The B. Braun Perifix ONE® Pediatric Catheter is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery for pediatric patients within the subgroups of Child (2 to 12 years of age) and Adolescent (12 to 21 years of age). Routes of Administration include epidural and perineural (peripheral nerve block) with a duration of use no longer than 72 hours.

Device Description

B. Braun's Perifix ONE® Pediatric Catheter is a coextruded anesthesia conduction catheter consisting of an inner layer of polyamide and an outer layer of polyurethane. The catheters will be available in 20 Ga. and 24 Ga. diameters. The 20 Ga. catheter will have a length of 1010 millimeters and the 24 Ga. catheter will have a length of 720 millimeters. The catheters are designed in a rounded closed tip configuration with six side ports for distribution of anesthetics and analgesics. Both catheters will have depth markings beginning within 2 millimeters from the tip of the catheter and ending at approximately 180 millimeters from the tip. The product is an individually packaged, sterile, non-pyrogenic, single use disposable device.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga." It focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria or reporting performance from a clinical study. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided based on the input:

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

Cannot be provided: This document does not define specific performance acceptance criteria for the device itself (e.g., sensitivity, specificity, accuracy for a diagnostic device) or report performance metrics from a study that would demonstrate it meets such criteria. The "tests" mentioned are likely bench tests to demonstrate equivalence in materials, design, and manufacturing process, not clinical performance measures.

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

Cannot be provided: This document does not describe a "test set" in the context of clinical performance evaluation (e.g., patient data for an AI algorithm). The safety and effectiveness of the device were demonstrated through "a variety of tests" to show substantial equivalence to predicate devices, which typically refer to bench or engineering tests, not a clinical study involving a test set of patient data.

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)

Cannot be provided: There is no mention of a "test set" requiring ground truth established by experts.

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

Cannot be provided: There is no mention of a "test set" requiring 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

Cannot be provided: This document describes a physical medical device (catheter) and its substantial equivalence to existing devices. It does not involve AI or human "readers" in the context of a diagnostic or interpretive task. Therefore, an MRMC study is not relevant, and no information on AI assistance is available.

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

Cannot be provided: This device is a physical catheter, not an algorithm.

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

Cannot be provided: As this is not a diagnostic device or an AI algorithm, the concept of "ground truth" in this context is not applicable. The "ground truth" for showing the device works would be its physical properties, biocompatibility, and ability to deliver anesthetics/analgesics, which are typically assessed through engineering and bench testing, not expert consensus on diagnostic interpretations.

8. The sample size for the training set

Cannot be provided: There is no training set for this device, as it is a physical product and not an AI/ML algorithm.

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

Cannot be provided: There is no training set or ground truth in this context.

Summary of Relevant Information from the Document:

The document concerns the Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga. The submission is a 510(k) Premarket Notification seeking to demonstrate substantial equivalence to existing predicate devices.

Demonstration of Safety and Effectiveness: "The Perifix ONE® Pediatric Catheter has been subjected to a variety of tests to demonstrate substantial equivalence to the three predicate devices and to demonstrate the safety and effectiveness of the proposed device." While these "tests" are mentioned, no specific details about their nature, methods, results, or acceptance criteria (in terms of clinical performance) are provided in the extracted text. These tests typically include biocompatibility, sterility, material strength, flow rates, and other engineering specifications to ensure the device performs as intended and is safe.

In conclusion, this document is a regulatory submission focused on proving substantial equivalence for a physical medical device, not a study evaluating acceptance criteria or performance of an AI or diagnostic tool. Therefore, much of the requested information is not applicable or available within the provided text.

Summary

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Kogossy

March 27, 2009

B. Braun Medical Inc. 510(k) Premarket Notification Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga.

510(k) SUMMARY ડ.

JUN 2 9 2009

APPLICANT/ SUBMITTER:

B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500

Contact: Angela J. Caravella Sr. Regulatory Affairs Analyst Phone: 610-596-2966 Fax: 610-596-2502 E-mail: Angela.Caravella@bbraun.com

DEVICE NAME:

Perifix ONE® Pediatric Catheter, 20 Ga. & 24 Ga.

Pediatric Nerve Block/ Epidural Catheter

Class II, Product Code BSO, 21 CFR 868.5120

COMMON OR USUAL NAME:

DEVICE CLASSIFICATION:

PREDICATE DEVICES:

DESCRIPTION:

B. Braun Medical Regional Anesthesia Catheter (K042488), Smiths Medical ASD, Inc. Portex @ 24 Ga. Pediatric Epidural and Peripheral Block Anesthesia Catheter (K033080) PAJUNK Pediatric epidural catheter (K062902)

B. Braun's Perifix ONE® Pediatric Catheter is a coextruded anesthesia conduction catheter consisting of an layer of polyamide and an outer layer of inner polyurethane. The catheters will be available in 20 Ga. and 24 Ga. diameters. The 20 Ga. catheter will have a length of 1010 millimeters and the 24 Ga. catheter will have a length of 720 millimeters. The catheters are designed in a rounded closed tip configuration with six side ports for distribution of anesthetics and analgesics. Both catheters will have depth markings beginning within 2 millimeters from the tip of the catheter and ending at approximately 180 millimeters from the tip. The product is an individually packaged, sterile, non-pyrogenic, single use disposable device.

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B. Braun Medical Inc. 510(k) Premarket Notification

Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga.

INTENDED USE:

SUBSTANTIAL EQUIVALENCE:

The Perifix ONE® Pediatric Catheter is similar in design, function, and intended use to the predicate device, the currently marketed B. Braun Medical Inc. Regional Anesthesia Catheter. The Perifix ONE® Pediatric Catheter and the B. Braun Regional Anesthesia Catheter have a similar intended use since they both provide infusion of local anesthetics and analgesics to the epidural space or near a nerve.

The Perifix ONE® Pediatric Catheter and the B. Braun Regional Anesthesia Catheter both are sterile, individually packaged, single use, disposable catheters. They are both composed of the same materials and components, have the same basic design and are manufactured using similar processes. The only difference between the Perifix ONE® Pediatric Catheter and the B. Braun Regional Anesthesia Catheter is designed for pediatric use among Children (2 to 12 years of age) and Adolescents (12 to 21 years of age). As a result of the pediatric use, the Perifix ONE Pediatric Catheters will also possess different catheter depth markings with the small gauge size of 20 and 24 Ga.

The Perifix ONE® Pediatric Catheter is also similar to the Smiths Medical ASD, Inc. Portex® 24 Ga. Pediatric Epidural and Peripheral Block Anesthesia Catheter. Both the proposed and this 24 Ga. predicate device are labeled for pediatric use and are intended for children (2 to 12 years of age). Both are used for providing infusion of local anesthetics and analgesics to the epidural space or peripherally.

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March 27, 2009

B. Braun Medical Inc. 510(k) Premarket Notification Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga.

SUBSTANTIAL EQUIVALENCE: (continued)

The Perifix ONE® Pediatric Catheter is also similar to the PAJUNK Pediatric Epidural Catheter. Both devices are intended for use within the pediatric population. The Perifix ONE® Pediatric Catheter and the PAJUNK Pediatric Epidural Catheter are both available in the 20 Ga. diameters for the infusion of local anesthetics and analgesics to the epidural space.

The Perifix ONE® Pediatric Catheter has been subjected to a variety of tests to demonstrate substantial equivalence to the three predicate devices and to demonstrate the safety and effectiveness of the proposed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 29 2009

Ms. Angela J. Caravella Senior Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

Re: K090884

Trade/Device Name: Perifix ONE® Pediatric Catheter, 20 Ga. & 24 Ga. Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: March 27, 2009 Received: March 31, 2009

Dear Ms. Caravella:

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 classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Ms. Caravella

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Susan Fraser

Susan Runner, D.D.S., M.A. Acting 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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B. Braun Medical Inc. 510(k) Premarket Notification: Perifix ONE® Pediatric Catheter, 20 Ga. and 24 Ga.

INDICATIONS FOR USE STATEMENT 4.

510(k) Number (if known):

Device Name:

Perifix ONE® Pediatric Catheter, 20 Ga. & 24 Ga.

Indications For Use:

Prescription Use _ X (Per 21 CFR 801.109)

Over-The-Counter Use

March 27, 2009

Page

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sver Pearson

Division Sign-Off) ·vision of Anesthesiology, General Hospital · ection Control, Dental Devices

0(k) Number: K01084

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).