SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18

K992471 · Sims Portex, Inc. · BSO · Oct 22, 1999 · Anesthesiology

Device Facts

• Record ID: K992471
• Device Name: SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18
• Applicant: Sims Portex, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Oct 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.

Device Story

The SIMS Portex Epidural Catheter is a flexible nylon tube used for the administration of local anesthetics or analgesics into the epidural space. It is available in 20g or 21g sizes with a nominal length of 38 inches, featuring a marked tip for depth indication (up to 20 cm). The catheter may be closed-ended with lateral eyes or open-ended and can include a stylet. It is provided sterile, either individually or as part of a continuous epidural procedure tray, and utilizes a catheter connector for drug delivery. The device is intended for use by healthcare professionals in clinical settings to facilitate regional anesthesia or pain management, providing a direct conduit for medication delivery to the epidural space.

Clinical Evidence

No clinical data. Bench testing only. Data provided includes dimensional characteristics, flow rate, compression resistance, hub/catheter detachment, deflection resistance, modulus of elasticity, tensile strength, elongation, ETO residuals, and biological safety per ISO 10993.

Technological Characteristics

Flexible nylon tubing; 20g (0.042" OD/0.023" ID) or 21g (0.033" OD/0.019" ID) sizes; 38-inch nominal length; marked tip for depth measurement; sterile; includes catheter connector; biocompatibility per ISO 10993.

Indications for Use

Indicated for patients requiring the injection of local anesthetics into the epidural space.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• SIMS Portex Inc. epidural catheters; 4910-16/17, 20g nylon, closed-end (Preamendment)
• SIMS Portex Inc. epidural catheters; 4910-18, 21g nylon, closed-end, three-eyed (Preamendment)

Reference Devices

• catheter connector (K965017)
• continuous epidural procedure tray (K965017)

Submission Summary (Full Text)

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K692471

Image /page/0/Picture/1 description: The image shows the logo for Smiths Industries Medical Systems. The logo is divided into two parts. The left side has the word "SIMS" in a stylized font, and the right side has the words "SMITHS INDUSTRIES" in a bold, sans-serif font above the words "Medical Systems" in a serif font.

OCT 222 1999

#### SIMS Portex Inc.

10 Bowman Drive PO Box 0724 Keene NH 03431 USA Telephone: [phone] Fax: [phone]

## H: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 510(K) SUMMARY:

#### COMPANY INFORMATION:

SIMS Portex Inc 10 Bowman Drive Keene, NH 03431 [phone] Contact: Timothy J. Talcott Manager, Regulatory Affairs

#### PREPARATION DATE OF SUMMARY:

July 23, 1999

TRADE NAME:

SIMS Portex Epidural Catheter

#### COMMON NAME:

Anesthesia Conduction Catheter

#### PRODUCT CLASS/CLASSIFICATION:

Class II, 73 BSO, 21 CFR 868.5120

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#### PREDICATE DEVICE(S):

SIMS Portex Inc. epidural catheters; 4910-16/17, 20g nylon, closed-end. three-eved 4910-18, 21g nylon, closed-end, three-eyed

These devices are marketed as 'Preamendment'.

#### DESCRIPTION:

The SIMS Portex Epidural Catheter is made of flexible, nylon tubing. The catheter may be closed-ended with lateral eyes or an open-ended catheter with finished tip. The tip of the catheter is marked. The catheter has a single mark at 5 cm from the tip with 1 cm increments, up to 20 cm. The 10 cm mark is indicated by two marks, 15 cm by three marks, and 20 cm by four marks.

The catheter is available in 20g (O.D. .042"/I.D. .023") or 21g (O.D. .033"/I.D. . 019") sizes. The catheters have a nominal length of 38 inches. The catheters may include a stylete.

The catheters are provided with a catheter connector (K965017) to provide a means of administration of anesthetics and/or analgesics. They are provided sterile in individual packages or as a component of a continuous epidural procedure tray (K965017).

#### INDICATIONS FOR USE:

The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.

#### TECHNICAL CHARACTERISTICS:

The design of the catheter is identical to the predicate device, accept for the change in material. This change in material has no affect on performance criteria, accept an increase in percent elongation.

#### NON-CLINICAL DATA:

Data submitted demonstrates that the epidural catheter performs equivalently to the predicate device. Data submitted covers; dimensional characteristics, flow rate, compression resistance, hub/catheter detachment, defection resistance modulus of elasticity, tensile strength, elongation, ETO residuals, and biological safety per ISO 10993.

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## CLINICAL DATA:

Not applicable

### CONCLUSION:

The comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.

Very truly yours,

SIMS PORTEX INC.

Timothy J. Talbott

Timothy J. Palcott Manager, Regulatory Affairs

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human figure in profile, with three flowing lines representing the body and head. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 1999

Mr. Timothy J. Talcott SIMS Portex Inc. 10 Bowman Drive Keene, NH 03431

K992471 Re: Epidural Catheter Requlatory Class: II (two) Product Code: 73 BSO Dated: July 23, 1999 Received: July 26, 1999

Dear Mr. Talcott:

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. The general controls provisions 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 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 Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Paqe 2 - Mr. Timothy J. Talcott

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/dsma/dsmamain.html".

Sincerely yours,

Jean A Welsh-fer,

Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# B: INTENDED USE OF DEVICE

## PROPOSED INDICATIONS FOR USE:

Page 1 of 1

510(k) Number (if known): Unknown

Device Name: Epidural Catheter

Indications For Use:

The SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use Prescription Use

ter Use

(Division Sign Off)

(Div Div sion of Cardiovascular, Respiratory, and Neurological Devi

510(k) Number K99247/

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