(436 days)
Not Found
No
The summary describes a physical catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as permitting "access to the administration of epidural anesthetic," which is a therapeutic intervention.
No
The device is used for the administration of anesthetic, which is a treatment, not a diagnosis.
No
The device description clearly indicates a physical catheter made of polyurethane with wire reinforcement, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit access to the administration of epidural anesthetic." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a catheter for delivering substances into the body, not for analyzing samples taken from the body.
- Anatomical Site: The epidural space is a location within the body where the device is used, not a sample being analyzed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
Product codes (comma separated list FDA assigned to the subject device)
BSO, CAZ
Device Description
ARROW® FlexTip Plus® Epidural Catheters are single lumen catheters featuring a wire re-enforced polyurethane body with centimeter markings to facilitate placement.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation of Magnetic Field Interactions, Heating and Artifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90-cm, Nonmagnetic SS Version by Shellock R&D Services, 12/09/11, Revised 7/15/2013. The same testing was submitted in support of the MR Conditional statements cleared in the predicate 510(k) K103658. However, the test was found to contain an error and was revised, producing the 7/15/2013 version of the report. This performance testing is presented in support of the MR Conditional statements and is not intended to support substantial equivalence.
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).
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2015
Teleflex, Inc. ARROW International, Inc. Chet Jones Regulatory Affairs Specialist 2400 Bernville Rd. Reading, PA 19605
Re: K140110
Trade/Device Name: ARROW FlexTip Plus Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO, CAZ Dated: February 23, 2015 Received: February 24, 2015
Dear Mr. Jones:
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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,
Erin I. Keith -S
Erin I. Keith, M.S. Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140110
Device Name
ARROW® FlexTip Plus® Epidural Catheter
Indications for Use (Describe)
The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/1 description: The image features the logo for Arrow International. The word "ARROW" is written in large, white, sans-serif font, with a horizontal line extending from the left side of the "A" to the left side of the "R". Below "ARROW", the word "INTERNATIONAL" is written in a smaller, white, sans-serif font. The background is a solid blue color.
Submitter Information
| Name | ARROW International, Inc. (subsidiary of Teleflex Inc.) |
|---|---|
| Address | 4024 Stirrup Creek Dr., Suite 720 |
| PO Box 12600 | |
| Durham, NC 27703 | |
| Phone number | 919-433-2579 |
| Fax number | 919-433-4996 |
| Contact Person | Chet Jones |
| Date prepared | June 30, 2014 (Revised March 26, 2015) |
Trade Name
- ARROW® FlexTip Plus® Epidural Catheters
Common/Usual Name
- Epidural Catheter
Classification Name
Catheter:
BSO - Anesthesia Conduction Catheter 21 CFR 868.5120 Class 2
Kit:
CAZ – Anesthesia Conduction Kit 21 CFR 868.5140 Class 2
Predicate Device
- FlexTip Plus Epidural Catheter - K103658
Modification and Changes to Predicate
The purpose of this traditional 510(k) is to update the MR Conditional statements in the Instructions for Use (IFU). The update is based on magnetic resonance testing performed by Shellock R&D Services. The purpose of the update is to make a correction and to align the MR Conditional statements to the current best practices.
The update to the MR Conditional statements in the IFU is the only modification. The devices that are the subject of this submission are identical to their respective predicates in all other respects, including their technological characteristics, materials, indications for use, and FDA classification.
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Image /page/5/Picture/1 description: The image shows the logo for Arrow International. The word "ARROW" is in large, bold, white letters on the top line. Below that, the word "INTERNATIONAL" is in smaller, white letters. The background is a solid blue color.
Device Description
ARROW® FlexTip Plus® Epidural Catheters are single lumen catheters featuring a wire re-enforced polyurethane body with centimeter markings to facilitate placement.
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.
Substantial Equivalence Comparison to Predicates
ARROW FlexTip Plus Epidural Catheters were cleared under K103658. No changes have been made to the catheters or components since receiving clearance. Substantial equivalence between the device subject of this submission and the predicate device is based upon the fact that they are identical in regards to technological characteristics, design, materials, indications for use, and FDA classification.
The only change for these devices is an update to the MR Conditional labeling based on magnetic resonance testing performed by Shellock R&D Services. The update are provided in Section 014 Proposed Labeling. The test report is provided in Attachment C.
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Image /page/6/Picture/1 description: The image shows the logo for Arrow International. The word "ARROW" is in large, white, sans-serif font on the top line. Below that, the word "INTERNATIONAL" is in a smaller, white, sans-serif font. The background is a solid blue color.
| Characteristic | Comparison to Predicate |
|---|---|
| Product Classification | No change |
| Intended Use | No change |
| Technological Characteristics | No change |
| Materials | No change |
| MR Conditional Labeling | See Table 1 in Section 014 Proposed Labeling. |
| Performance Testing | Evaluation of Magnetic Field Interactions, Heating and |
| Artifacts for FlexTip Plus Epidural Catheter, 19-gauge x 90- | |
| cm, Nonmagnetic SS Version by Shellock R&D Services, | |
| 12/09/11, Revised 7/15/2013. * |
Table 1 Substantial Equivalence Comparison to Predicates
- The same testing was submitted in support of the MR Conditional statements cleared in the predicate 510(k) K103658. However, the test was found to contain an error and was revised, producing the 7/15/2013 version of the report. This performance testing is presented in support of the MR Conditional statements and is not intended to support substantial equivalence. Substantial equivalence is based upon the devices being identical to their predicates in all respects.
Substantial Equivalence Conclusion
The proposed update to the MR Conditional labeling establishes parameters for the safe use of these catheters in a magnetic resonance environment. It does not impact the safety and effectiveness of ARROW FlexTip Plus Epidural Catheters, and does not raise new questions of safety or efficacy.