(147 days)
No
The 510(k) summary describes a standard IV administration set with UV-resistant tubing and does not mention any AI or ML components or functionalities.
No
This device is an IV administration set designed to deliver fluids, not to treat a specific condition or disease itself. Its primary function is fluid delivery, not therapy.
No
The device is described as an IV administration set for delivering fluids to a patient, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like tubing, chamber assembly, injection site, etc., 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 for the "pump or gravity administration of IV fluids involving light sensitive solutions" to a patient's vascular system. This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description details a tubing set for administering fluids, including components like tubing, chambers, injection sites, filters, etc. These are all components of a system for delivering IV fluids, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostic testing.
In summary, the device is an IV administration set, which is a medical device used for therapeutic purposes (delivering medication or fluids), not for diagnostic purposes.
N/A
Intended Use / Indications for Use
The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.
Product codes
FPA
Device Description
The IV Administration Sets with Ultrablock UV-Resistant Tubing are a single-use, sterile, non-pyrogenic tubing set intended for the administration of light sensitive solutions from a container to a patient's vascular system. The device is composed of UV-Resistant IV tubing and may include one or more of the following: universal chamber assembly, injection site, male luer lock, slide clamp, 0.2 micron air eliminating filter, flow clip assembly, and pump cassette.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021480, Abbott LifeShield Primary Microbore Device Set
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
K04/490
:
OCT 2 9 2004
| 510(k) Summary | |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| (610) 266-0500, ext. 2376 | |
| Contact: Scott Pease, Manager, Regulatory Affairs | |
| DEVICE NAME: | IV Administration Sets with Ultrablock UV-Resistant |
| Tubing | |
| COMMON OR USUAL | |
| NAME: | Set, Administration Intravascular |
| DEVICE | |
| CLASSIFICATION: | Class II, 21 CFR §880.5440, |
| Product Code: FPA | |
| PREDICATE DEVICE: | K021480 Codan US Corporation Light-Safe Extension Set |
| (BC565) and | |
| Abbott LifeShield® Primary Microbore Device Set | |
| DESCRIPTION: | The IV Administration Sets with Ultrablock UV-Resistant |
| Tubing are a single-use, sterile, non-pyrogenic tubing set | |
| intended for the administration of light sensitive solutions | |
| from a container to a patient's vascular system. The device | |
| is composed of UV-Resistant IV tubing and may include | |
| one or more of the following: universal chamber assembly, | |
| injection site, male luer lock, slide clamp, 0.2 micron air | |
| eliminating filter, flow clip assembly, and pump cassette. | |
| INTENDED USE: | The IV Administration Sets with Ultrablock UV-Resistant |
| Tubing are intended for the pump or gravity administration | |
| of IV fluids involving light sensitive solutions. | |
| SUBSTANTIAL | |
| EQUIVALENCE: | The B. Braun Medical Inc. IV Administration Sets with |
| Ultrablock UV-Resistant Tubing are similar in indications | |
| for use to the Codan US Corporation Light-Safe Extension | |
| Set marketed by Codan under their 510(k) Premarket | |
| Notification K021480 and the Abbott LifeShield Microbore | |
| Device Sets marketed by Abbott Healthcare. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 2004
Mr. Scott Pease Manager, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K041490
Trade/Device Name: IV Administration Set with Ultrablock UV-Resistant Tubing Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 9, 2004 Received: September 10, 2004
Dear Mr. Pease:
.
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 such 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.
2
Page 2 - Mr. Pease
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
C. Shin Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
2.0 Indications for Use Statement
Page
510(k) Number (if known): K041490
IV Administration Sets with Ultrablock UV-Resistant Tubing Device Name:
Indications For Use:
The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.
Arton V, m
(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital, Division of Anton Dental Devices
510(k) Number: K941490
Prescription Use
(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)