(353 days)
No
The device description and performance studies focus on the physical properties and safety of a catheter, with no mention of AI or ML.
Yes.
The device is used for the injection of local anesthetics for pain management, which constitutes a therapeutic application.
No
The device is an epidural catheter, indicated for the injection of local anesthetics. Its purpose is therapeutic (drug delivery), not diagnostic.
No
The device description clearly states it is a physical device made of nylon tubing with specific dimensions and features, intended for insertion into the body. It also details physical performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Medline Epidural Catheter is a device used to deliver local anesthetics directly into the epidural space within the body. It is a physical device used for a therapeutic purpose (pain management via anesthetic delivery), not for analyzing biological specimens outside the body.
- Intended Use: The intended use clearly states "for the injection of local anesthetics into the epidural space". This is a direct intervention within the body, not an in vitro test.
Therefore, the Medline Epidural Catheter falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
BSO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
patients over 22 lbs. (10kgs.)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Functional performance testing of the Medline Epidural Catheter demonstrates device substantial equivalence in accordance with relevant test methods.
- ISO 109993-5, Test Method: Cytotoxicity, Data Generated: Cytotoxicity, Test Result: Pass
- ISO 109993-10, Test Method: Intracutaneous reactivity, Data Generated: Dermal irritation, Test Result: Pass
- ISO 109993-10, Test Method: Maximization sensitization, Data Generated: Dermal sensitization, Test Result: Pass
- ISO 109993-11, Test Method: Subacute toxicity, Data Generated: Subacute toxicity, Test Result: Pass
- ISO 109993-11, Test Method: Systemic injection, Data Generated: Systemic injection, Test Result: Pass
- ASTM F 756-13, Test Method: Hemolysis assay, Data Generated: Hemolytic potential, Test Result: Pass
- USP Pyrogen Test Procedure, Section (USP37), Test Method: Pyrogen, Data Generated: Non-pyrogenic, Test Result: Pass
- ASTM F 623, Test Method: Flow rate, Data Generated: Flow rate, Test Result: Pass
- Not Specified, Test Method: Extractables analysis, Data Generated: Extractables analysis, Test Result: No toxicological risk
- Not Specified, Test Method: Appearance / ink / x-ray detection, Data Generated: Visual appearance / ink tenacity / x-ray detection, Test Result: Pass
- Not Specified, Test Method: Tensile strength, Data Generated: Tensile properties, Test Result: Pass
- Not Specified, Test Method: Particulate matter, Data Generated: Particulate size, Test Result: Pass
- Not Specified, Test Method: Kink / dimensional analysis testing, Data Generated: Flow rate / marking accuracy, Test Result: Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 (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
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
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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 AND | |
| CONTIPLEX CATHETER | n/a | ||
| 510(k) | To be assigned | K042488 | n/a |
| Intended Use | The Medline Epidural | ||
| Catheter is indicated for the | |||
| injection of local anesthetics | |||
| into the epidural space for | |||
| patients over 22 lbs. (10kgs.) | The B. Braun Regional Anesthesia | ||
| Catheter is a device intended to | |||
| provide, via percutaneous | |||
| administration, continuous and/or | |||
| intermittent infusion of local | |||
| anesthetics and analgesics in the | |||
| epidural space or near a nerve for | |||
| regional anesthesia and pain | |||
| management during the pre- | |||
| operative, perioperative and | |||
| postoperative periods associated | |||
| with general and orthopedic surgery | |||
| as well as labor and delivery. Routes | |||
| of administration include epidural and | |||
| 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 | |||
| 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:
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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 Test | |||
| Procedure, Section | |||
| (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.