The subject device is a single use device. It has ten models and their features are listed in Table 1. The ten models have differences in configurations. The differences are provided in Table 2.

The I.V. Administration Set is used to deliver sterile, infusion fluid from a container to the patient with or without flow control features. The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

There are ten different models, each configuration containing various components which may include: Spike Protector, Vented Air Cap, Air Filter, Spike, Drip Chamber, 10 Drops, Tubing, Back Check Valve, Needle Free TYPE Y, Clamp, Roller, Precision Filter, Robert Clamp, Male Luer Slip, Luer Lock Ring, Protective Cap, 15um Filter, Flow Regulator, Female Luer Connector. The devices are provided sterile and single use.

AI/ML Overview

This document generally describes the submission of an I.V. Administration Set and I.V. Extension Set for FDA 510(k) clearance, asserting substantial equivalence to a predicate device. However, it does NOT contain the type of acceptance criteria and performance study data typically found for AI/ML-based medical devices.

The acceptance criteria and performance data provided in this document are based on bench testing and adherence to established medical device standards for physical and mechanical properties, not on the performance of a software algorithm or AI model in a clinical diagnostic setting.

Therefore, the following information, which is relevant to AI/ML device performance, is NOT available in the provided text:

A table of acceptance criteria and the reported device performance (for AI/ML): The tables provided compare technological characteristics (e.g., product code, regulation, indications, configuration, materials, physical specifications) and note adherence to standards (e.g., ISO 8536-4 for infusion set performance). There's no AI/ML specific performance metrics like sensitivity, specificity, AUC, etc.
Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study. The "test sets" mentioned refer to physical samples of the IV sets for bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these devices is established by physical measurements and compliance with engineering standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI/ML context. Ground truth for this type of device involves measurements and physical properties.
The sample size for the training set: Not applicable as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Based on the provided text, here is the information that is available regarding the device's acceptance criteria and the study proving it meets them:

The document describes the requirements for a traditional medical device (I.V. Administration Set, I.V. Extension Set) based on substantial equivalence to a predicate device, rather than an AI/ML-driven device.

1. Table of Acceptance Criteria and Reported Device Performance (as pertains to this type of device)

The acceptance criteria here are based on meeting design specifications and complying with recognized national and international standards. The "reported device performance" is the demonstration of compliance through non-clinical testing.

Acceptance Criteria Category	Specific Criteria / Standard Compliance	Reported Device Performance (Demonstrated Compliance)
Indications for Use	Deliver sterile infusion fluid from a container to the patient with or without flow control features. Act as an extension to existing infusion tubing.	Same as predicate device, indicating functional equivalence.
Material Biocompatibility	ISO 10993-1 (Biological evaluation of medical devices), specifically: ISO 10993-4, -5, -10, -11, and USP <151> Pyrogen Test A.	Conducted in accordance with ISO 10993-1, demonstrating safety despite material differences from predicate.
Sterilization	EO sterilized, SAL 10-6. Compliance with ISO 11135:2014.	Conducted to achieve SAL 10-6. Compliance with ISO 11135:2014.
Performance - Infusion Set	ISO 8536-4:2019 (Infusion sets for single use, gravity feed)	Conform with ISO 8536-4.
Performance - Check Valves	ISO 8536-12:2007 AMD 1:2012 (Check valves)	Conform with ISO 8536-12.
Performance - Clamps & Flow Regulators	ISO 8536-14:2016 (Clamps and flow regulators for transfusion and infusion equipment without fluid contact)	Conform with ISO 8536-14. Test results demonstrate ability to meet intended flow rate requirements.
Performance - Small-bore Connectors	ISO 80369-7:2016 (Connectors for intravascular or hypodermic applications)	Conform with ISO 80369-7.
Performance - Filter Effectiveness	ASTM F838-15a (Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration)	Conform with ASTM F838-15a.
Performance - Particulate Matter	USP <788> (Particulate matter in injections)	Conform with USP <788>.
Packaging & Sterility Maintenance	ASTM F88/F88M-15 (Seal Strength), ASTM F1929-15 (Seal Leaks), ASTM F1980-16 (Accelerated Aging), Microbial Ingress Testing. Also, 3-year shelf life sterility maintenance.	Conducted to demonstrate seal integrity and sterility maintenance.
Bacterial Endotoxins	USP <85> (Bacterial Endotoxins Test)	Conform with USP <85>.
Hemolytic Properties	ASTM F756-17 (Assessment of hemolytic properties of materials)	Conform with ASTM F756-17.
Shipping Performance	ASTM D4169-16 (Performance Testing of Shipping Containers)	Conform with ASTM D4169-16.
Flow Rate Accuracy (Flow Regulator)	Within specified range (20 to 250 ml/h for subject, compared to 5 to 250 ml/h for predicate).	Test results demonstrate the flow regulator meets its intended flow rate requirements based on ISO 8536-14.
Priming Volume	$15.04\pm2ml \sim 17.85\pm2ml$ (I.V. Administration Set); $4.24\pm0.5ml \sim 4.32\pm0.5ml$ (I.V. Extension Set)	Measured values provided and deemed acceptable despite differences from predicate (Analysis 4, 9).
Total Length	$2320\pm 100 \sim 2580\pm 100mm$ (I.V. Administration Set); $435 \pm 15mm \sim 460 \pm 15mm$ (I.V. Extension Set)	Test results demonstrate meeting specified dimensional requirements (Analysis 5, 10).

2. Sample Size Used for the Test Set and the Data Provenance:

The document describes non-clinical (bench) testing rather than clinical study data. Specific sample sizes for each test (e.g., how many devices were tested for seal strength or biocompatibility) are not detailed in this summary. The data provenance is implied to be from the manufacturer's internal testing (BQ PLUS Medical Co., Ltd, China), as is typical for 510(k) submissions based on non-clinical testing. This is retrospective data from device manufacturing and testing processes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable in the context of an AI/ML device. For a traditional medical device like an IV administration set, the "ground truth" for performance is established by adherence to engineering standards, validated test methods, and quantitative measurements (e.g., flow rate, seal strength, material properties). This is typically performed by qualified engineers, technicians, and potentially third-party labs specializing in medical device testing, not "experts" in the sense of clinical reviewers for diagnostic accuracy.

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for establishing ground truth in clinical data (e.g., expert consensus on image reads), not for bench testing of physical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not relevant to an IV administration set.

6. If a Standalone Performance Study was done:

No, an AI "standalone" performance study was not done. The performance studies conducted were non-clinical bench tests (e.g., flow rate, material biocompatibility, sterility) to demonstrate that the device meets its design specifications and complies with relevant international standards.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on quantifiable physical and chemical properties measured against established international and national standards (e.g., ISO, ASTM, USP). It is verified through laboratory testing and engineering principles to ensure the device functions as intended, is safe for patient contact, and is sterile.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text around it, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

May 18, 2023

BQ PLUS Medical Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China

Re: K223645

Trade/Device Name: I.V. Administration Set, I.V. Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: April 17, 2023 Received: April 17, 2023

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K223645

Device Name

I.V. Administration Set. I.V. Extension Set

Indications for Use (Describe)

The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.

The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

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)

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 Drug 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."

{3}------------------------------------------------

K223645- 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: K223645

1. Date of Preparation: 05/18/2023
1. Sponsor Identification

BQ PLUS Medical Co., Ltd

No. 18, Cheye Road, Chedun Town, Songjiang Shanghai 201611, China

Establishment Registration Number: 3013023255

Contact Person: Jin Zhang Position: R&D Director Tel: +86-21-57609106 Email: eddie@bq-medical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Xingqi Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86-21-2281-5850 Fax: 360-925-3199 Email: info@mid-link.net

{4}------------------------------------------------

1. Identification of Subject Device and Predicate Device
  Trade Name: I.V. Administration Set, I.V. Extension Set Common Name: Intravascular Administration Set

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

Predicate Device 510(k) Number: K111351 TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION Product Name: SET, TRUECARE BIOMEDIX EXTENSION SET

Indications for Use:

The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.

The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

Device Description:

The subject device is a single use device. It has ten models and their features are listed in Table 1. The ten models have differences in configurations. The differences are provided in Table 2.

Model	Feature
BQAS-0201	I.V. Administration Set with Clamp, Back Check Valve
BQAS-0202	I.V. Administration Set with Clamp
BQAS-0203	I.V. Administration Set with Flow Regulator, 15um Filter
BQAS-1201	I.V. Administration Set with Back Check Valve
BQAS-1202	I.V. Administration Set with Clamp
BQAS-1203	I.V. Administration Set with Flow Regulator, 15um Filter
BQES-MF01	I.V. Extension Set with Female Lure Connector
BQES-MF02	I.V. Extension Set with Female Lure Connector

Table 1 Description of Models

{5}------------------------------------------------

BQES-MF03	I.V. Extension Set with Needle free Type Y
BQES-MF04	I.V. Extension Set with Needle free Type Y

Configuration	BQAS-0201	BQAS-0202	BQAS-0203	BQAS-1201	BQAS-1202	BQAS-1203	BQES-MF01	BQES-MF02	BQES-MF03	BQES-MF04
Spike Protector	X	X	X	X	X	X			X	X
Vented Air Cap	X	X	X	X	X	X			X	X
Air Filter	X	X	X	X	X	X			X	X
Spike	X	X	X	X	X	X			X	X
Drip Chamber	X	X	X	X	X	X
10 Drops	X	X		X	X
Tubing	X	X	X	X	X	X	X	X	X	X
Back Check Valve	X			X
Needle Free TYPE Y	X	X	X	X	X	X			X	X
Clamp	X	X	X	X	X
Roller Clamp	X	X	X	X	X	X
Roller	X	X	X	X	X	X
Precision Filter	X	X	X	X	X	X	X	X	X	X
Robert Clamp	X	X	X	X	X	X	X	X	X	X
Male Luer Slip	X	X	X	X	X	X	X	X	X	X
Luer Lock Ring	X	X	X	X	X	X	X	X	X	X
Protective Cap	X	X	X	X	X	X	X	X	X	X
15um Filter			X			X
Flow Regulator			X			X
Female LuerConnector							X	X
Female Luer Cap							X	X

Table 2 Configuration of I.V. Administration Set

{6}------------------------------------------------

Component	Function
Spike Protector	The spike protector is used to protect the piercing device to prevent stab wounds
Vented Air Cap	When the plastic needle is punctured, the cap should be tightly covered to preventliquid from flowing out
Air Filter	It is used to filter air.
Spike	The spike is used to puncture the infusion bottle (or infusion bag).
Drip Chamber	The drip chamber is used to observe the liquid level.
10 Drops	The 10 drops is used to calculate the drop rate.
Tubing	The tubing is intended to deliver fluid.
Back Check Valve	The back check valve is intended to prevent the liquid backflow.
Needle Free TYPE Y	It is used to add medicine with syringes without needle
Clamp	The clamp is intended to stop the fluid flowing.
Roller Clamp	Adjust the fluid flow
Roller	Adjust the fluid flow
Precision Filter	Filter particulate matter in liquid medicine
Robert Clamp	The robert clamp is intended to stop the fluid flowing.
Male Luer Slip	For connection between pipes (or with patient end)
Luer Lock Ring	For connection between pipes (or with patient end)
Protective Cap	The protection of the Luer connector and the exhaust of the pipeline
15µm Filter	Used to filter particulate matter in liquid medicine.
Flow Regulator	The flow regulator is intended to adjust the liquid flow.
Female Luer Connector	The female luer connector is intended to connect the injection accessories.

The description for each component is provided as follows:

The subject devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

{7}------------------------------------------------

5. Summary of Technological characteristics

Item	Subject Device	Predicate DeviceK111351	Remark
Product Code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indication forUse	The I.V. Administration Setintended use is to deliver sterile,infusion fluid from a container tothe patient with or without flowcontrol features.The I.V. Extension Set may actas an extension of other infusiontubing in delivering intravenousfluids from a container topatient.	Truecare Biomedix Intravascularadministration set intended use isto deliver sterile, infusion fluidfrom a container to the patient withor without flow control features.Truecare Biomedix infusion tubingmay act as an extension of otherinfusion tubing in deliveringintravenous fluids from acontainer to patient.	Same
Configuration	Spike ProtectorVented Air CapAir FilterSpikeDrip Chamber10 DropsTubingBack Check ValveNeedle Free TYPE YClampRoller ClampRollerPrecision FilterRobert ClampMale Luer SlipLuer Lock RingProtective Cap15um FilterFlow Regulator	Universal spikeDrip ChamberTubingFlow RegulatorRoller clampSlide ClampLuer LocksFiltersY-injection site	Analysis 1
Operation Mode	Manual	Manual	Same
Label/Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Same
Item	Subject Device	Predicate DeviceK111351	Remark
Infusion SetPerformance	Conform with ISO 8536-4	Conform with ISO 8536-4	Same
Flow Rate ofFlowRegulator(ml/h)	20 to 250	5 to 250	Analysis 2
FilterCharacteristics	0.2µm, 1.2µm	0.2µm, 1.2µm	Same
Patient-contact Material
Vented Air Cap	PVC
Air Filter	PTFE
Spike	ABS
Drip Chamber	PVC
10 Drops	ABS	Acrylonitrile Butadiene Styrene
Tubing	PVC
Back CheckValve	MABS	Non-DEHP Poly Vinyl Chloride
Needle FreeTYPE Y	MABS, PP, Silicone	Polypropylene	Analysis 3
Precision Filter	PTFE, PES, MABS	Silicone
Male Luer Slip	PC		Silicone
Luer Lock Ring	PC
Protective Cap	PP
15um Filter	ABS, Nylon
Flow Regulator	ABS,TPE
Physical specifications
ConnectionType	Luer Connection	Luer Connection	Same
Priming Volume	$15.04\pm2ml~17.85\pm2ml$	Unknown	Analysis 4
Total Length	$2320\pm 100~2580\pm 100mm$	127~2667mm (5"~105")	Analysis 5
Colorofcomponent	Vented Air Cap	Blue	Unknown	Analysis 6
	Air Filter	White
	Spike	White
	10 Drops	White
	Back Check Valve	White
	Needle Free TYPE Y	Blue
	Protective Cap	Blue
	15um Filter	White
Item	Subject Device	Predicate DeviceK111351	Remark
	Flow RegulatorWhite
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same
Item	Subject Device	Predicate DeviceK111351	Remark
Product Code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indication for Use	The I.V. Administration Setintended use is to deliversterile, infusion fluid from acontainer to the patient with orwithout flow control features.The I.V. Extension Set mayinfusion tubing in deliveringintravenous fluids from acontainer to patient.	Truecare BiomedixIntravascular administration setintended use is to deliver sterile,infusion fluid from a containerto the patient with or withoutflow control features. TruecareBiomedix infusion tubing mayact as an extension of otherinfusion tubing in deliveringintravenous fluids from acontainer to patient.	Same
Configuration	Spike ProtectorVented Air CapAir FilterSpikeTubingNeedle Free TYPE YPrecision FilterRobert ClampMale Luer SlipLuer Lock RingProtective CapFemale Luer ConnectorFemale Luer Cap	Universal spikeDrip ChamberTubingFlow RegulatorRoller clampSlide ClampLuer LocksFiltersY-injection site	Analysis 7
Operation Mode	Manual	Manual
Label/Labeling	Conform with 21 CFR Part801	Conform with 21 CFR Part 801	Same
Infusion SetPerformance	Conform with ISO 8536-4	Conform with ISO 8536-4	Same
Patient-contact Material
Vented Air Cap	PVC	Acrylonitrile Butadiene Styrene	Analysis 8

Air Filter	PTFE
Spike	ABS		Non-DEHP Poly Vinyl Chloride
Tubing	PVC
Needle Free TYPE Y	MABS, PP, Silicone		Polypropylene
Precision Filter	PTFE, PES, MABS
Male Luer Slip	PC		Silicone
Luer Lock Ring	PC
Protective Cap	PP
Female LuerConnector	PC
Filter Characteristics	0.2µm, 1.2µm		0.2µm, 1.2µm	Same
Physical specifications
Connection Type	Luer Connection		Luer Connection	Same
Priming Volume	4.24±0.5ml~4.32±0.5ml		unknown	Analysis 9
Total Length	435 ± 15mm~460 ± 15mm		177mm (5inch)	Analysis10
	Vented Air Cap	Blue
	Air Filter	White
	Spike	White
	10 Drops	White
	Back Check Valve	White	Unknown	Analysis11
Color of component	Needle FreeTYPE Y	Blue
	Protective Cap	Blue
	15um Filter	White
	Flow Regulator	White
Sterilization
Method	EO sterilized		EO sterilized	Same
SAL	10-6		10-6	Same

Table 3 Comparison for Technology Characteristics of I.V. Administration Set

{8}------------------------------------------------

{9}------------------------------------------------

Analysis 1-Configuration

The predicate device components are a subset of the subject device components. The common components between the subject and predicate devices names are different, but the components functionality are the same. The common components and additional components of the subject device have been adequately tested for performance, biocompatibility and sterlity. The differences do not raise new questions of safety and effectiveness.

Analysis 2- Flow Rate of Flow Regulator

The flow rate for subject device is different from predicate device. However, the flow rate range of the subject device is within the flow rate range of the predicate device. The subject device was tested according to the standard of ISO 8536-14:2016, and the test results demonstrate that the flow regulator can meet its intended flow rate requirements. Thus, the difference does not raise new questions of safety and effectiveness.

Analysis 3- Patient-contact Material

The patient contact materials for the subject device are different from the predicate device. However, biocompatibility testing has been conducted on the subject device in accordance to ISO 10993-1. Thus, the differences do not raise new questions of safety and effectiveness.

Analysis 4-Priming Volume

The priming volume for the subject device is different from the predicate device. The priming volume depends on the length of the device, so the priming volume of the subject device and predicate device is different. However, the indications for use and functionality of the devices are the same; therefore, the differences do not raise new questions of safety and effectiveness.

Analysis 5-Total Length

The total length for the subject device is different from the predicate device. However, the length of the subject device is within the specification limits of the predicate device. The subject device was tested according to ISO 8536-4:2019, and the test results for subject device demonstrate that the length can meet its specified dimensional requirements. Thus, the differences do not raise new questions of safety and effectiveness.

Analysis 6-Color of Component

The color of the component of the predicate device is unknown; however, biocompatibility testing has been

{10}------------------------------------------------

conducted on the subject device demonstrating safety. Thus, the differences do not raise new questions of safety and effectiveness.

Table 4 Comparison for Technology Characteristics of I.V. Extension Set

{11}------------------------------------------------

Analysis 7-Configuration

The predicate device components are a subset of the subject device components. The common components between the subject and predicate devices names are different, but the components functionality are the same. The common components and additional components of the subject device have been adequately tested for performance, biocompatibility and sterility. The differences do not raise new questions of safety and effectiveness.

Analysis 8- Patient-contact Material

{12}------------------------------------------------

Analysis 9-Priming Volume

Analysis 10-Total Length

The total length for subject device is different from predicate device. However, different lengths can be used for different patients and clinical conditions. The subject device was tested according to ISO 8536-4:2019. and the test result for subject device show that the length can meet its specified dimensional requirements. Thus, the differences do not raise new questions of safety and effectiveness.

Analysis 11-Color of Component

The color of the component of the predicate device is unknown; however, biocompatibility testing has been conducted on the subject device demonstrating safety. Thus, the differences do not raise new questions of safety and effectiveness.

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following complete standards:

Performance

A ISO 8536-4:2019 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 8536-14:2016 Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
ASTM F838-15a Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration
USP<788> Particulate matter in injections

Biocompatibility

{13}------------------------------------------------

The subject device contact classification is an externally communicating device, blood path indirect, prolonged exposure.

ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for > interactions with blood
A 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: Tests for irritation and skin sensitization;
ISO10993-11: 2017, Biological evaluation of medical devices-Part 11: Tests for Systemic Toxicity
USP <151> Pyrogen Test A

Sterilization

ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
A ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F756-17 Standard practice for assessment of hemolytic properties of materials
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
USP <85> Bacterial Endotoxins Test
Microbial Ingress Testing
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers
1. Summary of Clinical Testing

No clinical study is included in this submission.

1. Conclusion
  The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject device, I.V. Administration Set. I.V. Extension Set is substantially equivalent to the predicate device, TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET cleared under K111351.

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.