VacLok AT Vacuum Syringe

K163597 · Merit Medical Systems, Inc. · PUR · Jul 27, 2017 · General Hospital

Device Facts

• Record ID: K163597
• Device Name: VacLok AT Vacuum Syringe
• Applicant: Merit Medical Systems, Inc.
• Product Code: PUR · General Hospital
• Decision Date: Jul 27, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).

Device Story

VacLok™ AT Vacuum Syringe is a manual piston syringe used for fluid injection or aspiration. Device consists of a clear polycarbonate barrel, ABS plunger, and silicone piston seal. Features a locking mechanism allowing the plunger to be locked at specific positions along the barrel to maintain a vacuum. Operated manually by a clinician to advance or withdraw the plunger. Used in clinical settings for procedures requiring fluid management or vacuum-assisted aspiration. Output is the physical movement of fluids; healthcare providers use the device to perform aspiration or injection tasks, potentially improving procedural efficiency in fluid removal or delivery.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included ISO 7886-1 (cleanliness, graduation, leakage, capacity) and ISO 594-2 (luer lock fittings, torque, leakage). Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemolysis.

Technological Characteristics

Piston syringe with male luer lock connector. Materials: polycarbonate barrel, ABS plunger, silicone seal. Manual operation. Vacuum capability via cam locking mechanism. Sterilization: Ethylene oxide (ISO 11135). Compliant with ISO 7886-1 (manual syringes) and ISO 594-2 (luer fittings).

Indications for Use

Indicated for injection or withdrawal of fluids from the body, including cases where vacuum is preferred (e.g., thrombus, abscess fluid, bile, urine).

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Welmed Hypodermic Syringe (K070936)

Reference Devices

• VacLok Syringe (K994253)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 27, 2017

Merit Medical Systems, Inc. Ms. Angela Brady Senior Regulatory Affairs Specialist 1600 W Merit Parkway South Jordan, Utah 84095

Re: K163597

Trade/Device Name: Merit VacLok™ AT Vacuum Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: PUR Dated: July 25, 2017 Received: July 26, 2017

Dear Ms. Angela Brady:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark S. Fellman -S

for

Lori A. Wiggins, MPT, CLT Acting 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) K163597

Device Name VacLok™ AT Vacuum Syringe

Indications for Use (Describe)

VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| General<br>Provisions | Submitter Name:<br>Address:<br>Telephone Number:<br>Fax Number:<br>Contact Person:<br>Date Prepared:<br>Registration Number: | Merit Medical Systems, Inc.<br>1600 West Merit Parkway<br>South Jordan, UT 84095<br>[phone]<br>[phone]<br>Ms. Angela Brady<br>December 20, 2016<br>1721504 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:<br>Common/Usual Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Review Panel: | VacLok™ AT Vacuum Syringe<br>Piston Syringe<br>Syringe, Piston<br>2<br>PUR<br>880.5860<br>General Hospital |
| Predicate<br>Device | Trade Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Premarket Notification:<br>Manufacturer: | Welmed Hypodermic Syringe<br>Syringe, Piston<br>2<br>FMF<br>880.5860<br>K070936<br>Welmed, Inc. |
| Reference<br>Device | Trade Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code:<br>21 CFR §:<br>Premarket Notification:<br>Manufacturer: | VacLok Syringe<br>Syringe, Piston<br>2<br>FMF<br>880.5860<br>K994253<br>Merit Medical Systems, Inc. |
| Device<br>Description | The VacLok™ AT Vacuum Syringe is a general piston syringe<br>constructed using a barrel, plunger, piston seal, and locking<br>mechanism. It is designed to lock in any position along the length of<br>the barrel with the capability of holding a vacuum when the cam locking<br>mechanism is engaged. | |
| Indications for<br>Use | | The VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw<br>fluids from the body. It can also be used in cases where a vacuum syringe<br>is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).<br>The Indications for Use statement for the VacLok™ AT Vacuum<br>Syringe is not identical to the predicate device; however, the |

# 510 (K) Summary

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differences do not alter the intended therapeutic use of the device nor do they affect the performance of the device. Both the subject and predicate devices have the same intended use to inject fluids into, or withdraw fluids from, the body, as stated in 21 CFR 880.5860.

The proposed VacLok™ AT Vacuum Syringe incorporates the same intended use, as well as similar materials, design and principle of operation as the predicate Welmed Hypodermic Syringe. The subject device is substantially equivalent to the predicate device.

| | Attribute | Subject Device –<br>VacLok™ AT Vacuum<br>Syringe | Predicate Device -<br>Welmed Hypodermic<br>Syringe |
|--------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Design | Standard piston syringe<br>constructed with a clear<br>hollow barrel into which is<br>inserted a closely fitting<br>movable plunger and<br>tip/seal. Fitting offered<br>with male luer lock<br>connector. | Standard piston syringe<br>constructed with a clear<br>hollow barrel into which is<br>inserted a closely fitting<br>movable plunger and<br>tip/seal. Fitting offered<br>with male luer lock<br>connector. |
| Comparison to<br>Predicate<br>Device | Material | The barrel is constructed<br>from clear polycarbonate;<br>the plunger from ABS<br>material; the seal is made<br>of silicone material | The barrel is constructed<br>from clear polycarbonate.<br>The plunger/piston seal<br>unknown |
| | Principle of<br>Operation | Manually operated by<br>advancing and<br>withdrawing the plunger<br>within the barrel. | Manually operated by<br>advancing and<br>withdrawing the plunger<br>within the barrel. |
| | Operational<br>Volume | Operational volume of 20<br>and 30 mL. | Operational volume of 3,<br>5, 10, 20, 30 and 60 mL. |
| | Graduation | Printed with accurate<br>graduation lines that are<br>compliant with ISO 7886-<br>1. | Printed with accurate<br>graduation lines that are<br>compliant with ISO 7886-<br>1. |
| | Intended<br>Use | General purpose fluid<br>injection and aspiration<br>from the body, as outlined<br>in 21 CFR 880.5860 | General purpose fluid<br>injection and aspiration<br>from the body, as outlined<br>in 21 CFR 880.5860 |

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The reference device supports the vacuum technology for the subject device.

| Reference<br>Device<br>Comparison | Attribute | Subject Device –<br>VacLok™ AT Vacuum<br>Syringe | Reference Device –<br>VacLok Syringe |
|-----------------------------------|--------------------------------|--------------------------------------------------|--------------------------------------|
| Vacuum<br>Technology | Variable camlock<br>technology | Fixed stop position<br>technology | |

FDA quidance and recognized consensus standards have been established for Piston Svringes under FDA Product Code FMF and 21 CFR 880.5860. A battery of tests was performed based on the requirements of the below recognized consensus standards and guidance, as well as biocompatibility, sterilization, and packaging standards and guidance. Conformity to these standards demonstrates that the proposed VacLok™ AT Vacuum Syringe met the standards' established acceptance criteria for the device.

- . ISO 7886-1:1993, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [Including Technical Corrigendum 1 (1995)]
- ISO 594-2:1998, Conical fittings with 6% (Luer) taper for syringes, ● needles and certain other medical equipment - Part 2: Lock fittings .

## Performance Data

- 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
- ISO 10993-7:2008. Biological evaluation of medical devices Part ● 7: Ethylene oxide sterilization residuals
- AAMI TIR 28:2009, Product adoption and process equivalency for ● ethylene oxide sterilization
- ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)]
- ASTM D4169-14: 2014, Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-07:2007, Standard Guide for Accelerated Aging of ● Sterile Barrier Systems for Medical Devices (Reapproved 2011)
- . ISO 2233:2000. Packaging - Complete, filled transport packages and unit loads – Conditioning for testing
- ISO 10993-1:2009, Biological evaluation of medical devices Part . 1: Evaluation and Testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

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| | • ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood [Including: Amendment 1(2006)] |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity |
| | • ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization |
| | • ISO 10993-11:2006, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity |
| | • ASTM F756-08:2008, Standard Practice for Assessment of Hemolytic Properties of Materials |
| | • AAMI/ANSI ST72:2011, Bacterial Endotoxins – Test methods, routine monitoring, and alternatives to batch testing |
| | • United States Pharmacopeia 37, National Formulary 32, 2014 <151> Pyrogen Test |
| | • FDA Guidance Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, June 2016 |
| | • FDA Guidance Document, Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, April 1993 |
| | • FDA Guidance, The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications, March 1998 |
| Performance Data cont'd | • FDA Guidance, Recognition and Use of Consensus Standards, September 2007 |

# Performance Bench Testing

The VacLok™ AT Vacuum Syringe complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use. Testing included the following from these standards:

| ISO 7886-1 | |
|----------------------------------------|------------------------------------------------------------------|
| Cleanliness | Graduation Scale |
| Limits for acidity or alkalinity | Barrel |
| Limits for extractable metals | Piston/Plunger Assembly |
| Lubricant | Nozzle |
| Tolerance on Graduation | Performance - Freedom from air<br>and liquid leakage past piston |
| Capacity | |
| ISO 594-2 | |
| Gauging | Unscrewing torque |
| Liquid leakage | Ease of assembly |
| Air leakage | Resistance to overriding |
| Separation force | Stress cracking |
| Vacuum Performance Testing | |
| Air Leakage (Annex B of ISO<br>7886-1) | Vacuum Hold (Annex B of ISO<br>7886-1, 2 minutes) |

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| <b>Biocompatibility testing</b><br>Biocompatibility evaluation for the VacLok™ AT Vacuum Syringe was<br>conducted in accordance with ISO 10993-1 "Biological evaluation of<br>medical devices - Part 1: Evaluation and testing within a risk<br>management process", and the FDA guidance "Use of International<br>Standard ISO 10993-1, “Biological evaluation of medical devices - Part<br>1: Evaluation and testing within a risk management process,” June<br>2016. Testing included the following: | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Performance<br/>Data cont'd</b> | Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemolysis USP Physicochemical The VacLok™ AT Vacuum Syringe is considered an externally<br>communicating device with indirect blood contact for a duration of less<br>than 24 hours. |
| <b>Summary of<br/>Substantial<br/>Equivalence</b> | Based on the intended use, materials, design, and performance testing,<br>the VacLok™ AT Vacuum Syringe meets the requirements that are<br>considered essential for its intended use and is considered substantially<br>equivalent to the predicate device, the Welmed Hypodermic Syringe,<br>K070936. |