(29 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data-driven analysis.
Yes
The device is used to assist in gaining hemostasis, which is the stopping of blood flow, a therapeutic action.
No
The device description indicates its purpose is to assist in gaining and maintaining hemostasis (stopping bleeding) following catheterization procedures, which is a therapeutic function rather than a diagnostic one. It does not mention taking measurements, creating images, or identifying conditions.
No
The device description clearly outlines physical components like a wristband, thumb saddle strap, inflatable balloon, check valve, syringe inflator, and backer plate. The performance studies also detail testing of physical properties and materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in gaining hemostasis of arterial percutaneous access sites." This is a therapeutic/mechanical function performed directly on the patient's body.
- Device Description: The description details a physical compression device applied externally to the wrist.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, tissue, etc.) or providing diagnostic information. The device's function is purely mechanical compression.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The PreludeSYNC DISTAL™ is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The PreludeSYNC DISTAL™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial artery following catheterization procedures. It consists of a soft wristband and thumb saddle strap with secure hook and loop fasteners. The band delivers adjustable compression of the puncture site with an inflatable balloon, and a check valve for easy inflation and deflation with the accompanying 10mL syringe inflator. A clear curved backer plate provides optimal visualization of the puncture site and ease of placement.
PreludeSYNC DISTAL is available in a variety of graphic designs and a right or left-hand configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial artery
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 PreludeSYNC DISTAL Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standard:
- . ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- 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 10993-1:2009, Biological Evaluation of Medical Devices ● Part 1: Evaluation and Testing within a risk management process
- ISO 10993-7:2008, Biological evaluation of medical devices -● Part 7: Ethylene oxide sterilization residuals
- . ISO 2233:2000, Packaging - complete, filled transport packages and unit loads - conditioning for testing
- ASTM D4169:2016, Standard practice for performance testing ● of shipping containers and systems
The following tests were performed to demonstrate there were no unacceptable risks associated with the changes made to the device:
Performance Testing-Bench
- Bubble Emission Packaging .
- Visual Inspection - Packaging
- Adapted Connector Torque ●
- Dimensions - Band Sizing Verification
- Side Load and Leak Test
- Indicator Mark Adherence ●
- Hook and Laminate Integrity Test
- Balloon Burst Test .
- Adapted Cap to Valve Attachment ●
- Tensile Test Hook and Loop ●
- Tensile Test Band to Backer Plate .
- . Band Compliance
- Simulated Use .
Biocompatibility Testing:
All materials of the subject device (excluding the colorant in the plunger) are used in the legally marketed predicate PreludeSYNC with the same intended use, patient contact, processing and sterilization methods. Therefore, no further biocompatibility testing is required for these materials. The plunger in the inflation syringe is categorized as having no direct or indirect contact with the human body. Based on the contact categorization of the plunger component, biocompatibility testing is not required.
The PreludeSYNC DISTAL is categorized as a Surface Device with Breached or Compromised Surface Contact for a Limited (
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 17, 2018
Merit Medical Systems, Inc Susan Christensen Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K180723
Trade/Device Name: PreludeSYNC DISTAL™ Radial Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: March 15, 2018 Received: March 19, 2018
Dear Ms. Christensen:
We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good
1
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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
5.0 510(k) Summary
| General
| Provisions | Submitter Name: | Merit Medical Systems, Inc. |
|---|---|---|
| Address: | 1600 West Merit Parkway | |
| South Jordan, UT 84095 | ||
| Telephone Number: | (801) 208-4789 | |
| Fax Number: | (801) 253-6919 | |
| Contact Person: | Susan Christensen | |
| Date Prepared: | March 15, 2018 | |
| Registration Number: | 1721504 | |
| Subject Device | Trade Name: | PreludeSYNC DISTAL™ Radial Compression |
| Device | ||
| Common/Usual Name: | Radial Compression Device | |
| Classification Name: | Vascular Clamp | |
| Regulatory Class: | II | |
| Product Code: | DXC | |
| 21 CFR §: | 870.4450 | |
| Review Panel: | Cardiovascular | |
| Predicate | ||
| Device | Trade Name: | PreludeSYNC™ Radial Compression Device |
| Classification Name: | Radial Compression Device | |
| Premarket Notification: | K162988 | |
| Manufacturer: | Merit Medical Systems, Inc. | |
| The predicate has been the subject of a design-related recall, reference | ||
| Z-1766-2017 | ||
| Reference | ||
| Device | No reference devices were used in this submission. | |
| Device | ||
| Description | The PreludeSYNC DISTAL™ Radial Compression Device is a sterile, | |
| single use disposable device used to assist in gaining and maintaining | ||
| hemostasis of the radial artery following catheterization procedures. | ||
| It consists of a soft wristband and thumb saddle strap with secure hook | ||
| and loop fasteners. The band delivers adjustable compression of the | ||
| puncture site with an inflatable balloon, and a check valve for easy | ||
| inflation and deflation with the accompanying 10mL syringe inflator. A | ||
| clear curved backer plate provides optimal visualization of the puncture | ||
| site and ease of placement. | ||
| PreludeSYNC DISTAL is available in a variety of graphic designs and a | ||
| right or left-hand configuration. | ||
| Indications for | ||
| Use | The PreludeSYNC DISTAL™ is a compression device used to assist in | |
| gaining hemostasis of arterial percutaneous access sites. |
3
The design and technological characteristics of the subject PreludeSYNC DISTAL Radial Compression Device are substantially equivalent to those of the predicate PreludeSYNC. The subject device has the same materials and use as the predicate device. The main difference between the subject and the predicate device is the design of the PreludeSYNC DISTAL is slightly different (including addition of a thumb saddle strap and modified syringe inflator components) with different dimensions of the backer plate, straps, and balloon. The comparison between the subject and the predicate devices is based on the following:
Comparison to Predicate Device
Performance
Data
- Same Clinical use
- Same Intended use ●
- Same Indications for use ●
- Same Materials ●
- Similar design
- Same Sterilization methods ●
- Same Labeling and packaging .
- Same Fundamental technology/principle of operation .
No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject PreludeSYNC DISTAL Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standard:
- . ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- 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 10993-1:2009, Biological Evaluation of Medical Devices ● Part 1: Evaluation and Testing within a risk management process
- ISO 10993-7:2008, Biological evaluation of medical devices -● Part 7: Ethylene oxide sterilization residuals
- . ISO 2233:2000, Packaging - complete, filled transport packages and unit loads - conditioning for testing
- ASTM D4169:2016, Standard practice for performance testing ● of shipping containers and systems
4
The following tests were performed to demonstrate there were no unacceptable risks associated with the changes made to the device:
Performance Testing-Bench
- Bubble Emission Packaging .
- Visual Inspection - Packaging
- Adapted Connector Torque ●
- Dimensions - Band Sizing Verification
- Side Load and Leak Test
- Indicator Mark Adherence ●
- Hook and Laminate Integrity Test
- Balloon Burst Test .
- Adapted Cap to Valve Attachment ●
- Tensile Test Hook and Loop ●
- Tensile Test Band to Backer Plate .
- . Band Compliance
- Simulated Use .
Biocompatibility Testing
| | All materials of the subject device (excluding the colorant in the
plunger) are used in the legally marketed predicate PreludeSYNC with
the same intended use, patient contact, processing and sterilization
methods. Therefore, no further biocompatibility testing is required for
these materials. The plunger in the inflation syringe is categorized as
having no direct or indirect contact with the human body. Based on the
contact categorization of the plunger component, biocompatibility
testing is not required. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The PreludeSYNC DISTAL is categorized as a Surface Device with
Breached or Compromised Surface Contact for a Limited (