The ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.

Device Description

Sorenson Medical's amblT™ Intermittent 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 intermittent fluid delivery to specified output requirements.

AI/ML Overview

The provided text describes a 510(k) submission for the ambIT™ Intermittent Ambulatory Infusion Pump. It focuses on demonstrating substantial equivalence to a predicate device and details non-clinical tests conducted to verify its performance and safety. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies (MRMC) with human readers.

Here's a breakdown of what can be extracted and what is missing:

Information Extracted from the Document:

Study Type: Non-clinical verification and validation testing.
Ground Truth for the Test Set: "Documented performance and safety requirements specified for the new device." These requirements form the ground truth against which the device's performance was compared.
Sample Size for the Training Set: Not applicable, as this is pre-market non-clinical testing, not an AI/ML device training.
How the ground truth for the training set was established: Not applicable for the same reason.

Missing Information (and why it's missing based on the document):

Table of acceptance criteria and the reported device performance: The document states that "requirements and results of documented verification and validation testing were defined and were conducted," but it does not provide the actual acceptance criteria or the specific performance results in a table format. It only states that the device "met documented performance and safety requirements."
Sample size used for the test set and the data provenance: The document mentions "All tests were conducted according to written test protocol," but it does not specify the sample size (e.g., number of devices tested, number of hours of operation, number of cycles). Data provenance (country of origin, retrospective/prospective) is also not applicable as these are non-clinical hardware/software tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. The "ground truth" here refers to pre-defined engineering and safety specifications for the pump's performance rather than expert-labeled data.
Adjudication method for the test set: Not applicable. Tests were against engineering specifications, not expert consensus requiring adjudication.
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: Not applicable. This device is an infusion pump, which does not involve human "readers" or AI assistance in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "non-clinical tests" conducted on the device, which inherently means standalone performance testing against pre-defined specifications. The entire submission focuses on the device's inherent performance characteristics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): As mentioned, the ground truth was "documented performance and safety requirements specified for the new device" (i.e., engineering and functional specifications for proper fluid delivery).

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence for an infusion pump through standard engineering verification and validation testing. It is not an AI/ML-driven diagnostic device, which is why much of the requested information (like expert input, MRMC studies, training sets, etc.) is not present or applicable. The document confirms that non-clinical tests were performed and that the device "met" its specified performance and safety requirements, but the specific details of these criteria and results are not included in this summary.

Summary

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K033425

Special 510(k) - ambITTM Intermittent Infusion Pump

NOV - 6 2003

510(k) Summary

Submitted by:

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™ Intermittent Ambulatory Infusion Pump, or amblT™ 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 amblT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.

Device Description:

Summary of Technological Characteristics of New Device to Predicate Device:

The technological features of the ambIT™ Intermittent Ambulatory Infusion Pump are identical to the predicate Palm Pump except for the deletion of several software capabilities required for intermittent pumping action, a modified PCB and the addition of one additional roller qear in the disposable sterile infusion cassette. Case color has also changed from a blue to a cool grev. The subiect 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 and they do not raise issues of safety and effectiveness.

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Sorenson Medical, Inc.

Sorenson Confidential

Page 32 of 35

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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 quality 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned within a circular border. Encircling the bird and within the border is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

NOV - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K033425

Trade/Device Name: AmbIT ™ Intermittent Ambulatory Infusion Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 15, 2003 Received: October 27, 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 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,

Suze Runne

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

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Special 510(k) - ambIT™ Intermittent Infusion Pump

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ambIT™ Intermittent Ambulatory Infusion Pump

Indications for Use:

The ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at predetermined rates and volumes 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)

Patricia Cucente

General Hospital,

510(k) Number: K053425

Sorenson Confidential

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).