(65 days)
Not Found
No
The summary describes a mechanical compression device and does not mention any AI or ML components or functionalities.
Yes
The device is described as a compression device used to assist hemostasis and stop bleeding after a transradial procedure, which is a therapeutic function.
No
Explanation: The device is a compression device designed to assist hemostasis and stop bleeding after a transradial procedure. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly describes a physical compression band with an inflatable balloon, indicating it is a hardware device, not software only.
Based on the provided information, the IM Band ™ 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 physical intervention applied to the body to stop bleeding.
- Device Description: The description details a mechanical compression device with a balloon and band for applying pressure. It does not involve analyzing samples from the body (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
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. The IM Band ™ does not fit this description. It is a therapeutic/hemostatic device.
N/A
Intended Use / Indications for Use
The IM Band TM Adjustable Arterial Compression Band is a compression device to assist hemostasis of the radial artery after a transradial procedure..
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The IM Band TM Adjustable Arterial Compression Band is intended to be used to oppress the vascular puncture in order to stop the bleeding by the inflation of a balloon. Transparent balloon material allows clear monitoring of the hemostasis time. Oppressing inside the balloon can be adapt to the skin surface for better contact. Bleeding can be stopped by simply adjusting the band or turncap according to doctor's instruction. Soft and adjustable wrist band enhances patient comfort.
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)
The results of the performance testing demonstrated the safety and effectiveness of the IM Band TM Adjustable Arterial Compression Band
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K11 3600
ల్ల
510 (k) summary
FEB - 8 2012
5. 1 Submitter
Synexmed (Shenzhen) company limited B-11/F,ZTY Building, Taohua Road, Futian Free Trade Zone Shenzhen, 518038, China Tel: (86 755) 8358 0375 Establishment Registration Number: 3008388400
Official contact: Mr. Yongwei Chien, CEO Tel: (86 755) 8358 0375 ext 808 Fax: (86 755) 8359 1037 E-mail: echien@synexmed.com
5.2 Device
| Trade name: | IM Band |
|---|---|
| Classification Name: | Clamp, vascular |
| Classification: | Class II |
| Common Name: | Artery Compression Band |
| Regulation Number: | 870.4450 |
5.3 Predicate Device
The predicate devices used to determine substantial equivalence for the TR Band by the Terumo Medical Corporation (#K070423)
5.4 Device Description
The IM Band TM Adjustable Arterial Compression Band is intended to be used to oppress the vascular puncture in order to stop the bleeding by the inflation of a balloon. Transparent balloon material allows clear monitoring of the hemostasis time. Oppressing inside the balloon can be adapt to the skin surface for better contact. Bleeding can be stopped by simply adjusting the band or turncap according to doctor's instruction. Soft and adjustable wrist band enhances patient comfort.
1
Kii 3600
Page 2 of 2
5.5 Intended Use
The IM Band TM Adjustable Arterial Compression Band is a compression device to assist hemostasis of the radial artery after a transradial procedure..
5.6 Comparison of Characteristics
Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, and sterilization are identical or substantially equivalent to the currently marketed predicate devices.
5.7 Performance Data
The results of the performance testing demonstrated the safety and effectiveness of the IM Band TM Adjustable Arterial Compression Band
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002
Synexmed (Shenzhen Company, Ltd. % Mr. Yongwei Chien, CEO B-11/F, ZTY Building Taohua Road, Futian Free Trade Zone Shenzhen, 518038, China
FEB - 8 2012
Re: K113600
Trade/Device Name: IM Band™ Adjustable Arterial Compression Band Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: DXC Dated: November 30, 2011 Received: December 05, 2011
Dear Mr. Chien:
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
3
Page 2 - Mr. Yongwei Chien, CEO
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 (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K113600
Device Name:_IM Band ™
Indications For Use:
The IM Band ™ is a compression device to assist hemostasis of the radial artery after a transradial procedure.
Prescription Use × (Part 21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil REDsle formkn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K 113600