(373 days)
Not Found
No
The summary describes a mechanical compression device and does not mention any AI or ML components or capabilities.
Yes.
The device is used to assist hemostasis, which is the stopping of blood flow, a therapeutic action.
No
The device is described as a "compression device to assist hemostasis" which is a therapeutic function, not a diagnostic one. It helps to stop bleeding after a procedure, rather than diagnosing a condition.
No
The device description clearly states it is a physical, disposable compression device with a bladder, pump, and valves, indicating it is a hardware medical device.
Based on the provided information, the Syvek Radial™ Band is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "assist hemostasis of the radial artery after a transradial procedure." This is a direct therapeutic or procedural application on the patient's body.
- Device Description: The device is a "compression device" applied externally to the radial artery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Syvek Radial™ Band does not interact with or analyze such specimens.
Therefore, the Syvek Radial™ Band is a medical device used for external compression, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Syvek Radial™ Band is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
Syvek Radial™ Band is a sterile, single use, disposable device. The Syvek Radial™ Band is a radial artery compression device consisting of a clear medical grade polyurethane compression bladder, which is connected to both the pump and the release valves.
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)
To demonstrate substantial performance equivalence to the predicate devices, biocompatibility and bench top testing was performed. Performance Testing included:
- Biocompatibility Testing
- Pressure Equivalence to Predicate (AIR-BAND)
Bench top testing was performed to demonstrate substantial performance equivalience to the predicate device. Performance Testing included:
- Biocompatibility Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity testing performed per ISO. 10993 Biological Evaluation of Medical Devices. The conclusion drawn from the results of biocompatibility testing indicated the test articles met all test requirements.
- Pressure Equivalence to Predicate (AIR-BAND) - Pressure equivalency testing included both peak and hold pressure for extended periods of time. The Syvek Radial™ Band and the predicate device demonstrated similar performance in this testing.
The conclusions drawn from nonclinical testing demonstrate that the Syvek Radial™ Band is as safe, effective and performs as well as the legally marketed predicate device, AIR-BAND.
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
: .--
510(k) Summary VIII.
- I. General Information
- A. Applicant's Name and Address:
Marine Polymer Technologies, Inc. (MPT) 107 Water Street Danvers, MA 01923
-
B. Contact Person:
Sergio Finkielsztein President Tel: 781-270-3200 x13 Fax: 781-270-1133 -
C. Manufacturer's Name and Address:
Marine Polymer Technologies 461 Boston Road, Suite B5 Topsfield, MA 01983 Tel: 978-887-0341 Fax: 978-887-0329
D. Establishment Registration Number:
FDA Registration Number: 1225598 (Marine Polymer Technologies, Inc.)
E. Device Trade or Proprietary Names
- F. Classification Number/ Name:
- G. Regulatory Class:
- H. Product Code:
Syvek Radial Band 21 CFR § 870.4450 Vascular Clamp Class II (two) DXC
II. Indications for Use
A. Intended Use:
Syvek Radial™ Band is a compression device to assist hemostasis of the radial artery after a transradial procedure.
III. Device Description
Syvek Radial™ Band is a sterile, single use, disposable device. The Syvek Radial™ Band is a radial artery compression device consisting of a clear medical grade polyurethane compression bladder, which is connected to both the pump and the release valves.
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- IV. Substantial Equivalence-Predicate Devices:
- Datascope Corp .; Air-Band Radial Compression Device (K122405)
- V. Design Characteristics:
The Syvek Radial" Band has the same intended use and configuration (wristband) as the predicate device, AIR - BAND (K122405). The materials used are equivalent and the product design' is similar to that of the predicate device. Syvek Radial" Band is manually operated (inflated/deflated) like the predicate device.
- VI. Performance Data: To demonstrate substantial performance equivalence to the predicate devices, biocompatibility and bench top testing was performed. Performance Testing included:
- �� Biocompatibility Testing
- · Pressure Equivalence to Predicate (AIR-BAND)
- VII. Product Sterilization:
Each Syvek Radial™ Band is individually packaged in a two ply coated paper/polyester heat sealable pouch, which is a packaging commonly used in the medical device industry in the United States. Terminal sterilization is accomplished on the final packaged products by ionizing radiation.
- VIII. Summary:
Marine Polymer Technologies has submitted information on indication for use, design and principle of operation, biocompatibility and performance characteristics to establish that Syvek Radial" Band is substantially equivalent to a currently marketed predicate device.
Bench top testing was performed to demonstrate substantial performance equivalience to the predicate device. Performance Testing included:
- Biocompatibility Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity testing . performed per ISO. 10993 Biological Evaluation of Medical Devices. The conclusion drawn from the results of biocompatibility testing indicated the test articles met all test requirements.
- . Pressure Equivalence to Predicate (AIR-BAND) - Pressure equivalency testing included both peak and hold pressure for extended periods of time. The Syvek Radial™ Band and the predicate device demonstrated similar performance in this testing.
The conclusions drawn from nonclinical testing demonstrate that the Syvek Radial" Band is as safe, effective and performs as well as the legally marketed predicate device, AIR-BAND.
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2014
Marine Polymer Technologies Sergio Finkielsztein President 107 Water Street Danvers, Massachusetts 01923
Re: K132293
Trade/Device Name: Syvek radial band Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: June 27, 2014 Received: June 30, 2014
Dear Mr. Finkielsztein,
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
3
Page 2 - Mr. Sergio Finkielsztein
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/ReportalProblem/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 vours.
M. Afzal Durrani
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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Marine Polymer Technologies, Inc Syvek Radial™ Band
Indications for Use Statement
510(k) Number K132293 Page 1 of 1
Device Name: Syvek Radial™ Band
Indications for use:
Syvek Radial™ Band is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Prescription Use X (Per 21 C.F.R. 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MA.D.D.A.M.