LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526

K063239 · Hospira, Inc. · FPK · Dec 11, 2006 · General Hospital

Device Facts

• Record ID: K063239
• Device Name: LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
• Applicant: Hospira, Inc.
• Product Code: FPK · General Hospital
• Decision Date: Dec 11, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.

Device Story

LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are sterile, single-use medical devices designed to regulate the infusion rate of intravenous fluids. The device consists of non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut-off devices, CLAVE® ports, backcheck valves, and an air filter assembly. It incorporates a manual flow control mechanism with head height compensation to maintain consistent flow rates despite variations in fluid container height. The device is operated by healthcare professionals in clinical settings to deliver fluids to a patient's vascular system. By providing manual control and compensation, the device assists clinicians in managing infusion therapy, ensuring accurate fluid delivery to the patient.

Clinical Evidence

Bench testing only.

Technological Characteristics

Non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut-off devices, CLAVE® ports, backcheck valves, semi-rigid adapters, male adapter, air filter assembly. Manual flow control with head height compensation. Sterile, non-pyrogenic fluid path. Single-use.

Indications for Use

Indicated for patients requiring intravenous infusion where manual flow control of fluids from a container to the vascular system is desired.

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

• Dial-A-Flo® (PE)
• GraviTech™ Flow Controller Primary Set / GraviTech™ flow Controller Extension Set (K030467)

Submission Summary (Full Text)

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K0632399
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## 510(k) SUMMARY

| 1. | Submitted by: | Hospira, Inc.<br>D-389, Bldg. H2<br>275 N. Field Drive<br>Lake Forest, IL 60045<br>Attn: Diane Rennpferd | Phone: [phone]<br>Fax: [phone] |
|----|-----------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 2. | Date Prepared: | October 25, 2006 | |
| 3. | Name/Classification<br>of Device: | Fluid Delivery Tubing<br>Class II, 80-FPK, 21 CFR 880.5440 | |
| 4. | Trade Name of | LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets | |

#### 5. Predicate Devices:

Proposed Device:

| Device Name | 510(k) Number |
|-----------------------------------------------------------------------------------------|------------------------------|
| Dial-A-Flo® | PE |
| GraviTech™ Flow Controller<br>Primary Set / GraviTech™ flow<br>Controller Extension Set | K030467 (IV<br>Medical Inc.) |

#### 6. Proposed Device Description:

The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.

## 7. Statement of Intended Use:

The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.

### 8. Summary of Technological Characteristics of New Device Compared to Predicate Devices:

The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Set as described in this submission is substantially equivalent to the predicate LifeShield® Latex-Free Requiator I.V. Dial-A-Flo® set family with respect to the following characteristics:

### Similarities:

- · Intended for the delivery of fluids from a container to a patient's vascular system.
- · Provided with a sterile and non-pyrogenic fluid-path
- · Intended for one-time use
- · Technology and operating principles
- Method of sterilization
- · Similar materials of construction
- · Provides manual flow control

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K0632399
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Differences:

- · The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets will have head height compensation
The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Set will meet the functional The Enooming "Leaver Pros described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicates LifeShield® Latex-Free Regulator I.V. terms of Jubotantial oquralenoo coh™ Flow Controller Primary Set / GraviTech™ flow Controller Extension Set (cleared under K030467 to IV Medical Inc.)

The claim for substantial equivalence is supported by the information provided in the 510(k) submission.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diane Rennpferd Senior Associate, Global Regulatory Affairs Devices Hospira, Incorporated 275 North Field Drive Department 389, Building H2 Lake Forest, Illinois 60045

DEC 1 1 2006

Re: K063239

Trade/Device Name: LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: FPA, FPK Dated: October 25, 2006 Received: October 26, 2006

Dear Ms. Rennpferd:

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 such additional controls. Existing major regulations affecting vour 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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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. or the ret of with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (27 et read 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you dents of the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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)

063239

LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets Device Name:

Indications for Use:

The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

Sraell for m21

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Seniology, General Hospit ... Dartel Devices

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