(218 days)
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.).
The VacLok™ AT Vacuum Syringe is a general piston syringe constructed using a barrel, plunger, piston seal, and locking mechanism. It is designed to lock in any position along the length of the barrel with the capability of holding a vacuum when the cam locking mechanism is engaged.
The provided text is a 510(k) summary for the Merit VacLok™ AT Vacuum Syringe, a medical device. This document focuses on demonstrating the device's substantial equivalence to predicate devices, primarily through performance bench testing against recognized international standards and biocompatibility testing. It does not describe an AI/ML-based device or a study involving human readers or expert consensus for establishing ground truth in an AI/ML context.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I can extract information related to the acceptance criteria and performance testing that was conducted for this physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device complies with FDA-recognized consensus standards ISO 7886-1 and ISO 594-2, and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." Specific acceptance criteria values are not explicitly listed in a table, but the areas of testing and the general statement of compliance serve as the "reported device performance."
| Category | Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|---|
| ISO 7886-1:1993 | (Implicitly, the requirements of the standard for each test) | All tests met the established acceptance criteria for intended use. |
| Cleanliness | ||
| Limits for acidity or alkalinity | ||
| Limits for extractable metals | ||
| Lubricant | ||
| Tolerance on Graduation | ||
| Capacity | ||
| Graduation Scale | ||
| Barrel | ||
| Piston/Plunger Assembly | ||
| Nozzle | ||
| Performance - Freedom from air and liquid leakage past piston | ||
| ISO 594-2:1998 | (Implicitly, the requirements of the standard for each test) | All tests met the established acceptance criteria for intended use. |
| Gauging | ||
| Liquid leakage | ||
| Air leakage | ||
| Separation force | ||
| Unscrewing torque | ||
| Ease of assembly | ||
| Resistance to overriding | ||
| Stress cracking | ||
| Vacuum Performance Testing | All tests met the established acceptance criteria for intended use. | |
| Air Leakage (Annex B of ISO 7886-1) | ||
| Vacuum Hold (Annex B of ISO 7886-1, 2 minutes) | ||
| Biocompatibility Testing | (Implicitly, the requirements of the ISO 10993 series and related FDA guidance) | All tests demonstrated biocompatibility for the specified contact type and duration. |
| Cytotoxicity | ||
| Sensitization | ||
| Irritation | ||
| Acute Systemic Toxicity | ||
| Pyrogenicity | ||
| Hemolysis | ||
| USP Physicochemical |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (e.g., number of syringes) used for each bench test. The data provenance is also not detailed beyond the statement that testing was performed by the manufacturer against international standards. It's inherent to this type of device submission that testing is done in a controlled laboratory setting (prospective testing of manufactured devices), rather than using clinical patient data. The country of origin for the data (testing lab location) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this is a medical device (syringe) performance evaluation, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical records. The "ground truth" for the device's performance is established by the specifications and acceptance criteria of the referenced ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no human interpretation or subjective assessment being adjudicated. Device performance is measured objectively against predefined standards.
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 question is not applicable as the device is a physical syringe, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical syringe, not an algorithm. Bench testing evaluates the device's performance standalone relative to engineering standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on the objective technical specifications and acceptance criteria outlined in recognized international consensus standards (e.g., ISO 7886-1, ISO 594-2) and the FDA's guidance documents for biocompatibility and sterilization.
8. The sample size for the training set
This question is not applicable as there is no "training set" in the context of a physical medical device. Manufacturing processes are subject to quality controls and design validation, but not a data-driven "training" as in AI/ML.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design featuring three overlapping, curved shapes that resemble an abstract representation of a human figure or a bird in flight.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-4818(801) 316-4878Ms. Angela BradyDecember 20, 20161721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | VacLok™ AT Vacuum SyringePiston SyringeSyringe, Piston2PUR880.5860General Hospital |
| PredicateDevice | Trade Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Premarket Notification:Manufacturer: | Welmed Hypodermic SyringeSyringe, Piston2FMF880.5860K070936Welmed, Inc. |
| ReferenceDevice | Trade Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Premarket Notification:Manufacturer: | VacLok SyringeSyringe, Piston2FMF880.5860K994253Merit Medical Systems, Inc. |
| DeviceDescription | The VacLok™ AT Vacuum Syringe is a general piston syringeconstructed using a barrel, plunger, piston seal, and lockingmechanism. It is designed to lock in any position along the length ofthe barrel with the capability of holding a vacuum when the cam lockingmechanism is engaged. | |
| Indications forUse | The VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdrawfluids from the body. It can also be used in cases where a vacuum syringeis preferred (e.g. thrombus, abscess fluid, bile, urine etc.).The Indications for Use statement for the VacLok™ AT VacuumSyringe 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 –VacLok™ AT VacuumSyringe | Predicate Device -Welmed HypodermicSyringe | |
|---|---|---|---|
| Design | Standard piston syringeconstructed with a clearhollow barrel into which isinserted a closely fittingmovable plunger andtip/seal. Fitting offeredwith male luer lockconnector. | Standard piston syringeconstructed with a clearhollow barrel into which isinserted a closely fittingmovable plunger andtip/seal. Fitting offeredwith male luer lockconnector. | |
| Comparison toPredicateDevice | Material | The barrel is constructedfrom clear polycarbonate;the plunger from ABSmaterial; the seal is madeof silicone material | The barrel is constructedfrom clear polycarbonate.The plunger/piston sealunknown |
| Principle ofOperation | Manually operated byadvancing andwithdrawing the plungerwithin the barrel. | Manually operated byadvancing andwithdrawing the plungerwithin the barrel. | |
| OperationalVolume | Operational volume of 20and 30 mL. | Operational volume of 3,5, 10, 20, 30 and 60 mL. | |
| Graduation | Printed with accurategraduation lines that arecompliant with ISO 7886-1. | Printed with accurategraduation lines that arecompliant with ISO 7886-1. | |
| IntendedUse | General purpose fluidinjection and aspirationfrom the body, as outlinedin 21 CFR 880.5860 | General purpose fluidinjection and aspirationfrom the body, as outlinedin 21 CFR 880.5860 |
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The reference device supports the vacuum technology for the subject device.
| ReferenceDeviceComparison | Attribute | Subject Device –VacLok™ AT VacuumSyringe | Reference Device –VacLok Syringe |
|---|---|---|---|
| VacuumTechnology | Variable camlocktechnology | Fixed stop positiontechnology |
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 airand 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 ISO7886-1) | Vacuum Hold (Annex B of ISO7886-1, 2 minutes) |
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| Biocompatibility testingBiocompatibility evaluation for the VacLok™ AT Vacuum Syringe wasconducted in accordance with ISO 10993-1 "Biological evaluation ofmedical devices - Part 1: Evaluation and testing within a riskmanagement process", and the FDA guidance "Use of InternationalStandard ISO 10993-1, “Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process,” June2016. Testing included the following: | |
|---|---|
| PerformanceData cont'd | Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemolysis USP Physicochemical The VacLok™ AT Vacuum Syringe is considered an externallycommunicating device with indirect blood contact for a duration of lessthan 24 hours. |
| Summary ofSubstantialEquivalence | Based on the intended use, materials, design, and performance testing,the VacLok™ AT Vacuum Syringe meets the requirements that areconsidered essential for its intended use and is considered substantiallyequivalent to the predicate device, the Welmed Hypodermic Syringe,K070936. |
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).