VENTED I.V. SET

K965027 · Jms Co., Ltd. · FPA · Jun 24, 1997 · General Hospital

Device Facts

• Record ID: K965027
• Device Name: VENTED I.V. SET
• Applicant: Jms Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is connected between a patient and a container of administrated solution, and is used for gravity feed infusion into a patient's vascular system for medical use and is intended for single use only.

Device Story

Vented I.V. set facilitates gravity-driven delivery of medical solutions from a container to a patient's vascular system. Device consists of tubing, a vented spike for container access, and flow control components. Operated by clinicians in clinical settings to administer fluids or medications. Output is the controlled flow of solution into the patient. Benefits include reliable, single-use fluid delivery for intravenous therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Gravity-fed I.V. administration set. Components include vented spike, flexible tubing, and flow control mechanism. Single-use, sterile device.

Indications for Use

Indicated for gravity feed infusion of solutions into the vascular system of patients requiring intravenous therapy. Intended for single use only.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Tetsukaru Hirose
Manager, CQA and Regulatory Affairs
JMS Company, LTD.
12,17 Kako-Machi, Naka-Ku
Hiroshima 730
Japan

Re: K965027
Trade Name: Vented I.V. Set
Regulatory Class: II
Product Code: FPA
Dated: April 23, 1997
Received: April 28, 1997

Dear Mr. Hirose:

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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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

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Page 2 - Mr. Hirose

(GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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 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 the labeling regulation (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 "[e-mail]".

Sincerely yours,

*Patricia Cucchi* / *JC*

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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Attachment D

# INDICATION FOR USE

510(k) Number: K965027

Device Name: Vented I.V. Set

Indications For Use: This device is connected between a patient and a container of administrated solution, and is used for gravity feed infusion into a patient's vascular system for medical use and is intended for single use only.

(PLEASE DO NOT WRITE THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off) Pultecca Cucerite
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number: K965027

Prescription Use ____ or Over - The - Counter Use ____
(Per 21 CFR 801.109) (Optional Format 1-2-96)