The ambIT™ Infusion Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.

Device Description

Sorenson Medical's amblT™ Continuous Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for continuous fluid delivery to specified output requirements

AI/ML Overview

This document is a 510(k) premarket notification for the ambIT™ Continuous Infusion Pump. It focuses on demonstrating substantial equivalence to a predicate device (Palm Pump, K002434) rather than a comprehensive de novo validation study. Therefore, much of the information typically present in a study proving a device meets acceptance criteria (like specific acceptance criteria values, detailed study designs, expert involvement, and ground truth methodologies) is not explicitly provided in the provided text.

However, based on the information available, here's a breakdown of what can be inferred and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed with specific numerical targets in the provided text. Instead, the general requirement is that the device "met documented performance and safety requirements specified for the new device" and that "the design modifications made to the subject device met documented performance and safety requirements."

The reported device performance is that the modifications were "fully validated" and "do not raise issues of safety and effectiveness." The core performance claim is "continuous volumetric delivery... at a consistent volume for prescriptive treatment by a physician," which is the intended use shared with the predicate.

Acceptance Criteria (Inferred from text)	Reported Device Performance
Adherence to documented performance and safety requirements for the new device.	"All tests were conducted according to written test protocol, with defined test expectations and documented conclusions. All test data has been attached to the verification and validation testing performed and is a permanent record of Sorenson Medical's Design History Record."
Continuous volumetric delivery of intravenous medicines and/or fluids.	Confirmed implicitly by the device's intended use and the statement that it "provide[s] for continuous fluid delivery to specified output requirements."
Consistency of fluid delivery.	Confirmed implicitly by the device's intended use and the statement that it "provide[s] for continuous fluid delivery to specified output requirements."
No new issues of safety and effectiveness compared to the predicate device.	"The technological differences between the subject and predicate devices are minor, have been fully validated and they do not raise issues of safety and effectiveness."

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

The document states, "All tests were conducted according to written test protocol, with defined test expectations and documented conclusions." However, no specific sample sizes for the test sets are provided.

Given that it's a 510(k) for an infusion pump, the "tests" would likely involve laboratory-based performance testing (e.g., flow rate accuracy, occlusion detection, battery life) rather than clinical data from human patients. Therefore, the concept of "country of origin of the data" and "retrospective or prospective" as typically applied to clinical studies involving patient data is not directly applicable here. The data would be generated in a controlled laboratory environment by Sorenson Medical.

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

This information is not provided in the document. For a product like an infusion pump, "ground truth" for performance testing is typically established by engineering specifications and objective measurements using calibrated equipment, not by human expert assessment in the way it would be for diagnostic imaging.

4. Adjudication Method for the Test Set

This information is not provided and is generally not relevant for device performance testing of this nature. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving subjective interpretations (e.g., image reading), to resolve discrepancies between multiple human reviewers.

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

No MRMC comparative effectiveness study was done. This device is an infusion pump, not a diagnostic AI system that would involve human readers interpreting output. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

This question is not applicable in the context of an infusion pump. While the device has a "microcomputer-controlled" system and "software revision," it is a standalone medical device that operates autonomously to infuse fluids, not an "algorithm" in the sense of a diagnostic or assistive AI that would be evaluated for human-in-the-loop vs. standalone performance. The device itself is the "standalone" entity.

7. The Type of Ground Truth Used

The ground truth for the verification and validation tests would have been engineering specifications and measurable performance parameters (e.g., flow rate accuracy, pressure limits, alarm triggers, battery life). These are objective, quantifiable criteria established during the device's design and development, rather than subjective expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not provided and is not directly applicable in the traditional sense of a "training set" for machine learning with large datasets. While the software was revised, it's not described as an AI/ML model being "trained" on data. Any "training" would refer to the internal development and testing cycles of the software and hardware, where parameters are tuned and verified against expected outputs, using internal test data or simulations, rather than a distinct "training set" used for an algorithm.

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

As above, the concept of a "training set" and associated ground truth is not applicable in the context of this device in the same way it would be for an AI/ML product. The ground truth for the device's design, software development, and functional verification would have been established through engineering specifications, design requirements, and standard testing methodologies to ensure the device performs according to its intended function (e.g., precise fluid delivery).

Summary

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K03325

Special 510(k) - ambIT™ Continuous Infusion Pump

Submitted by:

NOV = 6 2003

Douglas Bueschel Director Regulatory Affairs and Quality Assurance Sorenson Medical, Inc. 1375 West 8040 South West Jordan, Utah 84088-1888

Name/Classification of the Device:

Infusion Pump/Class II, 80FRN - 21 CFR 880.5725

Trade Names:

ambIT™ Continuous Ambulatory Infusion Pump, or ambIT™ Pump

Predicate Device:

Palm Pump, #K002434 cleared on August 23, 2000. This predicate device is manufactured by Sorenson Medical, Inc.

Statement of Intended Use:

The ambIT™ Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.

Device Description:

Summary of Technological Characteristics of New Device to Predicate Device:

The technological features of the amblT™ Pump are identical to the predicate Palm Pump except for the deletion of several software capabilities required for continuous pumping action and the addition of one additional roller gear in the disposable sterile infusion cassette. Case color has also changed from a light green to "cool grey." The subject and predicate devices are similar in design, labeling and manufacturing and share the identical materials and components. The subject and predicate devices are the same in intended use. The technological differences between the subject and predicate devices are minor, have been fully validated and they do not raise issues of safety and effectiveness.

Sorenson Confidential

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Discussion of Non-Clinical Tests; Conclusions Drawn from Non-Clinical Tests:

The requirements and results of documented verification and validation testing were defined and were conducted according to Sorenson Medical guality system requirements to verify that the design modifications made to the subject device met documented performance and safety requirements specified for the new device. All tests were conducted according to written test protocol, with defined test expectations and documented conclusions. All test data has been attached to the verification and validation testing performed and is a permanent record of Sorenson Medical's Design History Record.

Labels and Labeling:

Labels and labeling, including the User's Manual are similar to the predicate Palm Pump and meet all FDA and E.U. requirements for a medical device product.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three lines that resemble an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 6 2003

Sorenson Medical Incorporated Mr. Douglas Bueschel Director Regulatory Affairs and Quality Assurance 1375 West 8040 South West Jordan, Utah 84088-8320

Re: K033325

Trade/Device Name: AmbIT™ Continuous Ambulatory Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 15, 2003 Received: October 20, 2003

Dear Mr. Bueschel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Bueschel

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Suse Runoxf

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) - ambIT™ Continuous Infusion Pump

510(k) Number (if known):	K033325
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Device Name: ambIT™ Continuous Infusion Pump

Indications for Use:

The ambIT™ Infusion Pump is intended for continuous volumetric delivery of intravenous medicines and/or fluids into patients at a consistent volume for prescriptive treatment by a physician.

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

Concurrence OF CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use

(Optional Format 1-2-96)

Patricio Cucurete

ivision Sign-Off Seneral Hospital, sion of Anesthesiology, Infection Control, Dental D

510(k) Number: KD53325

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).