The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.

Device Description

The Arrow Epidural Needles are sterile, single use, disposable devices. They are used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.

The Arrow Epidural Needles consist of a plastic cannula hub with integrated wings that come with either Luer Connector and NRFit Connector, stainless steel cannula, and plastic stylet. The purpose of the stylet is to prevent tissue coring during needle insertion. The needle assembly is protected with a guard to prevent damage to the needle.

AI/ML Overview

This document is an FDA 510(k) summary for the Arrow Epidural Needles. It does not present a study proving the device meets acceptance criteria in the way typically seen for AI/ML medical devices where performance metrics like sensitivity, specificity, or AUC are evaluated on a test set against a ground truth.

Instead, this document describes a traditional medical device submission where "acceptance criteria" are related to engineering performance standards, material characteristics, and biological safety, rather than diagnostic accuracy or clinical effectiveness in a comparative human-AI study.

Therefore, many of the requested fields are not applicable to the content provided. Here's a breakdown based on the provided document:

Device: Arrow Epidural Needles
Regulatory Class: Class II
Product Code: BSP (Anesthesia Conduction Needle)
K190026

1. Table of Acceptance Criteria and Reported Device Performance

The "Performance Data" section in the document outlines the tests performed to demonstrate substantial equivalence to a predicate device. These are engineering and biocompatibility tests, not clinical performance metrics for diagnostic accuracy.

Test	Standard (if applicable)	Principle of Test
Joint Between the Needle Hub and Needle Cannula Joint Between the Stylet Hub and Stylet Cannula	BS 6196	A tensile force is applied for a specified time to the union being tested, and the union observed to determine if it parts. (Performance results are not explicitly numerical values but are implied to have met the standard, as the device was cleared for substantial equivalence)
Stiffness	ISO 9626	A specified force is applied to the centre of the specified length of tubing, which is supported at both ends, and the amount of deflection measured. (Implied to have met the standard)
Resistance to breakage	ISO 9626	One end of the tubing is firmly fixed, and a force applied to the tubing at a specified distance from the point of fixation, so as to bend the tubing through a specified angle, first in one direction and then in the opposite direction, for a specified number of cycles. (Implied to have met the standard)
Resistance to corrosion	ISO 9626	The tubing is partially immersed in sodium chloride solution for a specified time and afterwards the immersed portion compared visually with the un immersed portion for signs of corrosion. (Implied to have met the standard)
Luer Connector	ISO 594-1, ISO 594-2	To test unscrewing gauging, liquid leakage, air leakage, separation force. (Implied to have met the standard)
NRFit Connector	ISO 80369-6	To test unscrewing gauging, liquid leakage, air leakage, separation force. (Implied to have met the standard)
Biocompatibility	ISO 10993	Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity and Material Mediated Pyrogenicity. (Implied to have met the standard)
LAL Bacterial Endotoxin	AAMI ST72	LAL Bacterial Endotoxin testing of medical devices that have contact with CSF. (Implied to have met the standard)
Packaging	ISO 11607-1, ASTM D4169	Stability and Distribution simulation testing. (Implied to have met the standard)

Note: For traditional medical devices like this, the "acceptance criteria" are the successful completion of these standard tests, demonstrating that the device performs as intended and is safe and effective when compared to a legally marketed predicate device. The "reported device performance" is the successful completion of these tests, leading to the substantial equivalence determination. Specific numerical results are not typically summarized in the 510(k) summary unless critical for comparison.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not specified in the 510(k) summary. These tests are typically conducted on a sample number of manufactured devices according to the respective standards and internal quality control procedures.
Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are laboratory-based engineering and biological evaluations of the physical device. The testing was conducted by or for Teleflex Medical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is not an AI/ML device requiring clinical ground truth establishment by medical experts for diagnostic accuracy. The "ground truth" for these tests is defined by the passing criteria of the international and industry standards (e.g., ISO, BS, ASTM, AAMI).

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or an algorithm. The tests are objective measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/ML device that assists human readers.

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

Not applicable. This device is a physical epidural needle, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the AI/ML sense. The "ground truth" for the performance tests described are the established specifications and pass/fail criteria defined by the relevant international and industry standards (e.g., tensile strength, resistance to breakage, corrosion resistance, Luer/NRFit connector integrity, biocompatibility, sterility) these devices are required to meet.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of device.

In conclusion, this FDA 510(k) summary is for a traditional medical device (an epidural needle) and demonstrates substantial equivalence based on engineering performance, material characteristics, and biocompatibility testing against international and industry standards, not on clinical performance or diagnostic accuracy evaluated with a clinical test set and human readers as would be typical for an AI/ML medical device.

Summary

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August 21, 2019

Teleflex Medical Lakshmi Kanuri Regulatory Affairs Specialist 3015 Carrington Mill Blvd Morrisville, North Carolina 27560

Re: K190026

Trade/Device Name: Arrow Epidural Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: July 19, 2019 Received: July 22, 2019

Dear Lakshmi Kanuri:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190026

Device Name Arrow Epidural Needles

Indications for Use (Describe)

The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

K190026

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

Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 919-361-4087 Fax: 919-433-4996

2. Contact Person

Lakshmi Kanuri Regulatory Affairs Specialist

3. Date Prepared

August 21, 2019

4. Device Name

Trade Name:	Arrow Epidural Needles
Classification Name:	Anesthesia conduction needle (w/wo introducer)
FDA Product Code:	BSP
CFR Number:	868.5150
Regulatory Class:	II

5. Predicate Device

K131006 - AN-E Epidural Needle

6. Device Description

7. Indications for Use

The Arrow Epidural Needles are intended to inject local anesthetic into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.

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CHARACTERISTIC	PREDICATE DEVICEK131006	SUBJECT DEVICE
Applicant Name	LCCS PRODUCTSLIMITED	ARROW INTERNATIONALINC.
Device Classification Name	Anesthesia conductionneedle(w/wo introducer)	Anesthesia conduction needle(w/wo introducer)
FDA Product Code	BSP	BSP
CFR Number	868.5150	868.5150
Regulatory Class	II	II
Trade Name	AN-E Epidural Needle	Arrow Epidural Needle
Intended Use/Indications forUse	Intended for the transientdelivery of anesthetics toprovide neuraxialanesthetics or to facilitateplacement of an epiduralcatheter.	The Arrow Epidural Needlesare intended to inject localanesthetic into a patient toprovide regional anesthesia orto facilitate the placement of anepidural catheter.
Needle Guage Size	15 GA - 20 GA	17 GA
Needle Length	50 mm - 150 mm	88.9mm (8.89 cm) (3-1/2")
Tip Design	Tuohy, Quincke, PencilPoint	Tuohy
Needle Cannula Material	304 Stainless Steel	304 Stainless Steel
Needle Hub Material	K-Resin KR03	Clear Acrylic
Stylet Cannula Material	304 STAINLESS STEEL	Clear Polypropylene
Stylet Hub Material	HDPE	Gray Polypropylene
Connector Type	ISO 594 Luer	ISO 594 LuerISO 80369-6 NRFit
Final Needle AssemblyProtection	Not stated	Guard
CHARACTERISTIC	PREDICATE DEVICE K131006	SUBJECT DEVICE
Markings	Not stated	1 cm (10 mm)
Performance	ISO 7864 Hub to Needle Bond StrengthISO 9626 StiffnessISO 9626 Resistance to breakageISO 594-1 and ISO 594-2 Luer Connector	BS 6196 Joint Between the Needle Hub and Needle Cannula and Joint Between the Stylet Hub and Stylet CannulaISO 9626 StiffnessISO 9626 Resistance to breakageISO 9626 Resistance to corrosionISO 594-1 and ISO 594-2 Luer ConnectorISO 80369-6 NRFit Connector
Method of Sterilization	Not stated	Ethylene Oxide
Shelf Life	Not stated	One year
Packaging	Not stated	Tyvek Pouch

8. Technological Characteristics Comparison to the predicate

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9. Performance Data

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

Test	Standard (if applicable)	Principle of Test
Joint Between the Needle Hub and Needle CannulaJoint Between the Stylet Hub and Stylet Cannula	BS 6196	A tensile force is applied for a specified time to the union being tested, and the union observed to determine if it parts.
Stiffness	ISO 9626	A specified force is applied to the centre of the specified length of tubing, which is supported at both ends, and the amount of deflection measured.
Resistance to breakage	ISO 9626	One end of the tubing is firmly fixed, and a force applied to the tubing at a specified distance from the point of fixation, so as to bend the tubing through a specified angle, first in one direction and then in the opposite direction, for a specified number of cycles.
Resistance to corrosion	ISO 9626	The tubing is partially immersed in sodium chloride solution for a specified time and afterwards the immersed portion compared visually with the un immersed portion for signs of corrosion.
Luer Connector	ISO 594-1ISO 594-2	To test unscrewing gauging, liquid leakage, air leakage, separation force.
NRFit Connector	ISO 80369-6	To test unscrewing gauging, liquid leakage, air leakage, separation force.
Biocompatibility	ISO 10993	Testing included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity and Material Mediated Pyrogenicity
LAL Bacterial Endotoxin	AAMI ST72	LAL Bacterial Endotoxin testing of medical devices that have contact with CSF
Packaging	ISO 11607-1ASTM D4169	Stability and Distribution simulation testing

10. Conclusion

The Arrow Epidural Needle has similar indications for use and technology of construction as the predicate device. Performance test results demonstrate that the proposed device meets its intended use. It is for these reasons that the proposed device is substantially equivalent to the proposed predicate device and does not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

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