(26 days)
No
The device description and intended use are purely mechanical, describing a physical connector for transferring fluids. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a transfer device used in a pharmacy setting to mix drugs, not to treat a medical condition or perform a diagnostic function on a patient.
No
This device is a double-ended transfer device used in a pharmacy setting to mix drugs and solutions, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (bag spike, vial spike, needle, plunger, caps) made of materials like polycarbonate and stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag." This describes a process for preparing medication for administration to a patient.
- Device Description: The device is a "double ended transfer device" designed for connecting containers and mixing their contents. It does not perform any diagnostic testing on biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for preparing medication, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV 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
LHI
Device Description
The addEASE 20 mm Binary Connector with 17 Ga. needle is a double ended transfer device intended to connect a B. Braun 250 mL Excel® IV solution bag to a 20 mm drug vial. The device contains a bag spike on one end and a vial spike on the other end. The vial spike is composed of polycarbonate and the bag spike is composed of a 17 Ga. stainless steel needle. The device contains a plunger which keeps the contents of the connected containers separate until the plunger is purposely deployed and the contents of the bag and vial are mixed. The bag spike and vial spike are protected with caps that maintain the sterility of the device until the caps are removed prior to use.
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
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)
Design verification testing has been completed and all specifications have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
B. Braun Medical Inc. Special 510(k) Premarket Notification addEASE 20mm Binary Connector with 17 Ga. Needle
March 27, 2009
Koroops
5. 510(k) SUMMARY
| APPLICANT/
SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
610-266-0500 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Angela J. Caravella
Sr. Regulatory Affairs Analyst
Phone: 610-596-2966
Fax: 610-596-2502
E-mail: Angela.Caravella@bbraun.com |
| DEVICE NAME: | addEASE 20mm Binary Connector with 17 Ga. Needle |
| COMMON OR
USUAL NAME: | Binary Connector |
| DEVICE
CLASSIFICATION: | Class II per 21 CFR § 880.5440
Product Code LHI |
| CURRENTLY
MARKETED
DEVICE (PREDICATE): | addEASE Binary Connector, 13 and 20 mm (Add-A-Vial II
510(k) K900865) |
| DESCRIPTION: | The addEASE 20 mm Binary Connector with 17 Ga. needle
is a double ended transfer device intended to connect a B.
Braun 250 mL Excel® IV solution bag to a 20 mm drug
vial. The device contains a bag spike on one end and a vial
spike on the other end. The vial spike is composed of
polycarbonate and the bag spike is composed of a 17 Ga.
stainless steel needle. The device contains a plunger which
keeps the contents of the connected containers separate
until the plunger is purposely deployed and the contents of
the bag and vial are mixed. The bag spike and vial spike
are protected with caps that maintain the sterility of the
device until the caps are removed prior to use. |
| INTENDED USE: | The addEASE 20 mm Binary Connector with 17 Ga. needle
is a double ended transfer device intended for use in a
pharmacy setting to connect a B. Braun 250mL Excel® IV
solution bag to a 20 mm drug vial for reconstituting or
mixing the drug in the vial with the solution in the bag. |
APR 2 7 2009.... . .
.
1
B. Braun Medical Inc. Special 510(k) Premarket Notification addEASE 20mm Binary Connector with 17 Ga. Needle
SUBSTANTIAL EQUIVALENCE:
The addEASE 20mm Binary Connector with 17 Ga. needle has the same intended use and utilizes the same fundamental technology as the predicate device, the currently marketed addEASE device cleared in B. Braun 510(k) K900865 (entitled Add-A-Vial II). The addEASE 20 mm Binary Connector with 17 Ga. needle is similar to the predicate device in material composition and components except for the 17 Ga. needle that replaced one of the polycarbonate spikes. The addition of a 17 Ga. needle to the device does not have a significant impact upon the fundamental technology of the addEASE product. Design verification testing has been completed and all specifications have been met. The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.
Public Health Service
Image /page/2/Picture/12 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name arranged in a circular fashion around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract caduceus, a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2009
Ms. Angela Caravella Senior Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K090905
Trade/Device Name: addEASE 20 mm Binary Connector with 17 Ga. Needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 27, 2009 Received: April 21, 2009
Dear Ms. Caravella:
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.
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 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
3
Page 2- Ms. Caravella
and listing (21 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Suarez
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Page __ 1 _ of _ 1_
510(k) Number (if known):
109 09 05
addEASE 20 mm Binary Connector with 17 Ga. Needle Device Name:
Indications For Use:
The addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.
Prescription Use _ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K090905
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