Sunmed Haemostatic Valves

K153685 · Sunny Medical Device (Shenzhen) Co., Ltd. · DQX · Oct 13, 2016 · Cardiovascular

Device Facts

• Record ID: K153685
• Device Name: Sunmed Haemostatic Valves
• Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Sunmed™ Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

Device Story

Sunmed Haemostatic Valves consist of Y-connector, insertion tool, and torquer; available in Push-pull, Screw, Y-click, and Double Screw configurations. Device maintains hemostasis during introduction/withdrawal of diagnostic/interventional catheters/guide wires (up to 9 Fr). Insertion tool assists guide wire placement; torquer provides handle for guide wire manipulation. Used in clinical settings by physicians during interventional procedures. Device prevents blood loss while allowing instrument passage. Benefits include procedural efficiency and patient safety during catheterization.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated through non-clinical bench testing only, including biocompatibility (cytotoxicity, sensitization, systemic toxicity, hemolysis, thrombosis, complement activity), package integrity, aging, and EtO/ECH residue testing.

Technological Characteristics

Components: Y-connector, insertion tool, torquer. Configurations: Push-pull, Screw, Y-click, Double Screw. Sizes: 7F, 8F, 9F. Sterilization: Ethylene Oxide (EtO). Materials: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for patients requiring diagnostic or interventional procedures involving the introduction or withdrawal of devices up to 9 Fr diameter, where maintenance of hemostasis is required.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• E-Pass™ (K113148)

Reference Devices

• CoLignTM Hemostasis Valve (K131124)
• The LiiSA Lever Integrated Interventional System AdaptorTM (K073260)
• The Guardian Hemostatic Valve (K052381)
• SunmedTM Inflation Device (K133795)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 13, 2016

Sunny Medical Device (shenzhen) Co., Ltd. James Zhang Manager General 56 Lehigh Aisle Irvine, California 92612

Re: K153685

Trade/Device Name: Sunmed Haemostatic Valves Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, DTL Dated: August 30, 2016 Received: September 13, 2016

Dear James Zhang:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hilleman
for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K153685

Device Name SunmedTM Haemostatic Valves

Indications for Use (Describe)

The SunmedTM Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7 Fr, 8 Fr or 9 Fr; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torquer provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 5. 510(k) Summary

- 1. Submitted by: Sunny Medical Device (Shenzhen) Co., Ltd. Registered Address: 4/F and 5/F, Dongpingxing Creative Science Park, Longgang District, Shenzhen, Guangdong, P.R. China 518172 Contact Address: 56 Lehigh Aisle, Irvine, CA 92612 Telephone: [phone] Fax: [phone] JamesQi Zhang, General Manager Contact: E-mail: [e-mail] Aug.20, 2016 Date:
- 2. Proposed Device:

| Trade/Proprietary Name: | Sunmed™Haemostatic Valves |
|-------------------------|---------------------------|
| Common/Usual Name: | Haemostatic Valves |
| Classification: | II |
| Classification Name: | Catheter guide wire |
| Regulation Number: | 870.1330 |
| Product Code: | DQX |

# Additional Product Code:

| Classification Name: | Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or<br>Fitting |
|----------------------|------------------------------------------------------------------|
| Regulation Number: | 870.4290 |
| Product Code: | DTL |

## 3. Predicate Device:

| 510(k)<br>Number | Trade Name | Manufacture | Note |
|------------------|------------|-----------------------------------------|-------------------|
| K113148 | E-Pass™ | Synexmed (Shenzhen) company<br>limited. | Primary predicate |

Sunny Medical Device (Shenzhen) Co., Ltd.

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| K131124 | CoLignTM Hemostasis<br>Valve | Jilin Coronado Medical Ltd. | Reference devices |
|---------|------------------------------------------------------------------|----------------------------------------------|-------------------|
| K073260 | The LiiSA Lever<br>Integrated Interventional<br>System AdaptorTM | Device Partners International | |
| K052381 | The Guardian<br>Hemostatic Valve | Zerusa Limited | |
| K133795 | SunmedTM Inflation<br>Device | Sunny Medical Device<br>(Shenzhen) Co., Ltd. | |

# 4. Device description

Hemostatic valves is composed of single Y connector, insertion tool and torquer. There are four models of the Hemostatic valves: Push-pull Y Connector, Screw Y Connector, Y click Connector and Double Screw Y Connector.

Each single Y connector has two different structures: one is that the end of sideon is female luer; Another is that the end of sideon is the tubing and a stopcock.

The Sunmed TM Hemostatic Valvesis designed to three external diameter of 7F, 8F, 9F for through different specifications of guide wire or catheter according to clinical need.

- 5. Intended Use
The Sunmed™ Haemostatic Valves is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices up to an external diameter of 7F, 8F or 9F; The insertion tool facilitates introduction of guide wire through the haemostatic valves to reach the guiding catheter; The torque provides a handle for easier manipulation of the guide wire when inserted into the proximal end of the guide wire.

- 6. Technological Comparison to Predicate Device
Sunmed™ The technological characteristics of the subject device, The Haemostatic Valves, is equivalent to the E-Pass™ in terms of intended use, materials, fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.

- 7. Summary of Non-Clinical Testing
The following tests were performed on the Sunmed™Haemostatic Valves: Biocompatibility Testing: Pyrogen Test Acute Systemic Toxicity Test(two kinds of solvent) Skin sensitization Test (two kinds of solvent)

Sunny Medical Device (Shenzhen) Co., Ltd.

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Endotoxin Test In Vitro Hemolysis Study Complement Activity Test (C3a,SC5b-9) Intracutaneous Reactivity Test (two kinds of solvent) In Vitro Cytotoxicity Test Thrombosis Test Package Penetrate Testing Asepsis Testing Aging Testing EtO and ECH Residue Testing Bench Testing

Conclusion: Comparisons of the proposed and predicate devices show that the technological characteristics such as materials, performance characteristics, sterilization and packaging are identical or substantially equivalent to the currently marketed predicate devices. The safety and effectiveness of the Sunmed™ Haemostatic Valves has been demonstrated through data collected from nonclinical bench tests and analysis. Please refer to the Predicate Device Discussion Table for detail.

- 8. Clinical Evaluation was not applicable.
- 9. Conclusions

Based on the information presented in this 510(k) premarket notification, the Sunmed™ Haemostatic Valves is considered substantially equivalent to the E-Pass™ and CoLign™ Hemostasis Valve.