COSEAL

K131411 · Jilin Coronado Medical , Ltd. · DXC · Sep 26, 2013 · Cardiovascular

Device Facts

• Record ID: K131411
• Device Name: COSEAL
• Applicant: Jilin Coronado Medical , Ltd.
• Product Code: DXC · Cardiovascular
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

CoSeal Arterial Compression Band is a sterile, single-use hemostasis device for radial artery puncture sites. It consists of a Velcro wristband, an inflatable balloon, and an injection port. Clinicians operate the device by securing the band around the patient's wrist and using an external syringe to inflate the balloon with air via the injection port. The balloon provides controlled, localized pressure to the puncture site to stop bleeding while maintaining site visibility. The device is used in clinical settings following transradial procedures. By providing adjustable, secure compression, it assists in achieving hemostasis and minimizes blood loss for the patient.

Clinical Evidence

Bench testing only. Performance testing included leak testing, performance testing, packaging performance, product stability (shelf life), product sterilization, and biocompatibility testing. No clinical data was provided.

Technological Characteristics

Device consists of a Velcro wristband (polyester/nylon blend), medical-grade PVC balloon, polyurethane flexible tube, and polypropylene syringe. Operates via manual air inflation using a luer-lock syringe to provide mechanical compression. Sterilized via ETO. Adjustable form factor for various wrist sizes.

Indications for Use

Indicated for patients undergoing transradial procedures to assist in achieving hemostasis at the radial artery puncture site.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• TR Band™ Radial Compression Device (K070423)
• Air-Band™ Radial Compression Device (K122405)

Submission Summary (Full Text)

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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: [phone] Establishment Registration Number: 3009718176

Official contact: Ms Tianya Ma, Regulatory Specialist Tel: [phone] ext 610 Fax: [phone] Email: [e-mail]

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.

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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 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------|------------|
| Manufacture<br>r | Jilin Coronado<br>Medical Ltd | Terumo Cooperation | MAQUET | - |
| Intended Use | The CoSeal™ Arterial<br>Compression Band is<br>a compression device<br>to assist haemostasis<br>of the radial artery<br>after<br>transradial<br>procedure, while<br>minimizing the loss of<br>blood. | Equivalent | Equivalent | Equivalent |
| Operational<br>Principle | It's used to fixed on<br>the top of the<br>puncture site after the<br>PCI procedure. The<br>balloon is expansion<br>by pressuring. It'll<br>continually pressure<br>on vascular, then<br>achieve the<br>hemostasis. | Equivalent | Equivalent | Equivalent |
| Sterilization<br>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 |

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

| Balloon<br>number | for the<br>needed<br>amont on the | Balloon volume | Single | Double | Single |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-----------------------|------------------------------|----------------|
| | puncture site | | 18ml, maximum<br>20ml | Normal 13ml, maximum<br>18ml | 7cc (7ml) |
| Accessory | syringe | | Similar Design | Similar Design | Similar Design |
| Luer check<br>valve | luer valve on the<br>end of the fill tube<br>enables a luer lock<br>syringe to be<br>connected to inflate<br>and deflate the<br>balloon with air to<br>provide compression | | Similar Design | Similar Design | Similar Design |
| Flexible tube<br>(PU tube) | Passage for the air<br>go through into the<br>balloon | | Similar Design | Similar Design | Similar Design |

# Comparison of materials

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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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'".