(577 days)
No
The description focuses on electromechanical and gravimetric weighing technologies, with a software upgrade for source solution verification. There is no mention of AI or ML terms, image processing, or data sets typically associated with AI/ML development.
No
The device is described as a fluid compounding device for gravimetric weighing, which is used for preparing medications, not for direct diagnosis, treatment, or prevention of disease in a patient.
No
The device is described as an electromechanical fluid compounding device, used for mixing fluids via gravimetric weighing, and includes a system to verify source solution identity. Its function is to prepare solutions, not to diagnose medical conditions or interpret clinical data. Its performance testing focuses on functional acceptability of hardware modifications for compounding.
No
The device is described as an "electromechanical positive displacement fluid compounding device" with "hardware modifications and enhancements," indicating it is a physical device with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as "compounding of fluids via gravimetric weighing." This is a process of preparing solutions, not a diagnostic test performed on biological samples.
- Device Description: The device is described as an "electromechanical positive displacement fluid compounding device." This further reinforces its function in preparing fluids.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in biological samples
- Providing information for the diagnosis, treatment, or prevention of disease
The device's function is to accurately mix fluids based on weight, which is a pharmaceutical compounding process, not an in vitro diagnostic test. The addition of the "Positive Identification Solution Family Monitor" is to aid in verifying the source solutions for compounding, not for diagnostic purposes.
N/A
Intended Use / Indications for Use
This device is an electromechanical positive displacement fluid compounding device that provides for the compounding of fluids via gravimetric weighing.
Product codes
LHI
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Pre-determined 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
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:
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.
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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines above and below them.
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
2
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