(296 days)
No
The device description and performance studies focus on mechanical components and standard biocompatibility/bench testing, with no mention of AI or ML.
No.
The document describes the device as intended to maintain hemostasis, which is a supportive function during medical procedures, not a direct therapeutic action to treat a disease or condition. Its purpose is to facilitate the use of other diagnostic and interventional devices, acting as an accessory rather than a standalone therapeutic agent.
No
Explanation: The device is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices, facilitating the manipulation of guide wires and catheters. It does not perform any diagnostic function itself.
No
The device description clearly outlines physical components (Y connector, insertion tool, torquer) and mentions bench testing related to material properties and physical performance, indicating it is a hardware device.
Based on the provided information, the SunmedTM Haemostatic Valves is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for maintaining hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices within the body. This is an in-vivo application, not an in-vitro (outside the body) diagnostic test.
- Device Description: The description details a physical device used to manage blood flow during procedures, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is a medical device used in interventional procedures, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX, DTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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) 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K131124, K073260, K052381, K133795
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, next to a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.
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
1
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 (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 Industry and Consumer Education 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,
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
-
- 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: (949)216-8838 Fax: (949)423-0168 JamesQi Zhang, General Manager Contact: E-mail: jamesqizhang@gmail.com Aug.20, 2016 Date:
-
- 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
Fitting |
|----------------------|------------------------------------------------------------------|
| Regulation Number: | 870.4290 |
| Product Code: | DTL |
3. Predicate Device:
| 510(k)
| Number | Trade Name | Manufacture | Note |
|---|---|---|---|
| K113148 | E-Pass™ | Synexmed (Shenzhen) company | |
| limited. | Primary predicate |
Sunny Medical Device (Shenzhen) Co., Ltd.
4
| K131124 | CoLignTM Hemostasis
Valve | Jilin Coronado Medical Ltd. | Reference devices |
|---------|------------------------------------------------------------------|----------------------------------------------|-------------------|
| K073260 | The LiiSA Lever
Integrated Interventional
System AdaptorTM | Device Partners International | |
| K052381 | The Guardian
Hemostatic Valve | Zerusa Limited | |
| K133795 | SunmedTM Inflation
Device | Sunny Medical Device
(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.
-
- 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.
- Intended Use
-
- 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.
- Technological Comparison to Predicate Device
-
- 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)
- Summary of Non-Clinical Testing
Sunny Medical Device (Shenzhen) Co., Ltd.
5
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.
-
- Clinical Evaluation was not applicable.
-
- 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.