K Number
K133602
Device Name
ADD-VANTAGE ADDAPTOR
Manufacturer
Date Cleared
2014-01-24

(60 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADD-Vantage ADDaptor™20 mm binary connector is a double ended for use in a pharmacy setting or patient care area, by trained clinicians, to connect an ADD Vantage diluent solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
Device Description
ADD-Vantage ADDaptor™ vial adapter transfer device is a double ended vial transfer device which allows the use of a 20mm single dose standard drug vial, to be connected to an ADD-Vantage diluent container bag.
More Information

Not Found

No
The summary describes a mechanical connector for drug reconstitution and makes no mention of AI or ML.

No.
The device is described as a connector for mixing drugs in a pharmacy setting, not as a device that delivers therapy to a patient or treats a condition.

No

Explanation: The device is described as a connector for reconstituting or mixing drugs, not for diagnosing any medical condition. Its function is to facilitate drug preparation and administration, not to provide diagnostic information.

No

The device description clearly indicates it is a physical, double-ended vial transfer device, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to connect a diluent solution bag to a drug vial for reconstituting or mixing drugs. This is a process related to drug preparation and administration, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The device is described as a vial transfer device for connecting a diluent container to a drug vial. This aligns with its intended use in drug preparation.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

The device is a medical device used in the preparation of medications, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

The ADD-Vantage ADDaptor™20 mm binary connector is a double ended for use in a pharmacy setting or patient care area, by trained clinicians, to connect an ADD Vantage diluent solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

Product codes (comma separated list FDA assigned to the subject device)

LHI

Device Description

ADD-Vantage ADDaptor™ vial adapter transfer device is a double ended vial transfer device which allows the use of a 20mm single dose standard drug vial, to be connected to an ADD-Vantage diluent container bag.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

pharmacy setting or patient care area, by trained clinicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The ADD-Vantage ADDaptor™ vial adapter transfer device has passed all specified test requirements.
The validation and verification testing have confirmed these devices meet user needs and design inputs for a vial adapter.
Testing also confirmed physical attributes and device performance meets requirements of the standards listed in the "Performance Test Summary-New Devices" table above. These standards address sterility, biocompatibility, and particulate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

B. Braun addEASE (K090905)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

0

JAN 2 4 2014

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. ADD-Vantage ADDaptor™ vial adapter transfer device

Submitter Information
NameHospira, Incorporated
AddressD-393, Bldg. H2
275 North Field Drive
Lake Forest, IL. 60045
Phone number(224) 212-5316
Fax number(224)-212-5401
Establishment
Registration NumberOwner/Operator #9063339
Establishment registration number #3005579246
Name of contact
personKaren Keener
Date preparedOctober 01, 2013
Name of device
Trade or proprietary
nameADD-Vantage ADDaptor™
Common or usual
nameBinary connector transfer device
Classification nameSet I.V., Fluid Transfer
Classification panelClass II
Regulation21-CFR-Part-880.5440
Product Code(s)LHI
Legally marketed
device(s) to which
equivalence is claimedB. Braun addEASE
(K090905)
Reason for 510(k)
submissionAccessory to the ADD-Vantage system which will
allow the use of a standard 20mm powdered drug
vial to be used with the ADDVantage diluent bag.
Device descriptionADD-Vantage ADDaptor™ vial adapter transfer
device is a double ended vial transfer device which
allows the use of a 20mm single dose standard drug
vial, to be connected to an ADD-Vantage diluent
container bag.
Intended use of the deviceThe ADD-Vantage ADDaptor™20 mm binary connector is a double ended transfer device intended for use in a pharmacy setting or patient care area, by trained clinicians, to connect an ADD-Vantage diluent solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag

Nov. 22, 2013

Page 1 of 4

1

Summary of the technological characteristics of the device compared to the
predicate device

CharacteristicPredicate DeviceProposed Device
Intended UseVial Transfer of Lyophilized
Molecule(s)Same
Transfer adapter Vial
Type20mmSame
Diluent BagB. Braun Diluent ContainersADD-Vantage Diluent
Container(s)
Device componentsTransfer Adapter
Sterile Cap_Qty 2Same
Vial AccessPlastic SpikeSame
Vial RetentionPlastic Snaps/GripsSame
Diluent Bag
connectionNeedle (17gauge)Threads, Face Seal
ReconstitutionMilking of systemSame
Transfer AdapterPolycarbonateABS-White,
Polypropylene- purple
Sterile Caps MaterialNot AvailableLow density polyethylene
(LDPE)
Manufacturing
AssemblyAssume Ultrasonic WeldingSame
Manufacturing
AssemblyAssume Ultrasonic WeldingInterference fit sterile caps
SterilizationGammaSame
BiocompatibilityAssume 10993-1Per 10993-1
Principle of
OperationSameSame

Nov. 22, 2013

Page 2 of 4

2

| Performance Data
Summary of non-clinical tests conducted for determination of substantial

equivalence*
Performance Test Summary-New Device
CharacteristicStandard/Test
MethodStandard / Test TitleDevice
Performance
BiocompatibilityISO 10993-1 : 2009/
AC 2010Biological evaluation of
medical devices- Part 1:
Evaluation and testing
within a risk
management processPass
BiocompatibilityISO 10993-5: 2009Biological evaluation of
medical devices- Part 5:
CytotoxicityPass
BiocompatibilityISO 10993-10: 2010Biological evaluation of
medical devices- Part 10:
Sensitization/ Irritation /
Intracutaneous ReactivityPass
BiocompatibilityISO 10993-11:2006Biological evaluation of
medical devices- Part 11:
Systemic Toxicity (Acute)Pass
BiocompatibilityISO 10993-4: 2002
AC: 2006Biological evaluation of
medical devices- Part 4:
HemocompatibilityPass
SterilizationANSI/AAMI/ISO
11137-2:2012Sterilization of health
care product-Radiation-
Establishing the
sterilization dosePass
SterilizationANSI/AAMI/ISO
11737-1:2006Sterilization of medical
devices- Microbiological
methods- Part1:
Estimation of population
of microorganisms on
products.Pass
SterilizationANSI/AAMI/ISO
11737-2:2009Sterilization of medical
devices-Microbiological
methods- Part 2: Tests of
sterility performed in the
definition, validation andPass
maintenance of a
sterilization process
PerformanceISO 8536-4 :2010Infusion Equipment for
medical use - Part 4:
Infusion sets for single
use, gravity feedPass
PerformanceISO 8536-6: 2009Infusion equipment for
medical use - Part
6:Freeze drying closures
for infusion bottlesPass

Nov. 22, 2013

·

Page 3 of 4

.

3

Summary discussion of Bench Performance Data

The ADD-Vantage ADDaptor™ vial adapter transfer device has passed all specified test requirements.

The validation and verification testing have confirmed these devices meet user needs and design inputs for a vial adapter.

Testing also confirmed physical attributes and device performance meets requirements of the standards listed in the "Performance Test Summary-New Devices" table above. These standards address sterility, biocompatibility, and particulate.

Conclusions drawn from non-clinical and clinical data " " " " "

Statement of Safety and Efficacy:

The ADD-Vantage ADDaptor™ vial adapter transfer device

meets the functional claims, and intended use as described in the product labeling.

The safety and effectiveness, are substantially equivalent to the predicate B. Braun addEASE 20MM Binary Connector cleared under 510(k) K090905 April 27, 2009.

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

January 24, 2014

Hospira, Incorporated C/O Ms. Karen Keener Regulatory Affairs 275 Field Drive, D-393, Bldg H2 LAKE FOREST IL 60045

Re: K133602

Trade/Device Name: ADD-Vantage ADDaptor Regulation Number: 21 CFR 880.5440 Regulation Name: Set I.V., Fluid Transfer Regulatory Class: II Product Code: LHI Dated: November 25, 2013 Received: November 26, 2013

Dear Ms. Keener:

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.

5

Page 2 - Ms. Ferguson

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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/6 description: The image shows the name "Kwame O. Ulmer" in bold, black font at the top. Below the name, there is a logo that appears to be for the FDA, but it is difficult to discern due to the image quality. To the left of the logo, there is a "-S".

for

Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133602

Device Name

ADD-Vantage ADDaptor™Vial Adapter transfer device

Indications for Use (Describe)

The ADD-Vantage ADDaptor™20 mm binary connector is a double ended for use in a pharmacy setting or patient care area, by trained clinicians, to connect an ADD Vantage diluent solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

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)

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

A RESOURCE AND FOR FOR FOR FOR FOR FOR FOR THE OWNER FOR A BOOK FOR A BOOK FOR A 15: - - - --------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman Date: 2014.01.24 16:13:36 -05'00'

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

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