PERIFIX CATHETER CONNECTOR by B. BRAUN MEDICAL, INC.

A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 18 - 19 gauge Perifix catheter for delivery of anesthetics, The connector is used in conjunction with 18 - 19 gauge Perifix catheters for continuous administration of anesthetic agents.

Device Description

The Perifix Catheter Connector is a connecting device used to connect an anesthesia conduction catheter (most commonly an epidural or nerve block catheter) to a luer device for the administration of anesthetic fluids. Catheter connectors are commonly used in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector will be available in two different configurations. The first configuration is the one cleared in 510(k) K022019. This new configuration is the same as the previously cleared device except it has a slightly larger inner diameter to more easily accept 18 - 19 gauge Perifix catheters, and the device is made with clear/translucent materials to easily distinguish it from the first configuration which is yellow.
The Perifix Catheter Connector is approximately 1.77 inches long and 0.43 inches in diameter. The connector consists of a luer device on one end for the attachment of a mating luer device, a threading hole, compressible catheter channel and hinged clamp mechanism.

AI/ML Overview

This looks like a 510(k) summary for a medical device that has been cleared based on substantial equivalence to a predicate device, rather than a device requiring a clinical study with acceptance criteria and performance data.

Therefore, most of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) is not applicable or present in this document.

Here's a breakdown based on the provided text:

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

Not Applicable. This document describes a medical device (Perifix® Catheter Connector) that received 510(k) clearance by demonstrating substantial equivalence to a previously cleared predicate device (B. Braun Medical Inc.; Perifix Catheter Connector; K022019). Substantial equivalence means the new device is as safe and effective as the predicate device and does not raise new questions of safety or effectiveness. This process generally does not involve establishing specific performance acceptance criteria and conducting a new study to prove those criteria are met in the same way a novel high-risk device or a device making new performance claims might. The changes are described as "minor" and not raising new issues of safety or efficacy.
- Description of Changes:
  - Slightly larger inner diameter to more easily accept 18 - 19 gauge Perifix catheters.
  - Made with clear/translucent materials (vs. yellow components for the predicate device).

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

Not Applicable. No test set or clinical study data is presented for this substantial equivalence determination.

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)

Not Applicable. No ground truth establishment was performed, as no clinical test set data is presented.

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

Not Applicable. No test set adjudication was performed.

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

Not Applicable. This device is a physical connector, not an AI-powered diagnostic or assistive device. Therefore, no MRMC study or AI-related effectiveness study was performed.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

Not Applicable. No ground truth data was used as this was a substantial equivalence determination based on device design comparison.

8. The sample size for the training set

Not Applicable. This is a physical medical device; there is no training set as would be found with an AI/ML algorithm.

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

Not Applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for one.

Summary of what the document does state:

Device: Perifix® Catheter Connector
Predicated On: B. Braun Medical Inc.; Perifix Catheter Connector; K022019
Key Differences from Predicate:
- Slightly larger inner diameter to accept 18 - 19 gauge Perifix catheters more easily.
- Made with clear/translucent materials (predicate had yellow components).
Conclusion: These minor changes do not raise any new issues of safety or efficacy, hence the device is substantially equivalent to the predicate.

Summary

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OCT = 1 2003

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510(k) Summary

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2597Contact: Amy Smith, RA Specialist
DEVICE NAME:	Perifix® Catheter Connector
COMMON OR USUALNAME:	Anesthesia Catheter Connector
DEVICECLASSIFICATION:	Class II per Code of Federal Regulations, Title 21, § 868.5120 -Anesthesia Conduction Catheter, 868.5140 - - AnesthesiaConduction Catheter Kit
PREDICATE DEVICE:	B. Braun Medical Inc .; Perifix Catheter Connector; K022019
DESCRIPTION:	The Perifix Catheter Connector is a connecting device used toconnect an anesthesia conduction catheter (most commonly anepidural or nerve block catheter) to a luer device for theadministration of anesthetic fluids. Catheter connectors arecommonly used in epidural anesthesia kits and nerve block kits.
	The Perifix Catheter Connector will be available in two differentconfigurations. The first configuration is the one cleared in 510(k)K022019. This new configuration is the same as the previouslycleared device except it has a slightly larger inner diameter to moreeasily accept 18 - 19 gauge Perifix catheters, and the device ismade with clear/translucent materials to easily distinguish it fromthe first configuration which is yellow.
	The Perifix Catheter Connector is approximately 1.77 inches longand 0.43 inches in diameter. The connector consists of a luerdevice on one end for the attachment of a mating luer device, athreading hole, compressible catheter channel and hinged clampmechanism.
INTENDED USE:	A connection device used to provide various anesthetic and fluidadministration devices with a single, common access point to 18 -19 gauge Perifix catheter for delivery of anesthetics. Theconnector is used in conjunction with 18 - 19 gauge Perifixcatheters for continuous administration of anesthetic agents.

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SUBSTANTIAL EQUIVALENCE:

The Perifix® Catheter Connector is substantially equivalent to the B. Braun Medical Inc. Perifix Catheter Connector, K022019. The Perifix Catheter Connector will be available in two different configurations. The first configuration is the one cleared in K022019. The new configuration is the same as the predicate device except it has a slightly larger inner diameter to more easily accept 18 - 19 gauge Perifix catheters, and the device is made with clear/translucent materials to easily distinguish it from the first configuration which has yellow components. These minor changes do not raise any new issues of safety or efficacy.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2003

Ms. Amy Smith Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K032144

Trade/Device Name: Perifix Catheter Connector Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSO Dated: June 10, 2003 Received: June 14, 2003

Dear Ms. Smith:

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 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.

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Page 2 -Ms. Smith

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); 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,

Susan Runyon

Susan Runner, DDS, MA Interim 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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2.0 Indications for Use Statement

Page

KO32144 510(k) Number (if known): Perifix® Catheter Connector Device Name:

Indications For Use:

DAu

Division Sian-Off on of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: K03Z144

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (Per 21 CFR 801.109)

Over-The-Counter Use

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).