TR BAND Radial Compression Device

K152525 · Terumo Medical Corporation · DXC · Nov 10, 2015 · Cardiovascular

Device Facts

• Record ID: K152525
• Device Name: TR BAND Radial Compression Device
• Applicant: Terumo Medical Corporation
• Product Code: DXC · Cardiovascular
• Decision Date: Nov 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

TR BAND is a tourniquet-style device for radial artery hemostasis post-transradial procedure. Device comprises plastic belt with hook-and-loop fasteners, two compression balloons, and air injection port. Operated by physician/clinician in clinical setting. Physician places belt around patient's wrist; inflates balloons using dedicated TR Band Inflator (20ml syringe) to apply pressure to access site. Clear plastic construction allows visual monitoring of site. Pressure adjusted via syringe to achieve hemostasis. Disposable, single-use device.

Clinical Evidence

No clinical data. Bench testing only, including dimensional verification, bond strength, balloon inflation/deflation, hemostasis valve testing, and dye leak testing per ASTM F1929-12. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Tourniquet-style compression device. Materials: clear plastic belt, hook-and-loop fasteners, compression balloons. Energy: manual pneumatic inflation via syringe. Sterilization: Ethylene Oxide (ISO 11135:2014) to SAL 10^-6. Biocompatibility: ISO 10993-1 (Surface Device, Limited Contact <24h). Packaging: ASTM F1929-12, ASTM F88/F88M, ASTM F2825-10.

Indications for Use

Indicated for patients requiring hemostasis of the radial artery following a transradial catheterization procedure.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• TR Band (K070423)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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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. [phone] Fax [phone]

#### 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. [phone] Fax [phone] E-mail: [e-mail]

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))

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

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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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Image /page/7/Picture/1 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is curved and points to the right.

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

Table 5.4: Summary of Substantial Equivalence

| Device<br>Characteristic | Predicate:<br>TR Band, K070423 | New Device:<br>TR BAND® Radial Compression<br>Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Corporation | Terumo Medical Corporation |
| Intended Use /<br>Indications for<br>Use | The TR Band™ is a compression<br>device to assist hemostasis of the<br>radial artery after a transradial<br>procedure. | Same |
| Operation<br>Principle | Operated manually or by a manual<br>process;<br>Pneumatic compression balloons are<br>filled to apply pressure to the access<br>site | Same |
| Design/<br>Construction | A plastic belt with hook and loop<br>adjustable fastener on each end, two<br>compression balloons, and an<br>injection port. The device also<br>contains a TR Band Inflator and an<br>Air Volume Regulator | Same design and construction.<br>(The only difference is that the TR<br>Band Air Volume Regulator is not<br>being made available for the new<br>device) |
| Package | • Unit Pouch<br>• Shelf Box<br>• Shipping Carton | • Lidded tray<br>• Shelf Box<br>• Shipping Carton |
| Specifications | Length of band (belt):<br>Large TR Band is 24 cm<br>Large TR Band is 29cm | Same |
| Sterilization | Ethylene Oxide (validated in<br>accordance with ANSI / AAMI / ISO<br>11135-1 to achieve SAL 10-6) | Same |
| Shelf life | 30 months | 12 months |
| Disposable<br>Single 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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Image /page/8/Picture/0 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word, creating a sense of motion and direction.

# 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.<br>1:2010 | Biological Evaluation of Medical Devices<br>Part 1: Evaluation and testing |
| ISO 10993-5: 2009 | Biological Evaluation of Medical Devices- Part 5:<br>Tests for in vitro cytotoxicity |
| ISO 10993-7:2008<br>Cor.1:2009 | Biological Evaluation of Medical Devices – Part 7:<br>Ethylene Oxide Sterilization Residuals |
| ISO 10993-10: 2010 | Biological Evaluation of Medical Devices- Part 10:<br>Tests for irritation and skin sensitization |
| ISO 10993-11: 2006 | Biological Evaluation of Medical Devices- Part 11:<br>Tests for systemic toxicity |
| ISO 10993-12: 2012 | Biological Evaluation of Medical Devices- Part 12:<br>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 - Ethylene<br>Oxide - Requirements For The Development,<br>Validation And Routine Control Of A Sterilization<br>Process For Medical Devices. (Sterility) |
| USP 38 <661> | Containers- Plastics, Physicochemical Tests |
| ASTM F-1980-07 | Standard Guide for Accelerated Aging of Sterile<br>Barrier Systems for Medical Devices. |
| ASTM D4169-14 | Standard Practice for Performance Testing of<br>Shipping Containers and Systems |
| ASTM F1929-12 | Standard Test Method for Detecting Seal Leaks in<br>Porous Medical Packaging by Dye Penetration |

### Table 5.4: Summary of Performance Testing

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Image /page/9/Picture/0 description: The image shows the logo for Terumo. 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.

| Standard Designation | Standard Name |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 11607-1:2006/A1:<br>2014 | Packaging For Terminally Sterilized Medical<br>Devices - Part 1: Requirements For Materials, Sterile<br>Barrier Systems And Packaging Systems. |
| ASTM F88/F88M:09 | Standard Test Method for Seal Strength of Flexible<br>Barrier Materials |
| ASTM F2825-10 | Standard Practice for Climatic Stressing of<br>Packaging Systems for Single Parcel Delivery |
| ISO 14971:2007/(R)2010 | Medical devices - Application of risk management to<br>medical devices |
| Internal Standards | - Visual/Appearance<br>- Dimensional<br>- 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
- 2. Sensitization

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- 3. Irritattion/Intracutaneous reactivity
- 4. Acute systemic toxicity
- 5. Pyrogenicity
- 6. 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