(269 days)
The Ancora Nerve Block Catheter Set is indicated for surgical pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The device allows physicians to locate peripheral nerves by transferring electrical impulses from a nerve stimulator and/or through ultrasound visualization of the device. The catheter may remain in dwelling for up to 72 hours.
The Ancora Nerve Block Catheter Set is a sterile, single-use, disposable device, intended for delivery of local anesthetic for continuous peripheral nerve blocks, in adult patients. The Ancora Nerve Block Catheter Set is intended to be placed with the use of nerve stimulation and/or ultrasound guidance. The device has a catheter-over-needle design, which consists of a 21-gauge needle and 18-gauge catheter with a twist lock connection between them. The device design includes an anchor and decoupler to help maintain the catheter position. Both the needle and catheter have NRFit connection for infusion. The device set includes two sizes of dressings.
The medical device in question is the "Ancora Nerve Block Catheter Set," which is designed for surgical pain management via continuous peripheral nerve blocks. The document provided outlines the device's characteristics, intended use, and a comparison to a predicate device (Braun Contiplex® C).
Here's an analysis based on the provided text, focusing on acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of "acceptance criteria" with numerical targets and reported specific clinical performance metrics (like sensitivity, specificity, or improvement in pain scores). Instead, it describes a series of non-clinical performance tests and their compliance with relevant ISO and ASTM standards. The overarching acceptance criterion for the premarket notification (510(k)) is demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a legally marketed device.
Here's a summary of the non-clinical performance areas and the general reported outcome:
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Performance Testing | Meets applicable sections of referenced standards (ISO 20698, EN 13868, ISO 7864, ISO 10555-1, ISO 10555-5, ASTM D4169-16, ISO 80369-6:2016, ANSI/AAMI/ISO 11135:2014) for: - Electrical performance (continuity, current transfer) - Flow rate - Occlusion - Kink resistance - Resistance to breakage - Joint bond strength - Leakage - Penetration force - Echogenicity - Corrosion resistance |
| Biocompatibility | Materials used are safe for their intended use, based on ISO 10993-1 requirements for externally communicating devices with tissue contact (limited duration for needle assembly, prolonged duration for catheter/decoupler, skin contact for dressing). |
| Sterilization | Meets requirements as per ANSI/AAMI/ISO 11135:2014 (Ethylene oxide sterilization). |
| Shelf-life | Performed, results not detailed but implied to be acceptable for substantial equivalence. |
| Substantial Equivalence | Concluded to be substantially equivalent to the predicate device, as differences in technological characteristics do not raise different questions of safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
The document does not mention any clinical study or human test set. The evaluation relies entirely on non-clinical performance data (bench testing) and a comparison of technological characteristics to a predicate device. Therefore, information about sample size for a test set and data provenance (country, retrospective/prospective) is not applicable here as no patient data was used for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there was no clinical test set requiring expert interpretation or establishment of ground truth. The "ground truth" for the non-clinical tests would be the specifications and requirements defined in the referenced industry standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as there was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a physical medical device (catheter set), not an AI algorithm or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this device, the "ground truth" in the context of demonstrating safety and effectiveness for substantial equivalence is primarily based on:
- Industry Standards: Compliance with recognized international and national standards (ISO, EN, ASTM) for characteristics like material safety, electrical performance, mechanical integrity (kink resistance, bond strength), and sterilization.
- Predicate Device Equivalence: The performance and characteristics of the legally marketed predicate device (Braun Contiplex® C) serve as a de-facto "ground truth" for what constitutes an acceptably safe and effective device in this product category. The new device must demonstrate it is at least as safe and effective.
8. The sample size for the training set:
This is not applicable as there was no AI model or complex algorithm requiring a training set developed. The device is a physical product.
9. How the ground truth for the training set was established:
This is not applicable as there was no AI model or complex algorithm requiring a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Ancora Medical Technology % Terri Bogucki Consultant Decus Biomedical Inc 2342 Shattuck Ave #333 Berkeley, California 94704
Re: K191290
Trade/Device Name: Ancora Nerve Block Catheter Set Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: January 6, 2020 Received: January 8, 2020
Dear Terri Bogucki:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191290
Device Name Ancora Nerve Block Catheter Set
Indications for Use (Describe)
The Ancora Nerve Block Catheter Set is indicated for surgical pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The device allows physicians to locate peripheral nerves by transferring electrical impulses from a nerve stimulator and/or through ultrasound visualization of the device. The catheter may remain in dwelling for up to 72 hours.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5 510(k) Summary
| Submitter's Name: | Ancora Medical Technology |
|---|---|
| Address: | 333 Ravenswood AveMenlo Park, CA 94025 |
| Contact Person: | Terese Bogucki |
| Title: | Regulatory Consultant |
| Telephone Number: | 650-488-7799 |
| Fax Number: | 650-227-2264 |
| Email: | terri@decusbiomedical.com |
| Date Summary Prepared: | 9 May 2019 |
| Device Proprietary Name: | Ancora Nerve Block Catheter Set |
| Model Number: | 10-04-SET1 |
| Common Name: | Peripheral Nerve Block Needle |
| Regulation Number: | 21 CFR 868.5150 |
| Product Code: | BSP |
| Device Class: | II |
| Predicate Device | Trade name: Braun Contiplex® CManufacturer: B Braun Medical Inc.Address: 901 Marcon BoulevardAllentown, PA 18109-9341Regulation Number: 21 CFR 868.5150Regulation Name: Needles, Conduction, Anesthetic, W/Wo introducerDevice Class: Class IIProduct Code: BSP510(k) Number: K121846510(k) Clearance Date: November 20, 2012 |
5.1 Description of the Device
The Ancora Nerve Block Catheter Set is a sterile, single-use, disposable device, intended for delivery of local anesthetic for continuous peripheral nerve blocks, in adult patients.
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The Ancora Nerve Block Catheter Set is intended to be placed with the use of nerve stimulation and/or ultrasound guidance. The device has a catheter-over-needle design, which consists of a 21-gauge needle and 18-gauge catheter with a twist lock connection between them. The device design includes an anchor and decoupler to help maintain the catheter position. Both the needle and catheter have NRFit connection for infusion. The device set includes two sizes of dressings.
5.2 Intended Use
The Ancora Nerve Block Catheter Set, consisting of the peripheral nerve block needle, catheter, and related dressing accessory, is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management.
Indications for Use 5.3
The Ancora Nerve Block Catheter Set is indicated for surgical pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The device allows physicians to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or through ultrasound visualization of the device. The catheter may remain in dwelling for up to 72 hours.
5.4 Summary of Technological Characteristics Comparison
The Ancora Nerve Block Catheter Set has the same intended use as the Contiplex C Continuous Peripheral Nerve Block Needle (K121846). The proposed device and predicate device both incorporate insulated needles to locate targeted nerve bundles by stimulation or ultrasound guidance in order to perform peripheral nerve block procedures. Both devices are used to place an indwelling catheter in position local to the target nerve and are intended to remain indwelling up to 72 hours. Both devices include a catheter over needle design.
Table 5-1 shows the similarities and differences between the two products. The differences in the technological characteristics of the devices result from the Ancora Nerve Block Catheter Set's features that enable the catheter to remain in position so that the anesthetics or analgesics are delivered to the targeted nerve. The Continuous Peripheral Nerve Block Needle secures the catheter to the patient's skin using the Perifix Pinpad. In the subject device, the decoupler assembly, anchor, and dressing work together to stabilize the catheter and catheter tip. While these characteristics are different, the testing demonstrates that they do not raise new questions of safety or effectiveness.
| TechnologicalCharacteristic | Predicate | Subject Device | Differences |
|---|---|---|---|
| Design | Catheter over needle | Same | None |
| TechnologicalCharacteristic | Predicate | Subject Device | Differences |
| Echogenic | Yes (catheter) | Yes (needle andcatheter) | None - ultrasound can beused with the both devicesto determine and confirmthe correct catheterplacement |
| Needle Gauge | 25G | 21G | The subject device has alarger diameter needle,which makes it easier tocontrol but does not impactclinical use (other similardevices on the market haveneedles as large as 18G);needle testing hasdemonstrated it meetsstandards |
| Needle Length | 190 mm | 100 mm | Minimal - the subjectdevice's shorter needle iseasier to manage |
| Needle Type | Straight | Same | None |
| Needle Bevel | 30 degree | Same | None |
| NeedleMaterial | Stainless steel | Same | None |
| Compatiblewith NerveStimulators | Yes -Stimuplex®HNS 12 SENSenerve stimulators | Yes - used withstimulators with a2 mm touchproofelectromedicalconnector anddelivering amaximum currentof 5 mA | None – the subject deviceuses a standard connector(that can be used with theHNS 12 stimulator);subject device testing hasdemonstrated the needlecan tolerate a much highercurrent than would beapplied clinically |
| StimulationWireConductionMaterial | Unknown | Copper | Conduction materials donot contact the patient; anymaterial differences wouldnot impact safety oreffectiveness |
| TechnologicalCharacteristic | Predicate | Subject Device | Differences |
| NeedleElectricallyInsulated? | Yes - parylenecoating insulates theneedle (except forthe bevel tip) | Yes - catheterconstruction(effectively 5layers) insulatesthe needle (exceptfor the tip) | The predicate device useda coating on the needle, butthe subject device has noinsulation attached to thebody of the needle. Whilethe catheter providesinsulation, it isn't adheredto the needle. |
| Catheter Gauge | 19G | 18G | Size difference is minimal |
| CatheterConstruction | Polyamide andpolyeurethane | Polyimide innersheath with innerspring coil, Pebaxouter sheath | Both devices areechogenic; subject deviceconstruction with a coiland air gap betweensheaths enhances thecatheter's echogenicity |
| CatheterEffectiveLength | 187 mm | 95 mm | Minimal - shorter cathetersare said to makesecurement easier, reducethe likelihood of catheterknotting, and reduce thepotential for the catheter toaccidentally leave thesterile field duringplacement |
| Catheter Tip | Open tapered tip | Open smooth,rounded, taperedtip | Minimal - the shapes ofthe tips do not impactsafety or effectiveness |
| Infusion SetConnectorType | Catheter clamp withyellow connector(likely NRFit) | NRFit | Subject device does notrequire extra step ofattaching clamp to the endof the catheter; NRFit isdesigned to meet ISO80369-6, an FDA-recognized consensusstandard related to smallbore connectors forneuraxial applications. Theyellow connector on thepredicate implies it is alsoNRFit. |
| TechnologicalCharacteristic | Predicate | Subject Device | Differences |
| CatheterFixation | Perifix PinPad is askin fixation devicefor the Perifix EFfilter (whichattaches to andstabilizes thecatheter) | Decouplerassembly, anchorand dressing | Testing demonstrates thedecoupler and anchor donot impact safety andeffectiveness. |
| Infusion Filter | Includes Perifix EFfilter (0.2µm) | Not included | Filters are used to addressconcerns the anesthetic isnon-sterile orcontaminated, for example,as result of disconnection.However, the twoadditional connectionpoints have raised clinicalconcerns that filtersactually increase the riskfor disconnection andinfection. Separate filtersare widely available andcould be attached to thesubject catheter. |
| CompatibleInfusion Pump | Luer connector,flow rate maximum35mL/hr | NRFit connector,flow ratemaximum 33ml/min | Minimal - the subjectdevice's labeling indicatesthe maximum flow ratesupported by the catheter,as does the predicate.Subject devices maximumflow rate is higher than thepredicate, and thereforematches or exceedscompatibility. |
| ExternalDressing | Not included orspecified | Small and largedressing sizesprovided in set | The dressing serves toprotect the skin at thecatheter insertion point,contain the decoupler andsecure the catheter;standard practice is toapply a dressing over theinsertion site. |
| TechnologicalCharacteristic | Predicate | Subject Device | Differences |
| DeviceInsertion Aid | Control Grip | Ridged edges onthe hubs | The moveable Control Gripon the predicate device isintended to facilitateinsertion of the needle andcatheter together at 2 cmintervals. This is neededbecause of the predicate'sthinner and longer needle.The ridged edges on thesubject device's hubs helpstabilize the twocomponents duringinsertion. The subjectdevice's thicker needledoes not need additionalsupport for insertion.These differences have noimpact on safety andeffectiveness. |
| Packaging | Individuallypackaged kitsprovided in a case of5 units | Individuallypackaged kitsprovided indispenser cartonof 6 units | Minimal difference innumber of units has noimpact on safety oreffectiveness |
Table 5-1. Summary of Technological Characteristics Comparison
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Non-Clinical Performance Data 5.5
Testing was performed with the Ancora Nerve Block Catheter Set to support substantial equivalence to the predicate device. Testing included performance testing, biocompatibility, sterilization, and shelf-life testing.
Performance testing completed included the following functional tests: electrical performance (continuity, current transfer), flow rate, occlusion, kink resistance, resistance to breakage, joint bond strength, leakage, penetration force, echogenicity, corrosion resistance.
The following standards were utilized in the evaluation:
- ISO 20698, Catheter systems for neuraxial application -- Sterile and singleuse catheters and accessories
- EN 13868, Catheters - Test methods for kinking of single lumen catheters and medical tubing
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- . ISO 7864, Sterile hypodermic needles for single use
- ISO 10555-1, Intravascular catheters -- Sterile and single-use catheters -- Part 1: General requirements
- ISO 10555-5. Intravascular catheters -- Sterile and single-use catheters -- Part . 5: Over-needle peripheral catheters
- . ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
In addition, Ancora Medical Technology conducted performance testing to demonstrate the subject device conforms with the following test standards:
- . ISO 80369-6:2016, Small bore connectors for liquids and gases in healthcare applications -- Part 6: Connectors for neuraxial applications
- . ANSI/AAMI/ISO 11135:2014, Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Results of performance testing indicate that the needle and catheter, in the Ancora Nerve Block Catheter Set meet applicable sections of the standards referenced and are safe and effective for their intended use. Based upon the results of this testing, it was determined the Ancora Nerve Block Catheter Set performance was substantially equivalent to the predicate device.
5.5.1 Biocompatibility Testing
Biocompatibility testing was performed based on the nature and duration of patient contact outlined in ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and the FDA guidance document: "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". The needle assembly was tested per the ISO 10993-1 requirements for an externally communicating device with tissue contact for a limited duration (< 24 hours). The catheter and the decoupler were tested per the requirements of ISO 10993-1 as an externally communicating device with tissue contact for a prolonged duration (>24 hours to 30 days). The dressing was tested per the requirements of ISO 10993-1 as a skin contacting device with skin contact for a prolonged duration (>24 hours to 30 days). Results of testing demonstrates that the materials used in the construction of the needle and catheter in the proposed Ancora Nerve Block Catheter Set are safe for their intended use.
5.6 Substantial Equivalence Conclusion
An analysis of the subject and predicate devices shows that the Intended Use and Indications for Use, principles of operation, and conditions of use are identical, and that differences in technical characteristics do not raise different questions of safety and
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effectiveness. Therefore, one can conclude that the Ancora Nerve Block Catheter Set is substantially equivalent to the predicate Contiplex C Continuous Peripheral Nerve Block Needle device.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).