(168 days)
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.
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.
I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) premarket notification letter from the FDA regarding a medical device called "IVY Devices Incorporated IV/Medical Line Stabilizer."
This type of document typically does not contain information about acceptance criteria, detailed study designs, sample sizes, expert qualifications, adjudication methods, or specific performance metrics of the device. Instead, it is an FDA letter confirming that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
The text focuses on regulatory compliance, product classification, and general information about the device's intended use (reducing entanglement of IV and medical lines in pediatric patients). It explicitly states that the device is "non-sterile, single use" and made of "latex-free food grade transparent plastic." It does not present any clinical study data or performance evaluations.
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Image /page/0/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle with three wing-like shapes and a wavy tail.
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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.
Image /page/2/Picture/4 description: The image shows a curved road with two lanes. The road appears to be winding, and there is a small object or marking on the side of the road. The road is surrounded by what appears to be a grassy or natural area.
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
§ 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.