(90 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or related concepts.
Yes
The device is used to assist in gaining and maintaining hemostasis of arterial percutaneous access sites, which is a therapeutic function.
No.
Explanation: The device description states that the PreludeSYNC is a compression device used to assist in gaining and maintaining hemostasis. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (wristband, backer plate, inflatable bulb, syringe inflator) and the performance studies focus on physical and biological testing of these components, not software validation.
Based on the provided information, the PreludeSYNC is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "assist in gaining hemostasis of arterial percutaneous access sites." This describes a physical intervention on the patient's body to control bleeding, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a physical compression device with a wristband, backer plate, and inflatable bulb. This aligns with a mechanical device used for external compression, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical properties, integrity, and biocompatibility of the device, which are relevant for a medical device used externally on a patient, not for an IVD.
In summary, the PreludeSYNC is a medical device used for external compression to control bleeding, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PreludeSYNC 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™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It consists of a soft wristband with a secure hook and loop fastener and a clear curved backer plate that provides optimal visualization of the puncture site and ease of placement. The inflatable bulb delivers adjustable compression of the puncture site. A check valve and tubing allow for easy inflation and deflation with the accompanying 20ml syringe inflator.
PreludeSYNC is available in a variety of graphic designs and in two band sizes: regular (24cm) and long (29cm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial and ulnar 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 - Bench
- Dimensions
- Tensile of Joints
- Submerged Air Leak Test
- Inflation Bulb Burst Test
- Hook-and- Loop Detachment Test
- Integrity Test
- Band Absorbency
- Backer Plate Transparency
- Ink Adherence
- Simulated Use
Biocompatibility testing
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
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
§ 870.4450 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 for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 25, 2017
Merit Medical Systems, Inc. Ileana Davis Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K162988
Trade/Device Name: PreludeSYNC Radial Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: December 22, 2016 Received: December 30, 2016
Dear Ms. Davis:
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
1
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/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.
Sincerelv.
M.A. Hillemann
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162988
Device Name
PreludeSYNC Radial Compression Device
Indications for Use (Describe)
The PreludeSYNC is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.
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
5.0 510(k) Summary
| 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) 208-4187
(801) 316-4065
Ileana Davis, Regulatory Affairs Specialist
26 October 2016
1721504 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | PreludeSYNC™ Radial Compression Device
Radial Compression Device
Vascular Clamp
II
DXC
870.4450
Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Vasc™ Band Hemostat
Vascular Clamp
K142359
Lepu Medical Technology (Beijing) Co., Ltd.
This predicate has not been subject to a design-related recall in the US. |
| Device
Description | The PreludeSYNC™ Radial Compression Device is a sterile, single use
disposable device used to assist in gaining and maintaining hemostasis
of the radial and ulnar artery following catheterization procedures. It
consists of a soft wristband with a secure hook and loop fastener and a
clear curved backer plate that provides optimal visualization of the
puncture site and ease of placement. The inflatable bulb delivers
adjustable compression of the puncture site. A check valve and tubing
allow for easy inflation and deflation with the accompanying 20ml
syringe inflator.
PreludeSYNC is available in a variety of graphic designs and in two
band sizes: regular (24cm) and long (29cm). | |
| Indications for
Use | The PreludeSYNC is a compression device used to assist in gaining
hemostasis of arterial percutaneous access sites.
The Indications for Use statement for the PreludeSYNC is not identical
to the predicate device; however, the differences do not alter the
intended therapeutic use of the device nor do they affect the safety and
effectiveness of the device relative to the predicate. Both the subject | |
| Comparison to
Predicate
Device | and predicate devices have the same intended use of providing
compression to assist hemostasis of percutaneous access sites. | |
| | The technological characteristics of the subject PreludeSYNC™ Radial
Compression device are substantially equivalent to those of the
predicate Vasc™ Band Hemostat.
At a high level, the subject and predicate devices are based on the
following same technological elements: | |
| | Clinical use Labeling Basic design Principle of operation Performance Band sizes | |
| | The following technological difference exists between the subject and
predicate devices: Materials | |
| | No performance standards have been established under Section 514 of
the Food, Drug and Cosmetic Art for these devices. Performance | |
4
rug and Cosmetic Act for testing of the subject PreludeSYNC™ Radial Compression Device was conducted based on the risk analysis and based on the requirements of the following international standards:
- ISO 594-1 Conical fittings with 6% (Luer) taper for syringes. ● needles and certain other medical equipment – Part 1: General requirements
- . ISO 594-2 - Conical fittings with 6% (Luer) taper for syringes. needles and certain other medical equipment – Part 2: Lock fittings
- ISO 2233:2001 Packaging Complete, filled transport packages . and unit loads - Conditioning for testing
Performance Data
- . ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems
- . ASTM D4169-09 - Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F1980-11 Standard Guide for Accelerated Aging of Sterile . Barrier Systems for Medical Devices
- . 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 10993-5:2009 - 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 residuals
5
- 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
The following performance data were provided in support of the substantial equivalence determination:
Performance Testing - Bench
- Dimensions ●
- Tensile of Joints ●
- Submerged Air Leak Test ●
- Inflation Bulb Burst Test ●
- Hook-and- Loop Detachment Test
- Integrity Test ●
- Band Absorbency
- Backer Plate Transparency ●
- Ink Adherence ●
- Simulated Use
Biocompatibility testing
The biocompatibility evaluation for the PreludeSYNC™ Radial Compression Device was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following:
- Cytotoxicity ●
- Sensitization ●
- Irritation
- Acute Systemic Toxicity ●
Based on the indications for use, design, safety and performance testing, the subject PreludeSYNC™ Radial Compression Device Summary of meets the requirements that are considered essential for its intended Substantial use and is substantially equivalent to the predicate device, the Vasc™ Equivalence Band Hemostat, K142359.