The proposed devices are indicated for the gravity infusion of fluids from a container to a patient's vascular system through an IV catheter or infusion needle. . There are ten different models, each a different configuration comprised of various components which may include: protective cap, spike, air filter, drip chamber, precision filter, flexible tube, injection site, roller clamp, flow regulator, pinch clamp and luer lock connector. The devices are provided sterile and are single use.

AI/ML Overview

This document describes the regulatory submission for an "Infusion Set for Single Use" (K162601). As an intravascular administration set, this device is a Class II product.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Table of acceptance criteria and reported device performance:

The document explicitly states that "Non clinical tests were conducted to determine that the proposed device met all design specifications to claim Substantially Equivalence (SE) to the predicate device."

Acceptance Criteria (Standard/Test)	Reported Device Performance
ISO 8536-4:2010 AMD 1 2013	Complies
ISO 8536-12:2007 AMD 1 2012	Complies
ISO 594-1:1986	Complies
ISO 594-2:1998	Complies
ISO 10993-7:2008	Complies
ASTM F 88/F88M-09	Complies
USP38-NF33 <85>	Complies
ISO 10993-5:2009 (Cytotoxicity)	Complies / Conform with ISO 10993 requirements
ISO 10993-10:2010	Complies
ISO 10993-11:2006	Complies
ASTM F 756-13 (Hemolysis Test)	Complies / Conform with ISO 10993 requirements
ISO 10993-1:2009	Complies
USP 38-NF 33 <151> (Pyrogen Test)	Complies / Conform with ISO 10993 requirements
Microbial Ingress Testing	Complies
ASTM F838-15	Complies
Flow Regulator Performance	Complies
1.2 Micron Filter Test	Complies
Biocompatibility: Intracutaneous Reactivity	Conform with ISO 10993 requirements
Biocompatibility: Skin Sensitization	Conform with ISO 10993 requirements
Biocompatibility: Acute Systemic Toxicity	Conform with ISO 10993 requirements

Sample size used for the test set and the data provenance:

The document lists the standards and tests performed but does not specify the sample sizes used for each test or the provenance of the data. It only states that "Non clinical tests were conducted."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The tests seem to be primarily laboratory-based "non-clinical tests" against established standards, rather than expert-driven ground truth assessment in a clinical context.
Adjudication method for the test set:

This information is not provided as the assessment relies on compliance with established technical standards, not expert adjudication of clinical outcomes.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/not provided. The device is an infusion set, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was conducted.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable/not provided as the device is not an algorithm.
The type of ground truth used:

The "ground truth" for the device meeting acceptance criteria is based on compliance with international and national standards for medical devices (e.g., ISO, ASTM, USP) and internal specifications. For biocompatibility, general conformity with ISO 10993 requirements serves as the ground truth.
The sample size for the training set:

This information is not applicable/not provided. The device is a physical medical device (infusion set), not a machine learning model, so there is no "training set."
How the ground truth for the training set was established:

This information is not applicable/not provided as there is no training set for this type of device.

Summary

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

May 31, 2017

SHINVA ANDE Healthcare Apparatus Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai 200120 CHINA

Re: K162601

Trade/Device Name: Infusion Set for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: April 26, 2017 Received: April 28, 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. 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 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/Resourcesfor You/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,

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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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Change Control Table, Change History

Change Control Table

Version	Document Author	Document Approver	Date Approved
1.00	Name, Title, Office	Name, Title, Office	MM/DD/YYYY

Complete Change Control Table (all versions) retained in SWIFT Docs.

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Indications for Use

510(k) Number (if known) K162601

Device Name Infusion Set for Single Use

Indications for Use (Describe)

The device is indicated for the delivery of fluids from a container to a patient's vascular system.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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: K162601

Date of Preparation: 05/25/2017 1.
1. Sponsor Identification

SHINVA ANDE Healthcare Apparatus Co., Ltd.

No.77 Development Zone North Road, Zibo, Shandong, 255086 China

Contact Person: Xiaolei Tian Position: R&D Director Tel: +86-533-3917821 Fax: +86-533- 3918218 Email: tianxiaolei@andemed.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

1. Identification of Proposed Device
  Trade Name: Infusion Set for Single Use

Regulatory Information Regulation Name: Intravascular administration set Classification: II Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital

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Indications for Use:

The device is indicated for the delivery of fluids from a container to a patient's vascular system.

Device Description

1. Identification of Predicate Device
  510(k) Number: K121803 Product Name: Intravascular Administration Set 510k Holder: Acta Medical
1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to determine that the proposed device met all design specifications to claim Substantially Equivalence (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 8536-4:2010 AMD 1 2013 Infusion equipment for medical use, Part 4: Infusion sets for single use, gravity feed
ISO 8536-12:2007 AMD 1 2012 Infusion equipment for medical use- Part 12: Check valves.
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 1: General requirements
ISO 594-2:1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals:
ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
USP38-NF33 <85> Bacterial Endotoxins Test.
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials
A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process
A USP 38-NF 33<151> Pyrogen Test
Microbial Ingress Testing (Needleless Valve-Y Injection Site)

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ASTM F838-15-Standard Test for Determining Bacterial Retention of Membrane Filter (0.2 Micron Filter test)
Flow Regulator Performance (Internal Specification)
1.2 Micron Filter Test (Internal Specification)
Clinical Test Conclusion 7.

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

	Table 1 Comparison of Technology Characteristics

Item	Proposed Device	Predicate Device
Product Code	FPA	Same
Regulation Number	21 CFR 880.5440	Same
Indication for Use	The device is indicated for thedelivery of fluids from a containerto a patient's vascular system.	Acta Medical Intravascular administration setintended use is to deliver sterile, infusion fluidfrom a container to the patient with or withoutflow control features. Acta Medical infusiontubing may act as an extension of other infusiontubing in delivering intravenous fluids from acontainer to patient.
	Configuration	Protector Cap of SpikeSpikeAir VentAir FilterDrip ChamberFluid FilterFlexible TubeCheck ValveNeedle Free Y Injection SiteRoller ClampY Injection SitePrecision FilterPinch ClampLuer Lock ConnectorProtector Cap of Luer LockConnector	Similar, except for the additional modelMinibore extension set
		Sterile	EO sterilized
SAL 10-6			Same
Single Use		Single Use	Same

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Biocompatibility
Cytotoxicity	Conform with ISO 10993 requirements	Conform with ISO 10993 requirements
Intracutaneous Reactivity
Skin Sensitization
Acute Systemic Toxicity
Hemolysis Test
Pyrogen Test

Device Comparison: The predicate device and subject device are similar in model configurations except the predicate device has an additional model, an extension set. The indications for use for the subject device and predicate device are similar except the predicate device has additional language to include the extension set and some models will come with or without a flow control feature. These minor differences in device design and indications for use do not raise different questions of safety or effectiveness.

9. Substantially Equivalent (SE) Conclusion

Based on the non clinical performance testing, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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.