EPIDURAL CATHETER MODELS 1210/1200

K983125 · Rusch Intl. · CAZ · Nov 17, 1998 · Anesthesiology

Device Facts

• Record ID: K983125
• Device Name: EPIDURAL CATHETER MODELS 1210/1200
• Applicant: Rusch Intl.
• Product Code: CAZ · Anesthesiology
• Decision Date: Nov 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To administer to a patient conduction, regional, or local anesthesia.

Device Story

Epidural Catheter and accessories kit includes epidural catheter, stylet, threading aid, and connector. Components packaged in tray within paperboard box. Used by clinicians to administer conduction, regional, or local anesthesia to patients. Device facilitates delivery of anesthetic agents; clinical decision-making relies on provider administration of anesthesia via catheter. Benefits include localized anesthetic delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Kit includes epidural catheter, stylet, threading aid, and connector. Materials and design are equivalent to predicate devices.

Indications for Use

Indicated for the administration of conduction, regional, or local anesthesia to patients.

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.

Predicate Devices

• Aries (K840201)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a logo for Rusch International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). Above the logo is the number K983125. The logo is in black and white and features a bold, sans-serif font.

Tall Pines Park laffrev, NH 03452 603) 532-7706 AX [phone] or 6108

## 510 (k) Summary

#### Submitter Name, Address, and Date of Submission. 1.

Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452

[phone] Telephone: [phone] Facsimile: [e-mail] E-Mail:

Contact: Same as above

## Name of the Device, Common, Proprietary (if Known), and 2. Classification.

Classification Name: Anesthesia Conduction Kit

Common Name: Epidural Catheter Kit

Proprietary Name: Epidural Catheter and accessories

## Identification of the legally marketed device to which 3. the submitter claims equivalence.

The Epidural Catheter and accessories is substantially equivalent to the Aries (K840201).

#### Description of the Device. 4 .

The Epidural Catheter and accessories consists of an epidural, a stylet, a threading aid and a connector. The components are packaged in a tray. The tray is placed

{1}------------------------------------------------

in a paperboard box with an outer box.

#### Intended Use of the Device. 5.

The Epidural Catheter and accessories is a product used to administer to a patient conduction, regional, or local anesthesia.

### Summary of Technological Characteristics. 6.

The technological characteristics are the same as, or equivalent to, predicate devices in design use and materials.

{2}------------------------------------------------

Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 17 1999

Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452

Re: K983125 Epidural Catheter Models 1210/1200 Requlatory Class: II (two) Product Code: 73 CAZ Dated: September 1, 1998 Received: September 8, 1998

Dear Mr. Whitney:

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 qeneral 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 leqally 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

{3}------------------------------------------------

Page 2 - Mr. James R. Whitney

forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 requlation 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/dsma/dsmamain.html".

Sincerely yours,

Ath. A. Carlows L.

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

Enclosure

{4}------------------------------------------------

| 510(k) Number (if known): | K983125 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:___Epidural Catheter and accessories

Indications for Use:

To administer to a patient conduction, regional, or local anesthesia.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krave

| Prescription Use | <div> <span style="float: right;">✓</span> </div> |
|------------------|---------------------------------------------------|
|------------------|---------------------------------------------------|

is

OR

Over-The-Counter Use___________

(Per 21 CFR 801.109)