TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET

K111351 · Us Infusion Dba Truecare Biomedix · FPA · Sep 29, 2011 · General Hospital

Device Facts

• Record ID: K111351
• Device Name: TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET
• Applicant: Us Infusion Dba Truecare Biomedix
• Product Code: FPA · General Hospital
• Decision Date: Sep 29, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Truecare Biomedix Intravascular Administration Set is a sterile, non-DEHP PVC tubing system designed to deliver intravenous fluids from a container to a patient. The device consists of a universal spike for fluid containers, a drip chamber with a 15-micron particulate filter, and various tubing lengths. Optional components include dial-type flow regulators (5-250 ml/hr), roller clamps, slide clamps, luer locks, and in-line air-eliminating filters (0.2 or 1.2 micron). The device is used in clinical settings to facilitate fluid administration; it acts as a primary infusion line or an extension set. Healthcare providers operate the device to manage fluid flow rates and secondary medication administration via integrated Y-sites. The system provides a controlled, sterile pathway for fluid delivery, benefiting patients requiring intravenous therapy.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: ABS, non-DEHP PVC, EVA, polypropylene, silicone, cellulose acetate. Components: Universal spike with hydrophobic vent, drip chamber with 15-micron filter, variable-bore tubing (minibore, microbore, standard), dial flow regulators, roller/slide clamps, luer locks, Y-sites, and 0.2/1.2 micron air-eliminating filters. Connectivity: Standalone. Sterilization: Sterile/pyrogen-free.

Indications for Use

Indicated for the delivery of sterile infusion fluids from a container to a patient, or as an extension set for intravenous fluid delivery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Vitalcare 3 In 1 Tubing (K050906)

Submission Summary (Full Text)

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KIII321

SEP 2 9 2011

t

## SECTION 5

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# 510(K) SUMMARY

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## 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<br>2003 NW 79th Ave Miami, FL 33122<br>Tel: [phone] Fax: [phone] | Received |
| Submitter Contact: | Aaron Compton<br>US Infusion Inc dba Truecare Biomedix<br>Tel: [phone] Fax: [phone]<br>Email: [e-mail] | |
| 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

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#### Name & Model Numbers of Devices.

- 1. TCBINF001, Intravascular administration set
- 2. TCBINF002, Intravascular administration set with 0.2 micron filter
- 3. TCBINF003, Intravascular administration set with flow regulator
- 4. TCBINF004, Intravascular administration set with flow regulator, 0.2 micron filter
- 5. 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

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- 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

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#### 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

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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.

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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 [phone] or [phone] 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

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### 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: