(24 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid administration properties, with no mention of AI/ML terms or functionalities.
No
The device is used for fluid administration and does not directly treat or diagnose a disease or condition. It is a delivery system, not a therapeutic agent itself.
No
The device is described as administering fluids to a patient's vascular system and has performance studies related to fluid administration, not diagnosis. It does not mention detecting, monitoring, or predicting diseases or conditions.
No
The device description clearly describes a physical, disposable medical device (solution sets with a burette chamber) used for fluid administration, not a software-only product.
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 "administration of fluids from a container into the patient's vascular system through a vascular access device." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description details a system for controlling and delivering fluids into the bloodstream. It mentions components like a burette chamber, valves, and clamps, all related to fluid administration. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic, prognostic, or screening information
- Using reagents or assays
The Buretrol Solution Sets are clearly designed for therapeutic or supportive purposes (fluid administration), not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Buretrol Solution Sets are intended for use in the administration of fluids from a container into the patient's vascular system through a vascular access device.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Buretrol Solution Sets are sterile, single use disposable devices indicated for use in the administration of fluids from a container into the patient's vascular system through a vascular access device. The sets contain a burette chamber which can be used to mix supplementary medication in a measured amount of diluent from the main container. The sets can be adjusted for either metered volume solution administration (intermittent) or continuous solution administration. The sets can be converted from intermittent to continuous administration by closing the air vent at the top of the burette and allowing continuous infusion from the main container. There are different configurations of the burette, based on presence of and differences in valve type.
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)
Performance Data: The following tests were conducted to evaluate the functional performance of the Buretrol Sets:
-. Spike Leakage Test Over Time
- Burette Squeeze Test.
- Burette Pressure Test.
- Burette Scale Legibility.
- Roller Clamp Immediate Shut-Off.
- Roller Clamp Shut-Off Over Time.
- Check Valve Backflow Evaluation.
- Regulating Roller Clamp Cold Flow Test.
- Regulating Roller Clamp Shut-Off Test.
- Air Vent Air Flow Test -
- ISO Luer Tests on Male Luer lock.
All tests met the acceptance criteria.
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
Special 510(k) Premarket Notification Buretrol Solution Sets
5. 510(K) SUMMARY
December 14, 2012
Owner:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
Contact person:
Nanette Hedden Associate Director, Global Regulatory Affairs 36250 N. Wilson Rd. Round Lake, IL 60073 Telephone: (224) 270-4871 Fax: (224) 270-4900
DEVICE NAME: IV Administration Sets
Trade Name: Buretrol Solution Sets
| Code Number | Name |
|---|---|
| 1C8441 | Interlink System Buretrol Solution Set, 77" (2.0 m), 150 mL Burette Ball Valve |
| 2H8862 | Clearlink System Non-DEHP Buretrol Solution Set, 115" (2.9 m), 150 mL Valveless Burette |
| 3C0128 | Interlink System Buretrol Solution Set, 105" (2.7 m), 150 mL Burette Drip Chamber Filter Valve |
| Large Bore 4-Way Stopcock Extension Set, 34" (87 cm), Vol. 4.6 mL | |
| Minivolume Extension Set, 2.9" (7 cm), Vol. 0.1 mL |
Table 5-1 Representative Product Codes for Buretrol Solution Sets
Section 5, 510(k) Summary Page 1 of 3
K123874
JAN 1 0 2013
35
1
Common Name: Solution Set with Burette Chamber
Classification Name: IV Administration Set (21 CFR 880.5440, Product Code FPA)
PREDICATE DEVICE:
Table 5-2 Previous 510(k)s
| Device | Company | Previous 510(k) | Clearance
Date |
|------------------------------------------------|---------------------------|-----------------|----------------------|
| Modified Buretrol Solution Sets | Baxter Healthcare | K984381 | February 19,
1999 |
| Burette Set with Air Control Lever -
2C0147 | Travenol
Laboratories1 | K780970 | July 27, 1978 |
Travenol Laboratories was renamed Baxter Healthcare in 1988.
DESCRIPTION OF THE DEVICE:
The Buretrol Solution Sets are sterile, single use disposable devices indicated for use in the administration of fluids from a container into the patient's vascular system through a vascular access device. The sets contain a burette chamber which can be used to mix supplementary medication in a measured amount of diluent from the main container. The sets can be adjusted for either metered volume solution administration (intermittent) or continuous solution administration. The sets can be converted from intermittent to continuous administration by closing the air vent at the top of the burette and allowing continuous infusion from the main container. There are different configurations of the burette, based on presence of and differences in valve type.
STATEMENT OF INTENDED USE:
The Buretrol Solution Sets are intended for use in the administration of fluids from a container into the patient's vascular system through a vascular access device.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed Buretrol Solution Sets are equivalent to Baxter's currently legally marketed Modified Buretrol Solution Sets cleared February 19, 1999 (K984381). The modification to the labeling does not impact the intended use or the fundamental scientific technology of the device. . The intended use, basic design, function and the materials for the proposed device are equivalent to the predicate device.
2
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the results of these analyses. All test results meet their acceptance criteria, and support that the devices are appropriately designed for their intended use.
Performance Data: The following tests were conducted to evaluate the functional performance of the Buretrol Sets:
- . Spike Leakage Test Over Time
- Burette Squeeze Test .
- Burette Pressure Test .
- Burette Scale Legibility .
- Roller Clamp Immediate Shut-Off .
- Roller Clamp Shut-Off Over Time .
- Check Valve Backflow Evaluation .
- Regulating Roller Clamp Cold Flow Test .
- Regulating Roller Clamp Shut-Off Test .
- Air Vent Air Flow Test ●
- ISO Luer Tests on Male Luer lock .
All tests met the acceptance criteria.
Biocompatibility: No new materials of construction are being introduced into these devices as part of this Special 510(k) Premarket Notification. Biocompatibility assessment of the Buretrol Solution Sets has been conducted based on ISO 10993, Biological Evaluation of Medical Devices for prolonged duration, external communicating, indirect blood path and Blue Book Memorandum G95-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," as recommended in the IV Administration sets guidance.
CONCLUSION:
The Buretrol Solution Sets are substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Silver Spring, MD 20993-0002
January 10, 2013
Ms. Nanette Hedden Associate Director, Global Regulatory Affairs Baxter Healthcare Corporation 36250 North Wilson Road ROUND LAKE IL 60073
Re: K123874
Trade/Device Name: Buretrol Solutions Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 14, 2012 Received: December 17, 2012
Dear Ms. Hedden:
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.
4
Page 2 - Ms. Hedden
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,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: Buretrol Solution Sets
Indication(s) for Use:
The Buretrol Solution Sets are intended for use in the administration of fluids from a container into the patient's vascular system through a vascular access device.
D AND/OR Prescription Use:
Over-the-Counter Use: T
21 CFR 801 Subpart D
21 CFR Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) (Division of Anestheslology, General Hospital Infection Control, Dental Devices
510(k) Number:
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