The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The syringe consists of barrel, plunger, piston, and the needle consists of needle tube, needle hub, needle cap. The proposed devices shall be operated manually, are not intended for use with syringe pumps. All specifications of proposed devices subject to the same design and the difference between each specification is syringe volume and needle size. The proposed devices are available in a variety combination of needle size and syringe volume.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a "Sterile Single-use Syringe with Needle." This document outlines the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to a predicate device.

Crucially, this document is for a medical device (syringe with needle), not an AI/ML software device. Therefore, the concepts of acceptance criteria for AI model performance, test/training sets for algorithms, ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable to this submission.

The "acceptance criteria" discussed in this document refer to adherence to established international and national standards for physical, mechanical, chemical, and biological properties of syringes, needles, and packaging. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing and biocompatibility assessments conducted according to these standards.

Here's an interpretation of the information provided within the context of a medical device submission, recognizing it does not fit the AI/ML framework:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are defined by various clauses within a range of ISO and ASTM standards. The reported device performance is that the "non-clinical tests were conducted to verify that the proposed devices met all design specifications and are Substantially Equivalent (SE) to the predicate device." The document implies that the device passed these tests, thereby meeting the acceptance criteria set by these standards.

Acceptance Criteria (Standard Clause)	Reported Device Performance
ISO 9626:1991/AMD-1:2001 (Needle)
Clause 3: Materials	Tests performed, device met design specifications.
Clause 4: Surface finish	Tests performed, device met design specifications.
Clause 5: Cleanliness	Tests performed, device met design specifications.
Clause 6: Limits for acidity and alkalinity	Tests performed, device met design specifications.
Clause 7: Size designation	Tests performed, device met design specifications.
Clause 8: Dimensions	Tests performed, device met design specifications.
Clause 9: Stiffness	Tests performed, device met design specifications.
Clause 10: Resistance to breakage	Tests performed, device met design specifications.
Clause 11: Resistance to corrosion	Tests performed, device met design specifications.
ISO 7864:1993 (Needle)
Clause 4: Cleanliness	Tests performed, device met design specifications.
Clause 5: Limits for acidity or alkalinity	Tests performed, device met design specifications.
Clause 6: Limits for extractable metals	Tests performed, device met design specifications.
Clause 7: Size designation	Tests performed, device met design specifications.
Clause 8: Colour coding	Tests performed, device met design specifications (hub color complies with ISO 6009).
Clause 9: Needle hub	Tests performed, device met design specifications.
Clause 10: Sheath	Tests performed, device met design specifications.
Clause 11: Needle tube	Tests performed, device met design specifications.
Clause 12: Needle point	Tests performed, device met design specifications.
Clause 13: Performance	Tests performed, device met design specifications.
ISO 7886:1993 (Syringe)
Clause 5: Cleanliness	Tests performed, device met design specifications.
Clause 6: Limits for acidity or alkalinity	Tests performed, device met design specifications.
Clause 7: Limits for extractable metals	Tests performed, device met design specifications.
Clause 8: Lubricant	Tests performed, device met design specifications.
Clause 9: Tolerance on graduated capacity	Tests performed, device met design specifications.
Clause 10: Graduated scale	Tests performed, device met design specifications.
Clause 11: Barrel	Tests performed, device met design specifications.
Clause 12: Piston/plunger assembly	Tests performed, device met design specifications.
Clause 13: Nozzle	Tests performed, device met design specifications.
Clause 14: Performance	Tests performed, device met design specifications.
ISO 594-1:1986 (Conical Fittings)
Clause 3: Dimension	Tests performed, device met design specifications.
Clause 4.1: Gauging	Tests performed, device met design specifications.
Clause 4.2: Liquid leakage	Tests performed, device met design specifications.
Clause 4.3: Air leakage	Tests performed, device met design specifications.
Clause 4.4: Separation force	Tests performed, device met design specifications.
Clause 4.5: Stress cracking	Tests performed, device met design specifications.
ISO 594-2:1998 (Luer-Lock Fittings)
Clause 4.1: Gauging	Tests performed, device met design specifications.
Clause 4.2: Leakage	Tests performed, device met design specifications.
Clause 4.3: Separation force	Tests performed, device met design specifications.
Clause 4.4: Unscrewing torque	Tests performed, device met design specifications.
Clause 4.5: Ease of assembly	Tests performed, device met design specifications.
Clause 4.6: Resistance to overriding	Tests performed, device met design specifications.
Clause 4.7: Stress cracking	Tests performed, device met design specifications.
Sterile Barrier Packaging Testing
ASTM F88/F88-09: Seal strength	Tests performed, device met design specifications.
ASTM F1140/F1140M-13: Internal pressure	Tests performed, device met design specifications.
Sterilization and Shelf Life Testing
ISO 10993-7:2008: EO residue	Tests performed, device met design specifications.
ISO 10993-7:2008: ECH residue	Tests performed, device met design specifications.
USP 36-NF 31<85>: Bacteria Endotoxin Limit	Tests performed, device met design specifications.
Shelf Life Evaluation (Physical, Mechanical, Chemical, Package, Sterility)	Tests performed on real-time aging samples to verify claimed shelf life.
Biocompatibility Testing (ISO 10993-1)
Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Hemolysis, Pyrogen	Tests performed, device met design specifications.

Since this document is not about an AI/ML device, the remaining points are addressed as "Not Applicable" for AI/ML concepts, or reinterpreted in the context of a traditional medical device submission if relevant.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set: The document does not specify exact sample sizes for each physical, mechanical, chemical, sterility, or biocompatibility test. It indicates "tests were performed on real time aging samples" for shelf life, implying prospective testing for that aspect. Other tests are generally conducted on representative samples of the manufactured device.
Data Provenance: The manufacturing company is JiangXi HongDa Medical Equipment Group Ltd. in China. The testing was likely performed in China, but the document does not explicitly state the country of origin for the testing data. The testing is performed on the proposed device itself, not on human data.
Retrospective/Prospective: Shelf-life testing is prospective (real-time aging). Other tests are typically performed on newly manufactured devices, which could be considered prospective testing for that specific batch.

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 (for AI/ML ground truth): Ground truth in this context refers to the verifiable performance of the physical device against established engineering and biological standards. There are no "experts" establishing ground truth in the AI/ML sense (e.g., clinicians labeling images). The standards themselves define the ground truth, and the testing methodology is designed to objectively measure compliance. The "experts" would be the engineers and technicians performing the tests, qualified in areas of materials science, mechanical testing, chemistry, microbiology, and biocompatibility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable (for AI/ML adjudication): This concept does not apply to the physical testing of a syringe and needle. Test results are objectively measured against defined limits in the standards.

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 a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Ground Truth (for physical device): The "ground truth" for this device is its adherence to the predefined physical, mechanical, chemical, sterility, and biocompatibility specifications as outlined in the referenced ISO and ASTM standards. This is determined by quantitative measurements and qualitative assessments described in these standards, rather than expert consensus on a diagnostic outcome or pathology.

8. The sample size for the training set

Not Applicable: This is a physical medical device, not an AI/ML algorithm. There is no "training set."

9. How the ground truth for the training set was established

Not Applicable: This is a physical medical device. There is no "training set" or ground truth established for training.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines connecting them.

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

March 20, 2017

JiangXi HongDa Medical Equipment Group Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 CHINA

Re: K163161

Trade/Device Name: Sterile Single-use Syringe with Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: February 14, 2017 Received: February 15, 2017

Dear Ms. Diana Hong:

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. Isting 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.

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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 device-related 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.

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" (21CFR 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,

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163161

Device Name

Sterile Single-use Syringe with Needle

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

Sterile Single-use Syringe with Needle is intent fluids into or withdraw fluids from the body.

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 Druq 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."

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K163161

1. Date of Preparation: 3/15/2017
1. Sponsor Identification

JiangXi HongDa Medical Equipment Group Ltd.

No. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, 331700, China

Establishment Registration Number: Not yet registered

Contact Person: Yang Xiaohua Position: Vice-general Manager Tel: +86-791-85628918 Fax: +86-791-85628881 Email: yxh2821006@126.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Sterile Single-use Syringe with Needle Common Name: Piston Syringe with Needle

Regulatory Information

Classification Name: Piston Syringe Classification: II Product Code: FMF Subsequent Product Code: FMI Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital

5. Identification of Predicate Device

510(k) Number: K072739 Product Name: Sterile Hypodermic Syringe for single use, with/without needle

Indications for Use; Sterile Single-use Syringe with Needle is intended to inject fluids into or withdraw fluids from the body.

Device Description

Syringe Size	Needle Gauge	Needle Length
Available in 1ml, 3ml, 5ml, 10ml, 20ml, 60ml	Available in 18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G, 28G, 29G, 30G	Available in 1/2", 5/8", 1", 1 1/4", 1 1/2"

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed devices met all design specifications and are Substantially Equivalent (SE) to the predicate device. The non-clinical tests conducted on the

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proposed devices include:

Physical, Mechanical and Chemical Tests performed on the proposed device

Materials	Clause 3 of ISO 9626:1991/AMD-1:2001
Surface finish	Clause 4 of ISO 9626:1991/AMD-1:2001
Cleanliness	Clause 5 of ISO 9626:1991/AMD-1:2001
Limits for acidity and alkalinity	Clause 6 of ISO 9626:1991/AMD-1:2001
Size designation	Clause 7 of ISO 9626:1991/AMD-1:2001
Dimensions	Clause 8 of ISO 9626:1991/AMD-1:2001
Stiffness	Clause 9 of ISO 9626:1991/AMD-1:2001
Resistance to breakage	Clause 10 of ISO 9626:1991/AMD-1:2001
Resistance to corrosion	Clause 11 of ISO 9626:1991/AMD-1:2001

Cleanliness	Clause 4 of ISO 7864:1993
Limits for acidity or alkalinity	Clause 5 of ISO 7864:1993
Limits for extractable metals	Clause 6 of ISO 7864:1993
Size designation	Clause 7 of ISO 7864:1993
Colour coding	Clause 8 of ISO 7864:1993
Needle hub	Clause 9 of ISO 7864:1993
Sheath	Clause 10 of ISO 7864:1993
Needle tube	Clause 11 of ISO 7864:1993
Needle point	Clause 12 of ISO 7864:1993
Performance	Clause 13 of ISO 7864:1993

Cleanliness	Clause 5 of ISO 7886:1993
Limits for acidity or alkalinity	Clause 6 of ISO 7886:1993
Limits for extractable metals	Clause 7 of ISO 7886:1993
Lubricant	Clause 8 of ISO 7886:1993
Tolerance on graduated capacity	Clause 9 of ISO 7886:1993
Graduated scale	Clause 10 of ISO 7886:1993
Barrel	Clause 11 of ISO 7886:1993
Piston/plunger assembly	Clause 12 of ISO 7886:1993
Nozzle	Clause 13 of ISO 7886:1993
Performance	Clause 14 of ISO 7886:1993

Dimension	Clause 3 of ISO 594-1:1986
Gauging	Clause 4.1 of ISO 594-1:1986
Liquid leakage	Clause 4.2 of ISO 594-1:1986
Air leakage	Clause 4.3 of ISO 594-1:1986

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Separation force	Clause 4.4 of ISO 594-1:1986
Stress cracking	Clause 4.5 of ISO 594-1:1986
Gauging	Clause 4.1 of ISO 594-2:1998
Leakage	Clause 4.2 of ISO 594-2:1998
Separation force	Clause 4.3 of ISO 594-2:1998
Unscrewing torque	Clause 4.4 of ISO 594-2:1998
Ease of assembly	Clause 4.5 of ISO 594-2:1998
Resistance to overriding	Clause 4.6 of ISO 594-2:1998
Stress cracking	Clause 4.7 of ISO 594-2:1998

Sterile Barrier Packaging Testing performed on the proposed device:

Seal strength	ASTM F88/F88-09
Internal pressure	ASTM F1140/F1140M-13

Sterilization and Shelf Life Testing performed on the proposed device:

EO residue	ISO 10993-7:2008
ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP 36-NF 31<85>
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package and SterilityTests were performed on real time aging samples toverify the claimed shelf life of the device

The hub is made of pigmented material and the hub color for different needle gauge comply with ISO 6009.

Biocompatibility Testing

The patient-contact materials of Sterile Hypodermic Safety Syringes for Single Use are identified and biocompatibility testing was performed according to ISO 10993-1 standards.

7. Clinical Test Conclusion

No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device
Product Code	FMF	Same
Regulation Number	21 CFR 880.5860	Same
Class	II	Same
Indications for Use	Sterile Single-use Syringe with Needle is intendedto inject fluids into or withdraw fluids from thebody.	Similar
Configuration andmaterial	Barrel	Same
	Plunger
	Piston
	Needle tube
	Needle hub
	Needle cap
Operation Mode	For manual use only	Same
Syringe Volume	1ml, 3ml, 5ml, 10ml, 20ml, 60ml	Similar
Connector Type	Luer Slip and Luer Lock	Same
Needle Gauge andlength	Gauge: 18G, 20G, 21G, 22G, 23G, 25G, 26G, 27G,28G, 29G, 30GLength: 1/2", 5/8", 1", 1 1/4", 1 1/2"	Similar
Biocompatibility	Cytotoxicity	Same
	Irritation
	Sensitization
	Systemic Toxicity
	Hemolysis
	Pyrogen
Sterilization	EO Sterilization	Same
SAL	10-6	Same
Single Use	Yes	Same
Label/Labeling	Complied with 21 CFR part 801	Same

Table 1 Comparison of Technology Characteristics

The Sterile Single-use Syringe with Needle is similar to the predicate device in device design, Indications for use, materials, sterilization, method of operation and technological characteristics. The differences are in needle lengths/gauges and barrel sizes. The predicate device submission K072739 also includes insulin syringes and safety syringes but the subject device is claiming substantial equivalence to the predicates standard syringe. Through performance testing comparison the subject

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device and predicate device have demonstrated substantial equivalence.

1. Substantially Equivalent (SE) Conclusion
  Based on the bench performance testing, comparison and analysis, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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).