The proposed device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the action of gravity. The proposed device is provided with/without injection needle. It is comprised of protective cap of spike, air vent, air filter, drip chamber, fluid filter, flexible tube, injection site, roller clamp, luer lock connector, protector cap of luer lock connector. The devices are provided sterile and single use.

AI/ML Overview

The provided text is a 510(k) summary for a Sterile Single-use Infusion Set. It describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study of AI performance. Therefore, many of the requested categories regarding AI-specific studies (e.g., sample size for test set, number of experts, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the non-clinical test conclusions.

Acceptance Criteria and Device Performance for Sterile Single-use Infusion Set

Acceptance Criteria	Reported Device Performance
Infusion Set Performance
Particulate contamination	Contamination index limit is less than 90 (Comply with ISO 8536-4)
Leakage	No leakage
Tensile strength	Withstand a static tensile force of not less than 15N for 15s
Closure piercing device	Comply the dimension of ISO 8536
Air-inlet device	Flow of fluid is reduced less than 20% of that from a freely ventilated container
Tubing	Length is not less than 1500mm
Fluid filter	Retention of latex particles is not less than 80%
Drip chamber and drip tube	20 drops of distilled water delivered by the drip are equivalence to a volume of (1±0.1)ml(1±0.1)g
Flow rate	Deliver not less than 1000ml
Injection site	No leakage
Construction	The clamps can resist the flow of fluid and air at an applied pressure of 50 kPa when closed.
Needle Performance
Cleanliness	Free from particles and extraneous matter (Comply with ISO 7864 and ISO 9626)
Needle length	38mm (Specific to the proposed device; predicate "Unknown")
Bond of hub and needle tube	Not broken by the minimum force
Stiffness	Deflection is less than 0.50mm
Dimensions of needle tubing	0.8mm (Specific to the proposed device; predicate "Unknown")
Resistance to breakage	The tubing is not break
Resistance to corrosion	No evidence of corrosion
Biocompatibility
Cytotoxicity	No Cytotoxicity (Conform with ISO 10993 requirements)
Intracutaneous Reactivity	No Intracutaneous Reactivity (Conform with ISO 10993 requirements)
Skin Sensitization	No Skin Sensitization (Conform with ISO 10993 requirements)
Acute Systemic Toxicity	No Acute Systemic Toxicity (Conform with ISO 10993 requirements)
Hemolysis	No Hemolysis (Conform with ISO 10993 requirements)
Pyrogen	No pyrogen (Conform with ISO 10993 requirements)
Sterile Barrier Packaging Testing
Seal strength, Internal pressure, Dye Penetration	Tested as per ASTM F88/F88-09, ASTM F1140/F1140M-13, ASTM F 1929-12 respectively. (Implicitly met based on SE conclusion)
Sterilization and Shelf Life Testing
EO residue, ECH residue	Tested as per ISO 10993-7:2008 (Implicitly met based on SE conclusion)
Bacteria Endotoxin Limit	Tested as per USP 36-NF 31 <85> (Implicitly met based on SE conclusion)
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package and Sterility Tests performed on accelerated aging samples to verify the claimed shelf life of the device. (Implicitly met based on SE conclusion)
Transportation Testing	Performed on the final product to verify its package integrity during transportation. (Implicitly met based on SE conclusion)

Here's an analysis of the study based on your requested items:

A table of acceptance criteria and the reported device performance
- See table above. The performance is reported as meeting the specified standards (e.g., ISO, ASTM, USP) or specific numerical/qualitative criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for individual non-clinical tests.
- The tests were conducted by a Chinese manufacturer (Jiangxi Hongda Medical Equipment Group, Ltd. in Nanchang City, Jiangxi Province, China). The data provenance is China.
- These are prospective tests conducted on the manufactured device to demonstrate compliance with standards.
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)
- This document describes non-clinical engineering and biological tests, not an AI or diagnostic study involving human expert interpretation for ground truth. Therefore, this question is not applicable. The "ground truth" for these tests is defined by the technical specifications of international and national standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this is not a study involving human adjudication of results for a diagnostic or AI algorithm.
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 MRMC or AI-related study was done. This is a 510(k) submission for a physical medical device (infusion set), not an AI algorithm. Therefore, this question is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone AI algorithm performance study was done. This is not an AI device. Therefore, this question is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on established international and national standards (e.g., ISO 8536-4, ISO 9626, ISO 7864, ISO 594-1, ISO 594-2, ASTM F88, ASTM F1140, ASTM F1929, ISO 10993-7, USP 36-NF 31). These standards define the acceptable performance limits and methodologies for testing.
The sample size for the training set
- Not applicable. This is not an AI device or a machine learning study.
How the ground truth for the training set was established
- Not applicable. This is not an AI device or a machine learning study.

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 eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

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

April 20, 2017

Jiangxi Hongda Medical Equipment Group, Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K163160

Trade/Device Name: Sterile Single-use Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 10, 2017 Received: March 21, 2017

Dear 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, 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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)

K163160

Device Name

Sterile Single-use Infusion Set

Indications for Use (Describe)

The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Exhibit #2 510(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: K163160

1. Date of Preparation: 04/17/2017
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: Xiaohua Yang 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) Ms. Ying Xu (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 Infusion Set Common Name: Disposable Infusion Set

Regulatory Information

Classification Name: Set, Administration, Intravascular; Classification: II; Product Code: FPA; Regulation Number: 21CFR 880.5440 Review Panel: General Hospital;

Indication for Use:

The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.

Device Description

న్. Identification of Predicate Device

Premark Notification 510(k) Number: K112204 Trade Name: KDL Disposable Infusion Set Classification Name: Set, Administration, Intravascular Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test provided in this submission include:

Physical, Mechanical and Chemical Tests performed on the proposed device

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Particulate contamination Leakage Tensile strength Closure-piercing device Air-inlet device Tubing Fluid filter Drip chamber and drip tube Flow regulator Flow rate of infusion fluid Injection site Male conical fitting Protective caps Reducing (oxidizable) matter Metal ions Titration acidity or alkalinity Residue on evaporation UV absorption of extract solution

Materials Tubing specifications Operating temperature Construction Flow rate

Materials Surface finish Cleanliness Limits for acidity and alkalinity Size designation Dimensions Stiffness Resistance to breakage Resistance to corrosion

Cleanliness Limits for acidity or alkalinity Limits for extractable metals

Clause 6.1 of ISO 8536-4:2010 AMD1 2013 Clause 6.2 of ISO 8536-4:2010 AMD1 2013 Clause 6.3 of ISO 8536-4:2010 AMD1 2013 Clause 6.4 of ISO 8536-4:2010 AMD1 2013 Clause 6.5 of ISO 8536-4:2010 AMD1 2013 Clause 6.6 of ISO 8536-4:2010 AMD1 2013 Clause 6.7 of ISO 8536-4:2010 AMD1 2013 Clause 6.8 of ISO 8536-4:2010 AMD1 2013 Clause 6.9 of ISO 8536-4:2010 AMD1 2013 Clause 6.10 of ISO 8536-4:2010 AMD1 2013 Clause 6.11 of ISO 8536-4:2010 AMD1 2013 Clause 6.12 of ISO 8536-4:2010 AMD1 2013 Clause 6.13 of ISO 8536-4:2010 AMD1 2013 Clause 7.1 of ISO 8536-4:2010 AMD1 2013 Clause 7.2 of ISO 8536-4:2010 AMD1 2013 Clause 7.3 of ISO 8536-4:2010 AMD1 2013 Clause 7.4 of ISO 8536-4:2010 AMD1 2013 Clause 7.5 of ISO 8536-4:2010 AMD1 2013

Clause 5 of ISO 8536-14:2016 Clause 6.1 of ISO 8536-14:2016 Clause 6.2 of ISO 8536-14:2016 Clause 6.3 of ISO 8536-14:2016 Clause 6.4 of ISO 8536-14:2016

Clause 3 of ISO 9626:1991/AMD-1:2001 Clause 4 of ISO 9626:1991/AMD-1:2001 Clause 5 of ISO 9626:1991/AMD-1:2001 Clause 6 of ISO 9626:1991/AMD-1:2001 Clause 7 of ISO 9626:1991/AMD-1:2001 Clause 8 of ISO 9626:1991/AMD-1:2001 Clause 9 of ISO 9626:1991/AMD-1:2001 Clause 10 of ISO 9626:1991/AMD-1:2001 Clause 11 of ISO 9626:1991/AMD-1:2001

Clause 4 of ISO 7864:1993 Clause 5 of ISO 7864:1993 Clause 6 of ISO 7864:1993

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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

Gauge	Clause 4.1 of ISO 594-1:1986
Liquid leakage	Clause 4.2.1 of ISO 594-2:1998
Air leakage	Clause 4.2.2 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
Dye Penetration	ASTM F 1929-12

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 accelerated aging samples toverify the claimed shelf life of the device

Biocompatibility Testing:

The patient-contact materials of blood collection sets are identified and biocompatibility testing is performed according to ISO 10993 standards.

Transportation Testing

Transportation test is performed on the final product to verify its package integrity during transportation.

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1. 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
			K112204
Product Code	FPA		Same
Regulation Number	21 CFR 880.5440		Same
Indication for Use	The device is intended to administer fluids from a container to a		KDL Disposable Infusion Set is intended to administer
	patient's vascular system through a needle or catheter inserted		fluids from a container to a patient's vascular system
	into the vein.		through a needle or catheter inserted into the vein.
Configuration and material	Configuration	Material	Configuration	Material
	Protector Cap of Spike	HDPE	Protective Cap of Closure-piercing Device
	Spike	ABS	Closure-piercing Device
	Air Vent	PVC	Air Filter
	Drip Chamber	PVC	Drip Chamber
	Fluid Filter	ABS	Fluid Filter
	Flexible Tube	PVC	Flexible Tube
	Roller Clamp	HDPE	Roller Clamp	Unknown
	Latex Tube	Polyisoprene	Check Valve
	Y Injection Site	ABS	Y Injection Set
	Luer Lock Connector	ABS	Clamp
	Protector Cap of Luer Lock Connector	HDPE	Injection Site
	Needle Hub	PP	Luer Lock Connector
	Needle Tube	Stainless Steel	Infusion Needle
Tubing Diameter	3.9mm		Unknown
Filter Characteristics	15um		15um

Table 1 Comparison of Technology Characteristics

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Needle Gauge	21G	Unknown
Sterile	EO sterilized10-6	Same
Single Use	Single Use	Same
Infusion Set Performance
Particulate contamination	Contamination index limit is less than 90	Comply with ISO 8536-4
Leakage	No leakage
Tensile strength	Withstand a static tensile force of not less than 15N for 15s
Closure piercing device	Comply the dimension of ISO 8536
Air-inlet device	Flow of fluid is reduced less than 20% of that from a freelyventilated container
Tubing	Length is not less than 1500mm
Fluid filter	Retention of latex particles is not less than 80%
Drip chamber and drip tube	20 drops of distilled water delivered by the drip are equivalenceto a volume of (1±0.1)ml(1±0.1)g
Flow rate	Deliver not less than 1000ml
Injection site	No leakage
Construction	The clamps can resist the flow of fluid and air at an appliedpressure of 50 kPa when closed.
Needle Performance
Cleanliness	Free from particles and extraneous matter	Comply with ISO 7864 and ISO 9626
Needle length	38mm
Bond of hub and needle tube	Not broken by the minimum force
Stiffness	Deflection is less than 0.50mm
Dimensions of needle tubing	0.8mm
Resistance to breakage	The tubing is not break
Resistance to corrosion	No evidence of corrosion
Biocompatibility
Cytotoxicity	No Cytotoxicity
Intracutaneous Reactivity	No Intracutaneous Reactivity
Skin Sensitization	No Skin Sensitization	Conform with ISO 10993 requirements
Acute Systemic Toxicity	No Acute Systemic Toxicity
Hemolysis	No Hemolysis
Pyrogen	No pyrogen

S001

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Substantially Equivalent (SE) Conclusion 9.

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

S001

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.