MANAN BLUNT NEEDLE

K981386 · Manan Medical Products, Inc. · FPA · Jun 29, 1998 · General Hospital

Device Facts

• Record ID: K981386
• Device Name: MANAN BLUNT NEEDLE
• Applicant: Manan Medical Products, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

For simplifying insertion of a guide-wire and/or catheter through various ports(such as a Touhy-Borst) used in intravascular administration sets.

Device Story

Blunt needle designed to facilitate insertion of guide-wires or catheters into intravascular administration set ports, such as Touhy-Borst adapters. Used by clinicians in clinical settings to simplify access and reduce risk of accidental puncture or damage to ports during catheterization procedures. Device functions as a mechanical aid for vascular access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical blunt needle for intravascular access. No software, electronics, or complex materials specified.

Indications for Use

Indicated for simplifying insertion of guide-wires and/or catheters through ports (e.g., Touhy-Borst) in intravascular administration sets.

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

JUN 2 9 1998

Mr. Michael Plishka New Product Development Engineer MANAN Medical Products, Incorporated 2200 Carlson Drive Northbrook, Illinois 60062

K981386 Re : Manan Blunt Needle Trade Name: Regulatory Class: II Product Code: FPA Dated: April 9, 1998 Received: April 16, 1998

Dear Mr. Plishka:

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 The general controls provisions of the Act 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in regulatory 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 obligation you might have under sections 531 through 542 of

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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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timoth A. 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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510(K) Number (if known): K981386

Device Name:

Blunt Needle

Indications For Use:

For simplifying insertion of a guide-wire and/or catheter through various ports(such as a Touhy-Borst) used in intravascular administration sets.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Patricia Ciocinite

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

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