(421 days)
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.
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.
The LILY Extension Tube and Needleless Connector is a sterile single-patient-use device intended for the administration of fluids into a patient's vascular system. It facilitates direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of solutions during IV therapy.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly present a table of "acceptance criteria" for the LILY Extension Tube and Needleless Connector. Instead, it presents a comparison of the subject device's technological characteristics with a predicate device (MaxZero Extension Sets with Needleless Connector, K140831), and then details performance testing results against recognized standards and FDA guidance.
However, based on the provided "Comparison of Technology Characteristics with the Predicate Device" and "Performance Testing" sections, we can infer some of the implicit acceptance criteria and the device's reported performance against them.
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implied / Inferred from Predicate or Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | - Cytotoxicity: No reactivity (ISO 10993-5) | Pass - No reactivity |
| - Sensitization: Non-sensitizing (ISO 10993-10) | Pass - Non-sensitizing | |
| - Intracutaneous reactivity/Irritation: Non-irritant (ISO 10993-23) | Pass - Non-irritant | |
| - Acute Systemic Toxicity: No acute systemic toxicity (ISO 10993-11) | Pass - Did not cause acute systemic toxicity | |
| - Subacute Toxicity: No subacute toxicity (ISO 10993-11) | Pass - Did not cause Subacute Toxicity | |
| - Hemo-compatibility: Compatible with blood (ISO 10993-4) | Pass - Hemo-compatibility | |
| - Hemolysis: Non-hemolytic (ASTM F756-17) | Pass - Non-hemolytic | |
| - Pyrogenicity: Non-pyrogenic (USP <40>, <151>) | Pass - Non-pyrogenic | |
| - Endotoxin: Less than 20 EU per device (USP <161>) | Pass - Less than 20 EU per device | |
| Functional / Physical Performance | - Sterility: Sterile (ISO 11135:2014/AMD 1:2018, ISO 10993-7:2008/Amd 1:2019) | Pass |
| - 3-Year Shelf Life: Maintain integrity and sterility over 3 years (ASTM F1980-16, ISO 11607-1) | Pass | |
| - Resistance to Separation (Axial Load, Unscrewing, Overriding): Meet specified requirements (FDA Guidance, AAMI ANSI CN27:2021) | Pass | |
| - Stress Cracking: Meet specified requirements (FDA Guidance) | Pass | |
| - Pressure Liquid Leakage: No leakage (FDA Guidance) | Pass | |
| - Subatmospheric-Pressure Air Leakage: No air leakage (FDA Guidance) | Pass | |
| - Backpressure: Meet specified requirements (FDA Guidance) | Pass | |
| - IPA Exposure: Maintain functionality after IPA exposure (FDA Guidance) | Pass | |
| - Infusate Compatibility: No adverse interactions with infusates (FDA Guidance) | Pass | |
| - Duration of Activation: Maintain functionality for specified duration (e.g., 7 days) (FDA Guidance) | Pass (7 days) | |
| - Number of Activations: Maintain functionality for specified number of activations (e.g., 200 or 600) (FDA Guidance) | Pass (200 for CIC-005S, CET-015S, CET-015SD; 600 for others) | |
| - Flow Rate (Gravity): Meet or exceed specified flow rate (e.g., ≥100 mL/min for many models, ≥75 mL/min for others) (FDA Guidance, ISO 8536-4:2019) | - CIC-005S: ≥250 mL/min- CIC-006SN: ≥170 mL/min- CIC-007NL: ≥100 mL/min- CET-015S, CET-015SD, CET-SS02L0, CET-SS02S0: ≥100 mL/min- CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: ≥75 mL/min | |
| - Priming Volume: Within acceptable limits for intended use (FDA Guidance, ISO 80369-7:2021) | - CIC-005S: 0.25 mL- CIC-006SN: 0.07 mL- CIC-007NL: 0.04 mL- CET-015S, CET-015SD: 0.55 mL- CET-SS02L0, CET-SS02S0: 0.34 mL- CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 0.36 mL | |
| - Residual Volume: Within acceptable limits for intended use (FDA Guidance, ISO 80369-7:2021) | - CIC-005S: 0.3 mL- CIC-006SN: 0.07 mL- CIC-007NL: 0.04 mL- CET-015S, CET-015SD: 0.60 mL- CET-SS02L0, CET-SS02S0: 0.34 mL- CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 0.36 mL | |
| - Flush Volume: Meet specified requirements (FDA Guidance, ISO 80369-7:2021) | - CIC-005S, CET-015S, CET-015SD: 5mL- CIC-006SN, CIC-007NL, CET-SS02L0, CET-SS02S0, CET-HS03L0, CET-HS03S0, CET-HT03L0, CET-HT03S0: 3mL | |
| - Displacement: Within acceptable limits (FDA Guidance, ISO 80369-7:2021) | - CIC-005S, CET-015S, CET-015SD: ≤0.05 mL- CIC-006SN, CET-SS02L0, CET-SS02S0, CET-HS03L0: ≤0.003 mL- CIC-007NL, CET-HS03S0, CET-HT03L0, CET-HT03S0: ≤0.001 mL | |
| - Power Injection: Capable of 10mL/sec @ 325 PSI (FDA Guidance) | Pass (10mL/sec @325 PSI) | |
| - Microbial Ingress: Prevent microbial ingress (FDA Guidance) | Pass | |
| - Tensile Strength: Meet specified requirements for material strength (FDA Guidance) | Pass | |
| - Particle Contamination: Meet USP <788> requirements | Pass (USP <788>) | |
| - Reducing (oxidizable) Matter: Meet specified requirements (FDA Guidance) | Pass | |
| - Metal Ions: Meet specified requirements (FDA Guidance) | Pass | |
| - Titration Acidity or Alkalinity: Meet specified requirements (FDA Guidance) | Pass | |
| - Residue on Evaporation: Meet specified requirements (FDA Guidance) | Pass | |
| - UV Absorption of Extract Solution: Meet specified requirements (FDA Guidance) | Pass | |
| Device Characteristics (Comparison) | - Indication for use: Administration of fluids from container into patient's vascular system through a vascular access device; for direct injection, continuous or intermittent infusion, aspiration, and needle-free delivery of solutions during IV therapy, similar to predicate device. | Matches predicate device in intended use and indications. |
| - Power Infusion Flow Rate: Capable of 10mL/sec @325 PSI, same as predicate. | Same as predicate. | |
| - Hemolysis: Non-hemolytic, same as predicate. | Same as predicate. | |
| - Use: Single Patient, same as predicate. | Same as predicate. | |
| - Method of Disinfection: 70% IPA, same as predicate. | Same as predicate. | |
| - Provided Sterile: Yes, same as predicate. | Same as predicate. | |
| - Packaged Quantity: Single Unit Per Package, same as predicate. | Same as predicate. | |
| Differences from Predicate (with Rationale for Equivalence) | - Physical Specification: Different component configuration (needleless connector alone vs. extension set with connector). Acceptance: Performance tests (biocompatibility, bench testing) demonstrated substantial equivalence. Physical specs (tubing length/ID/OD) are in User Manual. | Differences in models and specific dimensions exist, but testing validated safety and effectiveness. |
| - Gravity Flow Rate, Priming Volume, Residual Volume, Flush Volume, Displacement: Different values from predicate. Acceptance: Minor differences, performance evaluated per standards, no new safety/effectiveness issues. Values are detailed in User Manual. | Device meets specified flow rates (per model), and priming/residual/flush/displacement volumes are documented and deemed safe. | |
| - Number of Activations: Subject device has higher activation capacity for some models (600 vs. 200 for predicate). Acceptance: Microbial ingress testing demonstrated safety for expanded activation counts. Details are in User Manual. | Some models pass 600 activations, others 200, which is higher or equal to the predicate's 200. | |
| - Sterilization Method: Ethylene Oxide vs. E-beam (Radiation) for predicate. Acceptance: Both are widely used, FDA recognized methods; functional evaluation post-sterilization showed no issues. | ETO sterilization is validated and found safe and effective. | |
| - Sterile Barrier Packaging: Medical-Grade Papers vs. Tyvek Polyethylene for predicate. Acceptance: Both materials are suitable, and seal strength, dye penetration, burst, and creep tests demonstrated no issues. | Packaging materials and integrity tests (Seal Strength, Dye Penetration, Burst Test & Creep Test) passed. |
The Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed in the "Performance Testing" section of the 510(k) Summary. It consists of two main types of testing:
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1 and FDA guidance for an External Communicating Device, Blood Path Direct Contact (Infusion Only), Prolonged Duration.
- Bench Testing (Functional Testing): Conducted against specific FDA guidance and recognized ISO/ASTM standards relevant to intravascular administration sets and luer activated valves.
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each individual biocompatibility or bench test. It reports the results of these tests as "Pass."
The data provenance is from non-clinical data provided by LILY Medical Corporation, a manufacturer based in Taoyuan, Taiwan. The tests were likely conducted in laboratories associated with the manufacturer or certified testing facilities. The tests are "bench tests," making the concept of "country of origin of the data" less relevant in a clinical context; rather, it refers to the location where the physical tests were performed. These are non-clinical (pre-clinical) studies, not human subject studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes non-clinical performance testing (biocompatibility and functional bench testing), not a clinical study involving human readers or expert panels establishing ground truth for diagnostic or AI performance. The "ground truth" for these tests is defined by the acceptance limits of the scientific standards and FDA guidance used.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic imaging, where expert consensus is needed to establish a definitive diagnosis (ground truth). The tests described here have objective pass/fail criteria based on physical properties and known biological responses.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a physical medical device (extension tube and needleless connector), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing described is established by:
- International Standards: e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, ISO 11607-1 for packaging, ISO 8536-4 for infusion equipment, ISO 80369 series for small-bore connectors.
- National Standards: e.g., ASTM F1980-16 for accelerated aging, ASTM F756-17 for hemolysis, AAMI ANSI CN27:2021 for Luer activated valves.
- Pharmacopoeia Standards: e.g., USP <40>, <151> for pyrogenicity, USP <161> for endotoxin, USP <788> for particulate contamination.
- FDA Guidance Documents: Specifically, "Use of International Standard ISO 10993-1," "Intravascular Administration Sets Premarket Notification Submissions [510(k)]," which define acceptable performance and safety profiles for this class of device.
These standards and guidances provide the objective criteria and methodologies against which the device's performance is measured, effectively serving as the "ground truth."
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of physical medical device performance testing as described. Training sets are relevant for machine learning models.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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"
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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 (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
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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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
-
- 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-015SDCET-SS02L0, CET-SS02S0CET-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
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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.
-
- 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
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| Characteristic | Subject Device | Predicate Device | DifferenceRationale |
|---|---|---|---|
| Device name | LILY Extension Tube and NeedlelessConnector (K222780) | MaxZero Extension Sets withNeedleless Connector (K140381) | |
| Model | CIC-005S, CIC-006SN, CIC-007NLCET-015S, CET-015SDCET-SS02L0, CET-SS02S0CET-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 880.5440Set, Administration, Intravascular | SAME | |
| Product Code | FPA | SAME | |
| Indication for use | The LILY Extension Tube and NeedlelessConnector is a sterile single patient usedevice for the administration of fluids from acontainer into the patient's vascular systemthrough a vascular access device. It is fordirect injection, continuous or intermittentinfusion, aspiration and needle-free deliveryof solutions during IV therapy. | Pressure Rated: The MaxZero multi fuseextension set with needleless connector(s)is for single use only. The extension set maybe used for direct injection, intermittentinfusion, continuous infusion or aspiration.This set may be used with power injectorprocedures to a maximum pressure of 325psi at a flow rate of 10mL per second.Non Pressure Rated: The MaxZero multifuse extension set with needlelessconnector(s) is for single use only. Theextension set may be used for directinjection, intermittent infusion, continuousinfusion or aspiration | |
| PhysicalSpecification | ● 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, G2connector, tubing, slide clamp, male luerslip (5.9" Tubing Length, 0.050" Tubing ID,0.094" Tubing OD)● CET-SS02S0: Extension tube, G2connector, tubing, slide clamp, male luerlock (5.9" Tubing Length, 0.050" Tubing ID,0.094" Tubing OD)● CET-HS03L0: Extension tube, G3connector, tubing, slide clamp, male luerslip (5.9" Tubing Length, 0.040" Tubing ID,0.094" Tubing OD)● CET-HS03S0: Extension tube, G3connector, tubing, slide clamp, male luerlock (5.9" Tubing Length, 0.040" Tubing ID,0.094" Tubing OD)● CET-HT03L0: Extension tube, G3Tconnector with male luer slip end, tubing,slide clamp, female luer lock (5.9" TubingLength, 0.040" Tubing ID, 0.094" TubingOD)● CET-HT03S0: Extension tube, G3Tconnector with male luer lock end, tubing,slide clamp, female luer lock (5.9" TubingLength, 0.040" Tubing ID, 0.094" TubingOD) | ● MZ5301:Pressure rated extension set,MaxZero connector, slide clamp, spin maleluer lock (7" Total Length, 0.042" Tubing ID,0.079" Tubing OD)● MZ5302: Pressure rated extension set,MaxZero connector, slide clamp, spin maleluer lock (7" Total Length, 0.042" Tubing ID,0.079" Tubing OD)● MZ5303: Pressure rated extension set,MaxZero connector, slide clamp, spin maleluer lock (7" Total Length, 0.060" Tubing ID,0.144" Tubing OD)● MZ5304: Pressure rated extension set,MaxZero connector, slide clamp, spin maleluer 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, spinmake luer lock (7" Total Length, 0.042"Tubing ID, 0.079" Tubing OD)● MZ5307: Bi-fuse pressure rated extensionset, minibore tubing, (2) MaxZeroconnectors, (2) slide clamps, spin male luerlock. (7" Total Length, 0.042" Tubing ID,0.079" Tubing OD)● MZ3508: Bi-fuse pressure rated extensionset, minibore tubing, (2) MaxZeroconnectors, (2) slide clamps, spin makeluer lock. (6" Total Length, 0.060" TubingID, 0.144" Tubing OD)● MZ9284: Bi-fuse pressure rated extensionset, minibore tubing, (2) MaxZeroconnectors, (2) check valves (2) slideclamps, spin make luer lock (7" TotalLength, 0.042" Tubing ID, 0.079" Tubing OD) | Different1 |
| Characteristic | Subject Device | Predicate Device | DifferenceRationale |
| OD)● MZ9285: Bi-fuse pressure rated extensionset, minibore tubing, (2) MaxZeroconnectors, (2) check valves (2) slideclamps, spin make luer lock (7" TotalLength, 0.060" Tubing ID, 0.144" TubingOD) | |||
| 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 | DifferenceRationale |
| ● CET-HS03S0: ≤0.001 mL● CET-HT03L0: ≤0.001 mL● CET-HT03S0: ≤0.001 mL | |||
| Power InfusionFlow Rate | 10mL/sec @325 PSI | SAME | |
| Hemolysis | No-Hemolytic | SAME | |
| Use | Single Patient | SAME | |
| Duration of Use | 7 Days | SAME | |
| Number ofActivations | ● 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 ofDisinfection | 70% IPA | SAME | |
| SterilizationMethod | Ethylene Oxide | E-beam (Radiation) | Different4 |
| Provided Sterile | Yes | SAME | |
| Sterile BarrierPackaging | Medical-Grade Papers;Heat-Sealed | Tyvek Polyethylene;Heat-Sealed | Different5 |
| PackagedQuantity | Single Unit Per Package | SAME |
Table 7.1, Technology Characteristics
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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 | TubingLength | TubingID | TubingOD |
|---|---|---|---|---|
| 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 |
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| Model | Components | TubingLength | TubingID | TubingOD |
|---|---|---|---|---|
| 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, VentedMale Luer Cap | 5.9"(150mm) | 0.050"(1.27mm) | 0.094"(2.4mm) |
| CET-SS02S0 | Needleless Connector (G2), Tubing, Slide Clamp, Male Spin Lure LockAssembly, 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, SlideClamp, 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, SlideClamp, 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.
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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 MedicalDevices Part 5: Tests for in vitro Cytotoxicity | Pass- No reactivity |
| Sensitization | FDA Recognition Number 2-296, ISO 10993-10: 2021, Biological evaluation of medicaldevices Part 10: Tests for irritation and skinsensitization | Pass - Non-sensitizing |
| Intracutaneous reactivityIrritation in Rabbits | FDA Recognition Number 2-291, ISO 10993-23:2021, Biological Evaluation Of MedicalDevices - Part 23: Tests For Irritation | Pass - Non-irritant |
| Acute Systemic Toxicity | FDA Recognition Number 2-255, ISO 10993-11:2017,Biological evaluation of medicaldevices Part 11: Tests for systemic toxicity | Pass - Did not cause acutesystemic toxicity |
| Subacute Toxicity | Pass- Did not causeSubacute Toxicity | |
| Hemo-compatibility | FDA Recognition Number 2-248, ISO 10993-4: 2017,Biological evaluation of medicaldevices Part 4: Tests for Interactions withBlood | Pass-Hemo-compatibility |
| Hemolysis | FDA Recognition Number 2-250, ASTM F756 - 17: Standard Practice for Assessmentof Hemolytic Properties of Materials | Pass - Non-hemolytic |
| Pyrogenicity | USP <40>Pyrogen Test Procedure, Section<151> | Pass - Non-pyrogenic |
| Endotoxin (Limulusamebocyte lysate test) | USP <161>, Medical Devices-BacterialEndotoxin and Pyrogen Tests | Pass- Less than 20 EU perdevice |
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/AMD1:2018 Sterilization of health-care products – Ethylene oxide– Requirements for the development, validation and routinecontrol of a sterilization process for medical devices –Amendment 1: Revision of Annex E, Single batch releaseFDA Recognition Number 2-275, ISO 10993-7:2008/Amd | Pass |
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| 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 BarrierSystems for Medical DevicesFDA Recognition Number 14-530, ISO 11607-1 SecondEdition 2019-02: Packaging for terminally sterilized medicaldevices - Part 1. Requirements for materials, sterile barriersystems, and packaging systems | Pass |
| FDA Guidance Compliance:- Resistance to Separation fromAxial Load- Resistance to Separation fromUnscrewing- Resistance to Overriding- Stress Cracking- Pressure Liquid Leakage- Subatmospheric-Pressure AirLeakage- 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 PremarketNotification Submission [510(k)]: 2008FDA Recognition Number 6-481, AAMI ANSI CN27:2021,General requirements for Luer activated valves (LAVs)incorporated into medical devices for intravascularapplicationsFDA Recognition Number 6-447, ISO 8536-4:2019, Infusionequipment for medical use —Part 4:Infusion sets for singleuse, gravity feedFDA Recognition Number 5-133, ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcareapplications - Part 7: Connectors for intravascular orhypodermic applicationsFDA Recognition Number 5-97, ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcareapplications - Part 20: Common test methodsUSP <788> 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.
§ 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.