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.

Device 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Portex® 24g Pediatric Epidural and Peripheral Block Anesthesia Catheter. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with a specific study design and data.

Therefore, most of the requested information cannot be directly extracted from this document, as it outlines a regulatory submission process based on non-clinical data and comparison to predicates.

Here's an attempt to answer based on the available information, noting where data is not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for each performance metric, as it's a 510(k) submission relying on substantial equivalence to predicate devices. Instead, it states that the device's characteristics "fall within the values of the predicate Portex catheters and the B. Braun catheter."

The "reported device performance" is essentially that it performs equivalently to predicate devices across various non-clinical tests.

Performance Metric	Acceptance Criteria (Implicit from Equivalence)	Reported Device Performance
Dimensional Characteristics	Within values of predicate devices (K962696, K924541)	Data submitted demonstrates equivalence to predicate devices.
Flow Rate	Within values of predicate devices	Data submitted demonstrates equivalence to predicate devices.
Compression Resistance	Within values of predicate devices	Data submitted demonstrates equivalence to predicate devices.
Hub/Catheter Detachment	Within values of predicate devices	Data submitted demonstrates equivalence to predicate devices.
Deflection Resistance	Within values of predicate devices	Data submitted demonstrates equivalence to predicate devices.
Modulus of Elasticity	Within values of predicate devices	Data submitted demonstrates equivalence to predicate devices.
Tensile Strength	Within values of predicate devices (K924541)	Data submitted demonstrates equivalence to predicate devices.
Elongation	Within values of predicate devices (K924541)	Data submitted demonstrates equivalence to predicate devices.
Biocompatibility	Materials identical to predicate (K992471), ink identical to predicate (K935927)	Data submitted demonstrates equivalence (materials and ink).
Sterilization	Identical to predicate (K992471)	Data submitted demonstrates equivalence.
Packaging	Identical to predicate (K992471)	Data submitted demonstrates equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the sample sizes for the non-clinical tests (e.g., how many catheters were tested for flow rate, tensile strength, etc.).
Data Provenance: The data is presented as "Non-Clinical Data" submitted by Smiths Medical ASD, Inc., located in Keene, NH, USA. The document doesn't specify if the testing was done internally or by a third-party, nor does it explicitly state the country of origin of the raw data. It is inherently prospective in the sense that the sponsor conducted these tests specifically for this 510(k) submission on the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the submission relies on non-clinical engineering and material testing data, not expert-adjudicated clinical data to establish a "ground truth" for a test set. The "ground truth" here is the performance metrics themselves, measured against engineering specifications or comparison to predicate devices, not subjective expert assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable for the same reasons as #3. There was no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This is a submission for a physical medical device (catheter), not an AI/software device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the measured physical, mechanical, and material properties of the device, confirmed through standard engineering and laboratory testing, and compared against the known properties of the predicate devices. This includes dimensional characteristics, flow rate, mechanical resistances (compression, deflection), material strengths (tensile, elongation), and material compatibility (biocompatibility).

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of this 510(k) submission, which is based on demonstrating substantial equivalence through non-clinical testing, not machine learning or AI.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as #8.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K033080" written in a handwritten style. The text is oriented diagonally, starting from the bottom left and moving towards the upper right. The characters are slightly slanted, giving the impression of cursive writing, and the numbers are clearly distinguishable.

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: +1 603 352 3703 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 (603) 352-3812 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 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.

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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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three stylized wings.

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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:

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:

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
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.(b)
Classification. Class II (performance standards).