PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER

K033080 · Portex, Inc. · CAZ · Mar 10, 2004 · Anesthesiology

Device Facts

• Record ID: K033080
• Device Name: PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
• Applicant: Portex, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatric applications (children under 12 years, infants and neonates) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and peripheral blocks. The duration of use should not exceed 72 hours.

Device Story

The Portex 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is a flexible nylon tube used for the administration of anesthetics or analgesics. It features an open-ended, marked tip (1 cm increments up to 20 cm) and includes a stylet and catheter connector. The device is intended for use in clinical settings by healthcare professionals to provide regional anesthesia in pediatric patients. By facilitating continuous or intermittent drug delivery, the catheter enables pain management or anesthesia for up to 72 hours, potentially improving patient comfort and surgical outcomes.

Clinical Evidence

No clinical data. Bench testing only. Performance was validated through testing of dimensional characteristics, flow rate, compression resistance, hub/catheter detachment, deflection resistance, elasticity, tensile strength, and elongation.

Technological Characteristics

Flexible nylon catheter; 24g size (0.022" OD / 0.012" ID); 36-inch length. Features marked tip for depth indication. Includes stylet and connector. Sterile, single-use component of anesthesia conduction mini tray. Materials and ink are identical to previously cleared predicate devices.

Indications for Use

Indicated for pediatric patients (neonates, infants, children <12 years) requiring continuous or intermittent regional anesthesia, including epidural, caudal, and peripheral blocks. Duration of use limited 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.

Predicate Devices

• B. Braun Periflex Continuous Epidural Pediatric Tray (K962696)
• 16g and 18g Epidural Catheter kits (K992471)
• 23g Pediatric Epidural Minipack (K924541)
• 21g High Durometer Epidural Catheter (K935927)

Submission Summary (Full Text)

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MAR 1 0 2004

# smiths

Smiths Medical ASD, Inc.

Anesthesia and Safety Devices Division

10 Buwman Drive Keene NI103431-0724 USA [et: +] 403 352 3812 Fax: [phone] www.smiths-modical.com

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

#### 510(K) SUMMARY:

## COMPANY INFORMATION:

Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 [phone] Contact: Cynthia Engelhardt Technical Writer, Regulatory Affairs

## PREPARATION DATE OF SUMMARY:

March 94, 2004

#### TRADE NAME:

Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter

## COMMON NAME:

Anesthesia Conduction Catheter

# PRODUCT CLASS/CLASSIFICATION:

Class II, 73 BSO, 21 CFR 868.5120

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#### PREDICATE DEVICE(S):

Predicate 1: The B. Braun Periflex Continuous Epidural Pediatric Tray, K962696. This is the main predicate device cited for catheter size, design characteristics and indication for use.

Predicate 2: Our current 16g and 18g Epidural Catheter kits, K992471. This predicate device is cited, in conjunction with Predicate 1 above for materials, biocompatibility, sterilization and packaging.

Predicate 3: Our 23g Pediatric Epidural Minipack, K924541. This predicate device is cited, in conjunction with Predicate 1 above for tensile strength and elongation.

Predicate 4: Our 21g High Durometer Epidural; Catheter, K935927. This predicate device is cited, in conjunction with Predicate 2 above for biocompatibility for the ink.

#### DESCRIPTION:

The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catherer is made of flexible, nylon tubing. The catheter is open-ended catheter with finished tip. The tipe 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 catherer is available in 24g (O.I). 0.022"/I.D. 0.012") size. The catheters have a nominal length of 36 inches. The catheter includes a stylet.

The catheters are provided with a catheter connector to provide a means of administration of anesthetics and/or analgesics. They are provided sterile as a component of a continuous anesthesia conduction catheter mini tray.

#### INDICATIONS FOR USE:

The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatric applications (children under 12 years, infants and necures) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and periodenal blocks. The duration of use should not exceed 72 hours.

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## TECHNICAL CHARACTERISTICS:

The design of the proposed catheter is similar to predicate 1 marketed under premarket notification K962696 by B. Braun and predicate 3 that we have authorization to market under premarket notification K924541 . The catherer material is identical to predicate 2 that we have authorization to market under premarket notification K965017. The loak is identical to predicate 4 that we have authorization to market under premarket not fination K935927. The technical characteristics of the characteristics fall within the values of the predicate Portex catheters and the B. Braun catheter.

## NON-CLINICAL DATA:

Data submitted demonstrates that the anesthesia conduction catheter performs equivalently to the predicate devices. Data submitted covers; dimensional characteristics, flow rate, compression resistance, hub/catheter detachment, deflection resistance mounts of elasticity, tensile strength, and elongation.

#### 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.

SMITHS MEDICAL ASD, INC.

Cynthia Errigott

Cynthia Engelhardt Technical Writer, Regulatory Affairs

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2004

Ms. Cindy Engelhardt Regulatory Affairs/Technical Writer Portex Incorporated 10 Bowman Drive Keene, NH 03431

Re: K033080

Trade Name: Portex 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthetic Conduction Kit Regulatory Class: II Product Code: CA7. Dated: February 18, 2004 Received: February 19, 2004

Dear Ms. Engelhardt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 classificd (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 – Ms. Cindy Engelhardt

CFR Part 807); labeling (21 ClFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K033080

Device Name: Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter

Indications for Use:

The Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter is designed for use primarily in pediatic applications (children under 12 years, infants and neonates) for continuous or intermittent regional anesthesia, e.g. epidural, caudal and peripheral blocks. The duration of use should not exceed 72 hours.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tAill

510(k) Number: