EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS

K991719 · Medimex Holfeld GmbH & Co. · CAZ · Aug 18, 1999 · Anesthesiology

Device Facts

• Record ID: K991719
• Device Name: EPISTAR/EPISTAR CSE SPINAL/EPIDURAL ANESTHESIA ADMINISTRATION SETS
• Applicant: Medimex Holfeld GmbH & Co.
• Product Code: CAZ · Anesthesiology
• Decision Date: Aug 18, 1999
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEDIMEX Epistar CSE kit is intended for administration of epidural anesthesia that may be combined with a spinal anesthetic. The MEDIMEX CSE kit is intended for single epidural anesthesia or for introduction of the MEDIMEX catheter in the CSE kit for continuous epidural catheterization duration of up to 72 hours. The CSE epidural needle is also intended to allow passage of a pencil point-spinal needle into the intrathecal space to provide anesthesia immediately before or after placement of the epidural needle, is intended only to provide epidural kit containing the conventional epistar epidural space for collection of the epidural space for up to 72 hours.

Device Story

The MEDIMEX Epistar/Epistar CSE kit is a procedural tray containing components for epidural and spinal anesthesia. The kit includes an epidural needle designed to allow the passage of a pencil-point spinal needle into the intrathecal space, enabling combined spinal-epidural (CSE) anesthesia. It also includes a catheter for continuous epidural anesthesia for up to 72 hours. The device is used by clinicians in a clinical setting to facilitate the administration of regional anesthesia. The kit components are used to access the epidural and intrathecal spaces; the clinician uses the output (access to the target space) to deliver anesthetic agents, thereby providing pain management or surgical anesthesia for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Procedural kit containing an epidural needle and a pencil-point spinal needle for intrathecal access, and a catheter for continuous epidural administration. Components are intended for single use. Sterilization is required for kit components.

Indications for Use

Indicated for patients requiring epidural anesthesia, combined spinal-epidural (CSE) anesthesia, or continuous epidural catheterization for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1999

Mr. Donald F. Grabarz Medimex Holfeld GMBH & CO. c/o International Regulatory Consultants, L.C. Mid Valley Professional Plaza 7651 S. 700 West, Suite 105 Salt Lake City, UT 84047-7101

Re: K991719 MEDIMEX Epistar/Epistar CSE Spinal/Epidural Anesthesia Kits Regulatory Class: II (two) Product Code: 73 CAZ Dated: May 17, 1999 Received: May 20, 1999

Dear Mr. Grabarz:

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 legally marketed predicate 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 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. 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices:

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Page 2 - Mr. Donald F. Grabarz

with the Current Good Manufacturing Practice requirements, as set
with the Current Att Custom Rogulation (OS) for Medical Devices: with the Current Good Manufacturing Fractice roquest
forth in the Quality System Regulation (QS) for Medical Devices:
Christian (2) CER Bart R201 and that, through periodic forth in the Quality System Regulation (QS) for hourseriodic QS
General regulation (21 CFR Part 820) and that, through periodic Q5 comply w leron and the mail on (2) CR Part 820) and that, below to comply with
General regul FDA werify such assumptions. Failure to comply with inspections, FDA will verify such assumplies. Frances of the GMP of the GMP of the GMP of the the GMP regulation may result in fegulatory docem.
Food and Drug Administration (FDA) may publish further announcements: this Food and Drug Administration (EDA) May pabzen. Prease note:
concerning your device in the Federal Register. Please not affe concerning your device in the Federal Register. Trease not affect any
response to your premarket notification submission does not affect any
of the Act response to your premarket notifications 531 through 542 of the Act
obligation you might have under sections 531 through 542 of the Act obligation you might have under sections 351 through 002
for devices under the Electronic Product Radiation Control provisions,
The Section of Invesor Bogulations. for devices ander own or Regulations.
or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described This letter will allow you to begin marketing your and the manager substantial in your 510 (kinding of substantial ( in your 510(k) premarket notifically marketed predicate device
equivalence of your device to a legally marketed predicate your equivalence of your device to a legariy markeda post
results in a classification for your device and thus, permits your results in a classification for your device and on on on device to proceed to the market. It you are 801 and your device on the labeling regulation (2) crivices), please contact
additionally 809.10 for in vitro diagnostic devices), please contact additionally 809.10 for in vitto diagnoscio additionally, for the Office of Compliance at (301) 394 lovertising of your device, please in questions on the promotion and advertising of -general - and - please note
contact the Office of Compliance at [phone]. Also, please note contact the Office of Compliance at (301) of the mater the regulation entitled, "Misbranding by roal information on your notification" (21 CER 807.97) - Ocher general incom the Division of
responsibilities under the Act may be obtained from the (800) 638–20 responsibilities under the Act may be obcarned 2011 free number (800) 638–2041
Small Manufacturers at its internet address Small Manufacturers noblems internet address or [phone], 01 at 2007)
"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

'Voy Sepulken MD for

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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International Regulatory Consultants, L.C. MEDIMEX Holfeld GmbH & Co. Epistar / Epistar CSE 510(k)

Revised August 13, 1999

## Intended Ise:

- The MEDIMEX Epistar CSE kit is intended for administration of epidural anesthesia that may
need on the contraction of the MEDIMEX CSE enidural needle in the Epistar The MEDIMEX Epistar CSE kit is intended to administration in the Epistar
be combined with a spinal aneshetic. The MEDIMEX aresthesia or for introducti E.I be combined with a spinal ansthetic. CSE kit I is intended for single epidural infections for use enidural ansthesia, for
of the MEDIMEX catherer in the CSE kit for continuous epidural needle is also inten of the MEDIMEX catheter in the CSE Kit for continuous condum and our and on allow
catheterization duration of up to 72 hours. The CSE epidural needle is also intended to allo catheterization duration of up to 72 nouts. The CSL cpace to provide anesthesia
passage of a pencil point-spinal needle into the intratesal space to provide anesthesia passage of a pencil point-spinal needle into intrallect. The MEDIMEX Epistar
immediately before or after placement of the epidural parties only to provi immediately before or atter placement of the epiddral needle, is intended only to provide
epidural kit containing the conventional epistar epidural space for epidural kit containing the conventional epistal epistal collection of the epidural space for up to 72 hours.
J.A. Weatherspoon

ion of Cardiovascular, Respiratory, and Neurological Dev. 510(k) Number

-Prescription use