(183 days)
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.
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.
The provided document is a 510(k) premarket notification for the ARROW® FlexBlock® Continuous Peripheral Nerve Block Kit/Set. This submission focuses on updating the MR (Magnetic Resonance) Conditional statements in the Instructions for Use (IFU) based on new non-clinical testing. It explicitly states that "The device that is the subject of this submission is identical to its predicate in all other respects, including the technological characteristics, materials, indications for use, and FDA classification." Therefore, the study described here is not a clinical study involving human patients or a standalone algorithm performance study, but rather non-clinical testing to assess the device's compatibility with MRI environments.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for MRI compatibility. Instead, the non-clinical tests aimed to ensure the device could be labeled as "MR Conditional," meaning it can be safely used in a specified MRI environment under certain conditions. The reported device performance is that the tests concluded the FlexBlock Catheter should be labeled as MR Conditional and included labeling guidelines. This implies that the device successfully met the safety thresholds for MRI compatibility during the testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety thresholds for magnetic field interactions (3-Tesla) | Device passed, concluded suitable for MR Conditional labeling |
| Safety thresholds for MRI-related heating (1.5-Tesla and 3-Tesla) | Device passed, concluded suitable for MR Conditional labeling |
| Acceptable MRI imaging artifacts (3-Tesla) | Device passed, concluded suitable for MR Conditional labeling |
2. Sample sized used for the test set and the data provenance
The document specifies "the test article in both cases was the 19 ga FlexBlock catheter." This implies that the testing was performed on one or more samples of the 19 gauge FlexBlock catheter. The exact number of individual catheter units tested is not provided, but it would have been a sufficient number to represent the product and ensure robust testing according to ASTM guidelines.
The data provenance is from non-clinical laboratory testing conducted by specialized third-party organizations:
- Shellock R&D Services (MRI Testing, 2011)
- Exponent, Inc. (MRI Testing, 2015)
The testing was retrospective in the sense that it was performed on existing device designs to update labeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the provided document. The ground truth for MRI compatibility testing is established by physical measurements and adherence to recognized standards (e.g., ASTM F2182), not by expert consensus on clinical findings. The entities performing the tests (Shellock R&D Services and Exponent, Inc.) are specialized in medical device MRI safety assessments, implying their expertise in the field.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to clinical scenarios where multiple human readers assess a case and a consensus or tie-breaking mechanism is used. Here, the "test set" involves physical measurements against technical standards for MRI safety. The "adjudication" is implicitly the adherence to and interpretation of the results according to the ASTM F2182 standard and other relevant guidelines by the testing facilities.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical MRI compatibility testing of a medical device, not a comparative effectiveness study involving human readers and clinical cases.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This document is about the physical properties and MRI compatibility of a medical device, not a software algorithm.
7. The type of ground truth used
The ground truth used for this testing was based on established scientific principles, engineering measurements, and recognized industry standards for MRI compatibility, specifically:
- Physical measurements of magnetic field interactions.
- Measurements of temperature rise due to radiofrequency (RF)-induced heating.
- Evaluation of imaging artifacts.
- Methodologies prescribed in ASTM F2182 ("Standard Test Method for Measurement of Radiofrequency Induced Hearing Near Passive Implants During Magnetic Resonance Imaging") as a guide.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this document describes non-clinical physical testing of a medical device, not the development or evaluation of a machine learning algorithm.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set.
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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 (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
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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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FOR FDA USE ONLY
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Submitter Information
| Name | ARROW International, Inc. (subsidiary of Teleflex Inc.) |
|---|---|
| Address | 3015 Carrington MillBlvd 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.
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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 |
|---|---|---|
| ProductClassification | II | No change |
| Intended Use | The ARROW FlexBlock ContinuousPeripheral Nerve Block Kit/Set permitsplacement of catheters next to nerves andnerve plexuses for continuous nerve blockanesthesia or analgesia techniques includingupper extremity, lower extremity, abdominaland paravertebral locations for periods notexceeding 72 hours. | |
| TechnologicalCharacteristics | The catheter features a wire reinforced,polyurethane body with centimeter markings. | No change |
| Materials | Inner coil = XM19 Stainless SteelOuter 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-relatedheating at 1.5-Tesla and 3-Tesla; and MRI imaging artifacts at 3-Tesla. The evaluation concluded that the FlexBlock Cathetershould be labeled as MR Conditional and included labelingguidelines in the report. |
| MRI Testing, Exponent, 2015 | This study evaluated the MRI compatibility of the catheter inregards to radiofrequency (RF)-induced heating in 1.5 T and 3 Tclinical scanners. The evaluation was conducted usingmethodologies prescribed in ASTM F2182 as a guide andmodified for using a transmit/receive (TR) head coil.The evaluation concluded that the FlexBlock Catheter should belabeled 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.
§ 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).