(60 days)
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 | |
---|---|
Name | Hospira, Incorporated |
Address | D-393, Bldg. H2 |
275 North Field Drive | |
Lake Forest, IL. 60045 | |
Phone number | (224) 212-5316 |
Fax number | (224)-212-5401 |
Establishment | |
Registration Number | Owner/Operator #9063339 |
Establishment registration number #3005579246 | |
Name of contact | |
person | Karen Keener |
Date prepared | October 01, 2013 |
Name of device | |
Trade or proprietary | |
name | ADD-Vantage ADDaptor™ |
Common or usual | |
name | 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 marketed | |
device(s) to which | |
equivalence is claimed | B. Braun addEASE |
(K090905) | |
Reason for 510(k) | |
submission | Accessory 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 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. | |
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 Lyophilized | |
Molecule(s) | Same | |
Transfer adapter Vial | ||
Type | 20mm | Same |
Diluent Bag | B. Braun Diluent Containers | ADD-Vantage Diluent |
Container(s) | ||
Device components | Transfer Adapter | |
Sterile Cap_Qty 2 | Same | |
Vial Access | Plastic Spike | Same |
Vial Retention | Plastic Snaps/Grips | Same |
Diluent Bag | ||
connection | 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) | ||
Manufacturing | ||
Assembly | Assume Ultrasonic Welding | Same |
Manufacturing | ||
Assembly | Assume Ultrasonic Welding | Interference fit sterile caps |
Sterilization | Gamma | Same |
Biocompatibility | Assume 10993-1 | Per 10993-1 |
Principle of | ||
Operation | Same | Same |
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 | |||
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 | Pass | ||
maintenance of a | |||
sterilization process | |||
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 |
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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