Medline Epidural Catheter

K150731 · Medline Industries, Inc. · BSO · Mar 7, 2016 · Anesthesiology

Device Facts

• Record ID: K150731
• Device Name: Medline Epidural Catheter
• Applicant: Medline Industries, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Mar 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Medline Epidural Catheter is a single-use, flexible nylon tube designed for epidural anesthesia delivery. Device features a closed tip with 3 eyes for anesthetic distribution and a black radiopaque stripe for visualization. Catheter includes depth markings (1cm increments up to 25cm) and a wide warning mark indicating exit from the needle. Used in clinical settings by healthcare professionals; intended for use with a cleared epidural catheter connector. Device facilitates continuous or intermittent anesthetic administration, potentially benefiting patients requiring regional anesthesia or pain management.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-5, -10, -11), hemolysis (ASTM F 756-13), pyrogenicity (USP <151>), flow rate (ASTM F 623), tensile strength, and radiopacity.

Technological Characteristics

Flexible nylon tubing; 19G diameter; 800mm length; closed tip with 3 eyes; black radiopaque stripe; depth markings. Biocompatibility per ISO 10993; flow rate per ASTM F 623. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for injection of local anesthetics into the epidural space for patients > 22 lbs (10 kg) for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• B. Braun Medical, Inc. - Perifix Catheter and Contiplex Catheter (K042488)

Reference Devices

• Epidural catheter connector (K051171)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: [phone] Fax: [phone]

#### 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

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.

### Indications for Use

{4}------------------------------------------------

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 AND<br>CONTIPLEX CATHETER | n/a |
| 510(k) | To be assigned | K042488 | n/a |
| Intended Use | The Medline Epidural<br>Catheter is indicated for the<br>injection of local anesthetics<br>into the epidural space for<br>patients over 22 lbs. (10kgs.) | The B. Braun Regional Anesthesia<br>Catheter is a device intended to<br>provide, via percutaneous<br>administration, continuous and/or<br>intermittent infusion of local<br>anesthetics and analgesics in the<br>epidural space or near a nerve for<br>regional anesthesia and pain<br>management during the pre-<br>operative, perioperative and<br>postoperative periods associated<br>with general and orthopedic surgery<br>as well as labor and delivery. Routes<br>of administration include epidural and<br>perineural (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 |
| Catheter<br>markings | 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:

{5}------------------------------------------------

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 Test<br>Procedure, Section <151><br>(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.