(180 days)
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions 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.
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, abdominal and paravertebral locations for periods not exceeding 72 hours.
The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.
Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.
The provided text is a 510(k) summary for the Arrow SnapLock Catheter Adapter. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document outlines performance testing for the new device to show it meets specific "acceptance criteria." However, it is not a study that proves a device meets acceptance criteria in the context of medical AI/imaging devices, which typically involves clinical studies with human readers, ground truth establishment, and statistical analysis of performance metrics like sensitivity, specificity, AUC, etc.
The acceptance criteria and performance data described here are for mechanical and material properties of a medical device (a catheter adapter), not for an AI/imaging diagnostic device. Therefore, many of the requested points in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document's content.
Here's an interpretation based on the provided document, addressing the applicable points:
Device: Arrow SnapLock Catheter Adapter (a non-AI medical device; specifically, an adapter for pain management and nerve block catheters)
Purpose of the Study (as described in the document): To demonstrate substantial equivalence to predicate devices through performance testing related to mechanical properties, material biocompatibility, and functional aspects.
1. A table of acceptance criteria and the reported device performance
The document provides tables for Biocompatibility Testing and Performance Testing with their respective acceptance criteria and results.
Table 1: Biocompatibility Testing Acceptance Criteria and Results
| Test | Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity - L929 MEM Elution Assay | Grade of 0, 1, or 2 (not more than 50% of cells round, devoid of intracytoplasmic granules, no extensive cell lysis) | Acceptable |
| Sensitization - Kligman Maximization Assay | Non-irritant if difference between test article mean score and vehicle control mean score is 1.0 or less. | Acceptable |
| Irritation - Intracutaneous Injection Assay | Grade of 1, 0 or less using the Kligman scoring system. | Acceptable |
| Acute Systemic Toxicity - Systemic Injection Test | Does not induce a significantly greater biological reaction than the control. | Acceptable |
| Acute Systemic Toxicity - Material Mediated Test | No rabbit shows an individual rise in temperature of 0.5°C or more above baseline temperature. | Acceptable |
| Hemocompatibility - Rabbit Blood Hemolysis (Complete) ASTM Test | Hemolytic index above negative control article and negative control article extract is <5%. | Acceptable |
| Genotoxicity - Mouse Lymphoma Mutagenesis Assay | IMF is less than the Global Evaluation Factor (GEF) 128 X 10-6. | Acceptable |
| Genotoxicity - Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay with Confirmation – ISO | Not a positive response if at least one strain does not exhibit a reproducible and statistically significant increase (p<0.05) and a two-fold (for TA98, TA100, and WP2 strains) or three-fold (for TA1535 and TA1537 strains) increase in numbers of mutants over its concurrent negative control. | Acceptable |
| Subacute Systemic Toxicity | Animals treated with test article show similar biological reactivity (clinical observations, body weights, morbidity/moribundity, gross/histopathological evaluation) to control article. | Acceptable |
Table 2: Performance Testing Acceptance Criteria and Results
| Test | Acceptance Criteria | Results |
|---|---|---|
| Closing Force – SnapLock Adapter to Catheter body | Non-Next Gen: No greater than 17lb force (75N) to close with 19Ga or 20Ga catheter. Next Gen: No greater than 12lb force (53.8N) to close with 19Ga or 20Ga catheter. | Pass |
| Opening Force – SnapLock Adapter to Catheter Body | Not possible to open without retaining tab failure; minimum 10lb force (44.48N) required for tab to fail. | Pass |
| Component Compatibility/Interaction | Allow easy insertion of mating catheter. | Pass |
| Tensile Force – SnapLock Adapter to Catheter Body | ≥ 5N (1.12lbf) at failure. | Pass |
| Leakage – SnapLock adapter to catheter body | No leak when pressurized to 25 psi (172 kPa) for 30 seconds in a closed system. | Pass |
| Occlusion – SnapLock Adapter to Catheter Body | Shall not occlude the catheter when locked in mating position. | Pass |
| Spontaneous Partial Opening Test | Must remain closed, with retaining tab in place for 72 hours after full closure over mating catheter. | Pass |
| Flow Rate – Continuous Flow SnapLock | Minimum 60mL/hour (1mL/min) when tested by deionized or distilled water under 69 kPa (10psi). | Pass |
| Flow Rate - Single Shot or Bolus | Minimum 3.47 mL/min with 20mL syringe using deionized or distilled water. | Pass |
| Aspiration | Fluid presence visually verified when deionized or distilled water drawn through adapter. | Pass |
| Leakage, Maximum Duration at Continuous Pressure | No leak over 72 hours when continuous pressure is 1 psi in occluded setup. | Pass |
| Weld Force | Minimum 20lb force (88.96N) for weld joint between catheter insertion component and female housing to fail. | Pass |
| Conical Fittings | Luer version: Comply with applicable sections of BS 6196. Neuraxial version: Meet requirements of AAMI/CN6:2016 (ISO 80369-6). | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a number of devices (e.g., "N=XX devices"). The document generally states "All samples passed the established acceptance criteria" for performance tests. For biocompatibility, it refers to standard biological response tests on test articles (extracts of the device material, or the material itself) using in vitro (cell cultures) and in vivo (animal models like mice, rabbits) setups. The number of animals or specific replicates would be in the detailed test reports, not typically summarized in a 510(k).
- Data Provenance: Not applicable in the context of clinical data. This is laboratory-based performance and biocompatibility testing of a physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This is not an AI/imaging device requiring expert human interpretations for ground truth. Ground truth for these mechanical and material tests is established by objective physical measurements (e.g., force, flow rate, pressure, visual inspection for leakage/occlusion, and standardized lab test results according to ISO and ASTM standards), not by human expert consensus or clinical diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication process is described or implied, as the "ground truth" is derived from objective physical and biological test methods.
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
- No, not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm. The "standalone performance" here refers to the physical device's performance measured against engineering and biocompatibility standards. The tables provided (Biocompatibility and Performance Testing) are essentially the "standalone performance" evaluation for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" is based on objective physical and chemical/biological measurements against predefined engineering and biocompatibility standards (e.g., ISO 10993, BS 6196, AAMI/CN6:2016). For example, "tensile force" is measured by a machine, "leakage" is observed against a pressure standard, and "cytotoxicity" is assessed by a laboratory assay against defined cell viability criteria.
8. The sample size for the training set
- Not Applicable. This is not a device that uses machine learning, so there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for machine learning, the question of its ground truth establishment is irrelevant.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2023
Kristen Bisanz Regulatory Affairs Team Lead 3015 Carrington Mill Blvd. Morrisville, North Carolina 27560
Re: K230603
Trade/Device Name: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: Class II Product Code: CAZ, BSO Dated: July 27, 2023 Received: August 1, 2023
Dear Kristen Bisanz:
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.
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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 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 medical devices and radiation-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.
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of 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) K230603
Device Name
Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnaoLock Adapter (Luer Connection) (CA-00010-19): Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Comection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002)
Indications for Use (Describe)
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions 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.
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, abdominal and paravertebral locations for periods not exceeding 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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510(k) SUMMARY Arrow SnapLock Catheter Adapter K230603
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 3015 Carrington Mill Blvd Morrisville, NC 27560 USA Phone: 404.290.9807 919.433.4996 Fax:
Contact Person
Kristen Bisanz Kristen.bisanz@teleflex.com Regulatory Affairs Team Lead
Date Prepared
August 14, 2023
Device Name
| Trade Name: | Arrow SnapLock Catheter Adapter |
|---|---|
| Classification Name: | Anesthesia Conduction Kit |
| Product Code: | CAZ, BSO |
| Regulation Number: | 868.5140 |
| Classification: | II |
| Classification Panel: | Anesthesiology |
Device Models
K-05520-005C Arrow Non-Stimulating SnapLock Adapter CA-000010-19 Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) CA-000014-19 Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) TZ-02060-001 Arrow Stimulating SnapLock Adapter (with cable) TZ-05000-002 Arrow Stimulating SnapLock Adapter (with tab)
Predicate Device
The primary predicate device for this submission was cleared in K103658 on May 16, 2012. The reference predicate device for this submission was cleared in K1220247 on Aug 28, 2012.
Device Description
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The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.
Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.
| ProductCode | Product CodeDescription | Representative Photo | Description |
|---|---|---|---|
| K-05520-005C | Arrow Non-StimulatingSnapLock Adapter | Image: blue and black adapter | The non-StimulatingSnapLock contains noelecrical connectorsand is used withepidural andperipheral nerve blockcatheters. |
| CA-000010-19 | Arrow Next GenerationNon-StimulatingSnapLock Adapter (LuerAdapter) | Image: blue and yellow adapter | The Next GenerationSnapLock features asnap-of-center styleclosing mechanism. |
| CA-000014-19 | Arrow Next GenerationNon-StimulatingSnapLock Adapter(Neuraxial Adapter) | Image: blue and yellow adapter | The Next GenerationSnapLock features asnap-of-center styleclosing mechanism. |
| TZ-02060-001 | Arrow StimulatingSnapLock Adapter (withcable) | Image: blue adapter with cable | The SimulatingSnapLock is designedfor use with theStimuCath PeripheralNerve Block Catheter. |
| TZ-05000-002 | Arrow StimulatingSnapLock Adapter (withelectrical connector tab) | Image: blue adapter with electrical connector | An electrical currentcan be conductedthrough the connector. |
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Indications for Use
SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Management Catheter IFU for complete catheter instructions 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.
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.
Patient Population
This device is for adult patients requiring administration of local anesthetics for up to 72 hours.
Environment of use
The device is to be used in a hospital and sub-acute facility environment as directed by a physician.
Contraindications
There are no known contraindications for this device.
Substantial Equivalence
The proposed device is substantially equivalent to the predicate device:
| Predicate Device | Manufacturer | 510(k) Number | Date Cleared |
|---|---|---|---|
| SnapLock Adapter (component ofFlexTip Plus Epidural Catheter Kit) | Arrow | K103658 | May 3, 2012 |
| Reference Device : SnapLockAdapter (component of StimuCathPNB Catheter Kit) | Arrow | K122027 | Aug 28, 2012 |
Comparison to Predicate Device
The proposed device has similar or equivalent indications for use, operating principles, classification, sterilization and general design as the predicate device. Biocompatibility testing and performance testing has been performed on the proposed device in order to establish substantial equivalence to the predicate device. The proposed changes discussed above do not impact the safety or effectiveness of the SnapLock Catheter Adapter. The subject device is therefore substantially equivalent to the predicate device identified within this submission.
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| Primary PredicateK103658SnapLock Adapter(component ofFlexTip PlusEpidural CatheterKit) | Reference PredicateK122027SnapLock Adapter(component ofFlexBlockPeripheral NerveBlock Kit) | ProposedSnapLockCatheter Adapter | Equivalence | |
|---|---|---|---|---|
| ClassificationName | Anesthesia ConductionKit and Catheter,Conduction, Anesthetic | Anesthesia ConductionKit and Catheter,Conduction, Anesthetic | AnesthesiaConduction Kit | Identical |
| Device Name | SnapLock Adapter(component of FlexTipPlus Epidural CatheterKit) | SnapLock Adapter(component ofFlexBlock PeripheralNerve Block Kit) | Arrow SnapLockCatheter Adapter | Identical |
| Common Name | Catheter Adapter | Catheter Adapter | Catheter Adapter | Identical |
| Product Code | 73CAZ (primary)and73BSO (secondary) | 73CAZ (primary)and73BSO (secondary) | 73CAZ (primary) | Identical |
| Classification | Class II | Class II | Class II | Identical |
| RegulationNumber | 868.5140 | 868.5140 | 868.5140 | Identical |
| Indications forUse | The Arrow EpiduralCatheter permitsaccess to the epiduralspace for theadministration ofepidural anesthetic.The epidural catheteris intended for use upto 72 hours. | The ArrowFlexBlockContinuousPeripheral NerveBlock Kit/Setpermitsplacement ofcatheters next tonerves and nerveplexuses forcontinuous nerveblock anesthesiaor analgesiatechniquesincluding upper | SnapLockCatheter/SyringeAdapter is intendedto be used inconjunction with 19and 20 Ga. ArrowPain ManagementCatheters tofacilitate access tothe catheter so thatan infusion devicemay be used. Pleaserefer to applicableArrow PainManager Catheter | Identical |
| extremity, lowerextremity,abdominal andparavertebrallocations of theadult andpediatric patientfor periods notexceeding 72hours. | IFU for completecatheter instructionsfor use.The Arrow EpiduralCatheter permitsaccess to theepidural space forthe administrationof epiduralanesthetic. Theepidural catheter isintended for use upto 72 hours. | |||
| Prescription | Yes | Yes | Yes | Identical |
| Environment ofUse | Hospitals, Sub-acutefacilities, andemergency medicalservices | Hospitals, Sub-acutefacilities, andemergency medicalservices | The device is to beused in a hospitaland sub-acutefacilityenvironment asdirected by aphysician. | Identical |
| PatientPopulation | Patients requiringadministration oflocal anesthetics forup to 72 hours | Patients requiringadministration oflocal anesthetics forup to 72 hours | Patients requiringadministration oflocal anesthetics forup to 72 hours | Identical |
| Contraindications | None for stand-aloneSnapLock | None for stand-aloneSnapLock | None for stand-alone SnapLock | Identical |
| Shelf Life | Two (2) years fromdate of manufacture | Two (2) years fromdate of manufacture | Two (2) years fromdate of manufacture | Identical |
| TensileStrength | The joint tensileforce between theSnapLock Adapterand catheter shall be5N or greater, whentested in accordancewith BS 6196 | The joint tensileforce between theSnapLock Adapterand catheter shall be5N or greater, whentested in accordancewith BS 6196 | The joint tensileforce between theSnapLock Adapterand catheter shallbe 5N or greaterwhen tested inaccordance with BS6196 | Identical |
| Flow Rate | The SnapLock shallhave a minimumflow rate of 10ccwater per minute at30psi. | The SnapLock shallhave a minimumflow rate of 10ccwater per minute at30psi. | The catheter flowcapacity shall behigher than60mL/hour whentested by distilledwater underpressure of 10psi | Equivalent,seesubstantialequivalencesection |
| Leakage | There shall be noevidence of waterleakage on theSnapLock surface | There shall be noevidence of waterleakage on theSnapLock surface | Shall not have aleak sufficient toform a falling drop | Equivalent,seesubstantialequivalence |
| when subjected to15psi water for 30seconds. | SnapLock surfacewhen subjected to15psi water for 30seconds. | when pressurized to25psi (172 kPa) for30 seconds | section | |
| Sterilization | The sterilityassurance level of thedevice is 10-6. | The sterilityassurance level of thedevice is 10-6. | The sterilityassurance level ofthe device is 10-6. | Identical |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Per ISO 10993-1 | Identical |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Non-Pyrogenic | Identical |
| Materials | Polycarbonate, Resin,Delrin, Polyethylene | Polycarbonate, Resin,Delrin, Polyethylene | Polycarbonate,Resin, Delrin,Polyethylene | Equivalent,seesubstantialequivalencesection |
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Substantial Equivalence Discussion:
Flow Rate: The flow rate for the proposed SnapLock reflects an updated acceptance criteria which more accurately reflects what is seen in the clinical setting. Additional details and testing are included in the Performance Testing section. Due to the updated testing and clinical rationale, the acceptance criteria for the flow rate is equivalent to the predicate acceptance criteria.
Leakage: The acceptance criteria for the proposed SnapLock Adapter leakage test is more stringent than the predicate. The leakage tests the maximum duration usage of the SnapLock to ensure leakage will not occur. Due to this, the acceptance criteria for the leakage test is equivalent to the predicate acceptance criteria.
Materials: The proposed SnapLock Adapter contains a new resin for the extrusion tubing. Additionally, the Next Gen SnapLock Adapter contains an updated design of the slider as compared to the predicate. The slider helps to secure the catheter tightly and prevent disconnection during use. Comprehensive functional testing has been successfully completed on the SnapLock Adapter. The functional testing proves the proposed device meets the standard requirements and performs as well as the predicate device. Biocompatibility testing has been performed on the final finished proposed device. The materials tested all met the ISO 10993 requirements. There is no difference between the subject and predicate with respect to indications for use or technology
Materials and Biocompatibility Testing
All patient contacting materials, including those with indirect patient contact, are in compliance with ISO 10993-1. The SnapLock device is classified as an external communicating device with tissue/bone/dentin contact for a prolong duration.
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Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.
| Test | Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity - L929MEM Elution Assay | The test article will meet the requirements of thetest if it obtains a Grade of 0,1,or 2 (not morethan 50% of the cells are round, devoid ofintracytoplasmic granules, and no extensive celllysis) | Acceptable |
| Sensitization -KligmanMaximization Assay | The test article will be considered a non-irritantif the difference between the test article meanscore and the vehicle control mean score is 1.0or less. | Acceptable |
| Irritation -IntracutaneousInjection Assay | The test article will meet the requirements of thetest if it receives a Grade of 1, 0 or less using theKligman scoring system. | Acceptable |
| Acute SystemicToxicity - SystemicInjection Test | The test article will meet the requirements of thetest if it does not induce a significantly greaterbiological reaction than the control. | Acceptable |
| Acute SystemicToxicity - MaterialMediated Test | The test article will meet the requirements of thetest if no rabbit shows an individual rise intemperature of 0.5°C or more above the baselinetemperature. | Acceptable |
| Hemocompatibility -Rabbit BloodHemolysis(Complete) ASTMTest | The test article will meet the requirements of thetest and is not considered to have hemolyticactivity potential, if the hemolytic index abovethe negative control article and negative controlarticle extract is <5%. | Acceptable |
| Genotoxicity -Mouse LymphomaMutagenesis Assay | The test article will meet the requirements of thetest and will be considered non-mutagenic if itsIMF is less than the Global Evaluation Factor(GEF) 128 X 10-6. | Acceptable |
| Genotoxicity -SalmonellaTyphimurium andEscherichia ColiReverse MutationAssay withConfirmation – ISO | The test article will be considered to have apositive response in the assay if at least onestrain exhibits a reproducible and statisticallysignificant increase (p<0.05) an a two -fold (forTA98, TA100, and WP2 strains) or three-fold(for TA1535 and TA1537 strains) increase in thenumbers of mutants over its concurrent negativecontrol. | Acceptable |
| Subacute SystemicToxicity - | Overall, if animals treated with the test articleshow a similar biological reactivity, asdetermined by clinical observations, bodyweights, morbidity and moribundity, and grossand histopathical evaluation, to the animalstested with the control article, the test articlemeets the requirements of the test. | Acceptable |
| Test | Acceptance Criteria | Result |
| Closing Force –SnapLockAdapter toCatheter body | The SnapLock Adapter, when used with a 19Ga or 20Ga catheter, shallrequire no greater than 17lb force (75N) to close.Next Gen SnapLock Only: The SnapLock Adapter, when used with a 19Gaor 20Ga catheter, shall require no greater than 12lb force (53.8N) to close. | Pass |
| Opening Force– SnapLockAdapter toCatheter Body | It shall not be possible to open the SnapLock adapter without causing theretaining tab to fail while in the closed position. A minimum 10lb force(44.48N) is required to cause the retaining tab to fail. | Pass |
| ComponentCompatibility/Interaction | The SnapLock Adapter shall allow easy insertion of mating catheter. | Pass |
| Tensile Force –SnapLockAdapter toCatheter Body | The joint tensile force between the SnapLock Adapter and catheter shall be ≥5N (1.12lbf) at failure. | Pass |
| Leakage –SnapLockadapter tocatheter body | The SnapLock Adapter to catheter body joint shall not leak when pressurizedto 25 psi (172 kPa) for 30 seconds in a closed system. | Pass |
| Occlusion –SnapLockAdapter toCatheter Body | The SnapLock Adapter locked into a mating position shall not occlude thecatheter. | Pass |
| SpontaneousPartial OpeningTest | The SnapLock Adapter, when closed must remain closed, with the retainingtab in place for 72 hours after full closure of the adapter over a matingcatheter. | Pass |
| Flow Rate –ContinuousFlow SnapLock | When the SnapLock Adapter is locked over a mating catheter, the catheterflow capacity shall be at minimum 60mL/hour (1mL/min) when tested bydeionized or distilled water under 69 kPa (10psi) | Pass |
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Performance Data
Non-clinical performance testing has been conducted in order to support that the proposed device performs as intended and the product conforms to user needs. All samples passed the established acceptance criteria. The results concluded that the SnapLock Adapter has successfully passed all functional requirements to establish product safety and effectiveness for its intended use.
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| Flow Rate -Single Shot orBolus | When the SnapLock Adapter is locked over a mating catheter (19 or 20Ga),the catheter single shot or bolus shall be at minimum 3.47 mL/min whentested with a 20mL syringe using deionized or distilled water. | Pass |
|---|---|---|
| Aspiration | When deionized or distilled water is drawn through the SnapLock Adapteras it is locked over a mating catheter and connected to a 20mL syringe, fluidpresence shall be visually verified. | Pass |
| Leakage,MaximumDuration atContinuousPressure | In an occluded set-up, the SnapLock Adapter shall not leak over 72 hourswhen the continuous pressure is 1 psi. | Pass |
| Weld Force | A minimum 20lb force (88.96N) shall be required to cause weld jointbetween the catheter insertion component and the female housing to fail. | Pass |
| Conical Fittings | For luer version: The threaded and tapered portions of the SnapLock Adapterhousing shall comply with the applicable sections of BS 6196For neuraxial version: The threaded and tapered portions of the SnapLockAdapter shall meet the requirements of AAMI/CN6:2016 (ISO 80369-6) | Pass |
Conclusion
Based on the performance and comparative test results, the proposed Arrow SnapLock Catheter Adapter is substantially equivalent to the predicate device cleared to market in K103658. The modifications made to the SnapLock Adapter do not introduce any new issues of safety and effectiveness.
§ 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).