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.

AI/ML Overview

The information below is extracted from the provided text, primarily sections {2} and {3}. Please note that the document is a 510(k) submission for a medical device (vial adapter transfer device), which typically focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy trials. Therefore, much of the requested information, particularly around human reader studies or sophisticated ground truth establishment, is not present for this type of device.

1. Table of acceptance criteria and the reported device performance

Characteristic	Standard/Test Method	Standard / Test Title	Device Performance
Biocompatibility	ISO 10993-1 : 2009/AC 2010	Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process	Pass
Biocompatibility	ISO 10993-5: 2009	Biological evaluation of medical devices- Part 5: Cytotoxicity	Pass
Biocompatibility	ISO 10993-10: 2010	Biological evaluation of medical devices- Part 10: Sensitization/ Irritation / Intracutaneous Reactivity	Pass
Biocompatibility	ISO 10993-11:2006	Biological evaluation of medical devices- Part 11: Systemic Toxicity (Acute)	Pass
Biocompatibility	ISO 10993-4: 2002 AC: 2006	Biological evaluation of medical devices- Part 4: Hemocompatibility	Pass
Sterilization	ANSI/AAMI/ISO 11137-2:2012	Sterilization of health care product-Radiation- Establishing the sterilization dose	Pass
Sterilization	ANSI/AAMI/ISO 11737-1:2006	Sterilization of medical devices- Microbiological methods- Part1: Estimation of population of microorganisms on products.	Pass
Sterilization	ANSI/AAMI/ISO 11737-2:2009	Sterilization of medical devices-Microbiological methods- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process	Pass
Performance	ISO 8536-4 :2010	Infusion Equipment for medical use - Part 4: Infusion sets for single use, gravity feed	Pass
Performance	ISO 8536-6: 2009	Infusion equipment for medical use - Part 6:Freeze drying closures for infusion bottles	Pass

The summary states: "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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for each test listed. The tests are non-clinical (bench testing for performance, biocompatibility, and sterilization) rather than clinical studies on humans. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to laboratory-based non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of device and testing described. The "ground truth" for non-clinical performance and safety tests is typically established by fulfilling the requirements of the specified ISO or ANSI/AAMI standards, which are laboratory benchmarks and protocols, not expert consensus on medical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device underwent bench testing against established standards, not a diagnostic or interpretative study requiring adjudication.

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

No. This is a non-AI medical device (a vial adapter transfer device). MRMC studies are not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the tests performed is adherence to the specified international and national standards for device performance, biocompatibility, and sterility (e.g., ISO 10993 series and ANSI/AAMI/ISO 11137/11737 series). These standards define acceptable limits and methodologies, and passing these tests constitutes meeting the "ground truth" for the device's characteristics.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

{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
Name	Hospira, Incorporated
Address	D-393, Bldg. H2275 North Field DriveLake Forest, IL. 60045
Phone number	(224) 212-5316
Fax number	(224)-212-5401
EstablishmentRegistration Number	Owner/Operator #9063339Establishment registration number #3005579246
Name of contactperson	Karen Keener
Date prepared	October 01, 2013
Name of device
Trade or proprietaryname	ADD-Vantage ADDaptor™
Common or usualname	Binary connector transfer device
Classification name	Set I.V., Fluid Transfer
Classification panel	Class II
Regulation	21-CFR-Part-880.5440
Product Code(s)	LHI
Legally marketeddevice(s) to whichequivalence is claimed	B. Braun addEASE(K090905)
Reason for 510(k)submission	Accessory to the ADD-Vantage system which willallow the use of a standard 20mm powdered drugvial to be used with the ADDVantage diluent bag.
Device description	ADD-Vantage ADDaptor™ vial adapter transferdevice is a double ended vial transfer device whichallows the use of a 20mm single dose standard drugvial, to be connected to an ADD-Vantage diluentcontainer bag.
Intended use of the device	The 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

Characteristic	Predicate Device	Proposed Device
Intended Use	Vial Transfer of LyophilizedMolecule(s)	Same
Transfer adapter VialType	20mm	Same
Diluent Bag	B. Braun Diluent Containers	ADD-Vantage DiluentContainer(s)
Device components	Transfer AdapterSterile Cap_Qty 2	Same
Vial Access	Plastic Spike	Same
Vial Retention	Plastic Snaps/Grips	Same
Diluent Bagconnection	Needle (17gauge)	Threads, Face Seal
Reconstitution	Milking of system	Same
Transfer Adapter	Polycarbonate	ABS-White,Polypropylene- purple
Sterile Caps Material	Not Available	Low density polyethylene(LDPE)
ManufacturingAssembly	Assume Ultrasonic Welding	Same
ManufacturingAssembly	Assume Ultrasonic Welding	Interference fit sterile caps
Sterilization	Gamma	Same
Biocompatibility	Assume 10993-1	Per 10993-1
Principle ofOperation	Same	Same

Nov. 22, 2013

Page 2 of 4

{2}------------------------------------------------

Performance DataSummary of non-clinical tests conducted for determination of substantialequivalence*
Performance Test Summary-New Device
Characteristic	Standard/TestMethod	Standard / Test Title	DevicePerformance
Biocompatibility	ISO 10993-1 : 2009/AC 2010	Biological evaluation ofmedical devices- Part 1:Evaluation and testingwithin a riskmanagement process	Pass
Biocompatibility	ISO 10993-5: 2009	Biological evaluation ofmedical devices- Part 5:Cytotoxicity	Pass
Biocompatibility	ISO 10993-10: 2010	Biological evaluation ofmedical devices- Part 10:Sensitization/ Irritation /Intracutaneous Reactivity	Pass
Biocompatibility	ISO 10993-11:2006	Biological evaluation ofmedical devices- Part 11:Systemic Toxicity (Acute)	Pass
Biocompatibility	ISO 10993-4: 2002AC: 2006	Biological evaluation ofmedical devices- Part 4:Hemocompatibility	Pass
Sterilization	ANSI/AAMI/ISO11137-2:2012	Sterilization of healthcare product-Radiation-Establishing thesterilization dose	Pass
Sterilization	ANSI/AAMI/ISO11737-1:2006	Sterilization of medicaldevices- Microbiologicalmethods- Part1:Estimation of populationof microorganisms onproducts.	Pass
Sterilization	ANSI/AAMI/ISO11737-2:2009	Sterilization of medicaldevices-Microbiologicalmethods- Part 2: Tests ofsterility performed in thedefinition, validation and	Pass
		maintenance of asterilization process
Performance	ISO 8536-4 :2010	Infusion Equipment formedical use - Part 4:Infusion sets for singleuse, gravity feed	Pass
Performance	ISO 8536-6: 2009	Infusion equipment formedical use - Part6:Freeze drying closuresfor infusion bottles	Pass

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)

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.

{7}------------------------------------------------

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Regulation Number and Section

§ 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.