(28 days)
Not Found
No
The summary describes a mechanical fluid delivery system and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is intended for the controlled administration of thrombolytic agents, which directly contributes to a therapeutic outcome (thrombolysis).
No
The device is described as a "Fluid Delivery System" intended for the controlled administration of thrombolytic agents, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a "hand held instrument" designed to be "attached to a syringe and a catheter," indicating it is a physical hardware device, not software only. The performance studies also reference testing related to physical properties and biocompatibility, further supporting it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled administration of thrombolytic agents into the peripheral vasculature." This describes a therapeutic intervention performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is described as a "hand held instrument to provide consistent, forceful, pulsed injections" and is designed to be attached to a syringe and catheter for infusion. This is consistent with a device used for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Squirt® Fluid Delivery System is clearly designed for direct therapeutic use within the body.
N/A
Intended Use / Indications for Use
The Squirt Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Squirt® Fluid Delivery System is a hand held instrument to provide consistent, forceful, pulsed injections for optimal thrombolysis procedures. It's designed to be attached to a syringe and a catheter, to infuse controlled administration of thrombolytic agents into the peripheral vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
Performance testing of the subject Squirt® Fluid Delivery System was conducted based on the risk analysis and based on the requirements of the following international standards:
- ISO 8536-4:2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- ISO 8536-10:2015, Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment
- ISO 11135:2014, Sterilization of health care products – Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
- ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical devices – Part 4: Selection of tests for interaction with blood
- ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008, Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals
- 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 F756-13, Standard Practice for Assessment of Hemolytic Properties of Materials
- United States Pharmacopeia 38, National Formulary 33, 2015 Pyrogen Test
- AMMI TIR 28:2009, Product adoption and process equivalency for ethylene oxide sterilization
Additional tests conducted: - Merit Rotational Torque Test
- Merit Hydrostatic Pressure Test
- Merit Vacuum Leak Test
- ISO 8536-4 Chemical Requirements
- ISO 8536-10 Particulate
- ISO 8536-10 Leakage
Biocompatibility tests: - Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Hemocompatibility
- Chemical Characterization
The results of the testing demonstrated that the subject Squirt® Fluid Delivery System met the predetermined acceptance criteria and thus is substantially equivalent to the predicate device.
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.
Not Found
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 31, 2016
Merit Medical Systems, Inc. Ms. Angela Brady Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, UT 84095
Re: K162777
Trade/Device Name: Squirt Fluid Delivery System Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: September 30, 2016 Received: October 4, 2016
Dear Ms. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
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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/ResourcesforYou/Industry/default.htm. 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
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,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162777
Device Name Squirt Fluid Delivery System
Indications for Use (Describe)
The Squirt Fluid Delivery System is intended for the controlled administration of thrombolytic agents into the peripheral vasculature.
| 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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510(k) Summary
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-4818
(801) 316-4878
Angela Brady
September 30, 2016
1721504 |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Squirt® Fluid Delivery System
Fluid Delivery System
Catheter, Continuous Flush
II
KRA
870.1210
74 Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Squirt® Fluid Delivery System
Catheter, Continuous Flush
K981417
Merit Medical Systems, Inc. |
| The predicate has not been subject to a design-related recall. | | |
| Device
Description | The Squirt® Fluid Delivery System is a hand held instrument to provide
consistent, forceful, pulsed injections for optimal thrombolysis
procedures. It's designed to be attached to a syringe and a catheter, to
infuse controlled administration of thrombolytic agents into the
peripheral vasculature. | |
| Indications for
Use | The Squirt® Fluid Delivery System is intended for the controlled
administration of thrombolytic agents into the peripheral vasculature.
There is no change in the Indications for Use Statement from the
predicate to the subject device. | |
| Comparison to
Predicate
Device | The technological characteristics of the subject Squirt® Fluid Delivery
System are identical to the predicate device. Both devices use the
same components and materials, with the exception of the O-Ring
within the rotator assembly that is bonded on the end of the Squirt®
Fluid Delivery System which has undergone a chemical formulation
change in the subject device. The indications for use, principle of
operation, and technological characteristics of the subject device are
identical to the predicate device.
Both devices have the same mode of operation and indication for use. | |
| Performance
Data | No performance standards have been established under Section 514 of
the Food, Drug and Cosmetic Act for these devices. Performance
testing of the subject Squirt® Fluid Delivery System was conducted
based on the risk analysis and based on the requirements of the
following international standards:
● ISO 8536-4:2010, Infusion equipment for medical use - Part 4:
Infusion sets for single use, gravity feed
● ISO 8536-10:2015, Infusion equipment for medical use - Part 10:
Accessories for fluid lines for single use with pressure infusion
equipment
● ISO 11135:2014, Sterilization of health care products – Ethylene
oxide - Requirements for development, validation and routine
control of a sterilization process for medical devices
● ISO 10993-1:2009, Biological Evaluation of Medical Devices Part
1: Evaluation and Testing within a risk management process, and
FDA guidance Required Biocompatibility Training and Toxicology
Profiles for Evaluation of Medical Devices, May 1, 1995
● ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of medical
devices – Part 4: Selection of tests for interaction with blood
● ISO 10993-5:2009, Biological evaluation of medical devices - Part
5: Tests for in vitro cytotoxicity
● ISO 10993-7:2008, Biological evaluation of medical devices – Part
7: Ethylene oxide sterilization residuals
● 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 F756-13, Standard Practice for Assessment of Hemolytic
Properties of Materials
● United States Pharmacopeia 38, National Formulary 33, 2015
Pyrogen Test
● AMMI TIR 28:2009, Product adoption and process equivalency for
ethylene oxide sterilization | |
| • Merit Rotational Torque Test
• Merit Hydrostatic Pressure Test
• Merit Vacuum Leak Test
• ISO 8536-4 Chemical Requirements
• ISO 8536-10 Particulate
• ISO 8536-10 Leakage | Biocompatibility
• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogenicity
• Hemocompatibility
• Chemical Characterization | |
| Safety &
Performance
Tests cont. | | |
| The results of the testing demonstrated that the subject Squirt® Fluid
Delivery System met the predetermined acceptance criteria and thus is
substantially equivalent to the predicate device. | | |
| Summary of
Substantial
Equivalence | Based on the indications for use, design, and performance testing, the
subject Squirt® Fluid Delivery System meets the requirements that are
considered essential for its intended use and is substantially equivalent
to the predicate device, the Squirt® Fluid Delivery System, K981417
manufactured by Merit Medical Systems, Inc. | |
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