SUMMED HIGH PRESSURE LINE

K140356 · Sunny Medical Device (Shenzhen) Co., Ltd. · DQO · Mar 20, 2015 · Cardiovascular

Device Facts

• Record ID: K140356
• Device Name: SUMMED HIGH PRESSURE LINE
• Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
• Product Code: DQO · Cardiovascular
• Decision Date: Mar 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

Device Story

Sunmed High Pressure Line serves as a fluid conduit during coronary angiography; connects angiographic syringe to catheter via female and male luer fittings. Device facilitates delivery of contrast or saline diagnostic fluids. Used in clinical settings by medical professionals. Single-use, sterile, disposable tubing assembly. Benefits patient by enabling reliable fluid delivery during diagnostic imaging.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing included pyrogen, acute systemic toxicity, intracutaneous reactivity, in vitro cytotoxicity, skin sensitization, and in vitro hemolysis (ASTM F756-08). Additional testing included aging, package penetration, asepsis, and EtO/ECH residue analysis.

Technological Characteristics

Disposable high-pressure tubing assembly with female and male luer connectors (including rotating male luer). Materials include medical-grade tubing and luer components. Sterilized via Ethylene Oxide (EtO). Biocompatibility testing per ASTM F756-08. Single-use.

Indications for Use

Indicated for use as a connecting line for the injection of contrast, saline, or other diagnostic fluids during coronary angiography procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Disposable High Pressure Injection Lines and without Rotating Adapters (K071196)
• Ultra High Pressure Injector Lines (K023591)

Submission Summary (Full Text)

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

March 20, 2015

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

Re: K140356

> Trade/Device Name: Sunmed High Pressure Line Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: February 2, 2015 Received: February 18, 2015

Dear Mr. 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 vours.

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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## 2. Indications for Use Statement

## Indications for use

510(k) Number (if known): K140356

Device Name: Sunmed™ High Pressure Line

Indications for Use:

The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

文 Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 1. 510(k) Summary

| 1. | Submitted by: | Sunny Medical Device (Shenzhen) Co., Ltd. |
|----|---------------------|------------------------------------------------------------------------------------------------------------------|
| | Registered Address: | 4/F and 5/F, Dongpingxing Creative Science Park,<br>Longgang District, Shenzhen,<br>Guangdong, P.R. China 518172 |
| | Contact Address: | 56 Lehigh Aisle<br>Irvine, CA 92612 |
| | Telephone: | [phone] |
| | Fax: | [phone] |
| | Contact: | James Qi Zhang, General Manager |
| | E-mail: | [e-mail] |
| | Date: | Nov. 18, 2013 |

- 2. Proposed Device:

| Trade/Proprietary Name: | Sunmed™ High Pressure Line |
|-------------------------|-----------------------------------|
| Common/Usual Name: | Disposable High Pressure Line |
| Classification: | II |
| Classification Name: | Diagnostic intravascular catheter |
| Regulation Number: | 870.1200 |
| Product Code: | DQO |

- 3. Predicate Device:

| 510(K)<br>Number | Trade or Proprietary or Model Name | Manufacturer |
|------------------|---------------------------------------------------------------------------|--------------------------------------------|
| K071196 | Disposable High Pressure Injection<br>Lines and without Rotating Adapters | Coeur Medical, a division<br>of Coeur Inc. |
| K023591 | Ultra High Pressure Injector Lines | DeRoyal Industries, Inc. |

Sunny Medical Device (Shenzhen) Co., Ltd.

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- 4. Device description
The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.

The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.

Package: Material: Dupont Tyvek package for medical use.

- 5. Intended Use
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer (including rotating male luer), and tubing and with or without caps.

- Technological Comparison to Predicate Device 6.
The technological characteristics of the subject device, The Sunmed™ High Pressure Line, are equivalent to Disposable High Pressure Injection Lines and without Rotating Adapters and Ultra High Pressure Injector Lines in terms of intended use, materials, fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization.

- 7. Summary of the technological characteristics of our device compared to the predicate device:
The predicates were compared in the following areas and found to have identical technological characteristics and to be equivalent because they are the identical products.

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Indications for Use Material Components Technique (Components/Flexible/Packaging/Pressure ) Sterility Biocompatibility

- 8. Summary of Non-Clinical Testing
The following tests were performed on the Sunmed™ High Pressure Line:

Biocompatibility Testing: Pyrogen Test Acute Systemic Toxicity Test Intracutaneous Reactivity Test In Vitro Cytotoxicity Test Skin sensitization Test (two kinds of solvent) In Vitro Hemolysis Study( ASTM F756-08) Aging Testing Bench Testing Package Penetrate Testing Asepsis Testing EtO and ECH Residue Testing

- 9. Clinical Evaluation was not applicable.
## 10. Conclusions

Based on the information presented in this 510(k) premarket notification, the SunmedTM High Pressure Line is considered substantially equivalent to the Disposable High Pressure Injection Lines with and without Rotating Adapters and Ultra High Pressure Injector Lines.