(273 days)
Not Found
No
The device description and intended use focus on mechanical components for hemostasis and guidewire manipulation, with no mention of AI or ML capabilities. The performance studies are bench tests against standards, not AI/ML model validation.
No
The device is intended to minimize blood loss and facilitate the insertion and manipulation of other devices during diagnostic and interventional procedures, rather than directly treating a condition or restoring a function.
No
This device is designed to minimize blood loss and facilitate the introduction and manipulation of other devices (like guidewires) during diagnostic and interventional procedures. It does not perform any diagnostic function itself, such as detecting, identifying, or monitoring a disease or condition.
No
The device description clearly outlines physical components (Y-connector, Insertion tool, Torque device) and bench testing related to physical standards (ISO standards), 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 clearly states the device is for minimizing blood loss during diagnostic and interventional procedures involving the introduction and use of devices within the human vascular system. This is a direct interaction with the patient's body during a medical procedure.
- Device Description: The description details components like a Y-connector, insertion tool, and torque device used for manipulating catheters and guidewires within the vascular system. These are tools used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic purposes. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
The device described is a medical device used during a medical procedure on a patient, not a device used to perform tests on samples outside the body.
N/A
Intended Use / Indications for Use
Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.
The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.
The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.
Product codes (comma separated list FDA assigned to the subject device)
DTL, DQX
Device Description
The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system.
The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap.
The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.
The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vascular system
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)
Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device. The test result demonstrates that the proposed devices comply with the following standards:
ISO 594-1:1986, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 1: General Requirements.
ISO 594-2 1998, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings.
Biocompatibility testing and reference standards:
-
In Vitro Hemolytic Properties of Materials.
-
In Vitro Cytotoxicity -- ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity.
-- ISO 10993-10:2010, Biocompatibility Evaluation of Medical 3) Skin Irritation Device - Part 10: Tests for Irritation and Shin Sensitization.
-- ISO 10993-10:2010, Biocompatibility Evaluation of Medical 4) Skin Sensitization Device - Part 10: Tests for Irritation and Shin Sensitization.
-
Acute Systemic Toxicity -- ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity.
-
Pyrogen -- ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem depicting three stylized human profiles facing right, with flowing lines suggesting movement or connection. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2017
Shanghai Kindly Medical Instruments Co.,ltd. Jeffery Hui Official Correspondent No. 925 Jinyuan Yi Rd Shanghai. 201803 CN
Re: K170024
Trade/Device Name: Y-connector Kit Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, Or Fitting Regulatory Class: Class II Product Code: DTL, DQX Dated: August 3, 2017 Received: September 7, 2017
Dear Jeffery Hui:
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 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.
1
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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170024
Device Name Y-Connector Kit
T-Connector Kit
Indications for Use (Describe)
Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.
The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.
The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section III- 510(k) Summary
This 510(k) Summary of 510(k) is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 807.92.
510(k) Number: K170024
-
- Date of Submission: Sep.15, 2017
2. Submitter
Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan yi Road, Shanghai, 201803, China Establishment Registration Number: 3009605245 Contact Person: Xu Jianhai Position: RA Supervisor Tel.:+086-021-59140056 Fax: +086-021-59140056 Email: xujianhai@kdlchina.net
3. Proposed Device
Proposed Device Name: Y-connector Kit Proposed Device Model: YCK113 Classification: Class II Product Code: DTL&DQX Regulation Number: 21 CFR 870.4290, 21 CFR 870.1330 Classification Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass and catheter guide wire Review Panel: Cardiovascular
4. Predicate device
- a. 510(k) Number: K042060
4
Product Name: EasyPass™ US Y-connector Hemostatic Valve Manufacturer: Millimed A/S Product code: DTL&DQX Regulation Number: 21 CFR 870.4290, 21 CFR 870.1330
5. Device description
The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system.
The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap.
The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.
The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.
6. Intended Use Statement:
Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.
The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.
The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.
7. Non-clinical Test Conclusion
5
Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device. The test result demonstrates that the proposed devices comply with the following standards:
ISO 594-1:1986, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 1: General Requirements.
ISO 594-2 1998, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings.
Biocompatibility testing and reference standards:
-
In Vitro Hemolytic Properties of Materials.
-
In Vitro Cytotoxicity -- ISO 10993-5:2009, Biocompatibility Evaluation of Medical Device - Part 5: Tests for In Vitro Cytotoxicity.
-- ISO 10993-10:2010, Biocompatibility Evaluation of Medical 3) Skin Irritation Device - Part 10: Tests for Irritation and Shin Sensitization.
-- ISO 10993-10:2010, Biocompatibility Evaluation of Medical 4) Skin Sensitization Device - Part 10: Tests for Irritation and Shin Sensitization.
-
Acute Systemic Toxicity -- ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity.
-
Pyrogen -- ISO 10993-11:2006, Biocompatibility Evaluation of Medical Device - Part 11: Tests for systemic toxicity.
8. Clinical Test
It is not applicable
9. Summary Comparing the Technological Characteristics
Comparisons of the proposed and predicate devices show that the technological characteristics are identical or substantially equivalent to the currently marked predicate devices.
6
| Item | Proposed Device | Predicate Device
K042060 | Remark |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Product Code | DTL DQX | DTL DQX | SE |
| Regulation
No. | 870.4290, 870.1330 | 870.4290, 870.1330 | SE |
| Class | II | II | SE |
| Intended Use | Y-Connector hemostasis valve is
intended to minimize blood loss
during the introduction, withdrawal
and use of devices that have an
outer diameter of 8F catheter
during diagnostic and
interventional procedures.
The Insertion Tool facilitates
introduction of a guidewire
through the Y-Connector and into
the guiding catheter.
The Torque Device attaches to
guidewires and provides a handle
to assist in manipulation of the
guidewire. | The EasyPassTM US Y-connector
Hemostatic Valve is intended to
maintain hemostasis during the
introduction, use and withdrawal of
diagnostic and interventional devices
that have an outer diameter of 7
French or smaller.
The guide wire insertion tool
facilitates introduction of the guide
wire through the hemostasis valve
and into the guiding catheter.
The torque device, inserted over the
proximal end of the guide wire,
provided a handle for easier
manipulation of the guide wire. | SE |
| Principle
of
Operation | By manual operation | By manual operation | SE |
| Components | Y-connector, insertion tool torque
device | Y-connector, insertion tool torque
device | SE |
| Conical fitting | Comply with ISO 594-1:1986 ISO
594-2:1998 | Comply with ISO ISO 594-1:1986
ISO 594-2:1998 | SE |
| Design | The Y connector with a rotating
luer lock, a sidearm and a
hemostasis valve with push-rotate
mechanism. The seal of hemostasis
valve can be opened by
pushing-rotating the switch cap,
and closed by pulling-rotating
switch cap. | To open the hemostasis valve, a
valve opener cap with a center
passage tube is pushed distally. The
hemostasis valve is closed by
pulling the valve opener cap
proximally. | Analysis |
| Where used | Diagnostic and interventional
procedures | Diagnostic and interventional
procedures | SE |
10.Conclusion
The proposed device, Y-connector kit, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. The y-connector kit is substantially equivalent to the legally market predicate device.