(139 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is for transferring fluids, not for treating a disease or condition in a patient.
No
The device is described as a "fluid transfer device" for "transferring IV fluids/medication." Its function is solely to move fluids, not to diagnose any condition or disease.
No
The device description clearly outlines physical components (flexible PVC twist-off cap, PVC tubing, polycarbonate large bore male luer lock, polycarbonate/LDPE piercing pin, inline air filter assembly) and manufacturing processes (solvent bonding, packing, sterilization), indicating it is a hardware device, not software-only.
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 "For use in transferring IV fluids/medication from a 20 mm drug vial to an IV fluid administration device." This describes a physical transfer of substances, not a diagnostic test performed in vitro (outside the body) on biological specimens to obtain information about a patient's health.
- Device Description: The description details a mechanical device for fluid transfer, composed of components like tubing, luer locks, and a piercing pin. There is no mention of reagents, assays, or any components typically associated with diagnostic testing.
- Lack of Diagnostic Elements: The document does not mention any elements related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, genes, metabolites, etc.)
- Providing diagnostic information about a disease or condition.
- Performance Studies: The performance studies focus on functional aspects like occlusion, pressure, pull, insertion, and retention, as well as biocompatibility and chemical testing. These are relevant to a fluid transfer device, not a diagnostic device which would typically involve studies on sensitivity, specificity, accuracy, etc.
In summary, the device's purpose is to facilitate the delivery of medication or fluids, which is a therapeutic or supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The 20 mm Vial Fluid Transfer Adapter is intended for use in transferring IV fluids/medication from a 20 mm drug vial to an IV fluid administration device.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The 20 mm Vial Fluid Transfer Adapter is a sterile, single use fluid transfer device. The 20 mm Vial Fluid Transfer Adapter is composed of a flexible PVC twist-off cap, PVC tubing, a polycarbonate large bore male luer lock, polycarbonate/LDPE piercing pin, and an inline air filter assembly. The PVC components do not contain DEHP. Components will be solvent bonded to assemble the device. The finished device will be packed and sterilized.
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
Not Found
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)
Non clinical testing of the proposed device was conducted to demonstrate safety and effective and substantial equivalence to the predicate device. To verify that the design characteristics and input requirements of the 20 mm Vial Fluid Transfer Adapter are appropriate for the intended use and user requirements, functional performance testing has been executed in the test laboratory. This testing demonstrates that the 20 mm Vial Fluid Transfer Adapter functions as intended. Testing conducted included visual inspection, occlusion, pressure, pull, insertion and retention. The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria. CONCLUSION: Functional performance testing and material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid Transfer Adapter is both safe and effective and performs similarly to the predicate device.
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
K 100640
5. 510(k) SUMMARY
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Matthew J. Homa
Sr. Regulatory Affairs Analyst
Phone: (610) 596-2558
Fax: (610) 266-4962
E-mail: matthew.homa@bbraun.com |
JUL 22 2010
| DATE: | May 17, 2010 |
|---|---|
| DEVICE NAME: | 20 mm Vial Fluid Transfer Adapter |
| COMMON OR | |
| USUAL NAME: | Set, I.V. Fluid Transfer |
| DEVICE | |
| CLASSIFICATION: | Class II, Product Code LHI, 21 CFR $880.5440 |
| PREDICATE DEVICE: | IV Fluid Transfer Pin, B. Braun Medical Inc, K925401, Class |
| II, LHI and 21 CFR §880.5440. | |
| DESCRIPTION: | The 20 mm Vial Fluid Transfer Adapter is a sterile, single use |
| fluid transfer device. The 20 mm Vial Fluid Transfer Adapter | |
| is composed of a flexible PVC twist-off cap, PVC tubing, a | |
| polycarbonate large bore male luer lock, polycarbonate/LDPE | |
| piercing pin, and an inline air filter assembly. The PVC | |
| components do not contain DEHP. Components will be | |
| solvent bonded to assemble the device. The finished device | |
| will be packed and sterilized. | |
| INTENDED USE: | The 20 mm Vial Fluid Transfer Adapter is intended for use in |
| transferring IV fluids/medication from a 20 mm drug vial to an | |
| IV fluid administration device. | |
| SUBSTANTIAL | |
| EQUIVALENCE: | The 20 mm Vial Fluid Transfer Adapter has a similar intended |
| use and is comprised of components similar to the IV Fluid | |
| Transfer Pin (K925401). Both products have a plastic spike | |
| used to access the source container and withdraw IV fluid. | |
| Biocompatibility, chemical and functional testing have been | |
| completed to verify that there are no differences between the |
1
proposed device and the predicate device which raise new issues of safety or effectiveness.
Transfer Adapter is both safe and effective and performs
NONCLINICAL Non clinical testing of the proposed device was conducted to TESTING: demonstrate safety and effective and substantial equivalence to the predicate device. To verify that the design characteristics and input requirements of the 20 mm Vial Fluid Transfer Adapter are appropriate for the intended use and user requirements, functional performance testing has been executed in the test laboratory. This testing demonstrates that the 20 mm Vial Fluid Transfer Adapter functions as intended. Testing conducted included visual inspection, occlusion, pressure, pull, insertion and retention. The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria. CONCLUSION: Functional performance testing and material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid
similarly to the predicate device.
30
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Matthew J. Homa Senior Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18196-3941
JUL 2-2 2010
Re: K100640
Trade/Device Name: 20 mm Vial Fluid Transfer Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: July 16, 2010 Received: July 19, 2010
Dear Mr. Homa:
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 - Mr. Homa
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 vours.
hh for
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
Enclosure
4
B. Braun Medical Inc. 510(k) Premarket Notification 20 mm Vial Fluid Transfer Adapter
4. INDICATIONS FOR USE STATEMENT
Page _________ of ____________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name:
20 mm Vial Fluid Transfer Adapter
Indications For Use:
For use in transferring IV fluids/medication from a 20 mm drug vial to an IV fluid administration device.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
17
(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 mection Control, Dental Devices
:10(k) Number: _______________________________________________________________________________________________________________________________________________________________