The Arrow Epidural Catheter kit permits access to the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.

Device Description

The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations of accessory components including 0.2 Micron In-Line Flat Anesthesia Conduction Filter necessary for the catheter insertion procedure.

AI/ML Overview

This document describes the Teleflex Medical, Inc. Arrow Epidural Catheter Kit (K143581) and its substantial equivalence to predicate devices, not an AI/ML powered device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and studies for an AI device.

However, I can extract the information provided about the device's performance testing, which serves a similar purpose of demonstrating that the device meets certain criteria for its intended use.

Here's the closest possible interpretation of your request based on the provided document:

Description of Device: The Arrow Epidural Catheter Kit is intended to permit access to the epidural space for the administration of epidural anesthetic for up to 72 hours. It contains an epidural catheter and various accessory components, including a 0.2 Micron In-Line Flat Anesthesia Conduction Filter.

No AI/ML Powered Device: Please note that this document is a 510(k) summary for a medical device (an epidural catheter kit) and does not describe an AI/ML powered device. Therefore, sections related to AI/ML specific criteria (like human reader improvement with AI, standalone performance, training data, etc.) are not applicable and are not present in the document.

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

The document lists various performance tests conducted to demonstrate the device's substantial equivalence to predicate devices. The "reported device performance" is essentially that the device passed these tests and met internal requirements or relevant industry standards. The specific quantitative acceptance criteria are generally "Internal Requirement" or compliance with the specified standard.

Test	Acceptance Criteria (Principle of Test)	Reported Device Performance
Luer Strength Test	Force is applied to the male and female luer tapers until failure.	Meets internal requirement (implies satisfactory strength)
Housing Burst Pressure Test	Hydrostatic pressure is applied until part bursts.	Meets internal requirement (implies satisfactory burst integrity)
Flow Rate Test	Water is passed through the filter at a pressure of 10 psi and collected in a graduated cylinder for 60 seconds. The volume of water is recorded.	Meets internal requirement (implies satisfactory flow rate)
Filter Luer Slip	To test unscrewing gauging, liquid leakage, air leakage, separation force (ISO 594-1).	Complies with ISO 594-1 (implies satisfactory luer slip performance)
Filter Luer-Lock	To test unscrewing torque, ease of assembly, resistance to overriding, stress cracking (ISO 594-2).	Complies with ISO 594-2 (implies satisfactory luer-lock performance)
Bacterial Retention and Bubble Point Test	To test bacterial retention of membrane filter (ASTM F838).	Complies with ASTM F838 (implies 100% bacterial retention and appropriate bubble point)
Biocompatibility	Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic systemic toxicity, genotoxicity, implantation, and extractables & leachables (ISO 10993).	Complies with ISO 10993 (implies biocompatibility)
EO Residuals	EO residual testing for prolonged contact devices (ISO 10993-7).	Complies with ISO 10993-7 (implies acceptable EO residual levels)
LAL Bacterial Endotoxin	LAL bacterial endotoxin testing for medical devices that have contact with CSF (AAMI ST72).	Complies with AAMI ST72 (implies acceptable endotoxin levels)
Packaging	Packaging stability, Distribution simulation testing (ISO 11607-1, ASTM D4169).	Complies with ISO 11607-1 and ASTM D4169 (implies satisfactory packaging integrity and stability)

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

The document does not provide details on the specific sample sizes used for each of the performance tests nor the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in the full test reports, not in the 510(k) summary. The tests appear to be laboratory-based rather than clinical studies with 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)

This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring expert-established ground truth.

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

This is not applicable as the document describes physical and chemical performance tests of a medical device, not an AI algorithm requiring adjudication of interpretations.

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 is not applicable. The device is an epidural catheter kit, not an AI/ML system, and no MRMC study is mentioned.

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

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

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

For the performance tests described, the "ground truth" would be the established scientific principles, engineering specifications, and validated measurement techniques as outlined in the referenced ISO, ASTM, and AAMI standards, or the internal requirements. These are not types of ground truth typically associated with AI/ML systems.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.

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

This is not applicable as the document describes a physical medical device, not an AI/ML system that requires a training set.

Summary

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

June 26, 2015

Teleflex Medical, Inc. Ms. Angela Bouse Senior Regulatory Affairs Specialist 3015 Carrington Mill Blvd. Morrisville, NC 27560

Re: K143581

Trade/Device Name: Arrow Epidural Catheter Kit Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 22, 2015 Received: May 26, 2015

Dear Ms. Bouse:

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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Page 2 - Ms. Bouse

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 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/Resourcesfor You/Industry/default.htm. 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/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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division 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) K143581

Device Name Arrow Epidural Catheter Kit

Indications for Use (Describe)

The Arrow Epidural Catheter kit permits access to the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

A. Name, Address, Phone and Fax Number of Applicant

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-433-4904 919-433-4989 Fax:

B. Contact Person

Angela Bouse Senior Regulatory Affairs Specialist

C. Date Prepared

June 26, 2015

D. Device Name

Trade Name:	Arrow Epidural Catheter Kit
Classification Name:	Anesthesia Conduction Kit
Product Code:	CAZ
Regulation Number:	868.5140
Classification:	II
Classification Panel:	Anesthesiology

E. Predicate Device

This submission demonstrates substantial equivalence to the predicate device Portex Epidural Filter - K083451 Flextip Plus Closed Tip Epidural Catheter - K103658

F. Device Description

G. Indications for Use

The Arrow Epidural Catheter kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.

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H. Technological Characteristics Comparison to the predicate

The proposed Arrow Epidural Catheter Kit with 0.2 Micron In-Line Flat Anesthesia Conduction Filter is substantially equivalent to the predicate device with respect to indications for use, technology and construction. The differences between the predicate and the proposed devices are minor and any risks have been mitigated through testing. Table 1 summarizes the differences between the proposed and predicate devices.

ComparativeCharacteristic	Predicate Device:Smiths Medical, PortexEpidural FilterK083451	Predicate Device:Flextip Plus Closed TipEpidural CatheterK103658	Proposed Device:Arrow EpiduralCatheter Kit with 0.2Micron In-Line FlatAnesthesia ConductionFilter
ClassificationName	Anesthesia ConductionFilter	Anesthesia Conduction Kit	Same
Product Code /CFR	BSN, 868.5130	CAZ, 868.5140	Same
Intended Use/Indications forUse	An anesthesiaconduction filter is usedwhile administering to apatient injections of localanesthetics to minimizeparticulate (foreignmaterial) contaminationof the injected fluid.	The Arrow EpiduralCatheter permits access tothe epidural space for theadministration of epiduralanesthetic. The epiduralcatheter is intended for useup to 72 hours.	Similar
PatientPopulation	Patients that requireadministration of localanesthetics.	Patients that requireadministration of localanesthetics.	Same
Design	Round flat filter	Filter Kit Component:Round flat filter	Same
InletConnection	Female luer lock	Filter Kit Component:Female luer lock	Same
OutletConnection	Male Luer with arotating Locking Hub	Filter Kit Component:Male Luer	Same
Membrane PoreSize	0.2 micron	Filter Kit Component:0.2 micron	Same
Filtration Area	5.25 cm $^{2}$	Filter Kit Component:4.3 cm $^{2}$	3.8 cm $^{2}$
Bubble PointPressure	$\geq$ 46 psi	Filter Kit Component:$\geq$ 46 psi	Same
BacterialRetention	100% bacterial retention	Filter Kit Component:100% bacterial retention	Same
ComparativeCharacteristic	Predicate Device:Smiths Medical, PortexEpidural FilterK083451	Predicate Device:Flextip Plus Closed TipEpidural CatheterK103658	Proposed Device:Arrow EpiduralCatheter Kit with 0.2Micron In-Line FlatAnesthesia ConductionFilter
HousingMaterial	Modified acrylic	Filter Kit Component:Modified acrylic	Cyrolite G20 Hiflo,Modified Acrylic
Filter Material	Not stated	Filter Kit Component:Polyethersulfone	Sterlitech,Polyethersulfone
MembraneFiltration	Hydrophilic	Filter Kit Component:Hydrophilic	Same
RotatingLocking HubMaterial	Not stated	N/A – filter design doesnot include a rotating collar	Titanpro 6331,Polypropylene withUnicolour UYL0845 PPYellow
Shelf Life	Not stated	Two years	One year
Method ofSterilization	Not stated	Ethylene Oxide	Ethylene Oxide
Single Use	Yes	Yes	Same
KitComponents	Not Applicable	List of the main kit components:Epidural CatheterCatheter Syringe Adapter0.2 Micron AnesthesiaConduction FilterSnapLockTMEpidural NeedleInjection NeedleStandard SyringeLOR SyringeSharpsAway IITM LockingDisposal CupClear Fenestrated Drape withadhesiveTowel5 Micron Straw FilterGauze PadsPrep Sponge SwabsMedicine CupTray: Prep	Same, except forreplacement of the 0.2Micron AnesthesiaConduction Filter
IFU	Not stated	Arrow Epidural CatheterIFU	Similar

Table 1 - Differences Between the Proposed and Predicate Devices

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I. Performance Data

A brief summary of tests relied upon to demonstrate substantial equivalence to the predicate can be found in Table 2 below.

Table 2 – Performance Testing Summary
Test	Reference toStandard(if applicable)	Principle of Test
Luer Strength Test	Internal Requirement	Force is applied to the male and female luertapers until failure.
Housing BurstPressure Test	Internal Requirement	Hydrostatic pressure is applied until partbursts.
Flow Rate Test	Internal Requirement	Water is passed through the filter at a pressureof 10 psi and collected in a graduated cylinderfor 60 seconds. The volume of water isrecorded.
Filter Luer Slip	ISO 594-1	To test unscrewing gauging, liquid leakage,air leakage, separation force.
Filter Luer-Lock	ISO 594-2	To test unscrewing torque, ease of assembly,resistance to overriding, stress cracking.
Bacterial Retentionand Bubble PointTest	ASTM F838	To test bacterial retention of membrane filter.
Biocompatibility	ISO 10993	Testing included cytotoxicity, sensitization,irritation, acute systemic toxicity, subchronicsystemic toxicity, genotoxicity, implantation,and extractables & leachables.
EO Residuals	ISO 10993-7	The EO residual testing for prolonged contactdevices.
LAL BacterialEndotoxin	AAMI ST72	LAL bacterial endotoxin testing for medicaldevices that have contact with CSF.
Packaging	ISO 11607-1ASTM D4169	Packaging stabilityDistribution simulation testing

Performance Testing Summary Table 2 –

J. Conclusion

The Arrow Epidural Catheter kit has similar indications for use and technology of construction as the predicate devices. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device can be found substantially equivalent.

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).