Q2 Intravenous Adminstration Sets and Extension Sets

K151079 · Quest Medical, Inc. · FPA · Sep 30, 2015 · General Hospital

Device Facts

• Record ID: K151079
• Device Name: Q2 Intravenous Adminstration Sets and Extension Sets
• Applicant: Quest Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

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

Q2 Multiport IV Administration Sets and Extension Sets are sterile, single-use, non-pyrogenic devices for intravenous fluid delivery. Components include a multiport IV manifold, integrated back-check valves, pre-attached needleless injection sites, drip chamber, and roller clamps. Operated by clinicians in clinical settings (OR, ICU, etc.) to deliver single or multiple infusates to a patient's vascular system. The device facilitates simultaneous therapy via gravity, syringe, or infusion pump. The needle-free design aims to reduce needle-stick injuries. The current submission reflects a material change in the male luer component to Eastman Tritan MX-711. The device does not provide therapeutic claims itself but serves as a conduit for fluids.

Clinical Evidence

Bench testing only. Functional performance testing included high pressure, bond strength, and solvent exposure testing. Biocompatibility testing was conducted per ISO 10993-1:2009. Ethylene oxide residuals were tested per ISO 10993-7:2008. Results demonstrate the modified device performs similarly to the predicate.

Technological Characteristics

Sterile, single-use, non-invasive IV administration set. Materials: Male luer (Eastman Tritan MX-711), tubing (PVC), manifold (polycarbonate/silicone/polyisoprene), filter (copolyester/PVDF/polyestersulfone), swabable Y-site (polycarbonate/silicone), checkvalve (Plexi-Glas), drip chamber (PVC), spike (PVC/ABS/PP/LDPE). Principle of operation: Luer activation. Energy source: User-operated (gravity/pump). Sterilization: 100% EtO, SAL 1x10^-6. Packaging: Tyvek/polyethylene.

Indications for Use

Indicated for patients requiring intravenous fluid administration, including anesthesia drugs, chemotherapeutics, total parenteral nutrition, and antibiotics, via gravity, syringe, or infusion pump in clinical settings such as operating rooms and ICUs.

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

• Quest Medical, Inc. Extension Sets (K800825)
• Quest Medical, Inc. IV Administration 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

September 30, 2015

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

Re: K151079

Trade/Device Name: Q2® Multiport 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: April 20, 2015 Received: April 22, 2015

Dear Ms. 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 (QS) 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 yours,

Tina Kiang

for Erin I. Keith, M.S. 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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# Indications for Use

510(k) Number (if known)

K151079

Device Name

Q2 Multiport IV Administration Sets and Extension Sets

Indications for Use (Describe)

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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

| DATE PREPARED | September 29, 2015 | |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| SUBMITTER: | Quest Medical, Inc.<br>One Allentown Parkway<br>Allen, TX 75002 USA<br>972-390-9800/800-627-0226 | |
| | Contact: Amy Clendening-Wheeler, Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| DEVICE NAME: | Q2® Multiport IV Administration Sets and Extension Sets | |
| COMMON NAME: | IV Administration Set | |
| CLASSIFICATION NAME | Intravascular Administration Set | |
| Product Code: | FPA, FPK | |
| Regulation Number: | 880.5440 | |
| Class: | II | |
| PREDICATE DEVICES: | Quest Medical, Inc. Extension Sets (K800825)<br>Quest Medical, Inc. IV Administration Sets (K040385) | |
| DESCRIPTION: | Sterile, single use non-pyrogenic intravenous fluid administration sets<br>with a multiport IV manifold and integrated back-check valves, pre-<br>attached needleless injection sites, drip chamber and roller clamps. The<br>reason for the submission was a material change to the male luer<br>component. | |
| INTENDED USE: | For administration of intravenous fluids to a patient's vascular system<br>utilizing needleless components and an I.V. manifold for multiple<br>simultaneous intravenous therapy via gravity, syringe, or infusion pump. | |
| | Use of a needle-free system may aid in the prevention of needle-stick<br>injuries. | |
| SUBSTANTIAL EQUIVALENCE | | |

## Performance Testing

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#### Sterilization

There is no change to the sterilization process for the proposed Q2® Multiport IV Administration Sets and Extension Sets. Ethylene Oxide residuals testing performed for the modified Male Luer made from Tritan MX711 complies with ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals."

#### Shelf Life

Shelf life for the proposed Q2® Multiport IV Administration Sets and Extension Sets was verified to remains the same as for the current Q2® Multiport IV Administration Sets and Extension Sets at 3 years.

#### Bench Testing

Functional performance testing including high pressure testing, bond strength testing, and solventexposure 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 device.

#### Biocompatibility

The materials of construction of a fully assembled IV Administration Set were tested according to ISO 10993-1:2009. Test results successfully verified that the IV Administration Set materials of construction, including the male luer comprised of the Tritan MX-711 material, are biocompatible for their clinical application.

#### Comparison to Predicate:

The following table shows a comparison between the device components of the currently marketed Q2® Multiport IV Administration Sets and Extension Sets with the current Male Luer connector to the proposed Q2® Multiport IV Administration Sets and Extension Sets with new material Male Luer.

| | Predicate Devices | | Modified<br>Device |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------|
| 510(k) | K800825 | K040385 | Under Review |
| Brand Name | Q2 Extension Set | Q2 Multiport® Manifold IV Set with<br>Swabable Valves | SAME |
| Model # | 95902 | 9520, 9525A, 9526B, 9527B, 22-201-V | SAME |
| Manufacturer | Quest Medical, Inc. | | SAME |
| Device Description | Q2 extension sets and iv administration sets are sterile, non-pyrogenic, single-use intravenous fluid delivery devices. Some models have a multiport IV manifold with backcheck valves, pre-attached needleless injections sites, drip chamber and roller clamps. They are non-invasive devices for short-term use. They deliver either a single infusate or multiple infusates | | SAME |

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| | Predicate Devices | Modified<br>Device |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Clinical Use | based on the clinical need of the customer.<br>The devices are used by clinicians in a variety of clinical<br>settings such as operating rooms, chemotherapy regimens,<br>ICUs, ext. The devices have direct patient contact due to the<br>administration of fluids to the vascular system. A variety of<br>infusates such as anesthesia drugs, chemotherapeutics, total<br>parental nutrition (TPN) drugs, antibiotics, etc. The devices<br>themselves do not have any intended therapeutic claim. | SAME |
| Intended Use/<br>Indications for Use | For administration of intravenous fluids to a patient's vascular<br>system utilizing needleless components and an I.V. manifold<br>for multiple simultaneous intravenous therapy via gravity,<br>syringe, or infusion pump.<br>Use of a needle-free system may aid in the prevention of<br>needle-stick injuries. | SAME |
| Materials | | |
| Male Luer | Acrylic Cyro MED-2 plastic | Eastman Tritan<br>MX-711 |
| Tubing | PVC | Identical |
| 6 port Manifold | Polycarbonate housing, silicone stem, polyisoprene checkvalve | Identical |
| Filter | Copolyester housing, Durapel PVDF, Polyestersulfone | Identical |
| Swabable Y-site | Polycarbonate and silicone | Identical |
| Inline checkvalve | Plexi-Glas | Identical |
| Drip Chamber | PVC | Identical |
| Spike | PVC, ABS, PP, LDPE | Identical |
| Technology | | |
| Energy Source | User Operated | Identical |
| Principle of<br>Operation | Luer activation | Identical |
| Sterilization/Pkg | | |
| Method | EtO, 100% | Identical |
| Minimum SAL | $1 \times 10^{-6}$ | Identical |
| Packaging | Tyvek polyethylene; heat-sealed | Identical |
| Shelf Life | Three (3) Years | Identical |
| Disposable or<br>Reusable | Disposable | Identical |

## CONCLUSION:

Results of functional performance and biocompatibility testing conducted with the proposed and predicate devices demonstrate that the Q2® Multiport IV Administration Sets and Extension Sets are substantially equivalent to the legally marketed predicate device.