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.

AI/ML Overview

The provided document is a 510(k) summary for the Disposable High Pressure Injector Syringe, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed AI device performance study. Therefore, much of the requested information regarding AI device acceptance criteria, studies, and ground truth establishment is not present in this document.

However, I can extract the acceptance criteria and performance related to the non-clinical and clinical testing performed on the device itself.

Acceptance Criteria and Reported Device Performance (Non-AI device)

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Non-Clinical Testing	Maximum Rated Pressure Testing	Withstand pressures up to the stated maximum rated pressure (300psi or 1200psi depending on the model) without failure.	"The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies it met its own specified pressure ratings).
	Connection Strength Test	Maintain secure connections between all components (syringes, connecting tubes, aspirators) under intended use conditions.	"The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies connections were secure).
	Compatibility Testing between the Injector and Syringes	Function correctly and safely when used with the specified US legally marketed angiographic injectors (Medrad, Liebel-Flarsheim, Acist, Nemoto models listed in the "Models and Combinations" table).	"The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies compatibility was demonstrated).
	Aged Verification	Maintain performance and integrity after simulated aging processes to ensure shelf-life stability.	"The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies shelf-life stability was demonstrated).
	Biocompatibility Tests (ISO 10993-1, -5, -10, -7)	Meet the biological safety requirements for medical devices in contact with the patient (e.g., non-cytotoxic, non-irritating, non-sensitizing, acceptable ethylene oxide residuals).	"The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies biocompatibility standards were met).
	Transportation Validation (ASTM D4169)	Withstand typical shipping conditions without damage or compromise to sterility/functionality.	"The performance shows the subject device and predicate devices have the substantial equivalent performance." (Implies shipping integrity was demonstrated).
Clinical Testing	Appearance	Meet specified aesthetic requirements and be free from visible defects detrimental to function or safety.	"The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies acceptable appearance).
	Sliding Performance	Exhibit smooth and consistent plunger movement suitable for contrast media or saline injection.	"The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies acceptable sliding performance).
	Sealing	Prevent leakage of fluid during injection.	"The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies effective sealing).
	Fitting	Ensure proper and secure fit with compatible injector devices and accessories.	"The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device." (Implies proper fitting).

Since this document is a 510(k) summary for a physical medical device (Disposable High Pressure Injector Syringe) and not an AI/ML software device, the following points address what is available in the document and explicitly state where information relevant to AI/ML software performance studies is not applicable or provided.

2. Sample size used for the test set and the data provenance:
For Non-Clinical Testing: The document states "Performance testing" for various physical and biological characteristics. However, specific sample sizes for each test (e.g., number of syringes tested for pressure, number of samples for biocompatibility) are not provided. The data provenance is implied to be from the manufacturer (Wuxi Yushou Medical Appliances Co., Ltd) and "external laboratory testing," likely conducted in China given the manufacturer's location. The testing is for the physical device itself, not an AI algorithm.

For Clinical Testing: The document mentions "The clinical testing is used to evaluate the performance of the high pressure syringe and injectors" and lists evaluation points like Appearance, Sliding Performance, Sealing, and Fitting. However, no sample size, patient count, or study design details for this "clinical testing" are provided. It's unclear if this refers to actual human clinical trials or observational use. Given the context of a 510(k) for a basic device, it's highly likely to be limited usability testing rather than a full-scale clinical trial with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is for a physical medical device, not an AI algorithm requiring expert-established ground truth from medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is for a physical medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the physical device's performance, the "ground truth" is established through engineering and biological standards (e.g., pressure ratings, ISO 10993 for biocompatibility, ASTM D4169 for transportation). For the "clinical testing" aspects (Appearance, Sliding, Sealing, Fitting), the ground truth would be based on functional performance and visual inspection criteria, implicitly determined by the manufacturer's quality control and comparison to predicate devices, rather than medical ground truth.

8. The sample size for the training set:
Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI device that requires a training set or its associated ground truth establishment.

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 (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,

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: +86-510-83771274 Fax: +86-510-83772037

Dated: May 4, 2016

Contact Name: . Mr. Jun Peng P&L SCIENTIFIC INC. 6840 SW 45TH LN UNIT 5 MIAMI, FL 33155 Phone: 305-609-4701 Fax: 305-397-0289 Email: jpeng@plscientificinc.com
1. 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 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	MaximumRatedPressure
10060A/10060A	2-65ml Syringe1-255cm Multi-way ConnectingTube2-Punctured Medicine Aspirator	MEDRAD SOLARIS&SPECTRIS MRI	300psi
10060C/10060C	2-60ml Syringe1-255cm Multi-way ConnectingTube2-Punctured Medicine Aspirator	Liebel-Flarsheim OptistarMRI	300psi
100100C/10060A	1-115ml Syringe1-65ml Syringe1-255cm Multi-way ConnectingTube2-Punctured Medicine Aspirator	MEDRAD SOLARIS&SPECTRIS MRI	300psi
100100C/100100C	2-115ml Syringe1-255cm Multi-way ConnectingTube2-Punctured Medicine Aspirator	MEDRAD SOLARIS&SPECTRIS MRI	300psi
100100A	1-100ml Syringe	MEDRAD MCT PLUS CT	300psi
	1-150cmOne-way ConnectingTube1-J-type Tubular MedicineAspirator	MEDRAD VISTRON CTMEDRAD ENVISION CT
100100B	1-100ml Syringe1-150cm One-way ConnectingTube1-J-type Tubular MedicineAspirator	MEDRAD MCT PLUS CTMEDRAD VISTRON CTMEDRAD ENVISION CT	300psi
100100D	1-100ml Syringe1-J-type Tubular MedicineAspirator	Liebel-Flarsheim 3000 SeriesDSA	1200psi
100130A	1-130ml Syringe1-J-type Tubular MedicineAspirator	MEDRAD MARK IV &MARK III DSA	1200psi
100150A	1-150ml Syringe1-J-type Tubular MedicineAspirator	MEDRAD MARK V DSAMEDRAD MARK V ProvisDSA	1200psi
100150C	1-150ml Syringe1-J-type Tubular MedicineAspirator	MEDRAD MARK 7 DSA	1200psi
100200A	1-200ml Syringe1-150cm One-way ConnectingTube1-J-type Tubular MedicineAspirator	MEDRAD MCT PLUS CTMEDRAD VISTRON CTMEDRAD ENVISION CT	300psi
100200B	1-200ml Syringe1-150cm One-way ConnectingTube1-10cm Straight Tube1-J-type Tubular MedicineAspirator	MEDRAD STELLANT SingleCT	300psi
100200B/100200B	2-200ml Syringe1-J-type Tubular MedicineAspirator1-150cm Multi-way ConnectingTube2-10cm Straight Tube2-Punctured Medicine Aspirator	MEDRAD STELLANTDouble CT	300psi
100200D	1-200ml Syringe1-J-type Tubular MedicineAspirator	MEDRAD MARK V DSAMEDRAD MARK V ProvisDSA	1200psi
101100A/101100A	2-100ml Syringe1-255cm Multi-way ConnectingTube2-Punctured Medicine Aspirator	ACIST-MREZEM INC-CT	300psi
101200A	1-200ml Syringe1-150cm One-way ConnectingTube1-J-type Tubular Medicine	ACIST-CTEZEM INC-CT	300psi
	Aspirator
101200A/101200A	2-200ml Syringe1-255cmMulti-way ConnectingTube2-Punctured Medicine Aspirator	ACIST-CTEZEM INC-CT	300psi
	200150A	1-150ml Syringe1-J-type Tubular MedicineAspirator	Liebel-Flarsheim AngionmatIllumena DSA	1200psi
		200150B	1-150ml Syringe1-J-type Tubular MedicineAspirator	Liebel-Flarsheim Angionmat6000 DSA	1200psi
			200200A	1-200ml Syringe1-150cm One-way ConnectingTube1-J-type Tubular MedicineAspirator	Liebel-Flarsheim CT9000Single
200200A/200200A	2-200ml Syringe1-150cm Multi-way ConnectingTube1-J-type Tubular MedicineAspirator1-Punctured Medicine Aspirator			Liebel-Flarsheim CT9000Double	300psi
	300130A	1-130ml Syringe1-J-type Tubular MedicineAspirator		NEMOTO 120S DSA	1200psi
		300100B	1-100ml Syringe1-150cm One-way ConnectingTube1-J-type Tubular MedicineAspirator	NEMOTO A-25, A-60, Dual Shot CT	300psi
			300100B/300100B	2-100ml Syringe1-150cm Multi-way ConnectingTube1-J-type Tubular MedicineAspirator1-Punctured Medicine Aspirator	NEMOTO A-25, A-60, Dual Shot CT
300200B	1-200ml Syringe1-150cm One-way ConnectingTube1-J-type Tubular MedicineAspirator			NEMOTO A-25, A-60, Dual Shot CT	300psi
	300200B/100060B	1-200ml Syringe1-60ml Syringe1-150cm Multi-way ConnectingTube1-J-type Tubular MedicineAspirator1-Punctured Medicine Aspirator		NEMOTO Dual Shot, Dual Shot Alpha CT	300psi
		300200B/300100B		1-200ml Syringe1-100ml Syringe	NEMOTO Dual Shot, Dual Shot Alpha CT
		1-150cm Multi-way ConnectingTube1-J-type Tubular MedicineAspirator1-Punctured Medicine Aspirator		300psi
		2-200ml Syringe
	300200B/300200B	1-150cm Multi-way ConnectingTube1-J-type Tubular MedicineAspirator1-Punctured Medicine Aspirator	NEMOTO Dual Shot, DualShot Alpha CT
		2-60ml Syringe
		1-255cmMulti-way ConnectingTube2-Punctured Medicine Aspirator	NEMOTO Sonic Shot 50 MRI
100060B/100060B

Models and combinations

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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:

Maximum Rated Pressure Testing

1. Connection Strength Test
1. Compatibility Testing between the Injector and Syringes
1. Aged Verification
1. 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
1. 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
1. Sliding Performance
1. Sealing
1. 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.

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.