A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 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 anesthesia and/or therapeutic fluids. Catheter connectors are commonly used in epidural anesthesia kits and nerve block kits.

The Perifix Catheter Connector is approximately 1.77 inches long and can accept B. Braun Medical Inc. 18 and 20 Ga. Standard Perifix Catheters. The connector consists of a luer device on one end for the attachment of a mating luer device. The rest of the device consists of a threading hole, catheter channel and hinged clamp mechanism.

AI/ML Overview

The provided text is a 510(k) summary for the Perifix® Catheter Connector. It establishes substantial equivalence to a predicate device and includes information about the device's description, intended use, and material changes. However, it does not contain information regarding detailed acceptance criteria, a specific study proving it meets those criteria, or any of the detailed study parameters requested in your prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

The 510(k) process for this type of device typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with detailed performance metrics as might be seen for novel or higher-risk devices. For simpler medical devices like a catheter connector, acceptance criteria and performance are often demonstrated through:

Bench testing: Verifying physical properties, connection strength, fluid integrity, and material compatibility.
Biocompatibility testing: As mentioned in the document, "The material has been biocompatibility tested in accordance with FDA Guidance #G-95 and ISO 10993." This is a key "acceptance criterion" for new materials.
Comparison to the predicate device: Showing that the new device performs similarly in its intended function.

Therefore, many of the specific questions in your prompt cannot be answered from the provided text.

Here's an analysis based on the information available in the submission:

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

The document does not explicitly present a table of acceptance criteria and reported device performance. The primary "performance" reported is its substantial equivalence to existing predicate devices (B. Braun Medical Inc.; Twist Lock Adapter Hub with Luer lock; K840287 and K840179).

The key acceptance criteria implicit in the submission are:

Similar Indications for Use: The Perifix Catheter Connector has "similar indications for use as the predicate device."
Biocompatibility: "The material has been biocompatibility tested in accordance with FDA Guidance #G-95 and ISO 10993." This implies that the material met the acceptance criteria for biocompatibility as defined by those standards.
Functional Equivalence: The design "is different only in that there is a hinged clamp mechanism for the insertion and retention of the catheter, instead of a twisting screwing motion," and these "minor changes do not raise any new safety or efficacy issues." This implies that despite a design change, the function remains equivalent and safe.

Without a detailed test report, specific quantitative performance metrics (e.g., connection force, leak rate) are not provided in this 510(k) summary.

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

This information is not provided in the 510(k) summary. The summary refers to "biocompatibility tested" but does not detail the sample sizes or the study design (retrospective/prospective). For bench testing verifying mechanical properties, specific sample sizes would have been used, but they are not reported here.

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 information is not applicable and not provided. This device is a mechanical connector, not an imaging or diagnostic device that would typically involve expert ground truth establishment in the way described. Biocompatibility testing is typically performed by certified labs according to established protocols, not by clinical "experts" in this context.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical or imaging studies involving human interpretation or subjective assessment.

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 information is not applicable. This device is a catheter connector, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies or AI improvement metrics are irrelevant.

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

This information is not applicable. The device 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 device would be established through engineering specifications and recognized standards for medical device connectors, as well as biocompatibility standards (e.g., ISO 10993). Performance is typically verified against these objective criteria rather than expert consensus or clinical outcomes data in a primary submission for this type of device.

8. The sample size for the training set

This information is not applicable and not provided. As a physical device, there is no "training set" in the context of machine learning or AI.

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

This information is not applicable and not provided.

Summary

{0}------------------------------------------------

K022019

;

AUG 01 2002

510(k) Summary

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2597Contact: Amy S. Krall, 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 -Anesthesia Conduction Catheter Kit
PREDICATE DEVICE:	B. Braun Medical Inc.; Twist Lock Adapter Hub with Luerlock; K840287 (Accu-Bloc Brachial Plexus AnesthesiaTray)K840179 (Accu-Bloc Epidural Anesthesia Tray)
DESCRIPTION:	The Perifix Catheter Connector is a connecting device usedto connect an anesthesia conduction catheter (mostcommonly an epidural or nerve block catheter) to a luerdevice for the administration of anesthesia and/ortherapeutic fluids. Catheter connectors are commonly usedin epidural anesthesia kits and nerve block kits.The Perifix Catheter Connector is approximately 1.77inches long and can accept B. Braun Medical Inc. 18 and20 Ga. Standard Perifix Catheters. The connector consistsof a luer device on one end for the attachment of a matingluer device. The rest of the device consists of a threadinghole, catheter channel and hinged clamp mechanism.
INTENDED USE:	A connection device used to provide various anesthetic andfluid administration devices with a single, common accesspoint to an 18 or 20 gauge Perifix catheter for delivery ofanesthetics. The connector is used in conjunction with 18or 20 gauge Perifix catheters for continuous administrationof anesthetic agents.

{1}------------------------------------------------

SUBSTANTIAL EQUIVALENCE:

The Perifix Catheter Connector is substantially equivalent to the B. Braun Medical Inc. Twist Lock Catherer Hub Adapter (K840179/K840287). The new catheter connector has similar indications for use as the predicate device. The design is different only in that there is a hinged clamp mechanism for the insertion and retention of the catheter, instead of a twisting screwing motion. There is also one new material in the connector. The material has been biocompatibility tested in accordance with FDA Guidance #G-95 and ISO 10993. These minor changes do not raise any new safety of efficacy issues.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 01 2002

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

Re: K022019

Trade/Device Name: Perfix® Catheter Connector Regulation Number: 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: June 19, 2002 Received: June 20, 2002

Dear Ms. Krall:

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.

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.

{3}------------------------------------------------

Page 2 – Ms. Krall

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Correspondence to Ms. Angela Smith Pending 510(k) K022019 . July 17, 2002Page 3 of 3

Indications for Use Statement

trage		ﺮOl
-	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number (if known): K022019

Device Name: Perifix® Catheter Connector

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _____________

fesHWutr L

(Division Sign-Off) (Wision Sign-On)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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).