TRAcelet Compression Device

K162027 · Medtronic Vascular · DXC · Oct 21, 2016 · Cardiovascular

Device Facts

• Record ID: K162027
• Device Name: TRAcelet Compression Device
• Applicant: Medtronic Vascular
• Product Code: DXC · Cardiovascular
• Decision Date: Oct 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The compression device is used to assist patent hemostasis of the radial artery after a transradial procedure.

Device Story

TRAcelet™ is a vascular compression device consisting of a closure band and a customized syringe. It is used in clinical settings by healthcare providers to assist in achieving patent hemostasis of the radial artery following transradial percutaneous procedures. The device features a balloon assembly, a dial-threaded window assembly for pressure control, an air injection port with a luer check valve, and a strap assembly. The operator uses the syringe to inflate the balloon via the air injection port to apply localized pressure to the puncture site. The dial-threaded window allows for adjustment of the compression force. By maintaining controlled pressure on the radial artery, the device facilitates hemostasis, potentially reducing the risk of hematoma or other access-site complications for the patient.

Clinical Evidence

No clinical investigation was performed. Evidence is based on bench testing and biocompatibility evaluation. Bench testing included strap length, tensile strength of various joints (syringe to cap, side-tube to balloon/valve, rivet), balloon rupture, inflation pressure, pressure maintenance over time, dial torque, and dial lock disengagement force. Biocompatibility testing was conducted per ISO 10993-1:2009/Cor 1:2010, including cytotoxicity, sensitization, intracutaneous reactivity, and acute systemic toxicity.

Technological Characteristics

Consists of a closure band (regular 19.2cm or large 25.2cm) and customized syringe. Components include a frame, dial-threaded window assembly, balloon assembly, air injection port (luer check valve), and strap assembly. Biocompatibility testing performed per ISO 10993-1. Sterilization method is not specified but noted as similar to predicate.

Indications for Use

Indicated for patients undergoing transradial percutaneous procedures to assist in achieving patent hemostasis of the radial artery.

Regulatory Classification

Identification

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

Predicate Devices

• TR Band Terumo (K070423)

Submission Summary (Full Text)

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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

October 21, 2016

Medtronic Vascular Ms. Colleen Mullins Principle Regulatory Affairs Specialist 37A Cherry Hill Drive Danvers, Massachusetts 01923

Re: K162027

Trade/Device Name: TRAcelet™ Compression Device Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: September 8, 2016 Received: September 9, 2016

Dear Ms. Mullins:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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 [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,

M.A. Willhelm

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) K162027

Device Name
TRAcelet™ Compression Device

Indications for Use (Describe)

The compression device is used to assist patent hemostasis of the radial artery after a transradial procedure.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

| Submitter: | Medtronic Vascular<br>37A Cherry Hill Drive,<br>Danvers, Massachusetts 01923, USA | | | | | | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|
| Contact Person: | Colleen Mullins<br>Principle Regulatory Affairs Specialist<br>37A Cherry Hill Drive<br>Danvers, MA 01923, USA<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | | | | | | |
| Date Prepared: | October 13, 2016 | | | | | | | |
| Trade Name(s): | TRAcelet™ Compression Device | | | | | | | |
| Common Name: | Compression Device | | | | | | | |
| Classification Name: | Vascular Clamp | | | | | | | |
| Predicate Device: | Device Name Manufacturer 510(k) clearance # TR Band Terumo K070423 | | | | | | | |
| Device Description: | The TRAcelet™ compression device consists of a closure<br>band and customized syringe. The device is used to<br>assist in the hemostasis of the radial artery after a<br>transradial percutaneous procedure | | | | | | | |
| | The TRAcelet™ compression device is used to assist<br>dUhYbh hemostasis of the radial artery after a transradial<br>procedure. | | | | | | | |
| Summary of<br>Technological<br>Characteristics: | Medtronic's TRAcelet™ compression device consists of<br>a closure band and customized syringe. There are two<br>different size closure bands regular (19.2cm) and large<br>(25.2cm) comprised of the following technological<br>characteristics: | | | | | | | |

- Frame

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| | • Dial-Threaded Window Assembly<br>• Balloon Assembly<br>• Air Injection Port (Luer Check Valve Assembly<br>• Strap Assembly |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to<br>the predicate<br>devices: | The following information outlines the differences and<br>similarities between the subject device and the<br>predicate device:<br>• Similar Intended Use<br>• Similar Device Design Component/<br>Construction<br>• Different device materials<br>• Similar packaging type<br>• Similar sterilization technology/ method |
| | Medtronic's TRAcelet™ is substantially equivalent to<br>the predicate device based on similarities in intended<br>use and technological characteristics. The testing<br>performed to assess safety and effectiveness of the<br>TRAcelet™ demonstrates that the technological<br>differences do not raise any new concerns of safety<br>and effectiveness. |
| Summary of Non-<br>clinical Data: | The following non-clinical testing was performed to<br>assess safety and effectiveness of Medtronic's<br>TRAcelet™ |
| | 1. Design Verification Testing/ In-vitro bench<br>testing: |
| | Design Verification (DV) testing was completed to<br>demonstrate that the TRAcelet™ meets the key safety<br>and effectiveness requirements for its intended clinical<br>use. The Design Verification Testing included in-vitro<br>bench testing on finished devices which were<br>representative of commercial device and included: |
| | • Effective Strap Length<br>• Syringe to Anti-Lock Cap Tensile<br>• Balloon Rupture<br>• Side-Tube to Balloon Tensile<br>• Side-Tube to Check Valve Tensile<br>• Velcro to Lay flatTubing Weld Tensile<br>• Rivet Joint Tensile Regular |
| • | Initial Balloon Inflation Pressure |
| • | Balloon Internal Pressure Over Time |
| • | Dial Torque |
| • | Dial Lock Disengagement Force |
| <b>2. Biocompatibility Testing:</b> | |
| The following Biocompatibility Testing was completed<br>on the TRAcelet™ in compliance with the requirements<br>of ISO 10993-1: 2009/ Cor 1: 2010- Biological<br>evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process. | |
| • | Cytotoxicity testing |
| • | Sensitization testing |
| • | Intracutaneous reactivity testing |
| • | Acute systemic toxicity testing |
| No new safety or effectiveness issues were raised<br>during the testing. The bench testing qualification and<br>biocompatibility testing demonstrated that Medtronic's<br>TRAcelet™ is safe and effective for its intended clinical<br>use. | |
| Summary of<br>Clinical Data: | No clinical investigation was performed on the subject<br>device (TRAcelet™). |
| Conclusion from<br>Data: | The data provided in this 510(k) premarket notification<br>demonstrated that the subject device is substantially<br>equivalent to the predicate device. |

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Dial Removal Torque

Dial to Threaded Window Shear Strength

Initial Balloon Inflation Pressure

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