(134 days)
No
The device description and performance studies focus on mechanical compression and physical properties, with no mention of AI/ML terms or functionalities.
Yes
The device is described as assisting hemostasis, which is a therapeutic function aimed at controlling bleeding.
No
The device is described as a "compression device" and "hemostasis device" used to assist in blood clotting after a procedure, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like a Velcro belt, balloon, injection port, and syringe, indicating it is a hardware device, not software-only.
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 hemostasis of the radial artery after a transradial procedure by providing compression. This is a physical intervention applied to the body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical compression band with a balloon and syringe. It works by applying pressure externally.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), 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 diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
DXC
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.
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)
Performance Testing included:
- Leak test t
- Performance test :
- Packaging Performance {
- Product Stability (Shelf Life) é
- Product Sterilization દ
- Biocompatibility Testing f
The results of the performance testing demonstrated the safety and effectiveness of the CoSeal™ Arterial Compression Band is equivalent to the predicate devices.
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
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
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.
5 Intended Use
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.
1
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 |
|---|---|---|---|---|
| Manufacture | ||||
| r | Jilin Coronado | |||
| Medical Ltd | Terumo Cooperation | MAQUET | - | |
| Intended Use | The CoSeal™ Arterial | |||
| Compression Band is | ||||
| a compression device | ||||
| to assist haemostasis | ||||
| of the radial artery | ||||
| after | ||||
| transradial | ||||
| procedure, while | ||||
| minimizing the loss of | ||||
| blood. | Equivalent | Equivalent | Equivalent | |
| Operational | ||||
| Principle | It's used to fixed on | |||
| the top of the | ||||
| puncture site after the | ||||
| PCI procedure. The | ||||
| balloon is expansion | ||||
| by pressuring. It'll | ||||
| continually pressure | ||||
| on vascular, then | ||||
| achieve the | ||||
| hemostasis. | Equivalent | Equivalent | Equivalent | |
| Sterilization | ||||
| Method | 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 |
2
Jilin Coronado Medical Ltd. Premarket Notification Traditional 510(K) CoSeal™ Arterial Compression Device
| Balloon
number | for the
needed
amont on the | Balloon volume | Single | Double | Single |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------------|------------------------------|----------------|
| | puncture site | | 18ml, maximum
20ml | Normal 13ml, maximum
18ml | 7cc (7ml) |
| Accessory | syringe | | Similar Design | Similar Design | Similar Design |
| Luer check
valve | luer valve on the
end of the fill tube
enables a luer lock
syringe to be
connected to inflate
and deflate the
balloon with air to
provide compression | | Similar Design | Similar Design | Similar Design |
| Flexible tube
(PU tube) | Passage for the air
go through into the
balloon | | 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 grade | |||
| Polyvinylchloride | Elastoplasts | Medical grade polyurethane | Similar | |
| Syringe | Polypropylene | Equivalent | Equivalent | Equivalent |
| Flexible tube | polyurethane | Elastoplasts | Polyvinylchloride | Similar |
| Adhesives | MD UV light Curing | |||
| Adhesives | 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
3
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
4
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
5
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
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.
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'".