Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

K162304 · Quest Medical, Inc. · FPA · Dec 6, 2016 · General Hospital

Device Facts

• Record ID: K162304
• Device Name: Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets
• Applicant: Quest Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Dec 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Q2 and CheckMate Multiport IV Administration Sets are indicated for use for the following: For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Device Story

Sterile, single-use, non-pyrogenic IV administration and extension sets; includes multiport IV manifold, integrated back-check valves, needleless injection sites, drip chamber, and roller clamps. Used in clinical settings (OR, ICU, chemotherapy) by clinicians to deliver fluids (anesthesia, antibiotics, TPN, chemotherapeutics) to patient vascular systems. Operates via gravity, syringe, or infusion pump; needleless components facilitate safe fluid delivery and reduce needle-stick risk. Subject devices feature non-DEHP (phthalate-free) PVC tubing and drip chambers. Device provides physical pathway for fluid delivery; clinical decision-making relies on clinician assessment of patient fluid needs.

Clinical Evidence

Bench testing only. Functional performance testing (high pressure, bond strength, solvent exposure) and biocompatibility testing (hemocompatibility, cytotoxicity, sensitization, irritation, systemic toxicity, subchronic toxicity, material-mediated pyrogenicity) per ISO 10993-1:2009. Ethylene oxide residuals verified per ISO 10993-7:2008. Bacterial endotoxin levels verified via kinetic chromogenic LAL method.

Technological Characteristics

Materials: Non-DEHP PVC tubing (Alpha Gary 2235L-80 or multi-laminate: Alpha Gary 2222C-80, EVA, LDPE), non-DEHP PVC drip chamber (Colorite 7277G-402M), polycarbonate, silicone, polyisoprene, copolyester, PVDF, polyestersulfone, ABS, PP. Principle: Luer-activated fluid delivery. Energy: User-operated (gravity/pump). Sterilization: 100% Ethylene Oxide (EtO). Shelf life: 3 years.

Indications for Use

Indicated for patients requiring intravenous fluid administration via gravity, syringe, or infusion pump. Used for multiple simultaneous intravenous therapy. No specific age or gender restrictions noted.

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

• Q2 Multiport IV Administration Sets and Extension Sets (K151079)
• Q2 Multiport IV Administration Sets and Extension Sets (K800825)
• CheckMate IV Administration Sets and Extension Sets (K040385)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 6, 2016

Quest Medical, Inc. Amy Clendening-Wheeler Sr. Regulatory Affairs Specialist One Allentown Parkway Allen. Texas 75002

Re: K162304

Trade/Device Name: 020 Multiport IV Administration Sets and Extension Sets Checkmate® IV Administration Sets and Extension Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FPK Dated: November 9, 2016 Received: November 10, 2016

Dear Amy Clendening-Wheeler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

## 510(k) Number (if known)

K162304

#### Device Name

Q2 Multiport IV Administration Sets and Extension Sets CheckMate IV Administration Sets and Extensions Sets

#### Indications for Use (Describe)

The Q2 and CheckMate Multiport IV Administration Sets are indicated for use for the following: For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) SUMMARY K162304

| DATE PREPARED: | December 5, 2016 | | |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| SUBMITTER: | Quest Medical, Inc.<br>One Allentown Parkway<br>Allen, TX 75002 USA<br>972-390-9800/800-627-0226 | | |
| | Contact: Amy Clendening-Wheeler<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | | |
| DEVICE NAME: | Q2® Multiport IV Administration Sets and Extension Sets<br>CheckMate® IV Administration Sets and Extension Sets | | |
| COMMON NAME: | IV Administration Sets | | |
| CLASSIFICATION NAME: | Intravascular Administration Sets | | |
| PRODUCT CODE: | FPA, FPK | | |
| REGULATION: | 880.5440 | | |
| CLASS: | II | | |
| PREDICATE DEVICES: | Quest Medical, Inc. Q2 Multiport IV Administration Sets and Extension<br>Sets (K151079, K800825) and CheckMate IV Administration Sets and<br>Extension Sets (K040385) | | |
| DESCRIPTION: | Sterile, single use non-pyrogenic intravenous fluid administration sets<br>which may include a multiport IV manifold, integrated back-check<br>valves, pre-attached needleless injection sites, drip chamber and roller<br>clamps. The subject devices for this Premarket Notification are<br>manufactured with tubing and drip chamber materials not made with<br>the plasticizer Diethylhexylphthalate (DEHP). | | |
| INDICATIONS FOR USE: | The Q2 and CheckMate Multiport IV Administration Sets and<br>Extension Sets are indicated for use for the following:<br>For administration of intravenous fluids to a patient's vascular system | | |

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utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

### SUBSTANTIAL EQUIVALENCE

## Bench Testing

Functional performance testing including high pressure testing, bond strength testing, and solvent-exposure testing was completed with the proposed IV Administration Sets to demonstrate that the sets perform as intended. Results of testing successfully demonstrated that the proposed devices perform similarly to the predicate devices.

# Sterilization

There is no change to the sterilization process for the proposed Q2 and CheckMate Multiport IV Administration Sets and Extension Sets. Ethylene Oxide residuals testing performed for the devices manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber complies with ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals."

# Shelf Life

Shelf life for the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber was verified to remain the same as for the current Q2 and CheckMate Multiport IV sets and Extension Sets at 3 years.

### Biocompatibility

The materials of construction of a fully assembled representative IV Administration Set were tested according to ISO 10993-1:2009. Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Materialmediated Pyrogenicity tests were performed. Test results successfully verified that the IV Administration Set materials of construction, including the proposed new non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber, are biocompatible for their clinical application.

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# Pyrogen

Pyrogen testing for bacterial endotoxins was performed via the kinetic chromogenic LAL (Limulous Amebocyte Lysate) method. The results found that the proposed new materials do not introduce a level of endotoxin that exceed established guidelines.

# Comparison to Predicate:

The following table shows a comparison between the device components of the currently marketed Q2 and CheckMate Multiport IV Administration Sets and Extension Sets with the current PVC tubing and PVC Drip Chamber to the Q2 and CheckMate Multiport IV Administration sets and Extension Sets manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber.

| | Predicate Device | | | Modified Device |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------|
| 510(k) | K151079 | K040385 | K800825 | Under Review |
| Model # | 9520, 9525A,<br>9525B, 9527B,<br>95902, 22-201V | 9600, 9620,<br>9621, 9622,<br>9652, 9657, | 9219, 9250, 9541, 9543,<br>9545, 9546, 95701, 95702,<br>95704, 95707, 95710,<br>95711, 95712, 95713 | SAME |
| Brand Name | Q2 Multiport IV<br>Administration<br>Sets and Extension<br>Sets | Checkmate<br>Multiport IV<br>Sets with<br>Swabable<br>Valves | Q2 IV Extension Sets | SAME |
| Manufacturer | Quest Medical, Inc. | | | SAME |
| Device<br>Description | Q2 and Checkmate Multiport IV Administration Sets and<br>Extension Sets are sterile, non-pyrogenic, single-use intravenous<br>fluid delivery devices. Some models have a multiport IV manifold<br>with backcheck valves, pre-attached needleless injections sites,<br>drip chamber and roller clamps. They are non-invasive devices for<br>short-term use. They deliver either a single infusate or multiple<br>infusates based on the clinical need of the customer. | | | SAME |
| Clinical Use | The devices are used by clinicians in a variety of clinical settings<br>such as operating rooms, chemotherapy regimens, ICUs, ext. The<br>devices have direct patient contact due to the administration of<br>fluids to the vascular system. A variety of infusates such as<br>anesthesia drugs, chemotherapeutics, total parental nutrition<br>(TPN) drugs, antibiotics, etc. The devices themselves do not have<br>any intended therapeutic claim. | | | SAME |
| Intended Use/<br>Indications for<br>Use | For administration of intravenous fluids to a patient's vascular<br>system utilizing needleless components and an I.V. manifold for<br>multiple simultaneous intravenous therapy via gravity, syringe, or<br>infusion pump. | | | SAME |

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| | Predicate Device | Modified Device |
|---------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Use of a needle-free system may aid in the prevention of<br>needlestick injuries. | |
| Materials | | |
| Male Luer | Eastman Tritan MX-711 | SAME |
| Tubing | PVC, Colorite 5004A, clear | Single Laminate:<br>Alpha Gary 2235L-80<br>Multi Laminate:<br>Outer Layer: Alpha Gary<br>2222C-80<br>Middle Layer: EVA Dupont<br>Elvax 265<br>Inner Layer: LDPE Dow<br>690 HT+ |
| 6 port Manifold | Polycarbonate housing, silicone stem, polyisoprene checkvalve | SAME |
| Filter | Copolyester housing, Durapel PVDF, Polyestersulfone | SAME |
| Swabable Y-site | Polycarbonate and silicone | SAME |
| Inline checkvalve | Plexi-Glas | SAME |
| Drip Chamber<br>Barrel | PVC: PTV-402-BT 1 clear | PVC: Colorite 7277G-402M |
| Spike | PVC, ABS, PP, LDPE | SAME |
| Technology | | |
| Energy Source | User Operated | SAME |
| Principle of<br>Operation | Luer activation | SAME |
| Sterilization/Pkg | | |
| Method | EtO, 100% | SAME |
| Minimum SAL | 1 x 10-6 | SAME |
| Packaging | Tyvek polyethylene/Mylar pouch; heat-sealed | SAME |
| Shelf Life | Three (3) Years | SAME |
| Disposable or<br>Reusable | Disposable | SAME |

# CONCLUSION:

Results of all functional performance and biocompatibility testing conducted successfully demonstrate that the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets manufactured with the proposed non-DEHP patient-contacting tubing formulations and non-DEHP Drip Chamber are substantially equivalent to the legally marketed predicate devices.