TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

K990020 · Te ME NA S.A.R.L. · FMF · Jun 24, 1999 · General Hospital

Device Facts

• Record ID: K990020
• Device Name: TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC
• Applicant: Te ME NA S.A.R.L.
• Product Code: FMF · General Hospital
• Decision Date: Jun 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

THE LOSS OF RESISTANCE SYNINGE 15 INTENDED TO BE USED FOR THE DEFECTION AND CONFERMATION OF THE PLACEMENT OF THE ERIDORAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPINORAL ANDINESIAN THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY IT IS NOT INTENDED FOR ASPIRATION OR INVECTION,

Device Story

Loss of Resistance (LOR) syringe used by clinicians during epidural anesthesia procedures. Device facilitates identification of the epidural space by detecting the change in resistance encountered by the needle tip as it passes through the ligamentum flavum into the epidural space. Clinician applies manual pressure to the syringe plunger while advancing the needle; loss of resistance indicates successful placement. Device is a manual, non-powered instrument. Benefits include improved accuracy in needle localization for regional anesthesia.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual 10cc syringe designed for loss of resistance technique. Non-powered, mechanical device. No software or electronic components.

Indications for Use

Indicated for detection and confirmation of epidural needle placement in the epidural space prior to epidural anesthesia. Not for aspiration or injection.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 1999

TE ME NA S.A.R.L. c/o Mr. Donald F. Ryan 21981 U.S. 19N Clearwater, Florida 33765

K990020 Re : TE ME NA Loss of Resistance Syringe, 10CC Trade Name: Requlatory Class: II Product Code: FMF March 11, 1999 Dated: Received: April 5, 1999

Dear Mr. Ryan:

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 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. ਸ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Paqe 2 - Mr. Ryan

this response to your premarket notification Please note: 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 our 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 "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known): K 990020

Device Name: Loss OF RESISTANCE SYRINGE

Indications For Use:

THE LOSS OF RESISTANCE SYNINGE 15 INTENDED TO BE USED FOR THE DEFECTION AND CONFERMATION OF THE PLACEMENT OF THE ERIDORAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPINORAL ANDINESIAN THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY IT IS NOT INTENDED FOR ASPIRATION OR INVECTION,

(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)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Patricia Cascente

Division of Dental, Infection Cont and G eneral Hospital D 510(k) Number

EXHIBIT I