INTRAVASCULAR ADMINISTRATION SET

K121803 · Acta Medical, LLC · FPA · Dec 19, 2012 · General Hospital

Device Facts

• Record ID: K121803
• Device Name: INTRAVASCULAR ADMINISTRATION SET
• Applicant: Acta Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Dec 19, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

Device Story

Intravascular administration set delivers sterile infusion fluids from container to patient; includes tubing, universal spike, drip chamber with 15-micron filter, flow regulators, roller/slide clamps, luer locks, and optional air-eliminating filters (0.2 or 1.2 micron). Used in clinical settings for fluid administration; operated by healthcare professionals. Components include non-DEHP PVC, ABS, and silicone. Provides controlled fluid delivery via gravity or flow regulation. Benefits patient by enabling safe, sterile intravenous access and fluid/medication delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Sterile, pyrogen-free, non-DEHP PVC tubing. Components: ABS universal spike, PVC/EVA drip chamber with 15-micron filter, ABS/silicone flow regulator, ABS roller/slide clamps, PP/PVC/ABS luer locks, cellulose acetate membrane filters. Dimensions vary by model (ID 0.6mm to 3.0mm).

Indications for Use

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

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

• Truecare Biomedix Intravascular Administration Set (K111351)

Submission Summary (Full Text)

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Acta Medical, LLC

15 Minneakoning Road, Suite 203, Flemington, NJ 08822 USA

DEC 1 9 2012

K 121803

Date Submitted:

January 1, 2012

Submitted By:

Acta Medical, LLC 15 Minneakoning Road Suite 203, Flemington, NJ 08822 Fax: [phone] -Tel: [phone]

Submitter Contact:

Manufacturing Faility:

Acta Medical, LLC Fax: [phone] Tel: [phone]

Wei De Li Trade Co. Ltd. Li Xin Bridge Touqiao Township. Yangzhou City, Jiangsu Province. China Tel: [phone] Fax: [phone]

Common Name of Device:

Predicate Device:

Truecare Biomedix Intravascular Administration Set (K111351)

Panel:

General Hospital and Personal Use

Intravascular Administration Set

Product Code:

Device Classification:

II

FPA

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## Name & Model Numbers of Devices.

- 1. ACTINF001. Intravascular administration set
- 2. ACTINF002, Intravascular administration set with 0.2 micron filter
- 3. ACTINF003, Intravascular administration set with flow regulator
- 4. ACTINF004, Intravascular administration set with flow regulator, 0.2 micron filter
- 5. ACTEXT001, Minibore extension set

Other Model Numbers and configurations may be assembled per customer request

## Device Classification

- Set, Administration, Intravascular a.
- b. FPA
- c. 21CFR880.5440
- d. Device Classification II

## Indications For Use

Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

### Design Features

Acta Medical. LLC Intravascular administration set is sterile/pvrogen free. non-DEHP PVC tubing with the following combination of components.

- Universal Spike. Universal spike is constructed from ABS material and a. 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.
- Drip chamber with 15 micron filter. The drip chamber is constructed from b. non-DEHP PVC or EVA, is flexible and has inbuilt 15 micron particulate disc filter which filters solution passing through it.
- c. Non-DEHP PVC tubing. Variable length non-DEHP PVC tubing with 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

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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.
- Luer locks. Female luer locks and male luer locks may be a part of the g. infusion set as required and shall be constructed from medical grade ABS or non-DEHP hard PVC or medical grade PP.
- Filters. In-line air eliminating filters may be incorporated into the infusion h. 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.
- i. Latex free "Y" site or pre-approved needleless "Y" site for secondary 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

Acta Medical, LLC 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)
- Extension tubing minibore OD = 2.0mm, ID = 1.0mm (approximately) ﻦ ﺍﻟﻤﺮﺍﺟﻊ
- d. Extension tubing microbore OD = 1.6mm, ID = 0.6mm (approximately)
- e. Additional custom dimensions may be manufactured for customers
- 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 (non fluid pathway material, utilized in protective caps only) Silicone

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# Substantial Equivalence:

Acta Medical, LLC Intravascular Administration Set is substantially equivalent to the predicate device, Truecare Biomedix Intravascular Administration Set (K111351). Acta Medical utilizes the same contract manufacturer and manufacturing location (Wei De Li Trade Co. Ltd) as utilized by predicate device, identical component materials, identical indication for use, identical manufacturing process, identical sterilization process & SAL. Acta Medical Intravascular Administration Sets are identical to predicate device and present no additional safety concerns as compared to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three curved lines, symbolizing health and well-being.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

#### December 19, 2012

Mr. John Brewer President Acta Medical, Limited Liability Company 15 Minneakoning Road, Suite 203 FLEMINGTON NJ 08822

. Re: K121803

Trade/Device Name: Acta Medical Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 9, 2012 Received: November 9, 2012

Dear Mr. Brewer:

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.

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Page 2 - Mr. Brewer

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/ucm 115809.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 vours.

Anthony D. m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, 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): KILI803

:

.

Device Name: _ Acta Medical Intravascular Administration Set

Indications For Use: _ Acta Medical Intravascular administration set intended use is to deliver sterile infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|----------------------------------------------|---|
| AND/OR | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Digitally signed by Sajjad H. Syed

DN: c=US, o=U.S. Government,

ou=HHS, ou=FDA, ou=People,

cn=Sajjad H. Syed,

0.9.2342.19200300.100.1.1=2000601742

Date: 2012.12.19 17:12:27 -05'00'

| Sajjad H. Syed | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------------------------------|--------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices | |
| 510(k) Number: | K12 1803 |