APEX Compounding System Transfer Set

K151423 · B.Braun Medical, Inc. · LHI · Feb 19, 2016 · General Hospital

Device Facts

• Record ID: K151423
• Device Name: APEX Compounding System Transfer Set
• Applicant: B.Braun Medical, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Feb 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The APEX Transfer Set is intended to be used with the APEX Compounding System. The administration sets are to be used in a sterile compounding environment within a pharmacy to provide a fluid path for the compounding of ingredients from multiple source containers into a final solution.

Device Story

APEX Compounding System Transfer Set is a sterile, disposable, single-use fluid path component for pharmacy compounding. Device consists of a valved manifold with 26 source lines, each featuring a luer lock connector for attachment to source containers and a unique barcode for traceability. Manifold includes micro and macro fluid channels and silicone pump tubing, terminating in a final container connector. Operated by pharmacy personnel in conjunction with the APEX Compounding System; device facilitates automated, user-specified sequence withdrawal of ingredients from multiple containers into a final solution bag. System provides accurate, multi-ingredient sterile solution preparation. Benefits include increased efficiency and accuracy in sterile compounding workflows compared to manual methods.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including visual inspection, leakage, joint strength (ISO 8536-4), valve torque, vacuum testing, occlusion testing, luer gauging (ISO 594-2), barcode scanning, magnetic flux density, life cycle testing (USP 788), and biocompatibility (ISO 10993 series). Delivery accuracy was validated against specific gravity interchange requirements.

Technological Characteristics

Manifold body: Polycarbonate; Valve: TPV; Pump tube: Silicone; Final container adapter: ABS; Inlet connectors: ABS/Acrylic; Source tubing: PVC. Features 26 inlet sources, dual-channel (micro/macro) fluid path. Sterilization: Ethylene oxide (SAL 10^-6). Connectivity: Barcode-based traceability for source lines. Mechanical sensing/actuation via compounding system pump.

Indications for Use

Indicated for use in a sterile pharmacy compounding environment to provide a fluid path for compounding ingredients from multiple source containers into a final solution using the APEX Compounding System.

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

• Exacta-Mix 2400 Compounding System Administration set, Baxa Corporation (K002705)

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

August 25, 2017

B. Braun Medical Inc. Ms. Tracy Maddock Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109

Re: K151423

Trade/Device Name: APEX Compounding System Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI. NEP Dated: January 13, 2016 Received: January 14, 2016

Dear Ms. Tracy Maddock:

This letter corrects our substantially equivalent letter of February 19, 2016.

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 Actinclude 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device comples with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply

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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.

# Michael J. Ryan -S

for Lori A. Wiggins, MPT, CLT 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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### Indications for Use

510(k) Number (if known) K151423

#### Device Name

APEX Compounding System Transfer Set

#### Indications for Use (Describe)

The APEX Transfer Set is intended to be used with the APEX Compounding System. The administration sets are to be used in a sterile compounding environment within a pharmacy to provide a fluid path for the compounding of ingredients from multiple source containers into a final solution.

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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 5. 510(k) Summary | K151423 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500 |
| | Contact: Tracy Maddock, RAC<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| DATE: | February 18, 2016 |
| DEVICE NAME: | APEX Compounding System Transfer Set |
| COMMON OR<br>USUAL NAME: | IV Fluid Transfer Set |
| DEVICE<br>CLASSIFICATION: | Class II per 21 CFR 880.5440 Intravascular administration set<br>Product Code: LHI, NEP<br>Classification Panel: General Hospital |
| PREDICATE DEVICE: | Exacta-Mix 2400 Compounding System Administration set, Baxa<br>Corporation K002705, Class II, LHI, 880.5440. |

### DESCRIPTION:

The Apex Compounding System Transfer Set consists of a valved manifold with micro, macro and flex source lines. The proximal end of the source line consists of a luer lock connector which allows for connection to a transfer spike or connector depending upon the source container being used. The outlet tubing connects each valve, through the manifold body and consists of two sections of pump tubing just before ending at a final container connector, a luer adapter, to connect to a final container bag for eventual patient administration. There are 26 source lines on the manifold which correspond to the device's ability to support 26 source containers. Each individual line is labeled with a unique numeric identifier and barcode for traceability and scanning.

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# INDICATIONS FOR USE:

The APEX Transfer Set is intended to be used with the APEX Compounding System. The administration sets are to be used in a sterile compounding environment within a pharmacy to provide a fluid path for the compounding of ingredients from multiple source containers into a final solution.

# SUBSTANTIAL EQUIVALENCE:

The APEX Compounding System Transfer Set is substantially equivalent to the Baxa Exacta-Mix 2400 Compounding System Administration Set (K002705).

### Comparison of Technological Characteristics with the Predicate Device

The subject device has the same indications for use (to provide a fluid path for the compounding of ingredients from multiple source containers into a final solution) and the same principle of operation as the predicate device. The subject Transfer Set is similar in design with respect to components and materials of construction. Both devices are provided as sterile, nonpyrogenic, individually packaged devices to be used with their respective compounding devices.

A table summarizing the comparison between the APEX Transfer Set and the predicate device is provided below.

| SUBJECT DEVICE:<br>APEX COMPOUNDING SYSTEM TRANSFER SET | PREDICATE DEVICE:<br>EXACTA-MIX 2400 COMPOUNDING SYSTEM<br>ADMINISTRATION SET (K002705) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| INDICATIONS FOR USE | | |
| The APEX Transfer Set is intended to be used<br>with the APEX Compounding System. The<br>administration sets are to be used in a sterile<br>compounding environment within a pharmacy to<br>provide a fluid path for the compounding of<br>ingredients from multiple source containers into a<br>final solution. | The Exacta-Mix 2400 compounding system<br>administration sets, manufactured by Baxa<br>Corporation, are ancillary devices used in<br>conjunction with the Exacta-Mix 2400 compound<br>device. The administration sets are used in the<br>pharmacy to provide the fluid path for multiple<br>source ingredients into one final solution. | |
| DESCRIPTION | | |
| Transfer set is a sterile, non-pyrogenic,<br>disposable, individually packaged device<br>designed to work in conjunction with the APEX<br>compounding system to quickly and accurately<br>compound multi-ingredient sterile solutions by<br>withdrawing requested amounts of source<br>ingredients from their containers in a user<br>specified sequence into a final container. | Transfer set is a sterile, non-pyrogenic, disposable,<br>individually packaged device designed to work in<br>conjunction with the Baxa EM-2400 compounding<br>system to quickly and accurately compound multi-<br>ingredient sterile solutions by withdrawing requested<br>amounts of source ingredients from their containers<br>in a user specified sequence into a final container. | |
| SUBJECT DEVICE:<br>APEX COMPOUNDING SYSTEM TRANSFER SET | PREDICATE DEVICE:<br>EXACTA-MIX 2400 COMPOUNDING SYSTEM<br>ADMINISTRATION SET (K002705) | |
| TECHNOLOGY | | |
| ✓ Twenty-six (26) inlet sources | ✓ Twenty- four (24) inlet sources | |
| ✓ Micro or macro volume fluid transfer | ✓ Micro or macro volume fluid transfer | |
| ✓ 25 L max use, micro side / 300 L max use, macro side | ✓ 150 L max use | |
| ✓ Set requires attachment of transfer spikes or connector | ✓ Set requires attachment of inlet tubing sets | |
| COMPONENTS AND MATERIALS | | |
| Manifold Body: Polycarbonate | Valve Set Body: Polycarbonate | |
| Valve: TPV | Valve Core: Santoprene | |
| Pump Tube: Silicone | Outlet Pump Tube: Silicone | |
| Final Container Adapter: ABS | Large-Bore Connector: ABS | |
| Final Container Adapter Cap: ABS | Connector Cap: HDPE | |
| Inlet Male Luer Lock Connector: ABS, Acrylic | Inlet Connector: ABS | |
| Connector Cap: HDPE | Cap: Polycarbonate | |
| Source Line Tubing: PVC | Inlet tubing: PVC | |
| | Outlet Connector: Thermoplastic Elastomer | |
| TESTING | | |
| Visual inspection Leakage Static Load Joint tensile strength Valve torque Associate device (Delivery accuracy, Specific gravity interchange, Leakage, Fit) Life cycle testing - Spallation and Particulate contamination | Vacuum Occlusion Luer gauging Barcode scan Magnetic flux density | Accuracy<br>Fluid/air Leakage<br>Precipitant |
| STERILIZATION | | |
| Method: Ethylene oxide (EO) | Method: Gamma | |
| Sterility Assurance Level (SAL): 10-6 | Sterility Assurance Level (SAL): 10-6 | |

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The differences between the predicate device and the subject device include:

- > The subject device has pre-attached source lines with male luer lock connectors and barcoded flags indicating the line number. The predicate device consists of a valve set and separate inlet lines to be added by the user. Additionally, the user must attach barcode labels to the inlet lines.

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- > The subject device contains twenty-six (26) source lines giving the user the ability to compound solutions using 26 source containers. The predicate device has the potential for twenty-four (24) source lines.
- > The subject device and the predicate device allow the compounding of both micro and macro volumes. The predicate device has one fluid channel through the valve set. The subject device has two (2) channels, a micro channel and a macro channel.
- > The sterilization method for the subject device is ethylene oxide whereas the sterilization method for the predicate device is gamma irradiation.

The differences, between subject device and predicate device, do not raise any new issues of safety and effectiveness.

# Performance Testing

The proposed APEX Transfer sets were subjected to functional and performance testing to demonstrate that the sets perform as intended.

The following testing was performed on the subject device to the performance criteria listed or included in the referenced standard.

- Visual inspection - free of cracks, damage, kinked tubes, disconnected components, valves seated within 5% of alignment
- Leakage no bubbles observed at joints with 10 psi air pressure (positive pressure), vacuum . pressure shall not fall in 30s while applying 28 in Hg (negative pressure)
- Joint strength
- Static load tensile force (ISO 8536-4) O
- Peak pull force joints shall be > 5 lbf pulled to failure at 14 in/min (7 lbf for macro O pump tube joints)
- Valve torque micro valve torque shall not exceed 14.2 oz in, macro valve torque shall not ● exceed 42.5 oz in
- Vacuum test vacuum pressure shall not fall in 30s while applying 28 in Hg ●
- Occlusion test - bubbles shall be observed from end after applying 0.5 psi air pressure while immersed
- Luer gauging (ISO 594-2) ●
- . Barcode Scan - scan shall match human readable number
- Magnetic flux density - shall be > 40 Gauss at a distance of 0.28"
- Life cycle testing (Spallation and Particulate contamination) USP 788 after simulated use ●
- Biocompatibility (ISO 10993-1)
- Cytotoxicity (MEM Elution, ISO 10993-5) O
- Delayed-type hypersensitivity (Guinea Pig Maximization, ISO 10993-10) O
- Intracutaneous Reactivity (ISO 10993-10) O
- Acute Systemic Toxicity (ISO 10993-11) O
- Hemocompatibility (Hemolysis, ASTM F756, ISO 10993-4) O

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- Material-Mediated Pyrogenicity (Rabbit Pyrogen, USP <151>, ISO 10993-11) o
- Associate device (APEX Compounding System) ●
- Delivery accuracy o

Dextrose 70% at 20-25°C shall be ± 10% at 0.2 mL, ± 3% above 1 mL. Dextrose 70% at 15-30℃ shall be ± 10% at 0.2 mL, ± 6% above 1 mL. Other solutions at 15-30°C shall be ± 10% at 0.2 mL, ± 3% above 1 mL.

- Fit -set shall be able to be attached and removed with audible and tactile feedback o and without damage to components
- Associate device (B. Braun Spikes and Fluid Connector, B. Braun Final Containers) ●
- Leakage o
- Source lines - no bubbles observed at connections after applying air pressure while immersed, vacuum pressure shall not fall in 30s while applying 28 in He
- . Final container connector - no leakage when subjected to water pressure source of 20 psi

The following comparative testing was performed on the subject and predicate device:

- . Specific Gravity Interchange – mean concentration of unintended ingredient during compounding for the subject device shall be < mean concentration of unintended ingredient during compounding for the predicate device
No clinical testing was performed as the transfer set does not require clinical studies to demonstrate substantial equivalence with the predicate device.

## CONCLUSION:

Results of functional and performance testing conducted on the subject device demonstrate that the APEX Transfer Set is substantially equivalent to the predicate device.