The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through the infusion needle under the action of gravity. The proposed devices are comprised of air filter, protective cap of closure-piercing device, closure-piercing device, drip chamber, flexible tubing, flow regulator, filter and an infusion needle attached to a luer adaptor. For the Burette-type Infusion Sets for Single Use, an additional component of burette can used for quantitative infusion. For Disposable Infusion Sets with Precision Filters, a precision membrane is provided for filtration operation.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. This document is a 510(k) premarket notification summary for medical devices (infusion sets). It outlines the device description, indications for use, comparison to predicate devices, and non-clinical test conclusions to establish substantial equivalence.

It does not include:

A table of acceptance criteria and reported device performance beyond general compliance with ISO standards.
Details about a specific study proving the device meets acceptance criteria, such as sample sizes, data provenance, ground truth establishment, or expert qualifications.
Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot provide the requested information based on this text.

Summary

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

March 8, 2017

Beijing Fert Technology Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K161898

Trade/Device Name: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 28, 2017 Received: March 3, 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 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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Indications for Use

510(k) Number (if known)

K161898

Device Name

Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set

Indications for Use (Describe)

The devices are 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: K161898

1. Date of Preparation: 03/07/2017
1. Sponsor Identification

Beijing Fert Technology Co., Ltd.

No. 9, Zhangguozhuang Village, Changxindian Town, Feng Tai District, Beijing, 100072, China

Contact Person: Meng Zhang Position: Quality Director Tel: +86-10-83849578 Fax: +86-10-83805808 Email: zhangmeng@pwmedtech.com

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: Burette-type Infusion Sets for Single Use Disposable Infusion Sets with Precision Filters Disposable Infusion Set Common Name: Disposable Infusion Set

Regulatory Information

Classification Name: Set, Administration, Intravascular

Classification: Class II Product Code: FPA Regulation Number: 21CFR 880.5440 Review Panel: General Hospital;

Indications for Use:

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

Device Description:

Identification of Predicate Device

510(k) Number: K112204 Product Name: KDL Disposable Infusion Set

Identification of Reference Device

510(k) Number: K972839 Product Name: PROTOS® 100ml Burette Infusion Set/PROTOS® 150ml Burette Infusion

Non-Clinical Test Conclusion 7.

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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 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 8536-5:2004 Infusion equipment for medical use- Part 5: Burette infusion sets for single use, gravity feed
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 9626:1991 AMD 1 2001 Stainless steel needle tubing for the manufacture of medical devices;
ISO 7864: 1993 Sterile hypodermic needles for single use
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
ASTM F 88/88M-09 Standard test method for seal strength of flexible barrier materials;
ASTM F1140/1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages
USP38-NF33 <85> Bacterial Endotoxins Tests.
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
- 1. Clinical Test Conclusion

No clinical study is included in this submission.

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9. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device	Reference Device
Product Code	FPA	FPA	FPA
Regulation Number	21CFR 880.5440	21CFR 880.5440	21CFR 880.5440
Indications for Use	The devices are indicated for the delivery of fluids from a container to a patient's vascular system.	KDL Disposable Infusion Set is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein	For the delivery of I.V. solutions by on the order of a physician or other licensed practitioner.
Configuration	Protective Cap of Closure-piercing DeviceAir FilterClosure-piercing DeviceFlexible TubingClamp HookInjection SiteBuretteFluid FilterDrip ChamberFlow RegulatorY-shape Injection SiteConical FittingNeedle SeatWing	Protective Cap of Closure-piercing DeviceAir FilterClosure-piercing DeviceFlexible TubingClamp HookSite DripChamber FluidFilter FlowRegulatorInjection SiteConical FittingNeedle SeatWingInfusion NeedleProtective Cap of Infusion Needle	Protective Cap of Closure-piercing DeviceAir FilterClosure-piercing DeviceFlexible TubingClamp HookInjection SiteBuretteFluid FilterDrip ChamberFlow RegulatorY-shape Injection SiteConical FittingNeedle SeatWing
	Infusion NeedleProtective Cap of Infusion Needle	Check valve	Infusion NeedleProtective Cap of Infusion Needle
Sterile	EO sterilized	EO sterilized	EO sterilized
	10-6	10-6	10-6
Single Use	Single Use	Single Use	Single Use
Biocompatibility
Cytotoxicity	No Cytotoxicity	Conform with ISO 10993 seriesstandards	Conform with ISO 10993 seriesstandards
Intracutaneous Reactivity	No intracutaneous Reactivity
Skin Sensitization	No Sensitization
Acute Systemic Toxicity	No Systemic Toxicity
Hemolysis	No Hemolysis

Table 1 Comparison of Technology Characteristics

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Differences between the subject device indication for use are not identical word. However, the minor differences do . not raise new questions of safety and effectiveness of the reference device K972839 PROTOS® Burette Infusion Set was leveaged for the burette component of the subject device.

Substantially Equivalent (SE) Conclusion

Based upon the indications for use, technological characteristics, and the results of the subject devices have been demonstrated to be substantially equivalent to the predicate.

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.