Disposable High Pressure Injector Syringe

• K Number: K152906
• Device Name: Disposable High Pressure Injector Syringe
• Manufacturer: WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
• Date Cleared: 2016-11-22 ( 418 days)
• Product Code: DXT
• Regulation Number: 870.1650

Intended Use

Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

Device Description

The product has two types: one type is composed of one or several syringes and one or several accessories. The accessories include connecting tube and medicine aspirator (punctured medicine aspirator and tubular medicine aspirator); the other type is composed of individual accessory; the syringe is composed of barrel, plunger, piston or plunger cap. The connecting tube has one-way and multi-way. One-way connecting tube is composed of locking connector, tubing, female conical fitting, nozzle cap, protective cap or one-way valve; multi-way connecting tube is composed of multi-way connector, locking connector, tubing, female conical fitting, nozzle cap, protective cap, one-way valve or puncture. Maximum rated pressure for the Disposable High Pressure Injector Syringe is either 300psi (2.07MPa) or 1200psi (8.3MPa). The rated pressure for each models are listed in the following Models and Combinations Table. The aspirator has tubular medicine aspirator and punctured medicine aspirator. Punctured medicine aspirator has plastic pin. Product packaging: Primary package is heat-sealed by Tyvek paper and PS blister. The following configurations of various syringes and accessories are available than are in compatible with market available injectors from Medrad, Liebel-Flarsheim, Acist or Nemoto.

Predicate Devices

K082439, K072696

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a disposable syringe and its accessories for contrast media injection. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No
The device is described as a "Disposable High Pressure Injector Syringe" intended for "injection of contrast media or saline." It is an accessory to angiographic injectors and does not directly provide therapy.

Diagnostic

No

Explanation: The device is a syringe intended for injecting contrast media or saline, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like syringes, barrels, plungers, connecting tubes, and aspirators, and the performance studies focus on physical properties and compatibility with hardware injectors. There is no mention of software as a component or function of the device.

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 "for the injection of contrast media or saline." This describes a device used in vivo (within the body) for delivering substances during medical imaging procedures.
• Device Description: The description details a syringe and accessories designed for injecting fluids under high pressure. This aligns with the intended use of delivering contrast media or saline into a patient's bloodstream or other body cavities.
• Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with patient specimens or any diagnostic testing performed on those specimens.
• Performance Studies: The performance studies focus on the physical characteristics of the syringe (pressure, connection strength, compatibility, sealing, sliding) and clinical performance related to injection, not on the analysis of biological samples.

Therefore, the Disposable High Pressure Injector Syringe is a medical device used for in vivo procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

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

DXT

Device Description

The product has two types: one type is composed of one or several syringes and one or several accessories. The accessories include connecting tube and medicine aspirator (punctured medicine aspirator and tubular medicine aspirator); the other type is composed of individual accessory; the syringe is composed of barrel, plunger, piston or plunger cap. The connecting tube has one-way and multi-way. One-way connecting tube is composed of locking connector, tubing, female conical fitting, nozzle cap, protective cap or one-way valve; multi-way connecting tube is composed of multi-way connector, locking connector, tubing, female conical fitting, nozzle cap, protective cap, one-way valve or puncture.

Maximum rated pressure for the Disposable High Pressure Injector Syringe is either 300psi (2.07MPa) or 1200psi (8.3MPa). The rated pressure for each models are listed in the following Models and Combinations Table.

The aspirator has tubular medicine aspirator and punctured medicine aspirator. Punctured medicine aspirator has plastic pin.

Product packaging: Primary package is heat-sealed by Tyvek paper and PS blister.

The following configurations of various syringes and accessories are available than are in compatible with market available injectors from Medrad, Liebel-Flarsheim, Acist or Nemoto.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance shows the subject device and predicate devices have the substantial equivalent performance. Therefore, the Disposable High Pressure Injector Syringe is substantially equivalent to the predicate devices, there are no safety issues raised, and the device meets the requirements for FDA 510(k) clearance.

Performance testing:

1. Maximum Rated Pressure Testing
2. Connection Strength Test
3. Compatibility Testing between the Injector and Syringes
4. Aged Verification
5. Biocompatibility Tests

• ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing
• ISO 10993-5:1999 Biological evaluation of medical devices -- Part 5: Tests ● for In Vitro cytotoxicity
• ISO 10993-10:2002 Biological evaluation of medical devices Part 10: Tests ● for irritation and delayed-type hypersensitivity
• ISO 10993-7: 2008 Biological evaluation of medical devices Part 7: ● Ethylene oxide sterilization residuals

6. Transportation Validation

• ASTM D4169 14 Standard Practice for Performance Testing of Shipping . Containers and Systems

Clinical testing used to evaluate the performance of the high pressure syringe and injectors, the following are evaluated:

1. Appearance
2. Sliding Performance
3. Sealing
4. Fitting

The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device.

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.

K082439, K072696

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

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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 image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a single, continuous line. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

November 22, 2016

Wuxi Yushou Medical Appliances Co., Ltd % Jun Peng Principal Consultant P&L Scientific Inc. 6840 SW 45th Ln Unit 5 Miami, Florida 33155

Re: K152906

Trade/Device Name: Disposable High Pressure Injector Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: February 19, 2016 Received: March 2, 2016

Dear Jun Peng:

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 (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 [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 yours,

Brian D. Pullin -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) K152906

Device Name Disposable High Pressure Injector Syringe

Indications for Use (Describe)

Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

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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510(k) Summary

510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based:

The Assigned 510(k) Number is: K152906

• 1. Submitter Information:
  • Sponsor/510(K) Owner: . WUXI YUSHOU MEDICAL APPLICANCES CO., LTD. NO. 215 XIGANG ROAD, DONGBEITANG WUXI CITY, JIANGSU, 214191, CHINA Phone: [phone] Fax: [phone]

Dated: May 4, 2016

• Contact Name: . Mr. Jun Peng P&L SCIENTIFIC INC. 6840 SW 45TH LN UNIT 5 MIAMI, FL 33155 Phone: [phone] Fax: [phone] Email: [e-mail]
• 2. Device Name

Trade Name:	Disposable High Pressure Injector Syringe
Common Name:	Angiographic Injector and Syringe

3. Classification:

Classification Names	FR Number	Product Code
Injector and syringe, angiographic	870.1650	DXT

4. Predicate Devices:

Name	K number	Manufacturer information
DISPOSABLE ANGIOGRAPHIC SYRINGE MODEL(S) CT-200-NE CT-200-MA CT-200+200-MA CT-200-LF CT -100-NE CT-200NE CT-50+CT	K082439	SHANDONG WEIGAO MEDICAL POLYMER CO. LTD
ANT ANGIOGRAPHIC SYRINGES MODEL(S) 100101102103100201202203204100301200101201202 203200301101102202301	K072696	SHENZHEN ANT HI-TECH INDUSTRIAL CO. LTD

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5. Description of Device

The product has two types: one type is composed of one or several syringes and one or several accessories. The accessories include connecting tube and medicine aspirator (punctured medicine aspirator and tubular medicine aspirator); the other type is composed of individual accessory; the syringe is composed of barrel, plunger, piston or plunger cap. The connecting tube has one-way and multi-way. One-way connecting tube is composed of locking connector, tubing, female conical fitting, nozzle cap, protective cap or one-way valve; multi-way connecting tube is composed of multi-way connector, locking connector, tubing, female conical fitting, nozzle cap, protective cap, one-way valve or puncture.

Maximum rated pressure for the Disposable High Pressure Injector Syringe is either 300psi (2.07MPa) or 1200psi (8.3MPa). The rated pressure for each models are listed in the following Models and Combinations Table.

The aspirator has tubular medicine aspirator and punctured medicine aspirator. Punctured medicine aspirator has plastic pin.

Product packaging: Primary package is heat-sealed by Tyvek paper and PS blister.

The following configurations of various syringes and accessories are available than are in compatible with market available injectors from Medrad, Liebel-Flarsheim, Acist or Nemoto.

| Models | Composition | Compatible with | Maximum
Rated
Pressure | | |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| 10060A/
10060A | 2-65ml Syringe
1-255cm Multi-way Connecting
Tube
2-Punctured Medicine Aspirator | MEDRAD SOLARIS&
SPECTRIS MRI | 300psi | | |
| 10060C/
10060C | 2-60ml Syringe
1-255cm Multi-way Connecting
Tube
2-Punctured Medicine Aspirator | Liebel-Flarsheim Optistar
MRI | 300psi | | |
| 100100C/
10060A | 1-115ml Syringe
1-65ml Syringe
1-255cm Multi-way Connecting
Tube
2-Punctured Medicine Aspirator | MEDRAD SOLARIS&
SPECTRIS MRI | 300psi | | |
| 100100C/100100C | 2-115ml Syringe
1-255cm Multi-way Connecting
Tube
2-Punctured Medicine Aspirator | MEDRAD SOLARIS&
SPECTRIS MRI | 300psi | | |
| 100100A | 1-100ml Syringe | MEDRAD MCT PLUS CT | 300psi | | |
| | 1-150cmOne-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator | MEDRAD VISTRON CT
MEDRAD ENVISION CT | | | |
| 100100B | 1-100ml Syringe
1-150cm One-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator | MEDRAD MCT PLUS CT
MEDRAD VISTRON CT
MEDRAD ENVISION CT | 300psi | | |
| 100100D | 1-100ml Syringe
1-J-type Tubular Medicine
Aspirator | Liebel-Flarsheim 3000 Series
DSA | 1200psi | | |
| 100130A | 1-130ml Syringe
1-J-type Tubular Medicine
Aspirator | MEDRAD MARK IV &
MARK III DSA | 1200psi | | |
| 100150A | 1-150ml Syringe
1-J-type Tubular Medicine
Aspirator | MEDRAD MARK V DSA
MEDRAD MARK V Provis
DSA | 1200psi | | |
| 100150C | 1-150ml Syringe
1-J-type Tubular Medicine
Aspirator | MEDRAD MARK 7 DSA | 1200psi | | |
| 100200A | 1-200ml Syringe
1-150cm One-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator | MEDRAD MCT PLUS CT
MEDRAD VISTRON CT
MEDRAD ENVISION CT | 300psi | | |
| 100200B | 1-200ml Syringe
1-150cm One-way Connecting
Tube
1-10cm Straight Tube
1-J-type Tubular Medicine
Aspirator | MEDRAD STELLANT Single
CT | 300psi | | |
| 100200B/
100200B | 2-200ml Syringe
1-J-type Tubular Medicine
Aspirator
1-150cm Multi-way Connecting
Tube
2-10cm Straight Tube
2-Punctured Medicine Aspirator | MEDRAD STELLANT
Double CT | 300psi | | |
| 100200D | 1-200ml Syringe
1-J-type Tubular Medicine
Aspirator | MEDRAD MARK V DSA
MEDRAD MARK V Provis
DSA | 1200psi | | |
| 101100A/
101100A | 2-100ml Syringe
1-255cm Multi-way Connecting
Tube
2-Punctured Medicine Aspirator | ACIST-MR
EZEM INC-CT | 300psi | | |
| 101200A | 1-200ml Syringe
1-150cm One-way Connecting
Tube
1-J-type Tubular Medicine | ACIST-CT
EZEM INC-CT | 300psi | | |
| | Aspirator | | | | |
| 101200A/
101200A | 2-200ml Syringe
1-255cmMulti-way Connecting
Tube
2-Punctured Medicine Aspirator | ACIST-CT
EZEM INC-CT | 300psi | | |
| | 200150A | 1-150ml Syringe
1-J-type Tubular Medicine
Aspirator | Liebel-Flarsheim Angionmat
Illumena DSA | 1200psi | |
| | | 200150B | 1-150ml Syringe
1-J-type Tubular Medicine
Aspirator | Liebel-Flarsheim Angionmat
6000 DSA | 1200psi |
| | | | 200200A | 1-200ml Syringe
1-150cm One-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator | Liebel-Flarsheim CT9000
Single |
| 200200A/
200200A | 2-200ml Syringe
1-150cm Multi-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator
1-Punctured Medicine Aspirator | | | Liebel-Flarsheim CT9000
Double | 300psi |
| | 300130A | 1-130ml Syringe
1-J-type Tubular Medicine
Aspirator | | NEMOTO 120S DSA | 1200psi |
| | | 300100B | 1-100ml Syringe
1-150cm One-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator | NEMOTO A-25, A-60, Dual Shot CT | 300psi |
| | | | 300100B/
300100B | 2-100ml Syringe
1-150cm Multi-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator
1-Punctured Medicine Aspirator | NEMOTO A-25, A-60, Dual Shot CT |
| 300200B | 1-200ml Syringe
1-150cm One-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator | | | NEMOTO A-25, A-60, Dual Shot CT | 300psi |
| | 300200B/
100060B | 1-200ml Syringe
1-60ml Syringe
1-150cm Multi-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator
1-Punctured Medicine Aspirator | | NEMOTO Dual Shot, Dual Shot Alpha CT | 300psi |
| | | 300200B/
300100B | | 1-200ml Syringe
1-100ml Syringe | NEMOTO Dual Shot, Dual Shot Alpha CT |
| | | 1-150cm Multi-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator
1-Punctured Medicine Aspirator | | 300psi | |
| | | 2-200ml Syringe | | | |
| | 300200B/
300200B | 1-150cm Multi-way Connecting
Tube
1-J-type Tubular Medicine
Aspirator
1-Punctured Medicine Aspirator | NEMOTO Dual Shot, Dual
Shot Alpha CT | | |
| | | 2-60ml Syringe | | | |
| | | 1-255cmMulti-way Connecting
Tube
2-Punctured Medicine Aspirator | NEMOTO Sonic Shot 50 MRI | | |
| 100060B/
100060B | | | | | |

Models and combinations

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6

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6. Intended Use

Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.

7. Summary of Comparison in Technological Characteristics to Predicate Device

The Disposable High Pressure Injector Syringe is substantially equivalent to the predicate device ANT Angiographic Syringes (K072696) and DISPOSABLE ANGIOGRAPHIC SYRINGE MODEL(S) CT-200-NE CT-200-MA CT-200+200-MA CT-200-LF CT -100-NE CT-200NE CT-50+CT (K082439). The subject device and the predicate device are both of the

• same intended use. ●
• the method of use, ●
• device construction, ●
• . materials used.
• packaging, ●
• biological characteristics,
• and performance ●

8. Discussion of major difference vs. predicate device

Difference between subject device and predicate devices:

• Combination of syringes of volumes is different;
• Connection nozzles are different. .

9. Assessment of Non-Clinical Testing:

The performance shows the subject device and predicate devices have the substantial equivalent performance. Therefore, the Disposable High Pressure Injector Syringe is

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substantially equivalent to the predicate devices, there are no safety issues raised, and the device meets the requirements for FDA 510(k) clearance. Performance testing:

1. Maximum Rated Pressure Testing

• 2. Connection Strength Test
• 3. Compatibility Testing between the Injector and Syringes
• 4. Aged Verification
• 5. Biocompatibility Tests
  • ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing
  • ISO 10993-5:1999 Biological evaluation of medical devices -- Part 5: Tests ● for In Vitro cytotoxicity
  • ISO 10993-10:2002 Biological evaluation of medical devices Part 10: Tests ● for irritation and delayed-type hypersensitivity
  • ISO 10993-7: 2008 Biological evaluation of medical devices Part 7: ● Ethylene oxide sterilization residuals
• 6. Transportation Validation
  • ASTM D4169 14 Standard Practice for Performance Testing of Shipping . Containers and Systems

10. Assessment of Clinical Testing:

The clinical testing is used to evaluate the performance of the high pressure syringe and injectors, the following are evaluated:

• 1. Appearance
• 2. Sliding Performance
• 3. Sealing
• 4. Fitting

The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device.

11. Conclusion

After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is substantial equivalent as the predicate devices.