SIMS PORTEX ANESTHESIA CATHETER

K994275 · Sims Portex, Inc. · FRN · Feb 22, 2000 · General Hospital

Device Facts

• Record ID: K994275
• Device Name: SIMS PORTEX ANESTHESIA CATHETER
• Applicant: Sims Portex, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Feb 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Roures of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.

Device Story

Flexible nylon catheter; closed-end with lateral eyes or open-ended with finished tip; includes depth markings (1-20 cm). Used for infusion of anesthetics, analgesics, or narcotics into intraoperative sites for pain management. Operated by clinicians; may be used with infusion pumps. Provides delivery path for medication; facilitates post-operative pain control. Not for IV or IM use. Provided sterile; may include stylet, catheter connector, or insertion device.

Clinical Evidence

No clinical data. Bench testing only: dimensional characteristics, flow rate, leakage, hub/catheter detachment, tensile strength, elongation, ETO residuals, and biological safety per ISO 10993.

Technological Characteristics

Flexible nylon tubing; 21g (0.033" OD / 0.019" ID); 38-inch nominal length. Features depth markings. Sterile. Evaluated per ISO 10993 for biological safety.

Indications for Use

Indicated for infusion of local anesthetics or narcotics into intraoperative sites for post-operative pain management and regional anesthesia outside the epidural space. Routes include intraoperative or percutaneous. Contraindicated for intravenous or intramuscular use.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• SIMS Portex Inc., Epidural Catheter (K992471)
• B. Braun Medical Inc., PERIFIX® Epidural Catheter Set, EC20-C (K813186)

Submission Summary (Full Text)

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K994275

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FEB 2 2 2000

# 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 Director of Regulatory Compliance

#### PREPARATION DATE OF SUMMARY:

February 16, 2000

## TRADE NAME:

SIMS Portex Anesthesia Catheter

#### COMMON NAME:

Anesthesia Conduction Catheter

### PRODUCT CLASS/CLASSIFICATION:

Class II, 79 MEB, accessory to 21 CFR 880.5725 (infusion pump)

#### SIMS Portex Inc.

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

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#### PREDICATE DEVICE(S):

SIMS Portex Inc., Epidural Catheter; 4910-18, 21g nylon, closed-end, three-eyed This device is marketed under 510(k), K992471.

- B. Braun Medical Inc., PERIFIX® Epidural Catheter Set, EC20-C This device is marketed under 510(k), K813186 and the indications for use are as specified in I-Flow Corporation's 510(k)s, K980558 and K991543.
#### DESCRIPTION:

The SIMS Portex Anesthesia 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 as 21g (O.D. .033"/I.D. .019"). 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, analgesics, and/or narcotics. The catheter may be used in conjunction with an infusion pump. The catheter may be used, outside of the epidural space, for up to 30 days. An insertion device may be provided to aid the placement of the catheter into the introducer needle. They are provided sterile in individual packages or as a component of a regional anesthesia procedure tray (K965017).

#### INDICATIONS FOR USE:

The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Roures of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.

### TECHNICAL CHARACTERISTICS:

The design of the catheter and materials are identical to our current catherer. The catheter has been evaluated and demonstrated equivalency to the predicate devices for the following dimensional and functional characteristics: ID, OD, length, flow rate, leakage, eye patency, tensile strength, percentage elongation, luer taper, and security of connection of the catheter to the catheter connector.

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#### NON-CLINICAL DATA:

Data submitted demonstrates that the catheter performs equivalently to the predicate devices. Data submitted covers; dimensional characteristics, flow rate, leakage, hub/catheter detachment, tensile strength, elongation, ETO residuals, and biological safety per ISO 10993.

## 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. Fallon

Timothy J. Talcott Director of Regulatory Compliance

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 2 2000

Mr. Timothy J. Talcott Manager, Regulatory Affairs SIMS Portex, Incorporated 10 Bowman Drive P.O. Box 0724 Keene, New Hamphshire 03431

Re : K994275 SIMS Portex Anesthesia Catheter Trade Name: Regulatory Class: II Product Code: FRN Dated: December 17, 1999 December 20, 1999 Received:

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 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 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 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 requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Talcott

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 our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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.fdag.gov/cdrh/dsmamain.html".

Sincerely yours,

U. Whitcomb

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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b
510(k) Number (if known): Unknown 13994275

Page 1 of 1

Device Name: Anesthesia Catheter

Indications For Use:

The SIMS Portex Anesthesia Catheter is indicated for the infusion of local anesthetics or narcotics into the intraoperative site for post operative pain management and for regional anesthesia, outside of the epidural space. Routes of administration may include intraoperative or percutaneous. The catheter is not intended for intravenous or intramuscular use.

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

510(k) Number.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use **__**

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
Controly 994225