AUTOMIX 3+3/AS COMPOUNDER SYSTEM by BAXTER HEALTHCARE CORP.

This device is an electromechanical positive displacement fluid compounding device that provides for the compounding of fluids via gravimetric weighing.

Device Description

The Automix 3 + 3 / AS Compounder System is an electromechanical positive displacement fluid compounding device that provides for the safe, fast, and accurate compounding of a wide variety of fluids via gravimetric weighing. It has the same operational intended use and remains the same in all respects to the currently marketed system, except for the proposed modifications to incorporate a system to aid in the verification of source solution identity and placement.

The Positive Identification Solution Family Monitor, an equipment and software upgrade designed to aid in the verification of the identity of the source solutions being compounded, is a modification and upgrade to the compounding system currently marketed which is found substantially equivalent, for purposes of the Federal Food, Drug and Cosmetic Act only, to the Automix® 3+3 Compounder System under K894827, dated October 6, 1989.

AI/ML Overview

This document, a 510(k) Premarket Notification for the Clintec Automix® 3+3/AS Compounder System, is a submission to the FDA. It declares substantial equivalence to a previously marketed device (K894827). Due to its nature, it does not contain the detailed performance study information typically found in a clinical trial report or a comprehensive validation study.

Therefore, many of the requested criteria cannot be extracted from this document, as it focuses on demonstrating equivalence rather than presenting an exhaustive performance study with acceptance criteria in the way you've described.

Here's an attempt to answer what can be inferred from the provided text, along with explanations for what cannot be:

1. A table of acceptance criteria and the reported device performance

This information is not available in the provided 510(k) summary. A 510(k) summary generally states that performance testing was conducted and found acceptable, but it does not typically detail specific acceptance criteria or the raw performance data in a table format.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided 510(k) summary. The document mentions "performance testing" and "verification and validation procedures" but does not specify sample sizes or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable and not available. This device is an electromechanical fluid compounding system, not a diagnostic device that requires expert interpretation to establish a "ground truth" for a test set in the way a medical imaging AI would. The "ground truth" for this type of device would relate to the accuracy and precision of fluid compounding, which is typically measured by chemical/physical means, not expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable and not available. Similar to point 3, adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., medical images) to resolve discrepancies. This device is a machine, and its performance is assessed through objective measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable and not available. MRMC studies are used for diagnostic systems (often AI-powered) where human readers interpret cases. This device is an automated compounding system and does not involve "human readers" in its primary function. Its "Positive Identification Solution Family Monitor" is an aid for verification, not a system that improves human interpretation of cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device as an "electromechanical positive displacement fluid compounding device." The "Positive Identification Solution Family Monitor, an equipment and software upgrade designed to aid in the verification of the identity of the source solutions," suggests that the system operates in an automated or semi-automated standalone manner for compounding, with the new feature aiding in verification. However, a formal "standalone" performance study report in the context of an AI algorithm is not detailed or explicitly stated here. The overall device functions as a standalone system for compounding.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the concept of "ground truth" for this device relates to the accurate and precise compounding of fluids. This would typically be established through quantitative physical and chemical measurements (e.g., gravimetric analysis, chemical assays of compounded solutions) to ensure correct ingredient identity, volume, and concentration. The specific methods are not detailed in the provided summary.

8. The sample size for the training set

This is not applicable and not available. The document describes an "electromechanical positive displacement fluid compounding system" that relies on "gravimetric weighing" and an "equipment and software upgrade." This is a traditional engineering system, not a machine learning or AI system that requires a "training set" in the sense of supervised learning. The software aspects likely involve programming logic, control algorithms, and perhaps rule-based systems, but not a data-driven training set like deep learning.

9. How the ground truth for the training set was established

This is not applicable for the reasons stated in point 8.

Summary

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T.C.C.S.

510(k) Premarketing Notification Clintec Automix ® 3 + 3 / AS Compounder System March 11, 1996

OCT 1 0 1997

Attachment 9.

510(k) Summary

(as required by 21 CFR 807.92)

Dennis A. Ocwieja Submitted by: Vice President Regulatory Affairs and Quality Assurance Clintec Nutrition Company Three Parkway North, Suite 200 Deerfield. IL 60015 phone: (847) 317-3058 fax: (847) 317-3139

Date Prepared: 03/08/96

Trade/Proprietary Name: Clintec Automix 3 + 3 / AS Compounder System

Common/Usual Name: Electromechanical Positive Displacement Fluid Compounding System

Classification Name: Compounding System with Integrated Computer Software

Classification: Class II in 21 CFR & 880.5440, Set, I.V., Fluid Transfer

Clintec Automix 3 + 3 Compounder System Predicate Device:

Performance testing for the Clintec Automix ® 3 + 3 / AS Compounder System described in the submission demonstrates the functional acceptability of the proposed hardware modifications and enhancements.

The design changes are documented and their verification and validation procedures are described in the application.

390315

1 1 1996 MAH

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Ms. Marcia Marconi Vice President Requlatory Affairs Baxter Healthcare Corporation Route 120 & Wilson Road Roound Lake, Illinois 60073

OCT 1 0 1997

Re : K961008 Automix® 3+3/AS Compounder System Trade Name: Regulatory Class: II Product Code: LHI September 26, 1997 Dated: Received: September 30, 1997

Dear Ms. Marconi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ਼ਾ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Marconi

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Runnoe

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

, Enclosure

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510(k) Number (if Known): _ K961008

Device Name: Automix 3+3/AS Compounder System

Indications For Use:

This device is an electromechanical positive displacement fluid compounding device that provides for the compounding of fluids via gravimetric weighing.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patacia Crescentz

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K961008

V Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)

10/09/97

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.