The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions.

Device Description

The AutoDose Infusion System was designed to infuse Intravenous solutions of predetermined volumes in a predetermined order based on the configuration of the disposable bag. The system is capable of infusing Intravenous (IV) solutions of the following volumes in this order: Chamber 1 <= 10 mls., Chamber 2 ~ 25 – 120 mls, Chamber 3 <= 10 mls. A Pharmacist may decide to use the AutoDose Infusion System with an AutoDose Bag filled with 0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP in conjunction with an Administration IV fluid. In this configuration, the AutoDose would deliver the IV fluids using the deliver regimen, commonly known as SASH: (Saline, Administration, Saline, Heparin) and eliminate the need to use needles, syringes and access the IVAD (Intravenous Access Device) multiple times. When the Pharmacist chooses to use the AutoDose Infusion system in this manner, an empty AutoDose Bag is filled with Saline and Heparin solutions drawn and prepared from the Pharmacy stores. After the prescription is filled with the main medication (i.e. Administration solution), the solutions are administered to the patient using the AutoDose Infusion System following the Directions for Use.

AI/ML Overview

Here's an analysis of the provided text regarding the AutoDose™ Infusion System, focusing on acceptance criteria and the supporting study information:

Key Takeaways from the Document:

This submission is a 510(k) for substantial equivalence, meaning the device is being compared to an existing, legally marketed predicate device (itself, but with a new "for use with" claim). This type of submission often relies on demonstrating that the new use doesn't introduce new safety or effectiveness concerns, rather than comprehensive standalone clinical trials or AI performance evaluations.
The document describes a physical medical device (an infusion system) and its accessories, not an AI/software as a medical device (SaMD). Therefore, many of the typical AI-specific criteria (like expert consensus, adjudication, MRMC studies, training set details) are not applicable to this document.
The performance criteria are related to the physical function of the infusion system, device compatibility, and solution stability.

Acceptance Criteria and Study Information for the AutoDose™ Infusion System

Given that this is a 510(k) for an infusion system and not an AI/software device, the request for AI-specific metrics (such as MRMC, standalone algorithm performance, number of experts, etc.) is not directly applicable. However, I will interpret the request in the context of the provided document by extracting the performance criteria and how the device met them.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion / Benchmark	Reported Device Performance
Solution Compatibility & Stability	Solutions (0.9% NaCl, Heparin Lock Flush) meet USP 24/NF 19 monographs requirements over storage periods and conditions when filled in AutoDose Bag/Restrictor Set.	Confirmed solutions meet all requirements over storage periods and conditions.
Solution Infusion Rate & Pressure	Consistent infusion rates and predetermined volumes. Infusion pressures no greater than 25 psi.	Verified consistent delivery in predetermined order and volumes, and generated infusion pressures no greater than 25 psi.
Biocompatibility	Fluid-contact materials (AutoDose Bag, Restrictor Set) are biocompatible.	Demonstrated biocompatible.
Hazards Analysis	No new or increased risk factors identified with Sodium Chloride and Heparin solutions.	Confirmed; compatibility and stability of solutions verified.

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

Sample Size: Not explicitly stated as a numerical 'sample size' in the context of rigorous clinical trials. The document refers to "tests were performed" and "performance testing...verified." For a physical device like this, testing typically involves multiple units or cycles to demonstrate reliability and meet specifications. Specific numbers of units tested or cycles run are not provided.
Data Provenance: Not applicable in the context of human data. The testing was performed on the device itself and the solutions in question (0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP). The "data" are results from physical and chemical tests.

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

Not Applicable. This is a physical device, and "ground truth" as it applies to expert interpretation of medical images or patient data (which is relevant for AI devices) does not apply here. The "ground truth" is established through engineering and chemistry standards (e.g., USP monographs, pressure gauges, flow rate measurements).

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/software device, there is no expert adjudication process for image interpretation or clinical decision-making. Performance is determined by direct physical measurement and chemical analysis against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is designed to evaluate how human readers' diagnostic performance changes with and without AI assistance. This concept is not applicable to a physical IV infusion system.

6. Standalone (Algorithm Only) Performance

Not Applicable. This device is hardware for infusion. There is no standalone "algorithm" in the sense of an AI model to evaluate without human-in-the-loop performance. Its "performance" is its physical ability to infuse fluids correctly.

7. Type of Ground Truth Used

The "ground truth" for the performance claims in this document is based on:
- USP 24/NF 19 monographs: For demonstrating compatibility and stability of the solutions.
- Engineering specifications/measurements: For infusion flow rates, predetermined volumes, and pressures (e.g., pressure not exceeding 25 psi).
- Biocompatibility testing standards: For confirming material safety in contact with fluids.

8. Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI model requiring a "training set" of data. Device development and testing follow engineering design and validation processes, not machine learning training.

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

Not Applicable. As there is no training set for an AI model, this question is not relevant to the provided information.

Summary

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Image /page/0/Picture/1 description: The image shows handwritten text. The top line reads "K993832". The bottom line reads "1 cf 3" with each character underlined.

9 2000 FEB

SECTION 15: SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR807.92

15.1 SUBMITTER INFORMATION

Company Name: Tandem Medical, Inc. a. 15910 Bernardo Center Dr. b. Company Address: Company Phone: (858) 673-3900 C. Company Facsimile (858) 673-3566 d. Contact Person: Albert Misajon Director, Regulatory Affairs And Quality Assurance Date Summary Prepared: November 10, 1999 e. DEVICE IDENTIFICATION 15.2 AutoDose™ Infusion System - For Trade/Proprietary Name: a.
- Classification Name: b.

AutoDose Infusion System

For use with
S.A.S.H.

Infusion Pump 21 CFR 880.5725

IDENTIFICATION OF PREDICATE DEVICES 15.3

Company	Device	510(k) No.	Date Cleared
TandemMedicalInc.	AutoDose™ Infusion System	K990889	June 3, 1999

15.4 DEVICE DESCRIPTION

Chamber	Volume
1	$\leq$ 10 mls.
2	$\sim$ 25 – 120 mls
3	$\leq$ 10 mls.

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4 < 5 mls.

A Pharmacist may decide to use the AutoDose Infusion System with an AutoDose Bag filled with 0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP in conjunction with an Administration IV fluid. (Refer to figure 1). In this configuration, the AutoDose would deliver the IV fluids using the deliver regimen, commonly known as SASH: (Saline, Administration, Saline, Heparin) and eliminate the need to use needles, syringes and access the IVAD (Intravenous Access Device) multiple times.

When the Pharmacist chooses to use the AutoDose Infusion system in this manner, an empty AutoDose Bag is filled with Saline and Heparin solutions drawn and prepared from the Pharmacy stores. After the prescription is filled with the main medication (i.e. Administration solution), the solutions are administered to the patient using the AutoDose Infusion System following the Directions for Use.

ાર્ટે રે SUBSTANTIAL EQUIVALENCE

The AutoDose Infusion System used with 0.9% Sodium Chloride Injection and Heparin Lock Flush, USP solution is substantially equivalent to the original AutoDose Infusion System.

1. There is no change in the device Indications for Use, that is, the general use infusion of intravenous solutions.
1. There is no difference in the design of the unfilled AutoDose Bag and Restrictor Set. The design of the AutoDose Pump is unchanged. The materials used in the AutoDose Infusion System are unchanged.
1. The performance of the AutoDose Infusion System is the same in terms of infusion flow rates and pressures. The affect on the performance of the system due to the viscosity of either Sodium Chloride or Heparin solutions is insignificant. The compatibility and stability of the system with the two solutions have been verified.

15.6 INTENDED USE

The AutoDose™ Infusion System is intended for general use infusion of predetermined volumes of intravenous solutions.

15.7 PERFORMANCE

1. Device and Solution Compatibility and Stability The AutoDose™ Infusion System was tested to verify that both 0.9% Sodium Chloride, Injection and Heparin Lock Flush Solutions, USP are both compatible and stable. The AutoDose Bag and AutoDose Restrictor Set were

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filled with these solutions and tests were performed on the solutions per the applicable USP 24/NF 19 monographs. The results confirmed that the solutions meet all requirements over the storage periods and conditions.

1. Solution Infusion
  The AutoDose System infuses IV fluids at consistent rates and pressures. Performance testing of the AutoDose Infusion System verified that the Saline and Heparin fluids would be consistently delivered in predetermined order and volumes, and generated infusion pressures no greater than 25 psi.

SAFETY

1. Biocompatibility
  Safety testing performed on the AutoDose Bag and AutoDose Restrictor Set materials in fluid contact demonstrate they are biocompatible.

HAZARDS ANALYSIS

A Product Hazards Analysis was performed on the AutoDose Infusion System used with Sodium Chloride and Heparin solutions. The compatibility and stability of the solutions were tested and verified. No new or increased risk factors were identified.

S.A.S.H. is a widely used and accepted IV solution administration practice, especially in the intermittent administration of IV solutions using IVADs (Intravenous Access Devices). The solutions, Sodium Chloride and Heparin, proposed for use with the AutoDose Infusion System have previously been cleared for this purpose by FDA review. The performance testing of the AutoDose Infusion System verified safe consistent infusion times and pressures.

Therefore the use of the AutoDose Infusion System with 0.9% Sodium Chloride, Injection and Heparin Lock Flush Solutions, USP is deemed safe and effective based on the information presented.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 symbol resembling a bird or abstract human figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2000 FEB

Mr. Albert Misajon Director, Requlatory Affairs and Quality Assurance Tandem Medical, Incorporated 15910 Bernardo Center Drive San Diego, California 92127

Re: K993832 Trade Name: AutoDose™ Infusion System Requlatory Class: II Product Code: MEB Dated: November 120, 1999 November 12, 1999 Received:

Dear Mr. Misajon:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Misajon

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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,

Timothy A. Ulatowski

thy A. Ulatowski Timo 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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INDICATION FOR USE

510(k) Number:	K993832
Device Name:	AutoDose TM Infusion System - For Use With S.A.S.H.
Indications for Use:	The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions.

(PLEASE DO NOT WRITE BELOW TILIS LINE - CONTINUE ON ANOTHER PAGF. II: NEUDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrice Cuscente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use V

— ————— —

Over-The-Counter Use

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).