I.V. Administration Set, I.V. Extension Set
Device Facts
| Record ID | K223645 |
|---|---|
| Device Name | I.V. Administration Set, I.V. Extension Set |
| Applicant | Bq Plus Medical Co., Ltd. |
| Product Code | FPA · General Hospital |
| Decision Date | May 18, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 Story
Single-use, manual I.V. administration and extension sets; deliver sterile infusion fluids from containers to patients. Components include spikes, drip chambers, tubing, flow regulators, clamps, filters, and luer connectors. Operated manually by healthcare professionals in clinical settings. Device functions as a fluid path; flow rate controlled via manual roller clamps or flow regulators. Benefits include controlled, sterile delivery of intravenous fluids. No electronic or automated components.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including performance testing (ISO 8536 series, ISO 80369-7, ASTM F838, USP 788), biocompatibility (ISO 10993 series, USP 151), and sterilization validation (ISO 11135, ASTM standards).
Technological Characteristics
Materials: PVC, ABS, MABS, PC, PP, PTFE, PES, Silicone, TPE. Components: Spike, drip chamber, tubing, flow regulator, clamps, filters (0.2µm, 1.2µm, 15µm), luer connectors. Sterilization: Ethylene Oxide (EO) to SAL 10^-6. Standards: ISO 8536-4, ISO 8536-12, ISO 8536-14, ISO 80369-7, ASTM F838, USP 788, ISO 10993, ISO 11135.
Indications for Use
Indicated for delivery of sterile infusion fluids from a container to a patient, with or without flow control, or as an extension of existing infusion tubing. Applicable to patients requiring intravenous fluid therapy.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- TRUECARE BIOMEDIX INTRAVASCULAR ADMINISTRATION SET, TRUECARE BIOMEDIX EXTENSION SET (K111351)
Submission Summary (Full Text)
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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 (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
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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) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span style="text-decoration: overline;">X</span> 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: +86-21-57609106 Email: eddie@bq-medical.com
- 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: +86-21-2281-5850 Fax: 360-925-3199 Email: info@mid-link.net
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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-<br>0201 | BQAS-<br>0202 | BQAS-<br>0203 | BQAS-<br>1201 | BQAS-<br>1202 | BQAS-<br>1203 | BQES-<br>MF01 | BQES-<br>MF02 | BQES-<br>MF03 | BQES-<br>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<br>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<br>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<br>K111351 | Remark | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------|
| Product Code | FPA | FPA | Same | |
| Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 | Same | |
| Class | II | II | Same | |
| Indication for<br>Use | The I.V. Administration Set<br>intended use is to deliver sterile,<br>infusion fluid from a container to<br>the patient with or without flow<br>control features.<br>The I.V. Extension Set may act<br>as an extension of other infusion<br>tubing in delivering intravenous<br>fluids from a container to<br>patient. | Truecare Biomedix Intravascular<br>administration set intended use is<br>to deliver sterile, infusion fluid<br>from a container to the patient with<br>or without flow control features.<br>Truecare Biomedix infusion tubing<br>may act as an extension of other<br>infusion tubing in delivering<br>intravenous fluids from a<br>container to patient. | Same | |
| Configuration | Spike Protector<br>Vented Air Cap<br>Air Filter<br>Spike<br>Drip Chamber<br>10 Drops<br>Tubing<br>Back Check Valve<br>Needle Free TYPE Y<br>Clamp<br>Roller Clamp<br>Roller<br>Precision Filter<br>Robert Clamp<br>Male Luer Slip<br>Luer Lock Ring<br>Protective Cap<br>15um Filter<br>Flow Regulator | Universal spike<br>Drip Chamber<br>Tubing<br>Flow Regulator<br>Roller clamp<br>Slide Clamp<br>Luer Locks<br>Filters<br>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<br>K111351 | Remark | |
| Infusion Set<br>Performance | Conform with ISO 8536-4 | Conform with ISO 8536-4 | Same | |
| Flow Rate of<br>Flow<br>Regulator(ml/h) | 20 to 250 | 5 to 250 | Analysis 2 | |
| Filter<br>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<br>Valve | MABS | Non-DEHP Poly Vinyl Chloride | | |
| Needle Free<br>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<br>Type | 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 | |
| Color<br>of<br>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<br>K111351 | Remark | |
| | Flow Regulator<br>White | | | |
| Sterilization | | | | |
| Method | EO sterilized | EO sterilized | Same | |
| SAL | 10-6 | 10-6 | Same | |
| Item | Subject Device | Predicate Device<br>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<br>intended use is to deliver<br>sterile, infusion fluid from a<br>container to the patient with or<br>without flow control features.<br>The I.V. Extension Set mayinfusion tubing in delivering<br>intravenous fluids from a<br>container to patient. | Truecare Biomedix<br>Intravascular administration set<br>intended use is to deliver sterile,<br>infusion fluid from a container<br>to the patient with or without<br>flow control features. Truecare<br>Biomedix infusion tubing may<br>act as an extension of other<br>infusion tubing in delivering<br>intravenous fluids from a<br>container to patient. | Same | |
| Configuration | Spike Protector<br>Vented Air Cap<br>Air Filter<br>Spike<br>Tubing<br>Needle Free TYPE Y<br>Precision Filter<br>Robert Clamp<br>Male Luer Slip<br>Luer Lock Ring<br>Protective Cap<br>Female Luer Connector<br>Female Luer Cap | Universal spike<br>Drip Chamber<br>Tubing<br>Flow Regulator<br>Roller clamp<br>Slide Clamp<br>Luer Locks<br>Filters<br>Y-injection site | Analysis 7 | |
| Operation Mode | Manual | Manual | | |
| Label/Labeling | Conform with 21 CFR Part<br>801 | Conform with 21 CFR Part 801 | Same | |
| Infusion Set<br>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<br>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±0.5ml~4.32±0.5ml | | unknown | Analysis 9 |
| Total Length | 435 ± 15mm~460 ± 15mm | | 177mm (5inch) | Analysis<br>10 |
| | Vented Air Cap | Blue | | |
| | Air Filter | White | | |
| | Spike | White | | |
| | 10 Drops | White | | |
| | Back Check Valve | White | Unknown | Analysis<br>11 |
| Color of component | Needle Free<br>TYPE Y | Blue | | |
| | Protective Cap | Blue | | |
| | 15um Filter | White | | |
| | Flow Regulator | White | | |
| Sterilization | | | | |
| Method | EO sterilized |…
