K Number

Device Name

Angiography Syringe

Manufacturer

SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.

Date Cleared

2017-10-03

(273 days)

Product Code

DXT

Regulation Number

870.1650

Intended Use

The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures.

Device Description

The Angiography Syringe are plastic , single-use, disposable syringes to be offered in 6ml, 8ml, 10ml, 12ml size. As manual control syringe, each configuration includes bilateral, external finger rings located on the proximal barrel shaft. The proximal thumb rings located on the plunger, in tandem with the external finger rings on the barrel, allows for single handed movement to create aspiration and/or expulsion of fluids. The angiography syringe has two tip fitting: fixed adapter and rotating adapter

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K093830

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical function and material properties of a manual syringe, with no mention of AI or ML.

Therapeutic

No
The device is used to inject contrast media for diagnostic imaging, not for treating a disease or condition.

Diagnostic

No
The device is a syringe used for injecting contrast media, which is a tool used during diagnostic procedures (angiography) but does not itself provide a diagnosis.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical, single-use, disposable syringe made of plastic, which is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures. This is a procedure performed on the patient, not a test performed on a sample taken from the patient.
Device Description: The device is a syringe designed for injecting fluids into the body.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe is used for direct administration of a substance into the body for imaging purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures.

Product codes (comma separated list FDA assigned to the subject device)

DXT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Heart, great vessels, and coronary arteries.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospital

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
ISO 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual.
Biocompatibility testing and reference standards:

In Vitro Hemolytic Properties of Materials.
In Vitro Cytotoxicity - 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.
--4) Skin Sensitization ISO 10993-10:2010, Biocompatibility Evaluation of Medical 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.
ISO 10993-11:2006, Biocompatibility Evaluation of Medical -- 6) Pyrogen 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.

K093830

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

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem depicts a white abstract image of an eagle with three heads. 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: K170025

Trade/Device Name: Angiography Syringe (Fixed Adapter), Angiography Syringe (Rotating Adapter) 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 (OS) 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,

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K170025

Device Name

Angiography Syringe (Fixed Adapter), Angiography Syringe (Rotating Adapter)

Indications for Use (Describe)

The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during 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)

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."

Section III-510(k) Summary

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: K170025

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: Angiography Syringe (Fixed Adapter), Angiography Syringe (Rotating Adapter) Proposed Device Model: 6mL, 8mL, 10mL, 12mL. Classification: Class II Classification Name: Angiographic injector and syringe Product Code: DXT Regulation Number: 21 CFR 870.1650 Review Panel: Cardiovascular

4. Predicate device

510(k) Number: K093830 a.

Product Name: Medline Angiographic Control Syringe

Manufacturer: Medline Industries Inc.

5. Device description

6. Intended Use Statement:

The Angiography syringe is used to inject contrast media into the heart, great vessels, and coronary arteries during angiographic procedures.

7. Non-clinical Test Conclusion

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 7886-1:1993 Sterile hypodermic syringes for single use - Part 1: Syringes for manual.

Biocompatibility testing and reference standards:

In Vitro Hemolytic Properties of Materials.
In Vitro Cytotoxicity - 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.

--4) Skin Sensitization ISO 10993-10:2010, Biocompatibility Evaluation of Medical 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.

ISO 10993-11:2006, Biocompatibility Evaluation of Medical -- 6) Pyrogen Device - Part 11: Tests for systemic toxicity.

8. Clinical Test

It is not applicable.

9. Summary Comparing the Technological Characteristics

The proposed device and predicate device have the same classification information, same material, principle of operation and syringe tip style. The proposed device has four kinds of volumes, while the predicate has various sizes. So the volume range of the proposed device is included in the volume range of the predicate device. Therefore, they are considered to be substantial equivalent in the volume aspect.

Premarket Notification 510(k) Submission		Section III-Summary	File No.2016000-
Item	Proposed Device	Predicate Device(K093830)	Remark
Product Code	DXT	DXT	SE
Regulation No.	870.1650	870.1650	SE
Class	II	II	SE
Intended Use	The Angiography syringe is used to inject contrast
media into the heart, great vessels, and coronary
arteries during angiographic procedures.	An angiography syringe is a device that consist of a
syringe which is used to inject contrast material into the
heart, great vessels, and coronary arteries during
angiographic or CT procedures.	SE
Principle of
Operation	It is designed for single manual use. The plunger is free
to move. When pulled the plunger to aspirate the fluid
or pushed it to injection.	It is designed for single manual use. The plunger is free
to move. When pulled the plunger to aspirate the fluid
or pushed it to injection.	SE
Components	Barrel, piston, plunger, plunger cap, rotating adapter,
O-ring, thumb ring	Barrel, piston, plunger, plunger cap, Rotating connector,
O-ring thumb ring	SE
Conical fitting	Comply with ISO ISO 594-1:1986 ISO 594-2:1998	Comply with ISO ISO 594-1:1986 ISO 594-2:1998	SE
Where used	Hospital	Hospital	SE
Size	6mL,8mL,10mL,12mL	Various size	Similar
Syringe tip style	Fixed adapter and rotating adapter	LL connector and rotating connector	SE

10.Conclusion

The proposed device, angiography syringe, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols. The angiography syringe is substantially equivalent to the legally market predicate device.