(244 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a catheter, with no mention of AI or ML.
Yes
The device is indicated for the injection of local anesthetics into the epidural space, a direct intervention to manage pain, which is a therapeutic action.
No
The device is an epidural catheter indicated for injecting local anesthetics, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical, single-use catheter made of polyurethane elastomer tubing with an internal radiopaque spring and markings. The performance studies focus on physical and chemical properties, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "injection of local anesthetics into the epidural space". This is a direct medical intervention on a patient's body.
- Device Description: The device is a catheter designed to be inserted into the body for delivering medication.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a medical device used for drug delivery within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BSO
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.
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 22lbs. (10kg)
Intended User / Care Setting
trained healthcare practitioners in accordance with a particular healthcare institution's internal procedures, as well as current medical practice guidelines.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Particulate Matter Injections
- Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP 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
- 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
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, 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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)
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 PRAStaff@fda.hhs.gov
"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/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
4
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
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. The proposed Medline Reinforced Epidural Catheter will be available in the following design configuration:
| 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.
5
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.
6
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).
7
| Device Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 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 anesthetics
into the epidural space for patients over 22lbs.
(10kg), for duration of use up to 72 hours. | Permits access to the epidural space for the
administration of epidural anesthetic. The epidural
catheter is intended for use up to 72 hours. | Same |
| Regulation Number | 21 CFR 868.5120 | 21 CFR 868.5120 | Same |
| Design Features | Single lumen
Internal radiopaque reinforced coiled wire
Closed tip design - 2 ports | Single lumen
Internal radiopaque reinforced coiled wire
Available in open or closed tip design | Similar |
| Materials | Polyurethane Tubing | Polyurethane Tubing | Same |
| Available in Sterile Kit
Configurations | 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 24 hours Particulate Matter Injections ●
- Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP ● 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*
9
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, 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
10
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).