The TR BAND® Radial Compression Device is a tourniquet style device consisting of a plastic belt with hook and loop adjustable fastener on each end, two compression balloons, and an injection port. The device also contains a TR Band Inflator. After a Transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port. The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band. With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process. The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

AI/ML Overview

The provided text is a 510(k) summary for the TR BAND® Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study to establish new acceptance criteria and prove device performance against them.

Therefore, the document does not describe acceptance criteria for clinical performance or a study that proves the device meets such criteria. It explicitly states under section "H. CLINICAL TESTS (807.92(b)(2))": "This 510(k) does not include data from clinical tests."

Instead, it relies on non-clinical tests to demonstrate substantial equivalence to a previously approved predicate device (K070423 – TR BandTM). The acceptance criteria mentioned are related to these non-clinical tests, such as biocompatibility, sterilization, and material performance.

Here's an analysis of the information provided, focusing on what is available:

1. A table of acceptance criteria and the reported device performance:

The document lists performance tests and states "All testing met acceptance criteria." However, it does not provide specific quantitative acceptance criteria or detailed reported performance results in a table format for each test. Instead, it refers to compliance with standards.

Here's a summary of the non-clinical tests that were performed and implied acceptance criteria (compliance with standards):

Acceptance Criteria (Implied: Compliance with Standard)	Reported Device Performance
Biocompatibility:
ISO 10993-1, -5, -7, -10, -11, -12 compliance (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, Material Characterization)	All tests demonstrated biocompatibility; aging does not affect biocompatibility. TR Band Inflator excluded as not patient contacting.
Sterilization:
ISO 11135:2014 compliance for Ethylene Oxide sterilization (SAL 10-6)	Device is sterilized to SAL 10-6.
EN ISO 10993-7:2008/Corr.1:2009 for EO and ECH residuals (<4 mg EO, <9 mg ECH per device after 24 hrs aeration)	EO and ECH residuals meet requirements for limited exposure devices.
Packaging & Shelf Life:
ISO 11607-1:2006/A1:2014 (Packaging for Terminally Sterilized Medical Devices)	Met acceptance criteria.
ASTM F88/F88M:09 (Seal Strength of Flexible Barrier Materials)	Met acceptance criteria.
ASTM F2825-10 (Climatic Stressing of Packaging Systems)	Met acceptance criteria.
ASTM F1929-12 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)	Dye leak testing performed and met acceptance criteria.
ASTM F-1980-07 (Accelerated Aging of Sterile Barrier Systems)	Met acceptance criteria, demonstrating shelf life integrity.
Material/Device Performance:
USP 38 <85> (Bacterial Endotoxins Test)	Met acceptance criteria.
USP 38 <151> (Pyrogenicity Test)	Met acceptance criteria.
USP 38 <661> (Containers- Plastics, Physicochemical Tests)	Met acceptance criteria.
Internal Standards (Visual/Appearance, Dimensional, Functional performance - device bond strength, balloon inflation/deflation, hemostasis valve testing)	All testing met acceptance criteria, confirming function as intended.
Risk Management:
ISO 14971 (Application of risk management to medical devices)	Product Risk Analysis conducted; any new risks adequately captured and mitigated.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified for the non-clinical tests. Non-clinical studies (e.g., sterilization validation, biocompatibility) typically use statistically relevant sample sizes according to the specific test standard, but these are not explicitly stated in the summary.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Since these are largely lab-based non-clinical tests conducted by Terumo Medical Corporation (Elkton, MD, USA) and Steris Isomedix Services Inc. (South Plainfield, NJ), the data can be considered laboratory testing data. The studies are prospective in the sense that they were designed and executed to test the device's conformance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the submission explicitly states no clinical tests were performed. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome, usually confirmed by experts. The non-clinical tests rely on established scientific methods and standards, not expert consensus on medical diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable as no clinical studies were performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a radial compression device, not an AI-powered diagnostic tool, and no clinical studies were conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm, and no clinical studies were conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established scientific principles, test methods defined in ISO/ASTM standards, and the physical properties/performance of the device itself.

8. The sample size for the training set:

Not applicable, as this is not a machine learning/AI device, and no clinical studies or training sets were mentioned.

9. How the ground truth for the training set was established:

Not applicable, as this is not a machine learning/AI device, and no clinical studies or training sets were mentioned.

In summary: The provided FDA 510(k) summary is for a physical medical device (TR BAND® Radial Compression Device) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing, rather than establishing new clinical acceptance criteria or conducting clinical performance studies. The document explicitly states that no clinical data was included in this 510(k) submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 10, 2015

Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd Elkton, Maryland 21921

Re: K152525

Trade/Device Name: TR Band Radial Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: September 2, 2015 Received: September 3, 2015

Dear Mr. Lu:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803): good manufacturing practice requirements

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as set forth in the quality systems (OS) 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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 yours,

M.A. Hilleman

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) K152525

Device Name

TR BAND® Radial Compression Device

Indications for Use (Describe)

The TR BAND® Radial Compression Device is a compression device to assist hemostasis of the radial artery after a transradial procedure.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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SECTION 5 - 510(K) SUMMARY

Section Contents

A. SUBMITTER INFORMATION (807.92(a)(1))
B. DEVICE NAME (807.92(a)(2))
C. PREDICATE DEVICE (807.92(a)(3))
D. DEVICE DESCRIPTION (807.92(a)(4))
E. INDICATIONS FOR USE (807.92(a)(5))
F. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
G. NON CLINICAL TESTS (807.92(b)(1))
H. CLINICAL TESTS (807.92(b)(2))
I. CONCLUSION (807.92(b)(3))

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Image /page/4/Picture/0 description: The image shows the Terumo logo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and to the left of the word.

510(K) SUMMARY

A. SUBMITTER INFORMATION (807.92(a)(1))

Prepared by:

Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079

Prepared for: Owner/Operator

Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873, USA Registration Number: 2243441

Manufacturer (510(k) Applicant)

Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Registration Number: 1118880

Sterilization Facility Steris Isomedix Services Inc. 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552

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Image /page/5/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is positioned above and to the left of the word "TERUMO", creating a dynamic and recognizable brand symbol.

Contact Person: Liang Lu

Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com

Date prepared: November 3, 2015

B. DEVICE NAME (807.92(a)(2))

Proprietary Name:	TR BAND® Radial Compression Device
Common Name:	Radial compression device
Classification Name:	Vascular clamp
Classification Panel:	Cardiovascular
Regulation:	21 CFR 870.4450
Product Code:	DXC
Classification:	Class II

C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed is: K070423 – TR Band™, manufactured by Terumo Corporation, Japan

D. DEVICE DESCRIPTION (807.92(a)(4))

After a Transradial catheterization procedure, the TR Band is placed around the patient's wrist and the hook and loop strap is connected. Once the introducer sheath is removed from the patient's wrist, pressure is applied to the patient's access site by

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Image /page/6/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh is curved and points to the right, and the word "TERUMO" is in a bold, sans-serif font.

inflating the compression balloons of the TR Band. Both compression balloons are filled at the same time while air is being introduced through the air injection port.

The balloons are inflated when air is injected into the air injection port by the TR Band Inflator. The TR Band inflator is a specially designed syringe for use only with the TR Band. A valve on the air injection port assures that the air remains within the compression balloons. The volume of air can be reduced or increased by use of the TR Band Inflator (20ml syringe). This allows the physician to make fine adjustments to the pressure in the TR Band.

With the two compression balloons (large and small) the pressure is applied for efficient compression for hemostasis. The belt also has a support plate over the two compression balloons to assure that the balloons and belt conform to the contour of the wrist. The belt and compression balloons are made of clear plastic which allows the physician to view the access site during the hemostasis process.

The TR Band is a disposable device intended for single use only. This device is individually packaged and sterilized by ethylene oxide gas.

E. INDICATIONS FOR USE (807.92(a)(5))

The TR BAND® Radial Compression Device is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Note: The indications for use are identical to the predicate device.

F. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The TR BAND® Radial Compression Device, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the TR Band, manufactured by Terumo Corporation.

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A comparison of the technological characteristics is summarized on the table below.

Table 5.4: Summary of Substantial Equivalence

DeviceCharacteristic	Predicate:TR Band, K070423	New Device:TR BAND® Radial CompressionDevice
Manufacturer	Terumo Corporation	Terumo Medical Corporation
Intended Use /Indications forUse	The TR Band™ is a compressiondevice to assist hemostasis of theradial artery after a transradialprocedure.	Same
OperationPrinciple	Operated manually or by a manualprocess;Pneumatic compression balloons arefilled to apply pressure to the accesssite	Same
Design/Construction	A plastic belt with hook and loopadjustable fastener on each end, twocompression balloons, and aninjection port. The device alsocontains a TR Band Inflator and anAir Volume Regulator	Same design and construction.(The only difference is that the TRBand Air Volume Regulator is notbeing made available for the newdevice)
Package	• Unit Pouch• Shelf Box• Shipping Carton	• Lidded tray• Shelf Box• Shipping Carton
Specifications	Length of band (belt):Large TR Band is 24 cmLarge TR Band is 29cm	Same
Sterilization	Ethylene Oxide (validated inaccordance with ANSI / AAMI / ISO11135-1 to achieve SAL 10-6)	Same
Shelf life	30 months	12 months
DisposableSingle Use	Yes	Same

The materials of the proposed TR BAND® Radial Compression Device are identical to those of the predicate device.

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G. NON CLINICAL TESTS (807.92(b)(1))

Performance

Performance testing was conducted to demonstrate substantial equivalence to the predicate device, verify conformity to applicable external and internal standards, and verify that aging does not affect the TR Band Radial Compression Device. All testing met acceptance criteria. Tables 5.4 below provide a list of the performance tests that were performed on the proposed TR BAND® Radial Compression Device.

Standard Designation	Standard Name
ISO 10993-1:2009 Cor.1:2010	Biological Evaluation of Medical DevicesPart 1: Evaluation and testing
ISO 10993-5: 2009	Biological Evaluation of Medical Devices- Part 5:Tests for in vitro cytotoxicity
ISO 10993-7:2008Cor.1:2009	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
ISO 10993-12: 2012	Biological Evaluation of Medical Devices- Part 12:Sample preparation and reference materials
USP 38 <85>	Bacterial Endotoxins Test. (Sterility)
USP 38 <151>	Pyrogenicity Test (USP Rabbit Test)
ISO 11135: 2014	Sterilization Of Health-Care Products - EthyleneOxide - Requirements For The Development,Validation And Routine Control Of A SterilizationProcess For Medical Devices. (Sterility)
USP 38 <661>	Containers- Plastics, Physicochemical Tests
ASTM F-1980-07	Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices.
ASTM D4169-14	Standard Practice for Performance Testing ofShipping Containers and Systems
ASTM F1929-12	Standard Test Method for Detecting Seal Leaks inPorous Medical Packaging by Dye Penetration

Table 5.4: Summary of Performance Testing

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Standard Designation	Standard Name
ISO 11607-1:2006/A1:2014	Packaging For Terminally Sterilized MedicalDevices - Part 1: Requirements For Materials, SterileBarrier Systems And Packaging Systems.
ASTM F88/F88M:09	Standard Test Method for Seal Strength of FlexibleBarrier Materials
ASTM F2825-10	Standard Practice for Climatic Stressing ofPackaging Systems for Single Parcel Delivery
ISO 14971:2007/(R)2010	Medical devices - Application of risk management tomedical devices
Internal Standards	- Visual/Appearance- Dimensional- Functional performance

Preclinical testing, including dimensional verification, device bond strength, balloon inflation and deflation testing, and hemostasis valve testing was conducted to confirm the device would function as intended. Additionally, dye leak testing was performed in accordance with ASTM F1929-12 on the modified packaging. All testing met acceptance criteria.

Based on the results of the performance testing, the proposed TMC TR Band is substantially equivalent to the predicate.

Biocompatibility

Biocompatibility classification is based on the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

The TR BAND® Radial Compression Device is classified as Surface Device, Breached/Compromised Surface, Limited Contact (<24 hours). This is the same classification as the predicate TR Band (K070423).

The following tests are recommended by FDA and ISO 10993-1 to be performed per this device classification:

1. Cytotoxicity
1. Sensitization

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1. Irritattion/Intracutaneous reactivity
1. Acute systemic toxicity
1. Pyrogenicity
1. Material characterization

The full series of biocompatibility tests were conducted on the non-aged, sterile finished device except TR Band Inflator to demonstrate that all the test articles of the TR Band are biocompatible; furthermore, the limited testing was conducted on the accelerated-aged, sterile finished device except TR Band Inflator to demonstrate that aging does not affect the device's biocompatibility throughout its shelf life. The TR Band Exclusive Inflator is an accessory device that is not patient contacting and was excluded from biocompatibility testing.

We conclude therefore that the biocompatibility of the finished TR Band is maintained throughout its shelf life.

Sterilization

The sterility of the device is assured using a sterilization method validated in accordance with 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.

The TR BAND® Radial Compression Device is sterilized to provide a Sterility Assurance Level (SAL) of 10-6.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) will meet requirements for limited exposure devices (contact up to 24 hours) prior to use based on EN ISO 10993-7:2008/Corr.1:2009, Biological Evaluation of medical devices-Part 7: Ethylene Oxide Sterilization residuals.

Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device after 24 hours of heat aeration.

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Image /page/11/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, sans-serif font. The swoosh is positioned above and to the left of the word "TERUMO", creating a dynamic and modern look.

Risk Analysis

A Product Risk Analysis was conducted in accordance with ISO 14971, and it was determined that any new risks were adequately captured and mitigated.

H. CLINICAL TESTS (807.92(b)(2))

This 510(k) does not include data from clinical tests.

I. CONCLUSION (807.92(b)(3))

In summary, the TR BAND® Radial Compression Device, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device(s):

K070423 – TR Band™, manufactured by Terumo Corporation, Japan

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).