikes, drip chambers, tubing, clamps, and filters, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to deliver sterile, infusion fluid from a container to the patient". This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The components described (spikes, drip chambers, tubing, clamps, luer locks, filters, Y-sites) are all consistent with devices used for intravenous fluid administration. There are no components or descriptions related to analyzing biological samples (like blood, urine, etc.).
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
- Reagents or assays.
Therefore, the Truecare Biomedix Intravascular administration set is a medical device for fluid delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Truecare Biomedix Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Truecare Biomedix infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Product codes
FPA
Device Description
US Infusion Inc dba Truecare Biomedix Intravascular administration/extension set is sterile/pyrogen free, non-DEHP PVC tubing with the following combination of components.
- a. Universal Spike. Universal spike is constructed from ABS material and has a hydrophobic vent for transfer of fluids from closed containers such as infusion bottles. The spike dimensions are variable to deliver fluid at 10, 15, 20 and 60 drops per ml. Alternatively, the spike may have a luer lock at one end which connects to non-DEHP tubing for the purposes of transporting intravenous fluids from a vial to the patient.
- b. Drip chamber with 15 micron filter. The drip chamber is constructed from non-DEHP PVC or EVA, is flexible and has inbuilt 15 micron particulate disc filter which filters solution passing through it.
- Non-DEHP PVC tubing. Variable length non-DEHP PVC tubing with C. differing ID/OD combinations to ensure tubing performance. Extension tubing shall have ID/OD combinations of 0.03"/0.05" (minibore), 0.01"/0.03" (microbore), various lengths; 7" to 60". Infusion tubing shall have ID of 0.1" and OD of 0.125". Various combinations of the above tubing shall be designed to deliver desired performance.
- d. Flow Regulator. A commercially available dial type flow regulator may be incorporated in-line to control the flow rate of infusion fluids. The flow regulator will provide standard graduations of 5ml/hr to a maximum of 250ml/hr. The flow regulator shall be constructed from medical grade ABS and medical grade silicone disc. Optionally, a rate restricted tubing may be also incorporated in the infusion set whereby the ID and length of the tubing has been calibrated to provide a specific flow rate at gravity pressure from liquid height of 36-40"
- Roller clamp. A roller clamp may be inserted in combination with the e. above components to control flow rate or to turn fluid flow on and off. Roller clamp shall be constructed from medical grade ABS plastic
- Slide clamp. A slide clamp may be inserted in combination with the f. above components to turn the fluid flow on and off. Slide clamp shall be constructed from medical grade ABS material.
- g. Luer locks. Female luer locks and male luer locks may be a part of the infusion set as required and shall be constructed from medical grade ABS or non-DEHP hard PVC or medical grade PP.
- h. Filters. In-line air eliminating filters may be incorporated into the infusion tubing. These filters will have pore size of 0.2 micron or 1.2 micron and shall be constructed from medical grade PVC or medical grade ABS and cellulose acetate membrane.
- Latex free "Y" site or pre-approved needleless "Y" site for secondary i. infusions or medication administration. The "Y" site shall be integrated in combination with the above components and shall be constructed from hard PVC or PP or ABS (all components are medical grade). In case of latex free "injection port", the material shall be medical grade silicone .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KIII321
SEP 2 9 2011
t
SECTION 5
:
510(K) SUMMARY
1
US Infusion Inc dba Truecare Biomedix 2003 NW 79th Ave Miami, FL 33122 USA
| Date Submitted: | February 1, 2011 | MAY 13 2011 |
|---|---|---|
| Submitted By: | US Infusion Inc dba Truecare Biomedix USA | |
| 2003 NW 79th Ave Miami, FL 33122 | ||
| Tel: 866-593-8444 Fax: 305-590-5537 | Received | |
| Submitter Contact: | Aaron Compton | |
| US Infusion Inc dba Truecare Biomedix | ||
| Tel: 972-422-2220 Fax: 305-590-5537 | ||
| Email: Acompton@tcbiomedix.com | ||
| Common Name of Device: | Intravascular Administration Set | |
| Predicate Device: | Vitalcare 3 In 1 Tubing (K050906) | |
| Panel: | General Hospital and Personal Use | |
| Product Code: | FPA | |
| Device Classification: | II |
Section 5 / Page 1
FDA CDRH DMC
2
Name & Model Numbers of Devices.
-
- TCBINF001, Intravascular administration set
-
- TCBINF002, Intravascular administration set with 0.2 micron filter
-
- TCBINF003, Intravascular administration set with flow regulator
-
- TCBINF004, Intravascular administration set with flow regulator, 0.2 micron filter
-
- TCBEXT001, Minibore extension set
Other Model Numbers and configurations may be assembled per customer request
Device Classification
- a. Set, Administration, Intravascular
- b. FPA
- c. 21CFR880.5440
- d. Device Classification II
Indications For Use
Truecare Biomedix Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Truecare Biomedix infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Design Features
US Infusion Inc dba Truecare Biomedix Intravascular administration/extension set is sterile/pyrogen free, non-DEHP PVC tubing with the following combination of components.
- a. Universal Spike. Universal spike is constructed from ABS material and has a hydrophobic vent for transfer of fluids from closed containers such as infusion bottles. The spike dimensions are variable to deliver fluid at 10, 15, 20 and 60 drops per ml. Alternatively, the spike may have a luer lock at one end which connects to non-DEHP tubing for the purposes of transporting intravenous fluids from a vial to the patient.
- b. Drip chamber with 15 micron filter. The drip chamber is constructed from non-DEHP PVC or EVA, is flexible and has inbuilt 15 micron particulate disc filter which filters solution passing through it.
- Non-DEHP PVC tubing. Variable length non-DEHP PVC tubing with C. differing ID/OD combinations to ensure tubing performance. Extension tubing shall have ID/OD combinations of 0.03"/0.05" (minibore), 0.01"/0.03" (microbore), various lengths; 7" to 60". Infusion tubing shall have ID of 0.1" and OD of 0.125". Various combinations of the above tubing shall be designed to deliver desired performance.
Section 5 / Page 2
3
- d. Flow Regulator. A commercially available dial type flow regulator may be incorporated in-line to control the flow rate of infusion fluids. The flow regulator will provide standard graduations of 5ml/hr to a maximum of 250ml/hr. The flow regulator shall be constructed from medical grade ABS and medical grade silicone disc. Optionally, a rate restricted tubing may be also incorporated in the infusion set whereby the ID and length of the tubing has been calibrated to provide a specific flow rate at gravity pressure from liquid height of 36-40"
- Roller clamp. A roller clamp may be inserted in combination with the e. above components to control flow rate or to turn fluid flow on and off. Roller clamp shall be constructed from medical grade ABS plastic
- Slide clamp. A slide clamp may be inserted in combination with the f. above components to turn the fluid flow on and off. Slide clamp shall be constructed from medical grade ABS material.
- g. Luer locks. Female luer locks and male luer locks may be a part of the infusion set as required and shall be constructed from medical grade ABS or non-DEHP hard PVC or medical grade PP.
- h. Filters. In-line air eliminating filters may be incorporated into the infusion tubing. These filters will have pore size of 0.2 micron or 1.2 micron and shall be constructed from medical grade PVC or medical grade ABS and cellulose acetate membrane.
- Latex free "Y" site or pre-approved needleless "Y" site for secondary i. infusions or medication administration. The "Y" site shall be integrated in combination with the above components and shall be constructed from hard PVC or PP or ABS (all components are medical grade). In case of latex free "injection port", the material shall be medical grade silicone .
Specification & Dimensions
US Infusion Inc dba Truecare Biomedix Intravascular Administration Set will have the following dimensional specifications:
- a. Infusion tubing OD = 4.1mm, ID = 3.0mm (approximately)
- b. Extension tubing regular bore OD = 2.7mm, ID = 1.6mm (approximately)
- c. Extension tubing minibore OD = 2.0mm, ID = 1.0mm (approximately).
- d. Extension tubing microbore OD = 1.6mm, ID = 0.6mm (approximately)
- Additional custom dimensions may be manufactured for customers e.
- Length may vary from 5" for extension set to 105" for primary infusion set f.
Materials Acrylonitrile Butadiene Styrene Non-DEHP Poly Vinyl Chloride Polypropylene Silicone
Section 5 / Page 3
4
Substantial Equivalence:
US Infusion Inc dba Truecare Biomedix Intravascular Administration Set is substantially equivalent to the predicate device, Vitalcare 3 In 1 Intravascular Infusion Sot. The component materials, indication for use, and SAL are substantially equivalent and present no additional safety concerns as compared to the predicate device.
Section 5 / Page 4
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol on the right and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the symbol. The caduceus symbol is composed of three curved lines that resemble a stylized bird or wing-like shape. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Aaron Compton COO US Infusion dba Truecare Biomedix 2003 NW 79" Avenue Miami, Florida 33122
SEP 2 9 2011
Re: K111351
Trade/Device Name: Truecare Biomedix Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 9, 2011 Received: September 9, 2011
Dear Mr. Compton:
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 and the state of the same of the states of the states of the states Register.
6
Page 2 – Mr. Compton
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K (1 | 35 |
Device Name:__Truecare Biomedix Intravascular Administration Set
Indications For Use:_Truecare Biomedix Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Truecare Biomedix infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Prescription Use. x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
K111351 Rhat C. Aye 9/28/4
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Section 4 / Page 1
KIII 351 510(k) Number: