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

Device Description

The Medline Epidural Catheter is a single use device made of flexible, nylon tubing which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The epidural catheter is designed as a closed tip device with 3 eyes for distribution of anesthetic agents. The catheters have a black radiopaque stripe. The catheter is available in 19G and is 800 millimeters long. The catheter has a marked tip, with 1cm increments up to 25cm. The 10cm mark is indicated by two marks, 15cm by three marks, 20cm by four marks and 25cm by five marks. As an added safety feature, the solid wide warning mark indicates exit of catheter from needle when using a Medline Epidural Needle. This device is intended to be used in conjunction with an epidural catheter connector cleared under K051171.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Medline Epidural Catheter, seeking to demonstrate its substantial equivalence to a predicate device. This document does not pertain to an AI/ML device, and therefore, many of the requested criteria related to AI/ML device evaluation are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

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

The document does not explicitly present "acceptance criteria" in the typical sense for an AI/ML device where specific metrics like sensitivity, specificity, or AUC are outlined. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here are implicitly that the device performs comparably to the predicate or within established safety and performance standards for its type, as indicated by the "Pass" results for each test.

Standard or Reference	Test Method	Data Generated	Reported Device Performance (Result)
ISO 10993-5	Cytotoxicity	Cytotoxicity	Pass
ISO 10993-10	Intracutaneous reactivity	Dermal irritation	Pass
ISO 10993-10	Maximization sensitization	Dermal sensitization	Pass
ISO 10993-11	Subacute toxicity	Subacute toxicity	Pass
ISO 10993-11	Systemic injection	Systemic injection	Pass
ASTM F 756-13	Hemolysis assay	Hemolytic potential	Pass
USP Pyrogen Test Procedure, Section <151> (USP37)	Pyrogen	Non-pyrogenic	Pass
ASTM F 623	Flow rate	Flow rate	Pass
Not specified	Extractables analysis	Extractables analysis	No toxicological risk
Not specified	Appearance / ink / x-ray detection	Visual appearance / ink tenacity / x-ray detection	Pass
Not specified	Tensile strength	Tensile properties	Pass
Not specified	Particulate matter	Particulate size	Pass
Not specified	Kink / dimensional analysis testing	Flow rate / marking accuracy	Pass

2. Sample size used for the test set and the data provenance

The document provides a summary of non-clinical testing. It does not specify sample sizes for each test listed. The tests are laboratory-based and material-based, not involving patient data or clinical samples in the way an AI/ML device would. Data provenance is not applicable in the context of clinical populations for these types of tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical evaluation of a physical medical device. Ground truth is established by standardized laboratory methods and measurements, not by expert interpretation of data.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting images or clinical cases, which is not relevant to the non-clinical testing of this 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 device is not an AI-assisted diagnostic or therapeutic tool. No human reader studies (MRMC) were performed.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The ground truth for the non-clinical tests is based on established scientific and engineering standards and measurements (e.g., ISO, ASTM, USP standards) for material properties (cytotoxicity, dermal irritation, etc.), physical performance (flow rate, tensile strength), and safety (pyrogenicity, extractables).

8. The sample size for the training set

Not applicable. This device does not involve training data as it is not an AI/ML model.

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

Not applicable. This device does not involve training data.

Summary

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

March 7, 2016

Medline Industries, Inc. Matt Clausen Sr. Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060

Re: K150731

Trade/Device Name: Medline Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: October 27, 2015 Received: October 30, 2015

Dear Matt Clausen:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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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. 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) K150731

Device Name Medline Epidural Catheter

Indications for Use (Describe)

The Medline Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for patients over 22 lbs. (10kgs.), for a duration of use of 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/0 description: The image shows the logo for Medline. The word "MEDLINE" is written in blue, stylized, sans-serif font. Below the text is a blue, four-pointed star-like shape, with the bottom point extending further down than the other three. The logo is simple and clean, using only the color blue.

510(k) Summary (as required per 21 CFR 807.92)

Summary Preparation Date

March 4, 2016

Submitter / 510(k) Sponsor

Medline Industries, Inc. 1 Medline Place Mundelein, IL 60060

Contact Person

Matt Clausen Sr. Regulatory Affairs specialist Phone: 847-643-4785 Fax: 847-643-4482

Device Name / Classification

Device Name: Epidural Catheter Proprietary Name: Medline Epidural Catheter Common Name: Epidural Catheter or Anesthesia Conduction Catheter Classification Name: Catheter, Conduction, Anesthetic (21 CFR 868.5120, product code - BSO)

Predicate Device

B. BRAUN MEDICAL, INC. - PERIFIX CATHETER AND CONTIPLEX CATHETER, K042488

Device Description

Indications for Use

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Image /page/4/Picture/0 description: The image shows the Medline logo. The word "MEDLINE" is written in blue, with a stylized star-like shape extending above and below the text. The star shape is also in blue and appears to be a compass rose.

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

Summary of Technological Characteristics

Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's Epidural Catheter and the cited predicate device.

A summary of the technological characteristics of this subject device compared to the predicate device is provided below.

Attribute	Subject Device	Predicate Device	Comparison
Product	Medline's Epidural Catheter	PERIFIX CATHETER ANDCONTIPLEX CATHETER	n/a
510(k)	To be assigned	K042488	n/a
Intended Use	The Medline EpiduralCatheter is indicated for theinjection of local anestheticsinto the epidural space forpatients over 22 lbs. (10kgs.)	The B. Braun Regional AnesthesiaCatheter is a device intended toprovide, via percutaneousadministration, continuous and/orintermittent infusion of localanesthetics and analgesics in theepidural space or near a nerve forregional anesthesia and painmanagement during the pre-operative, perioperative andpostoperative periods associatedwith general and orthopedic surgeryas well as labor and delivery. Routesof administration include epidural andperineural (peripheral nerve block).	Same
Usage	Prescription use only	Prescription use only	Same
Materials	Polymer nylon	Polyamide/polyurethane	Similar
How supplied	Sterile	Sterile	Same
Diameter	19 and 20 gauge	19 and 20 gauge	Same
Length	800 millimeters	400-1010 millimeters	Similar
Type	Closed tip / 3 eyelits	Closed, open tips / 3-6 eyelits	Similar
Cathetermarkings	1-5 rings (black ink)	1-4 rings (blue ink)	Similar

Based on the differences in the table above the following tests were performed to mitigate risks:

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with the letters in red. Below the word is a blue star-like symbol with four points. The logo is simple and recognizable, and it is likely used to represent the Medline company or its products.

Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486

Summary of Non-Clinical Testing

The substantial equivalence of Medline's Epidural Catheter is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. Functional performance testing of the Medline Epidural Catheter demonstrates device substantial equivalence in accordance with relevant test methods.

Standard or Reference	Test Method	Data Generated	Test Result
ISO 109993-5	Cytotoxicity	Cytotoxicity	Pass
ISO 109993-10	Intracutaneous reactivity	Dermal irritation	Pass
ISO 109993-10	Maximization sensitization	Dermal sensitization	Pass
ISO 109993-11	Subacute toxicity	Subacute toxicity	Pass
ISO 109993-11	Systemic injection	Systemic injection	Pass
ASTM F 756-13	Hemolysis assay	Hemolytic potential	Pass
USP Pyrogen TestProcedure, Section <151>(USP37)	Pyrogen	Non-pyrogenic	Pass
ASTM F 623	Flow rate	Flow rate	Pass
	Extractables analysis	Extractables analysis	No toxicological risk
	Appearance / ink / x-ray detection	Visual appearance / ink tenacity / x-ray detection	Pass
	Tensile strength	Tensile properties	Pass
	Particulate matter	Particulate size	Pass
	Kink / dimensional analysis testing	Flow rate / marking accuracy	Pass

Summary of Clinical Testing

Not applicable.

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 Epidural Catheter is as safe, as effective and substantially equivalent to the predicate device [K042488] as described herein.

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).