(91 days)
Not Found
No
The summary describes a mechanical compression device and its components. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies are bench testing and biocompatibility, not studies related to algorithmic performance.
No.
A therapeutic device is typically understood to alter the course of disease or treat a condition. While the device assists patent hemostasis, which is supportive care, it is not described as directly altering a disease state or providing treatment in the sense of curing or resolving an underlying medical condition. It's used for post-procedural care rather than direct therapy for a disease.
No
The device is a compression device used to assist in the hemostasis of the radial artery after a transradial procedure. Its purpose is to physically apply pressure to stop bleeding, not to diagnose a condition.
No
The device description explicitly lists physical components like a closure band, syringe, frame, dial, balloon assembly, and strap assembly, and the performance studies describe bench testing on these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist patent hemostasis of the radial artery after a transradial procedure." This describes a physical intervention on the body to control bleeding, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is a "compression device" consisting of a "closure band and customized syringe." This is a mechanical device designed for external application to the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing. The performance studies described are bench testing and biocompatibility testing, which are typical for physical medical devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The compression device is used to assist patent hemostasis of the radial artery after a transradial procedure.
The TRAcelet™ compression device is used to assist hemostasis of the radial artery after a transradial procedure.
Product codes
DXC
Device Description
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
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:
• Dial-Threaded Window Assembly
• Balloon Assembly
• Air Injection Port (Luer Check Valve Assembly
• Strap Assembly
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial artery
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)
Summary of Non-clinical Data:
-
Design Verification Testing/ In-vitro bench testing:
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 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
- Dial Removal Torque
- Dial to Threaded Window Shear Strength
- Initial Balloon Inflation Pressure
-
Biocompatibility Testing:
The following Biocompatibility Testing was completed on the TRAcelet™ in compliance with the requirements of ISO 10993-1: 2009/ Cor 1: 2010- Biological evaluation of medical devices - Part 1: Evaluation and 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 during the testing. The bench testing qualification and biocompatibility testing demonstrated that Medtronic's TRAcelet™ is safe and effective for its intended clinical use.
Summary of Clinical Data:
No clinical investigation was performed on the subject device (TRAcelet™).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, with flowing lines beneath them.
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.
1
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
2
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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3
510(k) Summary
| Submitter: | Medtronic Vascular
37A Cherry Hill Drive,
Danvers, Massachusetts 01923, USA | | | | | | | |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|
| Contact Person: | Colleen Mullins
Principle Regulatory Affairs Specialist
37A Cherry Hill Drive
Danvers, MA 01923, USA
Phone: (978) 739-3267
Fax: (978) 750-8204
Email: 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 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. | | | | | | | |
| Summary of
Technological
Characteristics: | 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
4
| | • Dial-Threaded Window Assembly
• Balloon Assembly
• Air Injection Port (Luer Check Valve Assembly
• Strap Assembly |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to
the predicate
devices: | The following information outlines the differences and
similarities between the subject device and the
predicate 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 to
the predicate device based on similarities in intended
use and technological characteristics. The testing
performed to assess safety and effectiveness of the
TRAcelet™ demonstrates that the technological
differences do not raise any new concerns of safety
and effectiveness. |
| Summary of Non-
clinical Data: | The following non-clinical testing was performed to
assess safety and effectiveness of Medtronic's
TRAcelet™ |
| | 1. Design Verification Testing/ In-vitro bench
testing: |
| | 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 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 completed
on the TRAcelet™ in compliance with the requirements
of ISO 10993-1: 2009/ Cor 1: 2010- Biological
evaluation of medical devices - Part 1: Evaluation and
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
during the testing. The bench testing qualification and
biocompatibility testing demonstrated that Medtronic's
TRAcelet™ is safe and effective for its intended clinical
use. | |
| Summary of
Clinical Data: | No clinical investigation was performed on the subject
device (TRAcelet™). |
| Conclusion from
Data: | The data provided in this 510(k) premarket notification
demonstrated that the subject device is substantially
equivalent to the predicate device. |
5
Dial Removal Torque
Dial to Threaded Window Shear Strength
Initial Balloon Inflation Pressure
.
●