The B. Braun Perifix catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration are epidural. The catheters may remain indwelling for up to 72 hours.

The B. Braun Contiplex catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The catheters may remain indwelling for up to 72 hours.

Device Description

The B. Braun Perifix and Contiplex catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management. Routes of administration include epidural and perineural (peripheral nerve block). There is no difference in the catheter design of the Perifix catheter when compared to the Contiplex catheter (i.e. the catheters are the same). The only difference between the Perifix and Contiplex catheter is the intended route of administration; Perifix catheters are marketed for use in epidural anesthesia, while Contiplex catheters are marketed for use in peripheral nerve block procedures.

The B. Braun Perifix and Contiplex catheters consists of a hollow polyamide tube with depth markings thermo-diffused into the polyamide tube. The catheters are available in both 19 and 20 Ga. diameters. The Perifix/Contiplex catheters are available in an open-tip configuration (no side ports) as well as a closed-tip configuration (with side ports). The closed-tip catheters have a rounded closed-tip with three side ports for distribution of anesthetics and analgesics.

The catheters include depth markings to identify the depth of insertion during use. The tip of the catheter (proximal to the patient) is also marked to signify the end of the catheter.

AI/ML Overview

The provided document describes the B. Braun Perifix and Contiplex Catheters, which are regional anesthesia catheters. The information focuses on demonstrating their substantial equivalence to a predicate device (B. Braun Regional Anesthesia Catheter, K042488) for 510(k) clearance, rather than presenting a study proving a device meets specific acceptance criteria in the context of clinical performance or AI algorithm effectiveness.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission, as it concerns the substantial equivalence of a medical device based on design, materials, and functional performance, not an AI algorithm or a clinical effectiveness study.

However, I can extract the relevant information regarding acceptance criteria and reported device performance from the document.

Acceptance Criteria and Reported Device Performance

Here's an explanation of why other requested information is not applicable and what information the document DOES provide instead:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This document describes a 510(k) submission for a physical medical device, not an AI algorithm. The "tests" mentioned are engineering and biocompatibility tests performed on the device itself (e.g., measuring dimensions, tensile strength, flow rate, chemical residues), not a "test set" of patient data for an algorithm. There is no mention of a "test set" in the context of patient data.
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):
- N/A. As above, no "test set" of patient data is being evaluated with experts for ground truth. The "ground truth" for these tests are objective measurements (e.g., did the catheter break at X force, did it pass Y flow rate).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not relevant for this type of device submission.
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:
- N/A. This is a physical medical device, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the functional and dimensional tests, the "ground truth" is based on engineering specifications and physical properties measurements.
- For sterilization and biocompatibility tests, the "ground truth" is based on compliance with specific ISO and USP standards (e.g., SAL 10-6, ISO 10993-7 for EO residuals, USP <161> and <85> for endotoxins).
The sample size for the training set:
- N/A. There is no "training set" as this is not an AI algorithm.
How the ground truth for the training set was established:
- N/A. There is no "training set" as this is not an AI algorithm.

Summary of the Study (as described in the document):

The document describes a regulatory submission (510(k) Premarket Notification) for the B. Braun Perifix and Contiplex Catheters. The "study" presented is a series of performance tests conducted by the manufacturer to demonstrate substantial equivalence to a predicate device (B. Braun Regional Anesthesia Catheter, K042488).

Objective: To demonstrate that the new catheters do not raise different questions of safety or effectiveness compared to the predicate device, despite minor differences in design, dimensions, and materials.
Methodology: The manufacturer performed a range of tests categorized into:
- Dimensional Specifications: Checking outer diameter, inner diameter, overall length, and depth markings against requirements.
- Functional Testing: Evaluating properties like flexibility, legibility of markings, translucency, flow rate, kinking resistance, fluid pressure resistance, tensile strength (catheter-connector and body), and elongation properties.
- Associated Device Testing: Ensuring compatibility with procedural needles, threading assist guides, and sideport valve assemblies.
- Sterilization: Verifying SAL, EO residual levels, and LAL bacterial endotoxin levels according to relevant standards.
- Biocompatibility: Performing a comprehensive suite of tests recommended by ISO 10993-1, including cytotoxicity, intracutaneous reactivity, sensitization, pyrogenicity, systemic toxicity (single and subchronic), genotoxicity, implantation, and chemical characterization.
Results: The document states that the results of these tests (functional performance, biocompatibility, and chemical testing) demonstrate that the Perifix and Contiplex catheters are "substantially equivalent" to the predicate device and "do not raise different questions of safety or effectiveness." The specific quantitative results for each test are typically detailed in the full 510(k) submission, but this summary document only provides the conclusion of compliance.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 12, 2016

B. Braun Medical Inc. Ms. Lisa Giaquinto Sr. Specialist, Regulatory Affairs 901 Marcon Boulevard Allentown, PA 18109

Re: K153297

Trade/Device Name: Perifix and Contiplex Catheters Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: July 8, 2016 Received: July 13, 2016

Dear Ms. Giaquinto:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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) Unknown K153297

Device Name Perifix and Contiplex Catheters

Indications for Use (Describe)

The B. Braun Perifix catheters are regional anestheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration are epidural. The catheters may remain indwelling for up to 72 hours.

The B. Braun Contiplex catheters are regional anesthesia catheters intended to provide, via percutaneous administration. continuous and/or intermittent infusion of local anesthetics and anerve for regional anesthesia and pain management during the preoperative and postoperative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The catheters may remain indwelling for up to 72 hours.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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B. Braun Medical Inc. 510(k) Premarket Notification Perifix™ and Contiplex TM Catheters August 12, 2016

5. 510(k) SUMMARY

SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500
	Contact: Lisa Giaquinto, MS, RACSr. Specialist, Regulatory AffairsPhone: (610) 596-2354Fax: (610) 266-4962E-mail: lisa.giaquinto@bbraun.com
DEVICE NAME:	Perifix and Contiplex Catheters
COMMON OR USUAL NAME:DEVICE	Catheter, Conduction, Anesthetic(An anesthesia conduction catheter is a flexible tubular device usedto inject local anesthetics into a patient and to provide continuousregional anesthesia.)
CLASSIFICATION:	Class II, Product Code BSO, 868.5120
PREDICATE DEVICE:	B. Braun Regional Anesthesia Catheter,BraunMedical Inc., K042488, Class II, BSO, 868.5120.

DESCRIPTION

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The catheters include depth markings to identify the depth of insertion during use. The tip of the catheter (proximal to the patient) is also marked to signify the end of the catheter.

INTENDED USE

SUBSTANTIAL EQUIVALENCE

Predicate Device – B. Braun Regional Anesthesia Catheter (K042488)

Device Design

The proposed Perifix and Contiplex catheters are indicated for the same use as the predicate device. In addition, the proposed devices are available in the same gauges and configurations as the predicate device (19-20 Ga., open and closed-tip). The primary differences between the proposed catheters and the predicate catheters are the number of side ports included on the closed-tip version (six in the predicate vs. three in the proposed device), minor dimensional differences, and the materials of construction. The predicate device consists of a co-extruded catheter body, while the proposed device consists of a single polyamide extrusion. In addition, the depth marking ink on the proposed device differs from the predicate device. Despite the differences in design and materials, the proposed catheters meet or exceed the minimum performance requirements of the predicate catheters and do not raise different questions of safety or effectiveness.

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B. Braun Medical Inc. 510(k) Premarket Notification Perifix™ and Contiplex™ Catheters August 12, 2016

Intended Use

The predicate catheters cleared in K042488 are 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 pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration include epidural and perineural (peripheral nerve block). The proposed catheters are indicated for the same use as the predicate device, however, the intended routes of administration are distinguished by the respective proprietary names: 'Perifix' for the epidural route and 'Contiplex' for the peripheral nerve block route. In addition, the proposed catheters may remain indwelling for up to 72 hours. The indications for use of the predicate catheters cleared in K042488 does not include a limit for indwell time.

Performance Testing

Dimensional and functional performance, including associate device testing (summarized in Table 1) was completed with the proposed catheters. Results of testing demonstrate that the Perifix and Contiplex catheters are substantially equivalent to the predicate device.

Requirement	Test
Dimensional Specifications	Catheters meet dimensional requirements for outer diameter, innerdiameter, overall length and depth markings
Functional Testing	FlexibilityMarkings are legibleCatheter tubing is translucentCatheter achieves flow rate requirementsCatheter resists kinkingCatheter permits flow of fluid when attached to catheter connectorCatheter withstands fluid pressure without leakageCatheter withstands minimum tensile force when attached toconnectorCatheter body withstands minimal tensile forceCatheter has sufficient elongation properties
Associate Device Testing	Catheter passes through appropriate size proceduralneedlewithout being damagedCatheter passes freely through the threading assist guideCatheter passes freely through sideport valve assembly
Sterilization	-SAL 10-6-EO residual levels met per ISO 10993-7-LAL bacterial endotoxin levels met per USP <161> an USP<85>

Table 1: Performance Test Requirements

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B. Braun Medical Inc. 510(k) Premarket Notification Perifix™ and Contiplex™ Catheters August 12, 2016

Biocompatibility

The materials of construction of the Perifix and Contiplex catheters are either 1) used in another legally marketed device with the same type and duration of patient contact, and/or 2) are patient contacting and have been evaluated for biocompatibility through testing, which meets and/or exceeds the tests recommended for consideration in ISO 10993-1: 2009, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process." The tests completed with the Perifix and Contiplex catheters are provided in Table 2: Biocompatibility Tests.

Requirement	Test
Biocompatibility andChemical Testing	Cytoxicity
	Intracutaneous Reactivity
	Sensitization
	Rabbit Pyrogenicity
	Systemic Toxicity
	Subchronic Systemic Toxicity
	Genotoxicity (bacterial reverse mutation, mouse lymphoma,mouse peripheral blood micronucleus)
	Implantation
	Chemical Characterization of Materials (Exaggerated Extractionand Simulated Use)

Table 2: Biocompatibility Tests

Based on test results, the Perifix and Contiplex catheter materials of construction are considered substantially equivalent to the predicate device.

CONCLUSION:

Results of functional performance and biocompatibility/chemical testing demonstrate that the Perifix and Contiplex catheters do not raise different questions of safety or effectiveness when compared to the predicate device. The Perifix and Contiplex catheters are substantially equivalent to the predicate device.

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).

Acceptance Criteria Category	Specific Test / Requirement	Reported Device Performance (as stated in the document)
Dimensional Specifications	Catheters meet dimensional requirements for outer diameter, inner diameter, overall length, and depth markings.	"Catheters meet dimensional requirements for outer diameter, inner diameter, overall length and depth markings" (Table 1)
Functional Testing	Flexibility	"Results of testing demonstrate that the Perifix and Contiplex catheters are substantially equivalent to the predicate device." (Implies flexibility requirements were met.)
	Markings are legible	"Markings are legible" (Table 1)
	Catheter tubing is translucent	"Catheter tubing is translucent" (Table 1)
	Catheter achieves flow rate requirements	"Catheter achieves flow rate requirements" (Table 1)
	Catheter resists kinking	"Catheter resists kinking" (Table 1)
	Catheter permits flow of fluid when attached to catheter connector	"Catheter permits flow of fluid when attached to catheter connector" (Table 1)
	Catheter withstands fluid pressure without leakage	"Catheter withstands fluid pressure without leakage" (Table 1)
	Catheter withstands minimum tensile force when attached to connector	"Catheter withstands minimum tensile force when attached to connector" (Table 1)
	Catheter body withstands minimal tensile force	"Catheter body withstands minimal tensile force" (Table 1)
	Catheter has sufficient elongation properties	"Catheter has sufficient elongation properties" (Table 1)
Associated Device Testing	Catheter passes through appropriate size procedural needle without being damaged	"Catheter passes through appropriate size procedural needle without being damaged" (Table 1)
	Catheter passes freely through the threading assist guide	"Catheter passes freely through the threading assist guide" (Table 1)
	Catheter passes freely through sideport valve assembly	"Catheter passes freely through sideport valve assembly" (Table 1)
Sterilization	Sterility Assurance Level (SAL) 10-6	"SAL 10-6" (Table 1)
	Ethylene Oxide (EO) residual levels met per ISO 10993-7	"EO residual levels met per ISO 10993-7" (Table 1)
	LAL bacterial endotoxin levels met per USP <161> and USP <85>	"LAL bacterial endotoxin levels met per USP <161> and USP <85>" (Table 1)
Biocompatibility	Cytotoxicity, Intracutaneous Reactivity, Sensitization, Rabbit Pyrogenicity, Systemic Toxicity, Subchronic Systemic Toxicity, Genotoxicity (bacterial reverse mutation, mouse lymphoma, mouse peripheral blood micronucleus), Implantation, Chemical Characterization of Materials (Exaggerated Extraction and Simulated Use)	"The tests completed with the Perifix and Contiplex catheters are provided in Table 2: Biocompatibility Tests." and "Based on test results, the Perifix and Contiplex catheter materials of construction are considered substantially equivalent to the predicate device." (Implies all listed tests were met).