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.

AI/ML Overview

The provided text {0}-{4} does not contain sufficiently detailed information regarding the acceptance criteria, study design, or performance data of the IM Band Adjustable Arterial Compression Band to fully complete the requested table and study description.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to a predicate device rather than presenting extensive performance study results.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Expected)	Reported Device Performance (from text)	Notes / Missing Information
Safety & Effectiveness	(e.g., Hemostasis success rate, Complication rate, Patient comfort, Ease of use)	"The results of the performance testing demonstrated the safety and effectiveness of the IM Band TM Adjustable Arterial Compression Band" (Section 5.7)	The document states that safety and effectiveness were demonstrated, but provides no specific quantitative or qualitative metrics for performance. It does not define what percentages or values constitute "safety" or "effectiveness" for this device. For example, what is an acceptable rate of successful hemostasis or an acceptable rate of complications? These are not specified.
Technological Characteristics	Materials, Performance characteristics, Sterilization are identical or substantially equivalent to predicate.	"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." (Section 5.6)	This confirms the device is similar to the predicate but doesn't provide specific performance metrics for the IM Band itself. It implies that since the characteristics are similar, its performance would also be similar to the already cleared predicate.
Intended Use	Device functions as a compression device to assist hemostasis of the radial artery after a transradial procedure.	"The IM Band TM Adjustable Arterial Compression Band is a compression device to assist hemostasis of the radial artery after a transradial procedure." (Section 5.5)	This is the intended use, not a performance criterion with a specific metric. The "performance data" mentioned aims to show the device achieves this intended use effectively and safely.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not specified. The document does not mention a "test set" in the context of expert-adjudicated ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified. This is typically relevant for studies involving subjective assessments or image interpretation, which does not appear to be the focus here.

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:

No MRMC comparative effectiveness study is mentioned. This device is an arterial compression band, not an AI-powered diagnostic or assistive tool.

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

Not applicable/Not mentioned. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly defined. For a physical device like this, "ground truth" would likely refer to objective clinical outcomes such as successful hemostasis, time to hemostasis, incidence of complications (e.g., hematoma, bleeding), and patient comfort. The document only generically states "performance testing demonstrated safety and effectiveness."

8. The sample size for the training set:

Not applicable/Not specified. This device is not an AI model requiring a "training set."

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

Not applicable.

Summary of available information:

The provided K113600 submission summary indicates that Synexmed (Shenzhen) Company Limited submitted the IM Band Adjustable Arterial Compression Band for 510(k) clearance. The device is intended to assist hemostasis of the radial artery after a transradial procedure.

The core of the submission relies on demonstrating substantial equivalence to the TR Band by Terumo Medical Corporation (#K070423). The document explicitly states: "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."

Section 5.7, "Performance Data," concludes with a general statement: "The results of the performance testing demonstrated the safety and effectiveness of the IM Band Adjustable Arterial Compression Band." However, it does not provide any specific details about the nature of this performance testing, the acceptance criteria, the sample sizes, the methodology, or the actual numerical results obtained. This level of detail is typically not required in the publicly available 510(k) summary, which often provides a high-level overview. The detailed study reports would be reviewed by the FDA during their assessment but are not included in this extract.

Summary

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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

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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

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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

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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,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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

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).