LILY Extension Tube and Needleless Connector

K222780 · Lily Medical Corporation · FPA · Nov 9, 2023 · General Hospital

Device Facts

• Record ID: K222780
• Device Name: LILY Extension Tube and Needleless Connector
• Applicant: Lily Medical Corporation
• Product Code: FPA · General Hospital
• Decision Date: Nov 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LILY Extension Tube and Needleless Connector is intended for use in the delivery of fluids from a container to a patient's vascular system.

Device Story

LILY Extension Tube and Needleless Connector is a closed, luer-activated device designed to reduce needle-stick injuries during IV therapy. It facilitates fluid administration, aspiration, and infusion from containers to a patient's vascular system. The device features a solid, sealed surface for disinfection (3 seconds) and a clear housing with an open, fluid-filled design to enhance flushing of particles and reduce dead space. It is compatible with power injection up to 325 psi at 10 mL/sec. The device is used in clinical settings by healthcare providers. It connects to standard administration sets, extension sets, and syringes via ISO male luers. By providing a needle-free interface, it benefits patients by reducing the risk of needle-stick injuries and maintaining a closed system for fluid delivery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), sterility validation, shelf-life testing (ASTM F1980), and functional performance testing (e.g., pressure liquid leakage, flow rate, power injection, microbial ingress, and connector compatibility per ISO 80369-7).

Technological Characteristics

Device consists of needleless connectors and extension tubing with slide clamps and luer connectors. Materials are medical-grade; sterilization via Ethylene Oxide. Connectivity is via ISO 80369-7 compliant small-bore luer connectors. Designed for power injection (325 psi, 10 mL/s).

Indications for Use

Indicated for sterile single patient use for administration of fluids from a container into a patient's vascular system via a vascular access device. Used for direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of solutions during IV 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

• MaxZero Extension Sets with Needleless Connector (K140831)

Submission Summary (Full Text)

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November 9, 2023

LILY Medical Corporation % Steven Shen Senior Manager BenO Medical Technology Corporation 3F, No. 159, Shan-Ying Road, Shan-Ding Village Gueishan Dist. Taoyuan, Taiwan 333 China

Re: K222780

Trade/Device Name: LILY Extension Tube and Needleless Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 28, 2023 Received: October 10, 2023

Dear Steven Shen:

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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or 301-796-7100).

Sincerely,

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors

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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) K222780

Device Name

LILY Extension Tube and Needleless Connector

#### Indications for Use (Describe)

The LILY Extension Tube and Needleless Connector is a sterile single for the administration of fluids from a container into the patient's vascular system through a vascular access device. It is for direct injection, continuous or intermittent infusion, aspiration and needle-free delivery of solutions during IV therapy.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span></span> </div> |
|----------------------------------------------|----------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span></span> </div> |

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# K222780 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

The Assigned 510(k) number is K222780

Date Prepared: 11/08/2023

- 1. Submitter
LILY Medical Corporation (Manufacturer) No. 28-2, Shun Jeau Diann, Chunan Town, Miaoli County, 35056, Taiwan, R.O.C

Official Correspondence: Mr. Steven Shen Senior Manager BenQ Medical Technology Corporation 3F, No. 159, Shan-Ying Road, Shan-Ding Village, Gueishan Dist. Taoyuan City, TW 333 Phone: [phone] #5977 FAX: [phone] E-mail: [e-mail]

- Device Information 2.
Device Name: LILY Extension Tube and Needleless Connector Model:

| Device | Model |
|----------------------|-------------------------------------------------------------------------------------------------|
| Needleless Connector | CIC-005S, CIC-006SN, CIC-007NL |
| Extension Tube | CET-015S, CET-015SD<br>CET-SS02L0, CET-SS02S0<br>CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0 |

Common Name: IV Administration Set

Classification Name: Intravascular administration set Regulation Number: 21 CFR 880.5440 /General Hospital (80) Classification: Class II, Product Code: FPA

- 3. Predicate Device
MaxZero Extension Sets with Needleless Connector (K140831)

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#### 4. Device Description

The LILY Extension Tube and Needleless is a closed luer activated device and passively aids in the reduction of needle stick injuries. Fluid flow through the device is activated by the ISO male luer from standard administration set, extension sets and syringes.

The LILY Extension Tube and Needleless Connector provide a solid, sealed, surface for effective disinfection in 3 seconds. It is non-hemolytic. The clear housing and open, fluid filled design of the LILY Extension Tube and Needleless Connector enhance flushing particles. There is less volume of interstitial or dead space internal to the device.

The LILY Extension Tube and Needleless Connector may be sued with power injection procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second.

#### 5. Indications For Use

The LILY Extension Tube and Needleless Connector is a sterile single patient use device for the administration of fluids from a container into the patient's vascular system through a vascular access device. It is for direct injection, continuous or intermittent infusion, aspiration and needlefree delivery of solutions during IV therapy.

- 6. Intended For Use
The LILY Extension Tube and Needleless Connector is intended for use in the delivery of fluids from a container to a patient's vascular system.

- 7. Comparison of Technology Characteristics with the Predicate Device
The key technological characteristic of the subject device compared to the Predicate Device is summarized below:

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| Characteristic | Subject Device | Predicate Device | Difference<br>Rationale |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device name | LILY Extension Tube and Needleless<br>Connector (K222780) | MaxZero Extension Sets with<br>Needleless Connector (K140381) | |
| Model | CIC-005S, CIC-006SN, CIC-007NL<br>CET-015S, CET-015SD<br>CET-SS02L0, CET-SS02S0<br>CET-HS03L0, CET-HS03S0, CET-HT03L0,<br>CET-HT03S0 | MZ5301, MZ5302, MZ5303, MZ5304,<br>MZ5305, MZ5306, MZ5307, MZ5308,<br>MZ9284, MZ9285 | |
| Common Name | IV Administration Set | SAME | |
| Classification | Class II, 21 CFR 880.5440<br>Set, Administration, Intravascular | SAME | |
| Product Code | FPA | SAME | |
| Indication for use | The LILY Extension Tube and Needleless<br>Connector is a sterile single patient use<br>device for the administration of fluids from a<br>container into the patient's vascular system<br>through a vascular access device. It is for<br>direct injection, continuous or intermittent<br>infusion, aspiration and needle-free delivery<br>of solutions during IV therapy. | Pressure Rated: The MaxZero multi fuse<br>extension set with needleless connector(s)<br>is for single use only. The extension set may<br>be used for direct injection, intermittent<br>infusion, continuous infusion or aspiration.<br>This set may be used with power injector<br>procedures to a maximum pressure of 325<br>psi at a flow rate of 10mL per second.<br>Non Pressure Rated: The MaxZero multi<br>fuse extension set with needleless<br>connector(s) is for single use only. The<br>extension set may be used for direct<br>injection, intermittent infusion, continuous<br>infusion or aspiration | |
| Physical<br>Specification | ● CIC-005S: Needleless connector (A+)<br>● CIC-006SN: Needleless connector (G2)<br>● CIC-007NL: Needleless connector (G3)<br>● CET-015S: Extension tube, A+ connector,<br>tubing, slide clamp, male luer slip (5.9"<br>Tubing Length, 0.050" Tubing ID, 0.094"<br>Tubing OD)<br>● CET-015SD: Extension tube, A+ connector,<br>tubing, slide clamp, male luer lock (5.9"<br>Tubing Length, 0.050" Tubing ID, 0.094"<br>Tubing OD)<br>● CET-SS02L0: Extension tube, G2<br>connector, tubing, slide clamp, male luer<br>slip (5.9" Tubing Length, 0.050" Tubing ID,<br>0.094" Tubing OD)<br>● CET-SS02S0: Extension tube, G2<br>connector, tubing, slide clamp, male luer<br>lock (5.9" Tubing Length, 0.050" Tubing ID,<br>0.094" Tubing OD)<br>● CET-HS03L0: Extension tube, G3<br>connector, tubing, slide clamp, male luer<br>slip (5.9" Tubing Length, 0.040" Tubing ID,<br>0.094" Tubing OD)<br>● CET-HS03S0: Extension tube, G3<br>connector, tubing, slide clamp, male luer<br>lock (5.9" Tubing Length, 0.040" Tubing ID,<br>0.094" Tubing OD)<br>● CET-HT03L0: Extension tube, G3T<br>connector with male luer slip end, tubing,<br>slide clamp, female luer lock (5.9" Tubing<br>Length, 0.040" Tubing ID, 0.094" Tubing<br>OD)<br>● CET-HT03S0: Extension tube, G3T<br>connector with male luer lock end, tubing,<br>slide clamp, female luer lock (5.9" Tubing<br>Length, 0.040" Tubing ID, 0.094" Tubing<br>OD) | ● MZ5301:Pressure rated extension set,<br>MaxZero connector, slide clamp, spin male<br>luer lock (7" Total Length, 0.042" Tubing ID,<br>0.079" Tubing OD)<br>● MZ5302: Pressure rated extension set,<br>MaxZero connector, slide clamp, spin male<br>luer lock (7" Total Length, 0.042" Tubing ID,<br>0.079" Tubing OD)<br>● MZ5303: Pressure rated extension set,<br>MaxZero connector, slide clamp, spin male<br>luer lock (7" Total Length, 0.060" Tubing ID,<br>0.144" Tubing OD)<br>● MZ5304: Pressure rated extension set,<br>MaxZero connector, slide clamp, spin male<br>luer lock (7" Total Length, 0.060" Tubing ID,<br>0.144" Tubing OD)<br>● MZ5305: Pressure rated extension set,<br>MaxZero connector, spin male luer lock (7"<br>Total Length, 0.060" Tubing ID, 0.144"<br>Tubing OD)<br>● MZ5306: Pressure rated extension set,<br>minibore tubing, MaxZero connector, spin<br>make luer lock (7" Total Length, 0.042"<br>Tubing ID, 0.079" Tubing OD)<br>● MZ5307: Bi-fuse pressure rated extension<br>set, minibore tubing, (2) MaxZero<br>connectors, (2) slide clamps, spin male luer<br>lock. (7" Total Length, 0.042" Tubing ID,<br>0.079" Tubing OD)<br>● MZ3508: Bi-fuse pressure rated extension<br>set, minibore tubing, (2) MaxZero<br>connectors, (2) slide clamps, spin make<br>luer lock. (6" Total Length, 0.060" Tubing<br>ID, 0.144" Tubing OD)<br>● MZ9284: Bi-fuse pressure rated extension<br>set, minibore tubing, (2) MaxZero<br>connectors, (2) check valves (2) slide<br>clamps, spin make luer lock (7" Total<br>Length, 0.042" Tubing ID, 0.079" Tubing OD) | Different1 |
| Characteristic | Subject Device | Predicate Device | Difference<br>Rationale |
| | | OD)<br>● MZ9285: Bi-fuse pressure rated extension<br>set, minibore tubing, (2) MaxZero<br>connectors, (2) check valves (2) slide<br>clamps, spin make luer lock (7" Total<br>Length, 0.060" Tubing ID, 0.144" Tubing<br>OD) | |
| Priming Volume | ● CIC-005S: 0.25 mL<br>● CIC-006SN:0.07 mL<br>● CIC-007NL: 0.04 mL<br>● CET-015S: 0.55 mL<br>● CET-015SD: 0.55 mL<br>● CET-SS02L0: 0.34 mL<br>● CET-SS02S0: 0.34 mL<br>● CET-HS03L0: 0.36 mL<br>● CET-HS03S0: 0.36 mL<br>● CET-HT03L0: 0.36 mL<br>● CET-HT03S0: 0.36 mL | Avg. 0.66 mL - 0.99 mL | |
| Residual Volume | ● CIC-005S: 0.3 mL<br>● CIC-006SN: 0.07 mL<br>● CIC-007NL: 0.04 mL<br>● CET-015S: 0.60 mL<br>● CET-015SD: 0.60 mL<br>● CET-SS02L0: 0.34 mL<br>● CET-SS02S0: 0.34 mL<br>● CET-HS03L0: 0.36 mL<br>● CET-HS03S0: 0.36 mL<br>● CET-HT03L0: 0.36 mL<br>● CET-HT03S0: 0.36 mL | Unknown | |
| Gravity Flow rate | ● CIC-005S:≥250 mL/min<br>● CIC-006SN:≥170 mL/min<br>● CIC-007NL:≥100 mL/min<br>● CET-015S:≥100 mL/min<br>● CET-015SD:≥100 mL/min<br>● CET-SS02L0:≥100 mL/min<br>● CET-SS02S0:≥100 mL/min<br>● CET-HS03L0:≥75 mL/min<br>● CET-HS03S0:≥75 mL/min<br>● CET-HT03L0:≥75 mL/min<br>● CET-HT03S0:≥75 mL/min | ≥100 mL/min | Different² |
| Flush Volume | ● CIC-005S: 5mL<br>● CIC-006SN: 3mL<br>● CIC-007NL: 1.5mL<br>● CET-015S: 5mL<br>● CET-015SD: 5mL<br>● CET-SS02L0: 3mL<br>● CET-SS02S0: 3mL<br>● CET-HS03L0: 3mL<br>● CET-HS03S0: 3mL<br>● CET-HT03L0: 3mL<br>● CET-HT03S0: 3mL | 5 mL | |
| Displacement | ● CIC-005S: ≤0.05 mL<br>● CIC-006SN: ≤0.003 mL<br>● CIC-007NL: ≤0.001 mL<br>● CET-015S: ≤0.05 mL<br>● CET-015SD: ≤0.05 mL<br>● CET-SS02L0: ≤0.003 mL<br>● CET-SS02S0: ≤0.003 mL<br>● CET-HS03L0: ≤0.003 mL | ~Zero (16uL) | |
| Characteristic | Subject Device | Predicate Device | Difference<br>Rationale |
| | ● CET-HS03S0: ≤0.001 mL<br>● CET-HT03L0: ≤0.001 mL<br>● CET-HT03S0: ≤0.001 mL | | |
| Power Infusion<br>Flow Rate | 10mL/sec @325 PSI | SAME | |
| Hemolysis | No-Hemolytic | SAME | |
| Use | Single Patient | SAME | |
| Duration of Use | 7 Days | SAME | |
| Number of<br>Activations | ● CIC-005S: 200<br>● CIC-006SN: 600<br>● CIC-007NL: 600<br>● CET-015S: 200<br>● CET-015SD: 200<br>● CET-SS02L0: 600<br>● CET-SS02S0: 600<br>● CET-HS03L0: 600<br>● CET-HS03S0: 600<br>● CET-HT03L0: 600<br>● CET-HT03S0: 600 | 200 | Different3 |
| Method of<br>Disinfection | 70% IPA…