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.

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.

AI/ML Overview

This document describes the acceptance criteria and study for the Special 510(k) Premarket Notification for Buretrol Solution Sets.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Spike Leakage Test Over Time	Not specified, but implied to meet functional requirements	All tests met the acceptance criteria
Burette Squeeze Test	Not specified, but implied to meet functional requirements	All tests met the acceptance criteria
Burette Pressure Test	Not specified, but implied to meet functional requirements	All tests met the acceptance criteria
Burette Scale Legibility	Not specified, but implied to ensure clear and accurate reading	All tests met the acceptance criteria
Roller Clamp Immediate Shut-Off	Not specified, but implied to ensure immediate cessation of fluid flow	All tests met the acceptance criteria
Roller Clamp Shut-Off Over Time	Not specified, but implied to ensure sustained cessation of fluid flow	All tests met the acceptance criteria
Check Valve Backflow Evaluation	Not specified, but implied to prevent backflow	All tests met the acceptance criteria
Regulating Roller Clamp Cold Flow Test	Not specified, but implied to ensure proper flow regulation at low temperatures	All tests met the acceptance criteria
Regulating Roller Clamp Shut-Off Test	Not specified, but implied to ensure complete shut-off	All tests met the acceptance criteria
Air Vent Air Flow Test	Not specified, but implied to ensure proper air flow for burette function	All tests met the acceptance criteria
ISO Luer Tests on Male Luer Lock	Not specified, but implied to meet ISO Luer standards for secure and leak-free connections	All tests met the acceptance criteria
Biocompatibility (for new materials)	Meeting ISO 10993 standards and Blue Book Memorandum G95-1 for "Biological Evaluation of Medical Devices"	No new materials were introduced; previous assessments apply

2. Sample Size Used for the Test Set and Data Provenance:

The document reviews manufacturing changes rather than a new device; thus, it relies on design verification tests. The specific sample sizes for each performance test (e.g., Spike Leakage, Burette Squeeze) are not explicitly stated in the provided text. The data provenance is presumed to be from Baxter Healthcare Corporation's internal testing. The study is a retrospective analysis of the device's functional and biocompatibility performance based on existing designs and materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the document describes non-clinical performance and biocompatibility testing of a medical device, not a diagnostic algorithm that requires expert ground truth for interpretation (e.g., image analysis). The "ground truth" here is the pass/fail result of engineering and materials science tests against pre-defined acceptance criteria.

4. Adjudication Method for the Test Set:

This information is not applicable for the type of non-clinical device testing described. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving interpretation by multiple human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms with and without AI assistance in a clinical setting, which is not the subject of this 510(k) summary.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone algorithm performance study was not done. This device is a physical medical administration set, not an AI or software-based medical device.

7. The Type of Ground Truth Used:

The "ground truth" used for these tests is engineering specifications and recognized standards (e.g., ISO Luer tests, ISO 10993 for biocompatibility). The tests verify that the physical characteristics and functional performance of the Buretrol Solution Sets meet these established criteria.

8. The Sample Size for the Training Set:

This information is not applicable. The device is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for this device.

Summary

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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 ValveLarge Bore 4-Way Stopcock Extension Set, 34" (87 cm), Vol. 4.6 mLMinivolume 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

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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)	ClearanceDate
Modified Buretrol Solution Sets	Baxter Healthcare	K984381	February 19,1999
Burette Set with Air Control Lever -2C0147	TravenolLaboratories1	K780970	July 27, 1978

Travenol Laboratories was renamed Baxter Healthcare in 1988.

DESCRIPTION OF THE DEVICE:

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.

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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.

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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.

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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

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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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Regulation Number and Section

§ 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.