(127 days)
Not Found
No
The device description and performance studies focus on mechanical fluid transfer and material safety, with no mention of AI/ML terms or functionalities.
No.
The device is used for fluid transfer between containers, not for direct interaction with a patient for therapeutic purposes.
No
The device is intended for the transfer of fluid/medication between containers, not for diagnosing medical conditions or diseases.
No
The device description clearly describes a physical device with spikes and lumens for fluid transfer, not a software application.
Based on the provided information, the Dual Spike Transfer Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "direct transfer of fluid/medication from one rubber-stoppered container to another." This is a mechanical process for preparing or transferring medications, not for analyzing biological samples or providing diagnostic information.
- Device Description: The description focuses on the physical mechanism of fluid transfer between containers. There is no mention of analyzing samples, detecting analytes, or providing diagnostic results.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
- Intended User/Care Setting: The intended users are "healthcare professionals during medication preparation, admixture, or fluid transfer," which aligns with the use of a device for handling medications, not for diagnostic testing.
In summary, the Dual Spike Transfer Device is a medical device used for the physical transfer of fluids/medications, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
For the direct transfer of fluids/medications from one rubber-stoppered contamer to another.
The Dual Spike Transfer Device is intended for the direct transfer of fluid/medication from one rubber-stoppered container to another.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The Dual Spike Transfer Device is a device containing two opposing spikes. Each spike contains a second lumen (adjacent to the spike). which facilitates direct flow of fluid/medication from one container (glass or flexible comainer) to another (glass or flexible container).
The proposed device is designed for, use by healthcare professionals during medication preparation, admixture, or fluid transfer. When the Dual Spike Transfer device is attached to the additive container, only air within the vial or flexible container is released into the recipient container. Once fluid transfer is complete, the transfer device attached to the additive container is discarded. This device is intended for admixture only.
The Dual Spike Transfer Device is individually packaged with two guards placed on each spike that provide protection to the spike ends of the device and prevent touch contamination.
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
healthcare professionals
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)
Safety and functional testing was conducted on the Dual Spike Transfer Device to demonstrate that the performance of the device and the safety of its materials and components. Results of this testing show that differences between the proposed device and the predicate do not raise new issues of safety or efficacy.
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.
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
B. Braun Medical Inc. 510(k) Premarket Notification Dual Spike Transfer Device
K128150
5. 510(k) SUMMARY
DATE:
SUBMITTER:
May 18, 2012
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Dual Spike Transfer Device
Fluid Transfer Device
21 CFR 8880.5440
flexible container).
Contact: Bonnie J. Kincaid Phone: (610) 596-2970 (610) 266-4962 Fax: E-mail: bonnie kincaid(a)bbraun.com
DEVICE NAME:
COMMON OR USUAL NAME:
DEVICE CLASSIFICATION:
PREDICATE DEVICES:
DESCRIPTION:
MAY 2 4 2012
The Dual Spike Transfer Device is a device containing two opposing spikes. Each spike contains a second lumen (adjacent to the spike). which facilitates direct flow of fluid/medication from
one container (glass or flexible comainer) to another (glass or
B. Braun Medical Inc.'s IV Fluid Transfer Pin, K925401, LHI,
Class II, per 21 CFR §880.5440, Product Code: LHI
The proposed device is designed for, use by healthcare professionals during medication preparation, admixture, or fluid transfer. When the Dual Spike Transfer device is attached to the additive container, only air within the vial or flexible container is released into the recipient container. Once fluid transfer is complete, the transfer device attached to the additive container is discarded. This device is intended for admixture only.
The Dual Spike Transfer Device is individually packaged with two guards placed on each spike that provide protection to the spike ends of the device and prevent touch contamination.
INTENDED USE:
For the direct transfer of fluids/medications from one rubberstoppered contamer to another.
1
B. Braun Medical Inc. 519(k) Premarket Notification Dual Spike Transfer Device
SUBSTANTIAL EQUIVALENCE:
A single predicate, the IV Fluid Transfer Pin, was used for comparison with the proposed device. The Dual Spike Transfer Device has an intended use similar to the IV Fluid Transfer Pin. Both devices are used in admixture programs and they are not intended for direct patient administration. Each of these molded devices has a piercing spike designed for spiking a rubber stopper and a flange to assist in spiking. The spike ends are siliconized and capped by vented molded guards to protect the spike end from damage or touch containination. The proposed device and the predicate are manufactured in a similar process from similar matcrials and components. They are both sterile, non-pyrogenic, disposable, single use, individually packaged, fluid transfer devices.
While each device is designed for spiking a rubber stopper, the IV Fluid, Transfer Device is also intended to be luer connected to a syringe or other luer compatible container for subsequent transfer Direct transfer to or from rubber stoppered to a container. containers to or from a flexible container can be achieved with the use of the proposed device. Therefore, performance testing has been conducted to support the design and intended use of the device.
CONCLUSION:
Safety and functional testing were conducted on the Dual Spike Transfer Device to demonstrate that the performance of the device and the safety of its materials and components. Results of this testing show that differences between the proposed device and the predicate do not raise new issues of safety or efficacy.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. At the center of the seal is a stylized caduceus symbol, which is often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Bonnie J. Kincaid Manager, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
2 4 2012 MAY
Re: K120150
Trade/Device Name: Dual Spike Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: May 18, 2012 Received: May 21, 2012
Dear Ms. Kincaid:
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.
3
Page 2- Ms. Kincaid
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 (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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
fr
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
B. Braun Medical Inc.
510(k) Premarket Notification Dual Spike Transfer Device
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
: .
.
| Page 1 of 1 | |
|---|---|
| 510(k) Number (if known): | |
| Device Name: | Dual Spike Transfer Device |
Indications For Use:
The Dual Spike Transfer Device is intended for the direct transfer of fluid/medication from one rubber-stoppered container to another.
| Prescription Use (Per 21 CFR 801.109) | X 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: | 120150 |
|---|---|
| ---------------- | -------- |
.
:
.
.
18