ARROW® FlexTip Plus® Epidural Catheters are single lumen catheters featuring a wire re-enforced polyurethane body with centimeter markings to facilitate placement.

AI/ML Overview

This document is a 510(k) premarket notification for an ARROW FlexTip Plus Epidural Catheter (K140110). This specific submission is an update to the Magnetic Resonance (MR) Conditional statements in the Instructions for Use (IFU) for the previously cleared device (K103658).

Therefore, this document does not contain information about acceptance criteria and studies demonstrating device performance in the context of efficacy or clinical outcomes for an AI/software device. Instead, it focuses on demonstrating substantial equivalence for an updated MR safety label.

Here's an analysis of the provided text based on your request, highlighting why direct answers to some of your questions are not applicable to this type of medical device submission:

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

This document does not specify "acceptance criteria" and "device performance" in the context of clinical efficacy or diagnostic accuracy, as it is not an AI/software device. The performance testing mentioned is specifically for MR compatibility.

Table: MR Conditional Labeling Updates and Performance

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
MR Conditional	Safe for use under specified MR conditions (magnetic field interactions, heating, artifacts within acceptable limits).	Evaluation of Magnetic Field Interactions, Heating and Artifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version. The specific results (e.g., temperature rise, artifact size, deflection angle) are not detailed in this summary but are referenced as being in Attachment C of the submission. The study aimed to provide corrected and updated MR Conditional statements in the IFU based on this testing.

The following questions (2-9) are not applicable to this 510(k) submission because it is for a physical medical device (epidural catheter) with an update to its MR safety labeling, not a software or AI-driven diagnostic/therapeutic device. The concept of "test sets," "ground truth," "experts," "training sets," and "human-in-the-loop performance" are not relevant to demonstrating the MR compatibility of a catheter.

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. This is not a study involving human data, but rather a physical device being tested for MR compatibility in a controlled laboratory environment.

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. Ground truth, in this context, refers to scientific measurement and engineering principles for MR compatibility, established by trained personnel in the testing laboratory (Shellock R&D Services).

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

Not Applicable. No adjudication method is relevant for MR compatibility testing of a physical device.

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 is not an AI or diagnostic imaging device.

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

Not Applicable. This is not an AI or software algorithm.

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

Not Applicable. The "ground truth" for MR compatibility is derived from standardized testing methodologies and measurements (e.g., using phantoms, thermocouples, and physical measurements) as outlined by relevant standards (e.g., ASTM F2119, F2182, F2052).

8. The sample size for the training set

Not Applicable. There is no training set for a physical device's MR compatibility testing.

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

Not Applicable. There is no training set for a physical device's MR compatibility testing.

Summary of Relevant Information from the Document:

Device: ARROW FlexTip Plus Epidural Catheter
510(k) Number: K140110
Predicate Device: FlexTip Plus Epidural Catheter (K103658)
Purpose of Submission: To update the MR Conditional statements in the Instructions for Use (IFU) based on revised magnetic resonance testing.
Modification: Only the MR Conditional labeling was changed. The device's technological characteristics, materials, indications for use, and classification remain identical to the predicate.
Performance Testing: "Evaluation of Magnetic Field Interactions, Heating and Artifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version" by Shellock R&D Services, revised 7/15/2013. This testing was submitted to support the updated MR Conditional statements.
Substantial Equivalence Conclusion: The updated MR Conditional labeling establishes parameters for safe use in an MRI environment, does not impact safety or effectiveness, and does not raise new questions of safety or efficacy. Substantial equivalence is based on the device being identical to its predicate in all other respects.

Summary

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

March 27, 2015

Teleflex, Inc. ARROW International, Inc. Chet Jones Regulatory Affairs Specialist 2400 Bernville Rd. Reading, PA 19605

Re: K140110

Trade/Device Name: ARROW FlexTip Plus Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO, CAZ Dated: February 23, 2015 Received: February 24, 2015

Dear Mr. Jones:

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.

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

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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,

Erin I. Keith -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140110

Device Name

ARROW® FlexTip Plus® Epidural Catheter

Indications for Use (Describe)

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

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)

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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Submitter Information

Name	ARROW International, Inc. (subsidiary of Teleflex Inc.)
Address	4024 Stirrup Creek Dr., Suite 720
	PO Box 12600
	Durham, NC 27703
Phone number	919-433-2579
Fax number	919-433-4996
Contact Person	Chet Jones
Date prepared	June 30, 2014 (Revised March 26, 2015)

Trade Name

ARROW® FlexTip Plus® Epidural Catheters

Common/Usual Name

Epidural Catheter

Classification Name

Catheter:

BSO - Anesthesia Conduction Catheter 21 CFR 868.5120 Class 2

Kit:

CAZ – Anesthesia Conduction Kit 21 CFR 868.5140 Class 2

Predicate Device

FlexTip Plus Epidural Catheter - K103658

Modification and Changes to Predicate

The purpose of this traditional 510(k) is to update the MR Conditional statements in the Instructions for Use (IFU). The update is based on magnetic resonance testing performed by Shellock R&D Services. The purpose of the update is to make a correction and to align the MR Conditional statements to the current best practices.

The update to the MR Conditional statements in the IFU is the only modification. The devices that are the subject of this submission are identical to their respective predicates in all other respects, including their technological characteristics, materials, indications for use, and FDA classification.

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Device Description

ARROW® FlexTip Plus® Epidural Catheters are single lumen catheters featuring a wire re-enforced polyurethane body with centimeter markings to facilitate placement.

Indications for Use

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

Substantial Equivalence Comparison to Predicates

ARROW FlexTip Plus Epidural Catheters were cleared under K103658. No changes have been made to the catheters or components since receiving clearance. Substantial equivalence between the device subject of this submission and the predicate device is based upon the fact that they are identical in regards to technological characteristics, design, materials, indications for use, and FDA classification.

The only change for these devices is an update to the MR Conditional labeling based on magnetic resonance testing performed by Shellock R&D Services. The update are provided in Section 014 Proposed Labeling. The test report is provided in Attachment C.

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Image /page/6/Picture/1 description: The image shows the logo for Arrow International. The word "ARROW" is in large, white, sans-serif font on the top line. Below that, the word "INTERNATIONAL" is in a smaller, white, sans-serif font. The background is a solid blue color.

Characteristic	Comparison to Predicate
Product Classification	No change
Intended Use	No change
Technological Characteristics	No change
Materials	No change
MR Conditional Labeling	See Table 1 in Section 014 Proposed Labeling.
Performance Testing	Evaluation of Magnetic Field Interactions, Heating andArtifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version by Shellock R&D Services,12/09/11, Revised 7/15/2013. *

Table 1 Substantial Equivalence Comparison to Predicates

The same testing was submitted in support of the MR Conditional statements cleared in the predicate 510(k) K103658. However, the test was found to contain an error and was revised, producing the 7/15/2013 version of the report. This performance testing is presented in support of the MR Conditional statements and is not intended to support substantial equivalence. Substantial equivalence is based upon the devices being identical to their predicates in all respects.

Substantial Equivalence Conclusion

The proposed update to the MR Conditional labeling establishes parameters for the safe use of these catheters in a magnetic resonance environment. It does not impact the safety and effectiveness of ARROW FlexTip Plus Epidural Catheters, and does not raise new questions of safety or efficacy.

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).