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

• K Number: K223645
• Device Name: I.V. Administration Set, I.V. Extension Set
• Manufacturer: BQ PLUS Medical Co., Ltd
• Date Cleared: 2023-05-18 ( 163 days)
• Product Code: FPA
• Regulation Number: 880.5440

Intended 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. 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.

Predicate Devices

K111351

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard I.V. administration and extension set with various components, and there is no mention of AI or ML technology in the intended use, device description, or performance studies.

Therapeutic

No
The device is an I.V. administration set and extension set, used for delivering fluids to a patient, rather than for directly treating a disease or condition.

Diagnostic

No

The device is an IV administration set and extension set, designed for delivering fluids, not for diagnosing medical conditions. It does not provide any information or measurements for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly lists various physical components such as tubing, clamps, filters, and connectors, indicating it is a hardware device for fluid delivery.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to "deliver sterile, infusion fluid from a container to the patient". This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
• Device Description: The components listed (Spike, Drip Chamber, Tubing, Clamps, Luer connectors, etc.) are all consistent with equipment used for intravenous fluid delivery. There are no components mentioned that would be used for analyzing biological samples (like reagents, test strips, or analytical instruments).
• Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring specific substances (analytes)
  • Providing information for diagnosis, monitoring, or prognosis of a disease or condition.

The device described is clearly an intravascular administration set, which is a medical device used for therapeutic purposes (delivering fluids to a patient), not for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FPA

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.

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

• 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 Particulate matter in injections

Biocompatibility
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
• 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 Pyrogen Test

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)]
• 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 Bacterial Endotoxins Test
• Microbial Ingress Testing
• ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K111351

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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

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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 ([e-mail]) or phone [phone] 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

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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)

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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
• 2. 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: [phone] Email: [e-mail]

• 3. 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: [phone] Fax: [phone] Email: [e-mail]

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• 4. 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

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

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.

| 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 Luer
Connector | | | | | | | X | X | | |
| Female Luer Cap | | | | | | | X | X | | |

Table 2 Configuration of I.V. Administration Set

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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 prevent
liquid 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.

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5. Summary of Technological characteristics

| Item | Subject Device | Predicate Device
K111351 | 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 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. | Truecare Biomedix Intravascular
administration set intended use is
to deliver sterile, infusion fluid
from a container to the patient with
or without flow control features.
Truecare Biomedix infusion tubing
may act as an extension of other
infusion tubing in delivering
intravenous fluids from a
container to patient. | Same | |
| Configuration | Spike Protector
Vented Air Cap
Air Filter
Spike
Drip Chamber
10 Drops
Tubing
Back Check Valve
Needle Free TYPE Y
Clamp
Roller Clamp
Roller
Precision Filter
Robert Clamp
Male Luer Slip
Luer Lock Ring
Protective Cap
15um Filter
Flow Regulator | Universal spike
Drip Chamber
Tubing
Flow Regulator
Roller clamp
Slide Clamp
Luer Locks
Filters
Y-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 Device
K111351 | Remark | |
| Infusion Set
Performance | Conform with ISO 8536-4 | Conform with ISO 8536-4 | Same | |
| Flow Rate of
Flow
Regulator(ml/h) | 20 to 250 | 5 to 250 | Analysis 2 | |
| Filter
Characteristics | 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 Check
Valve | MABS | Non-DEHP Poly Vinyl Chloride | | |
| Needle Free
TYPE 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 | | | | |
| Connection
Type | Luer Connection | Luer Connection | Same | |
| Priming Volume | $15.04\pm2ml17.85\pm2ml$ | Unknown | Analysis 4 | |
| Total Length | $2320\pm 1002580\pm 100mm$ | 1272667mm (5"105") | Analysis 5 | |
| Color
of
component | 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 Device
K111351 | Remark | |
| | Flow Regulator
White | | | |
| Sterilization | | | | |
| Method | EO sterilized | EO sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
| Item | Subject Device | Predicate Device
K111351 | 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 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 mayinfusion tubing in delivering
intravenous fluids from a
container to patient. | Truecare Biomedix
Intravascular administration set
intended use is to deliver sterile,
infusion fluid from a container
to the patient with or without
flow control features. Truecare
Biomedix infusion tubing may
act as an extension of other
infusion tubing in delivering
intravenous fluids from a
container to patient. | Same | |
| Configuration | Spike Protector
Vented Air Cap
Air Filter
Spike
Tubing
Needle Free TYPE Y
Precision Filter
Robert Clamp
Male Luer Slip
Luer Lock Ring
Protective Cap
Female Luer Connector
Female Luer Cap | Universal spike
Drip Chamber
Tubing
Flow Regulator
Roller clamp
Slide Clamp
Luer Locks
Filters
Y-injection site | Analysis 7 | |
| Operation Mode | Manual | Manual | | |
| Label/Labeling | Conform with 21 CFR Part
801 | Conform with 21 CFR Part 801 | Same | |
| Infusion Set
Performance | 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 Luer
Connector | 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±0.5ml4.32±0.5ml | | unknown | Analysis 9 |
| Total Length | 435 ± 15mm460 ± 15mm | | 177mm (5inch) | Analysis
10 |
| | Vented Air Cap | Blue | | |
| | Air Filter | White | | |
| | Spike | White | | |
| | 10 Drops | White | | |
| | Back Check Valve | White | Unknown | Analysis
11 |
| Color of component | Needle Free
TYPE 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

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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

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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

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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

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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 9-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 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 Particulate matter in injections

Biocompatibility

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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 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 Bacterial Endotoxins Test

• Microbial Ingress Testing

• ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers

• 7. Summary of Clinical Testing

No clinical study is included in this submission.

• 8. 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.