The TRAcelet™ compression device consists of a closure band and customized syringe. The device is used to assist in the hemostasis of the radial artery after a transradial percutaneous procedure.

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

Medtronic's TRAcelet™ compression device consists of a closure band and customized syringe. There are two different size closure bands regular (19.2cm) and large (25.2cm) comprised of the following technological characteristics:

Frame
Dial-Threaded Window Assembly
Balloon Assembly
Air Injection Port (Luer Check Valve Assembly
Strap Assembly

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TRAcelet™ Compression Device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. No clinical study was performed to prove the device meets acceptance criteria. Therefore, many of the requested details related to clinical studies and human-in-the-loop performance are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

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

The document lists various design verification tests (in-vitro bench testing) and biocompatibility tests. While it states that the device "meets the key safety and effectiveness requirements for its intended clinical use" and that "No new safety or effectiveness issues were raised during the testing," specific quantitative acceptance criteria and reported performance values are not provided in this summary. The tests performed include:

Effective Strap Length
Syringe to Anti-Lock Cap Tensile
Balloon Rupture
Side-Tube to Balloon Tensile
Side-Tube to Check Valve Tensile
Velcro to Lay flat Tubing Weld Tensile
Rivet Joint Tensile Regular
Initial Balloon Inflation Pressure
Balloon Internal Pressure Over Time
Dial Torque
Dial Lock Disengagement Force
Dial Removal Torque
Dial to Threaded Window Shear Strength
Cytotoxicity testing
Sensitization testing
Intracutaneous reactivity testing
Acute systemic toxicity testing

2. Sample sized used for the test set and the data provenance

The document states that "Design Verification (DV) testing was completed to demonstrate that the TRAcelet™ meets the key safety and effectiveness requirements for its intended clinical use. The Design Verification Testing included in-vitro bench testing on finished devices which were representative of commercial device."

Sample Size: The exact sample size for each specific bench test is not specified.
Data Provenance: The tests are described as "in-vitro bench testing" performed on "finished devices which were representative of commercial device." This indicates the data is from non-clinical laboratory testing rather than human subjects or real-world clinical use. There is no information on country of origin as it's not patient data.

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

This question is not applicable as no clinical study or human-in-the-loop evaluation was performed where experts would establish ground truth for a test set. The evaluation was based on engineering bench tests and biocompatibility assessments.

4. Adjudication method for the test set

This question is not applicable as no clinical study or human-in-the-loop evaluation was performed. The non-clinical tests would have pass/fail criteria based on engineering specifications rather than expert adjudication.

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

This question is not applicable. The device is a physical compression device, not an AI-powered diagnostic or assistance tool. No MRMC study was conducted.

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

This question is not applicable. The device is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The type of ground truth used

For the non-clinical bench testing, the "ground truth" would be the engineering specifications and performance requirements that the device was designed to meet, as well as the standards for biocompatibility (ISO 10993-1).

8. The sample size for the training set

This question is not applicable as no AI model was developed or described in this submission. Therefore, there is no training set in the context of machine learning.

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

This question is not applicable as there is no training set in the context of machine learning.

Summary

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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 (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,

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)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	Medtronic Vascular37A Cherry Hill Drive,Danvers, Massachusetts 01923, USA
Contact Person:	Colleen MullinsPrinciple Regulatory Affairs Specialist37A Cherry Hill DriveDanvers, MA 01923, USAPhone: (978) 739-3267Fax: (978) 750-8204Email: colleen.mullins@medtronic.com
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 closureband and customized syringe. The device is used toassist in the hemostasis of the radial artery after atransradial percutaneous procedure
	The TRAcelet™ compression device is used to assistdUhYbh hemostasis of the radial artery after a transradialprocedure.
Summary ofTechnologicalCharacteristics:	Medtronic's TRAcelet™ compression device consists ofa closure band and customized syringe. There are twodifferent size closure bands regular (19.2cm) and large(25.2cm) comprised of the following technologicalcharacteristics:

Frame

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	• Dial-Threaded Window Assembly• Balloon Assembly• Air Injection Port (Luer Check Valve Assembly• Strap Assembly
Comparison tothe predicatedevices:	The following information outlines the differences andsimilarities between the subject device and thepredicate device:• Similar Intended Use• Similar Device Design Component/Construction• Different device materials• Similar packaging type• Similar sterilization technology/ method
	Medtronic's TRAcelet™ is substantially equivalent tothe predicate device based on similarities in intendeduse and technological characteristics. The testingperformed to assess safety and effectiveness of theTRAcelet™ demonstrates that the technologicaldifferences do not raise any new concerns of safetyand effectiveness.
Summary of Non-clinical Data:	The following non-clinical testing was performed toassess safety and effectiveness of Medtronic'sTRAcelet™
	1. Design Verification Testing/ In-vitro benchtesting:
	Design Verification (DV) testing was completed todemonstrate that the TRAcelet™ meets the key safetyand effectiveness requirements for its intended clinicaluse. The Design Verification Testing included in-vitrobench testing on finished devices which wererepresentative of commercial device and included:
	• Effective Strap Length• Syringe to Anti-Lock Cap Tensile• Balloon Rupture• Side-Tube to Balloon Tensile• Side-Tube to Check Valve Tensile• Velcro to Lay flatTubing Weld Tensile• Rivet Joint Tensile Regular
•	Initial Balloon Inflation Pressure
•	Balloon Internal Pressure Over Time
•	Dial Torque
•	Dial Lock Disengagement Force
2. Biocompatibility Testing:
The following Biocompatibility Testing was completedon the TRAcelet™ in compliance with the requirementsof ISO 10993-1: 2009/ Cor 1: 2010- Biologicalevaluation of medical devices - Part 1: Evaluation andtesting within a risk management process.
•	Cytotoxicity testing
•	Sensitization testing
•	Intracutaneous reactivity testing
•	Acute systemic toxicity testing
No new safety or effectiveness issues were raisedduring the testing. The bench testing qualification andbiocompatibility testing demonstrated that Medtronic'sTRAcelet™ is safe and effective for its intended clinicaluse.
Summary ofClinical Data:	No clinical investigation was performed on the subjectdevice (TRAcelet™).
Conclusion fromData:	The data provided in this 510(k) premarket notificationdemonstrated that the subject device is substantiallyequivalent to the predicate device.

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Dial Removal Torque

Dial to Threaded Window Shear Strength

Initial Balloon Inflation Pressure

●

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).