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)

K230603 · Teleflex Medical · BSO · Aug 30, 2023 · Anesthesiology

Device Facts

• Record ID: K230603
• 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)
• Applicant: Teleflex Medical
• Product Code: BSO · Anesthesiology
• Decision Date: Aug 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Arrow SnapLock Catheter Adapter connects anesthesia catheters to infusion devices; facilitates delivery of anesthetic substances to patients. Available in non-stimulating and stimulating versions; stimulating versions include electrical connector or tab for use with StimuCath catheters. Used in hospital and sub-acute facility environments by physicians. Device features snap-of-center closing mechanism to secure catheter and prevent disconnection. Output is a secure, leak-resistant fluid path between catheter and infusion pump. Benefits include continuous nerve block anesthesia or analgesia for up to 72 hours.

Clinical Evidence

Bench testing only. Performance testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, genotoxicity), closing/opening force, tensile strength, leakage, occlusion, spontaneous opening, flow rate, aspiration, and weld force. All tests met established acceptance criteria.

Technological Characteristics

Materials: Polycarbonate, resin, Delrin, polyethylene. Connectivity: Mechanical interface for catheters and infusion devices. Sterilization: SAL 10^-6. Standards: ISO 10993-1 (biocompatibility), BS 6196 (tensile/luer), AAMI/CN6:2016/ISO 80369-6 (neuraxial).

Indications for Use

Indicated for adult patients requiring administration of local anesthetics via epidural or peripheral nerve block catheters for up to 72 hours.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• SnapLock Adapter (component of FlexTip Plus Epidural Catheter Kit) (K103658)

Reference Devices

• SnapLock Adapter (component of StimuCath PNB Catheter Kit) (K122027)

Submission Summary (Full Text)

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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.

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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: [phone].433.4996 Fax:

#### Contact Person

Kristen Bisanz [e-mail] 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.

| Product<br>Code | Product Code<br>Description | Representative Photo | Description |
|------------------|-------------------------------------------------------------------------------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| K-05520-<br>005C | Arrow Non-Stimulating<br>SnapLock Adapter | Image: blue and black adapter | The non-Stimulating<br>SnapLock contains no<br>elecrical connectors<br>and is used with<br>epidural and<br>peripheral nerve block<br>catheters. |
| CA-000010-<br>19 | Arrow Next Generation<br>Non-Stimulating<br>SnapLock Adapter (Luer<br>Adapter) | Image: blue and yellow adapter | The Next Generation<br>SnapLock features a<br>snap-of-center style<br>closing mechanism. |
| CA-000014-<br>19 | Arrow Next Generation<br>Non-Stimulating<br>SnapLock Adapter<br>(Neuraxial Adapter) | Image: blue and yellow adapter | The Next Generation<br>SnapLock features a<br>snap-of-center style<br>closing mechanism. |
| TZ-02060-<br>001 | Arrow Stimulating<br>SnapLock Adapter (with<br>cable) | Image: blue adapter with cable | The Simulating<br>SnapLock is designed<br>for use with the<br>StimuCath Peripheral<br>Nerve Block Catheter. |
| TZ-05000-<br>002 | Arrow Stimulating<br>SnapLock Adapter (with<br>electrical connector tab) | Image: blue adapter with electrical connector | An electrical current<br>can be conducted<br>through 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 of<br>FlexTip Plus Epidural Catheter Kit) | Arrow | K103658 | May 3, 2012 |
| Reference Device : SnapLock<br>Adapter (component of StimuCath<br>PNB 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 Predicate<br>K103658<br>SnapLock Adapter<br>(component of<br>FlexTip Plus<br>Epidural Catheter<br>Kit) | Reference Predicate<br>K122027<br>SnapLock Adapter<br>(component of<br>FlexBlock<br>Peripheral Nerve<br>Block Kit) | Proposed<br>SnapLock<br>Catheter Adapter | Equivalenc<br>e |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Classification<br>Name | Anesthesia Conduction<br>Kit and Catheter,<br>Conduction, Anesthetic | Anesthesia Conduction<br>Kit and Catheter,<br>Conduction, Anesthetic | Anesthesia<br>Conduction Kit | Identical |
| Device Name | SnapLock Adapter<br>(component of FlexTip<br>Plus Epidural Catheter<br>Kit) | SnapLock Adapter<br>(component of<br>FlexBlock Peripheral<br>Nerve Block Kit) | Arrow SnapLock<br>Catheter Adapter | Identical |
| Common Name | Catheter Adapter | Catheter Adapter | Catheter Adapter | Identical |
| Product Code | 73CAZ (primary)<br>and<br>73BSO (secondary) | 73CAZ (primary)<br>and<br>73BSO (secondary) | 73CAZ (primary) | Identical |
| Classification | Class II | Class II | Class II | Identical |
| Regulation<br>Number | 868.5140 | 868.5140 | 868.5140 | Identical |
| Indications for<br>Use | The Arrow Epidural<br>Catheter permits<br>access to the epidural<br>space for the<br>administration of<br>epidural anesthetic.<br>The epidural catheter<br>is intended for use up<br>to 72 hours. | The Arrow<br>FlexBlock<br>Continuous<br>Peripheral Nerve<br>Block Kit/Set<br>permits<br>placement of<br>catheters next to<br>nerves and nerve<br>plexuses for<br>continuous nerve<br>block anesthesia<br>or analgesia<br>techniques<br>including upper | SnapLock<br>Catheter/Syringe<br>Adapter is intended<br>to be used in<br>conjunction with 19<br>and 20 Ga. Arrow<br>Pain Management<br>Catheters to<br>facilitate access to<br>the catheter so that<br>an infusion device<br>may be used. Please<br>refer to applicable<br>Arrow Pain<br>Manager Catheter | Identical |
| | | extremity, lower<br>extremity,<br>abdominal and<br>paravertebral<br>locations of the<br>adult and<br>pediatric patient<br>for periods not<br>exceeding 72<br>hours. | IFU for complete<br>catheter instructions<br>for use.<br>The Arrow Epidural<br>Catheter permits<br>access to the<br>epidural space for<br>the administration<br>of epidural<br>anesthetic. The<br>epidural catheter is<br>intended for use up<br>to 72 hours. | |
| Prescription | Yes | Yes | Yes | Identical |
| Environment of<br>Use | Hospitals, Sub-acute<br>facilities, and<br>emergency medical<br>services | Hospitals, Sub-acute<br>facilities, and<br>emergency medical<br>services | The device is to be<br>used in a hospital<br>and sub-acute<br>facility<br>environment as<br>directed by a<br>physician. | Identical |
| Patient<br>Population | Patients requiring<br>administration of<br>local anesthetics for<br>up to 72 hours | Patients requiring<br>administration of<br>local anesthetics for<br>up to 72 hours | Patients requiring<br>administration of<br>local anesthetics for<br>up to 72 hours | Identical |
| Contraindicatio<br>ns | None for stand-alone<br>SnapLock | None for stand-alone<br>SnapLock | None for stand-<br>alone SnapLock | Identical |
| Shelf Life | Two (2) years from<br>date of manufacture | Two (2) years from<br>date of manufacture | Two (2) years from<br>date of manufacture | Identical |
| Tensile<br>Strength | The joint tensile<br>force between the<br>SnapLock Adapter<br>and catheter shall be<br>5N or greater, when<br>tested in accordance<br>with BS 6196 | The joint tensile<br>force between the<br>SnapLock Adapter<br>and catheter shall be<br>5N or greater, when<br>tested in accordance<br>with BS 6196 | The joint tensile<br>force between the<br>SnapLock Adapter<br>and catheter shall<br>be 5N or greater<br>when tested in<br>accordance with BS<br>6196 | Identical |
| Flow Rate | The SnapLock shall<br>have a minimum<br>flow rate of 10cc<br>water per minute at<br>30psi. | The SnapLock shall<br>have a minimum<br>flow rate of 10cc<br>water per minute at<br>30psi. | The catheter flow<br>capacity shall be<br>higher than<br>60mL/hour when<br>tested by distilled<br>water under<br>pressure of 10psi | Equivalent,<br>see<br>substantial<br>equivalence<br>section |
| Leakage | There shall be no<br>evidence of water<br>leakage on the<br>SnapLock surface | There shall be no<br>evidence of water<br>leakage on the<br>SnapLock surface | Shall not have a<br>leak sufficient to<br>form a falling drop | Equivalent,<br>see<br>substantial<br>equivalence |
| | when subjected to<br>15psi water for 30<br>seconds. | SnapLock surface<br>when subjected to<br>15psi water for 30<br>seconds. | when pressurized to<br>25psi (172 kPa) for<br>30 seconds | section |
| Sterilization | The sterility<br>assurance level of the<br>device is 10-6. | The sterility<br>assurance level of the<br>device is 10-6. | The sterility<br>assurance level of<br>the 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,<br>Delrin, Polyethylene | Polycarbonate, Resin,<br>Delrin, Polyethylene | Polycarbonate,<br>Resin, Delrin,<br>Polyethylene | Equivalent,<br>see<br>substantial<br>equivalence<br>section |

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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.

{9}------------------------------------------------

Biocompatibility testing has been performed on the proposed device and meets the acceptance criteria.

| Test | Acceptance Criteria | Results |
|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Cytotoxicity - L929<br>MEM Elution Assay | The test article will meet the requirements of the<br>test if it obtains a Grade of 0,1,or 2 (not more<br>than 50% of the cells are round, devoid of<br>intracytoplasmic granules, and no extensive cell<br>lysis) | Acceptable |
| Sensitization -<br>Kligman<br>Maximization Assay | The test article will be considered a non-irritant<br>if the difference between the test article mean<br>score and the vehicle control mean score is 1.0<br>or less. | Acceptable |
| Irritation -<br>Intracutaneous<br>Injection Assay | The test article will meet the requirements of the<br>test if it receives a Grade of 1, 0 or less using the<br>Kligman scoring system. | Acceptable |
| Acute Systemic<br>Toxicity - Systemic<br>Injection Test | The test article will meet the requirements of the<br>test if it does not induce a significantly greater<br>biological reaction than the control. | Acceptable |
| Acute Systemic<br>Toxicity - Material<br>Mediated Test | The test article will meet the requirements of the<br>test if no rabbit shows an individual rise in<br>temperature of 0.5°C or more above the baseline<br>temperature. | Acceptable |
| Hemocompatibility -<br>Rabbit Blood<br>Hemolysis<br>(Complete) ASTM<br>Test | The test article will meet the requirements of the<br>test and is not considered to have hemolytic<br>activity potential, if the hemolytic index above<br>the negative control article and negative control<br>article extract is <5%. | Acceptable |
| Genotoxicity -<br>Mouse Lymphoma<br>Mutagenesis Assay | The test article will meet the requirements of the<br>test and will be considered non-mutagenic if its<br>IMF is less than the Global Evaluation Factor<br>(GEF) 128 X 10-6. | Acceptable |
| Genotoxicity -<br>Salmonella<br>Typhimurium and<br>Escherichia Coli<br>Reverse Mutation<br>Assay with<br>Confirmation – ISO | The test article will be considered to have a<br>positive response in the assay if at least one<br>strain exhibits a reproducible and statistically<br>significant increase (p<0.05) an a two -fold (for<br>TA98, TA100, and WP2 strains) or three-fold<br>(for TA1535 and TA1537 strains) increase in the<br>numbers of mutants over its concurrent negative<br>control. | Acceptable |
| Subacute Systemic<br>Toxicity - | Overall, if animals treated with the test article<br>show a similar biological reactivity, as<br>determined by clinical observations, body<br>weights, morbidity and moribundity, and gross<br>and histopathical evaluation, to the animals<br>tested with the control article, the test article<br>meets the requirements of the test. | Acceptable |
| Test | Acceptance Criteria | Result |
| Closing Force –<br>SnapLock<br>Adapter to<br>Catheter body | The SnapLock Adapter, when used with a 19Ga or 20Ga catheter, shall<br>require no greater than 17lb force (75N) to close.<br>Next Gen SnapLock Only: The SnapLock Adapter, when used with a 19Ga<br>or 20Ga catheter, shall require no greater than 12lb force (53.8N) to close. | Pass |
| Opening Force<br>– SnapLock<br>Adapter to<br>Catheter Body | It shall not be possible to open the SnapLock adapter without causing the<br>retaining tab to fail while in the closed position. A minimum 10lb force<br>(44.48N) is required to cause the retaining tab to fail. | Pass |
| Component<br>Compatibility/<br>Interaction | The SnapLock Adapter shall allow easy insertion of mating catheter. | Pass |
| Tensile Force –<br>SnapLock<br>Adapter to<br>Catheter Body | The joint tensile force between the SnapLock Adapter and catheter shall be ≥<br>5N (1.12lbf) at failure. | Pass |
| Leakage –<br>SnapLock<br>adapter to<br>catheter body | The SnapLock Adapter to catheter body joint shall not leak when pressurized<br>to 25 psi (172 kPa) for 30 seconds in a closed system. | Pass |
| Occlusion –<br>SnapLock<br>Adapter to<br>Catheter Body | The SnapLock Adapter locked into a mating position shall not occlude the<br>catheter. | Pass |
| Spontaneous<br>Partial Opening<br>Test | The SnapLock Adapter, when closed must remain closed, with the retaining<br>tab in place for 72 hours after full closure of the adapter over a mating<br>catheter. | Pass |
| Flow Rate –<br>Continuous<br>Flow SnapLock | When the SnapLock Adapter is locked over a mating catheter, the catheter<br>flow capacity shall be at minimum 60mL/hour (1mL/min) when tested by<br>deionized or distilled water under 69 kPa (10psi) | Pass |

{10}------------------------------------------------

# 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.

{11}------------------------------------------------

| Flow Rate -<br>Single Shot or<br>Bolus | When the SnapLock Adapter is locked over a mating catheter (19 or 20Ga),<br>the catheter single shot or bolus shall be at minimum 3.47 mL/min when<br>tested with a 20mL syringe using deionized or distilled water. | Pass |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Aspiration | When deionized or distilled water is drawn through the SnapLock Adapter<br>as it is locked over a mating catheter and connected to a 20mL syringe, fluid<br>presence shall be visually verified. | Pass |
| Leakage,<br>Maximum<br>Duration at<br>Continuous<br>Pressure | In an occluded set-up, the SnapLock Adapter shall not leak over 72 hours<br>when the continuous pressure is 1 psi. | Pass |
| Weld Force | A minimum 20lb force (88.96N) shall be required to cause weld joint<br>between the catheter insertion component and the female housing to fail. | Pass |
| Conical Fittings | For luer version: The threaded and tapered portions of the SnapLock Adapter<br>housing shall comply with the applicable sections of BS 6196<br>For neuraxial version: The threaded and tapered portions of the SnapLock<br>Adapter 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.