The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.

The SHANCHUAN Insulin Syringe is design for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange.

The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.

Device Description

The SHANCHUAN Piston Syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a nozzle for fitting the hub of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

The Hypodermic Single Lumen Needle is a device intended to inject below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a hub designed syringe or an intravascular administration set.

The Insulin Syringe is a piston syringe, typically sterile, single-use with a needle, used for subcutaneous injection of insulin.

AI/ML Overview

The provided text describes a 510(k) submission for the SHANCHUAN Syringe, claiming substantial equivalence to predicate devices (Terumo Disposable Hypodermic Syringe and BD Insulin Syringe). It is primarily a comparison against existing devices, rather than a study with specific acceptance criteria and detailed performance metrics to "prove" the device meets them as would be seen in a clinical trial for a novel AI device.

Therefore, many of the requested categories for a study proving acceptance criteria are not directly applicable or are not explicitly stated in this type of regulatory submission for a medical device like a syringe. The submission focuses on demonstrating that the new device is as safe and effective as previously cleared devices.

Here's an attempt to populate the table and answer the questions based on the provided text, highlighting where information is not available:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from text)	Reported Device Performance (from text)
Piston Syringe
1. Intended Uses	Intended to be used for injecting fluids or withdrawing fluids from the body.	SHANCHUAN Piston Syringe is intended to be used for injecting fluids or withdrawing fluids from the body (substantially equivalent to predicate).
2. Labeling	Includes identity (type, size, needle gauge/length) and quantity; prescription statement according to 801.109(b)(1) (except insulin syringes).	SHANCHUAN Piston Syringe labeling includes identity (type, size, needle gauge/length) and quantity; prescription statement according to 801.109(b)(1) (substantially equivalent to predicate).
3. Design and Materials	Comprised of barrel, plunger, gasket, needle. Materials are medical polypropylene (barrel, plunger, hub), rubber (gasket - no emulsion/natural rubber), X2C,N;18-9 stainless steel (needle), medical silicon oil (lubricant).	SHANCHUAN Piston Syringe design (barrel, plunger, gasket, needle) and materials (medical polypropylene, rubber gasket, stainless steel needle, medical silicon oil lubricant) are basically the same as the predicate (substantially equivalent).
4. Specifications	Physical specifications are basically the same, mechanical and biological according to the same international standard.	SHANCHUAN Piston Syringe physical specifications are basically the same as the predicate (difference in syringe sizes and needle length noted, but not raising new safety/effectiveness issues). Mechanical and Biological specifications are according to the same international standard (substantially equivalent).
5. Performance (Bench)	Performs equivalently to predicate devices and is effective when used as intended.	The bench test results demonstrate that the SHANCHUAN Piston Syringe performs equivalent to the predicate devices and is effective when used as intended.
6. Performance (Clinical)	Has been used in clinic for many years, ensuring effectiveness. (This is a statement about the predicate, implying the new device is equivalent).	"Both of them have been used in clinic for many years, which ensure the effectiveness of the SHANCHUAN Piston Syringe." (This refers to predicate devices, and by substantial equivalence, implies the SHANCHUAN Piston Syringe meets this criterion through its equivalence to existing clinically used devices).
Insulin Syringe
1. Intended Uses	Intended for the subcutaneous injection of insulin.	SHANCHUAN Insulin Syringe is intended for the subcutaneous injection of insulin (substantially equivalent to predicate).
2. Labeling	Includes identity (type, needle gauge/length) and quantity; "For use with U-100 insulin only" and graduations printed on barrel according to 801.403.	SHANCHUAN Insulin Syringe labeling includes identity (type, needle gauge/length) and quantity; includes "For use with U-100 insulin only" and graduations printed on barrel (substantially equivalent to predicate).
3. Design and Materials	Comprised of barrel, plunger, gasket, needle. Materials are basically the same as predicate (difference noted in gasket and lubricant).	SHANCHUAN Insulin Syringe design (barrel, plunger, gasket, needle) and materials are basically the same as the predicate (difference in gasket and lubricant noted, but not raising new safety/effectiveness issues).
4. Specifications	Physical specifications are basically the same, mechanical and biological according to the same international standard.	SHANCHUAN Insulin Syringe physical specifications are basically the same as predicate (differences in syringe sizes, needle gauge sizes, and needle length noted, but not raising new safety/effectiveness issues). Mechanical and Biological specifications are according to the same international standard (substantially equivalent).
5. Performance (Bench)	Performs equivalently to predicate devices and is effective when used as intended.	The bench test results demonstrate that the SHANCHUAN Insulin Syringe performs equivalently to the predicate devices and is effective when used as intended.
6. Performance (Clinical)	Has been used in clinic for many years, ensuring safety and effectiveness. (This is a statement about the predicate, implying the new device is equivalent).	"Both of them have been used in clinic for many years, which ensure the safety and effectiveness of the SHANCHUAN Insulin Syringe." (This refers to predicate devices, and by substantial equivalence, implies the SHANCHUAN Insulin Syringe meets this criterion through its equivalence to existing clinically used devices).
General Safety & Effectiveness (both devices)	No new issues of safety or effectiveness should be raised by differences compared to predicate devices. The device should be sterile, non-toxic, non-pyrogen, and single use, disposable.	"Any noted differences between the two devices do not raise new issues of the safety and effectiveness." (Repeated for both piston and insulin syringes). "All the results demonstrate that the SHANCHUAN Piston Syringe performs equivalently to the predicate devices and is safe and effective when used as intended." (Similar statement for Insulin Syringe). The syringe fluid path is stated to be sterile, non-toxic, non-pyrogen, and single use, disposable.

Study Details for Acceptance Criteria

The provided text is a 510(k) Summary, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing a detailed report of a formal study with specific acceptance criteria and performance results in the context of, for example, an AI/imaging device. For a syringe, "performance" is assessed through bench testing and comparison to established device standards and predicate devices' proven clinical use.

Therefore, for most of the detailed questions regarding study design, sample sizes, ground truth, and expert involvement (which are typical for AI/diagnostic device studies), the information is not applicable or not provided in this type of submission.

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. The document refers to "bench test results" but does not specify sample sizes for these tests. Data provenance is not mentioned.
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/Not provided. For a mechanical device like a syringe, "ground truth" is typically established through adherence to engineering specifications and international standards, and comparison to predicate devices, rather than expert interpretation of a test set in the way it would be for a diagnostic AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None specified. This is a concept related to human-expert review of diagnostic outcomes, not applicable to the bench testing of a syringe.
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:
- No, not done. This type of study is specifically for diagnostic AI tools that assist human interpreters. A syringe is a mechanical medical device with no interpretation component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance. A syringe is a manually operated device. The "performance" is its physical characteristics and functionality.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a syringe, "ground truth" is likely defined by adherence to specified engineering standards (e.g., ISO standards) for physical dimensions, material properties, sterility, force required for plunger movement, leakage, etc. The document states: "Both of the Mechanical and Biological are according to the same international standard." It also heavily relies on comparison/equivalence to predicate devices that are already considered safe and effective, rather than a novel "ground truth" derived from clinical outcomes or expert consensus on new data.
The sample size for the training set:
- Not applicable/Not provided. "Training set" is a concept for machine learning or AI models. This device is a physical product, not an AI.
How the ground truth for the training set was established:
- Not applicable. As above, this is for AI models.

Summary

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510(K) Summary

Submitter Information:

Name and Address:

Shandong Zibo Shanchuan Medical Instrument Co.,Ltd. Jixiang Road, Zichuan, Zibo City, Shandong Province, China 255100

Contact Person:

Che Xianliang Director, Shandong Zibo Shanchuan Medical Instrument Co.,Ltd. Phone Number: 086-533-5750228 Fax Number: 086-533-5750273

Device Name:

Trade Name:	SHANCHUAN Syringe
Common Name:	Piston Syringe, Hypodermic Needle; Insulin Syringe
Classification Name:	Piston Syringe

FDA classification (class I, II, or III)

Piston syringe 21 C.F.R. 880.5680 Class II Hypodermic single lumen needle 21 C.F.R. 880.5570 Class II

Predicate device_

Terumo Disposable Hypodermic Syringe (K980181); BD Insulin Syringe (K941657).

Intended Use:

The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.

These devices operate on the principles of a piston syringe. The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.

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Principle of Operation and Technology:

Each Shanchuan Syringe is designed for manual use therefore it is operated manually.

Design and Materials:

The SHANCHUAN Piston Syringe is consisting of 4 parts: a barrel, a plunger, a gasket and a needle. Barrel, plunger and hub are made from medical polypropylene. The gasket is made from rubber (not include emulsion and natural rubber). The needle is made from X2C,N;18-9, is stainless steel. The lubricant on barrel and needlepoint is the medical silicon oil, made in Dow Corning Inter-America in USA. Please see Table of Material List

Description of Device_1

The Insulin Syringe is a piston syringe, typically sterile, single-use with a needle, used for subcutaneous injection of insulin.

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Substantial Equivalence Comparison I:

SHANCHUAN Piston Syringe is substantially equivalent to the predicate Terumo Disposable Hypodermic Syringe as follows:

l. Intended Uses: Both SHANCHUAN Piston Syringe and Terumo Disposable Hypodermic Syringe are intended to be used for injecting fluids of withdrawing fluids from the body.
1. Labeling: Both of their labeling for the piston syringe includes the identity of the device (type, size, needle gauge and length) and quantity, they also include the prescription statement according to 801.109(b) (1), except for insulin syringes.
1. Design and materials: The design of SHANCHUAN Piston Syringe and Terumo Disposable Hypodermic Syringe is basically the same. Both devices are comprised of a barrel, plunger, gasket and needle. The materials of them are basically the same. The gasket and lubricant.
Specifications: The physical specifications of SHANCHUAN SYRINGE and Terumo 4. Disposable Hypodermic Syringe are basically the same. The difference between them is syringe sizes and needle length. Both of the Mechanical and Biological are according to the same international standard.
Performance: 5.
- Bench: The bench test results demonstrate that the SHANCHUAN Piston Syringe a. performs equivalent to the predicate devices and is effective when used as intended.
- Clinic: Both of them have been used in clinic for many years, which ensure the b. effectiveness of the SHANCHUAN Piston Syringe.

Substantial Equivalence Summary:

In summary, the SHANCHUAN Piston Syringe is substantially equivalent in intended uses, labeling, design and materials, specifications and performance to the predicate Terumo Disposable Hypodermic Syringe (K980181). Any noted differences between the two devices do not raise new issues of the safety and effectiveness. All the results demonstrate that the SHANCHUAN Piston Syringe performs equivalently to the predicate devices and is safe and effective when used as intended.

Substantial Equivalence Comparison II:

SHANCHUAN Insulin Syringe substantially equivalent to the predicate BD Insulin Syringe as follows:

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Intended Uses: Both SHANCHUAN Insulin Syringe and BD Insulin Syringe are intended for 1. the subcutaneous injection of insulin.
Labeling: Both of their Labeling for the insulin syringe include the identity of the device (type, 2. needle gauge and length) and quantity. According to 801.403, 'For use with U-100 insulin only 'and graduations should be printed on the barrel of the insulin syringe, please refer to Annex B.
1. Design and materials: The design of SHANCHUAN Insulin Syringe and BD Insulin Syringe is basically the same. Both devices are comprised of a barrel, plunger, gasket and needle. The materials of them are basically the same. The difference is the gasket and lubricant.
Specifications: The physical specifications of SHANCHUAN Insulin Syringe and BD Insulin 4. Syringe are basically the same. The differences between them are syringe sizes, needle gauge sizes and needle length. Both of the Mechanical and Biological are according to the same international standard.
న్. Performance:
- Bench: The bench test results demonstrate that the SHANCHUAN Insulin Syringe a) performs equivalently to the predicate devices and effective when used as intended.
- Clinic: Both of them have been used in clinic for many years, which ensure the safety and b) effectiveness of the SHANCHUAN Insulin Syringe.

Substantial Equivalence Summary:

In summary, the SHANCHUAN Insulin Syringe is substantially equivalent in intended use, labeling, design and materials, specifications and performance to the predicate BD Insulin Syringe (K941657). Any noted differences between the two devices do not raise new issues of safety and effectiveness. All the results demonstrate that the SHANCHUAN Piston Syringe performs equivalent to the predicate devices and is safe and effective when used as intended.

Conclusion:

In summary, the Shanchuan Syringe is substantially equivalent in intended use, labeling, design, materials, specifications and performance to the predicate Terumo Disposable Hypodermic Syringe (K980181) and BD Insulin Syringe (K941657). Any noted differences between them do not raise new issues of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles embedded within the eagle's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

*Shangdong Zibo Shanchuan Medical Instruments Company C/O Ms. Hairone Che 12951 Briar Forest Drive, # 303 Houston, Texas 77077

Re: K021993

Trade/Device Name: Shanchuan Syringe Regulation Number: 880.5860, 880.5570 Regulation Name: Piston Syringe, Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMF, FMF, FMI Dated: March 24, 2003 Received: March 31, 2003

Dear Ms. Che:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Che

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Simon Runa

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number: K021993

Device Name:

Shanchuan Syringe

Indication for Use:

The SHANCHUAN Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.

The syringe fluid path is sterile, non-toxic, non-pyrogen and single use, disposable.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE),

Pattica Cucente

General Hosnital

510(k) Number: K021995

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).