I.V. Administration Set

• K Number: K210381
• Device Name: I.V. Administration Set
• Manufacturer: BQ PLUS Medical Co., Ltd.
• Date Cleared: 2021-08-14 ( 186 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 intravenous fluids from a container to patient.

Device Description

The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1. There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use. The proposed 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.

Predicate Devices

K121803

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and standard performance characteristics of an I.V. administration set, with no mention of AI or ML.

Therapeutic

No
The device is described as an I.V. Administration Set used to deliver fluids, which is a delivery mechanism, not a treatment itself.

Diagnostic

No

Explanation: The device description states its intended use is to "deliver sterile, infusion fluid from a container to the patient." This is a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or analyze a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists various physical components such as IV Chamber, Tubing, Roller Clamp, etc., indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided text, the 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 (IV Chamber, Tubing, Clamps, Valves, Luer Locks, etc.) are all consistent with a system for delivering fluids intravenously. There are no components mentioned that would be used for analyzing biological samples.
• Performance Studies: The performance studies described focus on the physical and functional properties of the administration set (leakage, tensile strength, flow rate, biocompatibility, sterility), not on the accuracy or reliability of diagnostic measurements.
• Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.

Therefore, the I.V. Administration Set is a medical device used for therapeutic purposes (delivering fluids), not for in vitro diagnostic testing.

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 intravenous fluids from a container to patient.

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

FPA

Device Description

The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1.

Model	Feature
BQ-SYQ-001	I.V. Administration Set with T connector, Y site, flow regulator, NeedleFree Valve
BQ-SYQ-002	I.V. Administration Set with Hanger
BQ-SYQ-003	I.V. Administration Set with Y site, Needle free Valve
BQ-SYQ-004	I.V. Administration Set with Flow Regulator
BQ-YCG-017	I.V. Extension Set with T connector, Needle Free Valve
BQ-YCG-018	I.V. Extension Set with Needle Free Valve
BQ-YCG-019	I.V. Extension Set with male/female luer lock

There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use.

The proposed devices are sterilized by EO to achieve a SAL 106 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

Prescription Use

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 proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

• 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
• 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 cvtotoxicity:
• 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
• 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 43-NF 38 Bacterial Endotoxins Test
• USP 43-NF 38 Pyrogen Test

Biocompatibility Testing:
The contact level of the proposed device is blood path, indirect and the contact duration is prolonged duration. The proposed device was evaluated for the following tests. The results of the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

• Hemolysis Test Report
• Cytotoxicity Test Report
• Guinea Pig Maximization Test Report
• Intracutaneous Reactivity Test Report
• Systemic Toxicity Test Report
• Pyrogen Test Report

Performance Testing-Bench:

• Particulate contamination, leakage, tensile strength, dimension of the closure-piercing device, determination of flow rate when using an air-inlet device, tubing, efficiency of the fluid filter, drip chamber and drip tube, Flow rate of infusion fluid and injection site Performance Test Report of ISO 8536-4
• Check valves Performance Test Report of ISO 8536-12
• Flow regulator Performance Test Report of ISO 8536-14
• Luer Compliance Performance Test Report of ISO 80369-7

Performance Testing-Microbial Ingress Test:

• Microbial Ingress Testing

Clinical Study:
No clinical study is included in this submission.

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.

K121803

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 the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

August 14, 2021

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

Re: K210381

Trade/Device Name: I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: June 28, 2021 Received: July 15, 2021

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,

Payal Patel 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) K210381

Device Name I.V. Administration 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 intravenous fluids from a container to patient.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Ref 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart G)	☑ Prescription Use (Ref 21 CFR 801 Subpart D)	☑ Prescription Use (Ref 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart G)	☐ Over-The-Counter Use (21 CFR 801 Subpart G)
☑ Prescription Use (Ref 21 CFR 801 Subpart D)	☑ Prescription Use (Ref 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart G)	☐ Over-The-Counter Use (21 CFR 801 Subpart G)
☑ Prescription Use (Ref 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart G)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary K210381

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K210381

• 1. Date of Preparation: 06/28/2021
• 2. Sponsor Identification

BQ PLUS Medical Co., Ltd No. 18, Cheye Road, Chedun Town, Songjiang Shanghai 201611, China

Establishment Registration Number: Not yet registered.

Contact Person: Jin Zhang Position: R&D Director Tel: [phone] Email: [e-mail]

• 3. Designated Submission Correspondent
     Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: [phone] Fax: [phone] Email: [e-mail]

• Identification of Proposed Device 4.
  Trade Name: I.V. Administration Set Common Name: Intravascular Administration Set

Regulatory Information Classification Name: Set, Administration, Intravascular Classification: II Product Code: FPA Regulation Number: CFR 880. 5440

4

Review Panel: General Hospital

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 propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1.

Model	Feature
BQ-SYQ-001	I.V. Administration Set with T connector, Y site, flow regulator, Needle
Free Valve
BQ-SYQ-002	I.V. Administration Set with Hanger
BQ-SYQ-003	I.V. Administration Set with Y site, Needle free Valve
BQ-SYQ-004	I.V. Administration Set with Flow Regulator
BQ-YCG-017	I.V. Extension Set with T connector, Needle Free Valve
BQ-YCG-018	I.V. Extension Set with Needle Free Valve
BQ-YCG-019	I.V. Extension Set with male/female luer lock

Table 1 Description of Models

There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use.

The proposed devices are sterilized by EO to achieve a SAL 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.

• ડ. Identification of Predicate Devices
  510(k) Number: K121803 Product Name: Acta Medical Intravascular Administration Set

• 6. Non-Clinical Test Conclusion
     Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

5

• 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

• A ISO 8536-14:2016 Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
• A ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
• A 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 cvtotoxicity:

• A ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
• A ISO10993-11: 2017, Biological evaluation of medical devices-Part 11: Tests for Systemic Toxicity
• A 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 A
• A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
• A ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
• USP 43-NF 38 Bacterial Endotoxins Test A

• USP 43-NF 38 Pyrogen Test

Biocompatibility Testing

The contact level of the proposed device is blood path, indirect and the contact duration is prolonged duration. The proposed device was evaluated for the following tests. The results of the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

• Hemolysis Test Report A
• A Cytotoxicity Test Report
• A Guinea Pig Maximization Test Report
• A Intracutaneous Reactivity Test Report

6

• Systemic Toxicity Test Report

• Pyrogen Test Report

Performance Testing-Bench

Particulate contamination, leakage, tensile strength, dimension of the closure-piercing device, determination of flow rate when using an air-inlet device, tubing, efficiency of the fluid filter, drip chamber and drip tube, Flow rate of infusion fluid and injection site Performance Test Report of ISO 8536-4

• A Check valves Performance Test Report of ISO 8536-12
• A Flow regulator Performance Test Report of ISO 8536-14
• A Luer Compliance Performance Test Report of ISO 80369-7

Performance Testing-Microbial Ingress Test

• Microbial Ingress Testing

• 7. Clinical Test Conclusion

No clinical study is included in this submission.

• Summary of Technological Characteristics 8.

| ITEM | Proposed Device
I.V. Administration Set | Predicate Device
K121803 | Remark |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Regulation Number | CFR 880.5440 | CFR 880.5440 | Same |
| Product Code | FPA | FPA | Same |
| Class | II | II | Same |
| 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. | Acta Medical Intravascular
administration set intended use is
to deliver sterile, infusion fluid
from a container to the patient with
or without flow control features.
Acta Medical infusion tubing may
act as an extension of other
infusion tubing in delivering
intravenous fluids from a container
to patient. | Same |
| Configuration of
I.V. Administration
Set | IV Chamber,
Tubing,
Roller Clamp,
Y Site, | Protector Cap of Spike
Spike
Air Vent
Air Filter | Different
1 |
| | | | |
| Configuration of
I.V. Extension Set | Needle Free Valve,
Slide Clamp,
Back Check Valve,
Male Luer Lock,
3 Way Stop Cock,
Female Luer Lock,
Flow Regulator,
Rotating Luer Lock,
T-Connector,
Luer Lock Cap,
Hanger,
Drop | Drip Chamber
Fluid Filter
Flexible Tube
Flow Regulator
Check Valve
Needle Free Y Injection Site
Roller Clamp
Y Injection Site
Precision Filter
Pinch Clamp
Luer Lock Connector
Protector Cap of Luer Lock
Connector | Same |
| | Tubing,
Needle Free Valve,
Slide Clamp,
Male Luer Lock,
Female Luer Lock,
Rotating Luer Lock,
T-Connector,
Luer Lock Cap,
Female Luer Connector,
Cap | Tubing,
Needle Free Valve,
Slide Clamp,
Male Luer Lock,
Female Luer Lock,
Rotating Luer Lock,
T-Connector,
Luer Lock Cap,
Female Luer Connector,
Cap | |
| Operation Mode | Manual | Manual | Same |
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
| Infusion Set
Performance | Conform with ISO 8536-4:2010
and ISO 8536-12: 2004 | Conform with ISO 8536-4:2010
and ISO 8536-12: 2004 | Same |
| Flow Rate of Flow
Regulator (ml/h) | 20 to 250 | 5 to 250 | Different
2 |
| Pore Size of
Membrane | 15μm | 0.2μm, 1.2μm, 15μm | Different
3 |
| Patient- contact Material | | | Different
4 |
| IV Chamber | ABS,
PVC | Acrylonitrile Butadiene Styrene | |
| Tubing | PVC | | |
| Y Site | PC | Non-DEHP Poly Vinyl Chloride | |
| Needle Free Valve | ABS, PP, Silicone | | |
| Back Check Valve | ABS,TPE | Polypropylene (non fluid pathway
material, utilized in protective caps
only) | |
| Male Luer Lock | ABS | | |
| 3 Way Stop Cock | PC, PP, POM | | |
| Female Luer Lock | PC | Silicone | |
| Flow Regulator | ABS, | | |
| Rotating Luer Lock | PC | | |
| T-Connector | PC | | |
| Luer Lock Cap | PP | | |
| Drop | ABS | | |
| Female Luer
Connector | PC | | |
| Cap | ABS | | |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity. | | |
| Max Sensitization | No skin sensitization. | | |
| Intracutaneous
Reactivity Test | No intracutaneous reactivity. | The specific test items are
unknown. However, the product
should meet the requirements of
ISO10993 series standards. | Different
5 |
| Acute Systemic
Toxicity Test | No systemic toxicity. | | |
| Pyrogen Test | No potential febrile reaction. | | |
| Hemolysis Test | No Hemolysis | | |
| Sterilization | | | |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | $1.0×10-6$ | $1.0×10-6$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Single Use | Yes | Yes | Same |

Table 1 Comparison of Technology Characteristics

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Different 1 - Configuration

The configuration for proposed device is different from predicate device. The components of proposed device are same with the components of predicate device. Only the component name is different. Thus, this difference does not affect the safety and effectiveness of the proposed device.

Different 2- Flow Rate

The flow rate for proposed device is different from predicate device. However, the flow rate range of the proposed device is within the flow rate rang of the predicate device. And the test result for proposed device show that flow regulator can meet its declared flow rate requirements. Thus, this difference does not affect the safety and effectiveness of the proposed device.

Different 3- Pore Size of Membrane

The pore size of membrane for proposed device is different from predicate device. However, the pore size of membrane for proposed device is within the pore size of membrane for predicate device. And the test result for proposed device shows that the retention of latex particles on the filter can meet its declared pore size of membrane. Thus, this difference does not affectiveness of the proposed device.

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Different 4- Patient- contact Material

The patient contact materials for proposed device are different from predicate device. However, the biocompatibility test for proposed device was performed and the result show there is no adverse effect. Thus, this difference does not affect the safety and effectiveness of the proposed device.

Different 5- Biocompatibility

The biocompatibility of Proposed Device and Predicate Device are should meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device, but the biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Max Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Pyrogen Test and Hemolysis Test. These studies can demonstrate the biocompatibility of Proposed Device. Thus, this difference does not affect the safety and effectiveness of the proposed device.

• 9. Conclusion
     Through performance testing the subject device has demonstrated substantial equivalence to the predicate device.