SYVEK RADIAL BAND by MARINE POLYMER TECHNOLOGIES

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.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Syvek Radial Band, a vascular clamp. The information is limited to establishing substantial equivalence to a predicate device and does not contain details about a detailed study with acceptance criteria for device performance as typically expected for diagnostic AI/ML devices.

However, based on the provided text, I can infer and structure the information as best as possible within the constraints of the request.

Here's a breakdown of the available information and how it relates to your request:

Acceptance Criteria and Device Performance

The provided 510(k) summary is for a physical medical device (a vascular compression band), not an AI/ML diagnostic device, and therefore the "acceptance criteria" and "device performance" are framed around demonstrating substantial equivalence to a predicate device rather than precise diagnostic metrics like sensitivity or specificity.

Acceptance Criteria (Inferred from Substantial Equivalence Claim):
The primary acceptance criterion is substantial equivalence to the predicate device, the Datascope Corp.; Air-Band Radial Compression Device (K122405), in terms of safety and effectiveness. This is demonstrated by:

Equivalent Intended Use and Configuration: The device must have the same intended use and similar physical configuration as the predicate.
Equivalent Materials: The materials used must be equivalent.
Similar Product Design: The overall design should be similar.
Similar Operation: Manual operation (inflated/deflated) similar to the predicate.
Biocompatibility: Meet ISO 10993 standards for cytotoxicity, sensitization, and irritation/intracutaneous reactivity.
Pressure Equivalence: Demonstrate similar pressure performance (peak and hold pressure for extended periods) to the predicate device.

Reported Device Performance (from "Performance Data" and "Summary" sections):

Acceptance Criterion (Inferred)	Reported Device Performance
Intended Use & Configuration Equivalence	"The Syvek Radial™ Band has the same intended use and configuration (wristband) as the predicate device, AIR - BAND (K122405)."
Materials Equivalence	"The materials used are equivalent..."
Product Design Similarity	"...and the product design is similar to that of the predicate device."
Operational Similarity	"Syvek Radial™ Band is manually operated (inflated/deflated) like the predicate device."
Biocompatibility (per ISO 10993)	"Biocompatibility Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity 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."
Overall Safety and Effectiveness (Conclusion based on above)	"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."

Study Details (as inferable from the provided text):

Since this is a submission for a physical device, not an AI/ML algorithm, many of the requested points are not applicable or the information is not provided.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for any of the performance tests (biocompatibility or pressure equivalence). It only mentions "test articles" for biocompatibility and generic "testing" for pressure equivalence.
- Data Provenance: The studies were benchtop testing and biocompatibility testing, likely conducted by the manufacturer or contracted labs. Country of origin not specified (Marine Polymer Technologies is based in the US). These tests are inherently "prospective" in the sense that they are conducted specifically for this submission, but not on human patients in a clinical trial.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not Applicable. For benchtop and biocompatibility testing of a physical device, "ground truth" is established by adherence to engineering specifications, recognized standards (like ISO 10993), and direct measurement against a predicate device. This doesn't involve expert human interpretation in the same way as, for example, reading medical images.
Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of medical data determines ground truth, often with disagreement between reviewers. For mechanical and biocompatibility testing, outcomes are typically definitive measurements or pass/fail criteria.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance, which is not applicable to a physical compression band like the Syvek Radial Band. Therefore, there's no effect size reported.
If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Not Applicable. The Syvek Radial Band is a physical device, not an algorithm.
The Type of Ground Truth Used:
- Engineering/Performance Standards & Predicate Device Comparison:
  - For biocompatibility: ISO 10993 standards and their defined pass/fail criteria.
  - For pressure equivalence: Direct comparative measurements against the predicate device's measured pressure performance.
The Sample Size for the Training Set:
- Not Applicable. As a physical device, there is no "training set" in the context of machine learning.
How the Ground Truth for the Training Set was Established:
- Not Applicable. No training set exists for this device.

Summary

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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

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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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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

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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.

Regulation Number and Section

§ 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).