IVY DEVICES INC. IV/MEDICAL LINE STABILIZER

K033208 · Ivy Devices, Inc. · FPA · Mar 18, 2004 · General Hospital

Device Facts

• Record ID: K033208
• Device Name: IVY DEVICES INC. IV/MEDICAL LINE STABILIZER
• Applicant: Ivy Devices, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Mar 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The IV/Medical Line Stabilizer is non-sterile, single use, identified in 21 CFR 880.5440, as a medical device intended to be used by personnel who are most often in contact with pediatric patients that have intravenous lines or medical lines attached to them. The IV/Medical Line Stabilizer is made of latex-free food grade transparent plastic. The primary purpose of this device is to reduce the risk of intravenous and other medical line entanglement. The design of the IV Stabilizer helps prevent IV wraps or medical line(s) from entangling around itself and around the patient.

Device Story

The IV/Medical Line Stabilizer is a non-sterile, single-use plastic device designed to manage intravenous and medical lines. Used primarily by clinical personnel caring for pediatric patients, the device functions as a physical guide or organizer to prevent lines from wrapping around themselves or the patient. By maintaining line separation, the device reduces entanglement risks. It is a passive, mechanical device; no electronic or software components are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Latex-free, food-grade transparent plastic. Form factor: Designed for line stabilization/routing. Energy source: None (passive mechanical device). Sterility: Non-sterile. Connectivity: None.

Indications for Use

Indicated for pediatric patients with intravenous or medical lines to reduce the risk of line entanglement.

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.

Submission Summary (Full Text)

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 8 2004

Mr. William Reilly President IVY Devices, Incorporated P.O. Box 23241 Grande Prairie, Alberta Canada T8V-6X2

Re: K033208

Trade/Device Name: IVY Devices Incorporated IV/ Medical Line Stabilizer Regulation Number: 880.5440 Regulation Name: Intravascular powdered Fluid Injector Regulatory Class: II Product Code: FPA Dated: January 12, 2004 Received: January 20, 2004

Dear Mr. Reilly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have revels 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include convirements 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 (1 Writ), it may be adjust 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. Reilly

Please be advised that FDA's issuance of a substantial equivalence determination does not Flease of act PSG that 1 1971 b isbance on that your device complies with other requirements Incall that 1 DTT has made a aresulations administered by other Federal agencies. of the Act of ally I edelar states and segments, including, but not limited to: registration 1 od inust comply with an all all any labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 807), labelity systems (QS) regulation (21 CFR Part 820); and if requirences as set form in the quality 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) This letter wifi anow your to ocean mained of substantial equivalence of your device to a premarket notification. - The rice 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), If you desire speemie at 100 for your are 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 may obtain other generational and Consumer Assistance at its toll-free Driber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runne

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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### STATEMENT OF INDICATIONS FOR USE

# 510(k) Number: Ko33208

#### Device Name: IVY Devices Inc. IV/Medical Line Stabilizer

The IV/Medical Line Stabilizer is non-sterile, single use, identified in 21 CFR 880.5440, as a medical device intended to be used by personnel who are most often in contact with pediatric patients that have intravenous lines or medical lines attached to them. The IV/Medical Line Stabilizer is made of latex-free food grade transparent plastic. The primary purpose of this device is to reduce the risk of intravenous and other medical line entanglement. The design of the IV Stabilizer helps prevent IV wraps or medical line(s) from entangling around itself and around the patient.

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William Reilly

September 26, 2003

Date

033208

Pre-market Notification (510K Number)

Rene Nerean Interim Branch Chief
(Division Sign-Off)

Division of Sign-Off
Infection of Anesthesiology, General Hospital, The Control of Anesthesiology, Gental Device

510(k) Number: K133208

Prescription Use