ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set

K153652 · Teleflex, Inc. · CAZ · Jun 21, 2016 · Anesthesiology

Device Facts

• Record ID: K153652
• Device Name: ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set
• Applicant: Teleflex, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Jun 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The ARROW FlexBlock is a wire-reinforced, polyurethane catheter kit used for continuous peripheral nerve block anesthesia or analgesia. The device is placed by a clinician to deliver medication to nerve plexuses. It features a SnapLock adapter for infusion and a stylet for maneuverability. The kit includes a plexus block needle. The device is used in clinical settings to provide localized pain management. This submission updates the MR Conditional labeling based on non-clinical testing to address potential RF-induced heating and induced voltage in 1.5T and 3T MRI environments. The device itself remains unchanged from the predicate.

Clinical Evidence

No clinical data. Bench testing only. Non-clinical MRI compatibility testing was performed by Shellock R&D Services (2011) and Exponent, Inc. (2015) to evaluate magnetic field interactions, RF-induced heating at 1.5T and 3T, and imaging artifacts. Testing followed ASTM F2182 guidelines.

Technological Characteristics

Wire-reinforced polyurethane catheter; inner coil of XM19 stainless steel; includes SnapLock adapter and stylet; centimeter markings for placement. MR Conditional. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring continuous nerve block anesthesia or analgesia in upper extremity, lower extremity, abdominal, or paravertebral locations for up to 72 hours.

Regulatory Classification

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.

Predicate Devices

• ARROW FlexBlock Continuous Peripheral Nerve Block Catheter (K122027)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [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

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# 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)

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## Submitter Information

| Name | ARROW International, Inc. (subsidiary of Teleflex Inc.) |
|--------------------|-------------------------------------------------------------------|
| Address | 3015 Carrington Mill<br>Blvd Morrisville, NC,<br>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.

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## 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.

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| Characteristic | Predicate | Proposed |
|----------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Classification | II | No change |
| | Intended Use | The ARROW FlexBlock Continuous<br>Peripheral Nerve Block Kit/Set permits<br>placement of catheters next to nerves and<br>nerve plexuses for continuous nerve block<br>anesthesia or analgesia techniques including<br>upper extremity, lower extremity, abdominal<br>and paravertebral locations for periods not<br>exceeding 72 hours. |
| Technological<br>Characteristics | The catheter features a wire reinforced,<br>polyurethane body with centimeter markings. | No change |
| Materials | Inner coil = XM19 Stainless Steel<br>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<br>heating at 1.5-Tesla and 3-Tesla; and MRI imaging artifacts at 3-<br>Tesla. The evaluation concluded that the FlexBlock Catheter<br>should be labeled as MR Conditional and included labeling<br>guidelines in the report. |
| MRI Testing, Exponent, 2015 | This study evaluated the MRI compatibility of the catheter in<br>regards to radiofrequency (RF)-induced heating in 1.5 T and 3 T<br>clinical scanners. The evaluation was conducted using<br>methodologies prescribed in ASTM F2182 as a guide and<br>modified for using a transmit/receive (TR) head coil.<br>The evaluation concluded that the FlexBlock Catheter should be<br>labeled as MR Conditional and included labeling guidelines in the report. |

Table 2 Non-Clinical Testing

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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.