(218 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is a general-purpose syringe used for injecting or withdrawing fluids, which is not considered a therapeutic function that changes the composition of the body or cures a disease.
No
The device is a syringe used for injecting or withdrawing fluids, with a vacuum-holding capability. Its intended use focuses on fluid management, not on identifying or confirming a medical condition, disease, or its predisposition.
No
The device description clearly states it is a physical syringe constructed with a barrel, plunger, piston seal, and locking mechanism. The performance studies also focus on physical characteristics and compliance with hardware standards (ISO 7886-1, ISO 594-2, ISO 10993-1).
Based on the provided information, the VacLok™ AT Vacuum Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "inject fluids into, or withdraw fluids from the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description of a "general piston syringe" with a locking mechanism aligns with a medical device used for fluid management in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVD devices are specifically designed for testing samples in vitro (outside the body).
- Performance Studies: The performance studies focus on the physical properties and functionality of the syringe itself (leakage, strength, biocompatibility), not on the accuracy or reliability of diagnostic results obtained from analyzing samples.
- Predicate Device: The predicate device is a "Hypodermic Syringe," which is also a device used for in vivo fluid management, not an IVD.
In summary, the VacLok™ AT Vacuum Syringe is a medical device used for fluid management within the body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for 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.).
Product codes (comma separated list FDA assigned to the subject device)
PUR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, 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: Gauging, Liquid leakage, Air leakage, Separation force, Unscrewing torque, Ease of assembly, Resistance to overriding, Stress cracking.
Vacuum Performance Testing: Air Leakage (Annex B of ISO 7886-1), Vacuum Hold (Annex B of ISO 7886-1, 2 minutes).
Biocompatibility evaluation for the VacLok™ AT Vacuum Syringe was conducted in accordance with ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", and the 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. Testing included the following: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, USP Physicochemical.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-4818
(801) 316-4878
Ms. Angela Brady
December 20, 2016
1721504 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | VacLok™ AT Vacuum Syringe
Piston Syringe
Syringe, Piston
2
PUR
880.5860
General Hospital |
| Predicate
Device | Trade Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Premarket Notification:
Manufacturer: | Welmed Hypodermic Syringe
Syringe, Piston
2
FMF
880.5860
K070936
Welmed, Inc. |
| Reference
Device | Trade Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Premarket Notification:
Manufacturer: | VacLok Syringe
Syringe, Piston
2
FMF
880.5860
K994253
Merit Medical Systems, Inc. |
| Device
Description | 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. | |
| Indications for
Use | | The 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 Indications for Use statement for the VacLok™ AT Vacuum
Syringe is not identical to the predicate device; however, the |
510 (K) Summary
4
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 Vacuum
Syringe | Predicate Device -
Welmed Hypodermic
Syringe |
|--------------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Design | Standard piston syringe
constructed with a clear
hollow barrel into which is
inserted a closely fitting
movable plunger and
tip/seal. Fitting offered
with male luer lock
connector. | Standard piston syringe
constructed with a clear
hollow barrel into which is
inserted a closely fitting
movable plunger and
tip/seal. Fitting offered
with male luer lock
connector. |
| Comparison to
Predicate
Device | Material | The barrel is constructed
from clear polycarbonate;
the plunger from ABS
material; the seal is made
of silicone material | The barrel is constructed
from clear polycarbonate.
The plunger/piston seal
unknown |
| | Principle of
Operation | Manually operated by
advancing and
withdrawing the plunger
within the barrel. | Manually operated by
advancing and
withdrawing the plunger
within the barrel. |
| | Operational
Volume | Operational volume of 20
and 30 mL. | Operational volume of 3,
5, 10, 20, 30 and 60 mL. |
| | Graduation | Printed with accurate
graduation lines that are
compliant with ISO 7886-
-
| Printed with accurate
graduation lines that are
compliant with ISO 7886-
-
|
| | Intended
Use | General purpose fluid
injection and aspiration
from the body, as outlined
in 21 CFR 880.5860 | General purpose fluid
injection and aspiration
from the body, as outlined
in 21 CFR 880.5860 |
5
The reference device supports the vacuum technology for the subject device.
| Reference
Device
Comparison | Attribute | Subject Device –
VacLok™ AT Vacuum
Syringe | Reference Device –
VacLok Syringe |
|-----------------------------------|--------------------------------|--------------------------------------------------|--------------------------------------|
| Vacuum
Technology | Variable camlock
technology | Fixed stop position
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)]
6
| • 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 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 |
| 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 | |
| 7886-1) | Vacuum Hold (Annex B of ISO |
| 7886-1, 2 minutes) |
7
| Biocompatibility testing
Biocompatibility evaluation for the VacLok™ AT Vacuum Syringe was
conducted in accordance with ISO 10993-1 "Biological evaluation of
medical devices - Part 1: Evaluation and testing within a risk
management process", and the 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. Testing included the following: | |
|---|---|
| Performance | |
| Data cont'd | Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Hemolysis USP Physicochemical The VacLok™ AT Vacuum Syringe is considered an externally |
| communicating device with indirect blood contact for a duration of less | |
| than 24 hours. | |
| Summary of | |
| Substantial | |
| Equivalence | Based on the intended use, materials, design, and performance testing, |
| the VacLok™ AT Vacuum Syringe meets the requirements that are | |
| considered essential for its intended use and is considered substantially | |
| equivalent to the predicate device, the Welmed Hypodermic Syringe, | |
| K070936. |