(276 days)
Not Found
No
The device description and performance studies focus on the physical properties and pressure resistance of the tubing, with no mention of AI/ML or data processing.
No
The device is a connecting line for injection of contrast media or saline, not a device that provides therapy.
No
The device description indicates that the High Pressure Tubing is a connecting line for injection of contrast media or saline, and it is designed to withstand injection pressure. It acts as a conduit for substances used in diagnostic procedures (coronary angiography) but does not perform the diagnostic function itself (e.g., image acquisition, analysis, or interpretation).
No
The device description clearly states it is a physical tubing with connectors, made of materials like PU and polyamides, and is supplied sterile. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a connecting line for injection of contrast media or saline during coronary angiographic procedures." This describes a device used in vivo (within the body) for delivering substances during a medical procedure.
- Device Description: The description details a physical tubing device designed to withstand high pressure for injection. This is consistent with a medical device used for delivery, not for testing samples in vitro (outside the 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 diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing samples outside the body to gain diagnostic information. This device is clearly intended for direct use within the body during a medical procedure.
N/A
Intended Use / Indications for Use
The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.
Product codes
DXT
Device Description
The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi.
The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter.
The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary
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
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.
ISO 8536-4:2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, 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 consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The profiles are silhouetted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2017
Shanghai Kindly Medical Instruments Co., Ltd. Jeffery Hui Official Correspondent No. 925 Jinyuan Yi Rd Shanghai, 201803 CN
Re: K170014
Trade/Device Name: High Pressure Tubing Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT 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
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Indications for Use
510(k) Number (if known) K170014
Device Name High Pressure Tubing
Indications for Use (Describe)
The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.
| 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)
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3
510(k) Summary - K170014
This 510(k) Summary is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 807.92.
510(k) Number: K170014
1. Date of Submission: Aug.03, 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: High Pressure Tubing Proposed Device Model: 30cm, 60cm, 90cm, 120cm, 150cm, Classification: Class II Product Code: DXT Classification Name: Angiography Injector and Syringes Regulation Number: 21 CFR 870.1650 Review Panel: Cardiovascular
4. Predicate device
- 510(k) Number: K140356 a.
Product Name: SunmedTM High Pressure Line
4
Manufacturer: Sunny Medical Device (Shenzhen) Co., Ltd.
5. Device description
The High Pressure Tubing is a sterile, single use device which can withstand injection pressure to 1200psi.
The High Pressure Tubing is composed of tubing with connector at each end. The connector is a female-male combination and rotating adapter.
The High Pressure Tubing is supplied sterile by Ethylene Oxide and disposable device. The material of tube is PU with polvamides liner, and the appearance is braided.
6. Indications for Use Statement:
The High Pressure Tubing is indicated for use as a connecting line for injection of contrast media or saline during coronary angiographic procedures.
7. Non-clinical Test Conclusion
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.
ISO 8536-4:2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
8. Clinical Test
It is not applicable
9. Summary Comparing the Technological Characteristics
5
The predicate device was compare in the following areas and found to have identical technological characteristic.
| Item | Proposed Device | Predicate Device
K140356 | Remark |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Class | II | II | Same |
| Intended Use | The High Pressure Tubing is
indicated for use as a connecting
line for injection of contrast
media or saline during coronary
angiographic procedures. | The sunmedTM 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 angiography 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. | Same |
| Operating
principle | Manual connect the male luer or
rotating male luer of high
pressure with other catheter
device. | Manual connect the male luer or rotating
male luer of high pressure with other
catheter device. | Same |
| Pressure Rating | 1200psi | 500psi, 900psi, 1200psi | Similar |
| Conical fitting | Comply with ISO 594-1:1986,
ISO 594-2:1998 | Comply with ISO ISO 594-1:1986, ISO
594-2:1998 | Same |
| Components | Tubing, female/male luer,
rotating adapter | Female luer, male luer (including rotating
luer), and tubing and with or without caps. | Same |
| Flexible | Yes | Yes | Same |
| Design | Designed to multiple length and
connector types. PU tubing with
polyamides liner for 1200psi | Designed to multiple length and connector
types. PU tubing with Nylon liner for
1200psi and PVC tubing for 500psi. | Similar |
| Size | 30cm,60cm,90cm,120cm,150cm, | 30cm,50cm,60cm,90cm,75cm,100cm,120cm,
150cm,200cm | Same |
| Package
material | Dupont Tyvek Medical
paper-plastic pouch. | Medical paper-plastic pouch, Tyvek plastic
pouch | Same |
10.Conclusion
The proposed device, Pressure high tubing, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. The Pressure high tubing is substantially equivalent to the legally market predicate device.