The Medline Reinforced Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22lbs. (10kg), for a duration of use up to 72 hours.

Device Description

The Medline Reinforced Epidural Catheter is a single use device made of flexible polyurethane elastomer tubing. The subject device is sold sterile, and will be packaged inside of a convenience kit alongside a variety of other components that are outside the scope of this 510(k) submission. The proposed epidural catheter is designed as a closed tip device with two eyelets to provide for the dispersion of anesthetic agents. The catheter features a 19G design and is 913 millimeters (mm) long. The catheter has a marked tip, with 10mm increments up the length of the device (up to 913mm). The 100mm mark is indicated by two marks, 150mm by three marks, 200mm by 4 marks, and 250mm by 5 marks. In addition, the Medline Reinforced Epidural Catheter has an internal radiopaque inner spring that is evenly distributed inside the device, terminating 2+/-0.05mm from the liquid outlet end. As an added safety feature, a solid wide warning mark is featured on the proposed device to indicate exit of the catheter from a needle when used in conjunction with an epidural needle.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (Medline Reinforced Epidural Catheter) and as such focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information typical of a study that would define acceptance criteria for AI/Algorithm-based device performance and then prove the device meets those criteria using clinical data and expert input.

Therefore, many of the requested elements (1-9) regarding acceptance criteria, reported performance, sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI/algorithm performance are not applicable or not present in this document.

However, I can extract the information provided regarding the non-clinical testing and the company's conclusion of substantial equivalence.

Summary of Non-Clinical Testing and Conclusion of Substantial Equivalence:

The Medline Reinforced Epidural Catheter is seeking 510(k) clearance based on substantial equivalence to the ARROW® FlexTip Plus® Epidural Catheter (K140110). Instead of defining acceptance criteria for algorithmic performance, the submission focuses on demonstrating safety, performance, and functionality through various non-clinical tests.

No information provided in the document refers to an AI/algorithm-based device, nor does it contain data on acceptance criteria, reported device performance (in the context of AI), sample sizes for test/training sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/algorithm evaluation.

The document describes non-clinical testing for a physical medical device. Here's a summary of the non-clinical tests conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not define quantitative acceptance criteria for algorithm performance or report such performance metrics. Instead, it lists various non-clinical tests conducted to demonstrate the safety and functionality of the physical catheter. The "reported device performance" is implied by the successful completion of these tests in accordance with relevant standards.

Test Category	Specific Test	Acceptance Standard/Method	Reported Performance
Chemical Safety	Particulate Matter Testing	USP <788> Particulate Matter Injections	Results demonstrated overall safety and effectiveness (as stated in the submission). Specific particle counts or thresholds are not provided in this summary.
	Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing	USP <85> Bacterial Endotoxin Testing	Results demonstrated overall safety and effectiveness. Specific endotoxin levels or thresholds are not provided.
Functional Performance	Kink Testing	Not explicitly stated (implied internal protocol or recognized standard)	Results demonstrated overall safety and effectiveness, supporting substantial equivalence. Specific kink resistance values or criteria are not provided.
	Dimensional Analysis	Not explicitly stated (implied internal protocol)	Results demonstrated overall safety and effectiveness. Specific dimensional measurements or tolerances are not provided.
	Simulated Distribution Testing	ISTA 3A-2018 General Simulation Performance Test Procedure for Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less	Results demonstrated the ability to maintain functionality upon distribution. Specific test outcomes (e.g., integrity after simulation) are not detailed here beyond a general statement of effectiveness.
	Transportation Testing	ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems	Results demonstrated the ability to maintain functionality during transportation. Specific test outcomes are not detailed here.
	Visual Appearance Testing	Not explicitly stated (implied internal protocol)	Results demonstrated overall safety and effectiveness, presumably meeting visual inspection criteria.
	Ink Adherence Testing	Not explicitly stated (implied internal protocol)	Results demonstrated overall safety and effectiveness, indicating the markings adhere properly.
	Tensile Strength Testing	ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension	Results demonstrated overall safety and effectiveness. Specific tensile strength values are not provided.
	Flow Rate Testing	ASTM F623-99 Standard Performance Specification for Foley Catheter (Flow Rate) Note: While a Foley catheter standard is cited, it's used for flow rate testing of an epidural catheter, presumably for catheter-specific flow requirements.	Results demonstrated overall safety and effectiveness. Specific flow rates or thresholds are not provided.
	Connector Pull Out Testing	Not explicitly stated (implied internal protocol)	Results demonstrated overall safety and effectiveness. Specific pull-out forces are not provided.
	Leakage Testing	ISO 80369-6 Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications	Results demonstrated overall safety and effectiveness. Specific leakage rates or criteria are not provided.
	Packaging Integrity Testing	ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration	Results demonstrated overall safety and effectiveness, indicating packaging integrity.
	Seal Strength Testing	ASTM F88-16 Standard Test Method for Seal Strength of Flexible Barrier Materials	Results demonstrated overall safety and effectiveness, indicating appropriate seal strength.
	X-Ray Opaque Detection Testing	Not explicitly stated (implied internal protocol)	Results demonstrated overall safety and effectiveness, presumably confirming the radiopaque properties for visibility under X-ray.
Biocompatibility	Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, Hemolysis, Subacute Systemic Toxicity, Chemical Characterization	ANSI/AAMI/ISO 10993-1:2009 & specific sub-parts of ISO 10993 (e.g., -5, -10, -11, -4, -18) and USP <151>	The tests were conducted and the protocols/reports are available for FDA review (Appendix E). The overall conclusion is that the device's biocompatibility supports substantial equivalence. Specific results or pass/fail criteria from these tests are not
detailed in this summary document.
Sterilization	Sterilization Validation	ISO 11135:2014 Sterilization of Health Care Products - Ethylene Oxide...	Demonstrated a Sterility Assurance Level (SAL) of 1 x 10^-6.
	EO and ECH Residuals	ISO 10993-7:2008(R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals	The device was evaluated, and presumably, residuals were within acceptable limits as part of the overall safety determination. Specific residual levels are not provided.
Shelf Life	Accelerated Aging Studies	ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices	Verified a one-year shelf life, ensuring functionality and sterility are maintained.

Regarding your specific questions:

A table of acceptance criteria and the reported device performance: See the table above. Note that these are for a physical device, not an AI/algorithm.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for an AI/algorithm. For the non-clinical tests, sample sizes would be defined by the selected standards and internal protocols, but are not specified in this summary. Data provenance is not specified.
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 as this is not an AI/algorithm study requiring ground truth derived from expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical testing of a physical device.
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: No, this is not an AI/algorithm device submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI/algorithm device submission.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as this is not an AI/algorithm study. The "ground truth" for a physical device is its ability to meet engineering specifications and safety standards through physical and chemical testing.
The sample size for the training set: Not applicable; there is no training set mentioned, as this is not an AI/algorithm device.
How the ground truth for the training set was established: Not applicable; there is no training set mentioned, as this is not an AI/algorithm device.

Conclusion stated in the document:
Based on the non-clinical testing, Medline Industries, Inc. concludes that the Medline Reinforced Epidural Catheter is substantially equivalent to the predicate device, ARROW® FlexTip Plus® Epidural Catheters (K140110).

Summary

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Medline Industries, Inc. Claire Pigman Associate Manager Three Lakes Drive Northfield, Illinois 60093

Re: K181782

Trade/Device Name: Medline Reinforced Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: January 28, 2019 Received: January 29, 2019

Dear Claire Pigman:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. Courtney - S

for 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) K181782

Device Name Medline Reinforced Epidural Catheter

Indications for Use (Describe)

The Medline Reinforced Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22lbs. (10kg), for a duration of 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)

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Image /page/3/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, stacked on top of a white starburst symbol. The background of the logo is a solid dark blue color. The starburst symbol has four points, and it is positioned so that the word "MEDLINE" is centered above it.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

K181782 - 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592

Submission Correspondent(s)

Claire Pigman Associate Manager, Regulatory Affairs Medline Industries, Inc. Phone: 847-643-4071 Email: cpigman@medline.com

Stephanie Augsburg Manager, Regulatory Affairs Medline Industries, Inc. Phone: 847-643-3690 Fax: 847-643-4482 Email: saugsburg@medline.com

Summary Preparation Date June 29, 2018 (Updated January 28, 2019)

Type of Submission Traditional 510(k)

Device Name / Classification

Proprietary Name: Medline Reinforced Epidural Catheter Classification Name: Catheter, Conduction, Anesthetic Product Code: BSO Classification Panel: Anesthesiology

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Image /page/4/Picture/1 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is in white, and there is a white star-like symbol that is above and below the word. The star-like symbol is vertically oriented.

Medline Industries, Inc Three Lakes Drive Northfield. IL 60093

Regulatory Class: Class II Regulation Number: 21 CFR 868.5120

Predicate Device

Predicate Device Name: ARROW® FlexTip Plus® Epidural Catheter Predicate Device 510(k) Number: K140110 Predicate Device 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.

Device Description

Medline Item Number	Description	Gauge	Length
REPICATH19	Medline Reinforced Epidural Catheter	19G	913mm

Epidural catheters, like the proposed and predicate devices, are used during epidural administration procedures to allow for administration of local anesthetic medications into the epidural space of a patient. Epidural administration in general is a medical route of administration in which a drug, such as an epidural anesthetic, is injected into a patient's epidural space around the spinal cord. Though the is frequently employed by trained practitioners (i.e. physicians and nurse anesthetists) to administer anesthetic agents for patient pain relief, it is a procedure that is only performed by skilled healthcare personnel that are trained to be well-versed in anatomical landmarks, safe technique, and potential complications. The epidural technique employed during epidural administration procedures most commonly involve the injection of drugs through a catheter, like the proposed and predicate devices, that are placed into the epidural space. A high-level overview describing when these devices are used, how they are used, and by whom, is provided below.

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Image /page/5/Picture/1 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, with a stylized white cross extending from the top and bottom of the word. The background is a solid blue color. The logo is simple and clean, with a focus on the company name and a symbol that suggests healthcare.

Medline Industries, Inc Three Lakes Drive Northfield. IL 60093

Principle of Operation: Following puncture and verification of the epidural space with an epidural needle, the distal tip of an epidural catheter is introduced through the epidural needle. To facilitate this process, the Threading Assist Device that is included with the proposed and predicate devices is used to attach to the hub of the epidural needle to aid in inserting the catheter is then advanced the desired distance into the epidural space, as noted by the millimeter markings provided on the catheter. After the catheter has been advanced to the desired distance (not more than 5 cm), it is held in place while the needle is removed over it. As such, the catheter's position is maintained and will often be secured to the skin with adhesive tape to ensure it remains undisturbed per internal hospital protocols. The proximal end of the catheter can then be attached and inserted into the catheter connector, which is also provided with the proposed and predicate devices, to facilitate its connection to a syringe so that anesthetics may be injected through the catheter and ultimately into the epidural space.

Proposed Conditions of Use: Injecting medication into a patient's epidural space is primarily performed for analgesia and the proposed device is intended to be used during epidural medication on patients over 22 lbs. that require administration of local anesthetics. When the proposed device is advanced into the epidural space, it can remain in place for up to 72 hours, which allows for epidural medication administration to be continued post-operatively (and re-dosed intraoperatively) if needed. Epidural administration procedures are carried out by trained healthcare practitioners in accordance with a particular healthcare institution's internal procedures, as well as current medical practice guidelines. Epidural medication administration is most commonly used alone for analgesia to provide pain relief anywhere in a patient's lower body and as high as the chest, and is frequently employed during childbirth and for post-operative analgesia after an operation. However, a practitioner may also utilize it for an adjunct to general anesthesia during a wide variety of surgery, for example gynecological surgery (e.g. hysterectomy), orthopedic surgery (e.g. hip replacement), general surgery (e.g. laparotomy) and vascular surgery (e.g. open aortic aneurysm repair). Additionally, epidural administration procedures are also performed as a sole technique for surgical anesthesia, most frequently in Caesarean sections, for example, which can allow the patient to remain awake during the operation.

Anatomical Location of Use and Description of Users: The proposed device will be used during epidural administration procedures to allow for administration of local anesthetic medications into the epidural space of a patient. The epidural space is the area between the vertebral wall, containing fat and small blood vessels. Also in contact with the inner surface of the dura is another membrane called the arachnoid mater ("arachnoid"), which is the membrane that contains the cerebrospinal fluid surrounding the spinal cord. Therefore, epidural administration procedures, which involve inserting and threading an epidural needle between the bone, through the ligaments, and into the epidural space, are required to be performed only by trained and technically proficient healthcare practitioners, as great care needs to be taken to avoid puncturing the layer immediately below containing CSF. The level of the spine at which the catheter is best placed is dictated by the practitioner performing the procedure and depends mainly on the site and type of intended operation or the anatomical origin of pain. After placement of the tip of the needle into the epidural space, an epidural catheter, like the proposed device, is threaded approximately 3 to 4 centimeters through the needle is then withdrawn over the catheter.

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Image /page/6/Picture/1 description: The image shows the logo for Medline. The logo is set against a blue square background. The word "MEDLINE" is written in white, block letters on the left side of the square. To the right of the word is a white, stylized starburst symbol. A gray bar is visible in the upper right corner of the image.

Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093

Generally, while the catheter's placement is being maintained, it will be secured to a patient's skin with adhesive tape to prevent it from becoming dislodged.

Please refer to Figure 1 and Figure 2 for photographs of the proposed device.

Figure 1: Medline Reinforced Epidural Catheter (Photograph 1 of 2)

Image /page/6/Picture/6 description: The image shows a coiled medical guidewire on a white surface. The guidewire is silver and has black markings at regular intervals along its length. One end of the guidewire has a blue connector, while the other end is straight and unmarked. The guidewire is coiled in a circular pattern, with some sections overlapping.

Figure 2: Medline Reinforced Epidural Catheter (Photograph 2 of 2)

Image /page/6/Picture/8 description: The image shows two medical guidewires on a white surface. The guidewire on the top is straight and has a blue connector at one end and black markings along its length. The guidewire on the bottom is longer and curved, with a single black marking near one end.

Indications for Use

The Medline Reinforced Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 221bs. (10kg), for a duration of use up to 72 hours.

Summary of Technological Characteristics

Table 1 on the following page provides a side-by-side comparison between the proposed device, the Medline Reinforced Epidural Cather, and the predicate device, the ARROW® Flextip Plus® Epidural Catheter (K140110).

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Device Characteristic	Proposed Device	Predicate Device	ComparisonAnalysis
Product Name	Medline Reinforced Epidural Catheter	ARROW® FlexTip Plus® Epidural Catheters	N/A
510(k) Reference	TBD	K140110	N/A
Product Owner	Medline Industries, Inc.	Teleflex	N/A
Product Code	BSO	BSO	Same
Intended Use	Indicated for the injection of local anestheticsinto the epidural space for patients over 22lbs.(10kg), for duration of use up to 72 hours.	Permits access to the epidural space for theadministration of epidural anesthetic. The epiduralcatheter is intended for use up to 72 hours.	Same
Regulation Number	21 CFR 868.5120	21 CFR 868.5120	Same
Design Features	Single lumenInternal radiopaque reinforced coiled wireClosed tip design - 2 ports	Single lumenInternal radiopaque reinforced coiled wireAvailable in open or closed tip design	Similar
Materials	Polyurethane Tubing	Polyurethane Tubing	Same
Available in Sterile KitConfigurations	Yes	Yes	Same
Dimensions	19G x 913mm	19G x 900mm	Similar
Prescription vs. OTC	Prescription Use Only	Prescription Use Only	Same
Contact Type and Duration	Externally communicating/Contact-blood path, indirect /Duration: prolonged use (>24 hours <30days).	Externally communicating/Contact-blood path, indirect /Duration: prolonged use (>24 hours <30days).	Same
Patient Population	Adult (patients weighing over 10kg)	Adult	Same
Sterile vs. Non-Sterile	Sterile	Sterile	Same
Sterilization Method	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single Use	Single Use	Same
"MR Conditional" Claim	No	Yes	Different
Non-pyrogenic Claim	Yes (use for fluid pathway contacting components)	Yes	Similar
Shelf Life	1 year	Not indicated	N/A

Table 1: Comparison of Proposed and Predicate Devices

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Image /page/8/Picture/1 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white starburst-like symbol. The background is a solid dark blue color. The starburst symbol has four points, two pointing horizontally and two pointing vertically.

Medline Industries, Inc Three Lakes Drive Northfield. IL 60093

Shelf Life and Sterilization

The proposed Medline Reinforced Epidural Catheter is terminally sterilized by Ethylene Oxide (EO). The sterilization validation for the proposed device has been conducted in accordance with ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices, to ensure a Sterility Assurance Level (SAL) of 1 x 106. The proposed device has also been evaluated for EO and Ethylene Chlorohydrin (ECH) residuals in accordance with ISO 10993-7:2008(R)2012, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.

Additionally, in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify a one-year shelf life of the subject device and ensure that its functionality and sterility are successfully maintained throughout the duration of this shelf life. For additional information on the sterilization and shelf life of the proposed device, please refer to Section 14 of this submission.

Summary of Non-Clinical Testing

Non-clinical verification of the Medline Reinforced Epidural Catheter has been conducted to evaluate its safety, performance and functionality. The results of these tests have demonstrated the overall safety of the proposed device and its effectiveness in accordance with relevant test methods, and ultimately support a substantial equivalence determination. Particularly, chemical, safety, and functional performance testing of the Medline Reinforced Epidural Catheter were conducted to adequately demonstrate the effectiveness of this device in accordance with relevant test methods cited below:

Chemical Safety Testing

Particulate Matter Testing in accordance with USP <788> Particulate Matter Injections ●
Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP ● <85> Bacterial Endotoxin Testing

Functional Performance Testing

Kink Testing ●
Dimensional Analysis
Simulated Distribution Testing in accordance with ISTA 3A-2018 General Simulation . Performance Test Procedure for Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
Transportation Testing in accordance with ASTM D4169-16 Standard Practice for ● Performance Testing of Shipping Containers and Systems
Visual Appearance Testing ●
Ink Adherence Testing
Tensile Strength Testing in accordance with ASTM D412-16 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension*

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Image /page/9/Picture/1 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in white, bold, sans-serif font, set against a blue background. Above the word "MEDLINE" is a white, stylized starburst or cross shape. The overall design is simple and corporate, commonly used for branding purposes.

Medline Industries. Inc Three Lakes Drive Northfield. IL 60093

Flow Rate Testing in accordance with ASTM F623-99 Standard Performance Specification ● for Foley Catheter (Flow Rate)*
Connector Pull Out Testing ●
Leakage Testing in accordance with ISO 80369-6 Small-bore connectors for liquids and ● gases in healthcare applications – Part 6: Connectors for neuraxial applications**
Packaging Integrity Testing in accordance with ASTM F1929-15 Standard Test Method for ● Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Seal Strength Testing in accordance with ASTM F88-16 Standard Test Method for Seal Strength of Flexible Barrier Materials
. X-Ray Opaque Detection Testing

Additional information regarding the performance testing described above is located in Section 18 of this submission. In addition, full performance testing reports for the Medline Reinforced Epidural Catheter can be found in Appendix F.

The biocompatibility evaluation for the Medline Reinforced Epidural Catheter was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The proposed device is classified as an externally communicating device that comes in indirect contact with the blood path for a prolonged duration of use (>24 hours, <30days). The following biocompatibility tests were performed:

Cytotoxicity – ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro Cytotoxicity
Sensitization ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: ● Test for Irritation and Skin Sensitization
Irritation ISO 10993-10 2010 Biological Evaluation of Medical Devices-Part 10: Tests ● for Irritation and Skin Sensitization
Acute Systemic Toxicity ISO 10993-11: 2017 ISO 10993-11: 2017 Biological ● Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
Material-Mediated Pyrogenicity USP <151> Pvrogen Test as recommended in ISO ● 10993-11:2006 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
Hemolysis ASTM F756. Standard Practice for Assessment of Hemolytic Properties of ● Materials and ISO 10993-Part 4:2017 Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood
Subacute Systemic Toxicity-- ISO 10993-11: 2006 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
Chemical Characterization ISO 10993-18:2005 Biological Evaluation of Medical ● Devices – Part 18: Chemical Characterization of Materials

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Image /page/10/Picture/1 description: The image is a logo for Medline. The logo features the word "MEDLINE" in a sans-serif font, stacked on top of a white starburst-like shape. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a memorable graphic.

dline Indu

Final biocompatibility test protocols and reports are available for the Agency's review in Appendix E.

Summary of Clinical Testing

Not applicable. No clinical testing was conducted on the proposed device.

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Reinforced Epidural Catheter (i.e. REPICATH19) is substantially equivalent to the predicate device, ARROW® FlexTip Plus® Epidural Catheters (K140110).

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).