(421 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a standard medical device (extension tube and needleless connector) and do not mention any AI or ML components or capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is an extension tube and needleless connector for administering fluids, not a device that directly treats a condition or disease. It is a delivery mechanism for therapeutic fluids.
No
The device is an extension tube and needleless connector used for the administration of fluids into a patient's vascular system. Its function is to facilitate fluid delivery, not to diagnose a condition.
No
The device description clearly details a physical medical device (extension tube and needleless connector) used for fluid administration, not a software-only application.
Based on the provided information, the LILY Extension Tube and Needleless Connector is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "administration of fluids from a container into the patient's vascular system through a vascular access device." This describes a device used in vivo (within the living body) for delivering substances to a patient.
- Device Description: The description focuses on the physical characteristics and function of the device in facilitating fluid flow and reducing needle stick injuries during IV therapy.
- Anatomical Site: The anatomical site is the "Patient's vascular system," which is an in vivo location.
- Performance Studies: The performance studies described are related to biocompatibility, functional testing (like pressure resistance, flow rate, etc.), and shelf life – all relevant to a device used directly on a patient. There are no mentions of studies related to analyzing biological samples outside the body.
In Vitro Diagnostic (IVD) devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) in vitro (outside the body) to provide information for diagnostic, monitoring, or screening purposes. The LILY Extension Tube and Needleless Connector does not perform this function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
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)
Biocompatibility:
- Study type: Evaluation and testing within a risk management process, as required for an External Communicating Device, Blood Path Direct Contact (Infusion Only), Prolonged Duration.
- Key Results:
- Cytotoxicity: Pass- No reactivity
- Sensitization: Pass - Non-sensitizing
- Intracutaneous reactivity Irritation in Rabbits: Pass - Non-irritant
- Acute Systemic Toxicity: Pass - Did not cause acute systemic toxicity
- Subacute Toxicity: Pass- Did not cause Subacute Toxicity
- Hemo-compatibility: Pass-Hemo-compatibility
- Hemolysis: Pass - Non-hemolytic
- Pyrogenicity: Pass - Non-pyrogenic
- Endotoxin (Limulus amebocyte lysate test): Pass- Less than 20 EU per device
Bench Testing (Functional Testing):
- Study type: To determine the subject device is substantially equivalent to the predicate device.
- Key Results:
- Sterility: Pass
- 3 Year Shelf Life: Pass
- FDA Guidance Compliance (including Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Stress Cracking, Pressure Liquid Leakage, Subatmospheric-Pressure Air Leakage, Backpressure, IPA Exposure, Infusate Compatibility, Duration of Activation, Number of Activations, Flow Rate, Priming Volume, Residual Volume, Flush Volume, Displacement, Power Injection, Hemolysis, Microbial Ingress, Tensile Strength, Particulate Contamination, Reducing (oxidizable) Matter, Metal Ions, Titration Acidity or Alkalinity, Residue on Evaporation, UV Absorption of Extract Solution): Pass
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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 (1-800-638-2041 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
2
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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
-
- Submitter
LILY Medical Corporation (Manufacturer) No. 28-2, Shun Jeau Diann, Chunan Town, Miaoli County, 35056, Taiwan, R.O.C
- Submitter
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: +886-3-213-8899 #5977 FAX: +886-3-320-8552 E-mail: Steven.CH.Shen@BenQMedicalTech.com.tw
- 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 |
| CET-SS02L0, CET-SS02S0 | |
| 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
-
- Predicate Device
MaxZero Extension Sets with Needleless Connector (K140831)
- Predicate Device
5
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.
-
- 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.
- Intended For Use
-
- Comparison of Technology Characteristics with the Predicate Device
The key technological characteristic of the subject device compared to the Predicate Device is summarized below:
- Comparison of Technology Characteristics with the Predicate Device
6
| Characteristic | Subject Device | Predicate Device | Difference
Rationale |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Device name | LILY Extension Tube and Needleless
Connector (K222780) | MaxZero Extension Sets with
Needleless Connector (K140381) | |
| Model | CIC-005S, CIC-006SN, CIC-007NL
CET-015S, CET-015SD
CET-SS02L0, CET-SS02S0
CET-HS03L0, CET-HS03S0, CET-HT03L0,
CET-HT03S0 | MZ5301, MZ5302, MZ5303, MZ5304,
MZ5305, MZ5306, MZ5307, MZ5308,
MZ9284, MZ9285 | |
| Common Name | IV Administration Set | SAME | |
| Classification | Class II, 21 CFR 880.5440
Set, Administration, Intravascular | SAME | |
| Product Code | FPA | SAME | |
| Indication 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 needle-free delivery
of solutions during IV therapy. | Pressure Rated: The MaxZero multi fuse
extension set with needleless connector(s)
is for single use only. The extension set may
be used for direct injection, intermittent
infusion, continuous infusion or aspiration.
This set may be used with power injector
procedures to a maximum pressure of 325
psi at a flow rate of 10mL per second.
Non Pressure Rated: The MaxZero multi
fuse extension set with needleless
connector(s) is for single use only. The
extension set may be used for direct
injection, intermittent infusion, continuous
infusion or aspiration | |
| Physical
Specification | ● CIC-005S: Needleless connector (A+)
● CIC-006SN: Needleless connector (G2)
● CIC-007NL: Needleless connector (G3)
● CET-015S: Extension tube, A+ connector,
tubing, slide clamp, male luer slip (5.9"
Tubing Length, 0.050" Tubing ID, 0.094"
Tubing OD)
● CET-015SD: Extension tube, A+ connector,
tubing, slide clamp, male luer lock (5.9"
Tubing Length, 0.050" Tubing ID, 0.094"
Tubing OD)
● CET-SS02L0: Extension tube, G2
connector, tubing, slide clamp, male luer
slip (5.9" Tubing Length, 0.050" Tubing ID,
0.094" Tubing OD)
● CET-SS02S0: Extension tube, G2
connector, tubing, slide clamp, male luer
lock (5.9" Tubing Length, 0.050" Tubing ID,
0.094" Tubing OD)
● CET-HS03L0: Extension tube, G3
connector, tubing, slide clamp, male luer
slip (5.9" Tubing Length, 0.040" Tubing ID,
0.094" Tubing OD)
● CET-HS03S0: Extension tube, G3
connector, tubing, slide clamp, male luer
lock (5.9" Tubing Length, 0.040" Tubing ID,
0.094" Tubing OD)
● CET-HT03L0: Extension tube, G3T
connector with male luer slip end, tubing,
slide clamp, female luer lock (5.9" Tubing
Length, 0.040" Tubing ID, 0.094" Tubing
OD)
● CET-HT03S0: Extension tube, G3T
connector with male luer lock end, tubing,
slide clamp, female luer lock (5.9" Tubing
Length, 0.040" Tubing ID, 0.094" Tubing
OD) | ● MZ5301:Pressure rated extension set,
MaxZero connector, slide clamp, spin male
luer lock (7" Total Length, 0.042" Tubing ID,
0.079" Tubing OD)
● MZ5302: Pressure rated extension set,
MaxZero connector, slide clamp, spin male
luer lock (7" Total Length, 0.042" Tubing ID,
0.079" Tubing OD)
● MZ5303: Pressure rated extension set,
MaxZero connector, slide clamp, spin male
luer lock (7" Total Length, 0.060" Tubing ID,
0.144" Tubing OD)
● MZ5304: Pressure rated extension set,
MaxZero connector, slide clamp, spin male
luer lock (7" Total Length, 0.060" Tubing ID,
0.144" Tubing OD)
● MZ5305: Pressure rated extension set,
MaxZero connector, spin male luer lock (7"
Total Length, 0.060" Tubing ID, 0.144"
Tubing OD)
● MZ5306: Pressure rated extension set,
minibore tubing, MaxZero connector, spin
make luer lock (7" Total Length, 0.042"
Tubing ID, 0.079" Tubing OD)
● MZ5307: Bi-fuse pressure rated extension
set, minibore tubing, (2) MaxZero
connectors, (2) slide clamps, spin male luer
lock. (7" Total Length, 0.042" Tubing ID,
0.079" Tubing OD)
● MZ3508: Bi-fuse pressure rated extension
set, minibore tubing, (2) MaxZero
connectors, (2) slide clamps, spin make
luer lock. (6" Total Length, 0.060" Tubing
ID, 0.144" Tubing OD)
● MZ9284: Bi-fuse pressure rated extension
set, minibore tubing, (2) MaxZero
connectors, (2) check valves (2) slide
clamps, spin make luer lock (7" Total
Length, 0.042" Tubing ID, 0.079" Tubing OD) | Different1 |
| Characteristic | Subject Device | Predicate Device | Difference
Rationale |
| | | OD)
● MZ9285: Bi-fuse pressure rated extension
set, minibore tubing, (2) MaxZero
connectors, (2) check valves (2) slide
clamps, spin make luer lock (7" Total
Length, 0.060" Tubing ID, 0.144" Tubing
OD) | |
| Priming Volume | ● CIC-005S: 0.25 mL
● CIC-006SN:0.07 mL
● CIC-007NL: 0.04 mL
● CET-015S: 0.55 mL
● CET-015SD: 0.55 mL
● CET-SS02L0: 0.34 mL
● CET-SS02S0: 0.34 mL
● CET-HS03L0: 0.36 mL
● CET-HS03S0: 0.36 mL
● CET-HT03L0: 0.36 mL
● CET-HT03S0: 0.36 mL | Avg. 0.66 mL - 0.99 mL | |
| Residual Volume | ● CIC-005S: 0.3 mL
● CIC-006SN: 0.07 mL
● CIC-007NL: 0.04 mL
● CET-015S: 0.60 mL
● CET-015SD: 0.60 mL
● CET-SS02L0: 0.34 mL
● CET-SS02S0: 0.34 mL
● CET-HS03L0: 0.36 mL
● CET-HS03S0: 0.36 mL
● CET-HT03L0: 0.36 mL
● CET-HT03S0: 0.36 mL | Unknown | |
| Gravity Flow rate | ● CIC-005S:≥250 mL/min
● CIC-006SN:≥170 mL/min
● CIC-007NL:≥100 mL/min
● CET-015S:≥100 mL/min
● CET-015SD:≥100 mL/min
● CET-SS02L0:≥100 mL/min
● CET-SS02S0:≥100 mL/min
● CET-HS03L0:≥75 mL/min
● CET-HS03S0:≥75 mL/min
● CET-HT03L0:≥75 mL/min
● CET-HT03S0:≥75 mL/min | ≥100 mL/min | Different² |
| Flush Volume | ● CIC-005S: 5mL
● CIC-006SN: 3mL
● CIC-007NL: 1.5mL
● CET-015S: 5mL
● CET-015SD: 5mL
● CET-SS02L0: 3mL
● CET-SS02S0: 3mL
● CET-HS03L0: 3mL
● CET-HS03S0: 3mL
● CET-HT03L0: 3mL
● CET-HT03S0: 3mL | 5 mL | |
| Displacement | ● CIC-005S: ≤0.05 mL
● CIC-006SN: ≤0.003 mL
● CIC-007NL: ≤0.001 mL
● CET-015S: ≤0.05 mL
● CET-015SD: ≤0.05 mL
● CET-SS02L0: ≤0.003 mL
● CET-SS02S0: ≤0.003 mL
● CET-HS03L0: ≤0.003 mL | ~Zero (16uL) | |
| Characteristic | Subject Device | Predicate Device | Difference
Rationale |
| | ● CET-HS03S0: ≤0.001 mL
● CET-HT03L0: ≤0.001 mL
● CET-HT03S0: ≤0.001 mL | | |
| Power Infusion
Flow Rate | 10mL/sec @325 PSI | SAME | |
| Hemolysis | No-Hemolytic | SAME | |
| Use | Single Patient | SAME | |
| Duration of Use | 7 Days | SAME | |
| Number of
Activations | ● CIC-005S: 200
● CIC-006SN: 600
● CIC-007NL: 600
● CET-015S: 200
● CET-015SD: 200
● CET-SS02L0: 600
● CET-SS02S0: 600
● CET-HS03L0: 600
● CET-HS03S0: 600
● CET-HT03L0: 600
● CET-HT03S0: 600 | 200 | Different3 |
| Method of
Disinfection | 70% IPA | SAME | |
| Sterilization
Method | Ethylene Oxide | E-beam (Radiation) | Different4 |
| Provided Sterile | Yes | SAME | |
| Sterile Barrier
Packaging | Medical-Grade Papers;
Heat-Sealed | Tyvek Polyethylene;
Heat-Sealed | Different5 |
| Packaged
Quantity | Single Unit Per Package | SAME | |
Table 7.1, Technology Characteristics
7
8
Different1
The Physical Specification of subject device is different from the predicate device. The subject device consist of needleless connector and extension set with needleless connector. The predicate device consist of extension set with needleless connector only. Both subject device and predicate device on extension set have similar configuration consists of needleless connector, tubing, slide clamps, and male luer connector.
The subject device has been evaluated in performance tests including biocompatibility and bench testing (functional testing) in support of the substantial equivalence determination. The two devices have similar technical characteristics and physical properties, with no new or different questions of safety or effectiveness being raised that would affect the substantial equivalence of the two devices.
In order to ensure the end user to know the differences in technological characteristics of the subject device, the physical specification including components, tubing length and ID/OD are specified in User Manual.
| Model | Components | Tubing
Length | Tubing
ID | Tubing
OD |
|---------------|-------------------------------------------------|------------------|--------------|--------------|
| CIC-
005S | Needleless Connector (A+), Vented Male Luer Cap | NA | NA | NA |
| CIC-
006SN | Needleless Connector (G2), Vented Male Luer Cap | NA | NA | NA |
| CIC-
007NL | Needleless Connector (G3), Vented Male Luer Cap | NA | NA | NA |
9
| Model | Components | Tubing
Length | Tubing
ID | Tubing
OD |
|----------------|-----------------------------------------------------------------------------------------------------------------------------|------------------|--------------------|-------------------|
| CET-
015S | Needleless Connector (A+), Female Luer Lock, Tubing, Male Luer Slip,
Vented Male Luer Cap | 5.9"
(150mm) | 0.050"
(1.27mm) | 0.094"
(2.4mm) |
| CET-
015SD | Needleless Connector (A+), Female Luer Lock, Tubing, Slide Clamp,
Male Luer Lock, Vented Male Luer Cap | 5.9"
(150mm) | 0.050"
(1.27mm) | 0.094"
(2.4mm) |
| CET-
SS02L0 | Needleless Connector (G2), Tubing, Slide Clamp, Male Luer Slip, Vented
Male Luer Cap | 5.9"
(150mm) | 0.050"
(1.27mm) | 0.094"
(2.4mm) |
| CET-
SS02S0 | Needleless Connector (G2), Tubing, Slide Clamp, Male Spin Lure Lock
Assembly, Vented Male Luer Cap | 5.9"
(150mm) | 0.050"
(1.27mm) | 0.094"
(2.4mm) |
| CET-
HS03L0 | Needleless Connector (G3), Female Luer Lock, Tubing, Slide Clamp,
Male Luer Slip, Vented Male Luer Cap | 5.9"
(150mm) | 0.040"
(1 mm) | 0.094"
(2.4mm) |
| CET-
HS03S0 | Needleless Connector (G3), Female Luer Lock, Tubing, Slide Clamp,
Male Spin Lure Lock Assembly, Vented Male Luer Cap | 5.9"
(150mm) | 0.040"
(1 mm) | 0.094"
(2.4mm) |
| CET-
HT03L0 | Needleless Connector (G3T), Vented Male Luer Cap, Tubing, Slide
Clamp, Female Luer Lock, Non-Vented Female Luer Cap | 5.9"
(150mm) | 0.04"
(1 mm) | 0.094"
(2.4mm) |
| CET-
HT03S0 | Needleless Connector (G3T), Nut, Vented Male Luer Cap, Tubing, Slide
Clamp, Female Luer Lock, Non-Vented Female Luer Cap | 5.9"
(150mm) | 0.04"
(1 mm) | 0.094"
(2.4mm) |
Different2
The Priming Volume, Gravity Flow rate, Flush Volume, Displacement of subject device are different from the predicate device, but the Residual Volume of the predicate device is unknown. These minor differences in technological characteristics between the subject device and predicate device do not raise new issues of safety or effectiveness. The LILY Extension Tube and Needleless Connector has been evaluated performance testing according to specified standard of IV Administration Set.
In order to ensure the end user to know the differences in technological characteristics of the subject device, the Priming Volume, Residual Volume, Gravity Flow rate, Flush Volume, and Displacement of subject device are described in User Manual.
Different3
The Duration of Use and Number of Activations times of subject device are different from the predicate device. The subject device has undergone microbial ingress testing, and the test results demonstrate the model of CIC-005S, CET-015S, and CET-015SD can be used for 7 days and 200 activations, the others can be used for 7 days and 600 activations. Therefore, the difference will not affect the safety and effectiveness of the subject device.
In addition, in order to ensure the end user to know the Duration of Use and Number of Activations times of the subject device, the service time and activation times of subject device are described in User Manual.
Different4
The LILY Extension Tube and Needleless Connector is ethylene oxide gas sterilized compared to the predicate device which is sterilized by radiation. Both methods of sterilization are widely used in the medical device industry and utilize FDA recognized standards for sterilization validation. Both devices are functionally evaluated after all manufacturing processes including exposure to sterilization conditions which demonstrates no issues of safety or effectiveness.
Different5
The package of LILY Extension Tube and Needleless Connector is Medical-Grade Papers in Heat-Sealed compared to the predicate device which is Tyvek Polyethylene in Heat-Sealed. Both materials are considered for use in medical packaging, the Seal Strength, Dye Penetration, Burst Test & Creep Test are evaluated after all manufacturing processes including exposure to sterilization conditions which demonstrates no issues of safety or effectiveness.
10
8. Performance Testing
The following non-clinical data were provided in support of the substantial equivalence determination:
Biocompatibility:
Conducted per Guidance Document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"; Guidance for Industry and Food and Drug Administration Staff, Jun 16, 2016 and "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]," July 11, 2008, as recognized by the FDA. Biocompatibility testing was conducted in accordance with the cited guidance and standards as required for an External Communicating Device, Blood Path Direct Contact (Infusion Only), Prolonged Duration.
| Test | Standard | Result |
|---|---|---|
| Cytotoxicity | FDA Recognition Number 2-245, ISO 10993- | |
| 5: 2009, Biological Evaluation of Medical | ||
| Devices Part 5: Tests for in vitro Cytotoxicity | Pass- No reactivity | |
| Sensitization | FDA Recognition Number 2-296, ISO 10993- | |
| 10: 2021, Biological evaluation of medical | ||
| devices Part 10: Tests for irritation and skin | ||
| sensitization | Pass - Non-sensitizing | |
| Intracutaneous reactivity | ||
| Irritation in Rabbits | FDA Recognition Number 2-291, ISO 10993- | |
| 23:2021, Biological Evaluation Of Medical | ||
| Devices - Part 23: Tests For Irritation | Pass - Non-irritant | |
| Acute Systemic Toxicity | FDA Recognition Number 2-255, ISO 10993- | |
| 11:2017,Biological evaluation of medical | ||
| devices Part 11: Tests for systemic toxicity | Pass - Did not cause acute | |
| systemic toxicity | ||
| Subacute Toxicity | Pass- Did not cause | |
| Subacute Toxicity | ||
| Hemo-compatibility | FDA Recognition Number 2-248, ISO 10993- | |
| 4: 2017,Biological evaluation of medical | ||
| devices Part 4: Tests for Interactions with | ||
| Blood | Pass-Hemo-compatibility | |
| Hemolysis | FDA Recognition Number 2-250, ASTM F | |
| 756 - 17: Standard Practice for Assessment | ||
| of Hemolytic Properties of Materials | Pass - Non-hemolytic | |
| Pyrogenicity | USP Pyrogen Test Procedure, Section |
| Pass - Non-pyrogenic |
| Endotoxin (Limulus
amebocyte lysate test) | USP , Medical Devices-Bacterial
Endotoxin and Pyrogen Tests | Pass- Less than 20 EU per
device |
Table 8.1, Biocompatibility Testing
Bench Testing (Functional Testing):
The following bench testing was conducted on the LILY Extension Tube and Needleless Connector to determine the subject device is substantially equivalent to the predicate device.
| Test | Standard | Result |
|---|---|---|
| Sterility | FDA Recognition Number 14-529, ISO 11135:2014/AMD | |
| 1:2018 Sterilization of health-care products – Ethylene oxide | ||
| – Requirements for the development, validation and routine | ||
| control of a sterilization process for medical devices – | ||
| Amendment 1: Revision of Annex E, Single batch release | ||
| FDA Recognition Number 2-275, ISO 10993-7:2008/Amd | Pass |
11
| Test | Standard | Result |
|---|---|---|
| 1:2019 Biological evaluation of medical devices - Part 7: | ||
| Ethylene oxide sterilization residuals — Amendment 1: | ||
| Applicability of allowable limits for neonates and infants | ||
| 3 Year Shelf Life | FDA Recognition Number 14-497, ASTM F1980-16: | |
| Standard Guide for Accelerated Aging of Sterile Barrier | ||
| Systems for Medical Devices | ||
| FDA Recognition Number 14-530, ISO 11607-1 Second | ||
| Edition 2019-02: Packaging for terminally sterilized medical | ||
| devices - Part 1. Requirements for materials, sterile barrier | ||
| systems, and packaging systems | Pass | |
| FDA Guidance Compliance: |
- Resistance to Separation from
Axial Load - Resistance to Separation from
Unscrewing - Resistance to Overriding
- Stress Cracking
- Pressure Liquid Leakage
- Subatmospheric-Pressure Air
Leakage - Backpressure
- IPA Exposure
- Infusate Compatibility
- Duration of Activation
- Number of Activations
- Flow Rate
- Priming Volume
- Residual Volume
- Flush Volume
- Displacement
- Power Injection
- Hemolysis
- Microbial Ingress
- Tensile Strength
- Particulate Contamination
- Reducing (oxidizable) Matter
- Metal Ions
- Titration Acidity or Alkalinity
- Residue on Evaporation
- UV Absorption of Extract Solution | FDA Guidance: Intravascular Administration Sets Premarket
Notification Submission [510(k)]: 2008
FDA Recognition Number 6-481, AAMI ANSI CN27:2021,
General requirements for Luer activated valves (LAVs)
incorporated into medical devices for intravascular
applications
FDA Recognition Number 6-447, ISO 8536-4:2019, Infusion
equipment for medical use —Part 4:Infusion sets for single
use, gravity feed
FDA Recognition Number 5-133, ISO 80369-7:2021, Small-
bore connectors for liquids and gases in healthcare
applications - Part 7: Connectors for intravascular or
hypodermic applications
FDA Recognition Number 5-97, ISO 80369-20:2015, Small-
bore connectors for liquids and gases in healthcare
applications - Part 20: Common test methods
USP Particulate Contamination | Pass |
9. Clinical Studies
No clinical study is included in this submission.
10. Conclusion
The conclusions drawn from the performance testing tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.