PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET

K972839 · Globe Ent., Inc. · FPA · Dec 17, 1997 · General Hospital

Device Facts

• Record ID: K972839
• Device Name: PROTOS 100ML BURETTE INFUSION SET/ PROTOS 150ML BURETTE INFUSION SET
• Applicant: Globe Ent., Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.

Device Story

PROTOS® Burette Infusion Set is a medical device designed for the controlled delivery of intravenous (I.V.) solutions. It features a burette chamber (100ml or 150ml capacity) allowing for precise measurement and administration of fluids. The device is intended for use in clinical settings by healthcare professionals, including physicians, nurses, or other licensed practitioners. It functions as a gravity-fed or pump-compatible delivery system to ensure accurate fluid volume administration to patients. The device facilitates therapeutic fluid management, helping clinicians maintain patient hydration, deliver medications, or provide nutritional support. It is a single-use, sterile, disposable component of an I.V. administration set.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Burette infusion set with 100ml or 150ml capacity. Gravity-fed fluid delivery system. Sterile, disposable, single-use construction. Class II device (Product Code: FPA).

Indications for Use

Indicated for the delivery of I.V. solutions in patients requiring intravenous therapy, administered by or on the order of a physician or licensed practitioner.

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

Mr. Stephen Y. Jan Product Manager Globe Enterprises, Incorporated 4930 Campbell Road Houston, Texas 77041

DEC 17 1997

Re: K972839 PROTOS® 100ml Burette Infusion Set/PROTOS® Trade Name: 150ml Burette Infusion Requlatory Class: II Product Code: FPA Dated: October 28, 1997 Received: October 29, 1997

Dear Mr. Jan:

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, Druq, 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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

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Page 2 - Mr. Jan

not affect any obligation 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 regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fida.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 972839

510(k) Number (if known):_ 长 972839

Device Name: PROTOS® Burette Infusion Set

Indications For Use:

For the delivery of I.V. solutions by or on the order of a physician or other licensed practitioner.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Cucurella

(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)