(183 days)
Not Found
No
The summary describes a physical medical device (catheter kit) and its intended use for nerve blocks. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on physical properties like MRI compatibility.
Yes
The device is used to place catheters for continuous nerve block anesthesia or analgesia, directly treating pain and providing anesthesia, which are therapeutic functions.
No.
This device is designed for the placement of catheters for continuous nerve block anesthesia or analgesia, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components such as a catheter, adapter, stylet, needle, and other procedural components, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for placing catheters in vivo (within the body) for continuous nerve block anesthesia or analgesia. This is a therapeutic and procedural use, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a catheter, adapter, stylet, and needles, all components used for insertion and delivery of substances within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an IVD.
N/A
Intended Use / Indications for Use
The ARROW FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
The ARROW FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Product codes
CAZ
Device Description
The Arrow® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set features a wire reinforced, polyurethane body with centimeter markings to facilitate placement for continuous plexus and peripheral nerve blocks. The catheter includes a SnapLock™ adapter to enable infusion of medications, and a stylet for enhanced maneuverability. Procedural trays also include a stimulating or non-stimulating plexus block needle, and other procedural components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations
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)
MRI Testing, Shellock, 2011
Evaluation of magnetic field interactions at 3-Tesla; MRI-related heating at 1.5-Tesla and 3-Tesla; and MRI imaging artifacts at 3-Tesla. The evaluation concluded that the FlexBlock Catheter should be labeled as MR Conditional and included labeling guidelines in the report.
MRI Testing, Exponent, 2015
This study evaluated the MRI compatibility of the catheter in regards to radiofrequency (RF)-induced heating in 1.5 T and 3 T clinical scanners. The evaluation was conducted using methodologies prescribed in ASTM F2182 as a guide and modified for using a transmit/receive (TR) head coil. The evaluation concluded that the FlexBlock Catheter should be labeled as MR Conditional and included labeling guidelines in the report.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2016
Arrow International, Inc. (subsidiary of Teleflex Inc.) Jim Cochie Senior Regulatory Affairs Manager 3015 Carrington Mill Blvd Morrisville, North Carolina 27560
Re: K153652
Trade/Device Name: ARROW® FlexBlock® Continuous Peripheral Nerve Block Kit/Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: Class II Product Code: CAZ Dated: May 13, 2016 Received: May 16, 2016
Dear Jim Cochie:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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
2
Indications for Use
510(k) Number (if known) K153652
Device Name
ARROW® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set
Indications for Use (Describe)
The ARROW FlexBlock Continuous Peripheral Nerve Block Kit'Set permits placement of catheters and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Type of Use (Select one or both, as applicable)
2 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)
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 features the logo for Arrow International. The word "ARROW" is in large, bold, white letters, with the word "INTERNATIONAL" in smaller white letters underneath. The background is a solid, dark blue color, providing a strong contrast that makes the text stand out.
Submitter Information
| Name | ARROW International, Inc. (subsidiary of Teleflex Inc.) |
|---|---|
| Address | 3015 Carrington Mill |
| Blvd Morrisville, NC, | |
| 27560 | |
| Phone number | 919-433-2703 |
| Fax number | 919-433-4996 |
| Contact Person | Jim Cochie, Sr. Manager, Regulatory Affairs, Anesthesia, Teleflex |
| Inc. Date prepared | December 17, 2015, revised June 14, 2016 |
Trade Name
ARROW® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set
Common/Usual Name
Anesthesia Conduction Kit
Classification
Regulation: 21 CFR 868.5140
Class: II
Product Code: CAZ - Anesthesia Conduction Kit
Predicate Device
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter - K122027 Modification and Changes to Predicate
The purpose of this 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 and Exponent, Inc. The purpose of the update is to align the MR Conditional statements to the current best practices, and to respond to questions from the FDA on the possibility of induced heating and unintended stimulation (induced voltage) that were posed during the review of K140110.
The update to the MR Conditional statements in the IFU is the only modification. The device that is the subject of this submission is identical to it's predicate in all other respects, including the technological characteristics, materials, indications for use, and FDA classification.
Device Description
The Arrow® FlexBlock® Continuous Peripheral Nerve Block Catheter Kit/Set features a wire reinforced, polyurethane body with centimeter markings to facilitate placement for continuous plexus and peripheral nerve blocks. The catheter includes a SnapLock™ adapter to enable infusion of medications, and a stylet for enhanced maneuverability. Procedural trays also include a stimulating or non-stimulating plexus block needle, and other procedural components.
4
Image /page/4/Picture/1 description: The image features the logo for "ARROW INTERNATIONAL" in white text against a blue background. The word "ARROW" is in a larger, bolder font, with a horizontal line extending from the left side of the "A" to the right side of the "W". Below "ARROW" is the word "INTERNATIONAL" in a smaller, less bold font. A registered trademark symbol is to the right of the word "ARROW".
Indications for Use
The ARROW FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.
Substantial Equivalence Comparison to Predicate
ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set was cleared under K122027. No changes have been made to the catheters or components since receiving clearance. Substantial equivalence between the devices subject of this submission and their respective predicate devices is based on 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. Table 1 provides a substantial equivalence comparison to the predicate.
5
Image /page/5/Picture/1 description: The image shows the logo for Arrow International. The word "ARROW" is in large, white, sans-serif font on a blue background. Below that, the word "INTERNATIONAL" is in a smaller, white, sans-serif font.
| Characteristic | Predicate | Proposed |
|---|---|---|
| Product | ||
| Classification | II | No change |
| Intended Use | The ARROW FlexBlock Continuous | |
| Peripheral Nerve Block Kit/Set permits | ||
| placement of catheters next to nerves and | ||
| nerve plexuses for continuous nerve block | ||
| anesthesia or analgesia techniques including | ||
| upper extremity, lower extremity, abdominal | ||
| and paravertebral locations for periods not | ||
| exceeding 72 hours. | ||
| Technological | ||
| Characteristics | The catheter features a wire reinforced, | |
| polyurethane body with centimeter markings. | No change | |
| Materials | Inner coil = XM19 Stainless Steel | |
| Outer body = Polyurethane | No change |
Table 1 Substantial Equivalence Comparison to Predicate
Substantial Equivalence Conclusion
The proposed update to the MR Conditional labeling establishes parameters for the use of these catheters in a magnetic resonance environment. It does not impact the substantial equivalence of ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set, and does not raise different questions of safety or effectiveness.
Non-Clinical Testing
Non-Clinical testing was conducted as the basis of the MR Conditional claims that are proposed in this 510(k). The testing is listed in Table 2 below. Summaries of the testing are provided as well. The test article in both cases was the 19 ga FlexBlock catheter.
| Testing | Summary |
|---|---|
| MRI Testing, Shellock, 2011 | Evaluation of magnetic field interactions at 3-Tesla; MRI-related |
| heating at 1.5-Tesla and 3-Tesla; and MRI imaging artifacts at 3- | |
| Tesla. The evaluation concluded that the FlexBlock Catheter | |
| should be labeled as MR Conditional and included labeling | |
| guidelines in the report. | |
| MRI Testing, Exponent, 2015 | This study evaluated the MRI compatibility of the catheter in |
| regards to radiofrequency (RF)-induced heating in 1.5 T and 3 T | |
| clinical scanners. The evaluation was conducted using | |
| methodologies prescribed in ASTM F2182 as a guide and | |
| modified for using a transmit/receive (TR) head coil. | |
| The evaluation concluded that the FlexBlock Catheter should be | |
| labeled as MR Conditional and included labeling guidelines in the report. |
Table 2 Non-Clinical Testing
6
Image /page/6/Picture/1 description: The image is a 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.
The conclusions drawn from the non-clinical tests inform the MRI labeling that is proposed in this 510(k), K153652. As there is no change to the catheter itself, we can conclude that the device is substantially equivalent to the predicate 510(k) K122027.