AB2 MED-FLO SOLUTION SET

K984569 · Ab2 Medical Products, Llp · FPA · Aug 12, 1999 · General Hospital

Device Facts

• Record ID: K984569
• Device Name: AB2 MED-FLO SOLUTION SET
• Applicant: Ab2 Medical Products, Llp
• Product Code: FPA · General Hospital
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The AB2 Med-Flo Solution Set is intended to be used to provide a sterile pathway from the solution source (I.V.bag) to the patient's intravascular catheter. The flow of the solution is accomplished by gravity flow.

Device Story

AB2 Med-Flo Solution Set provides sterile fluid pathway between I.V. bag and patient intravascular catheter. Operates via gravity flow; no active components. Used in clinical settings by healthcare professionals to facilitate fluid delivery. Device ensures sterile connection; maintains fluid path integrity during administration. Benefits patient by enabling controlled, sterile intravenous therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sterile, gravity-fed intravenous administration set. Consists of tubing and connectors designed to maintain a sterile fluid pathway from I.V. bag to catheter. No electronic components, software, or active energy sources.

Indications for Use

Indicated for patients requiring intravenous fluid administration via a sterile pathway from an I.V. bag to an intravascular catheter using gravity flow.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Arthur Chandler, III AB2 Medical Products, L.L.P. 52 Buttonbush Court The Woodlands, Texas 77380

K984569 Re: AB2 Med-Flo Solution Set Trade Name: Regulatory Class: II Product Code: FPA May 10, 1999 Dated: Received: May 19, 1999

Dear Mr. Chandler:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). *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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Chandler

This letter will allow you to begin marketing your device as Inis lecter will arrow you owns to notification. The FDA finding described in your siew. I pour device to a legally marketed of Subscantial equivalor a classification for your device and produce are arrants your device to the market. chus, Delmics your device for your device on our labeling II you desire bpcorre and additionally 809.10 for in vitro reguration (ar c.n), please contact the Office of Compliance at Glaghobere actrocery promally, for questions on the promotion and [phone]. Thanksvice, please contact the Office of advertibing or your acticle , Also, please note the regulation Compriance at [phone] - 1059 - 10 premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small under the Act may be obsainsits toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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K984569

510(k) Number: K984569 Devicc Name: AB2 Mcd-110 Solution Sct

## Indications l'or Use:

The AU2 Med-I'lo Solution Sct is intended to be used to provide a sterile pathway from the solution source (T.V.bag) to the patient's intravascular catheter. The flow of the solution is accomplisched i by gravity flow.

(Division Sign-Off) Monde lle
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. 1984567

Prescription Use (Per 21 CFR 801.109)

510(k) Number: K984569