The CoSeal™ Arterial Compression Band is a compression device that indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist. minimizing the loss of blood.

Device Description

The CoSeal™ Arterial Compression Band ("CoSeal Band") is a hemostasis device which works by providing controlled compression on the radial artery without completely occluding blood flow or significantly compressing other structures. It consists of a Velcro belt attached with a balloon, and an injection port. The device also includes a separated syringe (inflator) for injecting air.The CoSeal band is a device that is sterile, for single use, and has a 24month shelf life with one adjustable wristband for different patient size.

AI/ML Overview

Here's an analysis of the CoSeal™ Arterial Compression Band's acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria (e.g., "hemostasis in X% of cases," "leakage rate below Y%"). Instead, it states that the performance testing "demonstrated the safety and effectiveness of the CoSeal™ Arterial Compression Band is equivalent to the predicate devices." This implies the acceptance criterion was "equivalence to predicate devices" in the tested areas.

The reported device performance is qualitative, indicating successful completion of the tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Equivalence to predicate devices for Leak Test	Passed (demonstrated safety and effectiveness equivalent)
Equivalence to predicate devices for Performance Test	Passed (demonstrated safety and effectiveness equivalent)
Equivalence to predicate devices for Packaging Performance	Passed (demonstrated safety and effectiveness equivalent)
Equivalence to predicate devices for Product Stability (Shelf Life)	Passed (demonstrated safety and effectiveness equivalent)
Equivalence to predicate devices for Product Sterilization	Passed (demonstrated safety and effectiveness equivalent)
Equivalence to predicate devices for Biocompatibility Testing	Passed (demonstrated safety and effectiveness equivalent)

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for any of the performance tests (leak test, performance test, packaging, shelf life, sterilization, biocompatibility). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts or the establishment of ground truth for any of the conducted performance tests. These tests (leak, packaging, sterilization, biocompatibility, product stability) are typically laboratory-based engineering and material science tests, not clinical studies requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

As the performance tests described are laboratory-based and do not involve human interpretation of clinical data in the context of ground truth, an adjudication method (like 2+1, 3+1) is not applicable and therefore not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The studies described are performance tests of the device itself, not studies comparing human readers' performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The CoSeal™ Arterial Compression Band is a physical medical device (hemostasis device), not an algorithm or AI software. Therefore, the concept of a "standalone" algorithm performance study is not applicable to this device. The performance tests conducted are inherently "standalone" in the sense that they evaluate the device itself.

7. Type of Ground Truth Used

For the performance tests listed:

Leak Test, Performance Test, Packaging Performance, Product Stability (Shelf Life), Product Sterilization, Biocompatibility Testing: The ground truth for these tests would be established by engineering specifications, validated test methods, and industry standards (e.g., biocompatibility standards like ISO 10993, sterilization standards, packaging integrity standards). The tests themselves define what constitutes a "pass" or "fail" based on these established benchmarks. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning algorithms. Since the CoSeal™ Arterial Compression Band is a physical medical device and not an AI/ML product, there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this device, this question is not applicable.

Summary

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K131411

5.510(k) Summary

1. Submitter

Jilin Coronado Medical Ltd. 9 South-west Circle Road, Fengman Economic Development Zone Jilin City, China Tel: 86-432-63529555 Establishment Registration Number: 3009718176

Official contact: Ms Tianya Ma, Regulatory Specialist Tel: 86-432-63529555 ext 610 Fax: 86-432-63528222 Email: tyma@coronadomed.com

SEP. 2 6 2013

2 Device

CoSealTM Arterial Compression Band Trade name: Common Name: Compression Device Classification Name: clamp, vascular Classification: Class II Regulation Number: 870.4450

3 Predicate Device

The predicate devices used to determine substantial equivalence are the TR Band™ Radial Compression Device marketed by Terumo Cooperation (K070423), and the Air-Band™ Radial Compression Device (K122405) marketed by MAQUET Medical Systems USA.

4 Device Description

5 Intended Use

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CoSea!™ Arterial Compression Device

6 Comparison of Technological Characteristics

Compared with the predicate devices, it shows that the technological characteristics of the proposed device such as operational principle, performance characteristics, and sterilization are identical or substantially equivalent to the currently marketed predicate devices. Device Comparison Table

The tables attached below listed the differences and similarities between CoSeal™ Band and TR ™ Band and Air Band (Predicate Device) in several aspects.

Item	CoSeal™	TR Band™	Air Band™	Comments
Manufacturer	Jilin CoronadoMedical Ltd	Terumo Cooperation	MAQUET	-
Intended Use	The CoSeal™ ArterialCompression Band isa compression deviceto assist haemostasisof the radial arteryaftertransradialprocedure, whileminimizing the loss ofblood.	Equivalent	Equivalent	Equivalent
OperationalPrinciple	It's used to fixed onthe top of thepuncture site after thePCI procedure. Theballoon is expansionby pressuring. It'llcontinually pressureon vascular, thenachieve thehemostasis.	Equivalent	Equivalent	Equivalent
SterilizationMethod	ETO	ETO	Irradiation	Similar

Comparison of General Information

Comparison of Design and Specifications

Sub-component	Function	CoSeal™	TR Band™	Air-Band™
Wristband length	Fix the device on the puncture site	28cm	24/29cm	26cm.
Wristband adjustability		Adjustable	Equivalent	Equivalent
Balloon	Hold the pressure	Transparent	Equivalent	Equivalent

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Jilin Coronado Medical Ltd. Premarket Notification Traditional 510(K) CoSeal™ Arterial Compression Device

Balloonnumber	for theneededamont on the	Single	Double	Single
	puncture site	18ml, maximum20ml	Normal 13ml, maximum18ml	7cc (7ml)
Accessory	syringe	Similar Design	Similar Design	Similar Design
Luer checkvalve	luer valve on theend of the fill tubeenables a luer locksyringe to beconnected to inflateand deflate theballoon with air toprovide compression	Similar Design	Similar Design	Similar Design
Flexible tube(PU tube)	Passage for the airgo through into theballoon	Similar Design	Similar Design	Similar Design

Comparison of materials

Component	CoSeal™	TR Band™	Air Band™	Comments
Wristband	Fabric (Velcro(Polyester and nylon blend material))	Elastoplasts	Non-woven textile	Similar
Balloon	Medical gradePolyvinylchloride	Elastoplasts	Medical grade polyurethane	Similar
Syringe	Polypropylene	Equivalent	Equivalent	Equivalent
Flexible tube	polyurethane	Elastoplasts	Polyvinylchloride	Similar
Adhesives	MD UV light CuringAdhesives	Similar	Similar	Equivalent

7 Performance Data

The results of the performance testing demonstrated the safety and effectiveness of the CoSeal™ Arterial Compression Band is equivalent to the predicate devices.

Performance Testing included:

Leak test t
Performance test :
Packaging Performance {
Product Stability (Shelf Life) é
Product Sterilization દ
Biocompatibility Testing f

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three curved lines that resemble a human figure.

September 26, 2013

Public Health Service

Food and Drug Administration 19903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Jilin Coronado Medical Ltd. c/o Ms Tianya Ma Regulatory Specialist 9 South-west Circle Road Fengman Economic Development Zone Jilin City, China

Re: K131411

Trade/Device Name: CoSeal™ Arterial Compression Band Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 22, 2013 Received: August 27, 2013

Dear Ms. Ma:

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 docs 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 cither 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 Eederal 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

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Page 2 - Ms. Tianya Ma

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 contact 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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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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KI31411

Jilin Coronado Medical Ltd. Premarket Notification Traditional 510(K) CoSeal™ Arterial Compression Device

4. Indications for Use Statement

510(k) Number (if known): Device Name: CoSeal™ Arterial Compression Band

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)

Image /page/5/Picture/10 description: The image shows the name "Bram D. Zuckerman -S" at the top. Below the name is the date and time "2013.09.26 20:45:28". The last line shows the time zone offset "-04'00'".

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).