(68 days)
Not Found
No
The device description details a mechanical compression device with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a compression device to assist hemostasis of the radial artery after a transradial procedure, indicating it is used for treatment.
No
The device is a compression device used to assist hemostasis of the radial artery after a transradial procedure; it does not diagnose any condition.
No
The device description clearly outlines physical components such as a plastic belt, compression balloons, an injection port, and an inflator (syringe), indicating it is a hardware device.
Based on the provided information, the TR BAND® Radial Compression Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "assist hemostasis of the radial artery after a transradial procedure." This is a therapeutic and mechanical function, not a diagnostic one.
- Device Description: The description details a physical device that applies pressure to the wrist. It does not involve analyzing biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device performing any tests, measurements, or analyses of biological specimens to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. The TR BAND operates in vivo (within the body) to achieve hemostasis.
N/A
Intended Use / Indications for Use
The TR BAND® Radial Compression Device is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Product codes
DXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial artery, wrist
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070423 – TR Band™
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into the design. The eagle and profiles are facing to the right.
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
1
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
2
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. (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))
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
Characteristic | Predicate:
TR Band, K070423 | New Device:
TR BAND® Radial Compression
Device |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Terumo Corporation | Terumo Medical Corporation |
| Intended Use /
Indications for
Use | The TR Band™ is a compression
device to assist hemostasis of the
radial artery after a transradial
procedure. | Same |
| Operation
Principle | Operated manually or by a manual
process;
Pneumatic compression balloons are
filled to apply pressure to the access
site | Same |
| Design/
Construction | 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 and an
Air Volume Regulator | Same design and construction.
(The only difference is that the TR
Band Air Volume Regulator is not
being made available for the new
device) |
| Package | • Unit Pouch
• Shelf Box
• Shipping Carton | • Lidded tray
• Shelf Box
• Shipping Carton |
| Specifications | Length of band (belt):
Large TR Band is 24 cm
Large TR Band is 29cm | Same |
| Sterilization | Ethylene Oxide (validated in
accordance with ANSI / AAMI / ISO
11135-1 to achieve SAL 10-6) | Same |
| Shelf life | 30 months | 12 months |
| Disposable
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. | |
| 1:2010 | Biological Evaluation of Medical Devices |
| Part 1: Evaluation and testing | |
| ISO 10993-5: 2009 | Biological Evaluation of Medical Devices- Part 5: |
| Tests for in vitro cytotoxicity | |
| ISO 10993-7:2008 | |
| Cor.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 | Bacterial Endotoxins Test. (Sterility) |
| USP 38 | Pyrogenicity Test (USP Rabbit Test) |
| 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. (Sterility) | |
| USP 38 | Containers- Plastics, Physicochemical Tests |
| ASTM F-1980-07 | Standard Guide for Accelerated Aging of Sterile |
| Barrier Systems for Medical Devices. | |
| ASTM D4169-14 | Standard Practice for Performance Testing of |
| Shipping Containers and Systems | |
| ASTM F1929-12 | Standard Test Method for Detecting Seal Leaks in |
| Porous 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 Medical |
| Devices - Part 1: Requirements For Materials, Sterile | |
| Barrier Systems And Packaging Systems. | |
| ASTM F88/F88M:09 | Standard Test Method for Seal Strength of Flexible |
| Barrier Materials | |
| ASTM F2825-10 | Standard Practice for Climatic Stressing of |
| Packaging Systems for Single Parcel Delivery | |
| ISO 14971:2007/(R)2010 | Medical devices - Application of risk management to |
| medical 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 (